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Session Overview
01. Posters
Time: Monday, 14/Nov/2011: 8:45am - 6:00pm


Literature Review of Gender and Drugs in Eastern Mediterranean Region Index Medicus

yomna mohamed Abd el-fatah, yomna tarek Abo-shadi

faculty of pharmacy,Alexandria university, Egypt

Problem statement: In recent years, concerted efforts have been taken by international and regional health organizations to promote women’s health and emphasize gender-related issues. One of the important concerns is shortage of scientific studies on areas related to women's health. This study was carried out to review the research studies available in the database of Index Medicus for the WHO Eastern Mediterranean Region (IMEMR).

Objectives: To search the IMEMR on available studies on women and drugs, and encourage academic institutions to carry out scientific studies on important issues related to women and health.

Design: This study was carried out by searching the IMEMR using key words relevant to women and medicine. IMEMR provides free access to the prestigious health and biomedical sciences literature published in the eastern Mediterranean Region. It contains more than 107,500 citations of peer-reviewed health and biomedical literature published in 483 journals from the region’s 19 countries.

Results: A search of the IMEMR database using the key words women and drugs and gender and drugs resulted in 144 and 40 research articles, respectively. The main topics covered by these articles are (1) ovarian induction and related issues emphasizing that clomifene citrate may be correlated to increasing the risk of ovarian cancer; (2) pregnancy disorders and drugs indicating that irrational use of drugs and herbs can decrease pregnancy outcomes; (3) labour-related issues providing suggestions to manage complications related to cesarean section and anaesthesia; and (4) hormonal replacement therapy studying the effect of this therapy on bone mineral density and on insulin resistance in diabetic postmenopausal women. There were fewer reports found on the important topics of self-medication, contraceptives, mental health of women, dysmenorrhea, breast diseases, and suicide and self harm. When searching the database with key words related to women and different disease conditions, several articles were found related to women and cancer, women and infection, women and mental health, women and trauma, and women and sexual health. A few reports were also found related to women and musculoskeletal problems, sensory impairment, and psychosocial considerations of menopause.

Outcomes: A review report on research studies published in the Index Medicus concerning women and medicine in EMR countries.

Conclusion: IMEMR provides an important database for research studies on women health. The database search indicated that many topics are well studied while other important areas related to women and medicines need more attention and research by academic community in EMR.

Funding source: Information not provided

1090-Abd el-fatah-_a.pdf
1090-Abd el-fatah-_b.pptx

Restricting the Availability of Anti-TB Medicines in the Private Market of Eastern Mediterranean Region Countries: A Call for Policy Intervention

Mohamed Abdelhakim1, Khaled Khalil1, Zafar Mirza2, Nada Ramy3, Akihiro SEITA4, Mohamed Binshahna1, Mohamed Ismail1

1WHO/EMRO, Egypt; 2WHO, Geneva; 3London School of Hygiene and Tropical Medicine; 4UNRWA

Problem Statement: Tuberculosis (TB) medicines should be dispensed only under control or supervision (according to DOTS principles), yet very few countries in the Eastern Mediterranean Region (EMR) have seriously considered the subject or issued any regulatory/legislative intervention to limit the presence of these medicines in the private market.

Objectives: Collecting evidence on the availability of TB medicines in the private market in EMR countries and mapping current legislative arrangements of countries from the region in relation to regulating the availability and dispensing of TB medicines.

Design: Questionnaires were sent to National Medicines Regulatory Authorities, requesting (1) A list of all registered TB medicines in the country (registered—got market authorization not necessarily circulating in the market); (2) whether there was exisiting legislation on selling these medicines in the private market (pharmacies/other licensed vendors). If so, we asked for a copy of the legislation, law, or provision on that issue. In addition, managers at Ministries of Health (MOH) and National Tuberculosis Programme (NTP) managers were interviewed by phone. In addition, data from field visits to 140 private pharmacies in14 of the 22 EMR countries were used from during the regular WHO/ Global Drug Facility travel missions.

Setting: The study was conducted in the 22 WHO EMR countries.

Intervention: One pilot intervention

Policy: No policy intervention took place yet, as the synthesis of the study is still on going

Outcome Measures: (1) Number of responses from countries; (2) number of laws and legal provisions received from countries; and (3) lists of anti-TB medicines registered in countries.

Results: Among the 22 EMR countries, 8 of them (36%) did not respond; in the remaining 14 countries (64%), the results were anti-TB medicines were present in all pharmacies visited for the survey in 9 (64%) of them. The type of medicines present varied between rifampicin, isoniazid, pyrazinamide, and ethambutol and their combination of different strengths and dosage forms. Prescribing anti-TB medicines was usually targeted towards treating TB and not other conditions requiring antibacterials. Over-the-counter dispensing of these medicines by pharmacists is practiced but not frequently. The level of education about anti-TB medicines is generally low.

Conclusions: There is an indispensable need to have a policy intervention on the issue of anti TB medicines availability in private market. Among the suggested recommendations are (1) facilitate further systematic operational research to be executed by the governments to provide evidence for a proper regulatory intervention; (2) mobilize policy makers for a favorable decision on deregistration of medicines that are present in the market and not complying with the global clinical and WHO recommendations; and (3) limiting the presence of anti-TB medicines to primary health care clinics in rural areas and primary health care hospitals in urban areas.

Funding Source: Global Drug Facility


Medicines Use in Oman: Public Knowledge, Attitudes, and Practices

Ahmed Abdo-Rabbo, Manal Al-ansari, Brian Conroy Gunn, Batool Jaffer Suleiman

Directorate of Rational Use of Medicines, Ministry of Health, Sultanate of Oman, Oman

Problem statement: Public knowledge, attitudes, and practices (KAP) influence the use of medicines in the community. The Oman National Medicines Policy (NMP) as formulated in 2000 contains guidelines for rational use of medicines (RUM) by both health care providers and the public. Investigations of medicines in the community and public education have not been allocated the necessary human and financial resources.

Objectives: Identify common medicine use problems in the community to improve the appropriate use of medicines

Methods: A cross-sectional, pilot-tested questionnaire was administered to patients or their accompanying caretakers at the patient exit of 75 primary health care centres from all 10 health regions in Oman. A total of 6,675 Omani respondents participated in the study.

Results: 66% of the respondents visited multiple facilities on the same date for the same complaint and 51% failed to go for follow up to the same facility; 39% did not accept non-medicine-therapy and 30% preferred prescriptions of 3 or more medicines per visit. Many failed to ask how or when to take the medicines and where to store them and to mention any current therapies they were taking. A total of 70% stopped taking their medicines when symptoms disappeared; 26% were unaware that most medicines have sideeffects and 61% did not realise that injections are the riskiest dosage form. A total of 54% had definite colour or taste preferences; 43% practised self-medication and 68% never consulted the dispenser when self-medicated; 36% choose medicines based on previous experience, and 33% exchanged medicines with others; 55% stored all their medicines in a fridge and 17% do not check the expiry date; 45% threw unused medicines away; 41% kept them for future use and only 12% returned them to a public pharmacy or health care facility.

Conclusion: There is a widespread lack of public knowledge about the appropriate use of medicines in Oman. This is compounded by certain attitudes and beliefs, which can contribute to health risks and unnecessary expenditures. Many of these results could be improved by a well-targeted, public education campaign. Also, changes in practices of health care professionals, especially doctors, nurses, and pharmacists, are expected.

Funding sources: Directorate of Rational Use of Medicines, Ministry of Health, Oman


Consultation and Dispensing Time at Primary Health Care Facilities in Oman

Ahmed Abdo-Rabbo, Manal Al-ansari, Brian Conroy Gunn, Batool Jaffer Suleiman, Hawraa Al-Lawati

Directorate of Rational Use of Medicines, Ministry of Health, Sultanate of Oman, Oman

Background: In Oman, the public primary health care (PHC) facilities are located in both urban and rural areas. Access to secondary and tertiary facilities cannot be acquired easily without referral from PHC or emergency services.

Problem statement: Information on medicine use regarding patient care by health care providers in Oman is lacking. However, it is essential for strategic planning. The time that prescribers and dispensers spend with each patient, as well as the accessibility of medicines, sets important limits on the potential quality of patient care and therefore should be adequate.

Objectives: Evaluate some of the outpatient care practices provided to patients by health providers in PHC facilities

Methods: A prospective cross-sectional survey was conducted in 44 PHC facilities from all health regions of Oman. The health facilities were selected by stratified random sampling including urban and rural areas. The study was restricted to a sample of general medical visits representing a mix of health problems, ages, and sex. The WHO/INRUD patient care indicators were used. The consultation time (CT) is the time that medical personnel spends with patients for the purpose of consultation and prescribing. The dispensing time is the time that dispensers spend with patients in the dispensing process. Direct observation of the consultation and dispensing times for 100 patients per facility was measured. Also, 100 prescriptions per facility were used for the analysis of the percentage of medicines actually dispensed. The data was collected during the patients’ visits that took place on the days of the investigators’ surveys.

Results: The overall mean consultation and dispensing times were 5.69 min (range: 2.00 – 12.90) and 102.23 sec (range: 30.2 – 351.60), respectively. The percentage of medicines actually dispensed was 99.09% (range: 95.04 – 100%). The CT and DT were longer when paper prescriptions were used than with electronic prescribing. The larger the number of average daily OPD visits, the shorter the mean CT and DT. Also, the larger the average number of medicines per prescription dispensed, the longer the mean DT.

Conclusion: Almost all medicines prescribed were dispensed. Like many other countries in the region, consultation and dispensing times in Oman are short and insufficient for active patient care. Qualitative studies are necessary to evaluate the different factors involved and to plan interventions. Continuing education, monitoring, and supervision would be beneficial.

Funding sources: Directorate of Rational Use of Medicines, Ministry of Health, Oman


Self Medication in a Kerala District, India - Prevalence and Analysis

Habeeb Ibrahim Abdul Razack1, Jegan RS2

1Accenture Services Pvt Ltd, India; 2Semlar Research, India

English philosopher-physician Sir William Osler (1849-1919) said, "One of the first duties of the physician is to educate the masses when not to take medicines".

Self medication is a positive change that provides a number of benefits to the individual as well as the society. But, it is also important to draw a line somewhere while choosing for a remedy appropriate for the condition.

The present work aimed to assess the prevalence of self-medication with analgesic and anti-pyretic drugs in Kollam district, Kerala and to identify the determination of self-medication. 100 families were selected, which contributed to a total sample population of 369 subjects. A structural and pre-tested questionnaire was used for collecting information from the participants.

The prevalence of self-medication with analgesic and anti-pyretic was found to be 41.7%, 95% CI, p<0.05. The prevalence was more among women (48.1%) than men (31.1%). Higher the educational status, higher was the prevalence (49.7%). Higher the socioeconomic status, higher was the prevalence (39.5%). Many (79%) was using these drugs for the treatment of fever, followed by headache (63.2%). Paracetamol was the choice of drug for the majority (93.2%) of the sample population. 68.0% were aware of the name of the drug. About 40% of those who were unaware of it identified the drug by its physical appearance. Previous prescription remained as the major source (37.5%) of self-medication. Only 27.5% obtained counseling from the concerned pharmacist. A majority of 51.0% of the subjects were advising their family member, friend and colleagues about the drugs to be administered in certain ailments.

World Self Medication Industry (WSMI) aims to convey the social and economic value of responsible self-medication to health professionals, health authorities, consumers and others. Better Patient-Pharmacist-Physician relationship can lead to responsible self-medication

The most common reasons for choosing to self-medicate among the southern parts of India were mainly could be: (1) Inability to afford physician's fees; (2) Relatives/Friends' advice/insistence to buy a particular medicine based on their experience; (3) Increased awareness of availability of medicines (especially among the higher class) and use for appropriate conditions through various advertisements. (4) Also the tendency to momentarily suppress the minor symptom/condition rather than wanting to go to the root cause of it because of hidden fears, cost factor, busy schedule etc.,

986-Abdul Razack-_a.pdf

Does Antimicrobial Use Granger-Cause Community-Based Antimicrobial Resistance?

Dele Olawale Abegunde, Kathleen Holloway, Elizabeth Mathai, Clive Ondari

World Health Organization Geneva, Switzerland

Problem statement: The autoregressive integrated moving average (ARIMA) has become the popular Box-Jenkins time series model for studying AM use and AMR, but they are limited in elucidating some analytical assumptions underlying the dynamic relationship between AMR and AM use. Establishing the causal relationship between use and resistance improves the validity of time-series estimates. We explore the vector autoregressive (VAR) model as an alternative to overcome potential biases in estimation results from ARIMA models. These biases are in part, the consequences of endogeneity or reverse causality between AM use and AMR.

Objectives: To determine and test for the presence Granger-causality between AM use and AMR; to demonstrate the presence endogeniety in the temporal relationship between AM use and AMR; and to demonstrate the application of VAR to overcome the problem of endogeneity

Design: Longitudinal, non-comparison time-series

Settings: We used data from Vellore and Mumbai study centers of the Indian component of a WHO multi-centre study on community AMR and AM use from India and South Africa.

Study population: Study isolated commensal E. coli from urine samples of pregnant women attending antenatal clinics in Vellore (N=2,026) and from stool samples of individuals (N=1,860) in Mumbai. Monthly AM-use data were obtained from exit interviews from hospitals or PHC clinics (including not-for-profit and for-profit hospitals in the urban area and public sector PHC clinics and a not-for-profit hospital in the rural areas); private sector pharmacies; and private sector general medical practitioners’ practices. 21,600 and 24,052 antibiotic-containing prescriptions were obtained from Vellore and Mumbai communities, respectively. Data were collected over a 24-month period.

Outcome measure(s): Monthly proportion of isolated E. coli resistant to co-trimoxazole, extended spectrum penicillin (ESP) and quinolones; monthly antibiotic use in defined daily doses (DDD) and proportion of patients prescribed antibiotics; presence of endogeneity; and positive Granger-causality

Results: Results of VAR suggests the presence of reverse causality between AMR and the two AM-use variables: monthly DDD per patient and monthly proportion of patient on specific antibiotics) or both. AM use did not Granger-cause AMR consistently across the three antibiotic classes and between the centers.

Conclusions: ARIMA time-series regression coefficients could be biased and inefficient if endogeneity is unaccounted for. Granger-causality tests are necessary to establish the dynamic temporal relationships between AM use and AMR and to eliminate risk of spurious time series-regression results. VAR models provide improved AM use/AMR time-series analysis tools. Results of this study have implications for the design of community AMR surveillance.

Funding source(s): WHO


In Scaling Up Health Related MDGs, How Much More Will It Cost to Procure Essential Medicines for 49 Low-Income Countries?

Dele Olawale Abegunde, Clive Ondari, Kathleen Holloway, Fatima Serhan, Barbara Milami, Gojka Roglic, Andreas Ullrich, Eva Mantzouranis, Shanthi Mendis

World Health Organization, Switzerland

Problem statement: Affordable access to essential medicines is crucial to achieving the health related Millennium Development Goals (MDGs). Financial requirement for providing access to medicines in the low- (and middle-) income countries has not been clearly estimated. Motivated by the need to accelerate the achievement of the MDGs, we have estimated the procurement (acquisition) cost of medicines for 49 low-income countries to achieve MDG 8 target 17.

Objectives: To estimate the cost of procuring essential medicines needed to achieve MDG 8 target 17 as part of estimations to scale up health related MDGs for 49 least developed countries.

Design: Longitudinal cohort model estimating (from 2009 to 2015) the cost of cardiovascular diseases, diabetes mellitus, asthma/COPD, cancers, mental disorders, parasitic infestations (Schistosomiasis), diseases of poor hygiene, gastrointestinal ulcers, and musculoskeletal illness (Buruli ulcer). The estimation model takes a normative view of the medicines required to treat the main diseases that cause the greatest health burden (morbidity and mortality) given feasible coverage, medicine acquisition costs, and possible wastages reflecting the typical health system scenarios. Modeling data were obtained from a number of WHO databases.

Setting: Estimations were aggregated for the 49 low-income countries adjudged least developed from Sub-Saharan Africa, East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, the Middle East and North Africa, and South Asia.

Study population: Aggregated population at risk of the respective diseases in the 49 countries adjusted for access to care (population-based estimation)

Outcome measure(s): Accumulated and incremental number of treatment opportunities; annual and accumulated acquisition cost and per capita cost of medicines; cumulative incremental cost and acquisition cost per capita from 2008 base-year

Results: The procurement cost of medicines accumulates to $7.4 billion from 2009 to 2015, of which 65% ($4.7 billion) represents the incremental component. These are $0.73 and $0.47 per capita, respectively. These amounts will provide an accumulated 529 million full treatment courses and 257 million additional treatments over the 2008 coverage. Cardiovascular diseases and risk factors, mental health, cancers, and diseases of poor hygiene account for the largest proportion.

Conclusion: We conclude that given innovative financing mechanisms, providing access to essential medicines could be globally affordable and is essential to reaching health-related MDGs. Incremental acquisition costs of medicines per capita is only a fraction of a dollar; however, poor countries may benefit from concerted international arrangements to enhance access to needed medicines to achieve the MDGs.

Funding source(s): WHO


Universal Health Insurance Coverage and Reimbursement for Medicines in Countries

Dele Olawale Abegunde, Runo Onosode, Clive Ondari

World Health Organization, Switzerland

Background: To achieve the MDGs and optimal care, the WHO World Health Report 2010 emphasizes universal coverage for health care services including reimbursement for medicines in countries. In 2005, WHO member states committed to developing their health financing systems to improve access to care. The majority of the burden of diseases in low- to middle-income countries can be assuaged with access to appropriate medicines, yet in a limited number of countries where there are insurance systems in place, coverage for medicines can be limited in scale and scope. Given this background, this study attempts to map the extent of insurance coverage for medicines in countries.

Objectives: To evaluate and compare the extent of insurance coverage for medicines and health care especially in low- and middle-income countries

Design: Cross-sectional descriptive evaluation of countries according to World Bank income grouping; data obtained from reviews of published and grey literature including country reports

Settings: Includes all 193 UN member countries and the types of health insurance cover

Study population: Estimates of coverage for health and medicines were denominated by countries and regional (aggregated) population.

Outcome measure(s): Number and proportion of countries with some forms of health insurance and medicines coverage; population coverage and types of health insurance schemes by countries and income group

Results: Universal health coverage has been achieved in only 65 (35%) UN member states, the majority (78%) of which are in the high-income group. Partial coverage has been achieved in about 86 (45%) of the 193 countries. Although almost all the population (93% population coverage) are covered in a form of health insurance in the high-income countries, only a relatively merger 14% coverage is achieved for the population in low-income countries. Medicines are covered for reimbursement in 46 of the 47 (92%) high-income countries. Although 35 of the 46 upper middle-income counties (76%) and 31 of the 54 (57%) of the upper middle- and lower middle-income countries, respectively, have established a form of health insurance, fewer (27 of 46 [27%] and 31 of 54 [35%]) have medicines benefits in their insurance system. These results indicate the existing global inequalities in access to health care services. Community-based insurance schemes are more common and increasing in the lower-income countries compared to social and private health insurance schemes which are present in higher- income countries.

Conclusions: Although community health insurance is growing in low- and middle-income countries, the majority of countries and populations have no access to health insurance compared to high-income countries. Coverage for medicines remains much more limited relative to coverage for health. Providing optimal health care and achieving MDGs in low- and middle-income countries could be doubtful without concerted global efforts.

Funding source: Information not provided


Parents’ and Caretakers’ Administration Practices and Formulation Preferences of Children’s Medicine in Tanzania

Lisa Virginia Adams1, Sienna R. Craig2, Elia John Mmbaga3, Helga Naburi3, Rodrick Kisenge3, Stephen P. Spielberg4,5

1Dartmouth Medical School, United States of America; 2Dartmouth College; 3Muhimbili University of Health and Allied Sciences; 4Institute for Pediatric Innovation; 5Mercy Children’s Hospital

Problem statement: The lack of medicines formulated for children contributes to the high mortality rate of children under age five. There are no data describing the current administration practices and formulation preferences for children’s medicines from parents and caretakers in resource-limited settings. Information on current practices and preferences can be used to guide new formulation development to ensure access, proper dosing, improved adherence, and optimal therapeutic outcomes.

Objectives: To determine parents’ and caretakers’ current administration practices of children’s medicines and their preferences for formulation, taste, and method of administration

Design: A descriptive cross-sectional survey using a validated questionnaire

Setting: Ten randomly selected regions throughout Tanzania, with one urban and one rural census enumerated area per region based on National Bureau of Statistics data

Study population: A sample totaling 202 parents or caretakers with children under age 12, randomly selected from households and outpatient health care facilities

Intervention: A validated questionnaire was administered by trained interviewers during the period March 15 through July 6, 2010.

Outcome measure(s): Current and preferred methods of administration of children’s medicines and preferred formulations and taste

Results: Parents and caretakers report administering medicines to their children by having them swallow pills whole (48, 24%) or having them swallow crushed or broken tablets mixed with water (59, 34%). Parents and caretakers report having administered a range of pill fractions to their children. In contrast to this information, the majority of parents and caretakers (155, 80%) reported that they prefer sweet-tasting medicines for children, with far fewer preferring no taste (13, 7%), deferring to the child’s preferences (9, 4.5%), and preferring bitter tasting medicines (2, 1%). Formulations preferred included syrups (172, 85%), suppositories (73, 36%), chewable tablets (64, 32%), and pills (24, 12%). Preferred methods of administration of children’s medicines vary by age group. Most preferred to administer syrups to newborns (178, 96%), infants (177, 93%), and toddlers (147, 76%), but to crush and dissolve a pill for preschoolers (93, 48%). Swallowing a whole pill was the preferred method for primary school-age children (165, 85%). Practices and preferences did not vary between urban and rural settings.

Conclusion: Parents and caretakers in Tanzania prefer sweet liquids for younger children and swallowing whole pills for primary school aged children. Parents and caretakers are unfamiliar with dispersible tablets.

Funding source(s): Better Medicines for Children, World Health Organization


Availability and Rational Use of Essential Drugs in the PHC Facilities in Bangladesh: Are We on the Right Track?

Syed Masud Ahmed, Shafayetul Islam

Research and Evaluation Division, BRAC, Bangladesh

Problem statement: A baseline survey done in 1994 by WHO at public sector primary health care (PHC) facilities in rural Bangladesh found that the availability and use of essential drugs were low, and irrational use and over-prescribing were common. Evidence shows that the situation has deteriorated over the years.

Objectives: This study aimed to explore to what degree the outcome objectives of the National Drug Policy of 1982 in terms of availability, affordability, and rational use of essential drugs have been achieved from a representative sample of public and private sector PHC facilities in rural and urban areas of Bangladesh.

Design: This study was designed as a facility-based cross-sectional study that can be easily implemented by individuals without special training or access to many resources.

Setting: The study covered a representative sample of Upazila (subdistrict) health complexes (UHCs) (n=30) and drug shops (n=30) in the rural areas plus a sample of urban clinics (UCs) (n=20) in the capital and used observations, exit interviews, and mini-market surveys to collect relevant data.

Study population: From each facility, 30 patients attending outpatient departments for curative services during typical working days were selected through systematic random sampling.

Outcome measures: WHO core indicators (prescribing, patient care, facility) to investigate drug use in health facilities

Results: Average consulting (120 seconds) and dispensing (60 seconds) time in the UHCs appeared to have increased marginally from 1994 levels. Drugs dispensed out of the total prescribed was higher in the UHCs (76%) compared to UCs (44%). Dispensed drugs were not labeled properly, though an improvement in knowledge of correct dosage was observed (from 57% in 1994 to 73% in the UHCs). Polypharmacy was on rise from 5% in 1994 to 33%; in the UHCs and in case of drug shops and urban clinics, polypharmacy was even more prevalent (46–61%). An essential drugs list (EDL) was available in only 55% UCs and 47% UHCs with only two-thirds of the drugs being prescribed from it. Availability of key essential drugs for common illnesses was poor, varying from 6% in the UHCs to 15% in the UCs. Polypharmacy was on rise (from 5% in 1994 to 33% in the UHCs), and on an average 2.2 drugs were prescribed per encounter in the UHCs compared to 1.4 drugs in 1994. In 44% of the encounters in the UHCs and UCs and in 60% in the drug shops, an antibiotic was prescribed. Interestingly, antibiotics were prescribed more frequently for fever (36–40%) and the common cold (26–34%) than for ARI and pneumonia (10–20%). Only 47% of the UHCs and 55% of the UCs had a copy of the EDL. Deterioration was observed in the availability of essential drugs for treatment of common illnesses. Prices of key essential drugs differed by brands, sometimes as high as 500%.

Conclusions: There has been deterioration in the availability and rational use of drugs since 1994 baseline survey and over the 27 years between the 1982 passage of the much acclaimed National Drug Policy in Bangladesh and this study.

Funding source(s): Swedish International Development Agency


Extension of market exclusivity and its impact on the accessibility to essential medicines, and drug expense in Thailand: Analysis of the effect of TRIPs-Plus proposal

Chutima Akaleephan1, Suwit Wibulpolprasert2, Rungpetch Sakulbumrungsil3, Paithip Luangruangrong4, Anchalee Jitraknathee5, Achara Aeksaengsri6, Siripa Udomaksorn7, Viroj Tangcharoensathien1, Sripen Tantivess1

1International Health Policy Program-Thailand, Thailand; 2Ministry of Public Health, Thailand; 3Faculty of Pharmaceutical Sciences, Chulalongkorn University, Thailand; 4Drug and Medical Supply Information Center, Ministry of Public Health, Thailand; 5Drug Control Division, Food and Drug Administration, Ministry of Public Health, Thailand; 6Research and Development Institute, Government Pharmaceutical Organisation, Thailand; 7Faculty of Pharmaceutical Sciences, Prince of Songkla University, Thailand

Background: In Thailand and the US negotiating FTA, the ‘TRIPs-Plus’ is one of the US proposal which would result in an extension of market exclusivity of innovative drugs. In addition, it would foreseeably lead to high and unaffordable medicine prices and inaccessibility to essential medicines.

Objective: To quantify the impact on medicine expense and medicine accessibility.

Methods: Based on 2000 to 2003 Thai Food and Drug Administration (FDA)’s and the Drug & Medical Supply Information Center (DMSIC), costs and accessibility were estimated upon the price and quantity costing between innovative medicines and their generics plus some parameters found from their competitive behaviour. Thereafter, we simulated the 10-year potential additional expense on the 2003 unit price of the patented and monopolized non-patented medicines.

Results: In 2003, the availability of generics helped to save 104.5% of actual expense and the accessibility would increase by 53.6%. By extension of market exclusivity, given that there were 60 new items approved annually, the cumulative potential expense was projected to be $US 6.2 million for the first year to $US 5215.8 million in tenth year.

Conclusion: The TRIPs-Plus proposal would result in a significant increase in the medicine expense; and a delay in the increase in medicines accessibility via generics. Several options as well as other related mechanisms to help reduce the negative impact are proposed.


Pattern of Medicine Use Among In-Patients in a Tertiary Health Care Setting Using the WHO Prescribing Indicators

Ehizokhale Peter Akhideno, Ambrose O Isah

Clinical Pharmacology and Therapeutics Unit, Department Of Medicine, University of Benin Teaching Hospital, Nigeria

Problem statement: Irrational use of medicines exemplified by polypharmacy, overuse of injections and antimicrobials have resulted in increased morbidity, mortality and cost burden for patients. This is especially more so in developing countries where in-patient medicines use are poorly characterized. This study evaluates the use of medicines amongst in-patients in a tertiary health care setting using the WHO drug use indicators.

Objectives: To outline the pattern of use of medications using the WHO prescribing indicators among in-patients in a tertiary health care setting with a view to attain a rational and safer pharmacotherapy for in-patients.

Design: A descriptive prospective study of patients admitted into the adult medical wards of a tertiary health care setting in Nigeria.

Setting: This study was conducted at the University of Benin Teaching Hospital, a 620-bed tertiary health care setting.

Study population: All patients admitted into the adult medical wards over a period of 9 months, numbering 507 were included in the study. Males were 269 and females 238. The mean age of participants was 48.9±17.8 years ranging from 17- 89 years.

Policies: The WHO indicator was designed for out-patient encounters. Some studies including this, have modified the indicators for use in in-patient setting. Admitted patients were evaluated on days 0, (day of admission), 1, 3, 7, 10, 14 and weekly thereafter and at discharge. All medicines prescribed for patients were noted. Doses, frequency, and route of administration were recorded.

Outcome measures: The WHO drug use indicator values.

Results: The average number of medicines used per patient for the period of admission was 9.1±3.8 (median 8); The number of drugs rose from 4.2 on admission to 8.3 on day 28, reducing to 6.3 on discharge. The percentage of medicines prescribed from essential medicines list was 88.1% while the percentage of medicines prescribed by generic name was 85.6%. The total percentage of admissions with injectables prescribed was 89.3%. This decreased from 75.1% on admission day to 48.7% on discharge, while the total percentage of admissions with antimicrobials prescribed was 61.9%, rising from 41.2% on admission to 68.4% on day 28, reducing at discharge to 49.3%. The percentage of admissions with antimalarials prescribed was 18.9%.

Conclusion: The WHO indicators would serve usefully perhaps with some modification in the study of drug use among in-patients. The rates of prescriptions of medicines on the EM list and use of generic names were fairly high, however the WHO recommendation is 100% leaving room for improvement. The rates of use of antimicrobials and injectables were high, suggesting overuse among in-patients. There is however a need to develop standard values for the basis of comparison as in-patients and out-patients differ in profile and severity of illness.

Funding source: Private (personal)


Data Disclosure: An Ongoing Process Towards Transparency

Abeer Ahmad Al Rabayah

The Jordanian Pharmaceutical Manufacturing Company, Jordan

Problem statement: Lacking a systematic process to collect pharmaceutical data on a regular basis in the Jordanian pharmaceutical sector minimizes the opportunity of of evidence-based decision making regarding pharmaceutical policy issues which leads to an inefficient system.

It is important to collect data in order to set the countries’ priorities based on what the pharmaceutical sector needs to improve access for Jordanian citizens. Establishing a culture of more applied research that leads to useful intervention that can be used locally to improve the efficiency and effectiveness of the sector should be a priority in any reform in the future. On the other hand, the public domain in Jordan is still not aware of the availability of data regarding the medicines supply chain, and more effort is needed to create awareness among the public and the different stakeholders; also the communication channels between different stakeholders (public, private, CSOs) are still limited and each sector is moving forward without knowing the needs and capabilities of the others that might be of mutual benefit for all of them.

Research design: One of the most important areas of the Medicines Transparency Alliance is the baseline assessment’s 3 components, which are the tools that MeTA is using in all countries to generate data and help the national councils in setting their priorities in an evidence-based way. The MeTA data disclosure survey is a descriptive, qualitative survey that used secondary data sources and conducted meetings and in-depth interviews to assess the data disclosure status in the Jordanian pharmaceutical sector. It was also an opportunity for the council member to understand each other perspectives.

Results: The data disclosure process helped the MeTA Council in highlighting some challenges that they have to work jointly to overcome such as limited contribution from CSO members, limited access to some data (requirement of fees), and engaging the private sector in disclosing data. Data disclosure should lead to more transparency and accountability about the pharmaceutical supply chain.

Conclusions: One of the most important impacts of the data disclosure survey in Jordan is that the council found that more work should be devoted to their organizations’ websites in terms of accessibility and awareness. The data disclosure report highlighted some gaps regarding publicly available data and created a debate for discussion between stakeholders (public, private, CSO). This debate can be considered as an ongoing exercise to assess the pharmaceutical data disclosure status on a regular basis in order for MeTA Jordan to track changes, improvements or drawbacks in data disclosure.

References: The Medicines Transparency Alliance Council in Jordan, Data Disclosure Survey Report, final version, 2010; http://www.medicinestransparency.org/meta-countries/jordan/

Funding sources: Information not provided

1064-Al Rabayah-_a.pdf
1064-Al Rabayah-_b.ppt

Unit Dose System – Implementation in a Secondary, Multispecialty Referral Hospital: Sohar Hospital, Ministry of Health, Sultanate of Oman

Mona Mohammed Ali Al shizawi

Sohar Hospital, Oman

Problem statement: The ward stock system of drug supply could not ensure prompt supply of medications to patients nor appropriate utilization; in addition, medication monitoring was inadequate.

Objective: The objective of the project was to ensure the 5 rights of drug delivery. To achieve this objective, it was decided to supply medication for each admitted patient in the ward based on their 24-hour requirement from an inpatient pharmacy.

Introduction: The ward stock system of drug supply was being practiced at Sohar Hospital from the time it opened in 1997 (408 beds). To ensure proper supply of medications and that the ministry guidelines regarding drug use were being implemented, the hospital decided to implement the unit dose system (UDS) of drug supply in 2008. During the first phase, only the general wards were included in the scheme. Critical areas were to be included in the next phase.

Settings: The first phase of the system has been implemented in 8 general wards. The specialties included medical, surgical, pediatrics, and gynecology. The total number of beds covered is 280.

Intervention: Utilize the services of a pharmacist before the prescribed medication is administered to the patient.

Methods: A UDS was set up comprised of 5 pharmacists and 12 assistant pharmacists. An area was set apart for setting up the unit. Trolleys with removable labeled cassettes to contain medicaments of individual patients were procured. The pharmacy works around the clock all days of the week. During rounds, physicians entered prescriptions in the patients’ files in the computer system. These authorized prescriptions received online in the inpatient pharmacy. After rounds, the nursing staff sent the trolleys with the labeled cassettes to the pharmacy.The pharmacist checks the prescriptions in the system and then prints the labels for the medications. The labels contain the name of patient, hospital number, sex, bed number, drug name, strength, dose, and frequency. The labels are then attached to the medication envelopes or bottles.

Policy: To replace the current ward stock system with UDS

Outcome: Better availability of medications to patients and meeting the 5 rights of drug delivery

Results: The system was appreciated by doctors and nurses. Regular supplies of prescribed medications were made available to all patients. Prescription errors were reduced and ministry policies regarding prescriptions were also closely adhered. There was a reduction in the consumption pattern of antibiotics and other medications. All the relevant data required for evaluating the intervention was obtained from the computer system as all patient records in the hospital are computerized.

Conclusion: Implementation of UDS increased the availability of medications to patients, reduced prescription errors, improved policy compliance, and reduced overall consumption of medicaments in the wards.

Funding source: MOH–Sultanate of Oman

563-Al shizawi-_a.pdf

Quality of Dispensing in Outpatient Pharmacy at Sultan Qaboos University Hospital: Peer Review Audit

Issa Sulaiman Al-Rashdi, Aqeela Taqi, Amna Al-Hashar, Manal Hatrushi, Ibrahim Al-Zakwani

SQU, Oman

Problem statement: The major activity of the outpatient (OP) pharmacy is dispensing prescriptions from different outpatient specialists’ clinics and discharge prescriptions from inpatient wards. Around 500 prescriptions are dispensed each day. The approved dispensing process is a stepwise work flow that incorporates best practices. It starts from receiving a prescription, validating and authorizing (station A), assembly of items (station B), and finally dispensing it to the right patient (station C).

Aim and objectives: The aim of this peer review audit is to assess the rate of adherence to the approved dispensing guideline at the OP pharmacy. The objectives include identifying dispensing and processing failures, recognizing staff abilities, and fixing the gaps to improve the quality of dispensing and processing prescriptions after the audit.

Setting: Sultan Qaboos University (SQU) hospital, pharmacy department, Oman

Methods: 120 prescriptions were audited by an independent auditor who was a staff member of a different pharmacy section (medicine information) over a period of 1 week; these prescriptions were processed by around 20 staff, each being allocated to the different dispensing processes or stations. A standard was set on the consensus of the senior pharmacist and an approved dispensing process (adopted from JCI standards) for each processing and dispensing step, against which the actual practice was compared. Data were collected from hard copies of prescriptions and from the computer system (TrakCare®) by filling a data collection form and analyzed using SPSS–12.

Outcome measure: Rate of adherence to the stated guidelines measured and the dispensing process at OP pharmacy evaluated

Results: The overall adherence to the approved dispensing process was 88%, while the overall set standard was 96%. Results showed that most non-adherences were at station B (74.5%) and that the most adherences were at station C (97%). Moreover, receiving and query stations also showed the highest adherence at 100%.

Conclusion and recommendations: This audit had enabled us to evaluate the dispensing process at the OP pharmacy. A follow-up audit is planned after giving feedback to individual staff members on their specific performance. Continuous awareness was always considered and a thorough education about station B for new staff and trainees was implemented.

Funding source: None


Analysis of Clinical Pharmacists’ Interventions on Discharged Patients’ Prescription in a Tertiary Care Teaching Hospital in Oman

Nasra Khalfan Al-Sharji1, Maryam Zahran Al-Kindi2, Badriya Ali Al-Zadjali2

1Dubai Pharmacy College, Dubai, UAE; 2Sultan Qaboos University hospital, Muscat, Sultanate of Oman

Problem statement: Clinical pharmacists in Sultan Qaboos University Hospital (SQUH) have developed a form to document their interventions and measure the clinical significance of their service. In addition, discharge patients’ prescriptions are reviewed by the clinical pharmacists before dispensing to the patients to make sure medications are appropriate.

Objectives: (1) To analyze clinical pharmacists’ interventions on discharged patients’ prescriptions and determine classification, type, and clinical relevance; (2) to find out the reasons for delay in reviewing the prescriptions if the review took more than 10 minutes

Methods: This was a three-week study (April 2010) conducted at SQUH, a 500-bed tertiary care teaching hospital in Muscat, Oman. Clinical pharmacists used a standard manual intervention documentation form. The form classified the interventions into five groups, namely; medicine choice, medicine regimen, monitoring, information, and prescribing issues. A peer review consisted of four clinical pharmacists who analyzed the clinical and cost significance and graded the clinical significance of each intervention.

Results: A total of 462 prescriptions were reviewed. Seventy-two prescriptions (15.5%) had interventions. The total number of interventions was 118 (mean = 1.6 interventions/prescription). The age of the patients ranged between 2 weeks and 85 years with mean age of 26 years. Most of the interventions were performed on prescriptions from general pediatrics (47%). The top medicine class with the highest number of interventions was antimicrobials (16%). Dose change (n = 37; 31%), addition of a medicine (n = 20; 17%), and frequency change (n = 15; 13%) were the most frequent interventions performed. Efficacy was improved and toxicity risk was reduced in 44% and 30% of the interventions, respectively. Death, major permanent injury, or organ damage was avoided in 0.8% of the cases whereas interventions of major significance were recorded in 30% of the interventions. On average, each prescription took 50 minutes to resolve the interventions, ranging from 3 minutes to 2 hours. Forty-seven prescriptions (65%) took more than 10 minutes from the start of the review to the time it was delivered to the outpatient pharmacist. The most common reason for delay was that the prescriber did not respond straight away to the pager (n = 28; 59%).

Conclusion: The above data show that there is a major problem with prescribing for discharged patients, especially in general pediatrics, and most of the interventions were for medicine doses. On some occasions, review of the prescriptions by the clinical pharmacist took more than 10 minutes because the prescribing physician did not immediately repond, which could be related to the communication system in the hospital. The clinical pharmacists play a significant role in medicine safety and efficacy and as part of health care team; they are reliable source of information on medicine-related issues.

Funding source: Self-funded


Caution! Look Alike, Sound Alike Medication

Badriya Ali Al-Zadjali, Samiya Al-Ajmi, Khalid Al-Siyabi, Shahida Rauf, Khalid Al-Zadjali

Sultan Qaboos University Hospital, Muscat, Oman

Problem statement: Look alike, sound alike (LASA) medications are medications with generic or proprietary names that look alike (appearance and name) or sound like (pronunciation) other medication names leading to avoidable mix-ups. It also includes medications that have similar packaging, but are different. With tens of thousands of medicines currently on the market, the potential for error due to LASA is significant. Every year, Food and Drug Administration reviews approximately 400 brand names for drugs before they are marketed. Approximately 33% of these drug names are rejected. Sometimes names are changed after marketing. Sultan Qaboos University Hospital (SQUH) is a 500-bed tertiary care teaching hospital in Muscat, Sultanate of Oman. There are more than 1000 medications included in the hospital formulary. Medications are purchased from different companies from all over the world.

Objectives: To share the experience of SQUH in dealing with medication errors due to LASA medication names/ packages

Methods: The hospital formulary was reviewed by four pharmacists and LASA medication names were identified. In addition, all similar medication packages were identified and separated from the others.

Results: There were a total of 38 pairs of confusing names and 99 medications with similar packaging identified in the hospital formulary. Examples of LASA medication names include Budesonide/Buserelin, Tamoxifen/Tenoxicam, and Azithromycin/Azathioprin. A “red alert” sticker was developed to be placed on LASA medications and shelves, and similar medication packages were placed on different shelves.

Conclusion: The existence of LASA medications is one of the most common causes of medication errors and is of concern worldwide. SQUH has implemented some strategies, including use of tall man lettering, double checking medications before dispensing, routine audits of medications storage areas, etc. Educational posters for pharmacy staff and other health care providers were developed and placed in pharmacies and all wards and units to improve staff awareness.

Funding source: Self-funded


Cost Impact of Purchasing Pharmaceuticals Jointly in the Public Health Sector in Jordan

Ibrahim Ali Alabbadi

University of Jordan, Jordan

Problem statement: The pharmaceutical sector in Jordan is considered a high priority to be examined by the government because it represents almost 35% of health spending. Double purchase is still considered a major problem that has led to higher spending and poor availability of medicines. The Joint Procurement Directorate (JPD) was established in Jordan in 2004, and the first joint tender was issued in 2007.

Objective: To investigate the cost impact of purchasing medicines jointly by the JPD

Methods: Medicine lists of purchased quantities and their tender-winning prices were obtained for 2006 and 2007. Defined daily dose (DDD) was used for comparing the costs of purchased drugs in 2006 and 2007 by converting actually purchased quantities into DDDs for each dosage form for each product for 2006 and 2007. Having DDDs for all dosage forms, estimated cost savings were calculated for each product assuming that same quantities purchased by each participating party in 2006 will be purchased through the JPD in 2007.

Results: Estimated savings achieved were 5.2%, which could increased to 17% after excluding one item that had had an unusual raw material price increase due to an international shortage.

Conclusions: Purchasing pharmaceuticals through JPD is recommended to reduce spending and improve availability.

Funding source(s): No information provided


One-Year Assessment of Joint Pharmaceutical Procurement in the Jordanian Public Health Sector

Ibrahim Ali Alabbadi, Abdelraouf Qawwas, Mahmoud Jaafreh, Taher Abosamen, Maisa Saket

University of Jordan, Jordan

Problem statement: Jordan is one of the fastest growing and modernizing countries in the Middle East. Small in size with a total population of 6 million, it is classified as a lower middle income country. The GDP growth rate in Jordan increased from 3.3% in 2002 to 7.6% in 2006. About 10% of the Jordanian GDP is spent on health, and almost one-third of this amount is spent on pharmaceuticals. The public health sector in Jordan has four main governmental parties that that purchase medicines independently. Double purchasing is still considered a major problem that has led to increased spending on drugs and poor availability of medicines. The Joint Procurement Directorate (JPD) was established in Jordan in 2004, and the first tender was issued in 2007 accounting for 15% of the annual pharmaceutical tender.

Objectives: To assess the first year of purchasing of pharmaceuticals in the public health sector in Jordan through JPD for the four participating parties compared with their independent purchasing before

Methods: A research committee was constituted. The committee revised the lists of purchased quantities of pharmaceuticals and obtained their tender-winning prices for 2006 (from each participating party) and for 2007 (from JPD). A quantity comparison method was used to compare the costs of purchased drugs in 2006 and 2007, and estimated cost savings were calculated for each product for each party for 2006 and 2007, assuming that the same quantities purchased by each participating party in 2006 would be purchased through the JPD (prices of 2007).

Results: The estimated savings achieved were 2.4%, which could increase to 8.9 % after excluding one item in which its raw material prices were increased markedly in 2007 than in 2006 due to an international shortage.

Conclusions: Applying a joint procurement system for pharmaceuticals in the Jordan public health sector has good potential to reduce waste and decrease the negative impact of double purchasing.

Funding source(s): No information provided


Improvements in Access to Malaria Treatment in Tanzania Following Community, Retail Sector and Health Facility Interventions—A User Perspective

Sandra Alba1,2, Angel Dillip3, Iddy Mayumana3, Christopher Mshana3, Ahmed Makemba3, Mathew Alexander3, Brigit Obrist1,2, Alexander Schulze4, Christian Lengeler1,2

1Swiss Tropical and Public Health Institute, Switzerland; 2University of Basel, Switzerland; 3Ifakara Health Institute, Tanzania; 4Novartis Foundation for Sustainable Development, Switzerland

Problem statement: Many African countries have introduced new, highly efficacious artemisinin-based combination therapies (ACTs) for the treatment of malaria thanks to international donor funding. The public health impact of such drugs, however, relies on the patient’s ability to access them, and little progress will be made unless broader access issues are considered.

Objectives: The ACCESS programme aims to understand and improve access to malaria treatment in a rural Tanzanian setting. Treatment-seeking surveys were conducted in 2004, 2006, and 2008 to evaluate the programme’s impact on treatment.

Design: An evaluation study based on before-and-after comparisons with no control group

Setting: The programme was implemented in the Kilombero and Ulanga districts in south-central Tanzania. Treatment-seeking surveys were conducted in the community.

Study population: For every survey, a random sample of 150 recent fever cases (i.e., within previous 2 weeks) was selected from the local demographic surveillance site, which covers both districts (~80,000 people).

Intervention(s): At the community level, the programme conducted a social marketing campaign for improved recognition of the disease and more effective care seeking (2004 to 2007). The campaign consisted of road shows, promotional materials, billboards, and posters. Interventions in the public health sector included strengthening of routine supervision and a refresher training based on Integrated Management of Childhood Illness (IMCI) algorithms (2004 to 2005). In parallel, the Accredited Drug Dispensing Outlets (ADDOs) programme was rolled out in the area in 2006 to improve access to quality treatment in the private retail sector.

Policies: In 2006 the Government of Tanzania switched from sulfadoxine-pyrimethamine (SP) to artemether-lumefantrine (AL) as first-line treatment for malaria. Subsidised AL was introduced in all public health facilities in January 2007 and made available to all ADDOs in July 2007.

Outcome measure(s): The primary outcome measure is the proportion of children under 5 with fever in the past 2 weeks who took a recommended antimalarial within 24 hours of onset of fever

Results: The proportion of children treated with an antimalarial within 24 hours increased from 66% (95% CI: 58% to 73%) to 89% (84% to 94%) between 2004 and 2008. Only 51% (42% to 60%), however, were treated according to the new treatment guidelines in 2008 because AL was not widely available in ADDOs

Conclusions: An integrated approach aimed at improving understanding and treatment of malaria has led to improvements in treatment outcomes. This testifies that even in a rural African setting, the Abuja targets can be achieved. A higher impact was hindered by the low availability of AL in the private retail sector.

Funding source(s): The ACCESS programme is funded by the Novartis Foundation for Sustainable Development.


Consumer behavior toward counterfeit drugs: scale development in a developing country setting

Abubakr Abdelraouf Alfadl1, Mohamed Izham Ibrahim2, Mohamed Azmi Hassali1

1Universiti Sains Malaysia, Malaysia; 2Qassim University, Saudi Arabia, Universiti Sains Malaysia, Malaysia

Introduction: Counterfeiting of medicines in developing countries has been reported as a distressing issue. Moreover, although desperate need and drug counterfeiting are linked, no much study has been carried out to cover this area, and there is a lack of proper tool and methodology.

Objective: The objective of this research is to develop a valid and reliable scale based on the currently accepted scale development paradigm to operationalize the main construct.

Design, Study Settings and Population: This is a quantitative survey conducted in Sudan through two rounds; pilot (n = 100), and final survey (n = 1003). Sampling approach was based on the availability of participants.

Results: The raw data were analyzed using SPSS version 16. Internal consistency was examined and improved. Cronbach’s alpha improved from 0.818 to 0.862. Finally, convergent and discriminant validity was demonstrated.

Conclusion: To the authors’ knowledge, this is the first work attempt to conceptualize and operationalize consumer behavior toward counterfeit drugs. High reliability and demonstration of convergent and discriminant validity indicated that the “Consumer Behavior toward Counterfeit Drugs Scale” is a valid, reliable scale existing within a solid theoretical base. Ultimately, the study offer public health policy makers and marketing manager a valid measurement tool to build a better understanding of the demand side of counterfeit drugs and hence aids in developing more effective strategies to combat the problem.

Keywords: Counterfeit drug, Consumer, Behavior, Scale

Funding Sources: Federal Ministry of Health – Sudan


Magnitude of and Contributing Factors to Antibacterial Resistance in Ethiopia

TENAW Andualem T.1, Negussu Mekonnen2, Gabriel Daniel3, Mohan P. Joshi3, Douglas Keene3, David Lee3

1MSH/SPS, INRUD Ethiopia; 2MSH/SPS Ethiopia; 3MSH/SPS USA

Problem statement: Bacterial infections are major causes of morbidity and mortality in humans and loss of production in animals. Antimicrobial resistance (AMR) results from use, overuse, and misuse of antibiotics in humans and animals.

Objective: To show the magnitude of AMR and contributing factors in Ethiopia

Design: (1) Review of 2004–08 census of culture and antibacterial sensitivity records, health professionals’ course contents on AMR containment, (2) cross-sectional survey of AMR containment practices in 73 public health facilities, and practices of random samples of 675 health practitioners using interviews and semi-structured observations; (3) analysis of systematic samples of 100 records per health facility and records to assess antibacterials prescribing from surgical and medical wards and outpatient prescriptions in 2006–07; and (4) exit interviews with 1,761 patients to understand their knowledge on the medicines dispensed and perceptions of antibacterial use.

Setting: The study was conducted in public hospitals and health centers sampled from nine regional states and two city administrations in Ethiopia in August 2008.

Study population: Culture and antibacterial sensitivity records across the country over five years, surgical and medical inpatient and outpatient prescriptions records from 2006–07, and all adult patients who were prescribed and dispensed antibacterial in August 2008 from 73 public health facilities

Outcome measure(s): Microorganism growth and sensitivity percentages for antibacterials and percentages of health facilities, practitioners, and patients related to knowledge and practice of AMR containment

Results: Out of 52,682 culture and antibiotic sensitivity records, 35.1% showed growth with varying levels of resistance. For example, Escherichia coli samples were resistant to amoxicillin (70%), tetracycline (75%), and penicillin G (88%); 18.3% of Staphylococcus aureus samples were resistant to vancomycin. Availability of key antibacterials, infection prevention materials, and standard treatment guidelines in health facilities were 73.0%, 82.9%, and 61.0%, respectively. Antibacterials prophylaxis was prescribed for 75.9% of surgical procedures, and antibacterials were prescribed to 70.6% of medical inpatients. Provider adherence to treatment guidelines for pneumonia was 19.6%. Patients’ knowledge about dispensed antibacterials was 82%, whereas 40.2% and 36.3% knew that antibacterials are not used for watery diarrhea and the common cold, respectively.

Conclusions: A high level of microorganisms is resistant to antibacterials in Ethiopia. Contributing factors include poor knowledge and practices among practitioners and patients, health facilities’ limited emphasis on preventing and containing AMR, and poor adherence to standard treatment guidelines. These factors require multifaceted interventions that can create synergy to prevent and contain AMR and to promote appropriate use.

Funding source(s): Drug Administration and Control Authority of Ethiopia and U.S. Agency for International Development through MSH/SPS

309-Andualem T.-_a.pdf

Generic Medicine Pricing Policies Evaluation in Indonesia and the Impact on Availability and Medicine Price in Private Sectors

Yusi Anggriani1, Mohamed Izham Mohamed Ibrahim2, Sri Suryawati3, Martuti S Budiharto4, Asrul Akmal Shafie5

1Faculty of Pharmacy Pancasila University, Indonesia, School Of Pharmaceutical Science, University Sains Malaysia, Penang, Malaysia; 2Department of Pharmacy Practice, College of Pharmacy, Qassim University, Al Qassim, Saudi Arabia; 3Center for Clinical Pharmacology and Medicine Policy Studies, Gadjah Mada University, Yogyakarta, Indonesia; 4National Institute Of Health Research and Development, Ministry of Health, Jakarta, Indonesia; 5School Of Pharmaceutical Science, University Sains Malaysia, Penang, Malaysia

Problem statement: The government of Indonesia has given a political commitment to the provision of affordable medicines. Pricing policies on generic medicines that have been implemented by MoH need to be evaluated.

Objectives: To evaluate generic medicines price policies and the impact on the price and availability of selected medicines in private sectors

Design: Policy evaluation, cross-sectional study

Setting: Survey was conducted in 52 private pharmacies from 4 provinces in Indonesia.

Study population: Five generic medicine price policies from the period 2005–10 and 50 medicines (14 global, 15 regional, and 21 supplementary) were evaluated.

Policies: Medicine price policy in Indonesia set maximum prices for generic medicine for procurement and retail. Public sectors procurement price must comply with the policy. Retail price of private sector cannot be more than maximum price.

Outcome measure(s): Number of items in price policy, trend of MoH generic medicine price, comparison of generic medicines price at private pharmacies with MoH maximum price, MPRs of latest MoH procurement price, MPRs and availability of generic medicine in private sectors. The 2009 International Reference Price (IRP) was used to compare MoH procurement price and retail price.

Results: Only 42 generic medicines price were evaluated; 8 global and regional medicines were not on the MoH list. 153 medicines were regulated in 2005 price policy. From 2006 to 2010, items on the policy nearly tripled over the number on the 2005 list. There were 387, 458, 455, and 453 items in 2006, 2006, 2008, and 2010, respectively. The trend of generic medicine prices showed that the highest medicine prices were in 2005. After the 2006 policies were enacted, most generic medicine prices decreased significantly from 2005 MoH prices. The changes in prices in 2006 were based on HAI and WHO survey recommendations in Indonesia on 2005. Two years after prices decreased, a new price policy was implemented in 2008. When comparing 2006 and 2008 MoH prices, 32 items did not change, 6 items increased, and 4 items decreased. When comparing current (2010) policy with 2008 price, 33 items did not change, 6 items decreased, 3 items increased. Of 42 items, only 36 items were calculated for MPRs, 6 items were not in IRP 2009. 25 items’ MPRs of MoH procurement price were >IRP, and 9 items MoH procurement price were <IRP. Most of medicine prices in the private sector were more than the MoH maximum price; only 2 items had MPRs <IRP and 34 items had MPRs >IRP. The availability of 42 medicines was very low for 11 items (26.2%), low for 5 items (11,9%), fairly high for 15 items (35,7%), and high for 11 items (26,2%).

Conclusions: MoH generic medicine prices 2005–10 tend to decrease. MPRs of MoH procurement prices were higher than IRP 2009. Most of retail prices in the private sector exceeded MoH maximum price. At private sector facilities, generic medicine prices in Indonesia are still expensive, and availability is still a problem.

Funding source(s): Self-funded


Assessing Local Manufacturing Capacity for Child-Specific Dosage Formulations: The Case of Ghana

Edith Asaabah Annan1, Martha Gyansa- Lutterodt2, Kwesi Poku Boateng3, Brian Adu Asare2, Augustina Koduah2

1World Health Organization, Ghana; 2Ministry of Health; 3Indepedent Consultant

Problem statement: Reducing child mortality is a global priority expressed in the Millennium Development Goals. Interventions to achieve these goalsinclude the availability of essential medicines for children. In Ghana, infant and under-five mortality rates are estimated at 50 and 80, respectively. Most of these deaths are caused by childhood diseases such as malaria, pneumonia, – diarrhea and neonatal sepsis, which could be averted by the use of safe paediatric formulations of medicines. An assessment was, therefore, undertaken under the Better Medicines for Children’s Project to determine the technical capacity of some local pharmaceutical manufacturers to produce a selected list of paediatric dosage formulations.

Objectives: To conduct a situation analysis of the domestic production of medicines made specifically for children

Design: Cross-sectional study using qualitative methods.

Setting: The study was conducted at the national level and was based on local manufacturers’ institutions, which were all privately owned.

Study population: The study identified a convenient sample of 22 out of 34 local manufacturers across the country from a database of the Pharmaceutical Manufacturers Association of Ghana. Informed consent was sought from the local manufacturers to be part of the study.

Intervention(s): Data were collected through visits to the selected pharmaceutical manufacturers for key informant interviews. A standardized questionnaire was used to collect background information on the manufacturer, manufacturing and starting materials, and the potential for the manufacturer to produce additional paediatric dosage forms as per a list of target medicines to be used for children.

Outcome measure(s): A mapping of domestic manufacturers in Ghana producing a target list of 26 paediatric medicines

Results: The local manufacturer in Ghana was found to have the capacity to produce medicines containing 20 out of the 26 active pharmaceutical ingredients on the list of dosage forms targeted. It was found that only 27% of the target medicines are produced locally in the required dosage form and strength.

Conclusions: Local manufacturing facilities in Ghana have the capacity to produce medicines in most of the therapeutic categories of the target paediatric medicines. If the potential to produce a majority of the target medicines locally is to be realized, then constraints with regards to equipment, regulatory and international cGMP, low investment in research and development, limited capacity to produce some paediatric dosage forms, and procurement of raw materials from reliable sources need to be addressed.

Funding source(s): Bill and Melinda Gates Foundation


Household Access to and Use of Medicines in Ghana

Daniel Kojo ARHINFUL1, Edith Andrews Annan2, Martha Gyansa-Lutterodt3, Anthony Kusi1, Augustina Koduah3

1Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; 2WHO Country Office, Accra, Ghana; 3Ghana National Drugs Programme, Ministry of Health, Accra, Ghana

Problem statement: As part of the first Five-Year Medium Term Strategic Framework (1997–2001) for health development, starting in 1997, Ghana implemented a set of interventions in the pharmaceutical sector to improve access to essential medicines and their rational use. This field study to measure access to and use of medicines in households was undertaken in May–June 2008.

Objectives: The main goal of the survey was to document access to and use of medicines in the population and across socioeconomic levels.

Design: A population-based survey using the standardized methodology developed by the World Health Organization (WHO) and the proposed Medicines Transparency Alliance (MeTA) sampling approach for Level II facility and household surveys.

Setting: It was conducted in six of the ten regions of Ghana systematically selected to represent varied socioeconomic profile and agro-ecological zones based on a combination of purposive and random sampling.

Study population: In each survey region, households were systematically chosen by purposive cluster sampling according to their distance from a reference facility: a third of sampled households were within 5 km, a third between 5 and 10 km, and a third farther than 10 km from the reference facility. A total of 1,065 household respondents were interviewed by means of a structured paper questionnaire and data entry was performed with EpiData software and analysis with Excel.

Outcome measure(s): The primary outcomes assessed information on socioeconomic level of households, access to and use of medicines for acute and chronic conditions, and opinions and perceptions about medicines including geographic access, affordability, and quality of medicines.

Results: The results show that geographical access to health facilities by households was high. The majority (80%) were close (less than 15 minutes travel time) to a health care facility, and have easy access to medicines in case of acute illness and for chronic diseases. The penetration of medicines insurance coverage in Ghana was fairly high (46% and 47% of households for acute and chronic conditions respectively). About a third of household respondents, however, believe that medicines are not affordable with the majority of them being in the lowest socio-economic status (SES) group (spending less than GhC16 (US$10) per person per month). Some 53% of households had medicines at home suggesting good access to medicines. Two monotherapies, chloroquine and quinine together, accounted for 1 in 4 of antimalarials kept at home.

Conclusions: Results of the survey show that while access to medicines in Ghana is fairly good, their appropriate use by households leaves much to be desired. To ensure appropriate and rational use, therefore, there is need to step up consumer education through providers and other community structures.

Funding source(s): Financial support was provided by the European Union and the World Health Organization (WHO) country office, Accra.


Health Facility Pharmaceutical Situation Assessment in Ghana

Daniel Kojo ARHINFUL1, Edith Andrews Annan2, Martha Gyansa-Lutterodt3, Augustina Koduah3, Anthony Kusi1

1Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana; 2WHO Country Office, Accra, Ghana; 3Ghana National Drugs Programme, Ministry of Health, Accra, Ghana

Problem statement: Periodic monitoring, evaluating, and assessing country pharmaceutical status is important in determining existing capacity to measure if people have access to essential medicines that are safe, efficacious, of good quality, and used appropriately. This survey was carried out in May–June 2008 to assess the situation at health facility level.

Objectives: Provide systematic data on access to medicines availability, affordability, geographical accessibility, quality, and rational use, among other issues.

Methods: An indicator-based approach using the standardized World Health Organization (WHO) methodology was used to assess country pharmaceutical situations and the proposed MeTA sampling approach through a facility-based survey.

Setting: Nationwide survey conducted in six of the ten administrative regions of Ghana. Public, mission, private heath care facilities, regional medical stores, and private pharmacies were surveyed.

Study population: In each region, 6 public heath care facilities, 6 private not-for-profit and private for profit health care facilities,12 private pharmaceutical retail outlets, and the regional medical stores were targeted. Altogether, 36 public, 19 mission/NGO, and 17 private health facilities; 68 private medicines outlets and 6 warehouses; and 4,061 outpatients/records were studied, of which the majority (57.12%) were female.

Outcome measure(s): Measures included availability of key medicines, average stock-out duration in public health facility dispensaries, and warehouses; drug prices and affordability in the public sector outlets and private sector outlets, and geographical accessibility to public health dispensaries and private drug outlets.

Results: Just about one in ten patients took more than one hour to reach a public dispensing facility; but all clients took less than an hour to reach private pharmacies. The key essential medicines selected for the country were to a greater extent available in public health facilities (80%) and mission health facilities (98%), but slightly less available at private pharmacies (73.3%). In the public sector, the procurement agency is purchasing medicines at 1.50 times higher than international reference prices. Final patient prices for generic medicines in the public sector were about 3.48 times their international reference prices. Public sector patient prices for generic medicines were 139.6% more than those for public procurement. Quite a high level of injection use (13.3%) and excessive levels of antibiotic (43.3%) prescribing were observed.

Conclusions and recommendations: The results of the survey show that access components such as pricing, affordability, and rational medicines use should be improved. The strategies should include price regulation backed by an effective enforcement and sustained rational drug use education.

Funding source(s):Financial support was provided by European Union and WHO country office, Accra.


Tackling Medicine Related Issues Affecting the National Health Insurance Scheme in Ghana

Daniel Kojo ARHINFUL1, Alexander Dodoo2, Daniel Ankrah3, Edith Andrews Annan4, Brian Asare5, David Ofori-Adjei1

1Noguchi Memorial Institute for Medical Research, University of Ghana, Ghana; 2Centre for Tropical Clinical Pharmacol.& Therapeutics, University of Ghana Medical School, Korle-Bu Teaching Hospital, Accra, Ghana; 3Pharmacy Department, Korle Bu Teaching Hospital, Accra, Ghana; 4WHO Country Office, Accra, Ghana; 5Ghana National Drugs Programme, Ministry of Health, Accra, Ghana

Problem statement: Ghana is one of seven pilot countries implementing the Medicines Transparency Alliance (MeTA) to make information available to the public on the quality, availability, pricing and promotion of medicines. MeTA seeks to provide an opportunity to develop a transparent and accountable pricing and quality monitoring mechanism to inform the National Health Insurance Scheme (NHIS) through systematic data analysis, and thereby provide decision support for management for the financial sustainability of the scheme.

Objectives: The main aim is to assess medicine prices, availability, and quality to inform and provide regular decision support for the programme and management activities of the NHIA and other relevant stakeholders.

Design: Periodic data extraction and analysis of the NHIS electronic data system and validation survey through primary data collection using the standardized methodology of World Health Organization (WHO) Level II Facility Survey and tracer medicines list developed with the NHIA.

Setting: Both electronic database and validation surveys utilize the proposed MeTA sampling approach and involve selected schemes and regions in the country. The pilot validation survey reported here was a two-stage facility-based survey conducted in four of Ghana’s ten regions.

Study population: At stage one, three regions were selected from the three ecological zones of Ghana. In each region, six public heath care facilities, two mission facilities, and one private facilitywere was selected and studied per survey area. All facilities were NHIS accredited. At the second stage, 10 private health facilities were selected in two regions and studied.

Outcome measure(s): Included availability of key medicines, drug prices and affordability, and rational use.

Results: The availability of key essential medicines selected for the country were higher in public health facilities (87.5%) than private facilities (83.3%). In the public sector, the procurement agency is purchasing medicines at 1.49 times higher than international reference prices compared to 1.67 in the private sector. Final patient prices for generic medicines in the public sector were 2.63 times higher the international reference prices and compared to 2.22 in the private sector. Quite a high level of injection use (10% and 18.3% for public and private, respectively) and antibiotic use (50% and 46.7% for public and private, respectively) are observed in both the public and private sectors.

Conclusions: Further analysis and comparison with data from the NHIA electronic platform is required to obtain a more in-depth understanding of the consequences of the findings.

Funding source: Financial support was provided by DfID with technical support from WHO


Pharmaceutical Regulation in 12 Countries

Paul Gamelie Ashigbie

Boston University School of Public Health, United States of America

Problem statement: To obtain data on pharmaceutical systems of its’ member states, the World Health Organization (WHO) in July 2010 conducted a pilot survey to develop model pharmaceutical profiles for 13 countries (Argentina, Armenia, Austria, China, Jordan, Kenya, Maldives, Nigeria, Pakistan, Sri Lanka, Sudan, Solomon Islands, and Suriname). We analyzed the pharmaceutical regulatory section of the survey on 12 out of the 13 study countries.

Study objective: To highlight the experiences of the pilot countries in medicine regulation and draw generic conclusions from which other countries and policy makers can learn

Setting and study population: The pilot study evaluated the regulation of private and public pharmaceutical sectors. The study countries were purposively selected from all the geographical regions of WHO to provide different regulatory environments.

Design: We reviewed the 2010 pharmaceutical country profile pilot study instrument and the supporting documents submitted by the study countries. In addition, we searched the websites of the medicines regulatory authorities (MRAs) for supplementary information.

Legislation evaluated: We evaluated the existence and functioning of the following legal and administrative provisions on pharmaceutical regulation: regulatory framework and capacity, marketing authorization, licensing of premises, import control, regulatory inspection, medicines advertisement and promotion, controlled substances, market control and quality control, clinical trial, and pharmacovigilance.

Results: All of the 12 countries had legal provisions establishing their MRAs. Also, 9 of the 12 MRAs had their own websites. Although legal provisions on the other regulatory functions widely existed in the study countries, pharmacovigilance and clinical trials were less governed by legislation. Legal provisions more widely existed on Good Manufacturing Practices (GMPs) than Good Distribution Practices (GDPs) (11/12 and 6/12, respectively). Legal provisions for publishing GMP and GDP requirements, the list of registered pharmaceutical products, and summary product characteristics of registered medicines were less common whereas quality testing results were published in only 2 countries. Only 7 of the countries reported assessing their regulatory system within 5 years prior to the study. The average ratio of the fee for registering a new chemical entity to that of a generic was 3, which may not favor generics enough.

Conclusions: The study countries generally had legislative structures for pharmaceutical regulation. However there were gaps in legal provisions governing pharmacovigilance and clinical trials. Furthermore, the publication of some regulatory documents, which could improve transparency in regulation, was not common in the study countries.

Funding source: WHO


Direct-to-Consumer Advertising for Pharmaceuticals in Jordan from a Gender Perspective

Hadeel Ashour, Ibrahim Ali Alabbadi

University of Jordan, Jordan

Problem statement: Although the Jordanian Drug and Pharmacy Law prohibits promotion of medicines directly to public for either over-the-counter drugs or prescription-only drugs, consumers in Jordan are directly exposed to the pharmaceutical advertising in different ways. Both patients and physicians agreed that the most drug classes being advertised directly to consumers are vitamins whereas drugs used to treat mental illness are the least advertised. Unexpectedly, the 10 top drug classes (out of 31 investigated) found to be advertised directly to consumers in Jordan were prescription-only drugs such as antibiotics and diabetes drugs.

Objective: To investigate to which extent direct-to-consumer advertising (DTCA) for pharmaceuticals is disseminated—if present—in Jordan and to identify gender differences in this regard

Methods: The study was conducted on two samples: the first represents the patients (drug consumers) coming to the Jordan University Hospital and the second represents the physicians working there (the prescribers). Two questionnaires were designed. The first was distributed to (550) male and female patients, and consequently, based on its results, a second questionnaire was designed and distributed to (200) male and female physicians. The response rates were high (513 and 144, respectively).

Results: Although the results revealed no gender differences toward pharmaceutical DTCA (i.e., no significant statistical differences were found: α ≥ 0.05 and in the tools used for pharmaceutical DTCA: α ≥ 0.05), the results showed a gender gap in the most targeted group exposed to pharmaceutical DTCA. Approximately 45% agreed that women are more likely to be targeted by DTCA than men. Only 2% believed that men are more likely to be targeted by DTCA than women.

Conclusion: We concluded that the prohibition of pharmaceutical DTCA did not prevent Jordanians to be exposed to pharmaceutical DTCA.

Funding source(s): No information provided


Pattern of Use of Complementary and Alternative Medicine (CAM) Among Patients with Type 2 Diabetes Mellitus (T2DM) in Alexandria, Egypt

S.H. Assaad-Khalil1, A. Zaki2, A.M. Ibrahim3, A.M. El-Moughazi3, A.M. Khater3, A.T. El-Sa'ed3, E.M. Rashed3, A.M. Youssif3

1Unit of Diabetes & Metabolism, Department of Internal Medicine, Faculty of Medicine, Alexandria University. Alexandria, Egypt.; 2Department of Bioinformatics and Medical Statistics , Medical Research Institute, Alexandria University. Alexandria, Egypt.; 3Students of the 5th year, Faculty of Medicine, Alexandria University. Alexandria, Egypt.

Problem statement: Despite the fact that the use of CAM is a common public practice, it has been seldom studied in diabetic patients in our community.

Objectives: To determine the pattern and determinants of the use of CAM among patients with T2DM in Alexandria, Egypt, and its impact on compliance to pharmacotherapy

Design: Cross-sectional study

Setting: Outpatient clinics

Study population: Randomly selected 1,100 patients with confirmed T2DM from among attendants of outpatient clinics in Alexandria. Clinics affiliated with the University Hospital, health insurance, MOH, and private health sectors were randomly selected from all major districts of Alexandria. The study was carried out between September and October 2010. Data was collected by trained medical students using a pre-tested questionnaire. Data collected included detailed information about socio-demographic variables (age, sex, and occupation), duration of diabetes, history of DM complications, medical care affordability, and the patients’ most recent laboratory investigations. We used the self-reported Morisky score to evaluate patients’ compliance with DM medications. Data was analyzed with SPSS-18. A pilot study (n = 217) was conducted to calculate the size of the study population and to refine the questionnaire.

Results: The rate of use of CAM was found to be 41.7% (26.3% regular users). The main 3 reasons patients gave for using CAM were believing in its benefits (80%), preferring natural products (20%), and being uncontrolled with drug therapy (13%). Patients acquired their knowledge of CAM mainly from friends and neighbors (59.2%), family (32.3%), and mass media (18.1%). The most commonly used CAMs: white lupine (43%), fenugreek (42.5%), onion (34.4%), and remedies for which patients are unaware of its components (29%). Higher rates of using CAM were associated with longer duration of diabetes (p < .001), presence of complications (p < .01), and medical care affordability problems (p < 0.05). As regards socioeconomic indicators, no significant association was found between use of CAM and education (p > .05), but it was more associated with white collar occupations than blue collar ones or nonworkers (p < .05). Considering the attitude of physicians toward CAM: 43.2% were in favor, 27.4% indifferent, and 29.5% against. Poor compliance to pharmacotherapy was significantly more reported in CAM users (p < .05). Complete stopping of the pharmacotherapy on their own was reported in 31.1% of the users and 22.5% of the nonusers (p < .005). Poor glycemic control and higher rates of diabetic complications were significantly associated with the use of CAM (p < .05 and .01, respectively).

Conclusion: The use of CAM is prevalent among patients with T2DM in Alexandria, Egypt. This has a significant impact on their compliance to pharmacotherapy and their risk of suffering diabetic complications. Awareness of physicians and patient education about the rational use of CAM is needed in our community.

Funding: Self-funded project


Trends of Current Treatment and Outcomes of the Management of Type 2 Diabetic (T2DM) Patients in Egypt: Results from the International Diabetes Management Practices Study (IDMPS)

Samir Helmy Assaad-Khalil1, Adel Zaki2, Magdy Helmy Megallaa1

1Unit of Diabetes & Metabolism, Department of Internal Medicine, Faculty of Medicine, Alexandria University, Alexandria, EGYPT; 2Department of Bioinformatics and Medical Statistics Medical Research Institute, Alexandria University, Alexandria, EGYPT

Problem statement: Numerous epidemiological studies have been conducted in western countries to assess the quality of medical care in diabetic patients. In most of the developing countries, including Egypt, these data are scarce. This article presents the results of T2DM data in Egypt collected from the cross-sectional component of the IDMPS.

Objectives: To assess the trends of current treatment and outcomes of management of T2DM patients in Egypt

Design: Cross-sectional descriptive study

Setting: The study was conducted at the national level including public and private sectors.

Study population and methodology: A total of 28 physicians (13 diabetologists and 15 GPs, internists, and cardiologists) and 289 T2DM patients were recruited. A cross-sectional survey of socio-demographic factors, management practices, and metabolic control has been conducted for all patients.

Results: The patients’ mean age was 54.25 ± 10.73 years, females represented 54.7%, and patients living in urban areas 91.9%. Their mean BMI was 32.08 kg/m2 and the mean waist circumference was 104.89 cm. The mean duration of diabetes was 9.25 ± 7.76 years with approximately 69.5% of a positive family history of diabetes. About 12.7% of the patients were illiterate, with most of the subjects (64%) having no health insurance. Insulin was more frequently described by diabetologists. The pre-mixed insulin was the most prevalent (diabetologists 50.0% and other specialties 66.7%). Screening for chronic diabetic complications was sub-optimal, with 33.6% of patients never screened for cardiovascular disease, 48.1% never for retinopathy, 49.6% never for neuropathy, and 66.4% never for diabetic foot disease. More than one-third of the patients never had their HbA1c measured during the previous year, only 60.7% of them were assessed for their lipid profile at least one time, and 60.3% of them have never had their urinary albumin measured. Approximately 88% of patients were never subjected to any form of therapeutic patient education and only 31% of them reported the performance of the SMBG. Almost none (0.4%) of the patients achieved the 3 ADA treatment targets (HbA1c, BP, and LDL-C), with 57.6% of them not achieving any of the targets. Only 16.5% of the patients had HbA1c < 7%. The prevalence of retinopathy, nephropathy, and neuropathy was 18.3%, 15.9%, and 46.0% respectively, with 31.8% of them having coronary artery disease. Hospitalization in the 3 months prior to enrollment was reported in 13.6% of patients, heart disease being the most common reason (80.7%).

Conclusion: In Egyptian patients with T2DM, metabolic control and prevention of complications are unsatisfactory. Thus, measures should be undertaken to elaborate a national program addressing adaptation of guidelines, continuous professional development, patients’ education, and tackling the barriers of good health care provision and patients’ empowerment.

Funding source: IDMPS was funded by Sanofi-Aventis International



Theresa Nimal Athuraliya1,2, Jane Robertson1, Sisira Dharmaratne2

1University of Newcastle, Australia; 2University of Peradeniya, Sri Lanka

Problem statement: Household surveys are an important tool to obtain accurate information on how people obtain and use medicines.

Objectives: To assess geographical access, availability, and affordability of medicines in the Kandy District, Sri Lanka

Design: Household survey (pilot study)

Setting: Kandy District, central province of Sri Lanka; Gampola Base Hospital was the reference facility

Study population: Clusters of households up to 15 km from the reference health facility (WHO guidelines)

Method: The best household informant was identified; 2 trained interviewers completed a structured paper questionnaire on the family’s behalf.

Outcome measures: Proportion (%) of households reporting recent acute and chronic conditions; sources of care used; access to, use, and affordability of medicines

Results: We screened 27 households (117 individuals); 26 (22%) household members reported an acute illness in the prior 2 weeks. Of those, 14 (54%) were children and had mainly suffered upper respiratory tract infections; 16 (56.3%) sought care from a public hospital, 2 (12.5%) a health centre or dispensary, and 4 (25%) a traditional healer; 88.9% reported easy access to the closest government hospital. Most patients (14/16, 88%) reported taking all medicines as prescribed. Of 117 household members, 13.7% reported a chronic illness (hypertension, diabetes, and heart disease were most common) and 81% received prescribed medicines; 56.3% of those with chronic illness reported purchasing all prescribed drugs. Most (81.5%) could afford their medicines. Drug costs were 26.2% per month of total household expenditure. None had insurance coverage. Labelling and storage of drugs issued by public hospitals was poor. Most were loose tablets or capsules in clear polythene bags with minimum written instructions. Of 82 medicines, 39.2%with appropriate labelling and packaging were purchased privately. Few participants had comments on cost and quality of drugs and quality of health care services, and most had limited knowledge of generic drugs. Respondents noted that Gampola has many health facilities. Convenient opening times and quality of services influenced facility choices. Methodological issues include possible concerns by household members on selection of the household; signing consent forms; divulging information on chronic diseases; selection of a single informant to provide information on costs, quality of drugs, and health service, given the shared responsibilities on household health care.

Conclusions: Pilot data show access and use of medicines are generally good in the Kandy District. Although health care is free in Sri Lanka, a substantial proportion of people with chronic diseases pay for their medication. Despite poor labelling, adherence to drug regimens was satisfactory, indicating people take note of verbal instructions. The survey tool needs modifications, and additional interviewer training is required to address some culturally sensitive issues in Sri Lanka.

Funding source: University of Newcastle, Australia


Antimalarial Prescribing and Dispensing Practices in Health Centres of Khartoum State, 2003–04

Abeer Abuzied Atta A/Mannan1, El Fatih Mohammed Malik2, Kamil Mergani Ali3

1Al Neelain University, Sudan; 2Federal Ministry of Health; 3University of Khartoum

Problem statement: In Sudan, inappropriate, ineffective, and inefficient use of drugs commonly occurs at health facilities and little is known about the determinants of poor use of antimalarial drugs.

Objectives: This study was indicator-based. The main objective was to assess the antimalarial drug prescribing and dispensing practices of health care providers in health centres of Khartoum state and to compare these practices with the national guidelines for malaria treatment.

Design: A facility-based, cross-sectional, descriptive, analytical study following WHO guidelines

Setting: Khartoum state includes the national capital of Sudan. Its population is a mixture of all Sudanese tribes and ethnic groups. Almost 68% of the population lives in urban areas, 21% live in rural areas, and 11% are displaced people.

Study population: 720 patients using the standard cross-sectional survey formula. Two-stage cluster sampling was used. The first stage was the selection of health centres using probability proportional to size, and the second stage was the selection of patients.

Policies: The practices described in this study were compared to the national protocol for treatment of malaria at that time before the introduction of the new combination therapy, which was launched late in 2004. The study provided information added to the pool of evidence needed to change the old national treatment guidelines for Malaria.

Outcome measures: Measuring WHO drug use indicators. After patients were interviewed, their information was recorded on a standard form (i.e., a patient care form), then their prescriptions were collected; the data extracted were recorded on another form (i.e., a prescribing indicator form). After the required number of patients had been interviewed, information on the types of antimalarial drugs available in stock and the presence of the national protocol poster in the health centre were recorded on a third form (i.e., a facility summary form).

Results: Prescribers adhered to national treatment guidelines for only 278 (38.6%) of patients. Although all were treated for malaria, only 77.6% patients had fever or history of fever and only 64.6% had fever and positive blood films. More than 90% of prescriptions prescribed antimalarial drugs by generic names but dosage forms were correctly written in only 23.5%. There was a high rate of prescribing antimalarial injections. Only half the patients had adequate knowledge of their treatment.

Conclusion: The study showed inappropriate prescribing practices and consequently inappropriate use of drugs for malaria.

Funding source(s): The National Administration for Control of Malaria, Federal Ministry of Health, Sudan

126-Atta AMannan-_a.pdf

Effects of the 2005 Change in National Antimalarial Treatment Policy on Prescribing Practices in Two Referral Hospitals in Benin City, Nigeria


Clinical Pharmacology and Therapeutics Unit, Department of Medicine, University of Benin Teaching Hospital, Benin-City, Nigeria.

Problem statement: The increasing difficulty in the management of multidrug resistant falciparum malaria led to the recommendation of Artemisinin-based Combination therapy (ACT) by the WHO. This change in treatment policy was adopted by Nigeria in 2005. Antimalarial prescriptions are expected to be influenced by this change in policy in order to improve the prevailing malaria morbidity and mortality.

Objective:To evaluate the prescription of antimalarial medicines a year prior to and for three years following the change in the National antimalarial policy.

Design: A pre- and post intervention, descriptive study. The study was carried out in the out-patient department of the University of Benin Teaching Hospital and Central Hospital, both in Benin City, Nigeria.

Study population: The study evaluated a total of 2343 case records of adult patients (≥ 18 yrs) treated for uncomplicated malaria from 2004 to 2008. Case records were selected by systematic sampling. Information extracted were patient’s age, gender, diagnosis type of antimalarial medicine prescribed.

Intervention: The National Antimalarial Treatment Policy was published and circulated by the Federal Ministry of Health in 2005. The demerits of the continuous prescription of chloroquine for the treatment of malaria was emphasized and the need to use the ACTs recommended.

Policy: The policy recommended the use of Artemether-Lumefantrine (AL) as the first-line medicine for treating uncomplicated malaria. Other ACTs recommended include Artesunate-Amodiaquine (AA) and Artesunate-Mefloquine (AM).

Outcome measures: The study outcome was to ascertain the shift to ACTs in the management of uncomplicated malaria.

Results: Prior to the policy change (2004), Artesunate monotherapy was the most prescribed antimalarial (37.3%), followed by Sulphadoxine-Pyrimethamine (SP) and Chloroquine (CQ) monotherapies,19.8% and 19.0% respectively. AL constituted 0.8%. Three years into the change in policy, AL was the most prescribed, with > 300% increase from 2004 (p < 0.05).This was followed by AA and AM, 24.3% and 23.6% respectively. Artemisinin monotherapies dropped to 10.4% and non-ACT combinations rose to 5.1% of prescribed Antimalarials.

Conclusion: This study showed good adherence of prescribers to the change in antimalarial policy in hospital settings. The study also highlights that chloroquine, the medicine of first choice in the previous policy was undermined by prescribers who opted for artesunate monotherapy prior to the ACT era. There is need for stiffer regulations to limit the use of Artemisinin monotherapies if successful case management of malaria is to be sustained.

Funding source: Personal


Safety and Tolerability Profile of Artemisinin-Based Antimalarial Combination Therapy (ACT) in Adult Nigerians


Clinical Pharmacology and Therapeutics Unit,Department of Medicine,University of Benin Teaching Hospital.

Problem statement: Malaria remains a major public health concern in tropical and sub-tropical regions of the world especially sub-Saharan Africa. The Artemisinin-Based Combination Therapy (ACT) has recently been introduced due to P. falciparum resistance to chloroquine following recommendations by the WHO .The use of these medicines raised safety concerns with tolerability, undermining therapy.

Objective: To characterize the safety and tolerability profile related to the use of the ACTs in our environment

Design: A longitudinal cohort and descriptive study.

Setting: The study was carried out in the Out-patient Department of the University of Benin Teaching Hospital and Central Hospital, both in Benin City, Edo state, Nigeria.

Study Population: Adult patients ( ≥ 18years) with a diagnosis of uncomplicated malaria and treated with ACTs were recruited for the study.

Policy: The WHO in 2001 advocated Antimalarial Combination Therapy especially those containing an Artemisinin derivative to countries experiencing resistance to Antimalarial monotherapies. Nigeria adopted Artemether-Lumefantrine (AL) as the first-line Antimalarial in 2005. Other ACTs adopted include Artesunate-Amodiaquine (AA) and Artesunate-Mefloquine (AM).

Outcome measures: The safety and tolerability profile of ACTs amongst the treated patients. ADRs were classified using the WHO causality assessment.

Results: 500 patients were enrolled for this study – AL (179), AM (149), AA (134). The mean age was 32.6years (range 18-68yrs). One hundred and eighty-eight (37.6%) patients reported at least one AE: 61% in the AA, 60% in the AM, 58% in the AL. AA treatment was associated with a significant higher risk of Gastrointestinal symptoms, Dizziness and Pruritus than AL and AM (p<0.05). Those treated with AM had a higher incidence of generalized weakness although it was not statistically significant. Moderate to severe AEs were observed in five patients each treated with AA and AM respectively, and in one patient treated with AL.

Conclusion: This study confirms the safety and tolerability of AL. AA and AM although safe are less well- tolerated, and this may affect patients’ adherence with its attendant consequences.

Funding sources: Personal


Evaluating Pharmacists’ Views, Knowledge, and Perception Regarding Generic Medicines in New Zealand

Zaheer-Ud-Din Babar, Piyush Grover, Joanna Stewart, Michele Hogg, Leanne Short, Hee Gyung Seo, Anne Rew

University of Auckland, New Zealand

Problem Statement: Generic medicines are commonly used in New Zealand; however, the Pharmaceutical Management Agency of New Zealand (PHARMAC) has indicated a need for better information for the public. Studies on consumers’ perceptions suggest that pharmacists play an important role in consumers’ choice; hence, “quality use of generic medicines” can be promoted with a better understanding of pharmacists’

views, knowledge, and perception.

Objectives: (1)To evaluate pharmacists’ perceptions, views, and knowledge of and willingness to recommend generic medicines; (2) to explore pharmacists perceptions of the safety, quality, and efficacy of generic medicines; and (3) to assess pharmacists’ views on current policy with respect to substitution of generic medicines.

Design: Descriptive study

Setting: National-level study, assessing individual pharmacists’ responses

Study Population: A cross-sectional survey using a postal questionnaire was conducted, and questionnaires were sent to 625 randomly selected pharmacists from a list of 1,594 pharmacists who had agreed to release their information for research purposes.

Results: Three-hundred and sixty pharmacists responded to the questionnaire (a response rate of 58%). Seventy percent of pharmacists stated there is no difference in safety between original brand and generic medicines. However, 65% stated that original brand medicines were of higher quality than their generic counterparts, and half stated that generic medicines and original brand medicines are equally effective. A large number of pharmacists reported concerns regarding brand substitution and offered suggestions, such as the need for advertising campaigns, patient pamphlets, updating prescribers’ software, and distinct packaging for generic medicines. It was found that pharmacists’ perceptions of generic medicines are primarily driven by PHARMAC’s policies and their experiences with consumers.

Conclusions: About one-third of pharmacists correctly defined the term “generic medicines,” suggesting discrepancies in pharmacists’ knowledge and perceptions of generic medicines. Concerns were raised regarding quality, safety, and effectiveness; however, most of the pharmacists acknowledged the economic benefits to the health care system.

Funding Sources: School of Pharmacy, University of Auckland


WHO Good Governance for Medicines Programme: Innovative Approach to Curb Corruption in the Pharmaceutical Sector

Guitelle Baghdadi-Sabeti1, Mohamed Ramzy Ismail2

1WHO-HQ, Geneva, Switzerland; 2WHO-EMRO, Cairo, Egypt

Problem statement: Corruption is increasingly recognized as a major impediment to reaching the Millennium Development Goals and to strengthening health systems. The health sector is an attractive target for corruption, with USD 5.3 trillion spent on health services each year and a global pharmaceutical market value of USD 750 billion. Corruption negatively affects access and quality of health care. It endangers the health of entire communities, wastes resources, and destroys public trust.

Objectives: To address this challenge, WHO launched the Good Governance for Medicines (GGM) programme. Its goal is to contribute to health systems strengthening and to prevent corruption by promoting good governance in the pharmaceutical sector.

Design and interventions: The programme assists countries through a 3-step process of assessing their vulnerabilities to corruption and developing and implementing specific programmes to maintain efficient health care systems that are not undermined by the abuse of corruption. The first step involves a nationwide study on transparency and vulnerability to corruption in the pharmaceutical sector using WHO methodology. The national assessment emphasizes the system’s actual structures, particularly the mechanisms to prevent unethical practices and the administrative procedures to measure transparency and accountability. It also looks at how different procedures and mechanisms are known by those involved in the pharmaceutical sector. Elements targeted include country regulations and official documents; written procedures and decision-making processes; committees, criteria for membership, and declaration of conflict of interest policy; and appeals mechanisms and other monitoring systems.

Setting: The willingness of governments to implement the GGM has exceeded initial expectations. Starting in 2004 as a pilot project in 4 Asian countries, the GGM rapidly became a global programme operating in 31 countries.

Results: After 6 years of implementation, successes are visible in countries. Medicine procurement practices have been enhanced, leading to lower costs for medicines and pharmaceutical services; information is publicly available on Ministry of Health websites; management of conflicts of interest has been implemented; legislation has been updated to ensure more transparency and accountability; and a culture of transparency is emerging.

Conclusions: Momentum for change is increasing and good governance often becomes one of the top priority items on Ministries’ agendas. Many challenges remain, but availability of evidence on areas of national pharmaceutical systems that are more vulnerable to corruption has led to positive change in several participating countries. More information and references can be found at http://www.who.int/medicines/ggm.

Funding source(s): AusAID, BMZ, DFID, European Commission, State of Kuwait, and WHO


Survey on the Use of Medicines by Consumers in Federal Territories of Kuala Lumpur and Putrajaya

Salmah Bahri1, Sook Tze Lai1, Yee Woon Yap1, Min Wei Ching1, Nadira Ahmad Khidzar1, Jennifer Kua2

1Federal Territories Of Kuala Lumpur & Putrajaya Health Department, Malaysia; 2Kuala Lumpur Hospital

Problem statement: Rational medicines use by consumers has become a major concern both in developed and developing countries. To date, there is limited local study to determine consumers’ knowledge and awareness with regards to rational medicines use. Also, no constructive interventions have been implemented to further enhance the quality use of medicine.

Objectives: To identify current medicine use patterns among consumers and assess the efficacy of the ‘Know Your Medicine’ campaign on patients’ understanding and knowledge of rational medicine use and sources of medicine information.

Design: Longitudinal, pre-post design survey was conducted from August 2007 till December 2009 with potential consumers in Federal Territories of Kuala Lumpur and Putrajaya.

Setting and population: Single-stage, random clusters sampling technique with 240 consumers

Interventions: The ‘Know your Medicines’ campaign was implemented through exhibitions, seminars, media, and various channels to educate consumers.

Outcome measures: Quantitative indicators of medicine use and effectiveness of the campaign.

Results: The descriptive data has shown consumers’ level of understanding on medicines use in terms of dosage was 74.6%, followed by 92.5% on frequency, and 97.9% in method of administration; however, only 41.3% of consumers know about medicine/food interactions. There were statistically significant improvements in consumers’ knowledge after the intervention, namely, generic name (27.9% vs. 48.3%, p < 0.05), trade name (40.4% vs. 80%, p < 0.05), side effects (32.7% vs. 51.7%, p < 0.05), and storage (59.4% vs. 73.8%, p < 0.05). Only 35.4% of consumers stopped taking medicine when feeling well compared to 74.7% (p < 0.05) before the campaign. Approximately 33.8% admitted that they shared their medicines with others, an improvement from 37.1% (p < 0.05), and 19.6% took modern and traditional medicines together compared to previously 23.7%. Although doctors remained the preferred person for medicine information, there was significant improvement in pharmacists as referral person after the intervention (16.8% vs. 36.7%, p < 0.05). Consumers’ attendance at the talks and exhibitions were significantly associated with their ability to recognise generic names (p < 0.001), understanding the requirement that traditional and modern medicines be registered (p < 0.001), and knowledge of the use of Meditag in ascertaining the authenticity of the products (p < 0.001).

Conclusions: Overall, 70% of the consumers have better understanding and knowledge on medicines use after implementation of the campaign. However, enhancements to the campaign are needed to increase awareness and knowledge of Malaysian consumers’, focusing on aspects with low awareness, particularly medicine/food interactions. Involvement of pharmacists in educating the public on rational use of medicine plays a vital role in achieving this end.

Funding source: Pharmaceutical Services Division, Federal Territories of Kuala Lumpur and Putrajaya Health Department


Survey on the Use of Medicines by Malaysian Consumers

Salmah Bahri1, Nour Hanah Othman1, Mohamed Azmi Ahmad Hassali2, Asrul Akmal Shafie2, Mohamed Izham Mohamed Ibrahim2

1Pharmaceutical Services Division, Ministry of Health Malaysia; 2Discipline of Social & Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia

Problem statement: There are serious problems related to the inappropriate use of medicines globally among consumers. Within this context, Malaysia is no exception. To date, there has not been a comprehensive nationwide study conducted to examine consumer knowledge and awareness on the rational use of medicines. Hence, this study is conducted to obtain current data so that health authorities are able to plan necessary strategies to enhance consumer understanding of the rational use of medicines in line with the Malaysian National Medicines Policy.

Objectives: To identify prescription and nonprescription medicine use patterns among consumers, look at the current knowledge of consumers on medicine usage, and identify the sources of information

Design: Descriptive, exploratory, cross-sectional survey was conducted November 2007–January 2008 in 14 states of Malaysia

Setting and population: Using one-stage, random cluster sampling, two clusters represented by two government health care facilities in each state (mostly rural and urban populations) were chosen by using population datasets from the Malaysia Department of Statistics. For each state, at least 200 consumers were included and a total of 3,014 consumers nationwide participated.

Interventions/policy change: Strategies for the quality use of medicines (QUM) which have been documented in the National Medicines Policy are institutionalised and implemented nationwide.

Outcome measures: Quantitative indicators of medicine use

Results: Approximately 32% of consumers surveyed are currently using medicines to treat their chronic diseases, followed by 43% of consumers using health supplements and 26% of them using traditional medicines. Although Malaysians do spend on health, their knowledge on medicine usage appears to be inadequate because 55.6% of consumers did not understand the proper use of their medicines. Additionally, the study has shown that 51% and 65.7% consumers are unable to recognise medicines’ trade and generic names, respectively. Also, this survey revealed that 34% and 26% of consumers found it difficult to obtain medicine information from doctors and pharmacists from the private sector; 74% of consumers preferred written medicine information from health care providers and 73% of them agreed that counselling sessions are necessary to help them in taking their medication.

Conclusions: QUM strategies identified in the National Medicines Policies should be implemented to ensure that Malaysian consumers are well informed about the medicines they are taking. Also, involvement of health care providers in educating the general public on the principles of rational use of medicines is important to increase awareness on the safe and rational use of medicines.

Funding source: Pharmaceutical Services Division, Ministry of Health Malaysia


Multi-Stakeholder Collaboration: Can It Improve Transparency, Disclosure

WJ {Wilbert} Bannenberg1,5, Samia Saad1, Christine Kalume1, Carolyn Green1, Claire Innes2, Saul Walker2, Gilles Forte3, Andreas Seiter4

1Medicines Transparency Alliance (MeTA) pilot; 2DFID; 3WHO; 4World Bank; 5Health Research for Action (HERA)

Problem Statement: After 30 years of a valid essential medicines concept, 2 billion people are still without access to essential medicines (ATM). Efforts to promote ATM have largely focused on interventions by governments; they have not yet seriously involved the private (for profit, nonprofit) sector or civil society.

Objectives: The MeTA pilot phase aimed to test the hypothesis that multi-stakeholder collaboration between government, private sector, and civil society improves disclosure, transparency, accountability, policies; and ultimately improves ATM.

Design: Review, qualitative study.

Setting: Global and national level, involving public and private sector, and civil society

Study Population: Seven countries (Ghana, Jordan, Kyrgyzstan, Peru, Philippines, Uganda, and Zambia),who accepted an invitation by DFID to pilot MeTA.

Intervention: In collaboration with stakeholders, MeTA established multi-stakeholder groups (MSGs) willing to perform a pilot of the MeTA hypothesis. These transformed into 7 national MeTA councils, establishing work plans, budgets, and national secretariats. Stakeholders were asked to transparently disclose key data about the overall medicines supply chain, analyse the information, seek country-specific solutions, and advocate for policies to improve access to medicines. Baseline studies were undertaken on the pharmaceutical sector and disclosure practices in all 7 countries. Four countries undertook WHO level II household and facility surveys. Five countries assessed the multi-stakeholder collaboration using a new tool. Civil society coalitions were formed and assisted with capacity building in all 7 countries. All 7 countries organised national fora to discuss MeTA data and reports. Establishing MSGs took more than 12 months; the pilot phase lasted 2.5 years. A second phase of MeTA started in 2012.

Policies: Several MeTA countries also discussed national medicines policies, and contributed to changes in legislation, drug regulatory transparency, price surveys/ monitoring, generic policies, and evidence-based treatment guidelines.

Outcome Measures: Baseline and country reports. MeTA review of the pilot phase. An independent evaluation of MeTA in February 2010 concluded that time was too short to reject or confirm the MeTA hypothesis, or to expect impact on ATM, but there were promising signs.

Results: All 7 countries established active MSGs, performed baseline studies, disclosed and analysed data, advocated for better policies, and presented results to national fora and through Internet.

Conclusions: Structured multi-stakeholder dialogue at country level can increase transparency and disclosure. The MeTA pilot phase was too short to prove whether or not it increases access to medicines.

Funding Source: DFID (with technical support by WHO, World Bank)


Effects of an Intervention on the Use of Medicines in Herat Province of Afghanistan

Jawahar Singh Bapna1, Inge-Lise Aaen2, Saeed Hamedi2

1Jaipur College of Pharmacy, Jaipur, India; 2Danish Afghan Committee, Heart, Afghanistan

Problem statement: No systematic study on quality of prescribing is available in Afghanistan.

Objective: To study the effect of educational intervention on prescribing in selected health facilities in Herat Province, Afghanistan

Design: It was a before-and-after face-to-face intervention with no control group. Baseline data on use of medicines, quality of prescribing, dispensing, and stock-outs were collected using WHO/INRUD indicators and the change that occurred after 1 year assessed.

Setting: The study was conducted at Herat Province of Afghanistan at public sector health facilities supported by a nongovernmental organization, the Danish Afghan Committee.

Study population: All the prescribers, a total of 60 working at 1 district, 2 community health centers, and 5 basic health centers of Herat Province were included in the study.

Intervention(s): Participants were trained at two 4-day participatory workshops at the beginning and after 3 months. In the first, the concept of essential drugs and rational drug use was presented to them. In the second, training was given on problem-based learning using Guide to Good Prescribing.

Outcome measure(s): The changes in prescribing practices, quality of medical and dispensing services, and stock-outs were measured after 1 year.

Results: The pooled data of 30 prescriptions or observations each at 8 facilities were analyzed before and after intervention. Drug use indicators showed a trend toward improvement; however, it was not statistically significant. The average number of drugs per prescription changed from 2.43±0.051 to 2.59±0.052, generic drugs 91.17±0.284 to 95±0.218±, combinations 37.9±0.20 to 30.8±0.19, injections 4.8±0.009 to 6.4±0.10, antibiotics 19.6±0.017 to 22.2±0.017, drugs from the essential medicines list 87.5±0.014 to 84.9±0.014, and drugs dispensed 81.5±0.016 to 82±0.015. Prescribing indicator showed that consultation time per patient increased significantly from 150.97±2.23 to 174.35±3.54 seconds (p<0.05). Dispensing time reduced from 41.90±0.092 to 37.33± seconds. The average number of stock-out days for key drugs decreased from 28.65 to 23.22% of days per year.

Conclusions: The study shows that the educational intervention can improve the prescribing practices. The drug use indicator showed a trend toward improvement. Consultation time increased significantly, which is helpful in rational use of drugs. The decrease in stock-outs also helps in promotion of rational prescribing. Training and motivation of prescribers is needed on regular basis to achieve these objectives. This study supports the view that a flash effect of education programs for rational prescription and use exists: immediately after training prescription patterns improve, but prescribers tend to return to old habits after a while, so long-term effects need more sophisticated interventions than just education. Educating patients along with the prescribers may be useful since the patients can be 50% of the problem and their requests are often driving the prescription patterns.

Funding source(s): Danish Afghan Committee, Herat, Afghanistan


Better Medicines for Children in India: A Project to Improve Access to Essential Medicines

Gitanjali Batmanabane, Kathleen Anne Holloway

World Health Organization - South East Asia Regional Office, India

Problem statement: A comparison of the National Essential Medicines List of India and the essential medicines lists (EML) of five empowered action-group states in India showed that children’s medicine formulations were found lacking in all 6 lists. The high cost of children’s formulations and unavailability in the public sector necessitates the use adult formulations in children.

Objectives: To improve the availability of children’s medicines, it was decided to prepare and implement an EML for children (EMLc) in Orissa and Chhattisgarh and to compare the availability and prices of a limited list of essential children’s medicines before and after the implementation of such a list.

Design: In each state, 2 committees were formed, 1 for the preparation of the EMLc and the other for conducting the pricing and availability survey. In Chhattisgarh, both activities were under the direction of 1 coordinator whereas in Orissa there were 2 (one for each activity). The pricing and availability surveys were done according to the WHO-Health Action International protocol for pricing and availability surveys.

Setting: The study was conducted in the states of Chhattisgarh and Orissa and was based in the community. Primary, secondary, and tertiary care facilities belonging to the public sector, pharmacies and dispensaries in the private sector, and nongovernmental organizations were included. The study examined both the public and private sectors.

Study population: The surveys were conducted in 6 geographical regions of both states with a minimum of 28 facilities per region from where data was collected. Public health facilities such as primary health centres, community health centres, and district hospitals as well as private facilities such as chemist shops were included.

Policy(ies): Procurement will be based on the EMLc prepared by the state.

Outcome measure(s): Intervention(s): The changes in the availability and prices of the list of essential medicines will be documented before and after implementation of the EMLc prepared by each state, after allowing sufficient time for procurement to be initiated.

Results: The baseline surveys in Chhattisgarh and Orissa show that availability of essential children’s medicines is very poor in the public sector, where medicines are given totally free of cost to patients, with only 17% availability in both states. In the for-profit private sector, availability was 46% in Chhattisgarh and 38.5% in Orissa. Simple antibiotics like Co-trimoxazole are not available whereas more expensive antibiotics, like the amoxicillin-clavulanic acid combination, are widely available. In Orissa, very poor availability of essential medicines in the public sector, such as zinc for acute diarrhoea (2.4%), contrasted with the good availability of ofloxacin (84.1%). In Chhattisgarh, 29% of public facilities had zinc, though it was unavailable in the private sector. There were no paediatric antiepileptic formulations available in the public sector in both states. Even though the EMLs have been prepared in both states, procurement based on the list is yet to begin. Hence the second part of the study, a post-procurement survey, could not be done.

Conclusions: Conducting a pricing and availability survey as the first step toward the implementation of an EMLc highlights the lack of access to essential medicines.

Funding source(s): WHO through the Bill & Melinda Gates Foundation


Facilitating the Preparation of Essential Medicines List for Children in India: Lessons Learned

Gitanjali Batmanabane, Kathleen Anne Holloway

World Health Organization - South East Asia Regional Office, India

Problem statement: The Better Medicines for Children in India project was initiated by WHO to improve access to essential children’s medicines in India. Comparison of the National Essential Medicines List of India and the Essential Medicines List (EML) of the two empowered action-group states of Orissa and Chhattisgarh with the WHO Model Essential Medicines list for children (EMLc) showed that the majority of children’s medicines were not on the lists.

Objectives: The objective was to facilitate the preparation of an EMLc for children in India, at the national level and in the two states of Orissa and Chhattisgarh.

Design: The study describes the process of facilitating the preparation of an EML at national and state levels and the issues related to them.

Setting: The Indian Academy of Paediatrics (IAP; 18,000 members) agreed to prepare the national list by involving its various chapters, each of which focuses on one area of pediatric medicine. In Chhattisgarh, the director of the State Health Resource Centre coordinated the whole process with the help of a subcommittee for essential medicines where all stakeholders were represented. In Orissa, the medical officer for the State Drug Medicinal Unit (SDMU) coordinated the preparation of the EMLc. He sent letters to the pharmacology departments of all medical colleges in the state and asked them to submit an EMLc.

Study population: The stakeholders who prepared the list.

Policy(ies): The WHO Model EMLc was taken as the baseline document for the preparation of all 3 lists.

Intervention(s): An EMLc or an EML with the inclusion of appropriate children’s formulations was the expected outcome. The process of selection of medicines for inclusion/deletion was also observed.

Results: The IAP prepared an EMLc that underwent major revisions 3 times because it contained too many expensive medicines which could not be termed as essential. This occurred because only specialists were involved in the selection of the medicines, and clinicians from the peripheral areas were not included in the deliberations. The final draft list was prepared by an independent clinical pharmacologist based on the suggestions of international and national experts, with major input from IAP. The final draft list with 113 medicines is yet to be ratified by the IAP; from inception to final draft version took 1 year. Chhattisgarh state incorporated paediatric medicines into its EML, stating that they wanted a single list that could then be used for procurement; this list was prepared in 7 months. Orissa prepared an EMLc with 117 medicines which took 11 months to complete. Chhattisgarh did not take as long because of the participation and engagement of all stakeholders from the very beginning. In Orissa, the SDMU delegated responsibility to the medical colleges where no one was ready to take the responsibility.

Conclusions: The preparation of an EMLc is possible only if all interested stakeholders are involved, and it is driven by a single person or a group of persons who have a thorough, basic understanding of the principles of selection of essential medicines.

Funding source(s): WHO through the Bill & Melinda Gates Foundation


Pharmaceutical Policies Used by Private Health Insurance Companies in Saudi Arabia

Saleh Abdullah Bawazir, Abdullah S. AlHumaidan, Larry Sasich, Mohammed Alkudsi, Maher Aljaser

Saudi Food and Drug Authority, Saudi Arabia

Problem statement: During the last decade, the health care system in the Kingdom of Saudi Arabia (KSA) has undergone the process of restructuring in order to develop a for-profit, private sector of health insurance for all citizens. The extent to which this restructuring has impacted the accessibility and price of pharmaceuticals now and in the future remains unknown. Under existing Saudi law, Saudi citizens have free access to health care. A national debate continues with regard to the advisability of changing from a totally public system to a system that includes participation by private, for-profit health insurance companies. Currently, the Council of Cooperative Health Insurance (CCHI) is the body responsible for regulating health insurance in the KSA. Although the cooperative health insurance schedule (i.e., model policy for health insurance) is available on the CCHI Web site, policies related to pharmaceuticals are ambiguous.

Objectives: The primary objective of this study was to assess the impact of health insurance policies provided by health insurance companies in KSA on access to medication and its use.

Design: This study was descriptive in design and used a survey, which was administered through face-to-face interviews with the medical managers of health insurance companies.

Setting: This study was national in scope. The interview process was conducted at the insurance company site or at the Saudi Food and Drug Authority (SFDA).

Study population: All 25 insurance companies accredited by CCHI were eligible for the study. Out of these 25 companies, 3 were excluded from this survey as no response was received. A third-party administrator represented 7 out of the 22 companies, and these 7 companies used identical insurance policies. As result, the total number of the companies counted and enrolled in the survey was 16.

Results: All 16 companies responded “yes” that they have a prior authorization policy; however, the reasons were varied; 8 (50%) of the companies were concerned with the duration of treatment. The result showed that 10 (62.5%) of the companies do not offer additional coverage beyond what the CCHI model policy offers; however, the other 6 (37.5%) companies reported that they can reconcile certain conditions. The survey also demonstrated that 10 of the companies allowed refilling of medication, but with some limitations. In other words, 6 out of the 10 restrict refilling to 3 months as a maximum time and the other 4 companies have no limits on refills. The other 6 companies rejected allowing refills without a prescription.

Conclusion: Although this paper was primarily descriptive, the findings revealed a substantial scope for improvement in terms of pharmaceutical policy standards and regulation in health insurance companies in the KSA. Additionally, the study highlighted other areas that affect the overall quality use of medication, such as overprescribing and irrational use of medication. Further research, thus, is definitely reasonable and needed.

Funding source: Saudi Food and Drug Authority, Riyadh, Saudi Arabia


Role of Free Provision on Household Expenditures for Medicines in Brazil

Andréa Dâmaso Bertoldi1, Aluísio J D Barros1, Aline Lins Camargo2, Pedro C Hallal1, Sotiris Vandoros3, Anita Wagner4, Dennis Ross-Degnan4

1Universidade Federal de Pelotas, Brazil; 2Universidade Federal de Ciências da Saúde de Porto Alegre, Brazil; 3The London School of Economics and Political Sciences, UK; 4Harvard Medical School and Harvard Pilgrim Health Care, USA

Problem statement: Medicine expenses contribute significantly to health care expenditures worldwide. In Brazil, among all health care expenses, medicines account for the largest share (41% in 2002/2003). The Brazilian national health system (SUS, Sistema Único de Saúde) is committed to supporting free access to medicines. To date, information is lacking about household spending on health care and medicines, particularly on who is getting free medicines supplied by SUS and how much households are saving because SUS is providing medicines for free.

Objectives: To investigate across different socioeconomic groups how much households spent on medicines and how much the Brazilian national health system supplied free of charge

Design: Cross-sectional study

Setting: This study was carried out in Porto Alegre, Brazil, from July to September 2003 and included 56 units of the Family Health Program (PSF, Programa Saúde da Família) from the Brazilian Public Health System. A two-stage sampling strategy was employed, with areas covered by the PSF constituting the primary sampling units. From the 56 units, 45 were selected with probability proportional to size and 20 households from each area were sampled.

Study population: All individuals living in the selected households were included in the study. Individuals older than 13 years were interviewed face-to-face and mothers of younger subjects responded on their behalf. Using a pre-coded questionnaire, we asked individuals about the use of medicines during the past 2 weeks and requested to see the medicines’ packaging and prescriptions. For each reported medicine, we asked how the medicine was obtained and when and the amount bought or obtained free of charge. A total of 869 households were visited and 2,988 individuals were interviewed.

Outcome measures: We defined two expenditure variables: “out-of-pocket medicines value” (sum of retail prices of all medicines used by family members within the previous 15 days and paid for out-of-pocket) and “free medicines value” (similar definition for medicines obtained without charge).

Results: The Brazilian national health system provided free of charge 78% of the monetary value of medicines reported (79% in the bottom wealth quintile and 32% in the top ones); 73% of the medicines for continuous use were provided free of charge, whereas the equivalent proportion for medicines for acute use was 58%. Of the products listed on the essential medicines list, 86% were provided free of charge. The mean out-of-pocket expense for medicines was 6 times greater among the top wealth quintiles as compared to the worse-off (P < 0.001), but free medicines constituted a 3-fold greater proportion of potential medicines expenditures among the bottom quintile than among the better-off.

Conclusions: In Brazil, free provision of medicines, along with other economic incentives, may improve access and avoid high medicines expenditures for poor people.

Funding source: TheWorld Bank through the “Reaching the Poor” program


Use of Medicines with Unknown Fetal Risk among Pregnant Women from the Pelotas Birth Cohort 2004, Brazil

Andréa Dâmaso Bertoldi1, Aline Lins Camargo2, Tatiane da Silva Dal Pizzol3, Aluísio J D Barros1, Alicia Matijasevich Manitto1, Iná S Santos1

1Universidade Federal de Pelotas, Brazil; 2Universidade Federal de Ciências da Saúde de Porto Alegre, Brazil; 3Universidade Federal do Rio Grande do Sul, Brazil

Problem statement: Prenatal exposure to medicines may represent potential risks to fetal development, with minor or major consequences to child health. It is possible to minimize the fetal risks with the rational use of medicines, based on previous knowledge about teratogenic and other fetal risks. The Food and Drug Administration (FDA) classification, one of the most used, is based on studies carried out in animals and humans to classify medicines into 5 risk categories (A, B, C, D e X).

Objectives: To estimate the exposure to medicines with unknown fetal risk during pregnancy and to analyze the maternal characteristics associated with it

Design: Cross-sectional study; an interview with the mother was carried out within 24 hours of delivery

Study population: All mothers of children belonging to the 2004 Pelotas (Brazil) birth cohort study

Outcome measures: A standardized and precoded questionnaire was administered to mothers about the use of any medicine during the gestation period, as well as the month in which the mother started and stopped taking each medicine. We used the FDA teratogenic risk categories. Results: Out of the 4,189 women, 92.7% reported using at least 1 medicine during pregnancy. The mean number of medicines reported was 2.4 (SD 1.5), ranging from 1 to 10. We identified 38.9% category C (unknown fetal risk) medicines and around 5% from the D and X categories (positive evidence for fetal risk). Multivitamins and the association between butylscopolamine and dipyrone were responsible for 40% of the category C medicines used in each trimester. In the adjusted analyses (logistic regression models), use of category C medicines was associated with white skin color, high school education, high income, 6 or more antenatal care consultations, hospital admission during pregnancy, morbidity during gestation (depression, anemia, threatened abortion, pre-term labor threat, and urinary infection).

Conclusions: The use of medicines with unknown fetal risks must be addressed with caution with the aim of restricting its use to cases in which the benefits of the use are greater than the potential threats.

Funding sources: Supported by WHO, the National Council for Scientific and Technologic Development (CNPq), the Fundação Nacional de Saúde, and the Pastoral da Criança


Medicine Prices and Availability in Southern Brazil

Andréa Dâmaso Bertoldi1, Ana Paula Helfer2, Aline Lins Camargo3, Noemia U L Tavares4, Panos Kanavos5

1Universidade Federal de Pelotas, Brazil; 2Universidade do Vale do Rio dos Sinos, Brazil; 3Universidade Federal de Ciências da Saúde de Porto Alegre, Brazil; 4Universidade da Região da Campanha, Brazil; 5The London School of Economics and Political Sciences, UK

Problem statement: Although in theory, the Brazilian health system (SUS) should be able to provide essential medicines for free to the entire population, medicines are often not available when needed. If medicines are not available in public sector facilities, patients purchase them out-of-pocket in the private market, which may also lead to excessive out-of-pocket spending. The availability of medicines, particularly in the public sector, and their prices in the private sector are important determinants of access to medicines.

Objectives: To evaluate medicine prices in private pharmacies and availability in the public and private sectors, considering the differences across 3 types of medicines available in the Brazilian market (originator brands, generics, and similar medicines)

Design: Descriptive study, using a HAI/WHO standardized methodology

Setting: The current study was drawn in the South region of Brazil, which is one of 5 geographical regions of the country. It includes 6 cities in the state of Rio Grande do Sul, which has a total population of 10.5 million inhabitants, representing 5.7% of the country’s total population. Data were collected from the beginning of November 2008 to the end of January 2009.

Study population: In each of the 6 cities, 4 public sector facilities with pharmacies were randomly selected (n = 22). The only exception was São Leopoldo, where only 2 health facilities dispensed medicines; 5 private pharmacies per city were also selected (n = 30).

Outcome measure(s): Prices and availability of 50 medicines were investigated. Of these, 29 medicines were part of the WHO/HAI global and regional core lists whereas the remainder (supplementary list) were selected from the Brazilian national and municipal lists of essential medicines. For each selected medicine, data for the following variables were obtained: availability at each sampled outlet, patient price for the originator brand, the lowest-price generic, and the lowest-price, similar medicine. Availability was defined as the proportion of pharmacies in which the medicines were available at the time of the survey. Prices were presented as median price ratios (MPR). The MPR is the ratio of a medicine’s median price divided by the median international reference price. The 3 types of medicines evaluated are originator brands, generics (unbranded medicines interchangeable with the originator brand), and similar medicines (all the other medicines available in the market).

Results: In the private sector, prices were 8.6 MPR for similar medicines, 11.3 MRP for generics, and 18.7 MRP for originator brands. Mean availability was 65%, 74%, and 48% for originator brands, generics, and similar medicines, respectively. The mean overall availability in the public sector ranged from 68.8% to 81.7%; mean availability of similar medicines was 2-7 times higher than that of generics.

Conclusions: This analysis finds that availability of medicines in the public sector does not meet the challenge for supplying essential medicines to the entire population, as stated in the Brazilian constitution. Policies targeted to reduce the prices of generics need to be implemented in Brazil, as well as making generics more widely available.

Funding source: This project was supported by a grant from the Brazilian Conselho Nacional de Pesquisa e Desenvolvimento – CNP and is a product of the post-doctoral internship of the first author at the London School of Economics and Political Science – LSE Health, funded by the Brazilian Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – CAPES.



Andréa Dâmaso Bertoldi1, Noemia U L Tavares2, Pedro C Hallal1, Cora Luiza Araújo1, Ana M B Menezes1

1Universidade Federal de Pelotas, Brazil; 2Universidade da Região da Campanha, Brazil

Problem statement: Medicine use is reaching high levels in both developed and developing countries. In Brazil, although the population has problems in accessing medicines, use is high in all age brackets. Various factors contribute to this situation, including difficulty in access to health services, lack of adequate pharmacovigilance, unrestricted sale of medicines in pharmacies and drugstores, and current society’s steadfast belief in the power of medicines. Since adolescence is a phase of new sensations and experiences, it is considered a risk period for the use of substances, including medicines, and the possible harm related to such use. In Brazil, epidemiological surveys on the use of licit and illicit psychoactive substances have identified medicines (e.g., anabolic steroids and amphetamines), next to alcohol and tobacco, as one of the most frequent substance abuse groups in adolescents.

Objectives: To investigate medicine use and associated factors in adolescents; to identify the main pharmacological groups used; to study the reasons for the use of medicines; and to evaluate the source of prescription

Methods: We used a prospective study including 4,452 adolescents born in Pelotas, Brazil in 1993, representing 87.5% of the original cohort. We selected variables from the perinatal study and interviews with mothers and adolescents that could be considered possible individual determinants of medicine use. We also described the most widely used pharmacological groups, reasons for use, and origin of the prescription. Statistical significance was evaluated using the chi-square tests for heterogeneity or linear trend in the unadjusted analysis and using Poisson regression in the adjusted analysis.

Results: The overall prevalence of medicine use by the adolescents was 30.9%; out of these, 64.7% were prescribed by a physician. The most frequently used pharmacological groups were medicines for the nervous system (35.9%), respiratory system (25.7%), and systemic antibiotics (10.3%). Medicine use was directly associated with socioeconomic status, maternal schooling, and maternal health problems during pregnancy or soon after delivery, resulting in the need of intensive health care. Adolescents who were thin or fat were more likely to use medicines in comparison to those with normal body mass index. A direct association was observed between maternal use of hypnotic drugs and sedatives and adolescent medicine use.

Conclusions: Drugs acting on the nervous system were the most widely used group, and analgesics were the most frequent among these. In the current study, about one-third of analgesics had been prescribed by a physician, and although analgesics are relatively safe medicines in this age bracket, chronic use and abuse should be avoided. The results reinforce the family’s important role, particularly the mother’s, on medicine use among adolescents. Although the prevalence of medicine use in adolescence is lower than in other age groups, it is during this life phase that use begins to increase until adulthood, thus highlighting the extreme importance of educational measures to raise awareness on the risks of improper use such as self-medication and use of medicines for non-therapeutic purposes.

Funding source(s): The cohort study is supported by the Wellcome Trust. The initial phases of the cohort were funded by the European Union and the Brazilian National Program for Centers of Excellence (PRONEX), National Research Council (CNPq), and Ministry of Health.


Balancing Gender-Based Inequities to Improve Access and Uptake of TB Treatment

Sadique Bhanbhro1, Rafiq Wassan2, Sayed Sada Shah3

1Mehran Research & Development Society, Pakistan; 2University of Sindh Jamshoro Sindh Pakistan; 3Mehran Research & Development Society, Pakistan

Problem statement: Pakistan ranks 8th on the list of 22 high-burden TB countries in the world, according to the WHO Global Tuberculosis Control 2009. In 2007, an estimated 297,108 people in Pakistan (primarily adults in their productive years) developed TB. The emergence of multidrug-resistant (MDR) TB and TB-HIV co-infection is a growing concern in the country. Inequities in access to TB treatment are rampant, and place-of-residence and gender-based disparities are deteriorating day by day. A participatory and holistic approach required to address these disparities.

Objectives: To identify and analyse inequities in access to TB treatment; to mobilise the community to address existing difference to access TB medicine; to improve access and uptake of TB treatment to rural women by raising awareness of TB and availability of TB treatment through participatory action research activities

Design: A participatory action research (PAR) approach, which focuses on research whose purpose is to enable action, was employed. Action is achieved through a reflective cycle, whereby participants collect and analyse data, then determine what action should follow. Social mapping and an illness matrix were used along with key informant interviews. The participants were engaged in monthly participatory sessions for six months, in which role play, workload exercises, and flow diagrams were carried out. Information sheets and pamphlets were distributed.

Setting: A rural union council (the smallest administrative unit of district government) of district Hyderabad Sindh Pakistan

Study population: A purposive sample of 286 male (n=155) and female (n=131) community members between 18 and 60 years of age were selected on the basis of a simple selection criteria: someone who has diagnosed TB and any one in his or her family with diagnosed or suspected TB.

Outcome measure(s): Number of women who received treatment after PAR activities; number of new female TB patients completing treatment (before and after initiative); number of female patients with correct knowledge of treatment duration and importance of adherence; and whether TB was added as key topic in the council meetings and monthly meetings of partnership

Results: We found an improvement in female patients’ diagnoses and treatment; for example, 65 out of 131 (49.6%) new female patients received TB treatment as compared to 46 out of 155 (29.7%) male patients. There was increased community awareness about TB diagnostic centre and seeking treatment process and centre locations; for example, after intervention, a random sample of 150 out of 286 (52.4%) male and female community members across the villages of targeted Union Council correctly identified treatment duration, location of diagnostic laboratory and treatment centre, and significance of adherence to treatment. At Union Council level, a multi-stakeholders committee of councillors under leadership of deputy mayor was established that will work on health issues mainly TB and hepatitis.

Conclusions: For sustainable improvement in TB prevention and control, a system-based holistic approach is needed. Such an approach embeds the best practices and drives cultural change. The study suggested that the overall approach be integrated in existing system such as through the lady health workers, the population welfare workers, the lady health visitors, the local councillors, and community-based organisations.

Funding source(s): Union Council Moosa Khatyan and Mehran Research and Development Society


A conceptual framework for a system-wide definition of access to medicines

Maryam Bigdeli1, Richard O Laing2, Abdul Ghaffar1

1Alliance for Health Policy and Systems Research, World Health Organization, Switzerland; 2Department of Essential Medicines and Policies, World Health Organization, Switzerland

Problem statement

WHO considers medicines and technologies as one of the six building blocks of health systems. Most health systems strengthening interventions are designed within single building blocks of the system and interconnections between systems components are not adequately considered. In particular, complex relationships between medicines and health financing, human resources, health information and service delivery are not straightforward. The role of medicines is narrowed down to a system input, a commodity that should be available to allow service delivery. As a consequence, populations access to medicines is addressed mainly through fragmented, often vertical approach usually focussing on supply, unrelated to the wider issue of access to health services and interventions. Access to Medicines (ATM) should address supply, quality assurance and use. This shortfall has considerable consequences: with a vertical and isolated approach, interventions and policies aiming at improving ATM can only have a limited and short-term effect in resource constrained settings. This phenomenon results in the current lack of access to essential medicines for vulnerable populations in low and middle income countries


The objective of this work is to provide a conceptual framework defining ATM in the broader context of health systems strengthening and equitable access to health services and interventions.


  • We identified available definitions ATM in the published literature and systematically analyse their strength and weaknesses
  • We extended this analysis to definitions of equitable access to health services and interventions for the poor and we extract from these definitions the missing elements allowing us to complete our definition of ATM
  • We conceived and proposed an extended framework which provides a system-wide definition of ATM, taking into account interconnections between medicines and all other elements of a responsive and functioning health system.

Intervention or policy change

We will use this framework to conduct health system and policy research in the area of ATM and generate evidence for more effective policy formulation and health systems interventions


The framework defining ATM will be presented at the conference. It will examine ATM with regard:

A- The determinants of ATM: health system issues and barriers in access to medicines,

B- The impact of medicines on the health system: components of the pharmaceutical sector that impact health system in a positive or negative manner, and that will in turn generate a system reaction that will impact ATM.


There is an urgent need to formulate policies and design interventions that support adequate access to medicines for vulnerable populations. A wider holistic definition of ATM would ensure that these policies and interventions are more effective at the system level and bear longer term equitable and sustainable results.


Bibliometric Study of Publication Patterns in Access to Medicines in Low- and Middle-Income Countries

Maryam Bigdeli, Saad Ahmad, Taghreed Adam

Alliance for Health Policy and Systems Research, World Health Organization, Switzerland

Problem statement: Low- and middle-income countries (LMICs) face many challenges in accessing medicines. One of the main issues is limited evidence and knowledge base on what works to improve access to medicines (ATM) in resource-poor settings.

Objectives: Search existing evidence base on ATM and ATM barriers in LMICs; analyse publications patterns, with attention to the origin of publications and publication topics, with the aim of assessing areas where information gaps exist

Design: Literature search and analysis

Setting: LMICs

Interventions: A PubMed search was conducted to retrieve publications on ATM between 1999 and 2009, using a systematic search strategy based on Cochrane Reviews. Retrieved articles were categorized by publication year, country of residence of corresponding author, and publication topic. Patterns of publications were analysed with respect to these categories.

Outcome measures: Number of publications on ATM between 1999-2009 according to publication year; country of residence of the corresponding author; classification of that country as low income, lower middle income, upper middle income, or high income; and publication topic (selection, intellectual property, regulation and quality assurance [QA], monitoring, financing and insurance, access, procurement and distribution, supply, policy reform, pharmacists, prescribing and utilization, information, marketing)

Results: Overall, 5491 publications on ATM were retrieved for the period 1999-2009. Publications on ATM have increased in the past 10 years, from 40 in 1999 to 111 in 2009; 48.27% of all publications originate from high-income countries, 18.8% from higher middle-income countries, and only 18.55% of evidence originates from low-income countries. The majority of publications relate to monitoring and regulation and quality assurance; together, 73.5% of available evidence on ATM. However, these categories are also those in which LMICs have the lowest input—only 5.53% of publications on monitoring and 7.87% of publications on regulation and QA. LMICs are very active in the fields of selection of medicines and general access issues; 46.87% and 42.97%, respectively, of publications in these areas originate from LMICs. Areas of concern, such as prescribing and utilization or financing and insurance, are underrepresented in the available evidence, with only minimal input from LMICs.

Conclusions: The majority of evidence on ATM originates from high-income countries, in areas where results and recommendations are irrelevant in resource-constrained settings (e.g., regulation and QA). There is a need to support more research in LMICs and extend this effort to publication and dissemination of research findings and recommendations for larger use in comparable contexts. Neglected areas of research, such as rational use or financing, lead to important evidence gaps; these areas need to be prioritized in future research and publications.

Funding source: None


Prescribing Pattern of Antibiotics in Health Facilities in Baghdad, Iraq

Ezechiel Bisalinkumi1, Abdul Rasoul Wais2, Manal M. Yunis3

1WHO Iraq Country Office, Jordan; 2Ministry of Higher Education, Iraq; 3Ministry of Health Iraq

Problem statement: Widespread drug resistance has been observed in Iraq’s health facilities. No systematic approach to identifying the magnitude of this problem has been followed. Antibiotics are among the most highly misused and irrationally prescribed medicines by health professionals, which directly contributes to the drug resistance problem.

Objectives: To investigate the prescribing pattern of antibiotics in various levels of health facilities in the Baghdad Governorate region and to quantify the magnitude of antibiotic misuse

Design: A retrospective study of the antibiotic prescribing pattern was conducted in 22 randomly selected health facilities in Baghdad Governorate. The health facilities studied included primary health care centres (n =16) and general hospitals (n = 6). Prescriptions were randomly collected and analysed using the WHO standard method of investigating drug use in health facilities; 300 prescriptions were selected from a pool of 3 months of prescriptions for each health facility.

Setting: The study was conducted in the public sector health facilities in the Grand Baghdad region, which is the largest city in Iraq with a population of more than 5 million. This region is served by about 200 PHCs and 30 hospitals (secondary and tertiary).

Results: Analysis of the data revealed that more than 70 % of prescriptions contain antibiotics, which is a high percentage compared to similar countries in the region. The rate was higher at PHCs than at outpatient clinics in hospitals. However, in both cases, the rate is considered higher than practically acceptable in such medical service settings, and this pattern is likely to be the same in other regions in Iraq.

Conclusion: Nationwide studies are needed to identify the pattern of antibiotic prescribing and to evaluate the interventional approaches to achieve a more rational use and prescribing of antibiotics.

Funding source: Information not provided


Gender Inequalities in Medicine Expenditure and Family Budget Allocated to Medicines in a Southern Brazilian City: Population-Based Study

Alexandra Crispim Boing1, Karen Glaser Peres1, Andréa Dâmaso Bertoldi2

1Universidade Federal de Santa Catarina, Brazil; 2Universidade Federal de Pelotas, Brazil

Problem statement: Gender inequalities are considered one of the main barriers for human development. Gender inequalities have been reported in the literature in different areas of knowledge, including the health sector. Recently, with the change in the social and economical positions of women, studies in the health field have explored in what manner and in what intensity men and women present unequal outcomes in health. However, there is a gap in the knowledge about gender differences related to medicine utilization, expenditures with medicines, and the proportion of the family income spent on medicines.

Objectives: To describe gender inequalities regarding the use of medicines and out-of-pocket expenses with medicines in an adult population

Design: Cross-sectional, household-based study

Setting: Multi-stage sampling strategy was used. Census tracts (delimited areas comprising approximately 300 households each) were the primary sampling units and the households were the secondary units. Utilization and expenses of medicines in the previous 30 days were investigated with a pre-tested questionnaire. Use of medicines and absolute and proportional values of out-of-pocket expenses for medicines were analyzed according to family income and gender, taking the clustering of the sample into account.

Study population: Adults aged 20 to 59 years, living in the urban area of Florianopólis, a medium-sized city in the south of Brazil, with an estimated population of 410,000 inhabitants; the final sample was made up of 2,016 people and the data were collected from September 2009 to January 2010.

Outcome measures: Use of medicines and absolute and proportional out-of-pocket expenses with medicine in the previous 30 days. All the values spent on medicines by each member of the family in the previous 30 days were added and divided by the per capita family income and shown as percentages. The proportion of the family income spent on medicines was also calculated considering a cut-point higher or equal to 10% of the per capita family income.

Results: The response rate was 85.3% (n = 1,720). The prevalence of medicine use was 77.4% (95% CI 74.8 to 80.0) and was higher among women (85.9% vs. 66.8%; p < 0.01). The average monthly expenditure on medicine was USD 26.7, with higher rates among women as compared to men (USD 31.8 vs. USD 20.2; p < 0.01). Although only 8.8% (95% CI 6.1 to 10.7) of the men committed more than 10% of their income to purchasing medicine, this figure reached 15.2% (95% CI 12.9 to 17.6) in women. Besides that, women committed 5.8% of their income and men 3.0% (p < 0.01). After unsuccessful attempts to obtain medicines in the public health service, the proportion of people who paid for medicines was higher among women.

Conclusions: There is significant gender inequality in the use of medicines and out-of-pocket expenses for medicines, with the worst results among women.

Funding source: Brazilian National Council for Scientific and Technological Development (CNPq)


Management of Drug-Resistant Tuberculosis Patients, Egypt Experience

Magdy Fawzy Boktor, Sherry Victor Michael, Alaa Mokhtar Morsy

Ministry of Health, National TB control program,Egypt

Problem Statement: Multidrug resistant tuberculosis (MDR-TB) is a global important problem represents , and among all cases (4.8%),, new (2.9%), and previously treated (15.3%). In Egypt, MDR-TB was 2.2% and 38.4% among new and retreated cases respectively.

Objective: To evaluate treatment outcome of the first treatment cohort and to identify factors affecting it.

Methods: One hundred sixty-eight MDR-TB patients were admitted to Abbassia Chest Hospital through the end of September 2008. Of these patients, , 65 completed their treatment course on an individualized regimen.

Results: Forty-four patients achieved successful treatment (67.7%). The proportion of failures, defaulters. and deaths were 6 (9.2%), 4 (6.2%), and 11 (16.9%) respectively. Successful treatment was associated with young age, nonsmoking, no regimen of second-line anti-TB drugs, sputum culture conversion before 3 months, and less extensive lung destruction. On multivariate analysis, independent factors were age, time to culture conversion, and extension of lung destruction.

Conclusions: The rate of successful treatment (67.7 %) is comparable with the average reached in other countries. The relatively high mortality rate (16.9%) mandates rapid diagnosis, treatment, and application of direct observation throughout the whole course. Age, time to culture conversion, and extension of lung lesion were independent predictors of successful treatment.

Funding Source: Information not available


Improving Adherence and Clinic Attendance Among Patients on Antiretroviral Treatment in Kenya: A System Level Intervention

Patrick Kibiwott Boruett1, Susan Njogo2, Dorine Kagai2, Peter Nguhiu1, Liliian Gitau1, Christine Awuor2, John Chalker1, Dennis Ross-Degnan3, Goran Tomson4, Rolf Wahlstrom4

1Management Sciences for Health/Strengthening Pharmaceutical Systems; 2National AIDS/STI Control Program, Kenya; 3Harvard Medical School and Harvard Pilgrim Health Care, USA; 4Division of Global Health (IHCAR), Karolinska Institutet, Sweden

Problem statement: With the recent rapid increase in access to antiretroviral therapy (ART), there is a need to address adherence to ART, which is critical to treatment outcomes. Few published studies to date have assessed the impact of health systems interventions to improve adherence.

Objectives: To measure the effectiveness of a health systems intervention to monitor patient adherence and clinic attendance

Design: A quasi-experimental study with 2 patient cohorts, using time series analysis

Setting: 12 government district hospitals, 6 for the intervention and 6 controls, in 3 regions

Study population: Adult patients who (1) had experience of treatment more than 6 months (n = 605) or (2) initiated treatment at the facility with no prior exposure to ART (n = 845).

Intervention: In April 2009, a tool for tracking patient clinic attendance and a modified national form to monitor appointment keeping and self-report on adherence were introduced, combined with training of health workers. Support visits were conducted to reinforce the implementation.

Outcome measures: Percentage of patients (1) attending the clinic on or before, or within 3 days of, the scheduled appointment date and (2) with a gap in medication of 15 days or more. Data were collected from 6 months before the start of the intervention until 12 months after the end of the intervention month.

Results: In experienced patients, the change in level and trend increased significantly for patients attending clinic on or before scheduled appointment by 5.7 percentage units (95% CI 2.1, 9.4) from a pre-intervention level of about 80%, and 1.03% per month (95% CI 0.6, 1.5), respectively, and for those keeping appointments within 3 days by 4.2 percentage units (95% CI 1.7, 6.8) and 0.82 (95% CI 0.56, 1.1). A reduction by 9.4 percentage units (95% CI −16.5,−2.4) in medication gap greater than 15 days from a pre-intervention level of about 25% was observed in the experienced patients cohort. There were no significant changes observed in trend and level for the new cohort during the study period.

Conclusions: The limited improvement in both trend and level of adherence measures after introducing an appointment tracking system are still of national interest for scaling up because all possible mechanisms should be utilized to minimize nonadherence to treatment.

Funding sources: The study is part of the INRUD Initiative on Adherence to Antiretrovirals funded by the Swedish International Development Cooperation Agency with additional funding from the USAID-funded Strengthening Pharmacy Systems Project through Management Sciences for Health.


An Audit of Case Management of Common Childhood Illnesses in Hospitals in Ghana

Mary Nana Ama Brantuo1, Cynthia Bannerman2, Isabella Sagoe-Moses2, Martha Gyansa-Lutterodt3, Edith Andrews-Annan1

1World Health Organisation, Ghana; 2Ghana Health Service; 3Ministry of Health, Ghana

Problem statement: Poor-quality care for sick children in peripheral hospitals contributes to deaths in the under-five age group. As part of the effort to improve the quality of care for sick children, the Ghana Ministry of Health plans to adapt the WHO pocket book, Hospital Care for Children, to serve as the national standard for managing childhood illness in hospitals. Therefore an audit was required to assess the current practices and services against the set standards, to provide the basis for actions to align practices with the recommended standards.

Objectives: To compare the case management of children in selected hospitals in Ghana against the minimum standards set by WHO

Design: This was a cross-sectional observational survey, comparing existing practices with set standards.

Setting: The assessment was conducted in 5 of 10 regions in Ghana to reflect the different ecological zones in the country. Ten hospitals were purposively selected to reflect rural vs. urban locations, the different levels (i.e., regional, district, and specialist hospitals), and the ownership of facilities (i.e., public and faith-based organization–owned hospitals).

Study population: The study population was hospitals providing care to children. The management of sick children with fever, cough or difficult breathing, HIV/AIDS, neonatal conditions, and malnutrition was assessed through observation and review of records. In each hospital, case management was assessed by reviewing (where available) at least two cases on the ward. If only one case was available, it was reviewed and case notes of previous cases as well. Where cases or case notes were not available, staff were interviewed on the management practices.

Outcome measure(s): The key outcome measures were case management practices including appropriate diagnosis, treatment, monitoring, and supportive care of children under age five who were being treated for the above-listed conditions.

Results: We found some case management practices that were in accordance with the WHO standards. Patients diagnosed with pneumonia in all 10 facilities were treated appropriately with antibiotics such as ampicillin, gentamicin, and ceftriaxone. Co-trimoxazole prophylaxis for children with HIV was correctly administered in all 10 facilities, and antiretroviral treatment in accordance with national guidelines was used in 8 out of the 10 facilities. Some weaknesses in the case management practices were also observed. Monitoring of intravenous fluid use in patients with diarrhoea was poor in 6 of the 10 facilities, and management of electrolyte imbalances in severely malnourished children was poor in 9 of the 10 facilities. Case management practices were better for children with HIV/AIDS, where protocols were available and staff had been trained on their use, and were poorer for diarrhoea and malnutrition cases because protocols and guidelines were often not available.

Conclusion: The assessment showed a significant gap in the clinical practice as against set standards, thus the need to develop or adapt guidelines for inpatient care of sick children.

Funding source(s): Bill and Melinda Gates Foundation


Study on National Essential Medicines Lists from 8 Countries of the Western African Economic and Monetary Union

Carinne Bruneton

Réseau Médicaments et Développement (ReMeD), France

Problem statement: The countries Benin, Burkina Faso, Ivory Cost, Guinea Bissau, Mali, Niger, Senegal, and Togo, who are members of the West African Economic and Monetary Union (WAEMU), have their own national essential medicines list (NEML) corresponding to their specific health needs and their programmes to promoting rational drug use. A comparative study of these NEMLs was undertaken to measure the impact of the 15th WHO Essential Model List (WHO/EML) in identifying the choice items of essential medicines in drawing up NEML.

Objectives: To compare 8 NEMLs with the 15th WHO/EML promulgated at the period of the study period with comparative analysis of data; to evaluate the level of use of the NEML in each country; to assess the therapeutic guidelines and standard therapeutic diagrams for nurses for promotion these lists; to collect the studies concerning the rational use of medicines in the 8 countries; and to write recommendations of rational use of NEML.

Design: It was a comparative study.

Setting: It was a regional study in western Africa.

Interventions: A circular mission was realized in April 2008 to collect the NEML from 8 countries and therapeutic guidelines on the main diseases (AIDS, malaria, and tuberculosis). A comparative analysis of the situation in each country with production of a temporary report was done. Additionally, a workshop involving pharmacists of the countries and validating the results was organized in February 2009 before the final report.

Results: The number of medicines increases year to year in all the countries, except in Guinea Bissau where the number was diminished slightly; 3 countries have compounds from traditional medicines in their NEMLs. The medicines are not divided in core and complementary list as described by WHO/EML. The demand for anti-infectives, analgesics, cardiovascular, and antineoplastics is very large; 91 medicines registered on the WHO/EML do not appear in the NEMLs, 560 medicines (dosages, pharmaceutical forms, diverse associations) appear in the 8 NEMLs but not in WHO/EML; 3 lists in the 8 countries countain medical devices in their NEMLs, and 3 other lists have traditional medicines.

Conclusions: Distinctions between a core and complementary list are not found in the 8 NEMLs, and some medicines existing in WHO/EML are not present in NEML. Traditional compounds from traditional medicines are presents in 3 country lists; 560 medicines are included with little evidence of their efficacy and/or safety; and they must be studied in the future in order to remove them from the 8 NEMLs.

Funding sources: WAEMU and ReMeD (Network for Medicines and Developpement)


The Impact of the 2008 Economic Recession on the Pharmaceutical Sector in the Baltic Countries

Joel Hernandez Buenaventura1, Richard Ogilvie Laing2, Kees de Joncheere3, Carandang Edelisa2

1Boston University School of Public Health, United States of America; 2World Health Organization Department of Essential Medicines and Pharmaceutical Policies; 3World Health Organization Regional Office for Europe

Problem Statement: The global financial crisis of September 2008 severely affected the economies of many countries. The World Health Organization, in line with its agenda to build global health security, is concerned with the assessment of the possible health consequences of the economic recession. An important area of interest is gauging how an economic recession can impact the access to health care of the population, particularly access to essential medicines.

Objectives: To investigate the impact of the 2008 economic recession on the pharmaceutical sector of two Baltic countries (Estonia and Latvia), which was shown to have the most substantial declines in pharmaceutical consumption and explore qualitatively what policies could have caused this decline to possibly provide a framework for policy making in times of economic recession.

Design: Descriptive study. Data were gathered through comprehensive literature review to identify possible contributory factors that led to the substantial decrease in pharmaceutical consumption in Estonia and Latvia. Country specific quarterly data from IMS Health and Economic Intelligence Unit (EIU) from 2007 to 2009 were also generated. Teleconference interviews with a focal person from Estonia and from Latvia each was done to validate findings.

Setting: International/Regional (Baltic). Examines public sectors in Estonia and Latvia.

Policy: Policies enacted in Estonia and Latvia during the 2008 economic recession.

Outcome Measure: Pharmaceutical expenditure, consumption, pricing index

Results: EIU data showed that the economies of Estonia and Latvia had been contracting even before the global economic crisis hit them and other countries. Because of their determination to fulfil the Maastricht Criteria for the adoption of the euro, they had limited flexibility in terms of policy changes in response to the economic crisis. While the economic crisis has led to reduced public expenditures in most countries with health budgets spared and medicine consumption remaining stable, Baltic countries gave mixed picture. IMS data showed that there was a substantial decline in the pharmaceutical expenditure and consumption, and an increase in pharmaceutical prices. Estonia had increase in public expenditure; Latvia had 10% decline in public sector budgets on medicines, but patients were protected from co-payments through social compensation funds. Decline in total market was mostly in therapeutically less relevant groups.

Conclusion: IMS data indicate that pharmaceutical consumption substantially declined in the Baltic countries among other European countries. Many individual patients were likely to have either reduced their consumption or increased their out-of-pocket expenditure as the prices of pharmaceuticals went up. However, the impact of the decline in pharmaceutical consumption during the economic recession on the health status of these populations remains to be seen.

Funding Source: WHO


Pharmaceutical Situation Assessment: Methodological Challenges for Different Contexts

Monica Rodrigues Campos, Isabel Emmerick, Vera Lúcia Luiza

Oswaldo Cruz Foundation, Brazil

Problem statement: The Pharmaceutical Situation Assessment (PSA) package is an approach proposed by the World Health Organization broadly and increasingly used by countries worldwide. The methodological approach is designed to be easily implemented by countries with low resources and scarcity of planning data. The sampling for the level II approach is defined considering the population of public health facilities (PHF) and is based on the premise of a low variability of indicators among PHF in a country. The current approach proposes 30 PHF, 6 in 5 country regions, independently of a country’s characteristics. The experience of supporting Latin American and Caribbean (LAC) and Portuguese-speaking countries allowed us to see that many times the utilization of results in the decision-making process is impaired by questions presented by local stakeholders in relation to reliability and validity of data and representativeness of sampling.

Objectives: Based on actual data, to present a sampling exercise to calculate the maximum error, (emax) considering the parameter for the proportion of indicators as 50% (p = 0.5) and estimate the error “esample” for selected indicators, considering the results found in 11 country surveys

Design: Exploratory study using actual data from PSA-level II applied in 11 countries; to calculate emax, the population and sample of PHF in each country was used. To calculate esample, selected indicators were organized in groups of measurement (organization, access, quality, and rational use) that express their use by countries. The esample was calculated to the median value in each group of indicators.

Setting: Selected LAC countries (10) and Portuguese-speaking countries (1)

Study population: PHFs

Outcome measure(s): Considering the parameter as 50% (p = 0.5), emax and esample for selected indicators

Results: The emax varies across countries from 6% to 17%. The esample varied according to the group of indicators measured—“Organization” 0% to 17%; “Access” 3% to 10%; “Quality” 6% to 14%; and “Rational Use” 6% to 17%.

Conclusions: The emax was low when the total number of PHF (population) in a country was small. The esample indicates that the homogeneity varies according to groups of indicators. Higher homogeneity was observed for access. Lower homogeneity was observed for rational use, because this group includes a greater number of indicators and because sources of data are diverse. The results point to the importance of considering error variability as well as actual indicator measurement for each indicator group. We propose to include information on the error associated with each sample size in the WHO standard methodology, which should consider the total number of PHFs. These possibilities must be negotiated with local stakeholders.

Funding source(s): Oswaldo Cruz Foundation – Ministry of Health of Brazil


Gender and Medicines In HIV/AIDS, Tuberculosis, and Malaria in Low- and Middle-Income Countries: A Systematic Review

Joao Carapinha1, Dennis Ross-Degnan2, Catherine Vialle-Valentin2, Anita Wagner2

1Northeastern University; 2Harvard Medical School and Harvard Pilgrim Health Care Institute

Problem statement: Medicines are essential tools that improve health in low and middle-income countries, and numerous studies have established their impact in the management of HIV/AIDS, tuberculosis, and malaria. Studies suggest that there are socioeconomic, geographic, institutional, and sectoral differences in medicine access and use, yet few explore gender differences, and no systematic review is available to summarize such differences.

Objectives: To systematically search and summarize literature that describes gender differences in medicine access and use in HIV/AIDS, tuberculosis, and malaria in low- and middle-income countries and to highlight opportunities for further research

Design: Systematic review of published literature

Setting and study population: Studies that describe gender differences in the HIV/AIDS, tuberculosis, and malaria population in low- and middle-income countries

Outcome measures: A conceptual framework that delineates an access and care-seeking pathway was used to categorize all literature, and key characteristics are described by disease area, geographic region, research design, and quality of evidence.

Results: We found 1,057 studies using popular citation databases, institutional databases, and web archives of key multilateral and donor organizations. All studies were manually searched; and 40 met our search criteria, 21 of which reported gender differences as a primary research concern and the remaining studies included some gender results. Most studies describe gender differences in sub-Saharan Africa (n = 10), Southeast Asia (n = 7), and Latin America (n = 2). Many are concerned with HIV/AIDS (n = 19); 1 study reports gender differences in tuberculosis, and no studies are available for malaria. Studies explore access (n = 12), adherence (n = 2), and acceptability (n = 1) of medicines from a gender perspective, and most describe the influence of livelihood assets (n = 10), transforming structures and processes (n = 4), and livelihood outcomes (n = 7). Some studies had acceptable research designs, either time-series (n = 6), pre-post design with a control group (n = 1), cross-sectional (n = 4), or qualitative research (n = 11).

Conclusion: The results of our systematic review suggest that gender research about medicines is dominated by access studies in HIV/AIDS in sub-Saharan Africa and Southeast Asia. Little is known about gender differences in Asia-Pacific, Latin America, and the Middle East. Studies that adopt a gender perspective employ time-series and qualitative research designs to explore social and individual resources that impact medicine access and use. Further research is required to understand contextual factors that determine gender differences, and more attention is required to understand such differences in tuberculosis and malaria. Capacity building, institutional commitment, and donor support will be required to resource and expand gender research.

Funding source: Grant from the United Kingdom Department for International Development


Evaluation of a Continuing Medical Education Program for Primary Care Services in the Hypoglycemic Agent’s Prescription in Diabetes Mellitus Type 2

Angelica Castro-Ríos1, Hortensia Reyes-Morales2, Ricardo Perez-Cuevas1

1Mexican Institute of Social Security, Mexico; 2National Institute of Public Health, Mexico

Problem statement: The organizational conditions and the lack of utilization of evidence-based clinical recommendations affect the potential effectiveness of treatments for diabetes. In Mexico, only 21% of public primary care physicians provide proper care to diabetic patients.

Objectives: To evaluate in primary care clinics the impact of a continuing medical education intervention in the prescription of hypoglycemic drugs.

Design: We conducted an observational study with 2 control/intervention groups with before and after periods. The groups correspond to patients treated in primary care clinics; the design matched the clinics geographically, by infrastructure and annual budget. The unit of analysis was the drug prescription of each visit.

Setting: The study took place in 4 primary care clinics belonging to the Mexican Institute of Social Security.

Study population: Patients with less than 10 years with type 2 diabetes diagnosis were included. Regarding the clinical homogeneity of the sample, patients with chronic complications of diabetes were excluded. The patients’ selection was a nonrandom sample by quotes with proportional distribution by primary care room. The sample size was 431 participants in each group using the formula for difference of proportions; assuming confidence of 95%, proportion of proper prescription 20%; effect of the program 10%; and non-response 10%.

Intervention: The intervention included two phases; the first one consisted of training physicians from the referral hospital as clinical instructors. The second phase consisted of training family physicians through sequential activities performed with the clinical instructor. An evidence-based clinical guideline was previously designed and served as the groundwork for the intervention.

Outcome measure: The outcome variable was the proportion of patients with proper hypoglycemic prescription. Two criteria served to evaluate the prescription: the selection of the drug and the indication of dose and interval. Three logistic regression models and the double differences technique were applied to determine the impact of the intervention on the improvement of each prescription criteria and the general prescription.

Results: The information of 2,116 visits relative to 824 patients served for the analysis. The intervention increased the probability of proper selection of the hypoglycemic drug by 78% [OR = 1.78 (95% CI, 1.1-2.9)] and the probability of proper prescription in patients with obesity by 185% [OR = 2.85 (95% CI, 1.8-4.4)]. These results were equivalent to an increase of 11% on the proportion of patients with proper selection of the drug and 0.6% on the proportion of patients with proper prescription (selection and indication).

Conclusions: The continuing medical education intervention for primary care services increased the proportion of proper prescription of hypoglycemic agents.

Funding source: Information not provided


School-Based Education Program Can Favorably Impact National Public Health Budget

Natalia Cebotarenco, Patricia Bush, Anaida Aivazyan, Svetlana Shetinina

CoRSUM - Coalition for Rational and Safe Use of Medicines, Moldova, Republic of

Problem Statement: One reason antimicrobial drug resistance is of concern is its economic impact on the public health system. Few programs designed to decrease inappropriate antibiotic use have demonstrated economic benefits relative to their cost.

Objectives: Estimate savings from decreasing antibiotic use for colds and flu by a student-taught program.

Design: Pre-post design with well-matched control.

Setting and Study Population: 3,586 sixth-level students and 2,716 of their primary caregivers in Chisinau, Moldova, in 2003–04.

Intervention: Parents and students in 21 schools (20 schools served as controls) were taught by classmates not to take antibiotics for colds and flu. Pre-intervention survey results indicated that during the winter, 73% of students and 57% of adults had 1+ cold and/or flu; 79% of students and 91% of adults believed that it is always or sometimes useful to take antibiotics for colds or flu. Of those with 1+ cold and/or flu, 51% of students and 71% of adults treated them with antibiotics; however, 32% of students didn’t know if they had taken an antibiotic or not. Post-intervention survey results adjusted for controls indicated that students who reported they did not treat colds or flu with antibiotics increased 34%; the comparable increase for adults was 38%. Logistic regression modeling indicated that intervention students were 3.7 times more likely than control students to indicate they had not taken an antibiotic and for adults, 5.5 times more. A conservative estimate of cost was based on these assumptions: (1) if antibiotic was used, it was used for only one cold/flu episode; (2) the average antibiotic prescription cost was 9 U.S. dollars (USD); (3) patient pays for prescription but not for physician visit to obtain prescription; and (5) student “do not know” response rate equals that of adults.

Policy: Implementation of ICIUM 2004 recommendation, “Children can be effective change agents to improve community medicine use. Countries should consider school-based education programs that involve children as a way for key messages to reach parents.”

Outcome Measures: Cost savings from reduced antibiotic use in target population and estimated savings if intervention implemented throughout Moldova.

Results: The cost savings in the reduction of antibiotic use for colds and flu from pre-intervention to post-intervention was estimated to be USD 1.94 per student and USD 2.01 per adult primary caregiver. Imputing this savings to the national population of seventh-form students (56,090 in 2004–2005) and their primary caregivers resulted in a national estimated savings of USD 221,556. This underestimates the actual savings as the cost of reducing physician visits to obtain the antibiotic prescriptions is not included nor is the probable reduction in antibiotic use by other family members.

Conclusion: School-based program is cost-effective and should be extended to national level.

Funding Source: CoRSUM.


Community Learns Appropriate Antibiotic Use Through Kindergarten Performances

Natalia Cebotarenco, Patricia Bush, Vera Grigorchuk, Anaida Aivazyan, Svetlana Shetinina

CoRSUM - Coalition for Rational and Safe Use of Medicines, Moldova, Republic of

Problem statement: One of the recommendations of ICIUM 2004 was, “Children can be effective change agents to improve community medicine use. Countries should consider school-based education programs that involve children as a way for key messages to reach parents”. Currently, children and adolescents have few opportunities to learn to use medicines appropriately, although use of medicines is a common everyday activity throughout the world. In 2002–2004, CoRSUM designed and implemented an innovative school-based, peer-taught program in Moldova middle schools that decreased antibiotic use for colds and flu among students and parents. Kindergarten students were the focus of the next program aimed at decreasing inappropriate antibiotic use.

Objectives: Design and implement an educational interactive program for kindergarten children and their parents to reduce inappropriate antibiotic use for colds and flu.

Design: Before–after intervention study with no control groups

Setting: Moldova communities of Tiraspol (18 kindergartens) and Briceni (3 kindergartens)

Study population: Convenience sample of 85 teachers, 54 health care workers, 1,200 parents and grandparents, and 548 children in the period 2006–2007

Intervention: Phase I: three focus group discussions (FGDs) with parents of kindergarten children (7 years old); four FGDs with kindergarten methodologists to assist development of appropriate scenarios for students; three meetings with Ministry of Education officials to obtain support. Phase II: 45 minute performances conducted with the active participation of the kindergarten children and parents and attended by health professionals, community residents, and administrators; each kindergarten presented a unique program within scenario guidelines; follow-up workshops with parents and teachers discussed the performances. Phase III: June 2007, a national conference introduced the program and promoted its dissemination.

Policy: Implementation of ICIUM 2004 recommendations re dissemination of the kindergarten program

Outcome measure(s): Parents knowledge of inappropriate antibiotic use for colds and flu

Results: A pre-intervention questionnaire given to the childrens’ parents indicated that 72% of the children had a cold or flu the prior winter. Of these, 76% had been given an antibiotic with 69% obtained via doctor’s prescription. At the end of the performances, which presented the primary message in various entertaining ways, the parents came to the stage to answer questions by lining up behind signs (Yes, No, DK), e.g., Do antibiotics kill viruses? It was clear that parents had learned the message, “Don’t take antibiotics for colds and flu.”

Conclusions: Kindergarten is not too young for health messages; parents will come to see their children perform; learning can be fun and children can serve as conduits to carry important public messages to their communities.

Funding source(s): CoRSUM



Natalia Cebotarenco, Manoj Kurian, Maria Cetulean, Sofia Alexandru

CoRSUM - Coalition for Rational and Safe Use of Medicines, Moldova, Republic of

Problem Statement: As the 21st century begins, tuberculosis (TB) remains a major public health threat and the world’s leading cause of death from a curable infectious disease. Pediatric TB did not have a high priority in many developing countries including Moldova as fewer children than adults have the disease and children are not usually infectious. A vast number of infected children remain undiagnosed—creating a reservoir of future adult disease. There are a limited number of pediatric TB departments in Moldova, and families with a child with TB have to pay for travelling to a clinic.. The next problem is the lack of pediatric dosages which can lead to increasing rate of resistance forms of tuberculosis among children.

Objectives: To investigate the situation in TB, and multidrug-resistant (MDR) –TB among children in Moldova. To identify obstacles in accelerating progress in the achievement of the Millennium Development Goals (MDG).

Design: Epidemiological study, pharmaceutical policy analysis, time series study

Setting: Children with TB in Moldova. Municipal tuberculosis hospital, pediatrics department, Chisinau, Moldova.

Study Population: All TB cases among children registered in Chisinau, Moldova, from 2000 to 2009

Interventions: Studied medical cards of children treated in municipal TB hospital, Chisinau; annual reports of anti-Tb medicines supply during 2000–2010 focusing on availability of pediatric forms.

Policy: Implementation of the MDG Target 4 and Target 6; and Resolution WHA 60_R20.

Outcome Measures: Number of TB and MDR-TB cases in children TB; availability of pediatrics forms and strengths of anti-TB medicines.

Results: In Moldova, the total number of children with TB was 85 in 2000. A DOTS program was implemented in Moldova in 2001. The number of new case notification of TB in children increased during four years to 217 cases in 2004. Since 2005, the total number of children with TB started to decrease; children received the treatment in Chisinau TB hospital and in two more settings— Balt and Bender. In 2005, 50% of all children with TB (86 of 170 total) in Chisinau municipal hospital were treated; in 2006–85 children out of 162 were treated; in 2007–70 children out of 162. In 2008 and 2009, about 30% were treated—51 (141) and 59 (150). Among all children with TB, the % of girls with TB increased: in 2005–43%, 2006– 48%; 200 – 47%; 2008–47% and in 2009– 53%. Patterns of drug resistance were registered among children since 2006: in 2006, there were 9 cases of MDR-TB in children (6 girls), in 2007, 3 cases (3 girls); 2008, 9 cases (5 girls), and in 2010, 14 cases (10 girls). Despite pediatric formulation being included in Essential Drug List of Moldova, at present no pediatric forms and strengths are available in Moldova.

Conclusions: MDR-TB among children is increasing during last few years, mainly among girls. There is the urgent need of procuring children’s dosage forms of anti-TB drugs.

Funding Sources: WCC, CoRSUM.


East African Health Budgets 2010/2011: An Analysis on Financing for Essential Medicines

Christina Anna Cepuch1, Thomas Maina2

1HAI Africa, Kenya; 2Health Economist, Kenya

Problem Statement: Access to essential medicines (EMs) is a goal for all the health systems in the East Africa Community (EAC). Insufficient financing is a barrier to access. Monitoring and tracking of national budget allocations to health and EMs provides evidence for advocacy surrounding government prioritization, expenditure tracking, and participation in the budget-making process.

Objectives: To analyze the national budgets of four East African countries to identify and determine the overall budget allocations to the public health sector. To understand the broad and specific budget lines where the allocations on health relate to current and development spending. To examine the allocations to EMs and to treating specific diseases. To identify other resources outside the budget that relate to the health sector such as health-related economic stimulus packages and complimentary donor resources.

Design: Economic analysis

Setting: Four EAC countries—Kenya, Rwanda, Tanzania, Uganda. Health policy strategic plans and priorities. Macroeconomic settings. 2010/11 budget estimates reviewed and compared with 2009/10 estimates. Analyses of budgets by recurrence and development and by economic categories with a focus on EMs.

Study Population: National health budgets of Kenya, Rwanda, Tanzania, Uganda.

Policy Change: Budgetary allocations for health and medicines were evaluated based on the same stated priorities in national budgets, future vision documents (e.g., Vision 2030), and strategic plans.

Outcome Measure: Budget allocations to health and essential medicines.

Results: For Kenya: from 2009/10 to 2010/11, total government budget for health increased by 19.3% but decreased (by 0.6%) in terms of percentage to health from total government budget. Expenditure on medicines remains low (8.8% of total MOH recurrent budget) and is decreasing over time. Significant shift of resources from recurrent budget to development budget. Rising share for primary health. Significant development partner funds are off-budget. Medicines dropped from economic stimulus package funding. Per capita expenditure on medicines 1.37 US dollars. We found similar findings for Rwanda, Tanzania, and Uganda.

Conclusions: Insufficient (and decreasing) budgetary allocations for essential medicines from national and health budget. Decreasing expenditure on health as a percentage of government budgets. Low financing for EMs is a major barrier to access.

Funding Source: Children’s Investment Fund Foundation (CIFF) through the Campaign to End Paediatric AIDS (CEPA) and Open Society Institute (OSI) through the Stop Stock-outs Campaign (SSO)


Monitoring Medicine Prices and Availability in Kenya Using WHO/HAI Methodology 2009–2010

Christina Anna Cepuch1, Regina Mbindyo2, Fred Moin Siyoi3, Njeri Mucheru4, Joanne Wakori5

1HAI Africa, Kenya; 2WHO Kenya Country Office; 3Pharmacy and Poisons Board, Kenya; 4Ministry of Medical Services, Kenya; 5Kenya Medical Supplies Agency

Problem Statement: Access to essential medicines (EMs) is a goal for Kenya’s health system. Price is a barrier to access especially in developing countries and where significant out-of-pocket spending occurs. Monitoring EM prices and availability (MMePA) gives evidence for policy development and strategic planning on pricing. Collaborative MMePA is carried out quarterly in Kenya.

Objectives: To document availability and price of EMs in the public, private, and faith-based health (FBH) sectors. To monitor affordability of treatment for ordinary Kenyans. To monitor procurement prices in public sector and compare them to international reference prices.

Design: Time series study; adapted WHO/HAI medicine price survey methodology

Setting: National monitoring in public, private, and FBH sectors in four provinces. Monitoring sites: hospitals, health centers, dispensaries, central warehouses, retail pharmacies

Study Population: 96 facilities (32 per sector) and 26 EMs in 2009/2010.

Policy Change: MMePA results used in the ongoing review of National Drug Policy 1994. Health SWAp implemented within the second Health Sector Strategic Plan. Some increase in medicines financing from government and donors. MMePA results are basis of innovative civil society Stop Stock-Outs campaign.

Outcome Measures: Availability, price, medicines for free, affordability

Results: Selected results for public, private, and FBH sectors: (1) median availability of EMs—69, 69, 80; (2) median price ratios for centralized procurement (public, FBH sector) —0.44, 0.61; (3) Pprcentage medicines issued for free—89, 15, 0; and (4) affordability of selected individual treatments: <1day’s reference wage.

Conclusions: Low and fluctuant availability of EMs especially in public and FBH sector facilities. Price efficient public and FBH sector centralized procurement. Low or no price barriers to accessing EMs in public sector. MMePA not integrated within health sector monitoring and evaluation framework.

Funding Sources: DFID-supported WHO/HAI Collaboration Project on Access to Essential Medicines and Directorate-General for International Cooperation, Netherlands through HAI Global


Piloting the Developement of a Cost-Effective, Evidence-Informed Clinical Pathway: Managing Hypertension in Jordanian Primary Care

Kalipso Chalkidou, Joanne Lord, Nour Obeidat, Ibrahim Alabbadi, Adrian Stanley, Rania Bader, Ayman Momani, Rachel O’Mahony, Lara Qatami, Derek Cutler

University of Jordan, Jordan

Objectives: The UK’s National Institute for Health and Clinical Excellence (NICE) and the Jordan office of the Medicines Transparency Alliance embarked on a pilot project to design an evidence-based guideline for cost-effective pharmacological treatment of essential hypertension in Jordan. The project’s objectives were to directly address a major health problem for Jordan by producing a guideline and to delineate the strengths and weaknesses of Jordan’s health care process to allow similar future efforts to be planned more efficiently.

Methods: The pilot spanned a period of approximately 8 months. Activities were overseen by local technical and guideline development teams, as well as experts from NICE. NICE’s hypertension guidelines and economic model were used as a starting point. Parameters in the economic model were adjusted according to input and feedback from local experts with regards to Jordanian physician and patient practices, resource costs, and quality of life estimates. The results of the economic model were integrated with the updated available clinical trial literature.

Results: The outputs of the economic model were used to inform recommendations, in the form of a clinical algorithm. A report of the process and the strengths and weaknesses observed was developed and recommendations for improvements made.

Conclusions: The pilot represented the start of what is intended to be a health care process change for the country of Jordan. Issues emerged that can inform strategies to ensure a more cohesive and comprehensive health care approach to the cost-effective use of appropriate drugs in managing chronic disease. The project highlighted how countries with relevant experience in evidence-informed policy making in health care can assist others in strengthening their decision-making systems.

Funding sources: NICE International (JL), WHO (NO), World Bank (NO, RO), Medicine Transparency Alliance-Jordan (IA), UK Department of Health (RO), UK Department for International Development (RO); some authors did not report funding sources.


Influence of Mefloquine Malaria Prophylaxis on HIV Disease Progression: A Randomized Placebo-Controlled Trial

Victor Chalwe


Problem statement: Malaria and HIV are 2 important diseases in sub-Saharan Africa. Malaria infection leads to transient increase of HIV-1 viral load and decrease of the absolute CD4 count. Therefore, malaria might accelerate HIV diseases progression in co-infected patients.

Objective: To evaluate the impact of mefloquine (MQ) prophylaxis on the progression towards AIDS in HIV-infected individuals

Materials and methods: A randomized, double-blind placebo-controlled trial of weekly MQ prophylaxis in asymptomatic HIV-positive individuals was carried out in Luanshya, Zambia. Inclusion criteria were HIV infection with a CD4 cell count ≥ 350/µL. CD4 count and clinical examination was carried out every 6 months. Cox regression models were used to estimate the time to AIDS or low CD4 count and repeated measurements modeling to assess CD4 count decline.

Results: Median CD4 count at enrolment was 471/µL. The median duration of follow-up was 16 months (range: 24 months). In the placebo group, 14.8% (22/149) reached a CD4 cell count of < 200/µL or developed AIDS stage III/IV compared to 19.5% (29/149) in the MQ group (p = 0.27). The placebo group had a CD4 count decline to 49 cells/µL/year compared with 53 cells/µL/year in the MQ group (p = 0.21). Haemoglobin increased from 12 g/L to 14.5 g/L in the placebo compared to 12.5 g/L to 13.5g/L in the MQ group over the period of follow-up (p = 0.14).

Conclusions: In HIV-infected individuals, MQ chemoprophylaxis did not have any effect on the evolution towards AIDS. The result could be underpowered as the malaria transmission decreased enormously during the short period of the study because of scale-up of malaria control interventions. Furthermore, only participants with high CD4 count, still immune competent and semi-immune for malaria, were selected. Malaria might still have an impact on immune-suppressed patients but these are eligible for antiretroviral treatment and Co-trimoxazole prophylaxis, an antibiotic with antimalarial properties.

Funding sources: DGCD funded framework agreement between ITM and TDRC


Effectiveness of an Antibiotic Policy in Containing Antibiotic Use at a Tertiary Care Hospital, Vellore, South India

Sujith John Chandy1,2, Kurien Thomas1, Reni Charles1, L Jeyaseelan1, Cecilia Stalsby Lundborg2

1Christian Medical College, Vellore, India; 2Karolinska Institutet, Stockholm, Sweden

Problem statement: Infections occupy a prominent place in most hospitals of low- and middle-income countries such as India. This invariably means using a large amount of antibiotics and consequently, the emergence of resistance to life-saving antibiotics. An antibiotic policy is one of the strategies employed by hospitals to contain resistance. In our hospital a policy was initiated and a manual published in 2005. The question remains, however, whether this is an effective strategy for containing antibiotic use.

Objective: To evaluate the role of an antibiotic policy in containing antibiotic use at a tertiary care hospital in Vellore, South India

Design: Interrupted time series (ITS) for policy evaluation

Setting: Christian Medical College (CMC) Hospital, a private, mission university teaching hospital in Vellore, South India with 1,957 beds and 4,500 outpatients per day that caters to all strata of society.

Study population: Antibiotics dispensed for hospital inpatients at CMC in a 7-year period, from 2003 to 2009, were included.

Policy evaluation: To assess impact of antibiotic policy on antibiotic density, monthly antibiotic consumption was calculated to provide data points before and after intervention in 2005. Antibiotic use in inpatients was calculated using the pharmacy computer system. Consumption of antibiotics was calculated as defined daily doses and normalized per 100 bed-days. Segmented regression analysis was done to assess how much the policy changed antibiotic density over time. Changes in level and slope after intervention were compared to level and slope before intervention.

Results: Newer and older antibiotics such norfloxacin and chloramphenicol were evaluated. For chloramphenicol, there was a significant difference in slope before and after intervention (p = 0.007). The difference between pre- and post-intervention level was −0.176 (SE 0.032; P = 0.000; CI −0.240, −0.112). For norfloxacin, there was no significant difference in slope before and after intervention (p = 0.597). However, there was a significant difference between pre- and post-intervention level = −0.529 (SE 0.059; P = 0.000; CI −0.646, −0.412). The densities of relatively newer antibiotics, however, showed increasing antibiotic consumption over the years.

Conclusion: Though some antibiotics are contained by the policy, many are not. Policy therefore may need to be constantly upgraded based on changing resistance patterns. Other strategies to contain antibiotic use and resistance in hospitals such as hygiene should be given urgent consideration.

Funding source: EMECW Lot 15 scholarship was granted to first author. Permission was granted by IRB, CMC Hospital, Vellore.


Practice of Community Pharmacists Dispensing Emergency Contraceptive Pills in Chiang Mai, Thailand

Surarong Chinwong, Napatsawan Akemanee, Piyanan Pothakieng, Pimploy Lertwanich

Faculty of Pharmacy, Chiang Mai University, Thailand

Problem statement: Emergency contraception plays an important role in lowering the rate of unintentional pregnancies. In Thailand, emergency contraceptive pills (ECPs) are available in community pharmacies and by law, community pharmacists must take responsibility for dispensing ECPs. Therefore, the practice of pharmacists in dispensing ECPs is crucial to ensure the appropriate use of ECPs.

Objectives: To investigate the practice of community pharmacists dispensing ECPs

Design: Cross-sectional study

Setting and study population: The population was community pharmacists working in pharmacies located in Amphur Muang, Chiang Mai Province, Thailand. The study aimed to target 48 community pharmacists (working at 48 pharmacies) using the quota sampling technique.

Method(s): The secret shopping technique was used in this study. During June to August 2010, 2 well-trained secret shoppers visited each community pharmacy to assess practices of pharmacists by asking for ECPs. The pharmacist would be asked how to use ECPs if they did not provide sufficient information. This study was approved by the Human Ethic Committee of the Faculty of Pharmacy, Chiang Mai University.

Outcome measure(s): Appropriateness of screening, medical history-taking, and advice-giving on how to use ECPs, their side effects, other methods for pregnancy prevention, and prevention of sexually transmitted infections (STIs) were measured.

Results: Forty-three community pharmacists were included for data analysis; 5 pharmacies were excluded because of the absence of a pharmacist on duty during the secret shopping. The result showed that the majority of pharmacists did not identify the clients and did not ask about the history of contraceptive use. Only 1 pharmacist asked about the time of the unprotected intercourse and drug allergies. Most of the pharmacists provided the clients with the correct time frame for effective use of ECPs; however, 60% gave the advice after being asked. About 90% of pharmacists did not give advice on side effects, other pregnancy prevention methods, and the prevention of STIs. In addition, none of the pharmacists identified contraindications to ECP use or asked the clients about underlying diseases and current medication used; none suggested to test for pregnancy if their period was more than a week late.

Conclusions: The majority of pharmacists gave insufficient and unclear information about ECPs; the consequences could be ineffective protection against pregnancy and taking a medication that could be dangerous. The study has identified opportunities for improving the quality of providing ECPs and educating clients by community pharmacists. To improve use of ECPs and ensure that clients receive appropriate information and care, the education of community pharmacists about ECPs should be reinforced.

Funding sources: Faculty of Pharmacy, Chiang Mai University, Thailand


The Practice of Community Pharmacists on Emergency Contraceptive Pills Dispensing in a Contraindicated Situation

Surarong Chinwong, Napatsawan Akemanee, Piyanan Pothakieng, Pimploy Lertwanich

Faculty of Pharmacy, Chiang Mai University, Thailand

Problem Statement: Unintended pregnancies rate in Thailand is quite high and with most unintended pregnancies, women decide to have induced abortions. Emergency contraceptive pills (ECPs) are effective in preventing pregnancy when it is correctly used. ECPs are more effective the soonerthey are taken but are contraindicated in pregnancy. In Thailand, ECPs can be dispensed in pharmacies without prescription; therefore; community pharmacists play a significant role to ensure the most effective and safest use of ECPs.

Objectives: To investigate the practice of community pharmacists on emergency contraceptive pills dispensing in a contraindicated situation

Design: Cross-sectional study

Setting and Study Population: The population was community pharmacists working in pharmacies located in Amphur Muang, Chiang Mai Province, Thailand. The study aimed to target 48 community pharmacists (working at 48 pharmacies) using the quota sampling technique.

Method: The secret shopping technique was used in this study. During June to August 2010, two well-trained secret shoppers visited each community pharmacy to assess practices of pharmacists by informing them that their periods were absent for 2 months and asking for ECPs. This study was approved by the Human Ethic Committee of the Faculty of Pharmacy, Chiang Mai University.

Outcome Measures: Appropriateness of screening and medical history-taking, advice-giving on how to use ECPs efficiently, pregnancy testing, other methods for pregnancy prevention, and ECPs dispensing were measured.

Results: Forty-one community pharmacists were included for data analysis. Seven pharmacies were excluded because of absence of pharmacist on duty during the secret shopping. The result showed that the majority of pharmacists did not identify the clients and did not ask about the history of contraceptive use. Twenty-six pharmacists (63%) asked the clients about the pregnancy testing history and 35 (85%) advised the clients to do the pregnancy test. Only 6 pharmacists (15%) inquired about other possible causes of absent periods. About half of the pharmacists gave the correct information about indication and efficacy of the ECPs. However, none of the pharmacist asked the clients about underlying diseases, drug allergies, or current medication used. Four pharmacists (10%) dispensed the ECPs in this contraindicated situation.

Conclusions: Most of the community pharmacists disregarded the importance of screening and medical history-taking before dispensing ECPs. These practices might be causing not only ineffective protection against pregnancy leading to the social problem but also danger from using it. The study has identified opportunities for improving quality of providing ECPs. The training of community pharmacists about ECPs should be supported to ensure that women who have unprotected intercourse will be provided with the most effective and safest contraceptive method.

Funding Source: Faculty of Pharmacy, Chiang Mai University, Thailand


Medication Errors of Intravenous Medication in Teaching Hospital in China

Yanqi Chu, Yuqin Wang, Suying Yan

Xuan Wu Hospital of Capital Medical University, Peoples Republic of China

Problem statement: Intravenous infusion, widely used in hospitals, is an important method for disease treatment and complementary nutrition. It was reported that the usage rate of drugs added during infusion in abroad hospitals is 45−76%, while it is up to 80% or more in China. Application of intravenous infusion is important for patient safety because infusion is a direct way for the liquid entering to blood circulation and reach vital organs in the human body. Although the process of infusion has become standardized gradually with the efforts of medical workers especially nursing staff, it still needs to be further researched for potential risks in the process of drug preparation and infusion. Any unreasonable phenomenon should be avoided and forewarning and prevention measures should be taken. Currently, there is limited literature on systematic observation of safety for application of intravenous medication at home and abroad.

Objective: To find potential risks existing in the process of preparation and infusion of intravenous medication, analyze influencing factors to put forward feasible measures or warning methods to avoid errors during preparation and infusion processes and increase intravenous medication safety

Design: Observations of intravenous medication administration in 5 intensive care units—general surgical ICU, coronary surgical ICU, vascular ICU, neurosurgery ICU, and neurology ICU.

Setting: Observe status of intravenous medication application in Beijing Xuanwu Hospital at the Capital Medical University

Study population: ICU patients

Intervention(s): Intravenous drugs with high usage frequency, high occurrence of errors, and relatively high risk were selected for observation; observed nursing staff in the process of preparation and infusion of intraneous medications

Policy(ies): Describe the essential features of any policy change evaluated, including content and implementation details.

Outcome measure(s): The medication error rate varies from 1% (or even less) to 20%, needed to collect at least 20 findings for each error, so the sample size would be 2000 cases (20/1%).

Results: 748 records of medication administration were collected. The most frequent classification of drugs given in all the intensive care units were anti-infectives. The percentage of medication errors was 13.39%. The most frequently reported error was wrong dose, wrong drug, wrong route, and wrong time. No errors were reported that involved giving medications to the wrong patient.

Conclusion: These data show that there are both multiple causes for medication administration errors and multiple opportunities for system checks that may help reduce the incidence of these errors.

Funding sources: Information not provided


Baseline Assessment of Pharmaceutical Situation in Southern African Development Community

Enrico Cinnella1, Gilles Forte1, Abayneh Desta2, Richard Laing1

1World Health Organization, Switzerland; 2World Health Organization, AFRO

Problem statement: The Southern African Development Community (SADC) is one of the regions in Africa with the highest prevalence of HIV/AIDS and has shown slow progress in meeting the health-related MDGs. The SADC Secretariat and its member states have agreed on a pharmaceutical business plan to improve availability and affordability of medicines for priority diseases. Up-to-date and quality information on access, quality, and use of medicines should be collected to help identify priority interventions to address weaknesses of the pharmaceutical sector in SADC.

Objectives: In 2009, countries in SADC embarked on a pharmaceutical sector baseline assessment; the results were to inform the pharmaceutical business plan’s priority setting and allow effective monitoring and implementation of the plan.

Design: Questionnaires on pharmaceutical sector structures, processes, and outcomes were developed covering areas such as policies, regulations, etc. All questionnaires were prefilled with data available from previous studies. The Ministry of Health in each recipient’s country was requested to validate and/or amend as necessary the prefilled information and to complete and endorse the finalized questionnaire.

Setting: The study was conducted in 15 SADC countries—Angola, Botswana, Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, United Republic of Tanzania, Zambia, and Zimbabwe.

Study population: All SADC member states participated in the study, representing a great diversity of population size, economic development, health, and pharmaceutical issues.

Outcome measure: The data collected were presented in the form of individual profiles for each of the responding countries and a sub-regional report providing comparative analysis on the pharmaceutical situation across SADC countries.

Results: Comprehensive data outlining the pharmaceutical situation of all SADC countries are the result of this study. Each country presents strengths and weaknesses, and the value of key indicators varies considerably; for example, pharmaceutical personnel per 10,000 populations ranged from 7.6 in Seychelles to only 0.3 in Lesotho and Malawi. Similarly, public annual expenditure per capita on pharmaceuticals ranged from USD 0.1 to 136. Other differences were found in regulation, such as fees for medicines registration (from USD 150 to 30,000) and number of medicines registered (from 1,400 to over 12,000).

Conclusions: The purpose of this study was to improve availability of quality pharmaceutical information in SADC countries to identify priority interventions to support implementation of national essential medicines programs, within the framework of the SADC pharmaceutical business plan. The study provided a better understanding of the challenges and opportunities for improving access to essential medicines across the SADC region.

Funding sources: WHO, DFID UK


Priority Policy Research Questions in the Area of Access to Medicines in Cameroon, Chad, Congo, and Gabon


1University of Yaoundé 1,CAMEROON; 2Alliance HPSR, WHO; 3Ministry of Public health, Cameroon

Problem statement: Access to medicines is often poor in low- and middle-income countries (LMICs). WHO estimates that the average availability of essential drugs in LMICs is 35% in public sector facilities and 66% in the private sector. Medicines account for a high proportion, between 20%–60%, of health spending in LMICs (developed country spending is around 18%). Moreover, between 50% to 90% of expenditure on medicines in LMICs is out-of-pocket. This inequitable mode of financing creates significant access barriers for the poor and may lead to catastrophic household expenditures. Despite progress in some areas, such as price and availability, data on access to and use of medicines is often weak. Even where data are available, there is limited contextual evidence and minimal capacity for analysis and interpretation to develop sound policy options. The present study lies with the framework of the Access to Medicines Policy Research project developed by WHO’s Alliance for Health Policy and System Research for which the aim is to increase the use of evidence in policies to improve access to medicines in LMICs.

Objectives: (1) Identify and rank, to the extent possible, policy concerns related to access to medicines as perceived by policy makers, civil society organizations, communities, and patients in Cameroon, Congo, Gabon, and Chad; and (2) identify and rank, to the extent possible, related policy research questions in the field of access to medicines in these countries.

Design: The study is divided in two parts : a literature review and a survey of key informants through structured interviews.Setting :This study is conducted at national level in Cameroon, Chad, Congo, and Gabon. It examines the public and private sector.

Study population: For the review, national and regional published and grey literature, policy documents, relevant reports, and prior priority setting exercises in accordance with the selection criteria were inventoried. The policy statements and concerns are recorded. For the survey, the keys informants were selected according to their significant involvement at different levels in medicines issues, especially high ranking officials of Ministry of Health, public and private sector pharmacists, and a convenience sample of patients recruited.

Outcome measure: Specific constraints related to access to medicines are identified according to the four areas of WHO Framework for Equitable Access to Essential Medicines at the four different levels of health systems described in the WHO Framework for Developing a Health Systems Research Agenda. The research priorities are set according the checklist for priority setting in health research developed by WHO.

Results and conclusions: Concerning the literature review; 82 documents were selected. 27 were included. 20 barriers and 23 research questions to access to medicines were identified and ranked. For the survey, 411 people agreed to participate. From their perceptions, 29 barriers and 24 research questions to access to medicines were identified and ranked. Minimal health services responsiveness to patients needs was ranked as the first barrier, followed by the low quality of human resources. Financial issues generally presented as the main barrier to access to medicines were ranked at the third place. The reliability of the health systems appeared as the weak point in all the four countries.

Funding source: Alliance for Health Policy and System Research (WHO)


Improved Safety Monitoring of Second Generation Antipsychotics Following a Rational Prescribing Intervention

Renier Coetzee1, Ruth Lancaster1, Jane Riddin1, Janine Munsamy1, Christine Njuguna1, Betty Patterson2, Sandi Willows3

1Rhodes University, South Africa, South Africa; 2North Dakota State University, United States of America; 3Fort England Psychiatric Hospital, South Africa

Problem Statement: Second generation antipsychotics (SGAs) pose increased metabolic adverse effects which may pose a health risk for mental health patients. There is consensus that these metabolic abnormalities associated with SGAs require regular screening so as to facilitate early intervention when required. There is, however, generally reluctance to perform these tests in resource-constrained environments for various reasons.

Objectives: To determine the impact of a rational prescribing intervention to improve the safety of SGAs through appropriate monitoring.

Design: A retrospective drug use evaluation was used to measure compliance with recommended safety monitoring of SGAs before and after a rational prescribing intervention. The baseline assessment and design of the intervention took place in March 2008 with a follow-up drug use review (DUR) in November 2009 to assess the impact.

Setting: Public health sector psychiatric hospital in South Africa.

Study Population: All admitted patients receiving SGAs were identified for possible inclusion; 48 patients’ SGA prescriptions were evaluated in the post-intervention DUE. Patients were included if they received an SGA for more than 1 month. Patients initiated on an SGA prior to the intervention in 2008 were excluded as well as those who were already receiving an SGA when referred to the institution.

Intervention(s): The baseline DUE identified that inadequate safety monitoring put patients at risk. The local Pharmacy and Therapeutics Committee approved a safety screening protocol, which formed the basis of the intervention. The final intervention comprised three aspects: (1) a paper monitoring tool that contained all the relevant baseline and follow-up safety tests; (2) in-service training of all levels of health care workers, which highlighted the importance of metabolic monitoring in patients on SGAs, to support the monitoring tool; and (3) educational posters to guide clinicians on appropriate monitoring recommendations.

Outcome Measure: Improved patient safety through increased monitoring of SGAs.

Results: Post-intervention monitoring improved overall. Fasting glucose and cholesterol monitoring at baseline increased by 40% and 36% respectively. There has been an increase in the annual cholesterol monitoring of 25%. A concerning finding was a reduction in monitoring of blood pressure and weight by nursing staff from baseline. Monthly weight monitoring was also reduced by 54%.

Conclusions: These data confirm that multiple interventions have improved compliance with safety monitoring of SGAs as judged by DUR findings. Follow-up data is planned for 2011 to confirm the durability of this finding; however, these data confirm that safety monitoring in a resource-constrained environment can indeed be achieved through appropriate support measures.

Funding Source: No funding


Adherence to Artemisinin Combination Therapies (ACTs) Purchased in the Informal Private Sector: Evidence from Soroti District, Eastern Uganda

Jessica Cohen1,2, Elif Yavuz1,2, Alexandra Morris1, Jean Arkedis1, Oliver Sabot1

1Clinton Foundation Health Access Initiative; 2Harvard School of Public Health

Problem Statement: Patient non-adherence has contributed to the emergence of drug-resistant malaria strains, prompting increasing failure rates to the most common antimalarial medications. Numerous studies have documented adherence to antimalarials obtained in the public sector; however, this is one of the first studies to estimate adherence rates among patients purchasing artemisinin combination therapies (ACTs), currently the most effective treatment for malaria, in the private retail sector.

Objectives: The study seeks to determine adherence rates to ACTs purchased in private drug shops in Eastern Uganda.

Design: Study participants were recruited in four licensed private drug shops in Eastern Uganda in December 2009. Participants were eligible to enroll if they elected to purchase subsidized artemether-lumefantrine (AL) made available through the project. Enrolled participants (n=395) were randomly assigned to one of three study arms: no follow up (10%; n=39), follow up after two days (40%; n=159), and follow up after three days (50%; n=197). The two-day follow-up arm captured whether participants completed the full course before the recommended treatment period concluded, while the three-day arm measured failure to complete the full course by the end of the treatment period.

Study Population: The study population consists of 359 patients or caregivers who purchased ACTs at privately owned drug shops in Soroti District, Eastern Uganda

Outcome Measure(s): The primary outcome is completion of the full treatment course, as assessed by blister pack observation.

Results: Loss to follow up was balanced in the follow up groups at approximately 17%. For the two-day group, the maximum time to follow up was 55 hours, whereas for the three-day group, participants were included in the main analysis if they were found within 96 hours after medicine purchase; 67% (n=106) and 77% (n=152) of these groups, respectively, were followed up within the specified time frame. Approximately 56% of participants had finished their medication as prescribed when followed up with after three days, indicating lack of treatment compliance is significant. More than a quarter of patients in this group (26%) had at least a full day of treatment (2 doses) left. There was limited evidence of participants finishing the treatment course early: about 9% of patients completed the treatment on the second day. Multivariate analysis to assess determinants of adherence is ongoing.

Conclusions: This study is one of the first to quantify adherence rate to ACTs obtained through the private sector, where between 60-80% of malaria patients seek treatment in sub-Saharan Africa. The results suggest that non-adherence to subsidized ACTs is substantial and notably lower than adherence in the public sector. Low levels of ACT adherence could lead to resistance to the only remaining effective antimalarial.

Funding: UK Department for International Development.


The Good, the Bad, and the Ugly: A System-Based Three-Pronged Strategy to Combat Substandard and Counterfeit Medicines in Low-Resource Countries

Veerle Coignez


Problem statement: The use of substandard and counterfeit medicines (SCM) constitutes an increasing public health problem, especially in low and middle income countries (LMIC). A USAID-USP program has documented cases where over 40% of sampled medicines were of poor quality. Medicines regulatory authorities (MRA) in LMIC often lack the technical, financial, human, and legal capacity to address the problem.

Objective: To present a strategy, and an organizational framework, to help policy makers and implementers address the SCM threat in a comprehensive, systematic, and sustainable manner.

Design; This is a technical brief. It builds on experience gained in the management of USAID medicines quality assurance activities, and on reference work by WHO and the U.S. Pharmacopeia.

Setting: The strategy and organizational framework adopt a national level perspective, covering the entire medicines supply chain, in the public and private sector.

Study population: The target audience is policy makers and program managers in ministries of health and MRAs in LMIC.

Intervention or policy change: The three-pronged strategy tackles both the supply of and the demand for SCMs. It consists of three complementary approaches that can best be characterized as “the good, the bad, and the ugly”: improving access to good-quality medicines, targeting substandard and counterfeit medicines, and raising public awareness about the negative (ugly) health consequences of SCM use. The strategy enables stakeholders to go beyond anti-counterfeit sting operations and to adopt a comprehensive approach as well as identify priority activities. The strategy integrates medicines quality assurance activities promulgated by WHO and helps stakeholders understand how these activities contribute to a sustainable reduction in SCM availability. The strategy can be implemented in a flexible manner, in full or in part, depending on the country.

Outcome measure(s): Outcome measures can be defined for each strategic prong depending on the country, for example, (1) number of medicines registered based on a process that includes quality control testing or (2) number of substandard lots identified and withdrawn. The strategy’s overall impact can best be measured by reduction over time in the proportion of sampled medicines found to be substandard.

Results: Cambodia is the best documented example of success in reducing the ratio of sampled antimalarials that fail basic quality control tests—from 16.9% to less than 1%—between 2003 and 2010 (for details, see abstract 248). Other relevant examples are (1) the renewed focus on establishing a MRA in Liberia and (2) the work on improving the registration process in Ethiopia as part of addressing the SCM problem in each country respectively.

Conclusions: Sting operations do not suffice to stem the SCM tide. The three-pronged strategy provides an actionable platform to tackle the problem in a comprehensive, systematic, and sustainable manner. Political commitment is key to success.

Funding source(s): USP


Characteristics of Medicines Found in the Households of the District of Chimbote – Ancash (Peru), December 2007

Raul Cruzado

Universidad Catolica Los Angeles de Chimbote, Peru

Problem statement: In Peru, some problems have been identified related to polypharmacy, drugs without effectiveness or safety, self-medication, lack of adherence to treatment, presence of counterfeit medicines, and inadequate conditions of drug storage in health services. In July 2007, the government through DIGEMID (e.g., FDA) started the first “National Campaign for the Dissemination of the Good Storaging Practices of Medicines at Households”. There is no research about this topic in the country.

Objectives: Determine the characteristics of the drugs that are found in the households from the district of Chimbote – Ancash (Peru).

Design: It is a descriptive and cross-sectional study, based on the design established in the document of WHO: How to investigate the use of medicines by consumers.

Setting: This study was conducted at the district level. The households were visited and people older than 18 were interviewed.

Study population: The sample was taken from the district of Chimbote. The design of the study was probabilistic, multi-stage sampling, and systematic sampling. A sample of 796 dwellings with a level of significance of 5 % and an error of 0.03252.

Intervention(s): The study took about 3 months and 25 ULADECH university students were trained to implement the survey.

Policy(ies): This research was exposed at a national meeting in the DIGEMID in 2010. There were public health workers of Ministry of Health from all regions of the country.

Outcome measure(s): Percentage of more commonly used pharmaceutical forms, pharmacotherapeutic groups, generic drugs, combinations drugs, where medicines were obtained/who gave advice, households who received information given by the health worker, and drug storage

Results: The tablets represented 53% and the pharmacotherapeutic groups were the apparatus skeletal muscle (27%) and anti-infectives (17%). The generic drugs represented 44% and fixed dose combinations 21%. The medicines were obtained from pharmacies (40%). The physicians and the pharmacists indicated the medicines in 57% and 29% respectively. Also, 96% stated they never received education about medicines in the community by any health workers. They store the medicines in the room (62%), bathroom (9%), kitchen (8%), and backyard (7%). The drugs not fit for human consumption represented 10%.

Conclusions: It was determined the characteristics of drugs were found in the households of people who lives at the district of Chimbote which need be improved in relation to the education for becoming better both the storage and the use of medicines principally.

Funding source(s): ULADECH


Drugs for Anemia

Gopal Dabade

Drug Action Forum - Karnataka, India

Problem Statement: Anaemia is an extremely common problem and a major public health problem in India and several developing countries. More than 50% of population is affected with anaemia and in several pockets of population around 95% of adolescents are suffering from it. Anaemia particularly strikes women and children. As per Essential Drug List of India and World Health Organisation, the drugs needed to treat anaemia are a combination of iron with Folic acid or just iron preparation in proper doses. Internationally renowned standard text books of medicine have also advocated the same.

Objectives: To look for availability of medicines to treat anaemia both in public and private health care systems.

Design: Popular drug guides used by doctors were chosen and drugs to treat anaemia were culled from it. Totally 338 drugs were listed. These drugs that were listed were compared to the WHO Essential Drugs and also reference was taken from standard pharmacology text books to see if they matched with rationality etc.

Setting: The study was situated in the South Indian state of Karnataka.

Results: After screening 338 drugs to treat anaemia from a popular doctors’ reference drug guide book, it revealed that there is just one drug that fits into the standards prescribed by the Essential Drug List of India and World Health Organisation. Many of the drugs listed, to treat anaemia; in the doctors’ popular publication contained substances never advocated in any standard text books. Some even contained alcohol, liver extract and haemoglobin. The one drug that fits into standards prescribed by WHO is NOT easily available at most chemists’ outlets, for the simple reason that it does not offer much profit margin.

The study observed that the cost of medicines to treat anaemia ranges from a low of Rupees 0.13 per tablet to Rupees 6.97 per tablet, which works out for 30 days treatment from a low Rupees 11.70 to as much as Rupees 660. It was also observed that anaemia patients spend anywhere from a minimum of 2 to 56 times than what they ought to.

The Indian drug industry has become a major global power in drug production it has not grown to meet the needs of this country, as a vast majority of the population does not have access to essential medicines. This situation holds good for drugs to treat anaemia as well. As per the Government of India figures, the Indian drug manufacturers had a turnover of Rupees 500,000 million during the year 2003-2004. The above estimates show that we need approximately Rupees 5,850 million to treat 50% of the Indian population of nearly 1,000 million for a treatment period of 30 days.

Conclusions: From the findings of the study it is clear that making available Essential Medicines is an important public health issue and needs urgent policy intervention.

Funding: Drug Action Forum – Karnataka independent, not for profit, registered organization with support from Health Action International AsiaPacific (http://www.haiap.org/).


Establishing a Nationally Consistent Approach to Implementing the Principles of Good Prescribing in Health Practitioner Education

Jonathan Dartnell, Michelle Koo, Lynn Weekes

NPS: Better Choices, Better Health, Australia

Problem statement: Despite prescribing being a fundamental task for many health practitioners, education and training to support good prescribing has not been a priority and new prescribers have reported being inadequately prepared to practice prescribing. In addition, the roles of several health practitioners are expanding to include prescribing. Is a nationally consistent approach to implementing the principles of good prescribing feasible?

Objectives: To develop online learning modules to support a nationally consistent approach to implement the principles of good prescribing in health practitioner education

Design: NPS: Better Choices, Better Health is a not-for-profit organisation that implements activities that aim to enable the best possible decisions about medicines by consumers and health professionals. The National Prescribing Curriculum (NPC) is a series of clinical, case-based, online learning modules that mirror the decision-making process outlined in the WHO Guide to Good Prescribing. The NPC emphasis is on learners building their own personal formulary of preferred drugs for specific conditions. The modules are based on real-life situations and include complex, authentic tasks.

Setting: Universities

Study population: Medical, pharmacy, nurse practitioner students

Intervention: The NPC online learning modules were introduced in 2002 and are now available to all Australian medical, pharmacy, and nurse practitioner schools. Individual schools determine how the NPC is utilised and assessed within the curriculum. This has included use in face-to-face tutorials, assessment with multiple choice questions on selected NPC topics, and oral examination on selected NPC topics. The NPC has been used to support good medication management practice as well as in the development of good prescribing practice.

Outcome measure(s): Uptake of NPC by health practitioner schools, student satisfaction

Results: In 2004, the modules were used in 9 of the 12 medical schools, compared with 16 of the 18 schools in 2011. The number of student users has increased from 1,100 in 2004 to >2,500 in 2011. The uptake of the modules by pharmacy, nurse practitioner, and dental schools is recent. In 2011, 6 of the 13 pharmacy schools and 5 of the 14 nurse practitioner schools used the modules. In an online survey in 2010, 95% of students found the modules engaging, clear, and relevant, and >90% reported that use of the NPC had improved their confidence and knowledge of therapeutics and prescribing.

Conclusions: The uptake of the NPC in medical schools is comprehensive and use in pharmacy and nurse practitioner and schools is being established. The model may be of assistance to other countries that are considering a national approach to implementing the principles of good prescribing.

Funding source(s): NPS is funded by the Australian Government Department of Health and Ageing.


Impact of policy revision on harmonization and transparency of quality assurance criteria for anti-Tuberculosis medicines

Joëlle Daviaud1, Paloma Marroquín Lerga2, Carmen Perez Casas1, Sophie Logez1, Rachel Bauquerez1, Mohamed Abdel Aziz1, Ha Thuy Huong1

1The Global Fund to Fight HIV, Tuberculosis and Malaria, Switzerland; 2Global Drug Facility of the Stop TB Partnership

Problem statement: Global Fund-financed programmes have provided 7.7 million of anti-tuberculosis treatment, and the Global Fund is the major contributor for the costly treatment of multi-drug resistant TB (MDR-TB).

With the introduction of the Global Fund’s revised Quality Assurance Policy for pharmaceuticals in July 2009, anti-TB medicines became subject to strict quality criteria for procurement. As few anti-TB products fulfilled the preferred criteria (WHO-prequalification or authorization by a stringent regulatory authority), there was significant reliance on the alternative criteria of the revised policy (review by a WHO-hosted expert panel). These criteria were similar but not identical with those of the Global Drug Facility procuring anti-TB medicines for grant-funded programmes, including all second-line TB products. There was thus a need for full policy alignment.

Objectives: To describe the implications of the Global Fund’s policy revision for procurement of anti-TB medicines in grant-funded programmes and outcomes of harmonization with partners.

Design: Descriptive, qualitative review of policy implementation and harmonization.

Setting and study population: Developing countries, international and national organizations involved in procurement of anti-TB medicines in the public sector through procurement entities or GDF.

Results: GDF was actively involved in the Global Fund’s policy review and in the subsequent one-year process to align the GDF criteria and procedures with the new Global Fund requirements. Since July 2010, the two organizations are sharing their invitations for expression of interest, process and outcomes of product questionnaire dossier assessment by a WHO-hosted expert panel, and of randomized pre-shipment quality control testing. This avoids duplication of work and reduces costs for manufacturers, the Global Fund, GDF and the expert review panel. Criteria, process and outcomes of these activities, and reports on purchasing transactions, are publicly available online. At country level, procurement of quality-assured anti-TB products has become simpler and quicker, reducing the risk of procurement delays. On the other hand prices for some products have increased, and challenges remain to ensure a sustainable supply e.g. for paediatric and second-line anti-TB formulations.

Conclusion: While a number of donors, implementers and procurement agencies have been working to harmonize their procurement practice for some time, this is the first time that common transparent quality criteria and processes are being fully shared by two organizations, conveying a single message to manufacturers and buyer countries. Based on first experiences, it is expected that this will incentivize manufacturers to produce medicines meeting these standards. Similar harmonized policy approach is under way with UNITAID for antiretrovirals, and with the World Bank and other stakeholders for other types of medicines.


Rational Drug Use Policy in Turkey

Burcak Deniz Dedeoglu, Hatice Demet Celik, Akif Akbulat, Halil Akar, Saim Kerman

Ministry of Health of TURKEY, Turkey

Problem Statement: Studies were conducted by Ministry of Health and many different associations on the issue about rational drug use in Turkey. Institutional activities regarding this issue were initiated on October 10, 2010, by the Ministry of Health of Turkey with the establishment of rational drug use department under the department of pharmacoeconomics.

Objectives: Among the main purposes of the Rational Drug Use Department is to use various methods to disseminate the accepted principles of rational drug use throughout Turkey and stress their importance.

Interventions: (1) To make suggestions to Social Security Institution (SSI) about the issues of considering the principles of rational drug use while developing the repayment (reimbursement) plans, (2) to educate health staff on principles of rational drug use, (3) to evaluate prescriptions according to principles of rational drug use, (4) to coordinate the publishing the national guidelines for diagnosis and treatment with updating and publishing the medicines guideline on a regular basis, and (5) to measure the awareness level of society and health care workers about rational drug use.

Outcome Measures: Based on the data taken from SSI, excluding the primary health care services, the number of patients who applied to a health care service and invoices for their care were sent to SSI in 2008, 2009, and 2010 were 216.930.000, 247.142.000, and 230.112.000 (for first ten months of 2010) respectively. These numbers were classified as “outpatients”, “inpatients,”,“others,” and “daily.” In monthly distrubition perspective, the applications were higher in summer than winter.

Results: Total prescription numbers for workers, civil servants, and green card owners in 2009 and 2010 (for first ten months of 2010) were 327.000.000 and 250.138.000 respectively and total prescription invoice number was 16.000 billion TL and 12.259 billion Turkey lira (TRY). while the average costs per prescription were TRY48.95 . and 49.01, respectively.

Conclusion:- The expectation is that the rational drug use policy will reduce the total drug cost and increase the awareness of society and health staff about rational drug use.

Funding Source: Information not available


Developing Superior Screening Technology for Monitoring Medicine Quality in Low-Resource Countries

Darash Desai1, Patrick Lukulay2, Veerle Coignez3, Muhammad Zaman1

1Boston University, United States of America; 2US Pharmacopeia; 3USAID

Problem statement: Substandard and counterfeit medicines are a serious public health problem in resource-limited countries where there is little oversight of the pharmaceutical market. Simple and qualitative tools exist for screening the quality of medicines on the market, but none offer a complete test, covering all important quality attributes. Further testing is costly, time consuming, and not scalable. Consequently, many substandard medicines pass through the net of medicines quality screening.

Objectives: To develop and implement an improved, easy-to-use, portable, and cost-effective microfluidic technology for comprehensive and effective screening of all important quality attributes of medicines.

Design: A low-cost microfluidic chip was designed to conduct both dissolution testing and chemical separation to quantify drug release kinetics and drug composition. Dissolution testing was conducted using fluorescent markers and a simple LED coupled with a cheap CCD chip. Separated drug components and related substances were quantified using standard colorimetric chemistry.

Setting: The final solution is designed for use in low-resource settings with unreliable power, extreme weather, and limited technical capacity. The chip was designed to be robust enough for use in the field.

Outcome measure(s): We characterized the effectiveness of our device by testing its ability to assess drug quality among a range of counterfeit, substandard, and authentic drugs. We compared our results to standard TLC and hand-held spectroscopic methods used in current, in-field screening tests.

Results: We were able to design and build a working prototype of our device. The dissolution component was able to quantify drug release kinetics to within 3% of standard USP Apparatus I tests. The chemical separation component demonstrated superior results to standard TLC techniques that serve as the current standard in resource-limited settings.

Conclusions: Our integrated microfluidic device is able to quantitatively identify substandard medicines by performing both dissolution testing and chemical separation on a single, portable chip. The dissolution test provided similar results to standard techniques, but used a fraction of the reagents and solvents due to the microfluidic platform. Chemical separation was achieved with higher precision than current field methods. This test will both improve accuracy and significantly lower testing costs. With these solutions offered on a single chip, this device offers a promising improvement to field-based counterfeit and substandard medicine screenings.

Funding source(s): USP, USAID, Coulter Foundation


Antibiotic Prescription by Informal Health Providers in Ujjain District, India

Vishal Diwan1,2, Maysa Mohammed Abdel Aziz2, Yogesh Sabde3, Gaetano Marrone2, AJ Tamhankar4,5, Cecilia Stalsby Lundborg2

1Department of Public Health and Environment, R.D. Gardi Medical College, Ujjain, India; 2Division of Global Health (IHCAR), Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden; 3Department of Community Medicine, R.D. Gardi Medical College, Ujjain, India; 4Department of Environment Medicine, R.D. Gardi Medical College, Ujjain, India; 5Indian Initiative for Management of Antibiotic Resistance (IIMAR), N.G. Acharya and D.K. Marathe College, Chembur, Mumbai, India

Problem statement: Informal health care providers lack state accredited medical qualifications. These providers mostly practice allopathic medicine and prescribe antibiotics and other drugs without relevant training. These providers, however, work in the deprived, poor, and rural areas, where qualified providers generally are not available to serve this highly needy population. In spite of their magnitude and influence on health care system in low- and middle-income settings, systematic research on these providers is scarce, and studies are needed on all aspects of this phenomena to devise effective policy interventions.

Objectives: To present and describe the antibiotic prescription by informal health care providers in rural Ujjain in India

Design: Cross-sectional study

Setting and study population: Six selected villages in the Ujjain District of the State of Madhya Pradesh in India. Target population was informal health care providers: 25 were approached and given specially designed prescription pads in duplicate to fill in.

Intervention: This study is part of the information gathering for planning locally sustainable interventions aimed at providers and the community on rational antibiotic use.

Outcome measure(s): Logistic model to test the causal relationship between the providers’ and the patients’ characteristics; two separate binary outcomes: the antibiotic prescription (yes or no) and the number of antibiotic prescribed (one or more than one).

Results: All the providers were male. Numbers of practicing years and education of providers were not associated with the changes in the antibiotics prescription patterns. In total, 565 patients prescription were collected and analyzed. Symptoms related to the cardiopulmonary system were the most frequent complaint (31.7%). Ciprofloxacin was the most frequently prescribed antibiotic (20.1%). 31.1% of the patients received antibiotics by intramuscular route. Patients without infections were significantly less likely to be prescribed antibiotics (p<0.001). For the patients who were prescribed antibiotics (one or more than one), availability of a pharmacy in the village was significantly associated with prescribing one antibiotic.

Conclusion: This study provided evidence that informal providers prescribed lot of drugs, including antibiotics. It exposes the need for urgent interventions through the development of a means to absorb the informal health care providers into the health system after relevant training. This study has raised some important points that may be helpful in understanding this highly under-researched but influential group in rural areas, where more than 70% of the Indian population lives and visits these informal providers regularly.

Funding source(s): Swedish Research Council; first author is the recipient of Erasmus Mundus Scholarship


Antibiotic Surveillance in Intensive Care Unit: Quality Assurance of Antibiotic Usage

Zunilda Djanun1, Rudyanto Sedono1, Yulia Rosa Saharman1, Bekti Wahyuningrum2

1Faculty of Medicine, Indonesia University/Cipto Mangunkusumo Hospital, Indonesia; 2Cipto Mangunkusumo Hospital, Indonesia

Problem statement: MOH of Indonesia requires that every hospital implements an antimicrobial resistance control program and report their work yearly. The ICU is one of the service clusters in hospitals that has high antibiotics consumption because critically ill patients are particularly susceptible to nosocomial infection.

Objectives: The primary objective was to determine the quality of antimicrobial (AM) use according to Gyssens criteria as part of AM surveillance activities. The result will also be compared with that from a pilot surveillance conducted in 2009 that was followed by interventions.

Design: Cross-sectional prospective observational study using patient’s chart and staff verification

Setting: ICU at the national central hospital in Jakarta, Indonesia

Study population: All patients admitted to the ICU at Cipto Mangunkusumo Hospital (CMH) in the first 2 months of 2010

Methods: Data on demography, admission and discharge dates, diagnoses prior to and during ICU admissions, reasons for transfer to ICUs, names, dosages, durations and reasons for AM prescriptions, microbiological test results, and outcomes of care were collected. AM prescriptions were classified into 4 categories—prophylaxis, empiric, definitive, and “not known”.

Outcome measures: Pattern of J01 class of AM; the quality of usage was assessed by a clinical pharmacologist using 2 standard references. AM use in 2010 and 2009 were compared to see the impact of feedback and intervention.

Results: 165 patients, 134 surgical and 31 medical, were admitted to the ICU during the surveillance period; 269 AM usages were found in 138 patients; 28 out of the 134 surgical patients did not received prophylaxis AMs, but 21 of them received AMs postoperatively. There were 25 kinds of AMs used for the 4 categories. AM prescriptions in 2010 were better than that in 2009 (e.g., less). AMs were prescribed for unknown reasons (22.3% vs. 38.5%). Ceftriaxone, ceftazidime, cefoperazone, meropenem, metronidazole, cefotaxime, and levofloxacin were the most frequent prescribed AMs in 2010, which differed slightly from 2009. About 18.8% AB were used appropriately (cat. I), 16.3% were inappropriate in dosaging and route of administration (cat. II); 22.8% were used for too long or too short a period (cat. III); 19.1% were selected inappropriately (cat. IV); and 16.4% were used without any reason (cat. V). When looking at the use of the 5 most frequently prescribed AMs, one can see that more AMs were prescribed appropriately in 2010 (e.g., more meropenem and levofloxacin fell into category I of Gyssens’ categorzation whereas neither fell into category V). There must be more cost containment. MRSA, A. baumannii, Ps. aeruginosa, and Klebsiella pneumoniae were the isolates most frequently identified, mostly from sputum. Patients with MRSA infections were successfully treated with vancomycin. The daily “case morning parade” was implemented after the 2009 surveillance, so the impact of the intervention was reflected in the 2010 data. Although the case parade has not involved the surgery department yet, clinical pharmacologists, clinical microbiologists, and clinical pharmacists are regular contributors at the meetings. Screening of MRSA has also become a routine measure for indicated cases since 2009.

Conclusion: The quality of AM use in ICU CMH was improved, probably because of feedback and interventions that have been made.

Funding source: Cipto Mangunkusumo Hospital


Impact of Implementing Antibiotic Sales Restrictions: Reactions of Key Stakeholders and Citizens in Mexico

Anahi Dreser-Mansilla, Veronika J. Wirtz, Edna Vazquez-Velez, Midiam Ibañez-Cuevas, Sandra Treviño-Siller

National Institute of Public Health, Mexico

Problem Statement. In many low / middle-income countries regulations of medicines sale with prescription are not enforced. There is little research regarding the barriers and opportunities to enforce efficiently these regulations. In March 2010 the Mexican government announced the enforcement of antibiotic sales regulations in pharmacies only with prescription. Analysis of the impact of its implementation in terms of stakeholders’ and citizens’ reactions can provide relevant lessons for other countries to anticipate barriers and take advantage of facilitating factors.

Objectives. To analyze the factors that affect the implementation of antibiotic sales regulation only with prescription in Mexico, focusing in the position and strategies developed by stakeholders, and in the reactions of the population.

Design. Stakeholder analysis of the position adopted and strategies developed by key actors: Pharmacies / medicines outlet associations (POA), Ministry of Health (MoH), pharmaceutical industry (PI), medical and pharmaceutical associations (MA and PA), academic institutions (AI), consumers associations (CA). Discourse analysis exploring citizens’ perceptions of the regulation. Data were derived from a revision of newspapers coverage on the issue and from an on-line newspaper discussion forum. A priori defined and emerging thematic codes were used.

Setting. Mexico

Population. 304 newspaper articles and 387 commentaries from the discussion forum retrieved between March 25 and December 31 2010.

Policy Change. Ministerial decree enforcing the regulation of antibiotic sales only with prescription, requiring to retain and register prescriptions.

Outcomes. Reactions of key stakeholders and citizens that could act as barriers or opportunities for its implementation.

Results. The MoH promoted the regulation arguing the dangers of self-medication and antibiotic resistance. POA were the leading opponents arguing that it diminishes their revenues, creates logistical difficulties and corruption, and has negative health and economic impact for the population given the limited access to medical care. Strategies developed were creating alliances attempting to delay implementation, press round-ups emphasizing negative impacts, and creating clinics in pharmacies. MA and AI manifested the concomitant need to improve prescription and create public awareness. Within the discussion forum, the majority of comments were against the regulation arguing negative impact on expenses (due to high cost of private services and prescriptions) and on health (lack of access and discontent with medical services) and distrust of the real reasons underlying the regulation.

Conclusions. Active opposition of key stakeholders and negative perceptions of the regulation among citizens hindered implementation. It is important to create awareness among the population and involve stakeholders and citizens to achieve successful implementation.

Funding National Institute of Public Health


Government, Civil Society, and WHO Partnership: a Catalyst for Better Access to Medicines In Countries

Nel Druce1, Gilles Forte2, Patrick Mubangizi3, Philippa Saunders4, Helen Tata2, Jean-Marie Trapsida2, Saul Walker5

1HLSP Institute; 2World Health Organization; 3HAI Africa (at time of study); 4Independent consultant; 5DFID

Problem statement: Evidence is limited that civil society and government can work in complementary ways to improve access to medicines, while retaining independent functions in the health system and governance structures. Information is needed on added value of government, WHO, civil society partnership for improving policies and practices for access to medicines.

Objectives: The 2009 evaluation of the WHO-HAI Africa Regional Collaboration (2002-2008) assessed its achievements against the WHO Medicines Strategy (WMS) 2004–2007 (policy, access, quality and safety, and rational use), and the added value of a civil society network (HAI Africa), WHO and government partnership in countries.

Design: The evaluation methodology comprised a review of programme documents, country policy guidelines, and tools produced;WHO surveys (Level 1 study on structures and processes, 2003 and 2007, n=14), WHO/HAI availability and affordability surveys in 14 countries, structured interviews (160); surveys of 15 WHO Medicines Advisers (Essential Drugs and Medicines Policy National Professional Officers,EDM/NPOs);WHO Representatives (WRs); and national counterparts (n = 45).

Setting: Case studies in 4 countries with EDM/NPOs (Republic of Congo, Ethiopia, Senegal, Tanzania); in 1 country without EDM/NPOs (Malawi), and in Kenya, Uganda and Ghana (focus of civil society activities), plus HAI Africa headquarter office and WHO regional and headquarter offices.

Study population: Government officials, civil society, and other regional and national stakeholders

Interventions: The evaluation reviewed inputs (staff and technical resources), outputs, and results for countries (improved policy, good practices, and access to medicines) for network of WHO Country Medicines Advisers (EDM/NPO); for WHO Geneva and AFRO; and HAI Africa and its regional network members.

Policies: Policies and programmatic strategies in WMS objectives.

Outcome measures: Progress against WMS 2004-2007 indicators (qualitatively and quantitatively assessed)

Results: Revised medicines policies that included consumer perspectives and mechanisms for involvement; robust, credible, and independent data on prices and availability across all market sectors; protection of public health safeguards in new trade laws; removal of taxes and tariffs; medicines higher on policy agenda; countries capacity strengthened.

Conclusions: The WHO-HAI Africa Regional Collaboration (2002-2008) provided a new and unique space for dialogue and collaborative activities. It helped to change attitudes and introduce new working approaches for civil society, government, and WHO in the pharmaceutical subsector. This was achieved through a complementary mix of approaches: use of methodology for generating quality information; collaborative research and policy advise; civil society advocacy and campaigning; and policy dialogue with government ministries including health, trade, and justice. Through its facilitatory role, WHO has helped to broker civil society’s contribution as a respected and strategic partner in policy fora.

Funding Source: DFID, WHO.


Anecdotal Evidence for Ways in which the Originator Pharmaceutical Industry Has Contributed to Improving the Appropriateness of Medicine Use in Low-Income Countries through Product and Packaging Adaptations

Suzanne Elizabeth Edwards, Frans Westerbos

Access to Medicine Foundation, Netherlands, The

Problem statement: At the level of the product, the main mechanisms originator pharmaceutical companies can use to positively influence rational use of medicines (RUM) are through the optimisation of product quality, product appropriateness, and patient compliance. We present some examples of positive emerging practices in the latter areas of adaptive R&D and product packaging.

Objectives: Use data from the Access to Medicine Index 2010 to highlight average and leading practices to make needs-based adaptations to both packaging and already approved products to meet index country (ICs) needs.

Design: This sub-anlaysis of index 2010 data takes data gathered from 3 indicators—one for needs-based packaging adaptations and the remaining indicators capturing companies’ commitments, transparency, and performance with respect to ‘adaptive R&D’ for products targeting ‘high-priority’ diseases.

Study population: The 20 largest originator pharmaceutical companies. Based on their 2008 and 2009 activities with respect to ICs, this works out to 88 countries based on the UN HDI list of low and medium income countries.

Policy(ies): Index 2010 represented the first time both of these areas were included in the methodology, based on stakeholder feedback regarding their expectations of companies. By publishing index data we hope to provide a clearer picture of current sector practice. The bi-annual nature of the index and use of consistent indicators will inform policy development and evaluation overtime, encourage peer-based learning to motivate more rapid adoption of leading practices within-sector, and act as a decision support tool for other interested stakeholders.

Results: At present only one company, GSK, makes specific, detailed commitments to undertake ‘adaptive’ R&D based on IC needs. Currently 10/20 companies are known to be conducting adaptive R&D for IC-relevant drug development. Of the (approximately 31) products that were disclosed to us, 80% of these were for HIV/AIDs. Children were the most frequent target of adaptive efforts. Evidence of needs-based packaging was found for 25% of the companies. Largely these efforts involved the inclusion of pictograms or colour coding to facilitate compliance and appropriate dosing. Although welcome, presently these efforts are mainly specific to a single product from each company’s portfolio. A number of cases of leading practice and innovative approaches are demonstrated.

Conclusions: Examples of needs-driven adaptations of preapproved products are relatively nascent across the sector but may be a growing trend which can offer significant benefits in ICs for patients, HCP, and health systems. Wider commitment to and adoption of these leading practices across companies’ portfolios and the sector would be welcomed by stakeholders who have also raised concern around the need to balance these incremental product improvements with affordable pricing. Although the data are likely an underestimation of companies current efforts, collaboration and partnering in this area can provide incentives to companies and clearer mapping of the ‘need gaps’ may further facilitate efforts.

Funding sources: Bill & Melinda Gates Foundation, UK Department for International Development, Dutch Ministry of Foreign Affairs


Medication Adherence: Comparative Study between Institutionalized and Community-Dwelling Elderly

Heba Mahmoud El Kady, Moataza M. Abdel Wahab, Noha S. Moustafa

High Institute of Public Health, Egypt

Background: Adherence to a prescribed medication regimen is difficult for all patients and particularly challenging for the elderly who suffer from multiple chronic diseases requiring long-term drug therapy. Non-adherence to medications reduces treatment benefits, can confound clinicians’ assessments of therapeutic effectiveness, and is thought to account for 30–50% of cases where medicines fall short of their therapeutic goals. Studies about non-adherence in elders emphasize that no single reason fits all patients.

Objective: To study self-reported medication adherence and its predictors among community dwelling in comparison to institutionalized elderly

Design: Comparative cross sectional

Setting: Sekina village (a slum area in Alexandria) and two governmental institutions for elderly in Alexandria, Egypt.

Study population: 50 community-dwelling elderly (60 years and above) as a part of the annual health survey conducted by the HIPH in slum areas and a sample of 50 institutionalized elderly selected by simple random sampling from two government homes for the elderly; all elders were interviewed by using a prescheduled questionnaire designed by the researchers covering socio-demographic characteristics, source of income and treatment expenses, and medical history

Outcome measure: Self-reported degree of adherence to treatment regimens; statistical analyses were performed by using the z test of proportion and logistic regression

Results: Self-reported medication adherence in the total sample was 76.6%. Adherence was higher among the institutionalized group (81.4%) in comparison to home dwellers (73.8%). Yet, the difference was not statistically significant (z = 0.8416). The main mentioned reasons for non-adherence were the cost of the medication (93.3%), side effects (33.3%), forgetfulness (13.3%), and lack of accessibility to buy the medications (13.3%). There was no significant difference between both groups as regards non-adherence reasons. Factors that favored adherence were pension as the basis for income, hypertensive or neurologic patients, and having a son, daughter, or nurse responsible for administration of medication. Meanwhile, none of them was a significant predictor on the basis of logistic regression.

Conclusion: Based on self reporting, medication adherence was better among institutionalized than among community-dwelling elderly, yet the difference was not statistically significant. Sex, marital status, income, education, and living with someone were not significant determinants for adherence; neither were the type of disease, number of medications, their route to the pharmacy, nor expenses. We suggest further research for nonstudied determinants, namely, psychological aspects, depression scores, and perception of treatment benefits.

Funding sources: HIPH supported the community dwelling part of the study and the institutionalized part was based supported by personal funds.

591-El Kady-_a.pdf
591-El Kady-_b.pptx

A Comparison of Generic and Originator Brand Drug Prices between Jordan and the United Kingdom

Faris El-Dahiyat, Reem Kayyali, Ibrahim Ali Alabbadi

University of Jordan, Jordan

Problem statement: When a pharmaceutical patent expires, generic companies may enter the market and start selling copies of the original drug. Because generic drugs contain exactly the same active ingredients, they are certified to be perfect substitutes to the originator branded drugs. In competitive markets, entry of generics would trigger fierce price competition, hence decreasing the monopoly enjoyed by the original patent holder.

Objective: To compare the retail prices of five generic and originator brand drugs between Jordan and the United Kingdom (UK); to investigate the relation between number of generics available, the retail price of originator and generic(s), and the effect of time in the market on these prices

Methods: Prices of originators and generics and the number of generics available in each market were obtained from the Jordanian Food and Drug Administration, Royal Pharmaceutical Society of Great Britain, British National Formulary, and the Chemist and Druggist generics lists. The prices were converted to British pounds expressed per one-dose unit. All data were tabulated in spreadsheets; prices were compared between the two countries at different preset times.

Results: The generics of all drugs investigated appeared in the Jordanian market before patent expiry of their originator worldwide due to lack of patency regulations in Jordan at the launch time of the drugs under investigation (before 2004). Unlike in the UK, the prices of originator drugs in Jordan did not change when the first generic was introduced to the market. The prices of generic drugs dropped dramatically in the UK (by approximately by 90%) at the time of the first generic launch compared to 15% in Jordan. There was no apparent correlation between the numbers of generics available or the number of years of the first generic being on the market and the prices of the drugs investigated in both countries. The current prices of all investigated drugs in Jordan are higher than in the UK, particularly for the generics.

Conclusion: Although Jordan has a much lower per capita income, generic drugs are more expensive than the equivalent drugs in the UK.

Funding source(s): No information provided



Karim Maged EL-Ghazouly1, Tarek Gamal El-Sawaf2, Nehal Mohamed Magdy Daebis1

1Pharos University in Alexandria (PUA); 2Faculty of Pharmacy, Alexandria University.

Background: Tuberculosis control efforts are often ineffective in controlling tuberculosis among patients who use illicit drugs1. The occurrence of multidrug-resistant tuberculosis is increasing in many parts of the world. Resistance of Mycobacterium tuberculosis (M. Tuberculosis) to Anti-tuberculosis drugs is man-made. In Egypt, private pharmacies constitute an important part of the private healthcare sector where some Anti-tuberculosis drugs dispensed without prescriptions. With such malpractice emergence of serious types of M. tuberculosis- resistant strains is highly likely to occur.

Methods: Surveys of a random sample of 78 pharmacies in Alexandria and Behira for Anti-tuberculosis drugs were included in our study. These pharmacies were divided into hospital pharmacies, pharmacies in rural areas and pharmacies in urban areas. Questionnaires were given to these pharmacies, and interviews were carried out based on a structured questionnaire.

Results: It was found that 90.8% of the pharmacies enrolled in this study hold in their inventoryAnti-tuberculosis drugs; however, 77% of them dispense these drugs without prescription, while 15.4% advice the patient about their risks. Nevertheless, 20% only ask the patient why they take these drugs

Conclusion: Awareness to patient taking Anti-tuberculosis drugs about their risk is of paramount importance, meanwhile; awareness to pharmacists dispensing these drugs about their risk. Imposing a penalty on pharmacists dispensing Anti-tuberculosis drugs without prescription. Limiting the dispensing of these drugs to hospitals curing tuberculosis . encouraging pharmacists to counsel the patient asking for these drugs, are all viable options.


Implementing an Egyptian Pharmacovigilance System: University and Public Hospitals’ Experience

Sawsan Aboul-fotouh El-Said1, Amr Saad2, Ahmed Noureldin Hassan1, May Hamza1, Ahmed Mohyeldin Abdel-tawab1

1Faculty of Medicine, Ain Shams University, Cairo, Egypt, Egypt; 2Egyptian PharmacoVigilance Center (EPVC), Ministry of Health, Cairo, Egypt.

Problem statement: Underreporting of adverse drug reactions (ADRs) has put a huge burden on the health care system in Egypt. Three years ago, the Clinical Pharmacology Unit (CPU) developed a mechanism for ADR-reporting involving different departments at Ain Shams University Hospitals (ASUH). Recently, a partnership was established between CPU and the newly established Egyptian Pharmacovigilance Center (EPVC). The later constructed a nationwide ADR-reporting system. Training and advocacy of health care professionals (HCPs) on pharmacovigilance (PV) sought to enhance reporting of ADRs.

Objectives: To assess the impact of PV training modules on the attitude of current and future HCPs towards reporting ADRs

Design: Comparative cross-sectional surveys

Setting: One setting included government medical school and hospital and a private school of pharmacy; the other setting included public hospitals.

Study population: The first cohort included physicians and pharmacists (n = 27) participating in the Searching and Appraising the Literature on Antibiotic Medication (SALAM) workshop, final-year pharmacy students (n = 93), and a cluster sample of third-year medical students (n = 325). The other cohort included practicing hospital pharmacists (n = 240) in public hospitals.

Intervention(s): Real cases from ASUH were presented as case scenarios on ADR reporting using yellow cards and causality assessment by searching different databases and applying probability scales. This training was delivered to undergraduate students as a part of their clinical pharmacology (CP) course; HCPs during the 6-day SALAM workshop; and hospital pharmacists during a 5-day PV module.

Outcome measure(s): Attitude towards ADR reporting and willingness to participate in the national mechanism for ADR reporting

Results: The mean ± SD years of experience was 10.2 ± 8.4 in the first setting compared with 7.4 ± 4.6 in the second setting. Only 40.7% vs. 31.2% were familiar with the mechanism of ADR reporting and only 14.8% vs. 10.4% have previously reported an ADR to a PV center, in the first and second cohorts, respectively. After the SALAM workshop, 96.3% were willing to participate in the national mechanism for ADR reporting in the future. At the end of the CP course, 92.2% of medical students and 75% of pharmacy students learned how to fill an ADR report. The percentage of medical and pharmacy students willing to participate in the national mechanism for ADR reporting were 83.9% and 74.2%, respectively. On the other hand, at the end of PV training for the hospital pharmacists, 90.8 % learned how to report ADRs, 87.1% were willing to report them, and 81.7% believed that this will positively influence health policy and costs in Egypt; 21 and 80 valid ADR reports were received following this advocacy by the CPU and EPVC, respectively

Conclusions: Training and advocacy on PV systems has positively influenced the attitude toward reporting ADRs in both settings.

Funding source: Information not provided


Assessment of the Effectiveness and Safety of Outpatient Treatment of Severe Pneumonia Among Egyptian Children with Oral Amoxicillin

Hesham Ahmed Fathey Mohamed El-Sayed1, Narendra Arora2, Ahmed El-Gohary1

1Faculty of Medicine, Suez Canal Univeristy, Egypt; 2INCLEN Trust, New Delhi, India

Problem statement: Pneumonia is an important cause of morbidity and mortality in young children in developing countries. Although a recent RCT-demonstrated, home-based treatment of WHO-defined severe pneumonia with oral amoxicillin was equivalent to hospital-based therapy and parenteral antibiotics, it may have had limited generalizability. We sought to determine if home-based treatment had similar rates of treatment failure and safety

Objectives: To assess the effectiveness and safety of home-based, 5-day treatment with oral amoxicillin for curing severe pneumonia in children

Design: A single-arm, cohort prospective intervention study

Setting: Outpatient clinics of 7 primary health centers in Isamilia governorate, Egypt

Participants: 237 children aged 3-59 months, with a mean age of 12.42 ± 10.05 months

Intervention: Oral amoxicillin was provided in a total dose of 80-90 mg/kg/day for 5 days in 12-hourly doses

Main outcome measurement: Treatment failure defined as clinical deterioration occurring at any time after enrollment, inability to take oral medication due to persistent vomiting, or change or addition of antibiotics for any reason. Patients lost to follow-up and hospitalized patients were considered treatment failures. Treatment failure was assessed on days 6 and relapse on day 14.

Results: Clinical cure rate with 5 days of amoxicillin therapy at day 6 was 90.7%; 3 patients were lost to follow up (1.3%), 3 patients were hospitalized (1.3%), and there were no deaths. No difference was observed between cured or failed, treated patients on antibiotics before therapy identified by urine antibacterial activity test. Adverse effects occured in 14 treated children (5.9%) in the form of mild diarrhea with vomiting and diarrhea in one patient. There were 8 relapses (3.4%) at day 14. Clinical failure was associated with rapid respiratory rate (> 50/minute) (p < 0.0000) and with low body weight (p < 0.01).

Conclusion: Oral amoxicillin is effective and safe in treating severe pneumonia in children in ambulatory setting, when given for 5 days in a dose of 80-90 mg/kg/day in 2 divided doses. Minor adverse effects occurred in small proportion of treated patients and did not affect cure rate.

Recommendations: We recommend a 5-day course of amoxicillin for treating children with severe pneumonia in an ambulatory setting, because it was effective and safe in this community-based study. These findings, if proved to be compatible with findings presented in other centers, could have global implications for a cost-effective management of childhood pneumonia.

Funding source: INCLEN-Inc/JHU through USAID grant No. GHS-A-00-03-0020-00



hager abd elkhalek elkazaz

ministry of health, Egypt

Problem Statement: Hospital formularies have been used in several health institutions to improve medicine use. Hospital pharmacists play important role in the development of hospital formularies, WHO published an important technical document on Drug Use and Therapeutic Committee. However, many of the hospitals in Egypt don’t have medicine formulary and irrational prescribing is commonly practiced.

Objective: To assess the short term impact of Formulary development at Alexandria hospital of ophthalmology on improving medication use and prescribing habits of glaucoma therapy.

Design: The formulary developed in this study was based on, evaluation of samples of glaucoma patient prescriptions and development of standard treatment guidelines, cost effectiveness analysis for glaucoma therapy, and analysis of the available budget. The formulary was developed as collaborative efforts between pharmacists and clinician.

Prescriptions of glaucoma out-patients were evaluated using a specially designed form and analyzed the following criteria: Quantity of medications dispensed and cost of each item, The most expensive drugs, The most frequently or infrequently used drugs, Average number of drugs per prescription, Percentage of drugs prescribed by generic name, percentage of drugs prescribed from essential drugs list or formulary, Average drug cost per prescription and Frequency of administration (recorded or not).

Setting: Ministry of health, Alexandria hospital of ophthalmology.

Study Population: Ophthalmologists in glaucoma outpatient clinic

Intervention: The Formulary was developed in 9/2010 and its impact was studied over a period of 6 month, 3month before and 3month after the use of formulary.

Results: Financial analysis indicated that most of the hospital budget was directed toward glaucoma therapy, Prostaglandin analogues were found to be the costliest among various drug groups. The most frequently prescribed drug for glaucoma was one of the brand medicines containing latanoprost constituting 38.4% of total prescriptions, followed by another brand medicine containing dorzolamide & timolol constituted 27.5% the consumption of which decreased after the use of the formulary to18.6 %. Both the prescription volume of glaucoma drugs and the average cost per prescription was high due to an ‘add-on’ prescribing effect of the more expensive carbonic anhydrase inhibitors. Changes in drug costs can result from changes in prescription volumes. Quantity per prescription changed from 1.4 to 1.3 and the average cost per prescription decreased from 87 L.E. to 72 L.E with total cost saving of 1762 L.E. over three months. Prescribing by generic name increased from zero to 12.5%, prescribing outside formulary decreased by 12.8%and no. of prescription without instructions decreased by 11.4%.

Conclusions: following the development of a formulary for the hospital, ophthalmologists prescribed from narrower range of drugs and the study suggests that formulary in Alexandria hospital of ophthalmology may favorably improve prescribing pattern and medication use.


Access to Medicines For Treating Acute Condition in Three Low- Income Countries In Central America

Isabel Cristina Martins Emmerick1, Dennis Ross-Degnan2, Vera Lucia Luiza1, Luiz Antonio Bastos Camacho1

1Oswaldo Cruz Foundation, Brazil; 2Departament of Medicine and Population - Harvard Medical School

Problem Statement: Access to medicines is a complex subject, linked to many economic, social, and demographic aspects. Different barriers from inside and outside of health system may affect access.

Objectives: Identify the main predictors of access to medicines for persons who had an acute health condition in the two preceding weeks in household surveys in Nicaragua (Nic), Honduras (Hon), and Guatemala (Gut).

Design: Cross-sectional analytic study based on data from a household (HH) survey implemented using methods developed by the World Health Organization, adapted to study exclusion from health care in Latin America. Data were analyzed using descriptive statistics and logistic regression.

Setting: 2,761 HH located in Nic, Hon, and Gut.

Study Population: One case of acute illness per household occurring during the two weeks preceding the survey was considered. If the household reported more than one case, the youngest person experiencing an illness was selected.

Outcome Measure(s): Two dependent variables were considered: "seeking care in the formal health system" and “having full access to medicines” (all medicines sought for the acute condition were obtained). Multivariate models included all independent variables related to the study outcomes with p<0.20 in bivariate analyses. All variables with p<0.10 were kept in the final model.

Results: Overall, 59.0%, 56.2%, and 30.9% of households experienced an acute illness in Nic, Hon, and Gut respectively. The proportion of persons who sought care in the formal health system for the acute condition varied from 41.3% in Hon to 47.1% in Nic, while full access to medicines ranged from 60.3% in Gut to 86.5% in Hon. The significant predictors of seeking care in at least one country included: urban geographic location, higher education level, age under 15 years, and treating an illness perceived to be severe. The strongest predictors of full access to medicines inside the health system were seeking care in the private sector, household head retired, higher education level, and more positive perceptions about quality of health care and medicines. For patients receiving care outside of the formal health system, the predictors of full access to medicines were urban geographic location, higher economic status, son or daughter of household head, female gender, and the duration of working hours in the public health facility.

Conclusions: Prevalence of acute health condition was different across countries. Around half people with acute conditions sought care in the formal health system. Predictors of full access to medicines inside and outside the health system were different.

Funding Source: Pan American Health Organization, Coordination for the Improvement of Higher Education People


Impact of the 30-Baht Scheme on Access to and Use of Medicines in Thailand: A Policy Evaluation Using Market Share Data

Laura Faden1, Peter Stephens2, Dennis Ross-Degnan1, Anita Wagner1

1Harvard Medical School and Harvard Pilgrim Health Care Institute, United States of America; 2IMS Health, London, UK

Problem Statement: In 2001, Thailand implemented the 30 Baht Scheme, a public health insurance scheme covering the poor and uninsured. Goals of the capitated payment scheme were to increase access to health care, including medicines, and to influence provider behavior to use resources efficiently. Under the policy, patients paid a flat fee of 30 baht for every encounter, including prescription medicines, at the area hospital they were assigned to. After implementation of the 30 baht scheme, the percentage of the Thai population covered by public insurance jumped from 40% in 2001 to 95.5% in 2004, with 75.2% of the population insured through the 30 baht scheme.

Objectives: To evaluate the immediate (first year) and long-term (five year) impact of the 30 baht scheme on pharmaceutical market size and composition in Thailand for medicines in four high-impact disease areas: cancer, cardiovascular disease, diabetes, and HIV/AIDS.

Design: Interrupted time series design without control group

Setting: Thailand (a lower-middle income country) from 1998 to 2006

Study Population: Quarterly purchases of medicines used for cancer, cardiovascular disease, diabetes, and HIV/AIDS from a representative panel of private pharmacies (approximately 350) and hospitals (approximately 200) collected by IMS Health between 1998 and 2006

Interventions/Policies: Thailand’s 30 baht scheme (also known as the Universal Coverage Scheme) implemented in 2001

Outcome Measures: (1) Volume: the number of units purchased, and (2) Market share: percent of total volume purchased of products in a therapeutic class in different categories (generic versus originator brands, older versus newer medicines, first-line drugs versus other therapies, etc.)

Results: We will report (1) changes in overall volume of medicines purchased by therapeutic category, and (2) changes in market share within therapeutic category (by branded versus unbranded products, older versus newer medicines and more expensive second-/third-line versus less expensive first-line therapies) in the hospital sector after the implementation of the 30 baht scheme compared to before 2001. We will also assess potential changes in the private retail sector.

Conclusions: To be determined

Funding Sources: This project was funded by the Harvard Medical School Fellowship in Pharmaceutical Policy Research. IMS Health provided data in kind. Drs. Wagner and Ross-Degnan were supported by a grant from the World Health Organization for the development of the ICIUM2011 scientific program.


Pharmaceutical Situation Assessment: Level II Health Facilities Survey in Syria

Hazar Faroun

MOH /Syria, Syrian Arab Republic

Problem statement: A field study to assess the pharmaceutical situation was undertaken in Syria in October 2009 using a standardized methodology developed by WHO.

Objectives: To answer questions related to availability, affordability, and access of medicines

Method: A descriptive study used a structured questionnaire as the main tool. In addition, patient records and medicines records were reviewed in the health facilities; 5 provinces were selected as “survey areas” representing different development levels. In each survey area, 6 public health facilities were identified. An additional 4 public medicine outlets per survey area were then selected randomly from all middle-level PH care facilities. For each public facility, the nearest private pharmacy was visited. Additionally, 1 warehouse that supplies the public sector was visited in each area, resulting in 30 public health facilities with their dispensaries, 30 private pharmacies, and 5 warehouses being visited. The number of outpatient interviews was 1787. The field team consisted of 15 data collectors and 5 supervisors. Data were typed into summary forms 1–4 and the workbook, both in Excel. For data on drug prices and affordability, the WHO-HAI workbook was used.

Results: Overall indicators of access show that key essential medicines selected for the country are partially available in public health centers (57%), warehouses that supply public health system (81.1%), and private pharmacies (96.3%). The length of stock out duration does not indicate a recurrent logistic problem. Few patients (5.2%) had to drive more than an hour to public and private dispensing facilities. Medicine prices at public facilities are lower than in private pharmacies. About 1/3 of final patient prices for generic medicines in the public sector are close to MSH prices and the rest of the products (18 products) are between 2-6 times more than MSH prices. When originator brand medicines are prescribed/dispensed in the private sector, patients pay about 1.4-7.7 times more than they would for generics. The percentage of expired medicines and adequate storage practices are indications of the adequate quality of medicines. An excessive level of antibiotics and a reasonable level of injectable medicines are prescribed. The national EML was found in only 26.7% and STGs in only 13.3% of surveyed health facilities. Physicians rarely consult STGs. The selling of prescribed medicines without prescription seems to be a widespread practice.

Recommendations: The access components such as strategies to improve availability and enhance affordability of medicines should be maintained. Appropriate use of drugs should be promoted.

Funding sources: Information not provided


Analysis of medicines dispensed by court order in the court of Rio de Janeiro: the application of scientific evidence in decision-making process.

Tatiana Aragão Figueiredo1, Vera Lucia Edais Pepe2, Claudia Garcia Serpa Osorio-de-Castro3

1Master of National School of Public Health Sergio Arouca (ENSP / FIOCRUZ); 2Collaborating Center on Health Surveillance (Cecovisa / ENSP / FIOCRUZ); 3Nucleus for Pharmaceutical Care (NAF / ENSP / FIOCRUZ)

Problem Statement: The Brazilian law guarantees the right to Pharmaceutical Assistance (PA), but there are still gaps in the effectiveness of the state citizens' access to medicines, so the medicines´s lawsuits have played an important role as an alternative to medicines in Brazilian Health System (SUS). This type of lawsuit is increasing annually and aims to both the medicines that are missing from the public as yet not incorporated into the health system.

Objective: To assess the medicines present in the lawsuits from the county Rio de Janeiro Central of Warrants referred to the Department of Health and Civil Defense of the State of Rio de Janeiro (SESDEC / RJ), from July 2007 to June 2008, compared to therapeutic alternatives present in the lists of public and in the light of scientific evidence.

Methods: This is a retrospective cross sectional study, the unit of analysis was the patient, the author of the judicial process. We analyzed the medicines registered in the Central of Warrants in SESDEC/ RJ referring to 281 patients.

Results: There were 804 requests for medicines, corresponding to 356 medicines and 269 drugs, with an average of 2.8 medicine per patient. They were part of the National List of Essential Medicines 23.9% and 66.6% of medications were missing im the component of funding for pharmaceutical services. The main subgroups therapeutic / pharmacological medicines were used for diabetes, eye care and drugs for diseases of airway obstruction.

With regard to the medications required, there was also a myriad of categories when considering the available evidence and existing information. Most of the medications they needed was not financed by the health system and between them stands out: 1) medications required with health information registered in the National Sanitary Agency (ANVISA)with scientific evidence and that presenting alternative therapies funded by the system, 2) medicines for which the evidence in long term are not yet well established, 3) medications for indications not approved by ANVISA, 4) medicines unregistered at Anvisa and 5) there are medicines without evidence for use or are not recommend their use.

Conclusion: The search for scientific evidence is extremely important for the medicines that are not present in the public lists and who also have no therapeutic alternatives.

In confronting the phenomenon of "court decisions, especially regarding the lawsuit of medicines, the approach of the Health System with the Judiciary is essential to guarantee the right to health without compromising the principles of the SUS and the management of pharmaceutical services.

Funding Source: National Council for Scientific and Technological Development (CNPq).


Investigating Medicine Supply as a Rate Limiting Step in the Scale-Up of Isoniazid Preventive Therapy in Kwazulu-Natal, South Africa

Fathima Fyzoo1, Nirupa Misra2

1Management Sciences for Health, SPS, South Africa; 2Department of Health, KwaZulu-Natal

Problem Statement: Tuberculosis (TB) is the commonest cause of morbidity and mortality amongst HIV-infected persons in South Africa (SA). In April 2010, SA published guidelines for TB preventive therapy among HIV-infected individuals and embarked on massive scale-up programme of isoniazid preventive therapy (IPT). In terms of the National Service Delivery Plan, 600,000 HIV-positive patients were to be initiated on IPT by June 2011. The SA province of KwaZulu-Natal (KZN) set a target of initiating 70,238 patients on IPT by September 2010. One of the initial challenges to this rapid scale-up was the unavailability of isoniazid (INH) 300 mg, so the implementation strategy included an accelerated plan for the procurement and supply of INH 300 mg. The uptake of IPT patients has been slow and by September 2010, only 21% of the provincial target had been achieved. One of the constant factors cited for the low uptake of IPT has been perceived problems with the supply of isoniazid to health facilities in the districts. An investigation into the supply of INH 300 mg to districts was needed.

Objective: To compare INH 300 mg tablets supply with the actual number of patients initiated on IPT for the period April to September 2010. The objective was to identify medicine supply problems and propose possible solutions.

Design: Comparative analysis

Methods: A desktop review was undertaken using medicine consumption data extracted from the provincial medicine supply depot for the period April to September 2010. Data on the actual number of patients initiated on treatment was extracted from KZN District Health Information System (DHIS) for the same period. Actual medicine requirements based on cumulative uptake of patients was calculated.

Results: The data was manipulated to show drug distribution patterns of INH to the 11 districts from April to September 2010. The analysis identified several important issues. Supply of INH appeared to be a challenge in some districts only during the initial phase of the rollout. Since inception of the programme, 9 out of 11 districts in KZN had more than the required amount of stock of INH 300 mg to initiate patients on treatment. In most districts, overstocking seemed to be the major problem with many districts having >6 times the quantity required. Only the medicine supply in Umkhanyakude district was lower than the number of patients initiated on treatment. It is possible that INH 100 mg was being to treat adult patients or there was incorrect reporting of patient enrolment into the programme.

Conclusions: The review showed that medicine supply of INH 300 mg was not a rate limiting step in the scale-up of IPT in KZN. With the exception of Umkhanyakude, all other districts had more than adequate stock of INH 300 mg. The recommendations included redistribution of excess stock in overstocked districts and further analysis into INH 300 mg stock levels and patient numbers per facility as well as an analysis of INH 100 mg use in districts.

Funding Source: United States Agency for International Development


Assessment of Generic Antimicrobial Unit Retail Price Mark-Ups Applied in Public Hospitals in Rwanda



Problem statement: Evidence-based medicine pricing policies for both branded and generic medicines can prevent high-price disparities among suppliers while increasing medicine accessibility. To date, little is known about how public hospital pharmacies conform to the 2007 Rwanda ministerial circular letter that fixes the maximum mark-up for medicines in the public sector.

Objectives: To assess the level of compliance to the ministerial circular letter on the maximum allowable medicine price mark-ups in public hospitals that use a set of antimicrobials

Design: A price survey was conducted to review the current generic antimicrobial price mark-up applied on health insurance and public hospital tariffs. We collected updated retail price lists of the 10 most used generic antimicrobials from 10 public hospital pharmacies and 4 health insurance institutions working with public hospitals. The theoretical retail prices for comparison were calculated by applying the maximum allowable mark-up of 20% on the average selling prices from 5 wholesale depots selected randomly.

Setting: We assessed prices in 10 public hospitals composing our convenience sample. The wholesale prices used came from the public medicine procurement agency (CAMERWA) and from 4 private wholesale depots.

Study population: Not applicable

Outcome measures: Average of wholesale and retail unit prices with allowable mark-up percentages applied

Results: By considering only the CAMERWA price list, mark-ups on medicine retail unit prices are significantly higher than our theoretical retail unit price. On average, a mark-up of 112% above the maximum allowable mark-up was found, with slight variations across studied products (SD = 1.5, Max = 1,118%, Min = −66.1%). By using the average selling prices from both private and public wholesale depots, we observed an average increase of 109% (SD = 1.6, Max = 1,128.1%, Min = −66.1%) above the maximum allowable mark-ups. Only one product (metronidazole inj.) was, on average sold at a lower price than the theoretical value (33.1% below the allowable mark-up), whereas the highest mark-ups were applied to gentamycine inj. (average of 214.7% above the allowable value).

Conclusions: Deviations to the allowable mark-ups applied to generic medicine prices exist in public hospital in Rwanda, which can negatively affect patients’ ability to afford treatment. Potential savings and increase of medicine accessibility can be maximized by reinforcing the current medicine pricing instructions and promoting transparency and fair competition between suppliers.

Funding sources: US Agency for International Development Strengthening Pharmaceutical Systems Program through Management Sciences for Health


Analysis of NMP Documents of the Region of the Americas

Claudia Garcia Serpa Osorio-de-Castro1, Angela Esher1, Elaine Silva Miranda1, Paula Pimenta de Souza1, Letícia Figueira Freitas1, Nelly Marín2

1Sergio Arouca National School of Public Health/Oswaldo Cruz Foundation, Brazil; 2Medicines and Health Technologies, Pan American Health Organization, WHO Regional Office for the Americas

Problem statement: Specific priorities and different contexts in terms of pharmaceutical policies have resulted in different levels of pharmaceutical policy development and implementation by countries in the region of the Americas. There is a perceived need in this region for a review of the WHO pharmaceutical policy guide.

Objective: We analyze pharmaceutical policy documents in the region of the Americas as a first step to updating the WHO policy guide for the region.

Design and setting: Search for policy documents was undertaken and centralized by PAHO, selected as the sole information source. Policy documents were included only if they were available as an official NMP document; no draft policies were analyzed. An analytical matrix was developed; analytical categories applicable to the information retrieved in the matrix were also developed by using the conceptual framework of content analysis and based on categories of the original WHO guideline document.

Outcome measures: Content of the introduction, topics and concepts in the documents, consistency of organization, references to WHO and national guidelines, and innovative issues present in the policies

Results: Of 17 countries with existing NMP documents, 14 were studied. All documents mention policy objectives and commit to implementation, but few cite explicit implementation plans with goals, policy development and stakeholders, review, and implementation strategies. There was no discernible standard in frequency of policy topics. Country NMPs generally adhered to WHO guideline structure. Some policy documents use pivotal topics around which they organize policy structure, such as generics. Concepts or ideals related to the essential medicines concepts, generic medicines, medicines selection committees, and market authorization must be reviewed in medicines policies in the future. Various extra issues not present in the WHO guideline were introduced by countries. Contributions in the 3 dimensions of access, quality, and rational use were found, although quality had fewer innovative ideas.

Conclusion: Documents were drafted in different contexts and periods. Differences in writing traditions may account for more or less emphasis on certain topics and in expressing country context. The 14 policies make up a fairly substantial sample of medicines policies in the region of the Americas. We propose that the instrument developed to analyze NMP was effective in revealing updating requirements for a new region-focused NMP guideline.

Funding source: PAHO

683-Garcia Serpa Osorio-de-Castro-_a.pdf

Pharmaceutical Services for Uncomplicated Malaria by P. vivax and P. falciparum in High-Risk Municipalities of the Brazilian Amazon: Organization of Services, Prescribing, Dispensing, and Adherence to Treatment

Claudia Garcia Serpa Osorio-de-Castro1, Monica Rodrigues Campos1, Elaine Silva Miranda1, Martha Cecília Suárez-Mútis2, Letícia Figueira Freitas1, Paula Pimenta de Souza1

1Sergio Arouca National School of Public Health/Oswaldo Cruz Foundation, Brazil; 2Oswaldo Cruz Institute/Oswaldo Cruz Foundation

Problem statement: Malaria is a serious public health hazard worldwide. In Brazil the disease is prevalent in the Amazon and the national program rationale is based on early diagnosis and treatment, thus making pharmaceutical services a key element for control.

Objective: To evaluate public sector pharmaceutical services for malaria complying with directives of the Brazilian National Medicines Policy

Design and development, setting, and study population: An evaluation methodology was developed, and indicators were assigned for the following outcomes: organization of services, prescribing, dispensing, and adherence to treatment. Field work involved a pilot study and visits to 15 public health facilities—primary care facilities or health centers—in 6 high-malaria risk municipalities of the Brazilian Amazon. In total, 15 managers and 601 patients were interviewed; 175 were followed prospectively. All participants gave informed consent. Data were analyzed descriptively.

Results: Ten out of 15 facilities presented an environment for receiving patients and for prescribing. National treatment guidelines were present in 12 of 15 facilities. These were over- or under-stocked, and supply was not based on forecasting. Only 2 had a storage area, and in these, Good Storage Practices scored 70%. Only 2 facilities in 2 municipalities provided prescriptions; only 34 patients (5.7% of total) were given a prescription or a written instructions on which medicines to take. Two to three antimalarials were included in 76.4% treatment regimens. Adequate labeling occurred in 44.4% of the cases for artemether-lumefantrine, 12.3% for chloroquine, and 6.9% for primaquine. All other medicines had inadequate or nonexistent labeling. Of 453 patients diagnosed with P. vivax, 450 (99.3%) received indication for first-line treatment scheme, and 102 (22.5%) were counseled on medicines. Of 120 P. falciparum cases, 57 (47.5%) were indicated for the first-line regimen (quinine-doxycycline-primaquine); 3 (2.5%) were recommended mefloquine and primaquine and 26 (21.7%) lumefantrine-artemether; 34 (28.3%) were indicated non-sanctioned treatments. Of the total number of P. falciparum patients, only 44 (36.6%) were counseled. Self-reported adherence was 61.1%, and pill-count adherence was measured at 56.6%. After application of mandatory criteria for adherence percentages fell to 6.7% in self-reporting and 7.3% in pill counts.

Conclusions: Pharmaceutical services for malaria in Brazil present problems in organization of services, prescribing, and dispensing. Services lack comprehensiveness and municipalities differ in service quality. Adherence to treatment is low and undermined by lack of service organization. Problems in pharmaceutical services may compromise care, leading to increase in disease prevalence and drug resistance in these municipalities.

Funding source: CNPq

211-Garcia Serpa Osorio-de-Castro-_a.pdf

Intensive Hospital-Based Adverse Drug Reactions Monitoring Studies on 5482 Patients of Kashmiri Origin in a Tertiary Care Hospital

Mohammad Ishaq Geer1, Mohammad Yasin Shah1, Parvaiz Ahmad Koul2, Shafiqa Aslam Tanki3

1Dept. of Pharmaceutical Sciences, University of Kashmir, India; 2Dept. of Internal Medicine, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, J&K, India; 3Dept. of Clinical Pharmacology, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, J&K, India

Problem statement: Prior to this study, there was no provision for monitoring drugs for their adverse effects in any of the leading hospitals of Kashmir division of the J&K state.

Objectives: To assess the prevalence, preventability, category, costs, and severity of drug-related adverse effects in Kashmiri patients at a Srinagar-based tertiary care hospital, Sher-i-Kashmir Institute of Medical Sciences (SKIMS)

Design: Prospective, observational, cohort study with follow-up

Setting: All adult patients admitted to internal medicine IPD, presenting to internal medicine OPD, and those visiting the accident and emergency department of SKIMS over a 270-day period were included in the study.

Study population: A total of 5482 adult, Kashmiri patients of both sexes were screened and monitored on a daily basis for the occurrence of any ADRs.

Intervention: Data was recorded using structured forms and then scrutinized for various assessment parameters by a multidisciplinary medical team consisting of a senior consultant in medicine, a clinical pharmacologist, and a pharmacist. Interventions relating to detection and management of ADRs were undertaken on a case-to-case basis. The study led to the establishment of a full-fledged pharmacovigilance centre in the hospital besides initiation of Pharmaceutical Care Services in its Internal Medicine ward.

Policies: No hospital drug policy or ADR monitoring policy/framework was available in SKIMS at the time of this study.

Outcome measures: Causality assessment, severity assessment, preventability assessment, extension of hospital stay, and cost due to ADRs

Results: ADRs account for 6.23% of Kashmiri patients visiting a tertiary care hospital like SKIMS, either for referral or hospitalization, with the majority (81.57%) of these ADRs being preventable; 23.68% of patients had mild ADRs, 69.29% had ADRs of moderate severity, and 7.01% had severe ADRs. The 4 classes of drugs most frequently suspected in admissions due to ADRs were anti-infective agents (40.92%) including anti-tubercular drugs (13.15%), steroids (14.03%), anti-coagulants (8.77%), and NSAIDs (7.89%). Increasing age and female gender were identified as risk factors. The organ systems most commonly affected were gastrointestinal (81%), dermatological (43%), central nervous (40%), hematological (34%), metabolic (33%), cardiovascular (22%), urinary (18%), ENT (18%), immunological (11%), and respiratory (10%) systems. The total cost to the hospital due to hospitalization of patients presenting with ADRs over the 9-month period in the internal medicine IPD was USD 22469.

Conclusions: The present work is the maiden pharmacovigilance study conducted on Kashmiri patients, especially at a tertiary care teaching hospital such as SKIMS that has provided baseline information about the prevalence of ADRs and their distribution among different age groups, genders, organ systems affected, and therapeutic classes of medicines. The data collected will be useful in the future for long term and more extensive ADR monitoring on Kashmiri patients and will also be useful in framing policies toward the rational use of drugs.

Funding sources: Nil


Effect of IEC Intervention on Awareness about Rational Pharmacy Practice in Pharmacy Students

Kunda Jayant Gharpure1, Vijay Thawani2, Smita Sontakke1, Kiran Chaudhari1, Mangesh Bankar1, Rajendra Diwe3

1Department of Pharmacology, Government Medical College, Nagpur, India; 2Department,VCSGGMSRI,Srinagar, Garhwal-246174.Uttarakhand,India.; 3The Hitavada, Nagpur, India

Problem statement: There is growing indifference among pharmacy practitioners towards their duty as information providers to patients. The pharmacy curriculum does not emphasise such practical pharmacy aspects. The patients do not always get enough information about the proper use of medicines from prescribers due to time constraints. This leads to improper use of medicines by patients.

Objectives: To collect baseline data from students and to intervene through information, education, and communication (IEC) to raise awareness among pharmacy students about rational pharmacy practice

Design: A pre-post design study with two interventions was planned using a sample of local graduate and final year pharmacy students from four colleges. After informed consent was obtained, their base knowledge was assessed through written testing, which comprised 27 objective questions related to awareness and attitude towards rational pharmacy practice. This was followed by the first intervention—publication of seven articles on rational medicine use in a leading local English news daily. The articles were displayed on the students’ notice board of their respective colleges, and the participants were reminded when these appeared in print. The second intervention was a half-day interactive session where six short lectures were delivered to participants on right and wrong approaches in pharmacy practice. Posters about do’s and don’ts of rational pharmacy practice were displayed at the venue. After the second intervention, repeat testing was done using the same pretest questions to assess change. Pre- and post-intervention data was compared using Fisher’s exact test.

Results: Awareness about DTCA, off-label use, schedules of medicines, books of reference, and pharmacovigilance was significantly changed post-intervention. False notions about need of medicine for every illness, side effects of OTC medicines, brand verses generic quality, newer and costly medicines, injections, and FDCs significantly changed. Attitudinal change was seen in rechecking doubtful prescriptions with the prescriber, lodging a complaint with FDA for quality check, and repeating prescriptions.

Conclusions: The role of pharmacist in health care provision is usually overlooked in India. Rational practice must be included at the student level so that when pharmacists enter the profession they are aware of their responsibilities. This study showed that a properly timed and meticulously constructed intervention brings about positive change in knowledge and attitude.

Funding source(s): The study was not funded, and there is no conflict of interest.


Antibiotics with Facilitated Referral to a Rural Health Center Using Zambian Trained Traditional Birth Attendants as a Strategy for Reducing Neonatal Mortality

Christopher J. Gill1, William B MacLeod1, Nicholas G. Guerina2, Mark Mirochnick3, Arthur Mazimba1, Anna Knapp1, Davidson H. Hamer1

1Boston University School of Public Health, United States of America; 2Tufts University School of Medicine; 3Boston University School of Medicine

Problem statement: Neonatal sepsis is a major cause of neonatal mortality. In communities with limited access to health care, early identification of bacterial infections and initiation of antibiotics could be lifesaving.

Setting: Lufwanyama—an underdeveloped, impoverished, rural agrarian district in Zambia

Study population: Trained traditional birth attendants (TBAs); mothers/infants that they worked with

Design: Nested observational descriptive analysis within a cluster randomized controlled study (The Lufwanyama Neonatal Survival Project)

Intervention: The intervention TBAs were trained to recognize any of a set of cardinal symptoms and signs of possible neonatal infection; if any were observed in the first 4 weeks of life, intervention TBAs were to administer a 500 mg dose of oral amoxicillin and facilitate referral (AFR) to the nearest health facility. The current analysis aims to better characterize the AFR process, with the ultimate goal of identifying areas that could be improved.

Outcome measures: Frequency of postpartum visits by intervention TBAs to the mother/infant pair; utilization of AFR; reasons for AFR; proportions of completed referrals; proportions of infants who later died who had been referred or treated

Results: In the month after delivery, intervention TBAs conducted a median of 4 (IQR 2-6) home visits (49% occurred in week 1, 51% in weeks 2-4 postpartum). TBAs who referred had nearly always given amoxicillin (96.8% [214/221]), and TBAs who gave amoxicillin nearly always referred (95.3% [204/214]). The most frequent reasons for referral were ‘cough’ 39.7% (75/189), ‘baby felt too hot’ 38.6% (73/189), ‘mother thought baby looked sick’ 35.5% (67/189) and ‘difficulty breathing’ 24.3% (46/189). A lower proportion of mothers completed the referral (75% [165/221]). Compared with live-born infants who survived, those who later died were significantly more likely to have been referred by the TBA compared with those who survived (RR 13.9; 95% CI 6.8-28.3), and were more likely to have been given amoxicillin (RR 9.2; 95% CI 4.6-18.4). However, only 2/3rd of live-born infants who died were referred, and only ~50% received amoxicillin.

Conclusions: The TBAs maintained frequent contact with the mother/infant pair after delivery. Referral and amoxicillin use occurred at similar rates, suggesting that the TBAs were correctly identifying many sick infants and responding appropriately. Further work is needed to improve the effectiveness of TBAs in reducing neonatal mortality and to understand why mothers often declined referral.

Funding source: USAID, NIH/NIAID


Routine Assessment of Patients’ Attendance and Adherence to Antiretroviral Treatment In Kenya – Providers’ Views on Usefulness to Improve Performance

Lilian Nyambura Gitau1, Susan Njogo2, Dorine Kagai2, Peter Nguhiu1, Patrick Boruett1, Christine Awuor2, John Chalker1,4, Göran Tomson3, Rolf Wahlström3

1Management Sciences for Health/Strengthening Pharmaceutical Systems Program; 2National AIDS/STI Control Program, Kenya; 3Division of Global Health (IHCAR), Karolinska Institutet, Sweden; 4International Network for the Rational Use of Drugs (INRUD) – IAA

Problem statement: The Kenya National AIDS Control Program has identified problems in identifying and tracking defaulters, weak community linkages, and lack of national guidelines and tools on adherence monitoring as challenges at the facility level for quality of care of patients on antiretroviral treatment (ART). Routinely collected data is often not used to improve performance.

Objective: To assess the implementation of facility-based appointment-keeping systems and the use of adherence-based indicators to inform decisions for performance improvement

Design: Qualitative explorative part of a quasi-experimental study

Setting: Six conveniently sampled health facilities in Kenya located in the Rift Valley, Central Province, and Eastern Province

Study population: We conducted in-depth interviews with 58 health care providers and reviewed the clinic appointment diaries in each facility. Minutes of facility meetings were examined for evidence of use of appointment-keeping indicators.

Intervention: We introduced an appointment diary in each facility to schedule patient visits. The two adherence indicators monitored each month were the percentage of patients who attended the clinic (1) on or before the day of their appointment and (2) within 3 days of their appointment. The indicators were calculated by trained facility staff using a summary sheet and were intended to inform multidisciplinary team meetings.

Outcome measures: Use of intervention tools and description of facilitating and hindering factors for successful monitoring and follow-up

Results: All facilities implemented the diary and monitored the two appointment-keeping indicators. Trends generated were discussed in the monthly team meetings at the clinic. This helped to motivate providers and empower them to initiate corrective measures. The diaries helped detect clients’ missing appointments and enabled timely actions. Information on individual patient attendance helped facility staff to provide targeted counseling and adjusting intervals of patient visits. Monitoring of the number of patients scheduled to visit on a given day was used to spread their workload. Data generated helped to establishing linkages with other neighbouring facilities for referral.

Conclusion: The use of intervention tools generated information, which led to better use of data in the decision-making process. The monitoring of routinely collected data plays a vital role in influencing health-seeking behavior of patients such as clinic attendance and adherence to medication.

Funding sources: The study is part of the INRUD Initiative on Adherence to Antiretrovirals funded by the Swedish International Development Cooperation Agency with additional funding from the USAID funded Strengthening Pharmacy Systems Project through Management Sciences for Health.


Care Needed When Comparing IMS and Administrative Databases in Cross National Comparative Studies?

Brian Barr Godman1, Kristina Garuoliene2,3, Jolanta Gulbinovic3

1Karolinska Institutet, Sweden; 2National Health Insurance Fund, Lithuania; 3Department of Pathology, Forensic Medicine and Pharmacology, University of Vilnius, Lithuania

Problem statement: Existing databases for cross national comparative (CNC) studies include administrative databases and commercial sources such as IMS. There can be substantial differences, however, in data collection methods, content, measurement units, and expenditure (e.g., factory, reimbursed, total) between the databases. In addition, there can be volume differences between the databases arising from high patient co-payment levels and prescribing restrictions in some countries. This could have major implications when comparing utilisation rates between countries unless the content of each database has been fully described.

Objective: To ascertain the extent of differences in one country and the underlying rationale where it is likely there will be appreciable differences between datasets to provide future guidance. Lithuania was chosen because recent publications have shown appreciable differences in statin utilisation between commercial (Soft Dent database containing data from wholesalers including OTC and self pay) and administrative (Health Insurance Fund) databases.

Design and policies: Observational drug utilisation study assessing DDDs in four classes (PPIs, statins, ACEIs/ARBs, and newer anti-depressants—ATC Level 5) between 2004 and 2009 in the Lithuanian Compulsory Health Insurance Database and among commercial databases (IMS—all four, Soft Dent—statins). Soft Dent data were taken from a publication (2005–07); IMS data (2004–09) were supplied directly. Both were converted to 2010 DDDs for comparison with administrative databases. 2010 DDDs were used in accordance with published recommendations. Details of ongoing reforms including prescribing restrictions were taken from published sources and updated by two of the authors (KG and JG). Narrative review of reforms subsequently undertaken by one of the co-authors (BBG).

Setting: Lithuania

Intervention and outcome: Differences in utilisation (2010 DDDs) rates were examined over the study years for 4 disease areas and databases (ATC Level 5). 4 disease areas were chosen because each one is a high-volume prescribing area in western European countries. Previous publications have shown, however, substantially lower utilisation of PPIs and statins in Lithuania vs. Western European countries.

Results: Appreciable differences in utilisation rates were found for the PPIs and statins between administrative and commercial sources; limited differences were found for ACEIs/ARBs and newer anti-depressants: (1) PPIs—five- to seven-fold increase in utilisation in IMS vs. administrative databases. Overall, PPI utilisation in the administrative database varied between 14.5 and 19.0% of IMS utilisation across the study years with no established pattern. (2) Statins—three- to over sixfold increase in utilisation in commercial (IMS and Soft Dent) vs. administrative databases. Overall, statin utilisation in the administrative database varied between 15.1 and 27.4% of IMS utilisation across the study years with no established pattern. (3) ACEIs/ARBs—limited difference between IMS and administrative databases. Overall, utilisation in the administrative database varied between 75.6 and 89.5% of IMS utilisation across the study years with no established pattern. (4) Anti-depressants—limited difference between IMS and administrative databases. Overall, utilisation in the administrative database varied between 70.7 and 88.4% of IMS utilisation across the years, with generally closer alignment in recent years.

Conclusions: Possible reasons for appreciable self purchasing of PPIs and statins include at least 50% co-payment for majority of indications (PPIs) and prescribing restrictions for both the PPIs and statins (only reimbursed for secondary prevention and only 6 months for majority of study period with co-payment of 20%). This compares with a median of only 15% in the EuroMedStat study for the statins comparing administrative and IMS databases (western European countries). Possible reasons for closer alignment between IMS and administrative databases for ACEIs/ARBs could be no prescribing restrictions (although still 20% co-payment) and that hypertension seen as a serious disease (less so for hypercholesterolaemia). Limited utilisation generally of anti-depressants in Lithuania due possibly to ongoing stigma associated with psychiatric hospitals (i.e., patients are rapidly transferred to a psychiatrist if they show no clinical improvement with current anti-depressants) and the use of alternative treatment approaches such as benzodiazepines may account for closer alignment in this class. In view of this, knowledge of the content of each database and associated reforms are essential when comparing reimbursed utilisation rates (administrative databases) across countries given the substantial variations seen in some classes. Such knowledge will ensure robust explanations when validating databases and their content. Consequently, this should become a standard validation criteria alongside describing the patient population and their representativeness (ESAC criteria) when undertaking CNC studies.

Funding source(s): In part grants from Karolinska Institutet


Trends in Pricing Policy of Generics: Global Implications

Brian Barr Godman1, Bjorn Wettermark1,2, Kristina Garuoliene3, F Cankat Tulunay4, Lesley Tilson5

1Karolinska Institutet, Sweden; 2Medical Knowledge Centre Stockholm Country Council, Sweden; 3National Health Insurance Fund, Lithuania; 4Department of Pharmacology, Medical School, Ankara, Turkey; 5National Pharmacoeconomic Centre, Ireland

Problem statement: Generic prices vary appreciably across Europe. Countries can learn from each other to realise considerable savings as resource pressures grow and more standard drugs lose their patents.

Objective: To document different pricing policies for generics across Europe in an understandable format and their impact to provide guidance in the future

Design, setting, and study population: (1) Documenting generic pricing policies through literature searches and via payers from across Europe; (2) narrative review of the reforms by one of the authors (BBG) and validated by the countries; (3) retrospective observational CNC study using only administrative databases in over 20 European countries or regions for generic PPIs, statins, ACEIs, and SSRIs at ATC Level 5 to determine price reductions over time vs. originator prices (expenditure/DDD) pre-patent loss or in 2001; (4) reimbursed expenditure rather than total expenditure as health authority perspective

Intervention: Changes in reimbursed expenditure/DDD (2010 DDDs) for generics in four classes in 2007 vs. pre-patent loss originator prices (2001) alongside documenting the respective generic pricing policies

Policies: Pricing policies for each country broken down into understandable categories for comparison

Outcome measure(s): (1) Percentage reduction in reimbursed expenditure/DDD for chosen generics in 2007 vs. 2001 originator prices; (2) percentage change in expenditure and utilisation in 2007 vs. 2001 for PPIs and statins; (3) € per 1,000 inhabitants per year in 2007 for PPIs and statins

Results: Three principal approaches to generic pricing were used and validated with the various payers in each European country: (1) prescriptive pricing (PP), established (prescriptive) reductions for reimbursement (e.g., up to 85% price reduction in Norway, 33% below for first generic in Turkey); (2) market forces (MF), no fixed amount, but mechanisms to enhance their utilisation to drive down prices (e.g., Sweden and UK); and (3) mixed approach (MA), PP for first generic(s) followed by MF (e.g., in Austria the third generic launched must be priced 60% below pre-patent prices for the originator molecule for reimbursement and market forces after that). Expenditure/DDD for simvastatin in 2007 was 97% below 2001 originator price levels in England (MF), 96% below in Sweden (MF), and 79% below in Lithuania (MA) vs. just over 50% in France (PP). Typically, less marked reductions in expenditure/DDD for generic omeprazole vs. pre-patent prices. There was also appreciable variation in expenditure/DDD for generic ACEIs and SSRIs within and between countries. Country size did not matter in terms of potential price reductions—more the environment to enhance prescribing of generics. These differences plus differences in generic utilisation resulted in considerable differences in reimbursed expenditure between countries for both the PPIs and statins, (e.g., €5832 and €5192/1000 inhabitants/year, respectively, for the PPIs and statins in Sweden in 2007 vs. over €60000 in Republic of Ireland for both—NB highly selective GMS population).

Conclusions: The categorisation system for the different approaches to the pricing of generics appears to work and is easily understandable. Considerable differences in reimbursed expenditure/DDD for high volume generics exist across Europe. This coupled with differences in their utilisation provides considerable opportunities for countries to learn from each other to enhance their prescribing efficiency as resource pressures grow.

Funding source(s): In part with grants from Karolinska Institutet


Intensity of Individual Reforms Results in Considerable Differences in Subsequent Utilisation; Implications for Countries When Contemplating Future Initiatives

Brian Barr Godman1, Bjorn Wettermark1,2, Lars Gustafsson1

1Karolinska Institutet, Sweden; 2Medical Knowledge Centre, Stockholm County Council, Sweden

Problem statement: Countries need to learn from each other when contemplating future demand-side reforms given appreciable and growing resource pressures, but the influence of even prescribing restrictions will depend on their nature and follow-up.

Objective: To assess the influence of different prescribing restriction regulations and their follow-up among different ambulatory care classes and European countries to provide future direction to countries contemplating similar initiatives

Design: Pre– and post–policy-analysis CNC study for statin, PPI, and ACEI/ARB utilisation in Austria, Croatia, Finland, and Norway before and after reimbursement restrictions for patent protected products

Setting and study population: Administrative databases covering total populations in each country; utilisation measured in terms of DDDs (2008 and 2010) for all products in the class (ATC Level 5) and as a percentage of total utilisation in the class

Interventions and policies: Details of prescribing restrictions (enforcement criteria) for more expensive patent-protected products in the class principally via payers in each country including peer-reviewed publications and validated with them to enhance the robustness of the findings

Outcome measure(s): Main measure: Percentage change in utilisation of omeprazole (O) and esomeprazole (E), simvastatin (S) and atorvastatin/rosuvastatin (A/R), and ARBs (total including combinations) vs. ACEIs (total including combinations) vs. total usitilisation for each class (DDD basis) before and up to 4 years after prescribing restrictions were introduced

Results: Considerable differences were found regarding the influence of prescribing restrictions within and between countries or classes. (1) A/R utilisation decreased from over 30% to 10% of total statins (DDD basis) in Austria (66%) 4 years after prescribing restrictions introduced with patients needing prior authorisation from the Chief Medical Officer (CMO) of their health insurance company for reimbursement. There was a 59% reduction in Finland 1.2 years later with strict criteria on the prescription form for reimbursement (indication and failing on generic statins) but only 44% reduction in Norway 4 years post-intervention with limited follow up and no prior authorisation (PA) scheme unlike Austria. (2) There was greater influence of prescribing restrictions on ARB utilisation in Croatia than Austria because greater follow-up in Croatia (via physicians with the Health Insurance Agency) with potential for fines for continued abuse vs. physician trust and no PA needed in Austria for reimbursement of ARBs. It is acknowledged that this is more difficult to police because an indication for switching is a patient-reported outcome (coughing). (3) We found limited influence also of prescribing restrictions on esomeprazole utilisation in Norway post-intervention because first prescription or recommendation is via hospital specialists where restrictions do not apply.

Conclusions: Prescribing restrictions (enforcement) can be effective in limiting the utilisation of more expensive patent protected products in a class once generics become available. Care is needed, however, because changes in utilisation patterns may be lower than envisaged depending on their nature and follow-up.

Funding source(s): In part grants from Karolinska Institutet


Intensity of Reforms Resulting in Considerable Differences in Generic Utilisation across Europe; Implications for Others

Brian Barr Godman1, Bjorn Wettermark1,2, Ott Laius3, Corrine Zara4, Lars Gustafsson1

1Karolinska Institutet, Sweden; 2Medical Knowledge Centre, Stockholm County Council, Sweden; 3State Agency of Medicines, Estonia; 4Catalan Health Service, Spain

Problem statement: There is appreciable variation in the utilisation of generics across Europe. Countries must learn from each other to fully realise savings from the increasing availability of generics to help combat growing resource pressures. The lessons may also be useful to low- and middle-income countries.

Objective: To assess the influence of multiple demand-side measures on the subsequent utilisation of generics vs. patent-protected products once they are available in a class to guide countries in the future

Design: Pre– and post–policy-analysis study for the PPIs and statins (ATC Level 5) in over 20 European countries and regions once generic omeprazole and generic simvastatin became available. Classes were chosen as both contain generics and patented products with limited outcome differences between them in the majority of patients. We found considerable price differences once generics are available in a class, however. No time series analysis was performed because typically health authorities and health insurance companies instigated a range of demand-side measures during the study period. In addition, the intensity of some of the demand-side measures may vary between regions. Both situations make time series analyses problematic.

Setting and study population: Administrative databases in over 20 European countries or regions mainly covering total populations. Utilisation was measured in DDDs (2010 DDDs) principally from 2001 to 2007. Years were chosen as generic simvastatin and generic omeprazole became available in western EU countries during this time.

Interventions and policies: (1) Demand-side reforms based on publications as well as input from payers themselves in each country (principal method); (2) narrative review subsequently undertaken by one of the co-authors (BBG) and validated; and (3) demand-side measures broken down by 4Es (education, engineering, economics, and enforcement) for each country and validated. The 4E approach had previously been used in a number of peer-reviewed publications to provide a comprehensive and easily understandable methodology for categorising and collating the plethora of demand-side measures to compare across countries.

Outcome measure(s): Main measure: Percentage change in the utilisation of omeprazole (O) and esomeprazole (E), simvastatin (S), and atorvastatin/rosuvastatin (A/R) in 2007 as a percentage of the total utilisation for class vs. the utilisation patterns seen before generic omeprazole and generic simvastatin became available and were reimbursed. Typically multiple demand-side initiatives were undertaken (broken down by the 4E approach) during the study period in each country. .

Results: There were considerable differences in the utilisation patterns in 2007 among the various European countries (e.g., utilisation of simvastatin varied between 5% to 85% of all statin utilistion and A/R utilisation varying between 1% to 75% of total statins depending on extent or intensity of the 4 Es): (1) atorvastatin utilisation decreased from over 30% to 10% of total statins in Austria 4 years after prescribing restrictions (enforcement) alongside other measures; simvastatin utilisation increased in Spain (Catalonia), Sweden, and the UK (England and Scotland) with lower or similar utilisation of A/R following a combination of 3 of the 4 Es (not enforcement); similar changes in utilisation were also seen for PPIs (omeprazole and esomeprazole). (2) In France, Turkey, and Ireland, A/R utilisation appreciably increased after generic simvastatin became available with limited demand-side measures to counteract pharmaceutical company activities. Similar patterns seen for PPIs. This led to appreciably higher expenditure (€/1000 inhabitants/year) in these countries than in Spain (Catalonia), Sweden, and the UK: (a) PPIs: €5832 in Sweden and €6186 in England vs. €15,194 in France and over €60,000 in Ireland (selective GMS population) and (b) statins: €5192 in Sweden, €9555 in Austria and €13,439 in England (utilisation increased 5.1 fold in England between 2001 and 2007 vs. 2.5 fold in Sweden, 2.4. fold in Austria and 72% in France) vs. €14,896 in France and over €60,000 in Ireland (7.1 fold; selective GMS population). Reforms in Estonia including obligatory INN prescribing led to statin utilisation increasing nearly twofold in 2007 vs. 2004 with only a 13% increase in reimbursed expenditure.

Conclusions: Multiple interventions are typically needed to change physician prescribing behaviours given the complexities involved in prescribing, mirroring other findings. The intensity of the measures is also important to favourably influence utilisation patterns. Countries are already learning from each other, but this needs to accelerate. 4E methodology is comprehensive and easily understandable to contrast the influence of the different demand-side measures and give future guidance. This methodology is also transferable between classes and countries; consequently, it should provide direction to low- and middle-income countries as they seek further initiatives to maximise health gain with available resources.

Funding source(s): In part grants from Karolinska Institutet


Risk-Sharing Arrangements—Opportunity or Threat to Fund New Medicines?

Brian Barr Godman1,2, Jakub Adamski3, Marija Kalaba4, Lars Gustafsson1

1Karolinska Institutet, Sweden; 2Mario Negri Institute, Milan, Italy; 3Ministry of Health, Warsaw, Poland; 4Republic Institute for Health Insurance, Serbia

Problem statement: Price-volume schemes especially for new drugs are now an integral part of pricing and reimbursement negotiations across a number of European countries to help control drug expenditures. Pharmaceutical companies are seeking new ways to gain reimbursement and funding for new drugs especially where there are concerns with their value (e.g., requested prices vs. the health gain seen). This has resulted in a growth of new arrangements including value based pricing, outcome guarantee, and patient access schemes, but the administrative burden can be intensive. There are also concerns with the variety of definitions that have been used, their probity, and their transparency.

Objective: To review available schemes and concerns to provide guidance to health authorities in the future. This includes providing a definition based on logic.

Design, setting, study population, intervention, and policies: A thorough literature review was undertaken by one of the authors (BBG) in PubMed, MEDLINE, and EMBASE between 2000 and February 2010 using key words including conditional coverage, conditional reimbursement, risk sharing, coverage with evidence, price volume agreements, value-based pricing, pharmaceuticals, no cure no pay, payback schemes, health impact guarantee, and outcome guarantee. The review was supplemented by unpublished or “grey literature” references known to the 17 co-authors and advisers from across Europe involved with assessing and implementing such schemes on behalf of payers. Only papers documenting the nature and content of actual schemes were considered for possible inclusion in this paper, with no attempt made to assess the quality of the papers.

Outcome measure(s): (1) Providing a definition of such schemes based on logic that is acceptable to health authority and health insurance personnel from across Europe; (2) documenting published studies using these definitions broken down by country; (3) summarising conditions and concerns when payers contemplate future schemes; and (4) proposing guidance for payers for the future based on considerable in-house experience among the co-authors

Results: Risk-sharing schemes should be considered to be agreements concluded by payers and pharmaceutical companies to diminish the impact on payers’ budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets. They can be broken down into financial-based and performance-based or outcomes-based models. There are concerns with existing schemes outside of traditional price-volume arrangements. These include high administration costs, not collecting rebates or refunds, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a drug’s development costs. The latter is particularly important with provisional coverage schemes. This is illustrated by the scheme for bortezomib in the UK, which is based on a 50% reduction in serum paraprotein levels (M-protein) by the fourth cycle. The NHS will continue funding treatment in responders, with the cost/QALY reduced from £38,000/QALY to a more acceptable £20,700/QALY, with manufacturers refunding the cost of the drug if a 50% reduction was not achieved. This is usually in the form of free drug. The following concerns arise, however: (1) whether M-protein is actually a good surrogate for life expectancy (alongside this, 10–15% of patients do not have measurable serum M-protein levels; (2) capacity to manage such schemes with current staff levels—73% of hospitals in the UK did not have the capacity; (3) lack of communication between physicians and pharmacists; (4) every missed claim loses GB£12000 for the hospital; (5) whether hospitals can in fact accept free goods or rebates from pharmaceutical companies; (6) whether refunds to hospitals are actually passed back to the payers in practice—this is not happening in 47% of UK hospitals with this scheme. The value-based pricing scheme for beta interferon in the UK has also been heavily criticised as unscientific and impractical given the 10-year follow-up period, with an initial assessment in 2009 highlighting important methodological issues with the scheme and the need for longer term follow-up before securing meaningful results.

Conclusions: Overall, there is only a limited number of situations where risk-sharing schemes should be considered based on the experiences of health authority and health insurance personnel across Europe, that is, (1) where response to therapy can be determined within a short time; (2) where there is high unmet need with the new technology, which has shown benefit based on translational science and clinical studies; (3) where there is potential for substantially lowering health care costs in targeted patients having factored in all administration costs (4) contain costs for new premium priced products where currently limited demand side measures; and (5) where only a limited time frame (e.g., 10-year UK study for MS drugs seen as far too long). Schemes should be rejected where (1) effective and low cost standards already exist since provisional reimbursement schemes may actually encourage the prescribing of new high-cost drugs vs. existing low-cost standard drugs; (2) patient compliance, which is key, has not been considered in the development of risk-sharing schemes; (3) there is a high administrative burden, (e.g. schemes for bortezomib and beta interferon in the UK); (4) there are concerns with transparency and access to data or data ownership; (5) long follow-up is needed and the number of potential patients is limited; and (6) health authorities will end up funding an appreciable proportion of the development costs.

Funding source(s): In part grants from Karolinska Institutet


Care Needed When Introducing Generic Policies to Reduce Costs: Experiences From Abu Dhabi

Brian Barr Godman3, Mohammed Abuelkhair1, Sahar Fahmy2, Shajahan Abdu4, Lars L Gustafsson5

1Health Authority - Abu Dhabi; 2Health Authority - Abu Dhabi; 3Karolinska Institutet, Sweden; 4Health Authority - Abu Dhabi; 5Karolinska Institutet, Sweden

Problem statement: Perverse incentives and regulations may prevent health authorities from fully realising savings from the availability of generics.

Objectives: To document the outcome of recent generic policies introduced by Health Authority Abu Dhabi (HAAD) on the pharmaceutical market in Abu Dhabi; to determine possible reasons behind the findings; to suggest potential reforms that HAAD could implement to achieve desired results in the future.

Design, setting, and study population: Pre– and post–policy-analysis study of the impact of recent generics policy in HAAD for 5 of the top 8 pharmaceutical expenditure areas in ambulatory care. These are proton pump inhibitors (PPIs), statins, NSAIDs, antihistamines, and oral fluoroquinolones.

Intervention and policies: The Unified Prescription Form introduced in March 2009 mandated generic prescribing (INN prescribing) apart from a minority of agreed situations. The comprehensive Generic Drug Policy published in August 2009 sought to further enhance the prescribing and dispensing of generics; however (1) pharmacists are still free to dispense either the originator or any branded generic and be fully reimbursed although there is a 20–30% co-payment for some patients; (2) originator manufacturers are not obliged to lower their prices for continued reimbursement once generics are available, and patients do not have to pay the difference for a more expensive molecule than current lowest priced molecule (in addition to any co-payment for the pack); (3) pharmacists can receive appreciable bonuses from manufacturers to preferentially dispense their products; and (4) no demand-side measures exist directing physician prescribing towards prescribing a generic first line where seen as standard treatment.

Outcome measure(s): Changes in expenditure (IMS) 12 months to November 2009 vs. 12 months to November 2008 for the chosen classes

Results: (1) Statin expenditures increased by 65% during this period aided by increased expenditure on rosuvastatin (+130%) and atorvastatin (+64%) vs. multi-sourced simvastatin (–2%). (2) PPI expenditure increased by 27% aided by increased expenditure on single-sourced pantoprazole (98%) and esomeprazole (71%) vs. multi-sourced omeprazole (-5%). (3) Expenditure on oral fluoroquinolones increased by 31% aided by, for example, levofloxacin (+81%) and moxifloxacin (+55%) vs. multi-sourced ciprofloxacin (-7%). (4) Overall expenditure in the 5 areas increased by 34% during the study period to $59.21mn in 2009 up from $44.07mn in 2008. Possible reasons for the unexpected results could be concerns among physicians that patients would be dispensed different generic preparations every time exacerbated by complaints regarding possibly reduced effectiveness and/or increased side-effect rates. Prescribing of single-sourced products alleviates this. In addition, currently limited demand-side reforms directing physicians to prescribe generics first line—apart from compulsory INN prescribing—to combat pressures from pharmaceutical companies promoting their patent protected products.

Conclusions: Anticipated savings from the generic policies were not realised in HAAD for a number of reasons. Further potential policies are being explored based on experiences among European countries including reference pricing for the molecule as well as prescribing guidance and possibly prescribing restrictions. Their influence will be analysed to provide further direction to other health authorities.

Funding source(s): Health Authority, Abu Dhabi


Challenges When Introducing Generic Policies to Enhance Their Utilisation: Impact and Next Steps

Brian Barr Godman3, Mohammed Abuelkhair1, Sahar Fahmy4, Shajahan Abdu2, Lars L Gustafsson5

1Health Authority - Abu Dhabi; 2Health Authority - Abu Dhabi; 3Karolinska Institutet, Stockholm, Sweden; 4Health Authority - Abu Dhabi; 5Karolinska Institutet, Stockholm, Sweden

Problem statement: Perverse incentives and regulations may prevent health authorities from fully realising savings from the increasing availability of generics in a class.

Objectives: To document the outcome of recent generic policies introduced by the Health Authority Abu Dhabi (HAAD) on the utilisation and expenditure of high-volume products in ambulatory care; to determine possible reasons behind the findings; to suggest potential reforms that HAAD could implement to achieve desired results in the future

Design, setting, and study population: Pre– and post–policy-analysis study of the impact of recent generics policy in HAAD on utilisation patterns for proton pump inhibitors (PPIs), statins, and ezetimibe in ambulatory care (2 highest expenditure areas in 2009) using IMS data for the Abu Dhabi market converted to 2011 DDDs; 12 months to September 2010 compared with 12 months to September 2009; in addition, utilisation and expenditure patterns from 2004 to 2010

Intervention and policies: The Unified Prescription Form introduced in March 2009 mandated generic prescribing (INN prescribing) apart from a minority of agreed-upon situations. The comprehensive Generic Drug Policy published in August 2009 sought to further enhance the prescribing and dispensing of generics; however, (1) pharmacists are still free to dispense either the originator or any branded generic and be fully reimbursed although there is a 20–30% co-payment for some patients; (2) originator manufacturers are not obliged to lower prices for continued reimbursement once generics are available, and patients do not have to pay the difference for a more expensive molecule (unlike typically seen across Europe); and (3) no demand-side measures exist directing physician prescribing such as generics first line in a class

Outcome measure(s): Principally, changes in utilisation patterns for different PPIs and statins as well as ezetimibe (2011 DDDs) in 12 months to September 2010 vs. 12 months to September 2009

Results: (1) PPI utilisation increased by 10% 2010 vs. 2009. Esomeprazole increased by 33% (31% total PPIs in 2010 vs. 21% in 2008), and omeprazole decreased by 10% (40% total PPIs in 2010 vs. 55% in 2008). There was increased utilisation of multi-sourced lanzoprazole but from a lower base (6% in 2009) helped by only one generic available in 2010. (2) Statin utilisation increased by 14% 2010 vs. 2009. Atorvastatin/rosuvastatin utilisation increased by 14% (already 88% of total utilisation in 2009), single-source pravastatin by 36%, single-source fluvastatin by 22%, and multi-source simvastatin by only13%. Utilisation of ezetimibe alone or in combination increased by 62% 2010 vs. 2009, increasing utilisation of lipid-lowering drugs by 17% during this period.

These changes in utilisation patterns following reforms regarding generics match those among Western European countries where currently only limited demand-side controls exist to combat the marketing activities from single-sourced manufacturers. Additional reasons for the limited increases in utilisation of multi-sourced products or even decreases may be concerns among physicians that patients could be dispensed different generic preparations, each prescription with possibly reduced effectiveness and/or increased side-effects. Prescribing of single-sourced patented products alleviates this concern.

Conclusions: Anticipated efficiency savings from generic availability in a class have not materialised in Abu Dhabi. Possible future policies that HAAD could implement are being explored based on experiences among European countries. These include reference pricing in a class as well as guidance on first- and second-line drugs in a class possibly backed up by financial incentives. Their influence will be analysed to provide further direction to other health authorities.

Funding source(s): Abu Dhabi Health Authority


Antibiotic Knowledge and Self-Care for Acute Respiratory Tract Infections in Mexico

Ralph Gonzales1, Alma López-Caudana2, Tulia González3, Janaki Jayanthan4, Kitty Corbett4, Hortensia Reyes-Morales5

1University of California, San Francisco. USA; 2Instituto Mexicano del Seguro Social, Mexico; 3Universidad de Guanajuato, Mexico; 4Simon Fraser University, Burnaby, BC. Canada; 5National Institute of Public Health, Mexico

Problem statement: Community-acquired infections caused by antibiotic-resistant microbes are a major and growing threat to global public health. Self-treatment with antibiotics is a concern not only because the antibiotics are frequently unnecessary, but also because even if the person actually needs antibiotics, he or she may be taking the wrong antibiotic.

Objective: To examine knowledge of and self-treatment with antibiotics among medically insured adults in Mexico

Methods: We conducted a cross-sectional, interviewer-administered survey among patients seeking care for acute respiratory tract infections (ARIs) in a family medicine clinic in Cuernavaca, Morelos, Mexico. The study population consisted of a convenience sample of patients over 13 years of age with ARIs who were seeking medical attention for their illness. Antibiotic knowledge scores were calculated as a composite of correct, incorrect, and “don’t know” responses to 4 common antibiotics and 8 common non-antibiotics. Factors associated with antibiotic knowledge and antibiotic self-treatment were explored with bivariate analyses.

Results: 101 participants completed the surveys. 47% of participants were taking antibiotics before the visit, and 20% were self-treating with antibiotics. Antibiotic knowledge was highly variable. Notably, high proportions of participants believed common non-antibiotic treatments for colds and coughs were antibiotics, such as ambroxol (45%), Desenfriol (45%), and paracetamol (44%). Older participants (>40 years) had much higher knowledge scores compared with younger participants. There was little difference in antibiotic knowledge scores by gender, education level, and prior antibiotic use or self-care with antibiotics.

Conclusion: Self-treatment with and misperceptions about antibiotics are common among medically insured patients in Mexico. Self-treatment behaviors with antibiotics among Hispanic communities in the United States may reflect a deeper sociocultural phenomenon rather than a response to limited access to physician services.

Funding source(s): This study was funded in part by a Fulbright Garcia-Robles All Disciplines award #8584 (RG).


Implementing a Self-Assessment and Continuous Quality Improvement Approach to Improve Hospital Infection Control Practices in Africa and Latin America

Wonder Goredema1, Mupela Ntengu2, Jane Briggs1, Chris Ntege3, Terry Green1, Jacqueline Sekgothe4, Christine Gordon5, Thabsile Dlamini6, Silvia Palma de Ruiz7, Jean-Pierre Sallet2, David Mabirizi3, Jude Nwokike1, Mohan P Joshi1

1Strengthening Pharmaceutical Systems (SPS) Program, Management Sciences for Health (MSH), Arlington, VA, USA; 2MSH/SPS, South Africa; 3MSH/SPS, Namibia; 4Formerly with the National Department of Health, South Africa; 5Ministry of Health and Social Services, Namibia; 6Ministry of Health and Social Welfare, Swaziland; 7Vice-Minister of Health and Social Assistance, Guatemala

Problem Statement: Infection control (IC) is a fundamental intervention to prevent the emergence and spread of antimicrobial resistance in hospitals. However, developing effective IC programs in resource-constrained countries remains a challenge.

Objective: The intervention was designed to improve hospital IC practices in resource-constrained settings using the SPS infection control self-assessment tool (ICAT) and continuous quality improvement (CQI) approach.

Design: Pre- and post-intervention surveys without control groups

Setting and Population: Eighteen hospital IC committees comprised mainly of nurses, pharmacists, physicians and environmental health staff in four countries: Guatemala, Namibia, South Africa, and Swaziland.

Intervention: The SPS Program and its predecessor, Rational Pharmaceutical Management (RPM) Plus, collaborated with ministries of health (MOH) to implement and evaluate the use of ICAT and CQI to improve IC practices in hospitals. IC teams conducted baseline surveys to assess their respective hospital adherence to recommended IC standards and practices from approved national or World Health Organization guidelines. Committees then developed and implemented IC improvement plans. National partners and RPM Plus/SPS staff supported IC teams through site visits and telephone or e-mail follow-up. The teams conducted post-intervention assessments, reviewed progress, shared experiences, and developed plans to scale up the approach.

Outcome Measures: Percentage improvement in: adherence to infection control standards and practices and availability of IC supplies.

Results: Pilot hospitals experienced measurable improvements over their initial 6–9 months of implementation. Guatemala—Percentage of staff who washed hands according to procedures improved on average from 23% for 5 pilot hospitals to 77% three months post-intervention. Availability of hand washing supplies rose from 36% at baseline to 84%. MOH expanded the approach to the national network of 43 hospitals. South Africa—One hospital improved adherence to hand hygiene policies by 29 percentage points from a baseline of 57% to 86%; a second hospital increased its compliance with contaminated waste policies from 38% to 73%. Swaziland—One hospital doubled its hand hygiene assessment score from 33% vs. 66%, and a second hospital’s waste management score increased from 12% to 83%. Namibia—Percentage of staff who washed hands according to internationally recognized procedures improved from 27% to 61% in one hospital. Supplies and equipment for hand washing improved from 78% to 94%.

Conclusions: The application of the ICAT tool coupled with CQI demonstrated improvement in IC practices. It is simple to apply and is a sustainable approach that builds teamwork and yields quantifiable improvements.

Funding Sources: RPM Plus and SPS through U.S. Agency for International Development; MOH (Guatemala, Namibia, South Africa, Swaziland)


Modelling the Potential for Market Impact and Supply Security Risks: Focus on Donations with Applications for Differential Pricing

Cheri L Grace1, Padmashree Gehl Sampath2

1HLSP Institute, United Kingdom; 2UNCTAD

Problem statement: In-kind product donations and differential pricing are strategies credited with improving access to medicines and, undoubtedly, they have improved static access to medicines in certain circumstances. This work considers the appropriateness of differential pricing and in-kind donations in the current supply environment, from the perspective of competition policy and market dynamics.

Objectives: To analyse the potential market impact of differential pricing and in-kind donations from the perspective of longer term dynamic access to medicines.

Design: Through an iterative process of market analysis, hypotheses generation, industry validation of these hypotheses, and economic modelling, we developed a risk framework which reveals the primary market characteristics which predispose a commodity sector to experiencing negative market impact from a donation or differential pricing offer. We constructed a theoretical, mathematical model to demonstrate how these risks would be experienced at the level of a single generic firm which is competing with a donation, including a sensitivity analysis to provide insight into how the results would differ according to varying assumptions, e.g., size of market share taken up by the donation or the differentially priced product, and degree of operating leverage of the competing firm.

Setting: The work is adapted from earlier research and analyses of the authors, commissioned to inform the Global Fund’s in-kind donations policy. The adapted work focuses not only on donations but also on differential pricing and is relevant to the World Health Organisation’s normative work, and to donors and international agencies who are interested in shaping markets towards enhanced consumer welfare and donor value for money.

Study scope: A recent paper provided a comprehensive summary of challenges experienced with donations. We focused only on market impact of donations and also transferred the analysis to encompass the risks of differential pricing as well.

Results: The risk framework revealed a key paradox—those health commodity product categories where there is most to gain in terms of resource mobilisation are those where market impact risk would be the highest (i.e., short-term gains could risk longer-term access). This paradox is demonstrated through economic modelling of the loss of margin suffered by a firm competing with a donation: m* = m - RS*F/((1- RS)*R)

(new margin = old margin minus reduction in market share multiplied by fixed cost, divided by new revenue [equivalent to old revenue multiplied by 1 minus percent reduction in market share]). Sensitivity analysis confirmed that volume dependent firms will be more severely affected by even small donations. Other factors which will affect whether the non-donor competitor will remain in the market are the size and time length of the donation, as well as ability to raise prices or recoup the lost volume through other markets or growth in the market with the donation.

Conclusions: The economic effect of differential pricing or donations (a differential price with price set at zero) may be akin to predatory pricing. Firms competing with donations and differentially priced products may respond by reducing output, raising prices, exiting the product line or deciding not to enter the product line in the first place. The degree to which a product or service sector can be negatively affected by donation (or differential pricing) offers depends partly on the market characteristics of that sector and partly on the size, duration and structure of the offer itself. Policies and guidance on donations and differential pricing need to account for possible negative effects on competition and risk to dynamic supply and access. Competition policies need to be developed, implemented, and monitored for global health product markets. WHO Guidelines on donations should also incorporate this perspective.

Funding source: (for original work only on donations) The Global Fund to Fight AIDS, Tuberculosis and Malaria


Value for Money Perspective on Global Health Initiative Market-Shaping Impact

Cheri L Grace1, Walker Saul2

1HLSP Institute, United Kingdom; 2UK Department for International Development

Problem statement: In the past decade, the global architecture around access to medicines for neglected diseases has changed, in particular with the rise of global health initiatives (GHIs) as major sources of health technology funding. However, our knowledge of the impact of GHIs on access to medicines as an essential part of functioning health systems is limited. The Lancet paper written by the Positive Synergies Collaborative Group had little to say about medicines and especially about GHI impact on upstream supply markets, even though such impact is important to understand from a pricing and supply security point of view.

Objectives: In the current economic environment, donors are under increasing pressure to demonstrate value for money (VFM). As a large portion of the money spent by major GHIs is on health technologies, an obvious question is, “are GHIs influencing market dynamics in ways that encourage VFM, and if so, how?” The objectives of the work included—to understand the methodological challenges of evaluating the market impact of GHIs from a VFM perspective and to guide donors and GHIs in their construction of monitoring and evaluation frameworks focused on VFM.

Design: This study employs inductive forms of analysis; conclusions are not drawn from statistical inference, but from analytical generalisation, a process by which theoretical insights are derived from comparable analysis across multiple cases. Interrelationships that were consistent within all technology sectors were identified as well as challenges in evaluating impact that were consistent across sectors. These repeated interrelationships and evaluation challenges were abstracted into a VFM conceptual framework. Case study material that illustrates the interrelationships and evaluation challenges across technology sectors are presented.

Results: If we map standard VFM dimensions (as defined by the UK Audit Commission) against GHI market shaping activities, then the ‘economy’ category would relate to the price of the health technology and cost to deploy it. ‘Efficiency’ can be translated as ‘lowest cost per effective use’, highlighting the importance of non-price features which promote product acceptance and uptake. Looking further down the impact chain, quality becomes paramount as a contributor to the effectiveness goal of ‘lowest cost per desired health impact’. The paper presents many examples of interventions undertaken by GHIs to shape markets in pursuit of 1 or several parameters affecting VFM. Attribution of market impact resulting directly from a given GHI intervention is challenging, because of system interdependencies on two levels: (1) interdependencies between policies and inteventions of different groups shaping the market and (2) the relationship (often inverse) between interventions that attempt to impact price balanced against those that aim to impact parameters of overall effectiveness, e.g., supply security, quality, acceptability, and delivery. Given these challenges, case study methodology, involving interviews with GHIs, independent experts, and industry, is an important method for determining relative influence and attribution of GHIs and others on the market. There is also a need for a comprehensive approach to monitoring and measuring the market impact of GHIs, focusing not only on static price impact, but balanced by evaluation of impact on other parameters important to achieving supply security and health impact over time.

Conclusions: Donors are increasingly under pressure to demonstrate that funds for medicines are being used in the most efficient way, placing emphasis on the role of GHIs in shaping markets. Price sometimes dominates these discussions, but price needs to be seen in relation to the other objectives driving health outcomes and also the importance of seeking dynamic as well as static improvements in health technology markets.

Funding sources: UK Department for International Development


Overview of Systematic Reviews on Pharmaceutical Policy and Their Relevance to Low- and Middle-Income Countries

Andy Gray1, Fatima Suleman2

1of Therapeutics and Medicines Management, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, South Africa; 2School of Pharmacy and Pharmacology, University of KwaZulu-Natal, South Africa

Problem statement: The evidence base for large-scale pharmaceutical policy interventions has not been systematically summarised or assessed for relevance in low- and middle-income countries (LMIC).

Objectives: To determine the impact of pharmaceutical policies by means of an overview of systematic reviews (SRs) on pharmaceutical policy and to assess the relevance of such evidence in LMICs

Design: Relevant databases (e.g., MEDLINE, EconLit, CINAHL, Cochrane, ProQuest, EMBASE, JOLIS, ISI Web of Science, IPA, INRUD, NTIS, PAIS, SourceOECD and WHOLIS) were searched from inception to May 2009 to identify SRs on 13 pre-determined policy categories. Pharmaceutical policies were defined as laws, rules, and financial and administrative orders made by governments, nongovernment organisations, or private health insurers that are intended to directly affect the use or cost of medicines.

Results: Searches yielded 7,129 citations; 55 were identified for full text retrieval but 38 were considered relevant only as background material or as policy options that have not yet been applied at scale; 17 were considered for inclusion into the review. Three were subsequently rejected and the findings of 14 SRs were extracted and their applicability in LMICs considered. No SRs assessed patent and profit policies, sales and dispensing policies, policies that regulate the provision of health insurance including medicines coverage, or policies that deal with the provision of patient information. One SR dealt with registration and classification policies (the scientific basis for generic medicine registration, applicable to all countries); 1 with marketing policies (the effects of direct-to-consumer advertising; though not explicitly allowed in any LMIC, still of relevance); 1 with policies on price and purchasing (reference pricing; of limited applicability in LMICs not using insurance financing); and 2 with prescribing policies that rely on financial incentives (replacing fee-for-service remuneration with alternatives, such as capitation; neither easily applicable in LMICs where there is no separation of health care financing from provision of services). Nine SRs dealt with one or more of the following: prescribing policies that rely on educational or regulatory policies targeting prescribers, policies that determine which medicines are reimbursed, restrictions on reimbursed medicines (such as prior authorization), co-payments, and caps. The dissemination of educational materials alone had little effect. Group education might have some effect, and one-on-one academic detailing, computerised alerts and reminders, and pharmacists’ interventions (such as pharmacist-led collaborative care) were effective in changing prescribing behaviour. Application at scale is limited in LMICs by the shortage of trained health professionals and computerisation. Managed care formulary management tools have little direct applicability in LMICs outside of private insurance schemes, and the effects of cost shifting from third-party payers to poor and vulnerable patients need attention. Such tools will be of greater relevance as more middle-income countries introduce national health insurance schemes.

Conclusions: More primary evidence of the application of pharmaceutical policies at scale in LMIC settings needs to be published. LMICs should be encouraged to fund monitoring and evaluation units within their national structures to generate and assess such evidence.

Funding source(s): Alliance for Health Policy and System Research


Development and Application of Selected Indicators to Investigate Antimicrobial Use in Hospitals

Terry L. Green1, Mohan P. Joshi1, Aisha Noorzaee2, Zahir Siddiqui3, Zafar Omari3

1Strengthening Pharmaceutical Systems (SPS) Program, Management Sciences for Health (MSH), Arlington, VA, USA; 2Ministry of Public Health, Afghanistan; 3MSH/SPS Afghanistan

Problem Statement: Detecting problems in antimicrobial use in hospitals is the first step in evaluating the underlying causes and taking remedial action. The World Health Organization (WHO) published “How to Investigate Drug Use in Health Facilities” in 1993, which focusedmainly on ambulatory departments of primary care settings. Participants at ICIUM 1997 and 2004 identified the need for indicators and methodology suitable for use in hospital settings. To fill this need, the Strengthening Pharmaceutical Systems Program (SPS), and its predecessor Rational Pharmaceutical Management (RPM) Plus, developed a set of indicators to investigate antimicrobial use in hospitals.

Objective: To field test and finalize the hospital antimicrobial indicators and implement them in a low-resource country

Setting and Intervention: Field test of the draft indicators in 3 public Ugandan hospitals in 2008 and application of the validated indicators in 14 public and private hospitals in Afghanistan in 2009

Outcome Measures: A set of antimicrobial indicators and data collection methodology validated, finalized, and used in low-resource setting hospitals

Results: The field test in Ugandan hospitals validated the indicators and led to their finalization. The resulting manual, “How to Investigate Antimicrobial Use in Hospitals: Selected Indicators” has five hospital indicators, nine prescribing indicators, and two patient care indicators along with detailed instructions and data collection forms for use in resource-constrained settings. The field test generated data on antimicrobial misuse, overuse, and underuse in Ugandan hospitals. The application of the finalized indicators in Afghanistan as a part of a medicine use study revealed problems in the availability and use of antimicrobials in hospitals. For example, 92% of patients received one or more antimicrobials in multiple doses over multiple days for surgical prophylaxis; half of the patients received a third-generation cephalosporin (100% in one private hospital); no hospital performed culture and sensitivity tests; and the average number of days out-of-stock per month for a set of key antimicrobials was 8.7. This study, along with the WHO health facility indicator study, led to recommendations to the Ministry of Public Health to develop standard treatment guidelines, establish drug and therapeutics committees (DTCs), and revise rational medicine use training programs for professional staff.

Conclusions: DTCs, physicians, pharmacists, managers, and researchers can

use this indicator manual to assess and monitor antimicrobial use in their hospitals. Its application in Afghanistan generated local hospital data and recommendations to improve antimicrobial use and contain antimicrobial resistance.

Funding Sources: SPS and RPM Plus through US Agency for International Development


Development of a Tool for Simple Visualisation of Periods of ARV Therapy Availability in a Context of Expanding Treatment Coverage

Etienne Guillard1, Xavier Paris1, Sophie Ouvrard2, Mouslihou Diallo3, Louis Pizarro1

1Solthis, France; 2Solthis, Niger; 3Solthis, Guinea

Problem statement: The increase in active patient files results in an increase in the supplies of ARV needed as well as in the complexity of evaluating coverage of needs. This lack of visibility makes it difficult to anticipate shortages and compromises the implementation of emergency procurement mechanisms.

Objectives: Our aim was to develop a simple tool to measure the period of availability of ARV supplies in a structure, a region, or a country, which takes into account the increase in ARV needs associated with expanding treatment coverage and to test it in Guinea and Niger.

Design: Intervention descriptive study

Setting: This intervention was conducted in collaboration with the National HIV/AIDS Control Program from Niger and Guinea.

Method: For each molecule the period of availability (n) can be determined from 3 parameters: monthly needs for treatment initiation (a); needs for patients already receiving treatment, determined with either morbidity or AMC data (b); available stock (AS). The model of the sum of needs during a period N corresponds to: a*factor time-inclusion+b*n; factor time-inclusion is the total number of months during which patients who are included for the period n will need treatment. This factor can be obtained by the formula: n*(n+1)/2 The resulting equation is: an²+(a+2b)n-2AS=0 and n is obtained by: n=[-(a+2b)+√((a+2b)²+8aAS)]/2a. Using a spread sheet, the periods of coverage for all ARV treatment can be obtained and visualized graphically. The number of patients concerned and stock-out beginning estimated date are mentioned in order to help decisions. Tests were performed to validate the results.

Intervention(s): This tool has been use at a national level in Guinea and Niger with National HIV AIDS Control Program with both available stock and short term orders.

Results: The use of this tool in Niger and Guinea allowed national partners to visualize the periods of ARV availability, to share this information easily, and to speed up ongoing procurement orders. Although this model is simple to use, a minimum of quality data are necessary

Conclusions: By its graphic representation, this tool makes it possible to have a rapid clear image of periods of ARV coverage and of the number of patients concerned by each drug, within the context of extending treatment. It also makes it possible to notify all the actors involved in case of impending shortages or oversupply, which was possible in Niger and Guinea. Nevertheless, precision of the results is correlated to the quality of data. To act effectively on stock-outs or overstocks, it is essential to regularly update this tool and to act at different stages of the procurement and supply management cycle (accelerate ongoing procurement orders, emergency procurement). To optimize supply management of HIV medical products, opportunistic infections drugs, reagents, and diagnostics, similar tools have been developed by Solthis.

Funding source: Solthis/Fondation Bettencourt Schueller (France)


Introducing a Revised Model for Pricing and Reimbursement of Medicines in Macedonia

Marija Gulija1, Tonci Buble2, Neda Milevska-Kostova3

1AD "Dr Panovski", Skopje, Macedonia, Republic of,; 2Belupo d.d, Zagreb, Croatia; 3Centre for Regional Policy Research and Cooperation “Studiorum”, Skopje, Macedonia

Problem Statement: Pricing and reimbursement policy of medicines (P&R) in Macedonia is defined by Ministry of Health (MOH) and implemented through Drug Bureau (DB) and Health Insurance Fund (HIF). MOH/DB regulates all registered drugs by defining “unified price” as ceiling price. Reference price system was complementarily introduced by HIF only for drugs financially covered by HIF through an health insurance scheme. The two mechanisms failed in improving P&R system for lacking of systematized methodology and transparency. A serious gap existed in relevant information on drug consumption. Revision of the model for P&R was needed.

Objective: To present and evaluate the impact of revised reference pricing model in improving access to drugs for primary health care (PHC). Improved access is described as reducing the copayment from patients and enabling more drugs to be available without payment. The financial aspect for the HIF is seen as paying “the same price” for more drugs by adjusting the prices of primary health care drugs financially covered by the HIF. Thus, HIF improves access to essential drugs for the population at the lowest cost and copayment.

Design: Study describes model development, its implementation, and evaluates the effects of P&R policy. All drugs for PHC from the national drug list were included (383 generics). This study uses public data from Consultancy on P&R Policy as a part of the World Bank’s Health Sector Management Project in Macedonia.

Methods: Unified methodology was used in several consecutive steps. Countries for comparison were defined (external reference system). Selected publications/sources of information on drug prices to be used as basis for comparison were defined. Three coefficients for price adjustment were defined as ratio gross domestic product/ purchasing power parity in percentages: maximum 100% comparative price for innovative drugs, adjustment up to 79%, 23% comparative price for generics and adjustment up to the minimum level of 51%, 46% comparative price.

Outcome Measure(s): Adjustment calculation of reference prices was implemented to all drugs with exceptions for specific drugs/population groups. Five pharmaco-therapeutic groups were identified (internal reference system) according to anatomic therapeutic chemical (ATC) and daily defined dose (DDD) classification system and reference price for each level of DDD within the group was determined. Methodology used was similar to the one implemented in Croatia (2006), having been adjusted to the needs and conditions of Macedonian pharmaceutical market. Implementation of the revised model started in May 2010.

Results: Implementing revised model for reference prices of drugs from PHC resulted in adjusting the prices of drugs. The previous model provided for 77 drugs to be available without copayment. Some drugs were above calculated maximum coefficient of 100% comparative price, other were below minimum coefficient of 51%, 46% comparative price.

Conclusion: Revised model enabled 209 generics (55%) to be available to the patients without copayment, since extremely low prices of locally produced generics were appropriately adjusted. Also, HIF can contain over expenditures on expensive drugs.

Funding Source: Funds used for this consultancy mission were part of a World Bank health sector management project (HSMP) component for assistance to the Macedonia MOH for improving the pharmaceutical sector.


Prophylactic Use of Antimicrobials During Surgery

Brian Conroy Gunn1, Ahmed Abdo-Rabbo1, Batool Jaffer Suleiman1, Syed Asrar Ali2

1Directorate of Rational Use of Medicines, Ministry of Health, Sultanate of Oman, Oman; 2Directorate of Communicable Disease, Ministry of Health, Sultanate of Oman

Problem statement: There is widespread concern about the rising rate of antimicrobial resistance, therefore rational use of antimicrobials is a high priority area for research. One of the most controversial uses of antimicrobials is for prophylaxis in various surgeries. Many questions arise about the overall need, the subsequent choice of antimicrobial (if deemed necessary), and then the dose, duration, and timing of administration. As the Oman Ministry of Health chemotherapeutic guidelines were last updated in 1998, it was considered apt to investigate the current practice.

Objectives: To investigate the antimicrobials used perioperatively in lower segment Cesarean section (LSCS), timing, and doses administered

Design: Retrospective study of defined patient group using manual or computerised records

Setting and population: 4 major hospitals throughout Oman with a systematic, random sample of 510 patients undergoing emergency or elective LSCS surgery

Results: There was a surprising diversity in the regimes from each hospital and only 1 had written guidelines. Although a cephalosporin was used in the majority of cases, there was little consistency in the generation prescribed with second-generation cefuroxime being the most popular (47% of all cases). The majority of cases also had metronidazole added. In 1 hospital, ampicillin was the prophylactic of choice and was routinely combined with oral amoxicillin. There were very few cases where only a single dose was given with most receiving at least 3 doses. In 1 extreme case, the majority of patients received 5 days of prophylaxis with a third-generation cephalosporin! The timing of the dose was usually stated as after clamping of the umbilical cord, but it was often difficult to determine exactly, especially when multiple dosing had been performed.

Conclusion: It appears that protocols for antimicrobial prophylaxis have developed in an ad hoc fashion over time. It was found that none of the studied hospitals followed the MoH guidelines for prophylactic use of antimicrobials, nor were they using any international defined standard or recommendation. Based on the available infection rates, a consistent policy with written guidelines appears to lead to the best outcomes for patients. The results have wide implications for future policy directions.

Addendum: A recent (2011) review of the study hospitals showed that they have all adopted new and very similar protocols and all now have a written policy in place

Funding source: MoH General Budget


Importance of Monitoring Patients on Atypical Antipsychotics

Brian Conroy Gunn, Hawraa Al-Lawati, Ahmed Abdo-Rabbo, Batool Jaffer Suleiman, Manal Al-ansari

DRUM, Ministry of Health, Sultanate of Oman, Oman

Background: Atypical antipsychotic use has been rising rapidly in Oman since 2000. Concern about potential side effects and the high cost of these drugs prompted a preliminary investigation into their use. A report was produced with recommendations and a preliminary guideline was prepared in consultation with the chief consultant psychiatrist. In subsequent years, use continued to rise and concern was growing about emerging diabetogenic side effects.

Problem statement: Although atypical antipsychotics like olanzapine have proven to be a great improvement in psychotherapy, they are not free of side effects and have their own spectrum of adverse reactions, especially associated with the endocrine system.

Objectives: Examine the pharmaceutical care given to patients receiving olanzapine therapy, in particular to monitor weight gain, loss of blood glucose control, and changes in lipid profile

Design: Patients’ records were examined retrospectively in 2009. In Muscat, the hospital had a computerized medical records system and in Sohar, a manual system is still in use.

Setting: Two of the largest psychiatric institutions in the public sector in Oman, the Ibn Sina Hospital in Muscat and the Sohar Polyclinic in Sohar

Study population: A total of 359 psychiatric patients in both hospitals were studied out of 704 patients on olanzapine throughout Oman.

Results: Of the studied patients, 70% had no weight recorded, 58% had no blood glucose measurement, and 98% had no lipid profile checked; some patients also received traditional antipsychotics and many other co-medicines, which were documented. The reasons for some of these failings were explored.

Conclusion: In spite of the availability of specific protocols and referral forms which ask for such information, monitoring of patients on olanzapine is suboptimal and there is a considerable risk of diabetogenic side effects in these patients which can lead to a considerable economic burden if it continues unchecked.

Funding sources: MoH general budget


Using Defined Daily Doses, Pivot Tables, and Charts as a means of Measuring Medicine Utilisation Trends

Brian Conroy Gunn, Batool Jaffer Suleiman

Directorate of Rational Use of Medicines, Ministry of Health, Sultanate of Oman, Oman

Problem statement: Measuring the trends in medicine utilisation is a vital means of control for ensuring the rational use of medicines. The defined daily dose (DDD) is a relatively underused and poorly understood tool for assessing medicine use and comparing trends.

Objectives: To set up a relatively simple and ongoing medicine utilisation trend analysis using DDDs and Excel pivot tables and charts

Resources: National data on medicine consumption in the public sector was obtained from the Director General of Medical Supplies and the Director of Information Technology at the autonomous Royal Hospital, Muscat, Oman. DDDs were obtained from the WHO Collaborating Centre for Drug Statistics Methodology using their ATC/DDD index. Excel 2003 or Excel 2007 spreadsheets were used to create the database and pivot tables for analyses.

Methods: Using raw consumption data from the above sources (manual or computerised), an Excel database was designed to permit the rapid generation of the most useful information. Total DDDs for the majority of medicines were calculated and then the internationally recognised standard formula DDD per 1000 population per day was calculated. The methodology is flexible enough to be adapted for other useful formulae to be calculated, such as DDD per 100 bed days, or DDD per 100 admissions for hospital inpatient use, or DDDs per inhabitant per year.

Results: Trends in medicine use have now been calculated for the public sector in Oman since 1999 with the most comprehensive results for 2006–2009. The results are best displayed as a series of column or stacked column pivot charts for each therapeutic group. Also, pivot tables showing the top 10 or 20 medicines used or the top 10 antibiotics are rapidly generated. An annual report with the most significant charts is produced highlighting positive and negative results. The trends can be looked at from several viewpoints. Positive trends are generally indicative of good prescribing rather than a decline in morbidity. In many cases there may be an increase in morbidity but the prescriber’s choice of therapy is considered rational and appropriate. A negative trend sometimes indicates an increased use of a drug pointing to an increase in morbidity, which is “bad” by itself rather than “bad prescribing” or it could be due to a poor choice of therapy. The relative results are usually more significant for comparison than the absolute values.

Conclusions: The methods used have enabled the rapid assessment of the trends in medicine use in the public sector of Oman over several years. Excel pivot tables and charts can produce an almost infinite number of views of the data with a few keystrokes. The results can be used by policy makers, planners, and researchers. It is hoped that as many as possible of the neighbouring countries can adopt similar methodology for reporting so that regional comparisons can be made.

Funding sources: MoH General Budget


Reasons for Rejection of Medications by Patients in Oman

Brian Conroy Gunn, Abdul Rasoul Wayyse, Batool Jaffer Suleiman

DRUM, Ministry of Health, Sultanate of Oman, Oman

Problem statement: Patient adherence to medications is one of the most critical aspects of therapy. It has been calculated that globally, there is an enormous waste of vital medicine. If patients fail to take medicine properly, it could increase morbidity and mortality and add to the general economic burden.

Objectives: To examine and quantify why many patients in Oman reject their prescribed medicines at the pharmacy.

Background: This research originated from observations that, on occasion, prescriptions were marked “patient refused” or “patient rejected”. As the drugs refused were usually associated with serious and often chronic conditions, it was decided to investigate further the reasons for this refusal. It was also hoped to establish the extent of this phenomenon throughout the Sultanate.

Methodology: Assistant pharmacists working in the field were recruited and trained as researchers for this study. A structured fill-in form in English and Arabic with 17 possible reasons for rejection was used, one reason being a ‘catch all’. The assistant pharmacist had to interview any patient who rejected or returned their medicines at the dispensing counter and ask for details with the patient’s permission. A total of 607 patients from 14 different facilities covering 8 health regions of Oman were interviewed about their rejections.

Results: The results indicate that most medicines are rejected because the patient already has a stock of the same medicine at home (41%). In several cases, the nature of the medicine itself adds an extra dimension of concern. For example, rejection of antibiotics, insulins, oral antidiabetic medicines, antihypertensives, and other drugs raises serious alarm about patient concordance. Other reasons given were no faith in a medicine they had received before (11.5%) and fear of side effects (10%). The overall result raises possible issues for the rational use of medicines in Oman. Some possible causes are lack of communication between doctor and patient, patient “drug shopping” at multiple facilities, faulty distribution of referral medicines, and patients not understanding their disease and the need to take their medicines.

Outcome: The current research revealed a rejection rate of 1.5% overall average at an approximate value of 85,000 Omani Rial (USD 221,000) per annum. This result is considered a minimum and it is possible that there may be many more occurrences of rejection of medicine once patients have left the facility. This could mean a fairly serious wastage of resources in addition to exposing flaws in patient care and health education.

Funding source: MoH general budget


Impact of Community Education Programme on Safe Use Oo Medicines in Two States of India

Usha Gupta Gupta1, Neera Agnimitra3, Sangeeta Sharma1, Dayanand Tondon2, Ranjitha Parameswar1

1Delhi Society for Promotion of Rational Use of Drugs, India; 2CREATE; 3Delhi University

Problem Statement: Irrational use of medicines amongst community is a global problem more so in developing countries. Several surveys conducted in different states of India have shown that inappropriate use of medicines is due to lack of awareness and knowledge about medicine use amongst the community.

Objectives: To educate community on medicine use, using the educational material and observe the impact

Design: Pre-post educational intervention study

Setting: The educational programme was conducted in 4 districts each in 2 states of India—Uttar Pradesh and Bihar.

Study Population: 400 households were included for assessing the knowledge and behavior about the use of medicines. A predesigned and pretested proforma was used for interview.

Interventions: Education material included 4 clusters; (1) advice seeking behavior during general ailments; (2) use of medicines as prescribed by the doctors including antimicrobials; (3) storing of medicines, and (4) care to be taken while purchasing the medicines. The programme was carried out for 6 months followed by assessment.

Outcome Measures: Primary outcome measures included self medication, probing about the prescription while consulting the doctor, awareness about expiry date while purchasing medicine, storage of medicine, knowledge of antimicrobials, and adherence to prescription containing antimicrobials.

Results: In Uttar Pradesh, 66% of respondents and in Bihar, 46% of respondents informed that they do not self-medicate. After the educational programme, the percentages increased to 77% and 86% who reported that they do not self medicate. In Uttar Pradesh, 80% respondents probed the prescription while consulting the doctor. It increased to 99% after educational programme. In Bihar, it increased from 63% to 72%. In Bihar, 56% respondents were aware of checking the expiry date and matching the medicines with prescription. This increased to 78% after the educational programme. Similar changes were seen in Uttar Pradesh. In both Uttar Pradesh and Bihar, the percentage of respondents having any knowledge about antimicrobials was quite low— 26% in Uttar Pradesh and 38% in Bihar; the majority of households believed that antimicrobials acted quickly to help heal. There was an improvement in the knowledge of respondents after educational programme (53% in Uttar Pradesh and 62% in Bihar). Since the knowledge about the antimicrobials was quite low, very small percent of respondents—26% in Uttar Pradesh. and 27% in Bihar—demanded antimicrobials. The change after educational programme was very low.

Conclusion: it was observed that all activities that involved one-to-one interactions were successful, and to achieve sustainability, reinforcement on continuous basis is required.

Funding Source: CORDAID


A Prospective Study of Prevalence, Severity and Preventability of Adverse Drug Reactions in Hospitalized Human Immunodeficiency Virus (HIV) Positive Patients

Parthasarathi Gurumurthy1,2, Sumathi Devaraj1, Anand Harugeri1, Madhan Ramesh1,2, Rajendra Prasad Shivaswamy3, Atiqulla Shariff1,2

1JSS College of Pharmacy, JSS University, Mysore, India; 2JSS Medical College Hospital, JSS University, Mysore, India; 3Vivekananda Youth Movement Hospital, Saragur, H D Kote Taluk, India

Problem statement: It is estimated that free antiretroviral therapy (ART) will be provided to 300,000 adults and 40,000 children by 2012 in India by National AIDS Control Organisation (NACO). Safety information for ART amongst the Indian population is lacking. There is a need to integrate pharmacovigilance in the ART program of NACO.

Aims: To determine the frequency and nature of adverse drug reactions (ADRs) in hospitalised human immunodeficiency virus (HIV) positive patients.

Design: Prospective observational study

Setting: Community Care Centre located at a secondary care hospital in southern India.

Study population: HIV-positive patients admitted to the study site.

Outcome measures: Prevalence, severity, preventability, and risk factors for development of ADRs in hospitalised HIV-positive patients.

Results: Total of 529 consecutive patient episodes from 463 patients (354 [66.9%] male) were followed throughout the hospital stay. Prevalence of ADRs was found to be 60.86% (439). ADR was the cause for hospital admission in 179 (33.83%) admission episodes, while 260 (49.14%) ADRs were observed during hospital stay. The majority of ADRs (243 [76.2%]) were due to ART and were moderate in severity (285 [64.92%]). Medications used to treat opportunistic infections were implicated in 196 (35.1%) ADRs. The gastrointestinal system (131 [29.82%]) was the organ system frequently affected by ADRs. The majority of ADRs 371 (84.51%) were probably preventable. Tuberculosis (OR: 3.6 [CI: 2.2-6.0], p<0.001), patients on ART treatment (OR: 4.0 [CI: 2.8-5.9], p< 0.001) length of hospital stay (>10 days) (OR: 3.64 [CI: 1.97-6.71], p< 0.001) and number of concomitant medications with ART (>10) (OR: 5.4 [CI: 2.9-10.0p< 0.001]) were identified as risk factors for developing ADRs.

Conclusion: ADRs were observed in 60.86% of the admission episodes in hospitalized HIV patients with majority (64.92%) being moderately severe. Interventions to reduce the risk of ADRs in hospitalized HIV-positive patients should focus on the identified risk factors. Creation of a registry for ADRs to ART linking all ART centres across India would prove very useful.

Funding Sources: No funding was available for this project.


Integrating Pharmacovigilance in Revised National Tuberculosis Control Programme of India: A Pilot Study

Parthasarathi Gurumurthy1,2, Niveditha Harapanahalli1, Anand Harugeri1, Madhan Ramesh1,2

1JSS College of Pharmacy, JSS University, Mysore, India; 2JSS Medical College Hospital, JSS University, Mysore, India

Problem statement: The Directly Observed Treatment Short Course (DOTS)/Revised National Tuberculosis Control Programme (RNTCP) of India is one of the largest public health care programmes in the world. About 3,500 patients are initiated on antituberculosis therapy (ATT) every day at DOTS centres in India. Safety information of DOTS in the local population is lacking and pharmacovigilance needs to be integrated into the DOTS programme.

Objectives: To develop DOTS centres as sentinel sites for monitoring adverse drug reactions (ADRs) to ATT

Design: A prospective study

Setting: 10 DOTS centres attached to government primary health care centres in Mysore, India

Study population: Medical officers, pharmacists, and TB health visitors of DOTS centres

Intervention: Workshops for training on safety monitoring of antitubercular therapy (SMART) were organized. Pre- and post-workshop assessments without control were conducted. A SMART trigger tool was developed and implemented to assist the sites’ personnel in detecting ADRs to ATT. Personnel monitored the ADRs in patients receiving DOTS between September 2009 and February 2010. ADR reporting forms and patient information leaflets regarding adverse reactions to ATT were made available at all selected sites. Investigators visited the sites periodically to further train and assist site personnel in detecting and reporting ADRs.

Outcome measures: Awareness about ADRs to ATT; detection and reporting of ADRs to ATT

Results: 44 health care professionals from 10 DOTS/RNTCP centres were trained on ADR detection, reporting, and medication safety counseling; pre- and post-workshop assessments found a 25% increase in the understanding of ADRs to ATT and 68% of the participants detected the ADRs to ATT in dummy TB patients by using the trigger tool developed for the study. The participants of the programme opined that the project helped them to develop their skills in patient safety monitoring. The programme did not necessitate employing any extra human resource at the sites. Of the 274 patients treated with DOTS at the sentinel sites during the study period, 201 adverse reactions to ATT were detected/reported from 112 patients (prevalence 40.9%) in the post-training period. Completion of TB treatment by 98% (110) of patients who experienced ADRs demonstrated the effectiveness of the programme.

Conclusion: Extension of the sentinel site approach in a phased manner to other DOTS/RNTCP centres will improve patient safety monitoring in a large population. SMART workshops can enhance the understanding of ADRs to ATT among the health care professionals of DOTS/RNTCP centres. Our approach to safety monitoring of ATT may prove useful to integrate pharmacovigilance in public health care programmes in resource poor settings.

Funding source: Mysore Physicians Medical Research Trust, Mysore sponsored workshops for training on SMART


Containing Health Care Costs in Ghana: Role of Evidence-Based Selection of Medicines

Martha Gyansa-Lutterodt1, Edith Andrews Annan2, Augustina Koduah1, Brian Adu Asare1, Francis Ofei3

1Ghana National Drugs Programme; 2WHO, Ghana; 3University of Ghana Medical School

Problem statement: Standard treatment guidelines (STGs), if properly developed, usually reflect the consensus among health practitioners on the optimal treatment options within a health system and aim at beneficially influencing prescribing behavior at all levels of care. In Ghana, prescribing according to national STGs, initiated from 1998 to 2010, is high and could potentially influence health outcomes positively in the long term. At the implementation of national health insurance, a 2007 Ministry of Health report on a nationwide survey indicated that, on average, 90.5% of children and 87.5% of adults with pneumonia received 1 of the first-line antibiotics recommended in the STGs. For hypertension in adults, recommended first-line anti-hypertensive agents were prescribed in 96.4% of patients on average across the country.

Objectives: To select cost-effective treatments based on the strength of current evidence and to provide evidence-based selection of medicines for disease conditions

Setting: Various experts with practical knowledge in internal medicine (adults and children), the surgical disciplines, clinical pharmacy, pharmacology, and pharmaceutical policy are selected from leading health care facilities in the country by the Ministry for Health. The experts disclosed conflicts of interest. The experts peer-reviewed each other’s work and this was later subjected to stakeholder analyses in the public and private health sectors. An editorial group of physicians and pharmacy experts reviewed the draft document, using clearly set out procedures, after which the document and selected treatments were presented to a stakeholder forum for further inputs, comments, clarifications, and recommendations.

Study population: A sample of experts in several medical disciplines purposely selected

Intervention(s): Updated selection of medicines for procurement and reimbursements; levels of use based on various evidence ratings with built-in trigger mechanisms for referral to the higher levels of care

Policy: Evaluate cost effectiveness of medicines selected for use in Ghana

Outcome measure: Evidence-based selection of medicines; prescribing guidelines based on current evidence and levels of use; medicines status with respect to national health insurance authority benefits package

Results: A regularly updated evidence-based treatment guideline for various common disease conditions and an essential medicines list 2010 with levels of use outlined. Average percentage of patients receiving antibiotics has improved from 54.0% in 1998 to 42.8% in 2002 and 47.7% in 2006. The 2008 median value was 43.3%. Average percentage of patients receiving injections has improved from 42.0% in 1998 to 34.9% in 2002 and 30.59% in 2006. The 2008 median value was 13.3%. Likewise, the average percentage of prescribed medicines on the EML reveals the following trend: 96.1% in both 1998 and 2002 and 78.92% in 2006; the 2008 median value was 87.5%, which indicates the long-term effect of STGs on medicines use.

Conclusions: Treatment guidelines development and use are critical cost-containment tools for reducing wastage and gaining efficiency for the Ghana National Social Health Insurance Scheme.

Funding Sources: The Kingdom of the Royal Netherlands Embassy, WHO, and MSH


Empathic Caring Consultation (ECC): Will It Be Able to Reduce the Unnecessary Use of Analgesics?

Johana E. P. Hadiyono

Gadjah Mada University, Indonesia

Problem statement: Myalgia complaints and the use of analgesics were high in health centers in Sleman District, DIY, Indonesia. Using analgesic prescriptions to manage pain without considering patients’ other illnesses increases clinical risk, such as liver damage, and has adverse economic impact. The question is whether psychological intervention, or ECC, can play a role in improving specific cases of mylagia that are affected, in part, by the emotional turmoil of every day life.

Objectives: To assess the efficacy of ECC to improve the quality of care in the health centers

Design: Retrospective randomized controlled trial

Setting: 4 public health centers in 1 district randomized into 2 intervention and 2 control groups in June-July 2009

Intervention: Prescribers in the intervention group attended training workshops in ECC that consisted of active listening, expressions of empathy using selected words and facial expressions and gestures, and a short version of deep muscle relaxation. They also received refresher training in prescribing skills and in giving proper information regarding the use of analgesics, including the side effects of the drugs.

Outcome measures: Samples were 30 prescriptions per center per month for myalgia cases. In October 2009, a prescribing survey and observation of health centers’ services, specifically patient-provider interactions, 3 months before and 3 months after the intervention, were conducted by the Sleman District Health Office. Rates of analgesics per prescription were computed separately for each center. Time-series analyses in each health center were presented to see the trends of the analgesics used.

Results: No effect of ECC on the use of analgesics was found at the study sites. For myalgia cases, almost all patients were treated with analgesics before and after the intervention in all 4 health centers. Patients’ perceptions toward the quality of care in the intervention groups improved slightly. Health providers in the intervention groups showing more concern (by using nonverbal communication) were perceived as more empathetic. They also referred more cases to the psychologists when needed.

Conclusions: This study was a replication of the previous study, yet neither result was conclusive (see Prawitasari-Hadiyono, Tana, and Sunartono, 2004). More thorough study and extensive observations are needed if ECC is to be used to lessen the use of analgesics and become an indicator of success. Methodologically, the use of in-depth understanding of the phenomenon must be explored using a qualitative approach, such as in-depth interviewing of health providers, management, and policy makers at the District Health Office; reviewing documents; on-site observation of health providers; and focus group discussions of policy makers, such as those at WHO and involved in INRUD.

Funding source: Professor Research Grant, Faculty of Psychology, UGM


Characteristics and Outcomes of Public Campaigns with the Aim to Improve Outpatient Antibiotic Use in High Income Countries

Stephan Harbarth1, Herman Goossens2, Theo Verheij3, Benedikt Huttner1

1Geneva University Hospitals, Switzerland; 2University of Antwerp, Belgium; 3UMC Utrecht, Netherlands

Objective: Public campaigns have attempted to educate the public regarding prudent outpatient antibiotic use. We reviewed characteristics and outcomes of these campaigns as part of an international collaborative project.

Methods: Through Medline, internet searches and contact with expert informants, we identified public campaigns aimed at improving antibiotic use conducted on a national or regional level in high-income countries between 1990 and 2007. Campaign managers were contacted to obtain unpublished information. Randomized clinical trials and campaigns carried out on a community level were excluded. Analyses were performed using a mixed approach (quantitative and qualitative methods).

Results: We retrieved information on 16 national campaigns and 6 regional campaigns (16 in Europe, 3 in North America, 2 in Oceania and 1 in Israel). All but four campaigns were conducted over more than 1 year (range, 1-13 y) and 12 campaigns were still ongoing in 2007. Most campaigns (n=17) were organized by health authorities and publicly funded. Two national campaigns were entirely funded by the pharmaceutical industry. All campaigns focused on upper respiratory tract infections and used similar key messages. All but one campaign targeted physicians and the public in parallel, with an emphasis on parents of young children (n=17). Interventions were multifaceted and varied in intensity. Distribution of information material was the most common intervention (n=22). Twelve campaigns used television and two campaigns used intensive academic detailing for physicians. Nine campaigns observed a reduction in antibiotic prescriptions and two campaigns in self reported antibiotic use. The impact on antimicrobial resistance was difficult to evaluate because of poor data availability and the concomitant introduction of the pneumococcal conjugate vaccine in several countries. Potential adverse outcomes and sustained effects have not been evaluated systematically.

Conclusions: Antibiotic campaigns are widely used and some have resulted in a reduction in antibiotic use, although a clear cause-effect relationship is difficult to establish. The lack of detailed evaluation, the multifaceted approach and the differences in healthcare systems make identifying the most effective interventions a challenge. Although the impact on antibiotic resistance is difficult to assess at the current moment, policy makers and epidemiologists can use our findings to develop initiatives suited to different country settings. In summary, although the most effective interventions and potential adverse outcomes remain unclear, public campaigns can probably contribute to more judicious outpatient antibiotic use, at least in high-prescribing countries.



Titien Siwi Hartayu1,2, Aji Rustamaji2, Nurita Prasidayani2, Sri Suryawati2

1Sanata Dharma University, Indonesia; 2Gadjah Mada University, Indonesia

Problem Statement: As a chronic disease, diabetes-mellitus is a high risk in complications. In order to reduce diabetes-related complications, adherence to treatment program is necessary. Unfortunately, adherence to treatment program of diabetic patients remains problematic. Therefore, developed a strategy to improve diabetic patients’ adherence to treatment program by adapting the CBIA (Mothers’ Active Learning Method). The new strategy is called CBIA-DM.

Objectives: To evaluate the impact of CBIA-DM strategy on diabetic patients’ knowledge, attitude, practice and adherence to treatment program.

Design: Intervention study, utilizing time series, pre and post quasi-experimental with control group study design.

Setting: The study was conducted in two charity hospitals in Yogyakarta, i.e.: Panti Rapih and Panti Rini hospitals. Panti Rapih DM club was selected as intervention site and Panti Rini DM club was chosen as control site.

Study Population: Members of DM club, and/or their family, and/or their caregiver of Panti Rapih and Panti Rini hospitals.

Intervention: Small group discussion interactive approach in one session program with two hours duration of activities. The activities covered introduction, active self-learning using CBIA-DM package, and wrap up and conclusion by DM experts. Data were collected at pre intervention, immediately, 2 weeks and 4 weeks post intervention. Adherence to treatment program was assessed by calculating the number of remaining tablets on the day pre test and post test, recording patients’ recall in diet, exercise and foot care practices per day and per week by nurses. Effectiveness of this hospital-based patient community program in charity hospital setting was assessed based on the increasing of knowledge, attitude, practice, adherence, intervention cost and acceptance of CBIA-DM by providers and participants; using Wilcoxon test, p < 0.005.

Policy: CBIA-DM strategy can be used as patients’ empowerment in hospital setting.

Outcome Measures: Knowledge, attitude,practice and adherence to treatment program, cost of intervention and acceptance of CBIA-DM program by the head of diabetic club and participants

Results: CBIA-DM group significantly improved the knowledge score from 7.7 to 8.6 (p < 0.005) and practice from 4.6 to 6.0 (p < 0.005) with score range 0-11, but not for the atttude score. Adherence increased from 30% vs. 16.7% at baseline, 46.7% vs. 23.3% at post 1, 30% vs. 13.3% at post 2. CBIA-DM program was conducted in two hours with unit cost US$ 4.00 per person cheaper than regular seminar in DM Club (US$ 8.00). Participants and provider expressed that CBIA-DM was easy to be followed and enjoyable.

Conclusions: CBIA-DM package improved patients’ knowledge, practice and adherence to treatment program. It is an effective strategy which is easy to be followed and enjoyable. It is also feasible to be implemented in hospital- based setting as medium for RUM (Rational Use of Medicines) education. However, improvement of the program is still needed to sustain the impact of the program.

Keywords: CBIA-DM, Diabetes Mellitus, Adherence, Hospital-based patient community, DM club.

Funding Source: WHO-SEARO.


Assessment of Pharmaceutical Situation in Suriname

John Hasrat1, Thiago Botelho Azeredo2, Vera Lucia Luiza2, Adriana Mitsue Ivama3, Primnath Ritoe1, Miriam Naarendorp4

1Ministry of Health of Suriname; 2Nucleo de Assistencia Farmaceutica/National School of Public Health/Fiocruz, Brazil; 3Pan-American Health Organization/World Health Organization (PAHO/WHO), Office of Caribbean Programme Coordination (OCPC); 4Pan-American Health Organization/World Health Organization (PAHO/WHO), Suriname

Problem statement: In Suriname, the Ministry of Health is responsible for assuring a functioning health care system. Prevalence and incidence of chronic diseases are increasing and cardiovascular disorders top the mortality list.

Objective: Assess the pharmaceutical situation in Suriname related to access, quality, and rational use of medicines

Design: A cross-sectional study was undertaken from October 2009 to April 2010 using WHO Level II methodology of health facilities and household surveys. Analysis was done with Epidata and Excel.

Setting: Suriname is located in the north of South America and is part of the Amazonian tropical rainforest with a population of 492,829 (2004) with several ethnic groups.

Study population: 38 public health facilities (PHFs), which dispense medicines to outpatients, 22 private pharmacies (PFs), and 3 warehouses were surveyed; 656 outpatients and 960 households were interviewed

Outcome measures: Indicators of medicines access and use

Results: Access to medicines: availability of key essential medicines was 93% in PHF and 100% in warehouses and PFs. The average cost for prescription for an acute illness was USD 4.00 and a monthly treatment of a chronic disease was USD 6.16. Quality: no expired medicines were found in any of surveyed facilities. Presence of pharmacists was 100% in all facilities and PFs. Storage conditions were adequate in 60% of storerooms of PHFs, in 90% of public warehouses, and in 70% of PFs. Rational use: the percentage of prescriptions by non-proprietary name (INN) in PHFs was very low (45.5%); 78% of people with chronic diseases reported taking medicines recommended in the prescription; 62% of the medicines found at home was adequately labeled.

Conclusions: There is very good access to medicines, nevertheless, quality and rational use are areas with room for improvement. It can be addressed through the updating of the National Medicines Policy. It is recommended to develop and adopt Good Practices in the medicines supply chain, centred on the patient, community, and families. Special attention can be paid to the promotion of rational use of medicines, such as promoting prescribing by the INN, as well as the development of a National Therapeutic Formulary and active development and dissemination of standard treatment guidelines for the main conditions.

Funding source: The study was part of the Partnership on Pharmaceutical Policies Project funded by the European Union and PAHO/WHO.


Public Knowledge and Attitudes Toward Antibiotic Usage: Findings from a Cross-Sectional Survey in the State of Penang, Malaysia

Mohamed Azmi Hassali, Asrul Akmal Shafie, Ahmed Awaisu, Mahmoud Sadi AL-Haddad, Imran Masood, Fahad Saleem, Harith Al-Qazaz

Universiti Sains Malaysia, Malaysia

Problem statement: The public, as the ultimate consumer in the antibiotic utilization pathway, plays a vital role in overcoming the misuse of antibiotics in the community. This study aimed to assess public knowledge and attitudes toward antibiotic usage and could serve as the baseline data at the institutionalized level in Malaysia.

Methods: A cross-sectional survey involving 408 respondents was conducted using a validated questionnaire at an outpatient pharmacy department in Penang Hospital, Malaysia, in February and March 2009.

Results: Nearly 55% of the respondents had a moderate level of knowledge with a median total score of 6 out of 14. Three-quarters of the respondents (76.7%) could correctly identify that an antibiotic was indicated for the treatment of bacterial infections, but 67.2% incorrectly thought that antibiotics were also used to treat viral infections. About 59.1% of the respondents were aware of the antibiotic resistance phenomenon in relation to overuse of antibiotics. With regard to attitudes, 38% believed that taking antibiotic when having symptoms of cold could help them recover faster, whereas 47.3% expected an antibiotic to be prescribed for common cold symptoms.

Conclusion: Age, race, and educational level were among the demographic characteristics significantly associated with knowledge and attitudes toward antibiotic use. Educational interventions are needed to promote the prudent use of antibiotics among the public.

Funding source(s): No funding was received for this study.


People Living with HIV/AIDS : Role of Community Pharmacist

Nahla Maher Hegab, Ahmed Ali Ahmed

College of pharmacy, University of Alexandria.

Problem statement: All people living with HIV should have a core set of interventions to prevent opportunistic infections, maximize their health,prevent further HIV transmission and in some cases delay the progression of the disease. In Egypt people living with HIV/AIDS receive the proper medication according to the national HIV/AIDS guidlines. Although the prevalence of HIV/AIDS in Egypt is low but there is a limited access health services due to discrimination, social marginalization and unfavorable legalization.

Objectives: To identify the role of community pharmacists to encourage suspected HIV/AIDS patients to seek healthcare service available in the national HIV/AIDS programme.

Design: A questionnaire was designed to evaluate the community pharmacists in Alexandria information about HIV/AIDS and availability of medication.

Study population: 100 community pharmacists in Alexandria governorate, Egypt were randomly selected.

Policy: The questionnaire is a primary evaluation of community pharmacists' knowledge about HIV/AIDS,national guidlines,anti retroviral drugs,patient counseling and whether they are willing to join the national campaign to encourage people living with HIV/AIDS to seek medication within the national programme.

Outcomes: community pharmacist participation in national programme to encourage suspected HIV/AIDS Egyptian patients to seek healthcare within the national programme.

Results: It was found that 80% of community pharmacist know definition of HIV/AIDS, 70% of them don't know the available anti retroviral drugs and that tha medication is available in the national HIV/AIDS programme, 100% of them never dealt with any HIV/AIDS patient . Only 65% of community pharmacists are willing to participate in the national campaign to encourage people living with HIV/AIDS to seek medication within the national programme in public sector hospitals.

Conclusion: Community pharmacists are potential partners that can be deployed highly effectively and they can play a key role in controlling AIDS epidemic in Egypt . It is important to provide them with appropriate knowledge about the disease , social aspect , treatment guidelines and bridging the gap between sexual and reproductive health and HIV. The contribution of community pharmacist can improve the number of people seeking access to proper medication at the national HIV/AIDS programme health facilities.

Funding source: Information not provided


Affordability of Medicines for Treating Chronic Diseases in Southern Brazil

Ana Paula Helfer1, Andréa Dâmaso Bertoldi2, Aline Lins Camargo3, Noemia U L Tavares4

1APESC – Hospital Santa Cruz, Brazil; 2Universidade Federal de Pelotas, Brazil; 3Universidade Federal de Ciências da Saúde de Porto Alegre, Brazil; 4Universidade da Região da Campanha, Brazil

Problem statement: By evaluating the affordability of medicines for treating chronic diseases, we can measure the impact of drug prices on family income. All Brazilian citizens are eligible for receiving medicines included in the national list of essential medicines free of charge through the public health system (SUS). SUS should be able to provide essential medicines for free, but if medicines are not available in public sector facilities, patients need to purchase them out-of-pocket in the private market.

Objectives: To evaluate affordability of medicines used for treating chronic diseases across the 3 types of medicines in the Brazilian market (originator brands, generics and “similar”- other brands)

Design: Cross-sectional study

Setting: Southern region of Brazil using the HAI/WHO methodology; included 6 cities in the Rio Grande do Sul state. The total population of these 6 cities represents one-quarter of the state’s total population. Data were collected from the November 2008 to January 2009.

Study population: In each of the 6 cities, 5 private pharmacies were selected (N = 30).

Outcome measure(s): Prices of 21 medicines, used for the treatment of asthma, depression, diabetes, dyslipidemia, epilepsy, hypertension, and peptic ulcer were investigated. For each selected medicine, data for the following variables were obtained: patient price for the originator brand, the lowest-priced generic, and the lowest-priced similar medicine. Affordability was estimated as the number of days that the lowest-paid unskilled government worker earning the minimum monthly wage would need to work in order to purchase a complete course of treatment in a private pharmacy.

Results: The affordability of originator brand medicines used to treat chronic diseases ranged from 0.4 to 21.1 working days; for similars, 0.3 to 7.5; and for generics, 0.2 to 16.8. The number of working days needed to pay for a complete medicine treatment varied considerably across therapeutic classes and type of medicine. For example, in a 30-day diabetes treatment with glibenclamide 5 mg, the differences between the 3 types of medicines were very small. However, a 30-day ulcer treatment with ranitidine 150 mg would cost 9.2, 3.3, and 3.0 days for originator brand, generics, and similar medicines, respectively.

Conclusions: Affordability is directly related to market prices and may cost up to 50% of the monthly income of the lowest-paid unskilled government worker. An overall reduction in medicine prices should be a key priority in Brazil. High prices, poor availability in public sector facilities, and low affordability suggest a number of policy implications for the Brazilian government.

Funding source:This project was supported by a grant from the Brazilian Conselho Nacional de Pesquisa e Desenvolvimento – CNP and is a product of the post-doctoral internship of the first author at the London School of Economics and Political Science – LSE Health, funded by the Brazilian Coordenação de Aperfeiçoamento de Pessoal deNível Superior – CAPES.


Up-to-Date, Evidence-Based Advice for Busy Clinicians

Mary Hemming

Therapeutic Guidelines Ltd, Australia

Problem statement: Prescribers need to base their therapeutic decisions on the latest and best available medical literature, but the continual surge of medical information (more than 12,000 articles and 300 reports of trials are added to the MEDLINE database each week) means that prescribers cannot, by themselves, keep abreast of the relevant literature.

Objective: To provide prescribers with independent, up-to-date, critically appraised therapeutic guidance that is credible, comprehensive, timely for decision making, succinct, and formatted for optimum readability and ease of use

Setting: The target audience is primary care clinicians throughout Australia; these include medical practitioners, pharmacists, and other prescribing health professionals. The information is also used by clinicians in hospitals and by educators and students in medical and pharmacy schools. International demand, especially from the developing world, is increasing.

Design: Therapeutic Guidelines Limited (TGL), an independent not-for-profit, self-funding organisation, writes and publishes independent and expert advice for prescribers on the best use of medicines, the focus being on the information needs of the end users.

These therapeutic guidelines provide clear and concise, independent, and evidence-based recommendations for patient management. They are produced using a unique process involving Australia’s leading experts who, with their many years of clinical experience, work with TGL’s medical editors to develop the material. Features of the content development process are (1) extensive literature searches; (2) appraisal of Cochrane reviews, systematic reviews, and any other credible guidelines; (3) a series of day-long face-to-face meetings of the expert writing group over several months to discuss, debate, and challenge draft content; (4) consideration of feedback from a representative group of users; and (5) peer review. The rigorous process ensures the recommendations that are developed are based on the best available evidence. All topics are regularly updated in iterative cycles. The enterprise has been operating and evolving since 1978.

Outcome measure(s): TGL employs a dedicated evaluation officer to actively solicit feedback from a network of 200 users of therapeutic guidelines. Participants in the network reflect the mix of actual users in both urban and regional or remote areas.

Results: Therapeutic guidelines are used by health professionals at all levels, from undergraduates to opinion leaders, in all public hospitals, in community practice, and in pharmacy and medical schools throughout Australia.

Conclusions: The guidelines are firmly entrenched as part of the Australian medical, pharmacy, and health professional culture. They are valued and respected, and are often referred to by clinicians as a “national treasure.”

Funding source(s): No external funding received. All funding comes from the sale of therapeutic guidelines.


Taking Stock: Provider Prescribing Practices in the Presence and Absence of ACT Stock

Bernadette Hensen1, Lucy Smith Paintain1,2, Rima Shretta3, Jane Bruce1,2, Alexandra Hyde1,2, Caroline Jones1,2, Jayne Webster1,2

1London School of Hygiene and Tropical Medicine, United Kingdom; 2Pfizer Inc. Corporate Responsibility; 3Management Sciences for Health

Problem statement: Artemisinin-based combination therapy (ACT) stock-outs are common and adversely affect achievement of prompt and effective treatment of malaria.

Objectives: To assess provider prescribing of ACTs and alternative antimalarial medicines in the presence and absence of ACT stock

Design: Literature review. Study inclusion criteria: disease of focus was uncomplicated malaria; region of focus was in Africa; country’s first-line antimalarial at the time of study was an ACT. The study included an assessment of prescribing practices at time of treatment. Prescribing practices were assessed in the context of ACT stock and stock-outs (with health facility surveys used to collect stock data).

Setting: Africa

Study population: Populations vary based on studies included in the review.

Policy change: To increase the use of process analyses of ACT prescribing in the public sector in order to evaluate current practices and enable the design of evidence-based interventions to improve prescribing practices.

Outcome measure(s): Malaria prescribing practices in the presence and absence of ACT stock at time of treatment

Results: Only 14 studies evaluating the prescribing of ACTs in the public sector were identified and just 6, from 3 countries (Kenya, Uganda, and Zambia), met the full study inclusion criteria. Across all studies, regardless of stock context, ACT prescribing ranged from 10.7% of children ≥10 kg (Zambia 2004) to 66.4% of children <5 years (Uganda 2007), and alternative antimalarial prescribing from 0.4% of children <5 years prescribed sulfadoxine-pyrimethamine (SP) (Uganda 2007) to 67.5% of children ≥10 kg prescribed SP (Zambia 2004). Comparing facilities where ACT was in stock to facilities without ACT stock: (1) ACT prescribing was significantly higher in all six studies, increasing by a range of 21.3% for children <5 years weighing ≥5 kg (p<0.001; Kenya 2006) to 51.7% for children ≥10 kg (p<0.001; Zambia 2006); (2) prescribing of SP decreased significantly in five studies, by a range of 14.4% (p<0.001; Kenya 2006) to 46.3% (p<0.001; Zambia 2006); (3) where quinine was an alternative treatment, prescriptions decreased in five of the six studies by 0.1% (p=1.0 , Kenya 2010) to 10.2% (p<0.001; Zambia 2006). At facilities with no ACT stock on the survey day, the proportion of febrile patients prescribed ACT was <10% in five of the nine target groups across the six studies; The proportion prescribed ACT ranged from 0 to 28.4% (Uganda 2007).

Conclusions: Prescriber practices in the presence and absence of ACT vary. Although in the presence of ACT stock ACT prescribing increases and alternative antimalarial prescribing decreases, ACTs are prescribed in the absence of stock, and alternative antimalarial drugs are prescribed in the presence of ACT stock. More health facility surveys are needed to understand provider ACT and alternative antimalarial prescribing practices within the context of stock. Without such operational data, there is a risk that interventions will misinterpret needs and bear little impact.

Funding source(s): DFID TARGETS Research Consortium


Reimbursement Price, Market Structure, and Pharmaceutical Firm Behavior in Korea

Jaeheon Heo, Soonman Kwon

Seoul National University, Korea, South (Republic of)

Problem statement: Regulation of reimbursement price for pharmaceuticals in national health insurance is a key issue for the government and pharmaceutical industry in Korea.

Objective: To examine the effect on pharmaceutical firm behavior of market structure and reimbursement price regulated by the government in Korea.

Design: Using a panel data of frequently used medicines in 2003–07, this study examines the impact of competition and government price regulation on production of pharmaceutical firms.

Outcome measure(s): Based on the structure-conduct-performance framework of industrial organization economics, various measures are used for market definitions (e.g., therapeutic categories, ATC classifications) and concentration indices such as Herfindahl index. Other independent variables include the length of being listed in the benefit package, potential market size, and prescription vs. non-prescription drugs.

Conclusion: The effect of market competition on production varies depending on therapeutic categories, but the reimbursement price regulation by the government has no negative effect on the production of pharmaceutical firms.

Funding source(s): N/A


CBIA-Pregnancy to Improve Skills of Pregnant Mothers in Selecting OTC Common Cold Preparations

Sri Hidayati1, Titien Siwi Hartayu2, Siti Munawaroh3, Sri Suryawati1

1Gadjah Mada University, Indonesia; 2Sanata Dharma University, Indonesia; 3Agency for Women and Community Empowerment, Indonesia

Problem statement: Pregnant women may have common cold episodes during pregnancy and need medicine to soothe the symptoms. Therefore, skills in selecting medicines for common cold in pregnancy are important. Mothers’ active learning method (known as CBIA) is one of the strategies which is not only improving knowledge but also changing behavior. Since information on the use of medicine in pregnancy is also available in the medicines’ package, it is expected that the CBIA-Pregnancy program can be developed and be focused on the medicines used in pregnancy.

Objective: To pilot-test CBIA-Pregnancy in improving knowledge and skills of pregnant women to select common cold medicines

Design: An intervention study with pre- and post-quasiexperimental design; data collected at baseline, one-day (Post I), 2 weeks (Post II), and 4 weeks (Post III) after intervention

Setting: The study was conducted in 2 hospitals in Yogyakarta, Indonesia, Sakina Idaman and Panti Rapih. Women visiting antenatal care (ANC) in Sakina Idaman were assigned as intervention group, and those visiting Panti Rapih were assigned as control.

Study population: Pregnant women who visited ANC program in Sakina Idaman and Panti Rapih hospital on regular basis

Intervention: CBIA-Pregnancy is a 2-hour small group discussion using information in the medicines’ package as training material and the CBIA-Pregnancy module as an activity guide. There were 5 groups of 5–6 participants; midwives in the study hospital served as facilitators. Participants searched information on active compound, indication, dosage, side effects, and contra-indications and also specific information on the use of the medicine during pregnancy.

Policies: This strategy will provide hospitals with tools for hospital-based community empowerment and promoting self-learning behavior among the community.

Outcome measures: Score of knowledge on the most familiar medicine, percentage of subjects who could select the correct medicine, and feasibility assessment

Results: Score of knowledge increased significantly (p<0.05) from 4.08 + SD 2.42 at baseline to 6.88 + SD 2.41 at Post I, to 6.92 + SD 2.31 at Post II, and to 6.65 + SD 1.72 at Post III in the intervention group. Percentage of subjects who could select the correct medicine increased significantly after CBIA-Pregnancy training from 46% at baseline to 92% at post I (X2 test p<0.05), to 85% at post II, and to 90% at post III (X2- test, p<0.05 compared to baseline). Feasibility assessment showed that CBIA–Pregnancy needed less time to conduct and cost less than seminar and was supported by legal statements on medicine and law of consumers’ protection.

Conclusions: CBIA-Pregnancy improved knowledge and skills of pregnant women on selecting OTC common cold preparations. This strategy is considered easy to follow and feasible to implement in hospitals.

Funding source(s): WHO-SEARO


The Use of Medicines and Standard Treatment Guidelines in Rural Timor-Leste

Michiyo Higuchi1,2, Junko Okumura3, Asuko Aoyama2, Sri Suryawati4, John Porter1

1London School of Hygiene & Tropical Medicine, UK; 2Nagoya University School of Medicine, Japan; 3Institute of Tropical Medicine, Nagasaki University, Japan; 4Faculty of Medicine, Gadjah Mada University, Indonesia

Problem Statement: Appropriate use of medicines and treatment of common diseases are critical in resource-limited settings.

Objectives: The aim of this study was to investigate the use of medicines and adherence to standard treatment guidelines (STGs) in community health centres (CHCs) in Timor-Leste. Factors that influence the utilisation of the STGs were then analysed.

Design: Mixed methods research was employed.

Setting: Targeted CHCs are categorized as subdistrict CHCs under the Ministry of Health (MoH). Those in the enclave and the capital were excluded. When the data were collected from February to August 2006, there were no inpatient facilities and no laboratory equipment in these CHCs, and the majority of the posted health professionals were nurses and midwives who had graduated from a nursing high school with/without 1-year midwifery education.

Study Population: In 20 randomly sampled CHCs, 1,799 cases were collected from patient registration books in 2005 and 583 cases were directly observed for quantitative analysis. Furthermore, individual interviews for qualitative analysis were conducted with 55 nurses/midwives identified in the 20 selected CHCs.

Outcome Measures: (1) The INRUD/WHO indicators were used to assess the use of medicines. (2) Adherence to STGs was examined on the basis of selected guidelines published by the MoH.(3) Nurses’/midwives’ knowledge of and attitudes toward STGs were qualitatively analysed based on in-depth interviews.

Results: Very few injections, 0.4% or 0.3% of all encounters, were used in the CHCs. Of 32 prescribers, those with clinical nurse training prescribed significantly fewer antibiotics than those without such training (P < 0.01). The adjusted odds ratio of prescribing adherence for clinical nurse training, after accounting for confounders and prescriber clustering, was 6.6 (95% CI: 2.5–17.6; P < 0.01). Qualitative analysis revealed that the respondents believed that they “should” follow the STGs. This feeling arose from their self-awareness as frontline health professionals and as local government workers. Self-confidence was more clearly identified in the clinical nurse interviews. The changes brought about by the introduction of STGs were positively perceived by respondents and few difficulties in using STGs were indicated.

Conclusions: Clinical nurse training positively influenced prescribing attitudes and practice. The STGs’ understandable and manageable contents led to the nurses’/midwives’ acceptance of the policy changes which introduced the STGs and consequent changes in daily practice, and further, resulted in their positive perception of these changes. Development of STGs in a health policy framework was considered a key factor to interconnect related policies and programmes. When appropriately developed and introduced, comprehensive STGs for non-physician health professionals at the PHC level have potential value in delivering basic health care in resource-limited communities.

Funding Source: The Takagi Fund for Citizen Science, the Dr. Gordon Smith Travelling Scholarship, and the Toyota Foundation


Access to and Use of Medicines in Barbados: Evidence from a Household Survey

Maryam Hinds1, Adriana M. Ivama2, Carol Mulder3, Dennis Ross-Degnan4, Catherine E. Vialle-Valentin4

1Barbados Drug Services, Ministry of Health, Bridgetown, Barbados; 2Office of Caribbean Program Coordination (CPC), Pan American Health Organization/ World Health Organization (PAHO/WHO), Bridgetown, Barbados; 3University of the West Indies, Cave Hill, Barbados; 4Harvard Medical School, United States of America

Problem Statement: Barbados is a middle-income country with high prevalence of diabetes and hypertension. Medicines are free at all public and private points of service for persons over age 65 or under age 16, and for those receiving prescribed medicines listed on the National Drug Formulary (NDF) for diabetes, hypertension, cancer, asthma, and epilepsy. At all dispensing facilities, all citizens and permanent residents, that are elegible, do not pay for prescribed medicines that are in the BNDF. Since April 1, 2011, at private pharmacies, a dispensing fee has been re-introduced. Monitoring the effects of this policy is critical to ensure that it meets the objective of adequate cost-effective access to medicines and appropriate use for all Barbadians.

Objective: To generate reliable evidence for policy makers in Barbados about current medicines access and use at the community level.

Design: Descriptive analysis of survey data with technical support from PAHO/WHO and Harvard Medical School.

Setting: Household survey conducted in Barbados in 2010 with a questionnaire developed by WHO.

Study Population: Surveyed households were selected by random stratified sampling (n = 317). Those with asset and expenditure data (n = 272) were classified into “higher” (n = 160) or “lower” (n=112) Socio-Economic Status (SES) groups according to their total monthly expenditure (predefined threshold at BBD800) and reported ownership of preselected assets. The percentage of households reporting at least one chronic disease in the higher and lower groups was 53% and 67% respectively.

Outcome Measures: Indicators of medicines access and use.

Results: Most households (99%) could reach a public health care facility within 1 hour; 4% in the higher group lived at over 1 hour from a public hospital vs. 11% in the lower group. The percentage of households keeping medicines at home in the higher and lower groups was 76% and 71% respectively. The percentage of persons who obtained medicines free for their chronic disease was 74% in the higher group vs. 98% in the lower group; for those who paid, the average monthly medicines cost was 177 Barbados dollars (BBD) in the higher vs. BBD 9 in the lower group. In the higher group, 6% of persons with a chronic disease had not been told to take medicines vs. 15% in the lower group. Respondents in the lower group had a better opinion of care and access to medicines in public facilities than those in the higher group. In both groups, a high percentage of persons with chronic disease did not take the medicines prescribed (23% in higher and 17% in lower group) most often because they felt symptoms had improved.

Conclusions: Overall, our results indicate good community access to medicines in Barbados with notable differences in access between lower and higher SES groups for people with chronic disease. They draw attention to misconceptions about treatment of chronic diseases and point to the need for interventions convincing people with chronic disease to continue treatment even if symptoms improve.

Funding: The study was part of the EU/WHO ACP Partnership on Pharmaceutical Policies Project funded by the European Union.


Pharmaceutical Situation in Barbados: WHO Level II Health Facilities Survey, 2010

Maryam Hinds1, Cheryl Ann Yearwood1, Catherine Vialle-Valentin2, Dennis Ross-Degnan2, Adriana Mitsue Ivama3, Jenifer Nunes4, Gabriel Vivas5

1Barbados Drug Service, Ministry of Health of Barbados; 2Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.; 3Pan-American Health Organization/World Health Organization (PAHO/WHO), Office of Caribbean Programme Coordination (OCPC); 4University of West Indies (UWI); 5Pan-American Health Organization/World Health Organization (PAHO/WHO), Office of Eastern Caribbean Countries (ECC)

Problem statement: In Barbados, the key contributors of morbidity and mortality are heart disease, cerebrovascular disease, diabetes mellitus, cancer, hypertension, and HIV/AIDS among adults. Medicines from the Barbados National Drug Formulary (BNDF) are provided free at pharmacies of the public health facilities (PHFs) and with payment of a dispensing fee at private pharmacies (PPs) to patients 65 years old (yo) and over, children under 16, yo and persons prescribed for hypertension, diabetes, cancer, asthma, and epilepsy. Patients from 16 to 64 can receive the same medicines at subsidized prices.

Objective: Assess the pharmaceutical situation in Barbados related to access, quality and rational use of medicines

Design: A cross sectional study was undertaken from October 2009 to July 2010 using WHO Level II Health Facilities survey. Analysis was done with Epidata and Excel.

Setting: Barbados is a middle-income country with a population of 275,700 (2009).

Study population: All 18 public health facilities (PHFs) which dispense medicines to outpatients and 30 private pharmacies (PPs) randomly selected were surveyed and 1026 outpatients interviewed.

Results: Key essential medicines were available in 100% of PHFs and 94% of PPs; 99% of prescribed medicines were dispensed in the PHFs. No expired medicines were found and adequacy rates of storage conditions were 85% in PHFs and 90% in PPs. The BNDF was found in 92% of PHFs. Standard treatment guidelines (STGs) for diabetes, hypertension, and asthma were found in 55% of PHFs; 23 % of patients were prescribed antibiotics and 7 % were given injections. All patients interviewed in the PHFs and PPs knew how to take their medicines; 97% of patients travel less than an hour to reach a PHF. The international non-proprietary name (INN) in PHF was used for only 36 % of prescription medicines; 38% of private pharmacies sold at least 1 prescription medicine without prescription at the time of visits. Based on STGs, the survey found that there was underuse of antibiotics to treat pneumonia in children under 5 and overuse to treat non-bacterial upper respiratory infections. Also, some children under 5 with diarrhoea were not prescribed the appropriate treatment of oral rehydration salts.

Conclusions: Even though the availability of medicines in public pharmacies was excellent at the time of the survey, only the data from current stock was available. The software used needs to be improved for retrieving historical data. It is also necessary to expand availability of STG. Use of INN for prescribing should be encouraged, as part of the promotion strategy of generics. Dispensing of prescription medicines without a prescription should be discouraged and addressed regarding legal and ethical aspects. Managerial policies related to pharmaceuticals need to be improved. The development of Good Practices through the distribution chain is recommended. These findings were used as evidence for updating the National Pharmaceutical Policy, discussed with stakeholders in early 2011, and submitted to Cabinet for approval.

Funding source: EU/ACP/WHO Project Partnership on Pharmaceutical Policies funded by the European Union


Antibiotics and Pediatric Acute Respiratory Infections in Rural Vietnam: Health Care Providers’ Knowledge, Practical Competence, and Reported Practice

Nguyen Quynh Hoa1,2, Mattias Larsson3, Chuc Thi Kim Nguyen1, Bo Eriksson4, Nguyen Vu Trung5, Cecilia Stalsby Lundborg3

1Hanoi Medical University, Viet Nam; 2Vietnam Cuba Hopsital, Hanoi, Vietnam; 3Karolinska Institutet, Stockholm, Sweden; 4Nordic School of Public Health, Gothernburg, Sweden; 5National Institute of Infectious and Tropical Diseases, Hanoi, Vietnam

Problem statement: Acute respiratory infections (ARIs) are among the leading

causes of morbidity and mortality among children in low and middle-income countries. In Vietnam, ARI symptoms are the most common reason for seeking health care for children.

Objectives: To assess knowledge, practical competence, and reported practices among health care providers about antibiotics to treat acute respiratory infections in children under 5 in rural Vietnam

Design: This is a descriptive cross-sectional study conducted June to July 2007 in Bavi district, Vietnam. Inclusion criteria were all health care providers (HCP) who prescribe or dispense drugs for treatment of children under 5 in the district, excluding traditional healers.

Setting: The study setting was Bavi district, 60 km west of Hanoi, where an Epidemiological Field Laboratory (Filabavi) was implemented in 1998. The district covers an area of 410 km2 divided into lowland, highland, and mountainous areas according to geographical characteristics.

Study population: HCPs who provided neither health services nor western drugs for children under 5 were excluded from the study. To check the completeness of the list, communal health staff and Filabavi surveyors travelled around the commune to double-check. In all, of the 457 health care providers on the list, 48 were ineligible due to incorrect address, not treating children, or using only herbal medicines for treatment.

Results: Of the total 392 respondents, 27% agreed with statements regarded as correct concerning the consequence of antibiotic resistance, which is ultimate treatment failure for both patients and community. 21% stated antibiotics should be used if the child had cough and runny nose without fever, and 79% in cases where fever is included. In all, 19% of HCP had correct knowledge about the use antibiotics for treatment of ARI among children under 5. The use rate of antibiotics in common colds (81%) was not significantly different compared with that in the pneumonia scenario, if referral cases (87%) are not considered; however, it was significantly lower among those who had correct knowledge. According to reported practice, children in the latest encounters were mild ARI 62%, then severe ARI 19%, and others 19%; of those, the antibiotic use for treatment was 90%, 87%, and 78%, respectively. Beta-lactams were most likely antibacterials used regardless of the severity of the diseases.

Conclusion: Antibiotics are commonly dispensed or prescribed unnecessarily for common colds. Continuous training in respiratory syndrome approach and supervision are needed. Furthermore, changes to the motivations and expectations surrounding physician-patient interaction are recommended to improve antibiotic use.

Funding source(s): Health Systems Research Project, funded by Sida/SAREC, Sweden and the Ministry of Science and Technology, Vietnam.


How Sustainable is the EU Regulatory Network in the Context of the Uptake of New Medicines?

Joëlle Hoebert1, Aukje Mantel-Teewisse1, Liset van Dijk2, Hubert Leufkens1

1Utrecht University/Utrecht WHO Collaborating Centre for Pharmacoepidemiology and Pharmaceutical Policy Analysis, The Netherlands; 2NIVEL, Netherlands institute for health services research, Utrecht, the Netherlands

Problem statement: The system of rapporteurs is seen as the backbone of the European Union (EU) Centralised Procedure, although there is increasing concern about the large variation among EU member states (MSs) regarding their individual contributions in terms of the number of rapporteur roles. The future strategy paper of the European Medicines Agency (EMA) aims to strengthen the European regulatory network and its contributions to patients’ access to medicinal products.

Objectives: In this study, we looked at variations in rapporteur contributions to the EU regulatory network between EU MSs in light of the uptake of new medicines approved in 2004 as measured through IMS data.

Design: Drug utilization study

Setting: Contributions to the EU regulatory network and international utilisation of newly approved medicines in both public and private sectors in 23 European MSs

Study population: All 24 medicines that received a central market authorisation by EMA in 2004

Outcome measures: The total number of (co-)rapporteurships of each EU MS between 2004 and 2009 was determined using the European Public Assessment Reports of all centrally authorised medicines. Data on medicines usage by volume in various EU MSs was collected fromIMS data. A medicine was defined as available if consumption in a certain year was ≥ 100 standard units (IMS volume measure). For each medicine, the volumes (per 1000 inhabitants/day) consumed in 2009 across all countries were divided into 4 equal parts (quartiles). Each EU MS was then ranked according to their consumption into a quartile. Finally, the average ranking (minimal 1, maximal 4) per country was set out against the number of (co-)rapporteurships.

Results: A crucial factor in the uptake of medicines is the actual availability of medicines. In some countries (e.g., Portugal and the Baltic States), over 40% of these medicines were not available 5 years after market authorization. Furthermore, a distinction was seen between newer and older EU member states. Newer EU MSs showed almost no variation in their (low) contribution in terms of number of rapporteurships (range 0-10) to the regulatory system but did show large variation in the relatively low uptake of new medicines (range average ranking 1.3–2.7). Older EU MSs showed large variation in their large contributions in terms of the number of rapporteurships (range 15-58), but almost no variation in their high uptake of these medicines (range average ranking 2.4–3.3).

Conclusions: Innovative medicines are not available for all citizens in the EU in a timely and equitable manner. The valuable input of high-quality specialist expertise provided by the MSs is limited to just some countries, mainly the older EU MSs. This phenomenon may fuel the debate around the current EU procedures that might not be sustainable if not all resources from all EU MSs are mobilized.

Funding sources: None


Do European Rheumatoid Arthritis Patients Have Equal Access to Treatment with New Medicines?

Joelle M. Hoebert1, Aukje K. Mantel-Teeuwisse1, Liset van Dijk2, Johannes J.W. Bijlsma3, Hubert G.M. Leufkens1

1Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology / Utrecht WHO Collaborating Centre for Pharmacoepidemiology and Pharmaceutical Policy Analysis, Utrecht University, the Netherlands; 2NIVEL, Netherlands institute for health services research, Utrecht, the Netherlands; 3Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, the Netherlands

Problem statement: Health care systems aim to achieve optimal health and economic outcomes for society as a whole as well as for the individual patient. Effective but expensive medicines, such as biologicals, may lead to different measures taken by governments or regulators and prescribers to achieve this goal thereby resulting in differences in access to treatment.

Objectives: Building on previous reports on access to treatment for rheumatoid arthritis (RA), the objective was to further explore the use of the biological tumour necrosis factor alpha (TNFalpha) inhibitors used in the treatment of RA as a proxy of access to treatment with new medicines over time and to add opinions from key leading rheumatologists to put the obtained results into perspective.

Design: Drug utilization study

Setting: This study examines the international use of a relatively new class of medicines in the in- and outpatient public sector in Ireland (IE), the Netherlands (NL), Norway (NO), and Portugal (PT).

Study (population) medicines: Three TNFalpha inhibitors that have been centrally approved in the European Union: infliximab (1999), etanercept (2000), and adalimumab (2003). Major indication for these biologicals is RA.

Intervention and policy change: NA

Outcome measure(s): Utilisation rates in defined daily doses (DDDs) per 1,000 inhabitants per day. Qualitative data such as country characteristics, national health policy characteristics, guidelines and other important policy events were obtained from literature. In addition, interviews were held with leading rheumatologists of each country to put obtained results into (cultural) context.

Results: Prevalence of RA varied between 0.46 (NL) and 0.56 (NO) per 100 inhabitants. Utilisation of TNFalpha inhibitors varied widely from 0.32 (PT) to 1.89 (NO) DDDs/1,000 inhabitants/day (2007). An association between health expenditures per capita and the degree of utilization of TNFalpha inhibitors was found (R2 = 0.81). When the use of TNFalpha inhibitors became more established (increased clinical evidence, increased number of prescriptions, extension of indications), the association was stronger. Differences in health expenditure were nevertheless not the only determinant of usage. Causes of intercountry variation were manifold including differences in guidelines, reimbursement regulations, and according to key rheumatologists, access to rheumatologists (PT), (non)adherence to guidelines (PT, NL), consultation of colleague before initiation (NO), and budgetary constraints.

Conclusions: The prospects of patients receiving TNFalpha inhibitor treatment depend on the country where they are living. If uniformity of management and treatment would be considered to provide health benefits, the extent and the causes of variation should feature prominently in future public health agendas.

Funding source(s): None


Do Countries with Pharmaceutical Policies Have Better Medicines Use Than Those without?

Kathleen Anne Holloway

World Health Organization, Regional Office S.E.Asia, India

Problem statement: Many countries do not implement basic policies to encourage better medicines use possibly due to lack of evidence of their effectiveness.

Objectives: To determine if medicine use is better in those countries with certain pharmaceutical policies compared to those without.

Design: Quantitative public sector medicine use data by country for 2002-8 was extracted from the WHO medicine use database containing data on medicine use extracted from published & unpublished articles & reports. Policy data was extracted from the WHO policy database containing data from 2 surveys sent to Ministries of Health (MOH) in 2003 & 2007. The extracted data were merged to form one database containing policy & medicine use data. Where policy differed in 2003 & 2007, the date of the medicine use survey(s) contributing to the data was determined & the policy chosen that was within one year of the policy survey date, otherwise the policy was marked as unknown. A comparison was undertaken for 12 different medicine use indicators, plus a composite indicator, between countries with & without policies. A difference in medicine use with & without a policy was judged present if 80% of the indicators showed either better or worse use in one group as compared to the other & if the composite indicator showed a difference of more than 10%.

Setting: Public sector in developing & transitional countries

Study population: Providers & consumers in primary care

Policies: All national policies hypothesized to impact on medicines use & for which more than 20 countries responded whether they had such a policy or not.

Outcome Measure(s): Standard indicators of the International Network for the Rational Use of Drugs (INRUD) & the Integrated Management of Childhood Illness (IMCI). A composite indicator was created by ranking all countries for each medicine use indicator & then assigning a number between 1 (worst) &10 (best use) according to the percentile within which the country lay. Then the median across all indicators measured in that country was taken to give a score out of 10 for medicine use performance in each country.

Results: Data on medicine use & policy was assembled from 59 countries. Policies strongly associated with better use included Drug & Therapeutic Committees, free medicines at the point of provision, training of health professionals on essential medicines & guidelines, a national strategy to contain antimicrobial resistance & a dedicated MOH unit to promote rational use of medicines. Policies strongly associated with worse use included using revenue from medicine sales to supplement salaries & surprisingly, continuing medical education - which needs further investigation.

Conclusions: The WHO databases on medicine use & policy can be used to monitor global progress in terms of medicines use & policy implementation. A suitable national policy framework is extremely important to promote rational use of medicines.

Funding Source(s): WHO


Surveillance of Antimicrobial Resistance in Resource-Constrained Community Settings

Kathleen Anne Holloway1, Elisabeth Mathai2, Andy Gray3

1World Health Organization, Regional Office S.E.Asia, India; 2World Health Organization, Geneva; 3Nelson R Mandela School of Medicine, University Kwa Zulu Natal, S Africa

Problem statement: Antimicrobial resistance (AMR) is increasing rapidly, but there is little good data on AMR in resource-constrained communities to inform public health decision making, nor are there standard methods for conducting such surveillance.

Objectives: To develop a community-based surveillance system and collect useful data on AMR in resource constrained settings in 3 Indian and 2 South African sites.

Design: Time series where monthly AMR data on target bacteria were collected over at least 12 months at each site. Each site sought to obtain 960 isolates per year.

Setting: Outpatient clinics in public, not-for-profit private, and/or for-profit private facilities

Study population: E. coli was target bacteria in 4 sites, it being isolated from the urine of pregnant women attending antenatal clinics and those suspected with urinary tract infections in 3 sites and from stool specimens in the other site. One site isolated S. pneumoniae and H. influenzae from the sputum of patients over 12 years with a productive cough. Resistance was determined by disc diffusion in the 4 sites isolating E. coli and by minimum inhibitory concentration (MIC) methods in the other site.

Intervention(s): None

Outcome measure(s): (1) percentage of E. coli isolates resistant to ampicillin, co-trimoxazole, nalidixic acid, ciprofloxacin, and cefotaxime; (2) percentage of S. pneumoniae and H. influenzae isolates resistant to co-trimoxazole, chloramphenicol, erythromycin, and ampicillin (H. influenzae only); and (3) lessons on setting up surveillance

Results: In South Africa, data were collected for 12 months in one site and 16 months in the other. In India, data were collected for 14 months in one site and 24 months in the other 2. Only 2 sites collected the required number of isolates. E. coli isolates were easier to obtain, and 2 sites developed methods to increase their yield; one site asked women without signs of urinary tract infection to deliberately contaminate their own urine specimens with perineal wipes and the other re-incubated urine specimens that showed no growth after 24 hours. Disc diffusion testing was more reliable and timely than MIC testing. Although methodological differences limit comparability of data, high AMR rates were seen in all sites. Highest rates were seen for those antibiotics historically in longer use. AMR did not vary between isolates from different types of facility within any site. In the 2 sites that distinguished commensal from pathogenic E. coli, resistance was higher in the pathogens for all antibiotics.

Conclusions: All 5 pilot sites provided useful data on AMR but also raised a number of technical and logistical issues related to long-term surveillance in resource-constrained community settings. E. coli is probably the best indicator bacterium and disc diffusion the easiest method to determine AMR in resource-constrained settings.

Funding source(s): WHO, USAID. Surveillance of Antimicrobial Use and Resistance in Resource-Constrained Settings Project Group


Health Systems Approach to Improving the Use of Medicines in the S.E. Asian Region (SEAR)

Kathleen Anne Holloway1, Krisantha Weerasuriya2, Chinta Abayawardana3, Selina Ahmed4, J.M.Faridur Rahman4

1World Health Organization, S.E.Asia Regional Office, New Delhi, India; 2World Health Organization, HQ, Geneva; 3World Health Organization, Country Office, Sri Lanka; 4World Health Organization, Country Office, Bangladesh

Problem statement: WHO recommends national programs to improve medicines use, deciding actions based on a situational analysis, but few low- and middle-income countries are doing this.

Objectives: To develop (1) a regional strategy and (2) country plans of action based on a national situational analysis

Design: A regional meeting to improve medicines use was held in July 2010. Thereafter a situation analysis was done in Sri Lanka and Bangladesh. The process was guided by a checklist and included a workshop/debriefing meeting to develop a national roadmap for action.

Setting: Pharmaceutical sector in SEAR countries

Study population: Public and private facilities, MOH departments, academia, and other stakeholders

Intervention(s): The situation analysis involved visits to the MOH (medicine supply, distribution, and regulation), public and private facilities, medical/pharmacy association and council, academia (clinical pharmacology, pharmacy, medicine), and discussion of the results with stakeholders.

Outcome measure(s): (1) Major determinants and factors in the pharmaceutical sector affecting medicines use and (2) recommendations for action

Results: In July 2010, 9 countries attended a regional meeting where it was recommended that (1) a health systems integrated approach was needed and that this approach required doing systematic situational analyses and (2) all MOHs have a unit dedicated to improving medicines use, guided by a multidisciplinary body. We then made visits, at the invitation of MOH, to Sri Lanka and Bangladesh to conduct a rapid situational analysis. Both countries have a good health service delivery infrastructure and a recently updated National Medicines Policy, although many components are not yet implemented. Weaknesses in both countries included (1) insufficient availability of essential medicines in the public sector, (2) lack of an electronic medicine inventory system to monitor consumption, (3) lack of updated national treatment guidelines, and (4) inadequate regulatory systems with severe human resources deficiencies. Regulatory problems included (1) too many brands on the market (8,000–23,000), (2) lack of pharmacists in shops to supervise dispensing, (3) lack of an updated over-the-counter (OTC) list with the availability of many prescription-only medicines OTC, and (4) inadequate monitoring of medicine promotional activities. Stakeholders in both countries appreciated the situational analysis findings and how it facilitated planning. Recommendations included (1) setting up a dedicated MOH unit to monitor medicines use, (2) initiating an electronic medicine inventory system, and (3) strengthening the medicine regulatory authority. Recommendations will be used for MOH and WHO planning for the pharmaceutical sector.

Conclusions: A country situational analysis is extremely useful in understanding the pharmaceutical situation and, in the absence of routine monitoring, is necessary to identify a roadmap for action for both public and private sectors. Resource mobilization for this roadmap is urgently needed.

Funding source(s): WHO


Development and Implementation of an Evidence-Based Drug List for Rural Health Insurance Program in Iran

Seyed Ali Reza Hosseini, Arash Tehrani Banihashemi, Shadan Darbooy

Ministry of Health and Medical Education, Iran, Islamic Republic of

Problem statement: A rural health insurance program launched in 2004 in Iran in which the Medical Services Insurance Organization (MSIO) acted as “purchaser” and the Ministry of Health and Medical Education (MOHME) as “provider” of the health services in target population. An original drug list (DL) of 390 items was introduced by MSIO, extracted from a data base of prescriptions, representing the most frequently prescribed medicines by general physicians (GPs) in the whole country. In this scenario, while MSIO were arguing equality, MOHME considered rationality of DL and the rational use of medicines. We sought to provide evidence for this argument and examine justifications described.

Objectives: To evaluate the original 390 items DL and develop an evidence-based, need-oriented DL and to implement it into the program

Design: This was a qualitative, questionnaire-based, action research with contribution of different professional stakeholders.

Setting and study population: PHCs involved in the program, GPs working in the field, specialists with high reputation from medical universities and other stakeholders

Interventions: (1) A questionnaire based on the original DL to categorize the medicines in the list, sent to 60 GPs from randomly selected PHCs, responses collected and analyzed; (2) a set of questionnaires based on 110 disease conditions, defined as the responsibilities of GPs, sent to specialists with high reputation asking to write a prescription for a given condition, responses collected, entered into a computer data base and analyzed; and (3) a panel of stakeholders who reviewed and discussed different reports and made expert decisions on the final outcome, the new DL

Outcome measure(s): (1) Drug categories in original DL, by definition: A (necessary), B (no difference) and C (unnecessary); (2) a disease-based DL; and (3) the final DL

Results: For the original DL results were A (241), B (78), C (71). The disease-based DL contained 363 items matched > 85% to (A+B) in original DL, and the final DL, which was constructed by merging the two DLs, contained 270 items including core and complementary lists and was approved by the expert panel. The new DL was presented in three seminars at the national level to the stakeholders and decision makers from MSIO and MOHME and was officially released as the new DL of the program.

Conclusions: We designed and provided evidence in our setting and developed an evidence-based drug list to achieve rational utilization of resources. Compliance to and regular monitoring and revision of the new DL will guarantee its success.

Funding source(s): MOHME


Prescribing Pattern of Physicians in Rural Health Insurance Program in Primary Health Care Facilities in Iran

Seyed Ali Reza Hosseini, Arash Tehrani Banihashemi, Shadan Darbooy

Ministry of Health and Medical Education, Iran, Islamic Republic of

Problem statement: Rational use of medicines has been one of the policy goals in rural health insurance program in Iran. To promote rational prescribing practice, a new drug list had been introduced and implemented in the program. At the same time, it became mandatory for the physicians to prescribe not more than 3 items in a prescription. Therefore, it was important to check for physician compliance to the new regulation and monitor the suitability of the new drug list in their everyday practice.

Objectives: To monitor prescribing patterns in the rural health insurance program by measuring drug use indicators and to get an oversight of compliance to the prescribing regulation introduced

Design: This is a cross-sectional study during the period 2005–06 in which prescriptions (Rx) were retrospectively collected and analyzed using a computer program developed for this purpose.

Setting and study population: 5,100 Rx from randomly selected primary health care facilities in 18 provinces were sampled. Data were manually punched into the computer program and analyzed, and the results were reported.

Outcome measure(s): Average number of drugs per Rx, percentage Rx with >4 drugs, percentage Rx with an injection, percentage Rx containing antibiotics, percentage Rx containing corticosteroids, percentage drugs prescribed from drug list, the most frequently prescribed and expensive medicines in Rx, and average cost of Rx

Results: The average number of drugs per Rx: 2.87; Rx with more than 4 drugs: 6.36%; Rx with injection: 38.6%; Rx with antibiotics: 47.6%; Rx containing corticosteroids: 21.5%; and drugs prescribed from the drug list: 96.6%. The most frequently prescribed medicines were: amoxicillin capsule, acetaminophen codeine tablet, and dexamethasone injection, in that order. The top 10 list of the highest frequency prescribed drugs accounted for 35% of the pharmaceutical expenditure, and the average cost of Rx was 11,875 Rials, one third of Rx cost at national level.

Conclusions: Prescribing patterns in rural health insurance program demonstrate that despite mandatory regulations and achievements, there is still room for promoting rational prescribing practice considering 35% consumption of the budget for 10 pharmaceutical items. In addition, although compliance to the new drug list accounts for more than 96% suggesting its suitability, more managerial interventions of an educational nature, including in service training for family physicians in the program, specifically on antibiotics and corticosteroids, are recommended to enhance rational use of medicines.

Funding source(s): Ministry of Health and Medical Education, Iran


The Evolution of Taiwan National Health Insurance Drug Policy—Review and Analysis

Chih-Sheng Hsu, Shan Jiang

Harvard Medical School, Harvard,University, USA

Problem statement: The rapid growth of medical costs is an issue faced by all countries, especially the growth of pharmaceutical costs. To lessen the increasingly heavy financial burden, the BNHI has implemented a series of drug policies, including Global Budget Payment System, Drug Payment System, Drug Reimbursement Rate Adjustment Policy, and Drug Copayment System.

Objectives: To systematically review Taiwan’s NHI system related drug policy development and evolution to analyze the implications, reasons, and benefits of the promotion of the four policies above, discuss the influence and impact that arise, following the policy implementations, and finally propose appropriate recommendations targeting Taiwan’s NHI drug policy

Design: A large number of history archives were collected. The qualitative analysis methods were adopted, including (1) a comparative method, (2) the historical research approach, and (3) the literature review method. Under the NHI system, the past and present of the drug policies were probed into and recommendations for the future were proposed.

Setting: The scope of this study focuses on the drug policies of Taiwan’s NHI system. This research was conducted at the national level.

Policies: The study covers a comprehensive review of Taiwan’s NHI in terms of changes in the four drug policies.

Results: (1) Taiwan’s Global Budget Payment System was implemented in phases. All Western medical institutions fully implemented it in July 2002. (2) Taiwan’s NHI Drug Payment System can be divided into four phases: before the national health insurance implementation, the internal audit price, the uniform price, and the benchmark drug prices. (3) Since April 1, 2000, the BNHI has implemented six drug price surveys, and the new drug reimbursement rate were announced and implemented. (4) The drug copayment displays significant effects on short-term drug price reduction, but the long-term effect is less significant.

Conclusions: Through analysis of the major drug policies, including the history, the problems faced in the pharmaceutical industry, the main issues related to the drug policies, the policy implementation motives and reasons, the decision model of the plan, the impact assessment, the drug economy, the performance and reasonability, and so on, a detailed discussion was conducted from the retrospective perspectives. In addition, the study gained an insight into the policy implementation effectiveness and impacts.


A Blended e-Learning Course—“Management of Medicines in International Health”—Contributes to Knowledge Transfer and Improving Medicines Use

Reinhard Huss1, Frans Stobbelaar2, Rob Summers3, Karin Anne Wiedenmayer4

1Nuffield Centre for International Health and Development, Leeds, United Kingdom; 2AGEG Consultants eG, Kirchheim unter Teck, Germany, on behalf of InWEnt – Capacity Building International, Germany; 3University of Limpopo, Medunsa Campus, Department of Pharmacy, Pretoria, South Africa; 4Swiss Tropical and Public Health Institute, Basel, Switzerland

Problem statement: Internationally, undergraduate training of health professionals in the management of medicines (MM) is often neglected. We therefore designed a supervised peer-to-peer, work-based, blended learning course, “Management of Medicines in International Health” (MMIH), with InWEnt using its learning platform Global Campus 21. MMIH consists of online modules, problem-based exercises, virtual group work, and chats. Participants learn about MM affecting medicine access and use and develop a project intervention during the contact course to improve MM in a specific context.

Objectives: To assess the course and its outcomes, including medicines use

Design: An outcome and impact evaluation with no control group using OECD DAC evaluation quality standards was developed.

Setting: The evaluation was conducted in 2009 as an international online survey of 67 participants from 18 countries and an outcome workshop in Tanzania with 18 participants from five countries, primarily in Africa and Asia. The respondents worked in the public, social, and private health sector.

Study population: The study population was 117 students from 27 countries from three MMIH courses between 2005 and 2008. All alumni were invited by e-mail to participate in an online survey with a 61% response rate. 63% were male; 94%, from Africa and Asia; 54%, pharmacists; and 26%, medical doctors.

Interventions: The evaluation included quantitative and qualitative data from an online questionnaire, semi-structured interviews of resource persons, an outcome workshop with 18 selected survey respondents, and analysis of projects presented by the respondents.

Outcome measure(s): Recorded changes in job situation; personal development in terms of knowledge, skills, and attitude; relevance and applicability of the course and specific components, sharing of knowledge and skills in the work environment, use of the Internet, and networking for professional development and projects to improve MM

Results: Two-thirds of respondents reported job changes, the majority of which were linked to the course. Almost 80% spent more time on MM than previously. 94% advocated MM to improve access. The topic of rational use was highly rated for relevance and applicability. More than half (53%) had initiated and 18% completed an MM project. Eleven of the 22 listed projects focused on improving medicines use.

Conclusions: The course responds to a need, and alumni feel empowered to work in MM. The course was more relevant for professional development and less for current work situations. Nevertheless, a number of projects were listed as being initiated, half of which addressed medicines use. The actual outcomes of these projects and the transfer of skills into practice still have to be measured. Course development needs to include promotion and dissemination skills and should widen the application perspective to work environments and country situations to improve its impact. Regional satellite courses can further strengthen the impact of the course.

Funding source(s): Federal Ministry for Economic Cooperation and Development (BMZ), Germany


Assessment of Drug Utilization Patterns in Some Health Insurance Outpatient Clinics in Alexandria

Samaa Zenhom Ibrahem

High Institute of Public Health, Egypt

Problem statement: The selection and rational use of medicines are accepted as key principles of health service quality and management in both the public and private sectors. Many researchers in developing countries, however, have described drug use as irrational, documenting cases of ineffective, unsuitable, suboptimal or unsafe prescribing, supply, and/or consumption of pharmaceutical products.

Objectives: To assess the pattern of drug use concerning prescribing, patient care, and facility standards in the selected outpatient clinics in Health Insurance Organization using World Health Organization (WHO) core indicators of drug use in health facilities

Design: A prospective cross-sectional study design was carried out.

Setting: The study was conducted in five randomly selected Health Insurance outpatient clinics in the Alexandria governorate.

Study population: A random sample of 30 encounters per each physician of all 62 general practitioners, internal medicine, and ENT specialists working in those clinics was carried out as recommended by WHO for studies describing current treatment practice, so the required sample of patients was 1,860.

Results: Results indicated that as regards prescribing indicators, the overall mean number of drugs prescribed per encounter was 2.8, the overall percentage of drugs prescribed by generic name was 61.0%, the overall percentage of prescriptions containing antibiotics was 52.2%, the percentage of encounters where an injection was prescribed was 20.6% overall. As regards health facility indicators, the essential drug list was found only in one clinic and the percentage of drugs prescribed from the list was 100.0% in that clinic. As regards patient care indicators, the overall average consultation time was 3.0 minutes, the mean time taken to dispense medications was 16.9 seconds, and the overall percentage of correct patient knowledge of dosage of prescribed drugs was 69.3%. Additionally in all clinics, the percentage of drugs adequately labeled was 0.0%.

Conclusions: It was concluded that continuous medical education of doctors at all levels of qualification on rational drug use should be instituted and treatment guides and training courses are recommended emphasizing the importance of adequate labeling and instructions to the patient.

Funding source(s): None


Caribbean Network on Pharmaceutical Education

Adriana Mitsue Ivama1, Eugenie Brown-Myrie2, Rian Extavour3, Sureshwar Panday4, Sandeep Maharaj4, Lesia Proverbs5, Evelyn Davis6, Bridget Hogg7, Janet Campbell-Shelly2, Rudolph Cummings8, Lydia Harris-Thurton9, Juana Castillo10, Emmanuel Cummings11

1Pan-American Health Organization/World Health Organization (PAHO/WHO), Office of Caribbean Programme Coordination (OCPC); 2University of Technology, Jamaica; 3Caribbean Association of Pharmacists, University of West Indies, Trinidad and Tobago; 4School of Pharmacy, University of West Indies, Trinidad and Tobago; 5Barbados Community College; 6T. A. Marryshow Community College; 7College of the Bahamas; 8Health Desk, CARICOM Secretariat; 9University of Belize; 10Escuela de FArmacia, Universidad Autonoma de Santo Domingo.; 11Faculty of Health Sciences, University of Guyana

Problem statement: In the Caribbean Community (CARICOM), health reform is on the agenda of many governments, with associated challenges of access and rational use of efficacious, quality, and safe medicines and health technologies. Another influence is the CARICOM Single Market and Economy (CSME), which includes free movement of labor, harmonization of social services, transfer of social security benefits, and establishment of common standards and measures for accreditation and equivalency. In this context, strengthening and harmonizing pharmacy education is a priority as part of the Caribbean Pharmaceutical Policy, supported by PAHO/WHO, CARICOM and the Caribbean Association of Pharmacists.

Objective: Establish the Caribbean Network on Pharmacy Education (CNPE)

Design: A descriptive study was conducted in December 2010 about the process of establishing the network from May 2009 until December 2010.

Setting: CARICOM countries and the Dominican Republic

Study population: 7 institutions with the Pharmacy Program in the Caribbean

Interventions: Identification of the existing pharmacy programs in the Caribbean (2008), 2 workshops (2009, 2010), several virtual meetings using “elluminate” ®, and a telephone survey with 11 interviews (2010)

Results: Six schools offering pharmacy programmes were identified in the English-speaking Caribbean and were invited for the workshop conducted in May 2009 with the technical advisory group of medicines of CARICOM. The background information and each program were presented. We identified 3 different degrees, namely, diploma and associate’s and bachelor’s degrees, with no difference in professional recognition or levels of responsibility. A decision for establishing the network was made, and each school nominated a focal point. Afterward, 2 schools were incorporated from the Dominican Republic and Belize. The survey’s findings with the main challenges and possible barriers for collaboration and harmonization were presented in the second workshop in October 2010. Based on the results, the proposal of network was validated with the mission to “promote strengthening and harmonization of pharmaceutical education and to contribute to strengthening of pharmaceutical policies and other initiatives for the achievement of the highest level of health in the Caribbean.” Working groups were established to address the identified priorities, namely, (1) develop a proposal for a harmonization, (2) study the requirements and standards for registration and the practice of pharmacists, and (3) develop a proposal for addressing pharmaceutical policy issues in the pharmacy curricula. A biennial work plan was prepared and its progress continued to be monitored with monthly virtual meetings, where results are reported and discussed.

Conclusions: The schools recognize their limited capacity and consider the network to be one alternative for improving pharmacy education both in the Caribbean and individually, with possibilities of sharing personnel and resources in the future.

Acknowledgement: The support of Prof. Dorothea Rudorf from Massachusetts University in collaboration with the WHO Collaborating Centre on Pharmaceutical Policies of Harvard University is acknowledged.

Funding sources: EU/ACP/WHO Project Partnership on Pharmaceutical Policies funded by the European Union


Pharmaceutical Situation in the Caribbean as Background for Policy Development

Adriana Mitsue Ivama1, Enrico Cinnella2, Edelise Carandang2, Nelly Marin3, James Fitzgerald3, Christophe Rerat4

1Pan-American Health Organization/World Health Organization (PAHO/WHO), Office of Caribbean Programme Coordination (OCPC); 2World Health Organization (WHO), Medicine Programme Coordination (MPC);; 3Pan American Health Organization/World Health Organization (PAHO/WHO), Medicines and Technologies; 4Pan American Health Organization/World Health Organization (PAHO/WHO), Brazil

Problem statement: Promoting access to safe affordable and efficacious medicines will certainly contribute to the implementation of the CARICOM single market and economy (CSME), the Port of Spain Declaration, the Caribbean Cooperation in Health Phase III, among other mandates. In the Caribbean, technical cooperation was provided from 2004 to 2010 in the framework of the EU/ACP/WHO Partnership on Pharmaceutical Policies.

Objective: Assess the pharmaceutical situation in the Caribbean

Design: A descriptive study, comparing results from the WHO level I survey in Caribbean countries in 2003 and 2007, was conducted in 2009. Analysis was done with Excel.

Setting: 12 CARICOM countries and the Dominican Republic.

Results: Progress was observed in all areas. The number of countries with a National Medicines Policy increased from 3 (27%) in 2003 to 7 (54%) in 2007, of which 2 were officially adopted in 2003 and 4 (57.1%) in 2007. In 2003, only 4 countries had legal provisions for a Medicines Regulatory Authority (MRA) and had a MRA established; in 2007, there were 11 (85%) countries. All the participating Caribbean countries mentioned having public sector procurement pooled at the national level. In 2003, the Ministry of Health performed the procurement function in all 7 countries that responded, and in 2007, in 12 countries (92%). The distribution function was performed by the Ministry of Health in 5 countries (100%) in 2003 and in 7 countries (88%) in 2007. The median public expenditure per capita/year was higher in the participating Caribbean countries (USD 20.9) than the median of whole region of the Americas (USD 11.5). In 2003, TRIPS flexibilities were under discussion. In 2007, only a few countries had implemented them. The availability and utilization of essential medicines lists (EML) and standard treatment guidelines (STG) increased between 2003 and 2007. On the other hand, not much progress has been achieved as regards the introduction of concepts related to RMU in the curricula of health in the Caribbean.

Conclusions: Special attention must be paid to implementation with monitoring and evaluation of pharmaceutical policies. Gaps were identified on regulatory functions with needs to strengthen the institutional and technical capacity with the need of joint collaboration. The results suggest the need to strengthen the medicines procurement and supply system thereby ensuring its sustainability and cost containment. It is necessary to strengthen the use of TRIPS flexibilities by member states. It would be useful to strengthen the development of human resources in the different areas. Taking into account limitations of the survey and the need of more specific information in some areas, the findings contribute to identify strengths and gaps that, combined with other subregional surveys, were used as evidence to support decision making informing the development of a Caribbean Pharmaceutical Policy.

Funding source: EU/ACP/WHO Project Partnership on Pharmaceutical Policies funded by the European Union


Partnership on Pharmaceutical Policies in the Caribbean: 2006-2009

Adriana Mitsue Ivama1, Gilles Forte2, Enrico Cinnella2, James Fitzgerald3, Nelly Marin3, Jose Luis Castro3, Nora Giron3, Jose Maria Parisi3, Malek Sbih3, Jaume Vidal3, Bernadette Theodore Gandi4, Dalia Castillo5

1Pan American Health Organization/World Health Organization (PAHO/WHO), Office of Caribbean Programme Coordination (CPC); 2World Health Organization (WHO), Medicine Programme Coordination (MPC); 3Pan American Health Organization/World Health Organization (PAHO/WHO), Medicines and Technologies; 4Pan American Health Organization/World Health Organization (PAHO/WHO), Representative Trinidad and Tobago; 5Pan American Health Organization/World Health Organization (PAHO/WHO), Dominican Republic

Problem Statement: WHO and the European Union signed an agreement in 2004 for the EC/ACP/WHO Partnership on Pharmaceutical Policies, whose purpose was to enhance accessibility, quality, and use of essential medicines and other key pharmaceuticals in African, Caribbean, and Pacific Island countries. In the Caribbean, the project was shaped by the mandates from PAHO/WHO as well as by sub-regional mandates and country priorities.

Objective: Assess the Partnership on Pharmaceutical Policies in the Caribbean from October 2006 to September 2009

Design: The basis for the assessment was the project framework inclusive of objectives and indicators for years 3−5. Quantitative information on targets met, activities carried out, and financial expenditures as well qualitative data was collected through interviews with stakeholders.

Setting: The project involved all CARICOM countries and Dominican Republic.

Study population: The CARICOM countries involved in the project are mostly small-island states with medium- to high-income level. Because of their size, they are less likely than other countries in the Americas to have key structures for the pharmaceutical sector.

Results: The expenditure in the Caribbean during years 3−5 was USD 1,215,203. The execution increased from USD 227,239 in year 3 to USD 651,787 in year 5. Half of the activities were implemented at the sub-regional level and the other half was related to country support. Most activities in the Caribbean were concentrated within 3 areas of the project framework, namely, pharmaceutical policies (27.5% of expenditure), rational use by health professionals and control of antimicrobial resistance (25.8%), and medicines regulation (22.6%). The key results of the project allowed concluding that the project met its targets. Both stakeholders and partners in Caribbean countries agreed with this conclusion. When interviewed, they considered that the project contributed to strengthen the technical capacity in the pharmaceutical sector in the Caribbean. The main contribution was the increase in the use of evidence for policy development and decision making at both sub-regional and national levels. Evidence also had an important role as the basis for the development of the Caribbean Pharmaceutical Policy.

Conclusions: Despite of the progress observed, there is still a lot of work to be done. The main strategies proposed to face the identified challenges are (1) to increase the profile of pharmaceutical policies and essential medicines to decision makers, (2) to support the strengthening of networking/collaboration, and (3) to provide country support in strategic areas, with an interprogrammatic and intersectoral approach.

Funding source: The EU/ACP/WHO Project Partnership on Pharmaceutical Policies was funded by the European Union.


Proposal for a Baseline Assessment for the Caribbean Pharmaceutical Policy

Adriana Mitsue Ivama1, Nelly Marin2, Vera Lucia Luiza3, Catherine Vialle-Valentin4, Maryam Hinds5, Princess Thomas-Osborne6, Miriam Naarendorp7, John Hasrat7, Enrico Cinnella8

1Pan-American Health Organization/World Health Organization (PAHO/WHO), Office of Caribbean Programme Coordination (OCPC); 2Pan American Health Organization/World Health Organization (PAHO/WHO), Medicines and Technologies; 3Nucleo de Assistencia Farmaceutica/National School of Public Health/Fiocruz, Brazil; 4Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.; 5Ministry of Health Barbados; 6Ministry of Health Jamaica; 7Ministry of Health Suriname; 8World Health Organization (WHO), Medicine Programme Coordination (MPC)

Problem Statement: The Caribbean Cooperation in Health, Phase 3, is the health agenda adopted by the Caribbean Community Ministries of Health in 2009. One of the areas for collaboration on Health Systems Strengthening is “Design and implementation of a Caribbean Pharmaceutical Policy (CPP) and mechanisms to enhance access, quality, and rational use of medicines.” The challenge is to develop mechanisms for monitoring implementation of the policy. It is proposed to use the WHO indicators for the pharmaceutical situation, including the WHO Level II surveys on access and rational medicine use (RMU) at health facilities and households.

Objective: The objective of this work is to propose a baseline assessment for the CPP based on the two to three selected indicators for each priority area based in the WHO Level II survey.

Design: This is a descriptive study. The WHO questionnaires on pharmaceutical outcomes at health facilities and households were adapted to the small island states and administered. Data was analysed using EpiData and Excel.

Setting: The study was conducted in 3 countries that were randomly tagged A, B, and C (Jamaica, Suriname, and Barbados). In each country, access, quality and RMU were assessed within the public and private health sector and in households.

Study Population: The three countries are middle income countries. The populations of Barbados and Suriname are below one million while Jamaica has 2.7 million inhabitants. On average, 27 public and private facilities were visited, 803 outpatients, and 694 households were interviewed per country.

Outcome Measures: For most selected indicators, results are presented by country as % of total facilities or households surveyed.

Results: For access to medicines, availability of essential medicines in both public and private pharmacies was good and varied from 93% to 100%. The average cost varied considerably for a prescription for an acute illness, from 4.00 US dollars (USD) in A to USD 33.00 in B. For medicine quality, no expired medicines were found and a good number of pharmacists were present in dispensing facilities in all countries. Adequacy of storage conditions was lowest in country A.

Rational use—The use of non-proprietary name for prescriptions in public facilities varied from 36% in country C to 45.5% in country A. The percentage of persons with a chronic disease that were told to take medicines and took them as recommended varied from 68% in B to 78% in A. With regards to adequate labeling of medicines at home, this varied between 62% of all medicines in country A to 82% in country C.

Conclusions: The CPP will provide the framework for strengthening the pharmaceutical sector both at subregional and national levels, continuing the work initiated within the current partnership. The indicators presented will certainly contribute to follow up and to assess progress.

Funding source: EU/ACP/WHO Project Partnership on Pharmaceutical Policies funded by European Union


Development of the Caribbean Pharmaceutical Policy

Adriana Mitsue Ivama1, Miriam Naarendorp2, Princess Thomas-Osborne3, Maryam Hinds4, Lucette Cargill5, Richard Aching6, Francis Burnett7, Rudolph Cummings8, Malcom Spence9, Rhonda Wilson10, Nelly Marin11, James Fitzgerald11

1Pan-American Health Organization/World Health Organization (PAHO/WHO), Office of Caribbean Programme Coordination (OCPC); 2Ministry of Health of Suriname; 3Ministry of Health of Jamaica; 4Barbados Drug Service, Ministry of Health of Barbados; 5Caribbean Regional Drug Testing Laboratory (CRDTL); 6Intellectual Property Office/ Ministry of Legal Affairs of Trinidad and Tobago; 7Organization of Eastern Caribbean States/Pharmaceutical Procurement Service (OECS/PPS); 8Health Desk, CARICOM Secretariat; 9Office of Trade Negotiations, CARICOM Secretariat; 10External Economic and Trade Relations, CARICOM Secretariat; 11Pan American Health Organization/World Health Organization (PAHO/WHO), Medicines and Technologies

Problem statement: Ministers of Health (MOH) of Caribbean Community (CARICOM) in April 2003 established a technical advisory group (TAG) to improve access to quality, safe, and cost-effective essential medicines and to promote rational use.

Objective: To describe the development of the Caribbean Pharmaceutical Policy (CPP)

Design: Descriptive study of the policy development

Setting: CARICOM countries and Dominican Republic

Study population: Policy includes CARICOM countries

Intervention: TAG commissioned 2 studies in 2009, namely, a regional assessment of drug regulatory and registration systems and a regional assessment on patent and related issues and access to medicines in the CARICOM and Dominican Republic. PAHO/WHO published the Pharmaceutical Situation in the Caribbean Countries from the WHO level I survey. Based on findings of the 3 publications, the CPP was developed.

Results: The results were discussed by TAG members and based on that, a policy paper was presented to the 18th meeting of CARICOM chief medical officers, who endorsed it. A draft CPP was prepared and discussed in a stakeholders’ workshop in July 2010. After amendments, it was circulated to countries and presented to the 19th caucus of CARICOM of MOH in September 2010. The CPP goal is, “to guide Caribbean countries to ensure: access, quality and rational use”. It is guided by the main principle of access to medicines as a Human Right, the values and principles of Public Health and the renewed Primary Health Care strategy. The seven objectives are organized under four strategic areas, namely: Pharmaceutical Policy Scope; Regulatory Framework; Access; and Rational Use of Medicines.

Mechanisms for implementation: An implementation plan is under development with indicators for monitoring and evaluation. It is proposed as an oversight mechanism with the Expanded Technical Advisory Group on Pharmaceutical Policy (TECHPHARM), with shared responsibilities with the national authorities and regional institutions, CARICOM Secretariat, and PAHO/WHO.

Conclusions: The CPP was developed using the existing evidence and it represents the necessary framework for collaborative action and includes the development of several networks and regional platforms of work that are already under development. Considering that most of the Caribbean countries are small islands development states and there are several constraints for development of the activities on their own, there is a willingness to collaborate expressed both at the technical and political levels that can facilitate CPP implementation.

Funding source: The activity was part of the EU/ACP/WHO Project Partnership on Pharmaceutical Policies funded by the European Union.


Drugs Identification and Interaction Checker to reduce Tuberculosis (TB) Drug Compliance and Improve Treatment Adherence

Antonio J. Jara1, Madeleine de Rosas-Valera2, Mona Alsaedy3, Miguel Zamora1, Antonio G. Skarmeta1

1University of Murcia, Spain; 2World Health Organization, Western Pacific Region; 3Kingston University London, UK

Tuberculosis treatment is a combinational therapy of antibiotic over a period of six months, subject to the clinician's discretions and diagnosis. Unsuccessful treatment may have various reasons including compliance. Poor compliance is due to prolonged treatment time and side effects such as nausea, itching and rashes. WHO DOT's (Directly Observed Therapy) recommendations are applicable for recommended candidates. It is a form of a medical treatment supervision that has shown to successfully enhanced patients compliance and treatment efficacy. However, this service is quite limited and inaccessible in the third world due to the high cost and the intensive human resources required for such supervised treatment.

This solution aims is to develop a new technology to increase the drugs compliance electronically. For this purpose, a novel “hand-held” personal device has been developed to assist the patient through different ways including; an inbuilt alarming system to remind the patient of the next dose, inform about encountered adverse drug reactions and side-effects, confirming that the right drug has been taken, and finally a warning system in case of consumption of additional pills.

A previous solution was defined, SMS Pill (Short Message Service reminders for treatment), but it is not feasible for third world due to cost limitations of the required GSM infrastructure. We have defined a solution based on Infrared communications (IrDA). This presents a low cost communication channel based on light, which is suitable for the requirements of the solution, more feasible and cheaper than other solutions. This presents additional functionality to SMS Pill by embedding intelligent system to detect common adverse drugs reactions.

Design issues have been focused on reach a low cost solution and with a high battery autonomy, since in some places is not easily accessible a electrical grid infrastructure. The cost solution reached is around 20$ (200-800$ the other found solutions), and the battery lifetime of the device has been optimized to 12 years.

The study population will be patients from Philippines, it has not been defined yet any trial out of our labs, but we are pending to carry it out with the support from WHO Western Pacific and Department of Health (DOH) Philippines. We hope get a similar results to SMS Pill, which presented that treatment adherence among 155 tuberculosis patients was 86-92% with a treatment success rate of 94% in a trial at three clinics in Cape Town that, after 10 months.

As a conclusion TB is a disease that requires new solutions and strategies to supervise the treatment, increase its efficacy, compliance and reduce costs. For that reason, it has been defined a flexible, low cost and preventive solution assisting patients during their treatment and allowing a more specific supervision for the healthcare professionals.

Funding sources: Foundation Séneca, Spanish Ministry for Industry, Tourism and infrastructure, and University of Murcia.


The rational use and access to medicines by the citizens: The Greek experience

Eleni Jelastopulu1, Pania Karnaki2, Mamas Theodorou3, Aris Sissouras2

1Department of Public Health, School of Medicine, University of Patras, Greece; 2Department of Operational Research and Health Management, University of Patras, Greece; 3Health Management Programme, Open University of Cyprus, Cyprus

Problem Statement:

Usually the use of medication is seen through a providers’ perspective and less from the perspective of consumers and users. Often, patients exhibit behaviors, which do not conform to prescribed guidelines, leading thus to a low level of compliance.


The aim of this study was to investigate the use and access to medicines in a representative population sample and to evaluate the rational use of drugs. Furthermore, we studied the effect of various factors, such as socio-demographical and insurance coverage, on drug compliance.


The investigation was in the context of a cross-sectional descriptive study (household survey) relating to a wider study on the use of health services by the citizens of a community.

Setting and study population:

The study was conducted at the local level, involving a random sample of near 2000 citizens in Patras, a major city in Western Greece, where opportunities and access to health care services are high and of good quality (medical school, university hospital, highly qualified medical personnel).

Outcome Measures:

Measurements referred to the use of drugs in the last three months according to gender, age, insurance fund, drug category, prescription by public or private physician and the tendency of patients to provide themselves with medicines without prescription, a usual phenomenon in Greece.


More than 66% had used medication in the past three months, while women showed significantly higher use than men (75% vs 55%, p<0.05). Medication use was higher as age increased and reached more than 80% in the age groups >55 years old (p<0.05). The main drug categories used were pain killers (61%), followed by medication for various heart conditions (29%). Nearly 75% obtained their medication through a doctor’s prescription, while 22% did not have a prescription. Except for painkillers, substantial number of antibiotics was consumed which were obtained without a prescription. Respondents without a doctor’s prescription followed their own advice for purchasing medication (52%) or the advice of their pharmacist (31%). Information regarding correct use of medicines was provided in 85%, counter effects in 31% and side effects in 30% of cases, respectively. About 11% did interrupt their medication as they experienced health problems. Adherence to medication instructions reached 80%, while women were more compliant than men as were older people compared to younger age groups, respectively (p<0.05). Nearly half of the people who used medication reported they kept left over medicine in their houses. Approximately, 65% of medication costs were partially covered by social funds, while 27% where out of pocket expenses.


We observed high use of medication in the last three months. With the exception of prescribed drugs a significant percentage of people purchased prescription medication without consulting their doctor. Information campaigns are needed to educate citizens about rational use of medication and stricter measures need to be taken in order to make it less easy to obtain prescription medication without a doctor’s prescription. This is particularly important in the case of antibiotics the use of which is high in Greece.


Attitudes, Beliefs, and Prescription Habits of Greek Physicians Regarding Generic Drugs

Eleni Jelastopulu1, Georgios Mantzouranis1,2, Christina Androutsopoulou1, Ioannis Lentzas3, Dimitris Lianas4, Charalambia Sampazioti5, Zoi Kontou2, Zafiro Tsantoula6, Georgios Tsiros1,7

1University of Patras, School of Medicine, Greece; 2Rural Medical Dispensary of Evinochori, Health Center of Aitoliko, Greece; 3Rural Medical Dispensary of Andravida, Health Center of Gastouni, Greece; 4Health Center of Erymanthia, Greece; 5Rural Medical Dispensary of Kalanos, Health Center of Chalandritsa, Greece; 6Department of Radiology, Patras University Hospital, Greece; 7Rural Medical Dispensary of Chavari, Health Center of Gastouni, Greece

Problem statement: During the last decade, a remarkable entry of generic drugs to the market of prescription medicines has been observed in many countries of the world. However, Greece’s highly developed pharmaceutical market is characterized by low penetration of generic drugs.

Objectives: Investigate the attitudes, beliefs, and prescription habits of Greek physicians toward generic drugs.

Design: Questionnaire-based, cross-sectional descriptive study

Setting: The study was conducted at the regional level, including several prefectures of Greece. It was based in primary care facilities, such as rural health centers and medical dispensaries as well as in urban health care facilities, both primary and hospital care. Both public and private sectors were examined.

Study population: A questionnaire of 25 questions was distributed to 210 randomly selected physicians of all specialties working in various health care facilities in several regions.

Outcome measures: Measurements referred to the prescription habits of Greek physicians regarding generics according to gender, age, specialty, health care facility, and work place. Furthermore, knowledge and beliefs related to safety, effectiveness, side effects, and bioequivalence were recorded as well as the impact of their scientific prestige when prescribing generics.

Results: Out of 185 physicians, 41.6% were specialized and 58.4% were doctors-in-training. The majority (47%) was working in university hospitals, 25% in district hospitals, 18% in public primary care facilities, and 10% in the private sector. Of the doctors, 23% declared that they never prescribed generic drugs, whereas 55% reported the percentage of generics prescribed was < 10% of their total prescriptions. Mainly women prescribe generics less frequently (48% vs. 64%, p = 0.006). General practitioners are more likely to prescribe generics than other specialties (60% vs. 38%, p = 0.004). Of the doctors, 44% consider generics to be of the same effectiveness and safety as brand name drugs.However, a significant difference between specialized and physicians-in-training is observed regarding the effectiveness and the safety (p < 0.05). More side effects of generics are observed by GPs in comparison to other specialties (47% vs. 28%, p < 0.05). More than 50% consider the prescription of generics as having a negative effect on their scientific prestige, mainly doctor-in-training compared with the specialists (64% vs. 40%).

Conclusions: A high percentage of Greek physicians do not prescribe and hold negative views of generics. They believe that generics are less effective and safe. Information about the safety and effectiveness of generic drugs may be particularly important information to convey to physicians to encourage them in prescribing generic drugs.

Funding sources: None


Provincial Essential Medicine List Comparison among 12 Provinces in China

Bin Jiang1,2,3, Anita Wagner3, Dennis Ross-Degnan3, Luwen Shi1,2

1Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, No. 38, Rd. Xueyuan, District Haidian, Beijing, 100191, P.R. China; 2International Research Center for Medicinal Administration, Peking University, No. 38, Rd. Xueyuan, District Haidian, Beijing, 100191, P.R. China; 3Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 133 Brookline Avenue, Boston, MA 02215, USA

Background: China introduced the concept of essential medicine in 1979 and issued its first National Essential Medicine List in 1982. But an integrated and systematic national essential drug policy hasn't been established until the issuance of _"the CPC Central Committee and State Council on Deepening the views of the medical and health system" (new healthcare reform for short) _in April 2009. In the current new healthcare reform, the Chinese government emphasized to set up a national essential medicine system and listed it as one of the five top priorities of the reform in the coming years. On August 17,2009, Chinese Ministry of Health (MOH) released the National Essential Medicine List (NEML) for the primary care institutions (PCI).Till the end of September,2009, totally 12 provinces in China have announced the related provincial essential medicine list(PEML). A scientific EML is the basis for access and rational use of quality essential medicines. Therefore the article analyzed and compared the available 12 PEMLs, aiming to prepare a foundation for the selection and modification of EMLs in future.

Result:(1) Provincial location: among the 12 provinces with PEMLs, 7 are located in the east China, 2 in the middle and 3 in the west.(2) Economy status: The 7 eastern provinces are among Top 10 in GDP ranking in China, the 2 middle provinces are famous for pioneers in new healthcare reform, the 3 western provinces rank at the bottom of GDP and can enjoy special financial support from central government.(3) Amount: the amount of essential medicines in PEMLs is quite different, ranging from 31 to 305. The average amount of essential medicines in eastern PEMLs is 214 (among which there are 128 western medicines and 86 traditional Chinese essential medicines), in middle pioneer is 212(among which there are 166 western medicines and 46 traditional Chinese essential medicines), and in western is 57(among which there are 25 western medicines and 32 traditional Chinese essential medicines).(4) Category: in the 12 PEMLs, there are totally 1025 medicines, among which 533 (52%) are western medicines and 492 TCMs (48%). TCM enjoys a larger proportion in PEMLs compared with NEMLs. Seventy-one percent of the medicines in PMELs belongs to Reimbursement Medicine List (RML), with 24% going to type A and 47% to type B

Conclusion: (1) More developed provinces or provinces with financial support are more likely to implement NEMP. (2) In PEMLs, there’re more local medicines for the sake of local medication habit, disease pattern and the development of local pharmaceutical industry. (3)except for EML, supporting policies such as education for medical professionals and patients, pricing, reimbursement, etc., are both urgent and important in order to achieve the goal of access to and rational use of quality essential medicines.

Indicator-Based Survey Tool to Determine the Use of Antimicrobials and Knowledge about Drug Resistance in the Community

Mohan P. Joshi1, Ani Hyslop2, Luis Ochoa2, Adrienne Cox2, Niranjan Konduri1, Nchimunya Nkombo3, Oliver Hazemba4

1Strengthening Pharmaceutical Systems (SPS) Program, Management Sciences for Health (MSH), Arlington, VA, USA; 2ICF Macro, Calverton, MD, USA (LO is a former employee); 3Central Statistical Office, Lusaka, Zambia; 4MSH/SPS, Lusaka, Zambia

Problem statement: Designing and evaluating effective consumer-focused, drug- resistance interventions requires quantifying the community’s awareness of drug resistance and knowledge and use of antimicrobials. However, survey tools that can help make such quantifications possible and are suitable for resource-constrained settings do not exist.

Objective: The field test’s objective was to validate an antimicrobial resistance (AMR) survey tool to quantify drug-resistance knowledge and antimicrobial use in the community.

Setting and population: The module was field-tested in Zambia in a convenience sample of 242 urban and rural households.

Interventions: Initially, we designed a questionnaire module to incorporate into a population-based survey and obtained AMR expert review. To validate the draft questionnaire module, we field-tested it in collaboration with the Central Statistical Office (CSO) of Zambia; nurses, pharmacists, and CSO survey and senior research staff acted as interviewers. The English AMR module was translated into three local languages—Nyanja, Bemba, and Tonga. The accuracy of the local translation and the adaptation of the questions were verified through a mini-test in 20 households in Lusaka. The field test was conducted in urban and rural areas of Lusaka. We held a structured feedback session with the interviewers to elicit their observations and experiences in implementing each component of the questionnaire. Based on the field-test experience, we finalized the module.

Outcome measures: Validated AMR module for population-based surveys available for global use

Results: The field test allowed validation, revision, and finalization of the module and the data collectors’ guide. The AMR tool consists of a module description (including the indicators), tabulation plan, questionnaire module, data collectors’ guide, and pretest of the module in Zambia. The questionnaire has a total of 24 questions and takes about 15 minutes to administer. The questionnaire items provide quantitative information on 10 indicators pertaining to antimicrobial medicine knowledge and use; AMR knowledge; and current use of medicines. The finalized AMR module is now available for country-level use on the Demographic and Health Survey website (http://www.measuredhs.com/aboutsurveys/dhs/docs/AMR_Mod_8_5_8_FINAL.pdf).

Conclusions: The AMR module fills the need for a population-based survey tool suitable for use in resource-constrained countries. Surveys using the module will generate household-level knowledge and behavior information, which can support advocacy, policy establishment, intervention development, and evaluation of AMR containment efforts among the general community.

Funding sources: MSH/Rational Pharmaceutical Management Plus and SPS through US Agency for International Development


The Effect of Community-Based Support Services on Clinical Efficacy and Health-Related Quality of Life in HIV/AIDS Patients in Resource-Limited Settings in Sub-Saharan Africa

Inoussa Kabore, Gina Etheredge

FHI, United States of America

Problem: Data on the efficacy of ART in developing countries are limited. The paper reports an investigation of the delivery of medical care combined with community-based supportive services for patients with HIV/AIDS in four resource-limited settings in sub-Saharan Africa, carried out between 2005 and 2007.

Objectives: To document changes over time in patients’ clinical outcome as measured by CD4 cell count, health-related quality of life (HRQOL), and adherence to ART and to correlate these changes with exposure to community support programs.

Design: The clinical and HRQOL efficacy of ART combined with community support services was studied in a cohort of 377 HIV-infected patients followed for 18 months, in community-based clinics through patient interviews, clinical evaluations, and questionnaires.

Setting: Four treatment sites in Maseru, Lesotho; Ladysmith, Kwa Zulu Natal, South Africa; Katima-Mulilo, Namibia; and Bobonong, Botswana.

Study Population: Consented HIV-infected adult patients who initiated ART beginning August 2005 at selected sites participated in an Enhanced Patients Evaluation observational cohort study; and followed-up for 18 months.

Intervention: The intervention consisted of community-based support services including community mobilization, prevention education and outreach, counseling and testing, home-based health care, tracing of defaulting patients, support groups, positive-living workshops, food security, nutritional support, financial and income generating support, and buddy services

Policy: The article was recently published (September 2010) in The Journal of AIDS Patient Care and STDs. The findings contributed to scaled-up of interventions with government ownership.

Outcome Measures: Changes over time in patients’ clinical outcome as measured by CD4 cell count, HRQOL, and adherence to ART and correlation of changes with exposure to community support programs.

Results: Patients exposed to community-based supportive services experienced a more rapid and greater overall increase in CD4 cell counts at 18 months than unexposed patients (increase of 51 cells/mm3 greater for exposed versus unexposed, p=0.016). They also had higher levels of adherence attributed primarily to exposure to home-based care services (80% in the exposed group with 90% or higher adherence versus 65.8% in the unexposed, p=0.049), as measured by multiple regression analysis, Patients receiving home-based care and/or food support services showed greater improvements in selected health-related QOL indicators and notably in overall HQOL (57.3% for the exposed versus 56.0% for the unexposed, p=0.010).

Conclusions: HBC and other community services, including food support, have a positive effect on HIV patients’ overall health, QOL, treatment adherence, and clinical outcomes. The association is still strong even when age, education, gender, and baseline CD4 counts are taken into account. A potential limitation includes a relatively high rate of lost to follow-up (LTFU). However, LTFU was taken into account in the design at the level of 20%, which does not significantly affect the magnitude of changes and the level of power desired for the analysis

Funding Source(s): Bristol Myers Squibb


Implementation of a Policy for Monitoring Prescribing Practices in Public Health Care Outlets in Nepal

Kumud Kumar Kafle1, Naveen Shrestha1, Shib Bahadur Karkee1, Gajendra Bahadur Bhuju1, Radha Raman Prasad1, Prabhakar Lal Das1, Bhuwaneshwori Datta Chataut1, Parasuram Shrestha2, Achyut Lamichhane2, Jivan Kumar Malla2

1INRUD Nepal, Nepal; 2Department of Health Services, Nepal

Problem statement: To improve the quality of health care in Nepal, periodic supervision of health facilities by district supervisors (i.e., the top-down approach) has been in practice. The implementation has not been found effective, however, because of the time required of district health officials, financial constraints, and the terrain of the country. A bottom-up approach consisting of self-monitoring and peer-group discussions was tested and piloted in some districts (2004), and the Ministry of Health and Population (MOHP) decided to incorporate the strategy into its Three-Year Plan (2007–10). The aim of this presentation is to describe the processes and the success of the implementation.

Objective: To improve the quality of care by monitoring prescribing practices and the availability of essential free drugs at PHC outlets in the country

Setting: All PHC outlets of 75 districts of Nepal

Study population: Paramedical health workers of all sub-health posts, health posts, primary health care centers (PHCs), and district hospitals; medical doctors of PHCs and district hospitals; and supervisors including district public health officers of all districts

Policy and intervention: MOHP approved a training curriculum, developed and published training manuals, conducted training of trainers (TOT) and district level trainings in districts, and distributed carbon-copy prescriptions for self-monitoring. Health workers participated with self-monitoring results in bimonthly peer-group discussion meetings organized at each district health office and discussed the results among the prescribers in the presence of a district health officer, who gave feedback on the results and instruction on the use of treatment protocols.

Results: The government allocated the budget for fiscal year 2009/10 to implement the strategy in all 4,085 PHC outlets including the district hospitals of all districts and assigned the responsibility of the implementation to the Management Division. In the same year, 281 persons from different health care levels received the TOT training. Besides the TOT, district-level trainings were also organized for all prescribers of the PHC outlets. Although, self-monitoring and peer group discussions were planned for all districts, during the fiscal year only one district could implement the district-level peer-group discussion. The remaining districts could not implement the strategy because of budgetary limitations. Both activities were monitored from the central and district level. In 2010–11, because of financial constraints, the government could allocate the budget for only 10 districts to implement the strategy, but the MOHP budget could not be released until the last quarter of the fiscal year. Immediately after release of budget, eight districts completed only 1 or 2 self-monitoring activities or peer-group discussions. The government also shifted the implementation responsibility to a newly established PHC Revitalization Division. The government has allocated the budget also for the current fiscal year (2011/12).

Conclusion: The activities could not be fully implemented as planned. Those districts that did implement it, however, followed the major processes and aspects of the strategy effectively. The government is committed to implementing the strategy, but the financial constraint is the limiting factor. The process of an evidence-based strategy, if implemented by the government, can be successfully adopted.

Funding source(s): Regular budget of Ministry of Health and Population, Nepal



Nahla Kandil, Ghada Abu Sheasha, Abd El Naser Khalef, Ibrahim Labouta

Andalusia group for medical services, Egypt

Problem Statement: Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drug in the world because they combine a high level of efficacy with low toxicity. Yet studies consistently show that proton pump inhibitors are being overprescribed worldwide in both primary and secondary care. Emergency department physicians generally prefer prescribing PPIs over H2-blockers to relieve acute pain of patients with gastritis with no evidence of gastrointestinal bleeding, although H2-blockers is considered a more suitable alternative for its quick onset of action according to its pharmacological and therapeutic properties.

Objectives: The purpose of the current study is to decrease the over-use of PPIs in Emergency Department (ED) and to encourage the usage of H2-blockers instead, to relieve acute pain of patients admitted to ED with gastritis with no evidence of gastrointestinal bleeding

Design: The current study is an intervention pretest-posttest study (without control group).

Setting: The study was conducted at the Emergency Department of Al Salama Hospital, Andalusia Group for Medical Services.

Study Population: All patients admitted to the ED complaining of gastritis during 1 month pre and post-intervention.

Intervention: An educative email was sent by the clinical pharmacy department concerning the pharmacological and therapeutic differences between PPIs and H2-blockers based on the fact that “PPIs are prodrugs and require an acidic environment for conversion to the active sulfonamide. This conversion requires an actively secreting proton pump.” It was made clear that H2-blockers are considered more suitable for relieve of acute pain for patients with gastritis. The email was followed by personal contact to assure that the message was reached.

Outcome Measure(s): The primary study outcome measurement is the consumption rates of PPIs and H2-blockers prescribed for patients admitted to ED complaining of gastritis before and after the intervention was made.

Results: In the pre-intervention phase, 28% of drugs prescribed for gastritis among patients admitted to the ED were of PPIs. After the intervention, this rate was significantly reduced to 12%. (Χ_1^2= 39.715, p<.0001).

Conclusions: Clinical pharmacists can influence the attitudes and priorities of prescribers in their choice of correct treatments. This is demonstrated in this study as significant decrease in the use of PPIs, and thus reflected on a reduction of expenditure and a reduction in medication errors.



Nahla Kandil, Maurice Hall, Ibrahim Labouta

Andalusia Group, Al-Salama Hospital

Problem Statement :

Nursing school curricula and hospital continuing education programmes lack sufficient information on the knowledge needed for safe administration of medication by nurses.

Objectives :

  • To assess critical care nurses' baseline medication knowledge, practice and skills and their learning needs regarding medication administration
  • To determine the effectiveness of continuous in-service education as a strategy for building awareness.

Design :

The study consisted of descriptive and interventional parts. The descriptive part included a cross-sectional study employing both quantitative and qualitative methods of data collection, using survey questionnaire and observation respectively. The interventional part consisted of 7 in-service training modules with pre- and post-intervention assessment using the same preliminary questionnaire.

Setting :

The study was conducted in the Critical Care Unit of Al-Salama Hospital, Alexandria; Egypt.

Study Population :

All critical care nurses were invited to participate in this study regardless their degree of education, age, grade or years of experience. Critical care nurses (n=47) participated in answering the pre-questionnaire, but only 27 nurses continued and answered the post-intervention questionnaire. A high dropout was observed (n=20) due to staff leaving the hospital during the 4 months of preparing and conducting the module, or due to other commitments.

Intervention :

The interventions phase consisted of 3 parts: development, conduction and evaluation of the continuous in-service training module.

Outcome Measure :

To compare the total and individual section scores of the questionnaire pre- and post-intervention.

Results :

Inadequate baseline total knowledge scores (54.3±11.7) of study nurses were obtained using the preliminary questionnaire. Nurses' grade (staff, registered, charge or head nurse) was the only factor with significant effect on baseline total knowledge score (P<0.05). Significant improvement of total knowledge scores post-intervention was found compared to pre-intervention using the same preliminary questionnaire (P<0.05). Increasing nurses' age and decreasing baseline total knowledge score were the only significant variables related to such improvement (P<0.05). Other variables, such as nurses' gender, years of total work experience and years of experience at Al-Salama Hospital were not found to influence performance.

Conclusions :

Critical care nurses have inadequate awareness of the pharmacological and pharmaceutical knowledge that is needed for safe administration of medication. Continuous in-service professional development programme resulted in significant improvement in total knowledge scores (P<0.05). The role of the clinical pharmacist in such educational activities is of paramount importance. There is a need for developing and implementing such programmes.


Outcomes of pharmaceutical care in schizophrenic patients

JUNTIP KANJANASILP, Chanuttha Ployleumsang

Mahasarakham university, Thailand

Problem Statement: Drug related problems of schizophrenic patients causes to increase the recurrent rate, the suicide rate and increase the cost of treatment. Pharmaceutical care is a process to identify, resolve, and prevent the drug related problems and improve the quality of life.

Objectives: The purpose of this experimental study was to examine the outcomes of pharmaceutical care in schizophrenic patients (clinical, humanistic, economic outcomes).

Design: Randomized controlled trial

Setting: 3 psychiatric hospitals in Northeast of Thailand

Study Population: The schizophrenic patients who visited the outpatient department of 3 psychiatric hospitals in Northeast of Thailand were recruited. Ninety-three patients were randomly assigned to receive pharmaceutical care (intervention group) and 95 patients received usual care (control group) both of them matching by the severity of disease and the right of treatment.

Intervention(s): Pharmaceutical care (obtaining medication history; Identifying, resolving and preventing for the patients’ DRPs; monitoring patients for desired and undesired outcomes) for 1 month

Policy(ies): Improvement for pharmaceutical services in the psychiatric hospital, especially for schizophrenic patients.

Outcome Measure(s): Clinical outcome(Drug related problems),humanistic outcomes( knowledge, quality of life, adherence), economic outcomes(cost)

Results: Number of drug related problems decreased in both groups (the intervention group decreased 107 DRPs (62.9%) and the control group decreased 15 DRPs (14.3%). The most DRPS was failure to receive drug in both groups. The mean knowledge score of schizophrenia and antipsychotics used statistical significantly increased in both groups (the intervention group 6.7 ± 1.68 to 8.2 ± 1.48 (p< 0.001); the control group (7.1 ± 1.73 to 7.6 ± 1.75 (p=0.010)). The mean score of quality of life was in the moderate level in both group, however, it tended to increase in the intervention group especially the physical domain and mental domain increase significantly(p<0.001). The average total costs in the pharmaceutical care group and usual care group were 16.19 and 14.03 USD/patient, respectively. The proportion of labour costs : material cost : capital cost for pharmaceutical care and usual care were 6.61: 92.96 : 0.43 and 5.05 : 94.92 : 0.03, respectively. The medication adherence and quality of life in the pharmaceutical care group had 97.8 % and 93.5% of successful patients, respectively, whereas the usual care group showed 87.4% and 93.7 %, respectively. Cost-effectiveness ratios (CER) of pharmaceutical care and usual care for good medication adherence was 16.54 and 16.06 USD/successful patient, respectively and CER for improved quality of life was 17.30 and 14.98 USD/successful patient, respectively. Incremental cost effectiveness ratio (ICER) of pharmaceutical care compared with usual care for improved adherence was 20.58 USD/successful patient.

Conclusions: In summary, the overall results of the study showed that pharmaceutical care can reduce the number of drug related problems, and increase knowledge of schizophrenia and antipsychotics used and quality of life especially in the physical and mental domain. However, 1-months of pharmaceutical care is not cost-effective, but if in the long time pharmaceutical care can increase the number of successful patients more than usual care by at least 20 cases, it will be cost-effective.

Funding Source(s): Mahasarakham university


Policies to Increase Use of Generic Medicines in Low- and Middle-Income Countries: A Literature Review of Implementation Research

Warren Kaplan1, Veronika Wirtz2, Lindsay Ritz1, Marie Vitello1

1Center for Global Health & Development, Boston University School of Public Health, United States of America; 2Instituto Nacional de Salud Publica, Cuernavaca Mexico

Problem statement: In large part due to the creation of the WHO Essential Medicines Concept, for several decades now many countries have been implementing pharmaceutical policies to encourage use of generic medicines. Monitoring and evaluating the implementation of such policies has taken place in the United States and the European Union, and there is a reasonably rich literature on this subject. It is not clear how much implementation research on the impact of pro-generic medicines policies has taken place in low- and middle-income countries (LMICs) and which policy options should been given priority in LMICs.

Objectives: To determine the extent of implementation research on pro-generic medicine policies in LMICs since 2000; to determine if the existing generic medicines policies in the United States and the European Union would be applicable in LMICs; and to suggest a minimum repertoire of pro-generic medicine policies suitable for all LMICs

Design: Literature review and bibliometric analysis looking at both supply side and demand side policies

Setting: High-income and LMICs as defined by the World Bank

Study population: Databases: PubMed, CINAHL, Popline, EMBASE, PAIS, ISI Web of Science, LILACS, and ScieLo (Latin America).

Intervention: Public policies introduced to promote the use of generic medicines

Outcome measure(s): Implementation research investigating the impact of pro-generic medicine policies on changes in price or volume share as a result of the policy change(s) (i.e., before-and-after study with or without control group, time-series analysis).

Results: (1) Out of a total of 439 relevant articles retrieved, 74 focused exclusively on LMIC and only 7 were implementation research. (2) Many policies in the United States and the European Union have been implemented via public health services or private insurance systems. (3) Medicines regulatory authorities play an important role to ensure quality of generic medicines and provide reliable information to all actors in the pharmaceutical sector.

Conclusions: There is very little implementation research on pro-generic medicine policies in LMICs, notwithstanding the fact that such policies have been in place in some countries for many years. Results of policy impact evaluation to promote generic medicines in LMIC would allow providing more support for LMIC in search for ways to effectively implement these policies. Given the general lack of insurance systems and prescriber, dispenser, and consumer education about generic medicines in many LMICs, not all US and EU policies would be successful there. Basic conditions for successful pro-generic policies in LMICs include (1) a medicines regulatory system that people trust, (2) sufficient in-country competition among generic manufacturers, and (3) alignment of financial incentives of prescribers or dispensers and consumers with regard to generics.

Funding source(s): World Health Organization and Health Action International


Exploring the Development, Design, and Implementation of a Pharmacotherapy Knowledge Center – A Qualitative Study

Therese Kardakis1, Göran Tomson1, Björn Wettermark2, Pia Bastholm Rahmner2

1Karolinska institute, Sweden; 2Stockholm County Council

Problem statement: Problems of irrational prescribing and use of drugs are associated with morbidity, mortality, medicalization, adverse drug reactions, increasing drug resistance, and increased expenditure on drugs. There are potential strategies for improvement. In recent years, computerized clinical decision support systems have been introduced to support evidence-based decision-making. The design of knowledge systems and implementation of change and innovations is complex. In Stockholm, Sweden, there is a successful example of an established pharmacotherapy center (PTC) which started to use computer-assisted support systems very early (around 1996) and developed a range of important service products—the e-prescription; the Wise Drug List of recommended drugs; the Janusinfo, a noncommercial website providing drug information; electronic decision-support system integrated into the medical record; knowledge databases on drugs and interactions, lactation, and environmental hazards. Through a close collaboration with the regional drug committee the PTC also provides continuous professional education and information.

Objective: Explore the development, design, and implementation of a PTC and to analyze important factors to the design

Design: We used a qualitative approach to get a deeper understanding of the design. Archival data was collected from organization plans and annual reports. Further data was collected face-to-face using semi-structured interviews. The empirical material was analyzed by using thematic data analysis. Participants were purposively selected and included key individuals involved in the establishment of the PTC. They represented academia, regulatory agencies, and practioners in the county council and amounted to n = 11.

Results: The external context emphasized clinical pharmacology as an important discipline and the need to counterbalance a powerful pharmaceutical industry with noncommercial interests. A few key individuals with the right knowledge and interest in information technology found financial resources and political support. In the beginning, they were given some “time and space” of creativity and risk taking. The mixed competence and working in teams as a whole made a difference as well as the visionary and dedicated leadership with a capacity to forecast the development. The leader was seen as quite controversial by some. The successful development and implementation of different computer-assisted support systems depended alot on the relative advantages these products gave the end users. The design process involved the prescribers’ needs from the beginning and a great amount of time was spent in dissemination efforts with the help of particular drug therapeutic committees.

Conclusion: Individuals can make a difference in introducing a multifaceted intervention using computer-assisted support systems to rationalize use of drugs as well as using drug committees and information to the public.

Funding source: Vinnvård Sweden


The Effectiveness of Therapeutics Committees (TCs) in Addressing Key Public Health Problems

Mary Katongo1, Victor Sumbi2, Dawn Pereko2, Dr Maina Wambugu1

1Ministry of Health and Social Services (MoHSS); 2Management Sciences for Health/Strengthening Pharmaceutical Systems (MSH/SPS)

Problem statement: During the April 2008–March 2009 fiscal year, an average of 82 dog bites per month were reported in the Kavango Region. Throughout this period, the rabies vaccine was among the top 10 expenditure items in all four districts of the region.

Objectives: To reduce the expenditure of anti-rabies vaccine in Kavango Region by addressing underlying factors which are responsible for high expenditure.

Design: Rabies, caused by bites from rabies-infected animals, is a preventable disease. The Therapeutics Committees’ (TCs) interventions were designed to reduce the number of bites from infected domestic animals.

Setting: As part of the intervention, district TCs held meetings in four districts at the Regional Health Directorate in Rundu with the Village Development Committees and traditional leaders in their localities. The regional TC invited the Chief Executive Officer of the Rundu Town Council, Regional Veterinary Officer, and the Head of the Society for the Prevention of Cruelty to Animals (SPCA) to attend two regional TC meetings to map out interventions.

Interventions: (1) The Regional Council mandated Constituency Councillors to sensitise their communities on the danger of rabies and the importance of having their pets and their farm animals vaccinated against rabies. (2) The Rundu Regional veterinary team embarked on a mass vaccination campaign for pets and farm animals against rabies. (3) The Rundu Town Council committed itself to expedite the allocation of land to the SPCA for the construction of larger kennels to accommodate stray dogs. The application had been pending for the last five years. (4) The Rundu Town Council began the process of developing bylaws to control the movement of domestic animals in the community. To date, no bylaws were in place. (5) The Rundu Town Council, together with the three other local councils in the region, improved the safe disposal of domestic waste, which was the major attraction for stray domestic animals. (6) The four regional hospitals had their perimeter fences mended and instructed security officers operating main entrances not to allow dogs into the premises.

Results: In Kavango region, for the period April 2008 to March 2009, the average number of dog bites per month decreased from 82 to 39 and annual expenditure on anti-rabies vaccine reduced from 56,600 to 29,600 US dollars. The position of anti-rabies vaccine in the top expenditure items list dropped as follows in the four districts: 8th to 47th in Andara, 1st to 4th in Nankudu, 5th to 20th in Nyangana, and 3rd to 27th in Rundu.

Conclusion: TCs working in a collaborative way can be drivers for implementing effective interventions to address critical medicine use problems in their jurisdictions. TC interventions can additionally lead to significant cost savings thus facilitating use of scarce resources for priority health problems.

Funding sources: Operations of the TCs were fully funded by the Kavango Regional Health Directorate, Namibia.


Decongesting Public Health Facilities is Associated with Better Clinical Outcomes Among Patients Initiating Antiretroviral Therapy in Uganda

Joshua Kayiwa1, Celestino Obua2, Dennis Ross Degnan3, John Chalker4, Paul Waako2, Hudson Balidawa5, Goran Tomson6, Rolf Wahlström6

1Data Department, Joint Clinical Research Centre, Kampala Uganda; 2Department of Pharmacology and Therapeutics, College of Health Sciences, Makerere University, Kampala Uganda; 3Department of Population Medicine, Harvard Medical School and Harvard Pilgrom Health Care Institute, Boston USA; 4Center for Pharmaceutical Management, Management Sciences for Health, Arlington Virginia, USA; 5AIDS Control Programme, Ministry of Health, Kampala Uganda; 6Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden

Problem statement: In resource-poor settings, public health facilities providing antiretroviral therapy (ART) are frequently overwhelmed with patients seeking health care and medicines. This has implications on the quality of services delivered, clinic-running costs, and subsequently, treatment outcomes.

Objectives: We aimed to discover the extent to which simple, low-cost, and minimal-input interventions intended to reduce daily patient loads would impact on weight retention among patients initiating ART, as a marker of treatment progress.

Design: This was a longitudinal cohort study involving 761 patients initiating ART. Demographic and treatment history information were retrospectively extracted from medical records. Data on appointment keeping and weight changes were collected for 6 months before and 11 months after the intervention.

Setting: The study was conducted in six public ART-providing health facilities in Uganda. The interventions were implemented at clinic level, mainly through dialogue with the facility staff.

Study population: Eligible facilities had been ranked with poor adherence in a prior baseline survey. Recruited patients were aged 18+ years who had initiated ART 3 months prior to baseline or during follow-up. These were conveniently identified from outpatient registers.

Interventions: We first introduced an appointment system under which stable patients were classified as refill-only patients who would be fast-tracked through the facilities’ workflows. We also asked clinicians to increase dispensed medication days for patients whom they deemed to be stable on treatment from the traditional 30 days to either 60 or 90 days. The overall aim was to decongest the facilities.

Outcome measures: We examined the effect of the interventions on the event-rates of patients experiencing non-declining weight changes during the first 90 days of treatment by using Mantel-Haenzel methods and Cox proportional hazards models. Effects were adjusted for patient-level characteristics.

Results: Patients’ mean age was 35.8 ± 12.5 years; mean baseline weight was 51.4 ± 12.7 kg; 68.0% were female; 58.8% commenced treatment with Zidovudine-Lamivudine-Nevirapine. The rates (95% confidence interval) per 1000 person-years of experiencing non-declining weight changes pre- and post-interventions were 10.8 (8.3 to 14.2) and 22.8 (17.6 to 29.6), respectively (p <0.0001). The interventions were associated with a significant 2.2 (95% confidence interval: 1.5 to 3.2) increase in the hazards of experiencing nondeclining changes in weight.

Conclusions: These findings suggest that interventions instituted at public health facilities to reduce patient loads are effective in improving treatment outcomes among ART-initiating patients in resource-poor settings.

Funding sources: This work was made possible through support from the Swedish International Development Cooperation Agency and the World Health Organization through Management Sciences for Health.


Transparency in the Armenian Pharmaceutical Sector

Irina Kazaryan (Ghazaryan)1, Anaid Sevikyan1, Lusine Vardanyan1, Anaid Amirkhanyan2, Margarita Melikyan2

1National Institute of Health, Armenia; 2Drug Utilization Research Group PO, Armenia

Problem statement: Many factors contribute to Armenia’s problems with access to medicines, irrational prescribing, and use. As successful and efficient use of still very restricted resources depends very much on behavior of persons involved at all the stages of “medicines chain”, a lack of transparency should also be an issue of concern, especially the health sector which is considered to be one of the most corrupt sectors in Armenia.

Objectives: To assess the current situation on transparency and accountability in the pharmaceutical sector, as well as to define perception of health care professionals concerning the current situation on and importance of transparency and accountability for the Armenian pharmaceutical sector

Design: Pharmaceutical situation analysis, stakeholders surveys, qualitative study

Setting: Yerevan, the capital of Armenia

Study population: 72 health care professionals completed the questionnaire A being asked to estimate using 5-mark scale the current situation on transparency/accountability in 13 main areas and to determine importance of providing them; 12 key informants filled a draft assessment instrument for measuring transparency to improve good governance in the public pharmaceutical sector (WHO, 2006); 136 health and pharmacy professionals were asked about necessity of wide use of transparency and accountability for the spheres of management and regulation of medicines.

Outcome measure(s): The set of indicators was developed for questionnaire A (13 areas). Scoring for the assessment instrument was implemented according to the methods described in the WHO tool. The percentage of professionals who believe that wide use of transparency and accountability for the spheres of management and regulation of medicines is necessary was calculated in the third survey.

Results: Armenian legislation and regulation documents related to medicines do not cover issues of accountability and transparency. Mark “5” was very rarely selected (6.9% and less) by professionals who completed the first questionnaire. No one component has been marked “3” or higher by even half of respondents; 82% of 72 respondents noted high importance of providing transparency/accountability for the sphere of counterfeit medicines. Analysis of the key informants’ responses revealed that the majority of important mechanisms necessary for providing transparency are still not introduced; 61% of 136 professionals consider that wide use of transparency and accountability is necessary for area of medicines supply.

Conclusions: According to opinion of local experts and professionals, transparency and accountability are not enough in the local pharmaceutical sector, and wide use of these tools is important for managing medicines supply. Draft of paragraph covering transparency issues was developed for a draft of a new law on medicines and submitted to the National Assembly of Armenia.

Funding source(s): None


Country Comparison of MeTA Baseline Pharmaceutical Sector Scan Data

Birgit Kerstens1, Samia Saad2, Wilbert Bannenberg1,2

1Health Research for Action (HERA), Belgium; 2Medicines Transparency Alliance (MeTA), United Kingdom

Problem Statement: Information about medicines is often lacking and not publicly disclosed.

Objectives: Improving transparency in the pharmaceutical sector through collection, disclosure, and analysis of information by a multi-stakeholder group (MSG).

Design: The MeTA Pharmaceutical Sector Scan (Component 1a) captures yes/no and quantitative responses to implicit questions and asks for sources on quality, availability, price, and promotion of medicines. Based on the pharmaceutical sector scan tool, developed with support from the WHO Harvard Collaborating Centre in Pharmaceutical Policy, the MeTA pilot countries collected and reported pharmaceutical sector data for more than 250 indicators. Forty-seven core indicators relating to medicine prices, quality, availability, promotion, transparency and accountability were selected for a cross-country analysis.

Setting: All seven MeTA pilot countries (low-middle income): Ghana, Jordan, Kyrgyzstan, Peru, Philippines, Uganda, and Zambia. Assessments were made at national level covering both public and private sectors.

Study Population: In each MeTA pilot country, the pharmaceutical sector scan was conducted with input and validation from a MSG, representing key national institutions from the public and private sector, civil society, and academia.

Interventions: The pharmaceutical sector scans were conducted between November 2009 and June 2010. Duration of the data collection was ~ 2 months. Technical validation by country MSG took a further 4–6 months. Cross-country summary tables were developed for comparison purposes.

Outcome Measures: Data on national medicines policy, regulatory framework, price control, promotion, and use of medicines were extracted from individual country reports and entered in a cross-country comparison table. Consumer and procurement prices in the public and private sectors were compared for both originator brand medicines and lowest price generics. A traffic light analysis was added to the multi-country comparative table to show the degree of availability and disclosure of the data. Individual country pharmaceutical sector scans and the cross-country analysis have been placed in the public domain.

Results: The cross-country analysis of data on price, quality, availability, and promotion of medicines not only shows in which areas the countries are similar or different and how they compare in terms of the degree of data disclosure, but also reveals some methodological interpretation differences as well.

Conclusions: The cross-country analysis enables comparison of the pharmaceutical sectors in seven diverse countries, highlights similarities and differences and assesses where there is room for improvement in terms of data collection and disclosure.

Funding Source: UK Department for International Development.


Country Comparison of Multi-Stakeholder Process Assessments in the MeTA Baseline

Birgit Kerstens1, Samia Saad2, Wilbert Bannenberg1,2

1Health Action for Research (HERA); 2Medicines Transparency Alliance (MeTA)

Problem statement: No suitable tool existed to measure multi-stakeholder collaboration in MeTA countries. The concept was also new to in-country stakeholders, and led to substantial confusion and barriers in pilot countries at the start of MeTA.

Objectives: To assess the multi-stakeholder process in (MeTA) pilot countries and suggest ways to overcome barriers and challenges, with the ultimate aim of improving access to medicines.

Design: Cross-country study, desk-based review

Setting: Five MeTA pilot countries (Jordan, Peru, Philippines, Uganda, and Zambia) and an assessment of the multi-stakeholder process involving public, private, and civil society sectors.

Study population: A high level multi-stakeholder group (MSG), representing key national institutions from public, private, and civil society sectors; and from academia.

Intervention: MeTA partnered with the Institute of Development Studies (IDS) to create a set of tools for the assessment . The multi-stakeholder process assessments were conducted between February and August 2010 through face-to-face interviews using standardised questionnaires, as well as two workshops with stakeholders involved in the MeTA multi-stakeholder alliances. Data collected for ~2 months. Findings were presented in country reports. Cross-country summary tables were developed for comparison purposes, and analyzed by a MeTA consultant.

Outcome measures: The cross-country study compares the governance and structure of each MeTA pilot country MSG, the in-country multi-stakeholder process, the barriers and levers to multi-stakeholder engagement and lists all recommended changes for future working.

Results: Report with a cross-country analysis of the multi-stakeholder assessments, showing in which areas the countries are similar or different, and how they compare in terms of governance, structures, communication, and data sharing. Lessons learned about the multi-stakeholder process: these can be used in the future by countries applying the MeTA concepts. Individual country assessment reports and the cross-country analysis have been placed in the public domain.

Conclusion: Analysis of the cross-country table of baseline component 3 can provide a quick overview of which country has built the best multi-stakeholder alliance through MeTA, whether there is balanced representation in the MSG, and whether communication and information sharing has improved.

Funding source: UK Department for International Development (DFID)


Patients’ Compliance and Adherence to 4-FDCs that are Provided by Global Drug Facility to 15 Countries in the Eastern Mediterranean Region

Khaled Khalil


Background: Tuberculosis still represents one of the main public health problem in the world. The World Health Organization (WHO) recommended the use of fixed-dose combination (FDCs) formulations as one step to ensure enough and adequate treatment of patients. The main advantage of using FDCs is simplified treatment which may bring about a possible increase in patient’s compliance and adherence to such medicines. Since 2001, GDF took the lead of introduction of FDCs medication to different countries in the world.

Method: A comparative study was done to compare the efficacy, safety, and acceptability of the 4FDCs and 2FDCs during the intensive continuation phase of treatment as compared to regimens using single formulations. The method was applied to 1,000 new +ve cases (male and female, adolescent and adults’ ≥ 15 years). The daily dose of four tablets of 4-FDCs was given to every patient in the FDCs group (weight bands 55-70 kg, average 65 kg); and 3 tablets of the 4FDCs were given to patients (45-54 kg, average 52 kg). Sputum microscopy was done after 2 months of therapy, after the continuation phase. At the end of treatment, a chest X-ray was required to ensure full recovery from the disease. The study components included treatment satisfaction and regimen acceptability on the number and size of tablets taken. Patient compliance and adherence to the treatment were monitored during and after the treatment. The above steps were applied to the same number of cases but using single component tablets of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E); and RH.

Results: So far, there was clear progress in 490 (98%) out of 500 cases in the FDCs group in 12 out of 15 countries (80%) of the efficacy of the 4FDCs compared to the given single formulations. Sputum conversion rates at the end of treatment by 4FDCs (RHZE) and 2FDCs (RH150/75) were 98.99 % and 98%, respectively, compared to 96.17 % and 97.27% for single tablets, respectively. After 2-months treatment, 88.25% of the 4DCS group have addressed their fully satisfaction to the number and size of the 4FDCs compared to 85% of the single formulations group who complained about swallowing the single formulations of RHZE. After 6-months treatment, 90.25% of the 2DCS (RH) group have addressed their fully satisfaction to the number and size of the 2FDCs they received during the continuation phase compared to 89.98% of the single formulations group. Thirteen cases out of 500 (FDCs group) were registered under default group compared to 89 out of 500 cases (single formulations group).

Conclusion: The results concluded the effectiveness and efficacy of and accessibility to the 4FDC tablets compared to the single tablets treatment regimens. Moreover, patients were more likely to be completely adherent to the FDCs compared to the single one. The results suggest that the countries should establish a policy for a sustainable using of FDCs other than single formulations.

Funding source: Information not provided


A survey on the quality of anthelminthic medicines in Cambodia

Mohiuddin Hussain Khan1, Junko Okumura2, Tey Sovannarith3, Nam Nivanna3, Manabu Akazawa4, Kazuko Kimura1

1Kanazawa University, Japan; 2Nagasaki University, Japan; 3Ministry of Health, Cambodia; 4Meiji Pharmaceutical University, Japan

Problem Statement: Counterfeit medicine is a global threat to the access of medicines, especially in the developing countries. In response to the counterfeit crisis of Cambodia the Ministry of Health initiated a project in collaboration with Kanazawa University, Japan in 2006. The overall infection rate of intestinal parasite ranged from 26% to 54% in different parts of Cambodia (Stich et al. 1999; Lee et al. 2002; Parak et al. 2004). On these backgrounds in 2008, the anti-counterfeit medicine project investigated the quality of anthelminthic medicines in the private pharmaceutical market, which is the first among such category of medicines in the country.

Objectives: The objectives of this survey were to assess prevalence of counterfeit anthelminthic medicines, and to find out influential factors.

Setting: Private pharmacies of the capital, Phnom Penh and three adjacent provinces, Kandal, Takeo and Kampong Speu of Cambodia.

Study Population: Albendazole, mebendazole and metronidazole were selected as candidate medicines from the Essential Drug List of Cambodia. Samples were collected from August 5 to 20, 2008 through a stratified random sampling scheme to cover all types of private drug outlets.

Intervention(s): Medicines were carefully observed including their registration labeling. Authenticity investigation was conducted with the respective manufacturers and with the Medicines Regulatory Authorities (MRAs). Analyses of the samples were conducted by High Performance Liquid Chromatography (HPLC) at the National Health Product Quality Control Centre (NHQC), Cambodia. Where appropriate, Fisher’s exact test was used to test the significance of categorical variables in 2X2 table, and Tukey’s HSD (Honestly Significant Difference) test was applied to identify association among levels of classification variables.

Results: A total of 203 samples of anti-helminthics were collected from 137 drug stores. Domestic products constituted 36.9% of the total samples. Unlicensed outlets were significantly more common in rural areas (25%, 25/102) than in urban areas (12%, 12/101) (Fisher’s exact test: p<0.05). Out of 196 samples which were verified for registration, 15.8% were not registered. The registration status of medicines was significantly associated with the type of drug outlet (Tukey’s HSD, p<0.05), package conditions (Fisher’s exact test, p<0.05), and urban/rural area (Fisher’s exact test, p<0.05). Among 165 samples, which were successfully investigated for their authenticity, 7 (4.2%) were identified as counterfeit. All of these medicines were purchased as loose conditions in open packs or containers, and most of them were foreign manufactured and/or without registration.

Conclusion: The survey urges strict implementation of registration system along with vigilance on the availability of unregistered medicines in the pharmaceutical markets to combat counterfeit medicines in Cambodia.

Funding source: Japan Pharmaceutical Manufacturers Association (JPMA)


Priority Policy Research Agenda to Achieve Access and Rational Use of Medicines in Thailand

Niyada Kiatying-Angsulee1,2, Nussaraporn Kessomboon3, Usawadee Maleewong2, Vithaya Kulsomboon2, Jiraporn Limpananont2

1Social Research Institute, Chulalongkorn University, Thailand; 2Social Pharmacy Research Unit, Faculty of Pharmaceutical Sciences, Chulalongkorn University; 3Faculty of Pharmacy, Khon Kaen University

Problem statement: Access to medicine is an issue of concern in developing countries. Thailand, as a low- and middle-income country, despite many attempts, still faces such problems. Public health strengthening and health system research were promoted but there has been no study in Thailand to elaborate the research priorities in health systems and health financing systems.

Objectives: To identify research priorities relevant to access to medicine by using health system approach

Design: Qualitative participatory study using WHO template of analysis

Setting: Community, health sector, and beyond health sectors

Study population: All relevant stakeholders within access to medicine arena

Outcome measures: Policy research priorities

Results: The first phase comprised of analyzing different sources; research questions were drawn up to identify which ones were known and which were needed for future study. The matrix of checklist was developed by means of existing documents review and experts consultation. Four core issues in health systems were rational selection and use, affordability, sustainability financing, and reliable health system. The second phase of analysis was based on 3 levels of perspectives as individual, health sector, and beyond health sectors. Priorities were performed through 3 steps: systematic and grey review, interview of key informants, and workshops among stakeholders. The Thai Ministry of Public Health has established 5 strategies for access to medicine after the resolution of the first National Health Assembly in 2008. The 5 strategies were drafted as (1) encourage patient group to get access to medicines and to take part in health promotion, (2) promote affordable prices of medicines, (3) make use of TRIPS flexibilities in patent law to reduce legal hurdles, (4) develop local pharmaceutical production, and (5) develop traditional medicines. Other priorities for research were identified as sustainable funding, human resources development, information, political commitment, governance, and monitoring and evaluation. Process of gathering data is on going to get the final result of research priorities and rank.

Conclusions: Policy priorities research to achieve access to medicine were drawn up using health system approach analysis via qualitative participatory method. These will be used as input for policy formation and implementation in the future.

Funding source: World Health Organization


Antibiotic Resistance Policy in Thailand: Role of Comprehensive Networking Campaign

Niyada Kiatying-Angsulee1,2, Yupadee Sirisinsuk2,3

1Social Research Institute, Chulalongkorn University, Thailand; 2Drug System Monitoring and Development Program, Chulalongkorn University, Thailand; 3Social Pharmacy Research Unit, Chulalongkorn University, Thailand

Problem Statement: Antibiotic resistance (ABR) has reached alarming levels as the consequence of many factors. Overuse and irrational use were observed at institutional and community levels. Antibiotics were available freely in the villages. While consumers perceived antibiotics as a magic bullet and health care providers seemed unaware of ABR, there has not beena real national antibiotic policy to combat the problem. Recently, however, there has been a comprehensive movement to lift an ABR policy to the national agenda.

Objectives: To elaborate roles of a comprehensive networking campaign as a model in analyzing ABR policy process.

Design: Analytical qualitative policy study

Setting: All levels of areas involving in an ABR policy

Study Population: All stakeholders within the ABR policy arena in Thailand

Policy Change: National ABR policy

Outcome measures: Policy formulation and implementation process and campaign strategy analyses

Results: The first and second National Drug Policy announced in 1981 and 1993, respectively, did not contain any phrase regarding ABR which emphasized unawareness of developing anABR policy. The first ABR policy, seen in 1987, was drafted by academia without any direct implications. Different organizations implemented selected policies such as drug use evaluation of certain classes of essential drug list including antibiotics and the pay for performance policy of national health security office (NHSO) to include rational use of antibiotics in hospital. The latest ABR policy was included in the overall seven strategies on rational use of medicines, which aims to tackle ABR both in human and animals. The policy climate was encouraging because of a comprehensive networking campaign during these years. Activities ranged from meeting with key policy makers, academic workshops at different levels, scale-up of activities in health care institutions, a public awareness campaign, and education in schools. Positive support for the policy was shown by dedicated professional groups, national health insurance payers, accrediting bodies, nongovernmental organizations, the media, and international support. The Drug System Monitoring and Development Program is one catalyst of the process with clear focus, good networking, and resources. ABR policy efforts, however, were hindered by industry, distributors, regulatory enforcement, and pharmacists at drugstores. Next step is to monitor the implementation process and evaluate the impact on ABR and rational use to maintain sustainability.

Conclusions: Comprehensive campaign and academic activities via networking among all relevant stakeholders can bring success to policy formulation against antibiotic resistance. Still, more needs to be done on policy implementation at different levels.

Funding source: Thai Health Promotion Foundation, ReAct, and World Health Organization


Good Governance of Medicines System in Thailand: From Assessment to National Policy Agenda

Niyada Kiatying-Angsulee1,2, Suntharee T.Chaisumritchoke2, Yaowalak Amrumpai3

1Social Research Institute, Chulalongkorn University, Thailand; 2Social Pharmacy Research Unit, Faculty of Pharmaceutical Sciences, Chulalongkorn University; 3Faculty of Pharmacy, Silpakorn University

Problem statement: The pharmaceutical or medicine sector is perceived as vulnerable to corruption and unethical practices, due in part to failure market and the high value of pharmaceutical products as one health technology in the prevention and treatment of diseases. Furthermore there are wide ranges of stakeholders with sometime different objectives or goal. There has been a move from WHO to alleviate such situation by introducing Good Governance in Medicine System (GGM) into all regions. Thailand is one country that started the project from the very beginning. Experience from Thailand can be learnt and shared.

Objectives: To assess transparency situation in medicines system and to elaborate process of bringing GGM to national policy agenda

Design: Mixed-method study

Setting: National and regional levels of medicine system

Study population: Stakeholders within medicines system

Outcome measures: Transparency situation in medicine system and policy agenda process

Results: Assessment of transparency situation of medicine system was performed in five areas out of ten areas according to WHO assessment tools. The first three areas were performed by using the previous version and will be updated later. Registration scored 7.0 out of 10. Selection scored 8.0 and procurement scored 7.1. All meant marginally vulnerable to corruption. Inspection and promotion were the next two under studying. From the results of first phase assessment, attempt has been done by introducing onto agenda as resolution of the second National Health Assembly in 2009 as entitle ‘Stop unethical drug promotion: to reduce risk of patient health and economic of the nation’. The process of putting this topic onto policy agenda required multifaceted approaches as technical study, assessing the situation, public communication, participation from concerned and relevant groups. Media was major channels for communication to the public which received good attention. More work is needed for further implement the policy agenda and the performance of monitoring system.

Conclusions: Assessment of transparency situation can help setting policy agenda on good governance in medicine system. Other components were technical study, public communication.

Funding source: World Health Organization, Thai Health Promotion Foundation


Drug System Monitoring and Development Project, Funded by Sin Tax, and the Roles in Promoting Rational Drug Use in Thailand

Niyada Kiatying-Augsulee, Yupadee Sirisinsuk

Faculty of Pharmaceutical Sciences, Chulalongkorn University, Thailand

Problem statement: The drug system in Thailand is faced with several problems, including availability of unsafe drugs in the market and irrational drug use. Since 2008, Thai Health Promotion Foundation (ThaiHealth), funded by a sin tax, has supported a drug system monitoring and development project (DMD) to monitor the drug system’s situation and implement interventions to further develop the system.

Objectives: To review the activities of DMD

Design: The study design was descriptive. Data were collected by document reviews and self assessment among the staff.

Setting: The study was carried out at the central office of the DMD.

Study population: All DMD activities were included in the study.

Program: DMD has been granted 53.05 million Baht from ThaiHealth, Chulalongkorn University, and WHO for a 3-year project (2008–2011).

Outcomes measured: The Center for Drug Monitoring and Development has been set up. The networks of both professional and civic groups have been formed and perform the key functions of monitoring and developing the drug system at the community, hospital, and country levels. The models to monitor and develop the drug system are applicable at several levels.

Results: DMD has 5 strategies—knowledge management, pilot model development, networking, public communication, and national drug policy and strategies advocacy. DMD performance in drug monitoring, especially unsafe drugs, has been recognized by the Center for Drug Monitoring and Development. DMD’s priority issues include drug selection to eliminate unsafe drugs, drug procurement to increase efficiency, drug distribution to protect against unethical dispensing, and drug use, especially promoting rational drug use in preventing antibiotic resistance and unethical drug promotion. Several network groups have been formed, including a pharmaceutical and therapeutic committee network, drug use evaluation pharmacist network, drug procurement network, community hospital pharmacist network, and the Public Health Provincial pharmacist network, as well as civic groups concerned with both patients and consumers. The networks have monitored and developed the drug system in their areas of interests. Initial pilot models for monitoring drug problems in the communities have been created, and specific interventions to solve problems were forthcoming. The major theme for DMD’s 2010–2011 campaign has been to promote the rational use of antibiotics. Interventions have focused on several levels, including national drug policy, prescribers, patients, and consumers.

Conclusions: DMD and its networks have joined hand in hand to monitor and develop the Thai drug system. Nowadays, DMD is recognized by the government as the responsible body in drug system monitoring and development.

Funding source: ThaiHealth


Using a Rapid Results Approach to Improve Supply Chain Efficiency and Increase Availability of Essential Medicines and Supplies

Rosalind Wanjugu KIRIKA1, Jackson Omondi2, John Odondi2, Mary Wangai1

1Management Sciences for Health, Kenya; 2Ministry of Public Health & Sanitatation

Problem Statement: Delivery of essential medicines and supplies (EMMS) to health facilities from the Kenya Medical Supplies Agency (KEMSA) is sometimes delayed, resulting in medicine stock-outs.

Objectives: Reduce delivery time of EMMS to health facilities in Kenya’s North Eastern Province from KEMSA by 40% (from 10 to 6 days) in 100 days.

Design: Intervention with before/after evaluation, no control

Setting and Study Population: The North Eastern Province was selected because of its poor infrastructure. It has 134 public sector facilities: 9 hospitals, 3 health centers, and 122 dispensaries, all which were included in the study. The intervention team comprised selected supply chain stakeholders including Ministry of Public Health and Sanitation, KEMSA, and SPS.

Intervention(s): The Rapid Results Initiative Is a results-focused methodology to jump-start system changes by implementing bite-sized, high-visibility, and momentum-building projects in 100 days. The Rapid Results Initiative’s commodity management team developed an action plan and clearly defined milestones with a goal of reducing KEMSA’s delivery time. The team undertook a survey to establish the baseline delivery time. The team sensitized stakeholders (KEMSA management, contracted transporters) and engaged them in analyzing the gaps in delivery. The team then developed appropriate interventions, namely to re-map the distribution route by geographic proximity of facilities; develop a real-time distribution schedule and communicate it to the lowest level (manually and electronically); and “containerize” each facility’s consignment, so that the transporter can deliver directly to the facility without needing to search and sort en route. The intervention was planned, implemented, and reported in 100 days.

Outcome Measure: The number of days for KEMSA to deliver EMMS to all North Eastern Province facilities.

Results: The 134 facilities received their EMMS within 4 days from dispatch at KEMSA. In addition, none of the consignments were returned because staff was available at each destination to receive the shipments. The activity was well documented and will be rolled out to the other provinces. The delivery in the second dispatch followed the same pattern and was accomplished in the same number of days. This may mean that the process is viable.

Conclusions: The rapid results initiative reduced delivery times, which improves supply chain efficiency and availability of health commodities. This method can be used in other settings to address a variety of supply chain and medicine use issues.

Funding Sources: Government of Kenya, U.S. Agency for International Development, Kenya.


Knowledges and Attitudes toward Emergency Contraceptive Pill among Thai Men in Bangkok and Its Utilization

Tanattha Kittisopee, Hathairat Jitlamun

The Faculty of Pharmaceutical Sciences, Chulalongkorn University, Thailand

Problem statement: Emergency contraception pills (ECPs) are available without prescription in Thailand. Use of the wrong dose and irrational use were found among teenagers. Males always bought ECP from drug stores for their female partners. As such, how much do Thai man know about the use of oral contraceptives for emergency contraception and what do they think about it? Do people with access to the regimen consider it a useful and appropriate method of fertility control? No research has previously assessed knowledge and opinions on the emergency contraceptive pill among Thai men.

Objectives: Explore knowledge and attitude toward ECPs in the male population in Bangkok and to investigate determinant and pattern of ECP in Thai women that were induced to use the pill by their partners

Method: An anonymous questionnaire was used to survey a convenient sample of 400 men from 7 administrative districts in Bangkok, the metropolitan area in Thailand. The questionnaire consisted of 45 questions: 5 inquired about males’ contraceptive behaviors; 8 asked males’ emergency contraceptive behaviors; 15 tested males’ knowledge on ECP; 12 investigated their attitude toward ECP; and 5 inquired about demographic information. Descriptive analysis was used to illustrate contraceptive and emergency contraceptive behaviors and attitudes toward and knowledge about ECP. Pearson’s r coefficient was used to test the correlation between knowledge and attitude.

Results: The most common contraception was a condom (40%); 50% of men know ECP and 41.5 % had used ECP with their sexual partners in the last 6 months. Major sources of information about ECP were friends (57%), pharmacists (17%), school (15%), TV/radio (14%), newspaper/magazines (11%), and parents (4%). Forty one percent of men knew the exact correct time for using it (within 72 h following an unprotected sex) and only 31% knew that ECP should not be used more than 4 tablets a month. Twenty five percent of them understood that ECP was able to prevent sexual transmitted disease. The better knowledge men had about ECP, the less shamed they felt about consulting doctors and pharmacists (r = -0.242; p = 0.01), the less likely that they will encourage their sexual partner to use ECP (r = -0.266; p = 0.000), and the more likely that it is needed to consult doctors and pharmacists before using ECP (r = -0.174; p = 0.015).

Discussion and conclusion: Because of its adverse effects, interactions with other pharmaceutical products, and ethical misgivings about the regimen, the results in the present study support that it is important to educate and counsel men about ECP so that they do not influence their partners to use it as a habitual anti-conceptive method.

Funding source: Chualalongkorn University


Treatment Cost of Metastatic Colon Cancer in Turkey

Guvenc Kockaya1, Mine Polat2, Ahmet Özet3, Pelin Tanyeri1, İsmail Mert Vural1, Akif Akbulat1, Halil Akar1, Saim Kerman1

1General Directorate of Pharmaceuticals and Pharmacy, Turkey; 2Baskent University, Turkey; 3Gazi University, Turkey

Problem statement: Colon cancer is the third most common in the top cancer incidence list—212,000 patients die in Europe per year because of colon cancer. In Turkey 150,000-180,000 new cancer patients are diagnosed every year, 13% of whom have colon cancer. Metastasis will occur among 50% of the patients who are newly diagnosed and operated on. It is believed that metastasis will occur in 9,000-10,000 colon cancer patients every year in Turkey.

Objective: Survival appears to be prolonged to more than 20 months with the new pharmaceuticals; however, these new pharmacuticals increase the total cost. The aim of our study is to calculate colon cancer treatment options for Turkey.

Method: Gazi University Hospital treatment protocols for colon cancer treatment were used. The cost of Irinotekan-Erbutix, B-IFL, Bevacizumab-FUFA, XELOX, XELIRI, IFL-Cetuximab, Irinotekan, FOLFIRI-Doillard, FOLFOX-4, FOLFIRI-Tornigard, Raltrexed, FUFA, and Inf-5 FU (Degramount) protocols were calculated. The cost of pharmaceuticals and medical treatment used in the protocols were taken from the Social Security Institution’s website. The exchange rate was USD 1 for TL 1.5.

Results: Inf-5 FU (Degramount) (USD 220) had the lowest cost for 1 cycle, followed by FUFA (USD 342), FOLFIRI-Tornigard (USD 390), Raltrexed (USD 504), FOLFIRI-Doillard (USD 521), Irinotekan (USD 619), FOLFOX-4 (USD 704), XELOX (USD 880), XELIRI (USD 947), IFL (USD 1785), Bevacizumab-FUFA (USD 2730), B-IFL (USD 5203), and Irinotekan-Cetixumab (USD 11625).

Conclusion: Every treatment protocol is administered for 6 cycles for each patient depending on the disease’s stage. If a treatment protocol is not successful, the patient will be given a different protocol. Different combinations of cycles can be administered, depending on the responses of the patients. Although Irinotekan-Cetixumab had the highest cycle cost, further analysis is needed to compare the cost and effectiveness of different protocols and combinations.

Funding source: There was no funding source or conflict of interest for the manuscript.


Off-Label and Non-Licensed Endocrinology Medicine Use in Turkey: A Retrospective Analysis of Computer Records in the Turkish Ministry of Health

Guvenc Kockaya, Pelin Tanyeri, İsmail Mert Vural, Akif Akbulat, Halil Akar, Mahmut Tokaç, Saim Kerman

General Directorate of Pharmaceuticals and Pharmacy, Turkey

Objectives: Off-label is defined by the Turkish Ministry of Health (MoHT) as the use of licensed pharmaceutical products in doses outside of or exceeding the scope of the registered indication, and the use of non-licensed, but imported medicinal products for the purpose of individual treatment.

Methods: The use of off-label or non-licensed endocrinology medicines was evaluated to provide an understanding of Turkey’s perspective within this area of health care provision. A computer search was performed of IEGM’s database. A patient base using off-label endocrinology medicine applications from 19 June 2009 to 19 June 2010 were searched. The key word “endocrinology” was used in the search. Outcomes were evaluated in the light of indications for use.

Results: The computer search showed that 357 applications were submitted for off-label endocrinology medicine use. It was concluded that the highest application percentage was established by “osteoporosis” in all of the applications (43%, 155/357). The highest application was established by Ankara province (28%, 44/155). University hospitals had the highest off-label osteoporosis medicine use applications within the given timeline (65%, 102/155). Specialized physicians in the fields of endocrinology and metabolism (adult and paediatric) had the highest number of off-label osteoporosis applications (71%, 111/155). It was concluded that the highest application percentage was established by “teriparatide use in osteoporosis” (87%, 136/155) in all of the osteoporosis applications; 92 of 136 applications were approved. There was a significiant difference between the T score (L1-4) of rejected and approved applications for patients (3,07 ± 1,85 and 3,23 ± 1.63, respectively; p < 0.001).

Discussion and conclusion: Yet, there was not a significiant difference between ages of patients for whom applications were rejected or approved. In addition, it could be said that off-label use can lead to reimbursement restrictions in endocrinology, especially for teriparatide-like oncology medicines. In Turkey, physicians who want to prescribe an off-label or non-licensed pharmaceutical or a medicine that has a different use from reimbursement indications needs to apply through the off-label medicine use process.

Funding sources: There was not any funding source or conflict of interest for the manuscript.


Is a Standard Kit an Effective Way to Optimise Use of Limited Resources and Increase Availability of Medicine? Experiences from Reintroducing Standard Kits in Resource-Poor Settings in Uganda

Dorthe Konradsen, Pito Jjemba, Timothy Nuwagaba, Birna Trap

Management Sciences for Health, Uganda

Problem statement: Funding for essential medicines and health supplies (EMHS) in Uganda’s public sector is limited, being only $0.7 per capita. Supply chain management capacity assessed at all levels of care is weak with stock cards kept for only 68% of EMHS and only 51% of stock cards with the correct balance. The financial gap combined with weak pharmaceutical management at the facility level contributes to low availability of EMHS. The average availability of the 6 tracer drugs was only 72% in a 6-month period in 2010. A standard kit system was introduced at the primary health care (PHC) level to increase availability of EMHS.

Objective: To assess the appropriateness of the kit system in Uganda in increasing availability of lifesaving EMHS

Design: Randomized before and after intervention study to assess impact of policy change using an indicator-based data collection tool; no control was available as the kits were introduced nationwide.

Setting: 35 PHC units situated in 9 districts out of 110 covering all 5 supply regions

Study population: 2 districts from 4 regions and 1 district from the central region were selected using a stratified population-based sampling method; within each district, 2 facilities were randomly selected from health centre (HC) levels 2 and 3, respectively.

Intervention: Changing from a pull to a push-based (kit) logistic system to increase availability of EMHS and optimize use of limited financial resources in PHC facilities

Policy: HC2 and HC3 kits containing 34 and 74 medicines, respectively, and 22 and 41 sundries, respectively, were introduced to replace facility orders. Each health facility receives 1 kit (according to the level of care) 6 times yearly, regardless of patient figures. The values of the kits were $470 and $825 for levels 2 and 3, respectively.

Outcome measures: Assessment of pharmaceutical management practices, EMHS availability, supply imbalances, prescription practices, content, staff view, and financial feasibility

Results: Of facility staffs, 27% were trained in stock management, and none could correctly calculate quantities to order EMHS. Kit introduction increased funding per patient by 38% and increased availability of items by reducing overall stock-out days 69% for vital items; 63% of items were oversupplied and expiry of extreme oversupplied items (> 12 months supply bimonthly) is estimated to cost $1.5 million per year nationwide. Kits include 59% vital items, and 80% of items were right for the level of care. Less than half of EMHS items had stock cards with a quarter having correct stock card balance. Two-thirds of staffs preferred kit system, because it had improved their supply situation.

Conclusion: Kit introduction increased funding and thereby availability of EMHS. Cost-effectiveness is questionable because of increased risk of wastage from oversupply with need for redistribution.

Funding source: United States Agency for International Development


Can the Indian Government Improve Access to Medicines Through Generic Drug Stores?

Anita Kotwani

V. P. Chest Institute, University of Delhi, Delhi, India

Problem statement: A key challenge for health care policy makers of developing countries is to increase the availability and affordability of essential medicines. In spite of the huge generic drug industry in India, access to essential medicines for the common citizen is still an issue.

Objective: To evaluate the policy of the Department of Pharmaceuticals (DoP) to open generic drug stores to improve access to essential medicines

Design: Policy evaluation

Setting: Generic drug stores called Jan Aushadhi stores (Jan = people and Aushadhi = medicines)

Study population: Generic drug stores opened by DoP operating in public facilities

Policy: DoP, Government of India has launched the Jan Aushadhi program to open generic drug stores in every district of India and make medicines available at prices that are lower than the popular brands available in the private sector. Five recently revived public sector drug manufacturing companies under DoP are the main suppliers of generic medicines to these stores. Few state governments have provided space for generic drug stores within the premises of public hospitals, and NGOs run these stores at reasonable margins.

Results: As of September 2010, approximately 45 such generic drug stores were opened in 6 states of India in public facilities where the Government is supposedly providing free medicines to the population. These stores sell limited numbers of generic medicines, mainly antibiotics, analgesics, antipyretics, combinations of analgesics and anti-inflammatory medicines, and anti-allergy medicines. Sales at these stores are minimal as we found out from a few stores. Patients who visit public facilities either want free medicines supplied through the facilities’ pharmacies, or if they can afford it, they purchase branded or branded-generic medicines from private retail pharmacies. Patients have little or no faith in the quality of generic medicines available at public facilities, but poor patients who cannot afford to purchase medicines have no choice but to take free medicines available. These stores are opened in big cities, where medicines are commonly available in private retail outlets.

Conclusion: The vulnerable population who rely on free medicines supplied at public facilities are not going to benefit from this scheme. The public also has doubts about the quality of generic medicines sold at public facilities. Quality testing of all the medicines being supplied to generic stores should be done and widely publicized. Advocacy and awareness for generic medicines should be preceded by opening generic drug stores. The Government should open generic drug stores either in remote places or along with the private sector. This would be a step in the right direction, but its implementation requires serious thought to make it a success. The current generic drug store policy will increase access of limited medicines for a very limited population, but not for the vulnerable population of India.

Funding source: None


Trends in Antimicrobial Use Among Outpatients in New Delhi, India

Anita Kotwani1, Kathleen Holloway2

1V. P. Chest Institute, University of Delhi, Delhi, India; 2World Health Organization, Regional Office for South East Asia, New Delhi, India

Problem statement: The overall volume of antimicrobial consumption in the community is one of the foremost causes of antimicrobial resistance. Enhanced surveillance is one of the strategies to control antimicrobial overuse or misuse. The ability to undertake extensive surveillance is lacking in resource-constrained settings, hence the lack of community-based databases. We conducted a detailed survey of antimicrobial use in the community by utilizing a recently established methodology of exit patient interviews for resource-constrained settings.

Objective: To determine the pattern and consumption of antibiotic use in the public and private sectors over one year (December 2007–November 2008) in New Delhi, India.

Design: Exit interviews of patients prescribed/dispensed/purchasing any antibiotic

Settings: 10 primary care public facilities, 20 private clinics, and 20 private retail pharmacies in 4 residential localities of Delhi

Study population: Outpatients visiting the enrolled facilities; 30 exit interviews/month/ public facility and private retail pharmacies; approximately 10–12 exit interviews/private clinic/month

Outcome measures: The Anatomical Therapeutic Chemical (ATC) Classification and the defined daily dose (DDD) measurement units were assigned to the data. Antibiotic use was measured as DDD/1000 patients visiting the facility and also as a percentage of patients receiving an antibiotic.

Results: Out of the patients visiting private retail pharmacies (17,995), public facilities (9,205), and private clinics (5,922) during the data collection period, 39% of the patients attending private retail pharmacies and public facilities and 43% of patients visiting private clinics were prescribed at least one antibiotic. The consumption pattern of antibiotics was similar at private retail pharmacies and private clinics where fluoroquinolones (J01MA), cephalosporins (J01DA), and extended spectrum penicillins were the 3 commonly prescribed groups of antibiotics. At public facilities, there was a more even use of all the major antibiotic groups including fluoroquinolones, penicillins (J01C), macrolides (J01FA), tetracyclines, cephalosporins, and Co-triamoxazole. Newer members from each class of antibiotics were prescribed. Not much seasonal variation was seen, but a relatively higher consumption of antibiotics, mainly fluoroquinolones, was observed during the rainy (hot and humid) season and few classes of antibiotics, such as penicillins, macrolides, Co-triamoxazole, and tetracyclines were used more in winter season.

Conclusions: A very high consumption of antibiotics was observed in both public and private sectors in the outpatient setting. Study shows a high use of broad spectrum and newer antibiotics consumption in the community. Suitable and sustainable interventions should be implemented to promote rational use of antibiotics that will help in decreasing the menace of antibiotic resistance.

Funding source: WHO


Impact of Standard Treatment Guidelines and Patient Education on Asthma Control and Knowledge in Asthmatic Patients: A Controlled Trial

Anita Kotwani1, Vandana Tayal2, S. K. Chhabra1

1V. P. Chest Institute, University of Delhi, Delhi, India; 2Maulana Azad Medical College, New Delhi, India

Problem statement: The prevalence of asthma is growing in developing countries. Evidence suggests that poor knowledge of the disease process, medication use, and poor self-management are some of the frequent reasons for increased morbidity in asthma and can be largely tackled by following standard treatment guidelines (STGs) and providing asthma education to patients.

Objectives: To evaluate the impact of STGs and additional asthma education program on asthma control and knowledge about asthma and its treatment

Design: Intervention non-randomized controlled study

Setting: Outpatient department of V. P. Chest Institute, Delhi, a tertiary care referral public hospital

Study population: A convenience sample of 50 patients visiting the referral facility the first time for asthma treatment were enrolled after confirming the diagnosis of asthma by symptoms and reversible spirometry; 38 patients completed the study (March 2006-December 2006).

Intervention: Patients were interviewed at week 0 (baseline) with 3 researcher-administered questionnaires that addressed asthma management, asthma control (questionnaire; ACQ), and asthma knowledge (questionnaire; AKQ). Of these, ACQ is a standardized, widely available instrument. The other two questionnaires were based on guidelines-recommended management and were developed for an Indian clinical setting. All patients were given inhalation medication according to STG and routine patient education. Alternate patients were given an additional face-to-face educational intervention on etiology, pathophysiology, symptoms, treatment, and self- management of asthma. Patients were asked to come for follow up at 2, 4, 8, and 12 weeks and the ACQ was used at each visit. The AKQ was reassessed at week 12 for all patients.

Outcome measure: Changes in all domains of asthma control and asthma knowledge

Results: Patients’ responses to quality of treatment questionnaire indicated poor asthma care by previous health care providers. Improvement in various domains of asthma control (i.e., wheezing, shortness of breath, limitation in activities, average awakeness in morning and at night) started by week 2, became significant (P = 0.0001) by week 4, and persisted until the week 12 in all patients. Assessment of asthma knowledge at week 12 revealed significant (P < 0.05) improvement in knowledge about pathophysiology, symptoms, and assessment of severity and prevention of asthma compared to week 0. Furthermore, for patients who received additional asthma education, their knowledge about pathophysiology at week 12 was significantly more than the patients who did not receive additional education.

Conclusions: The study provides the evidence of a poor standard of asthma care and poor knowledge of asthma in patients. STGs have a significant impact on asthma control and knowledge. This study also confirms that a single session of asthma education has little impact on treatment outcomes.

Funding sources: HAI-Asia Pacific


Factors Influencing Antibiotic Prescribing by Primary Care Doctors in Delhi, India: Qualitative Study

Anita Kotwani1, Chand Wattal2, Shashi Katewa3, P. C. Joshi3, Kathleen Holloway4

1V. P. Chest Institute, University of Delhi, Delhi, India; 2Sir Ganga Ram Hospital, New Delhi, India; 3Department of Anthropology, University of Delhi, Delhi, India; 4World Health Organization, Regional Office for South East Asia, New Delhi, India

Problem statement: To support the rational use of antibiotics, it is important to collect information on patterns of drug prescriptions and on factors influencing prescribing decisions. A pilot study conducted in New Delhi, India, showed high levels of antibiotic use and resistance in the community. It is necessary to understand physicians’ prescribing behaviour to develop interventions that will effectively improve the use of antibiotics.

Objectives: To explore the factors that influence primary care physicians to prescribe antibiotics and to investigate possible interventions to promote rational use of antibiotics

Design: Qualitative study

Setting: Focus group discussions (FGDs) of primary care doctors of the public and private sectors from five municipal wards (residential localities) of Delhi

Study population: Public sector doctors were invited from 10 public health facilities from which data on antibiotic drug use were collected. For the private sector, 60 doctors who were practicing in the survey area and were members of the doctors’ association were approached. All 10 doctors from the public sector participated, but only 26 of 60 doctors invited from private sector facilities participated in the FGDs. One group was composed exclusively of private sector doctors (n = 18), one group exclusively of public sector doctors (n = 8), and the third group contained doctors from both public (2) and private (8) facilities.

Outcome measure: The data from 3 FGDs were analysed by grounded theory. The method of ‘constant comparison’ was central to the process generating various themes and codes.

Results: Three broad themes were identified—behavioural characteristics of doctors and patients, laxity in regulation of prescribing and dispensing antibiotics; and intervention strategies to decrease misuse of and resistance to antibiotics. Important factors identified for antibiotic prescriptions by doctors were diagnostic uncertainty, perceived demand and expectation from the patients, practice sustainability and financial considerations, influence from medical representatives, and inadequate knowledge. For public sector doctors, besides the above, overstocked and near-expiry drugs and lack of time were the factors that promoted antibiotic overuse. Doctors also identified certain patient behaviour characteristics and laxity in regulation for prescribing and dispensing of antibiotics as aggravating the problem of antibiotic misuse. Interventions like continuing medical educations for doctors, raising awareness of patients, shared decision making, and stricter rules and regulations for antibiotic dispensing without prescription were suggested to promote rational use of antibiotics in the community.

Conclusion: Exploration of doctors’ antibiotic use practices and possible interventions will be helpful in carrying out interventions to promote appropriate use of antibiotics in the community.

Funding source: World Health Organization


Irrational Prescribing Pattern for Children with Upper Respiratory Tract Infection (URTI) in Indonesia

Yulianto Santoso Kurniawan, Purnamawati Pudjiarto, Windhi Kresnawati

Concern & Caring Parent Foundation, Indonesia

Problem statement: Many parents do not have sufficient knowledge in URTI guidelines and rational use of medicine (RUM). Most pediatric URTI consultations are treated with numerous medications.

Objectives: To obtain the prescribing pattern of URTIs in the pediatric population based on prescriptions submitted by parents

Design: Descriptive cross-sectional study; data is collected from prescriptions emailed and posted by parents of under-5 children who suffer from coughs and cold who join sehat@yahoogroups.com mailing list, the first IT-based approach in promoting RUM in Indonesia. Inclusion criteria is the prescription or a copy from the pharmacy for pediatric under-5 children with cough and cold < 7D.

Setting: The study collected prescriptions from parents in Jakarta and 17 other cities (later will be grouped as other cities) during 2008-2009.

Study population: Total sample is 583 prescriptions

Results: Drugs that are prescribed in pediatric URTI (Jakarta vs. other cities): antibiotics 67.3% vs. 78.4% (mostly cephalosporin-cefadroxil, cefixime); antihistamine 81.5% vs. 75.9%; steroid 58.3% vs. 56.9% (mostly branded triamnicolone); mucolytic/expectorant 61.5% vs. 69.1%; bronchodilator 57.5% vs. 51.4%; decongestant 48.8% vs. 47.2%; antipyretic 40.7% vs. 40.5%; antitussive 21.6% vs. 27.4%; supplement 39% vs. 35%; anticonvulsant 24.2% vs. 12.2%. Average number of drugs in URTI prescription is 5 vs. 5; average number of active substances in prescription is 6 vs. 6. Average URTI prescription cost is IDR 137.573 vs. 112.512. Generic use in URTI prescription 28.3% vs. 16.25%. Compounding drug preparation 91.9% vs. 88.6%.

Conclusions: Promoting RUM through active interaction in a health-based mailing list can be used as a new approach in raising community awareness. Patients as health consumers can participate in promoting RUM through such prescription pattern study. This study shows a high prescription rate of unnecessary and off-label use of medicines such as antibiotics, antihistamines, steroids, mucolytics/expectorants, bronchodilators, and compounded drug preparations; use of these should be discouraged until the safety profiles are known. These prescribing practices strongly suggested noncompliance with the URTI guideline. This study also shows that this polypharmacy prescribing occurs not only in big cities, but is also common in smaller cities. Both the low-rate use of generic drugs and the high- cost prescription (7.05% in Jakarta vs. 5.76% in other cities of GNI per capita annually) should alert health agencies, health institutions, and health professional organizations to reevaluate medicine use and health system audit policy. This finding should be followed up by a large prospective study to detect related factors influencing this prescription pattern. Integrated intervention to ensure RUM should be done to prevent antibiotic resistance, risks of adverse drug reactions, and costly health care.

Funding sources: Concern & Caring Parent Foundation


Knowledge, Attitudes, and Perceptions on Antimicrobial Resistance and Antibiotic Use Among Hospital Staff in Kenya

Donna Asiimwe Kusemererwa, Anke Meiburg

Ecumenical Pharmaceutical Network, Kenya

Problem statement: Antimicrobial resistance (AMR) is a global problem, however, little is known about the perceptions of health professionals in Africa on the phenomenon and the extent to which it influences their clinical practice.

Objectives: To establish the perceptions and beliefs of hospital staff in Kenya on AMR; the perceived drivers of antibiotic use; the possible existence of facility-level practices and interventions that contribute to the development or containment of AMR; and the presence or absence of incentives for such practices/interventions

Design: Exploratory descriptive study undertaken in April and May 2010

Setting and study population: 125 hospitals in two provinces, Nairobi (41 hospitals) and Nyanza (84 hospitals), formed the study population; 22 hospitals were chosen through purposive convenience sampling with roughly equal numbers of government, private, and faith-based institutions

Intervention: Face-to-face interviews were conducted with a clinician, a pharmacy professional (or staff), a laboratory professional, and a representative of accounts/administration in each hospital. The 86 staff interviewed were each nominated by a member of hospital management.

Results: 92.6% of interviewees considered AMR a significant national problem but only 63.8% considered it a problem in their hospital; clinicians were consistently more likely to consider AMR a problem than the other professionals interviewed; 80% of the health professionals rated the knowledge and awareness of their professional colleagues in the hospital on AMR as average or lower. Infection control in the hospitals was, in general, perceived as satisfactory and this perception was consistent across professions, regions, and facility types. At least 16 out of 22 hospitals reported having some form of infection control policies and structures in place although written guidelines were only seen in 1 hospital. Culture and sensitivity testing was common (80% of hospitals), but only 1 hospital appeared to have an AMR surveillance system in place. The most important driver of choice for an antibiotic for prescribers was the patient’s clinical presentation, and profit for the hospital or clinician were reported as having little influence on choice. Controls on the use of antibiotics were not common, and only 20% of the hospitals reported restricting the prescribing of selected antibiotics to certain groups.

Conclusion: The professionals interviewed appear to be aware of the seriousness of AMR as a national-level problem, but far less as a problem at the facility level. In addition, practices known to promote development of resistance are thought not to be common in these hospitals. Future studies may need to go beyond simple interviews to include observational studies on actual practices and resistance trends.

Funding sources: CDDEP, SPS/MSH, and ReAct


Human Resources for Health: Preservice Training of Pharmacy Students on Effective Management of Antiretroviral Therapy Commodities in Kenya

Ndinda Kusu1, Richard Kolute2, Lilian Gitau1, Julie Ogolla2, Charles Onudi2, Janet Kimeu1, Mary Wangai1, Sarah Muniu3

1Management Sciences for Health, Kenya; 2Kenya Medical Training College; 3Kenyatta National Hospital

Problem statement: Assessment of pharmaceutical services in Kenya has revealed inadequate training and skills among health care providers. In particular, the lack of preservice training on pharmaceutical management is a significant weakness.

Objective: To determine acceptability and knowledge gained during a 5-day, rapid orientation preservice pharmaceutical management course among diploma pharmacy students

Design: A before and after training assessment using scored pre- and post-training tests and a post-training course evaluation

Setting: 3 Kenya medical training college campuses in August 2009 and July 2010

Study population: Graduating diploma in pharmacy students of 2009 and 2010

Interventions: 5-day training course on effective management of ART commodities covering an overview of HIV and AIDS, antiretroviral drugs, commodity management, inventory management, rational use of medicines, pediatric ART, drug interactions, and adverse effects; this course incorporated classroom learning, exercises, case studies, and practicum

Results: A total of 297 students were trained in 2009 and 2010 and a pre-post test covering the key course content was administered on both occasions. In 2009 (n = 101), the mean score for the pretest was 65.2% and the mean score for the post-test was 79.4%. In 2010, (n = 196), the mean score for the pretest was 64.5% and the mean score for the post-test was 75.9 %. In 2009, the ranges of pre- and post-test marks were 38–78% and 60–93%, respectively. In 2010, the ranges of pre- and post-test marks were 44–86% and 60–98%, respectively. Of the 297 students, 96% proposed that the course content be included in the diploma curriculum and 78% recommended the inclusion of the course within year 3 of the diploma in pharmacy course.

Conclusions: Students responded positively to this course and recommended that it be institutionalized in the diploma curriculum. The training improved students’ knowledge and skills on effective management of ART and other medicines as evidenced by the improvements in post-test scores. A preservice curriculum for pharmaceutical cadres should include key topics of pharmaceutical management to equip future health workers with appropriate and relevant knowledge and skills.

Funding source: The President’s Emergency Fund for HIV/AIDS (PEPFAR) through USAID and the Kenya Medical Training College


Strengthening Pharmacovigilance Systems: Experiences from Kenya

Ndinda Kusu1, Jayesh Pandit2, George Muthuri2, Janet Kimeu1, Dorine Kagai3, Lilian Gitau1, Mary Wangai1, Fred Siyoi2

1Management Sciences for Health, Kenya; 2Pharmacy and Poisons Board; 3National AIDS and STI Control Program

Problem statement: Global initiatives to address public health priorities in developing countries such as HIV/AIDS, malaria, and tuberculosis (TB) have increased access to medicines. This has subsequently created the need to monitor and promote the safety and effectiveness of these medicines via national pharmacovigilance programs. However, many developing countries lack the appropriate structures, systems, and resources to systematically support the detection and prevention of adverse drug reactions (ADRs) and other medicine-related problems.

Objective: To promote patient safety by implementing a nation-wide pharmacovigilance system

Design: Intervention under the stewardship of the Pharmacy and Poisons Board (PPB). MSH/SPS worked with the PPB to implement a “one-national” integrated pharmacovigilance system.

Setting: Public, faith-based, and private sector health facilities throughout Kenya

Intervention: In collaboration with other stakeholders, MSH/SPS supported the development of national pharmacovigilance guidelines, reporting tools, training materials, and job aids. The national launch of the pharmacovigilance program was in June 2009. A national rollout was planned and initiated with dissemination of guidelines and reporting tools plus capacity building of regional trainers..MSH/SPS and PPB used a systematic capacity building approach that ensures that both institutional and human resource capacities are strengthened to become robust and functional. Strengthening structures, roles, responsibilities, staff, and infrastructure addressed institutional capacity, while tools and skills focused on health worker capacity. These activities required coordination among different public health programs and were supported by a variety of donors.

Outcome measures: Number of reports, regulatory actions taken, number of staff trained, and activities undertaken.

Results: By December 2010, Kenya became the 98th full member of WHO Programme for International Drug Monitoring and over 5000 staff were trained on pharmacovigilance. A post-market surveillance strategy was developed and undertaken for anti-TB and antiretrovirals (ARVs).The PPB has received over 100 reports of poor quality medicines and over 1000 reports on ADRs; 60% of ADR reports are ARV-related. Twelve sites have been identified to provide ARV ADR sentinel surveillance and facility medicines and therapeutic committee representatives trained. The PPB has a drug safety review committee and a communication mechanism that promotes timely and regular information feedback. A consumer reporting system for poor quality medicines and ADRs is now in place.

Conclusion: It is possible to leverage support from partners and parallel funding streams for comprehensive pharmacovigilance system strengthening. Involving the PPB built country ownership and is a sustainable approach to promote access to quality medicines and patient safety in resource-limited settings.

Funding source: Information not provided


International Comparison of Generic Medicine Prices

Soonman Kwon, Jaeheon Heo, Sujin Kim, Youn Jung

Seoul National University, Korea, South (Republic of)

Problem statement: Rapid increase in pharmaceutical expenditure is a big concern for health policy, and there is a controversy over whether the price of medicines are adequate in South Korea.

Objective: To carry out an international comparison of the prices of generic medicines of 80 molecules that are frequently used in South Korea

Method: Using IMS data on ex-manufacturer prices of generic medicines in 15 OECD countries and South Korea in 2008, we performed two analyses. Individual prices of selected molecules (having the same strength and formulation) were compared between South Korea and other countries. Then 4 types of bilateral price indexes for each country were computed relative to South Korea: Laspeyres index, Paasche index, Fisher index, and Walsh index, which are classified by the method of weighting.

Results: For the price comparison of individual molecules, the results varied depending on molecules because of the differences in pharmaceutical markets in each country, such as the pattern of preferred molecule and volume. Comprehensive price indexes showed generic prices in foreign countries, except Switzerland and Japan, are about 10–50 percent lower than those in South Korea. And the price indexes using gross domestic product purchasing power parities suggested that South Korea’s prices of generic medicines are the highest. Ex-manufacturer prices and consumption volumes of selected molecule-strength-formulation varied substantially between countries.

Conclusions: The results show that in South Korea more expensive molecules are consumed, and the overall price of generic medicines are higher than in other advanced countries.

Funding source(s): National Health Insurance Corporation (NHIC), Health Insurance Review and Assessment (HIRA)



Ibrahim Labouta, Akram Fayed, Ghada Abu Shesha, Mohamed Mosly, Nahla Kandil, Abeer Hassan, Muhammad Zaitoun

Andalusia group (Dr.Hazem Darweesh Zagzoug) - Al-Salama hospital, Egypt

Key words: Stress-ulcer prophylaxis, cost, guidelines, clinical pharmacy

Problem Statement: Routine pharmacologic stress ulcer prophylaxis (SUP) among critically ill patients has been questioned. Guidelines have proposed limiting the use of prophylaxis to ICU patients who are at high risk of developing stress-related hemorrhage.

Objectives: The purpose of this study is to compare prescription patterns according to whether stress ulcer prophylaxis is indicated or not, and the estimated cost savings pre and post the intervention of the clinical pharmacists to implement the guidelines of the (ASHP) for use of stress ulcer prophylaxis (1999) and International guidelines for management of severe sepsis and septic shock (2008) in critically ill patients.

Design: The current study is an intervention pretest-posttest study (without control group).

Setting: The study was conducted at the Intensive Care Unit of Al Salama Hospital, Alexandria; Egypt.

Study Population: Fifty four patients were identified for inclusion and evaluated in terms of adherence to the guidelines for two month. Then, the SUP guidelines were presented to the intensivists. Subsequently, 48 ICU patients were assessed prospectively for 6 weeks for proper indication of SUP.

Intervention(s): The study was conducted by the clinical pharmacists, it consisted of sending an educative email to the intensivists with a list of risk factors that predispose patients to stress ulcer so as to limit prescription of SUP to these patients; this list was also posted on the ICU board, and then followed by individual verbal communication.

Outcome Measure(s): The Number and percentage of ICU patients with and without correct prescription of SUP according to indication pre and post intervention were compared. The resulting costs pre and post intervention were also compared as the secondary measurement outcome.

Results: The clinical pharmacy intervention reduced the inappropriate prescription of overall stress ulcer prophylaxis by 6.3 percent (2 cases) (Fisher’s Exact test, p = .219). The improvement of inappropriate prescription according to indication did not differ significantly; however it was less frequent. No patients developed clinically significant gastrointestinal bleeding in the post-intervention phase. The estimated annual savings of (to be calculated) in patient charges and (to be calculated) in actual drug costs in our intensive care unit were decreased.

Conclusions: The interventions made by the Clinical Pharmacy Department in the form of sending an educative email and hanging posters as well as individual verbal communication were not effective in changing the prescription habits of SUP of the intensivists to meet the guidelines criteria. Limiting use of SUP to high risk patients can significantly reduce patient charges.

Funding Source(s): Al Salama Hospital, Andalusia Group for Medical Services


Reasons for Nonadherence to Antiretroviral Therapy among Adult Patients Receiving Free Treatment at a Tertiary Care Hospital in Delhi

Vivek Lal1, Shashi Kant2, Richa Dewan3, Sanjay K. Rai2

1Indian Institute of Health Management Research, India; 2All India Institute of Medical Sciences, New Delhi, India; 3Lok Nayak Hospital, New Delhi, India

Problem statement: Adherence to therapies is a primary determinant of treatment success in HIV/AIDS. Poor adherence attenuates optimum clinical benefits and therefore reduces the overall effectiveness of health systems. India-specific data on adherence is sparse. In light of the expansion of free antiretroviral therapy (ART) in the country, there is a need to learn what works and what does not. The reasons for nonadherence to ART need to be studied to identify patients who may need support in maintaining adherence and explore the means to do so.

Objectives: To ascertain self-reported reasons for nonadherence to ART by adult patients receiving free ART

Design: Cross-sectional, hospital-based study

Setting: ART Clinic of Lok Nayak Hospital (LNJP) at Delhi. LNJP is a tertiary care, government hospital. This hospital was identified by the Government of India as one of the first sites to offer free ART. The clinic has been functional since April 2004. The clinic provides free ART to patients.

Study population: HIV/AIDS patients attending OPD clinics, on self-administered ART for at least one week, and of age 18 years or older were included in the study. Consecutive sampling procedures were adopted, and OPD cards were marked to ensure that each patient was interviewed only once. The period of data collection was from January 2005 to December 2005.

Outcome measure(s): Adherence was assessed retrospectively over the previous four-day period, as used in the AIDS Clinical Trials Group (ACTG) follow-up questionnaire. Respondents self-reported when they last missed an antiretroviral (ARV) dose and, using a checklist, indicated the common reasons as to why they skipped their medication.

Results: In total, 200 patients were interviewed. The mean age was 33.3 years. The majority of patients were male and belonged to the age group 31–45 years. It was found that 90% had been adherent over the previous four-day period. 30% of the patients claimed to have ever missed a dose. Multiple responses were allowed for the patients in response to the reasons for ever having missed an ARV dose. The most commonly cited reasons were “away from home” and “simply forgot.” All the patients reported having been told about proper dosing, yet 6.5% reported having ever missed a dose when they felt sick.

Conclusion: Study results showed a high level of adherence over the previous four-day period (90%); however, 30% of patients reported having ever missed a dose. The data prove that free ART has been taken up well by the patients and lend support to the decision of the scaling-up of free ART. At the same time, these findings put greater responsibility on the system in terms of sustainability of the free ART program and support through formal counseling sessions to help patients to continue to adhere to this lifelong therapy.

Funding source(s): None


Cost of ARV Medicines in the Namibian Private Sector: Limitation to Increased Access

Jennie Lates2, Dawn Pereko3, Tiaan Serfontein4, Els Bindels5, Frank Feeley1, Wessels Afrikaner6

1Boston University School of Public Health, United States of America; 2Namibia Ministry of Health and Social Services; 3Management Sciences for Health; 4Medscheme Namibia; 5Pharmaccess Namibia; 6Namibian Association of Medical Aid Funds

Problem statement: Namibia has a substantial health insurance industry (covering about 18% of the population) as well as a major HIV epidemic (estimated adult prevalence ~18.8%). Insurers in the country have experimented with low-cost primary care health policies that include coverage for antiretroviral therapy, but uptake has been relatively low, increasing the proportion of the population insured by less than 1%. Almost half of formal sector workers still have no health insurance. Medicine costs are rising rapidly for insurers—from 20% of medical claims in 2008 to 35% in 2009. Costs for antiretroviral medicines in the private sector in Namibia are relatively high, raising the costs of the ART benefit in these low-cost policies. Treatment of HIV and AIDS is a national priority. The majority of clients receiving ART do so through the public health sector. Currently, over 95,000 clients receive ART at public health facilities, and this puts a huge strain on the public health sector. As a result Namibia is looking at ways that private health sector resources can be utilised in the fight against HIV/AIDS.

Objectives: The overall objective is to determine ways in which Namibia can increase the involvement of the private health sector in management of the HIV/AIDS epidemic. The specific objective of this study is to determine whether reducing the cost of ARVs in the private sector may have a significant effect on cost of ART provision in the private sector.

Methods: Using claims data from 1 private health insurer, we determined the normal cost at wholesale and retail levels for standard ART regimens within the national guidelines. These costs were then compared to the costs paid by the Ministry of Health and Social Services for similar regimens. Data from 1 low-cost private insurance plan was also reviewed from all clients on ART to assess the medicine costs as a proportion of total annual ART costs in a private insurance plan.

Results: Public sector costs for typical regimens were 35% to 72 % below costs at the wholesale level in the private sector. With the addition of the current retail markup, the annual cost of ART paid by private insurers is USD 202 to USD 1,510 per year, 54 % to 257% higher than costs for the same regimens in the public sector. In the low-cost private insurance plan studied, medicines accounted for 42% of the total annual cost of treatment for patients on ART.

Conclusions: The cost of ARVs in the private sector is much higher than in the public sector, and this cost contributes a large proportion of the cost of providing ART in the private sector. Therefore, providing ARVs at lower cost in the private sector has clear potential to make health insurance more affordable and thus increase the accessibility of low cost health insurance.

Funding sources: United States Agency for International Development (USAID)/Namibia


Prescribing Pattern of Psychotropic Substances in a Nigerian Neuropsychiatric Hospital

Mohammed Saheed Lawal, Ibrahim Oreagba, Olufunsho Awodele, Sunday Olayemi, Ishola Ismail

College of Medicine, University of Lagos, Nigeria

Background: Psychiatric disorder accounts for more morbidity than is often recognised. In developing countries, experience has shown that there are diverse patterns of psychotropic drug prescription, the commonest being polyphamacy.

Objective: To determine the prescription pattern of psychotropic drugs and to asses rational prescribing of these drugs in Neuro-psychiatric Hospital Yaba.

Methods: The study was carried out at the pharmacy department in the Federal Neuro-psychiatry Hospital, Yaba, Lagos. The hospital is a Federal Government owned specialist Hospital. Fifty prescriptions were systematically sampled for each month for a period of one year (January to December 2007), giving a total of six hundred prescriptions. Data was collected using standard prescription encounter sheets

Results: About 35.49% prescriptions contained at least an injection. 86.50% prescriptions contained antipsychotic drugs, other psychotropic drugs included antidepressants (27.50%), mood stabilizers (22.83%) and sedative/hypnotics (8.50%). Other drugs included anticholinergics (67.33%), analgesics (3.67%), antibiotics (3.67%), antihypertensive (11.67%), antihistamine (0.08%), antimalarials (4.50%), and haematinics (36.67%); 46.62% of prescriptions contained only 1 antipsychotic drug and 16.38% contained at least 3 antipsychotic drug combinations Chlorpromazine (49.32%), Fluphenazine (32.18%), Trifluoperazine (32.76%), were the 3 most frequently prescribed typical antipsychotic while Clozapine (1.15%), Olanzapine (0.96%) and Risperidone (5.97%) were the most frequently prescribed atypical antipsychotics.

Funding source: Information not provided

Unbranded Advertising of Prescription Medicines–A Systematic Literature Review

Teresa Leonardo Alves1,3, Barbara Mintzes2, Aukje K. Mantel-Teeuwisse3, Hubert G.M. Leufkens3

1Health Action International Europe, Amsterdam, the Netherlands; 2Department of Anesthesiology, Pharmacology and Therapeutics at the University of British Columbia, Canada; 3Utrecht WHO Collaborating Centre for Pharmacoepidemiology and Pharmaceutical Policy Analysis, the Netherlands

Problem statement: Various forms of promotion of prescription medicines to the general public have become increasingly common. These include an increasing volume of ‘disease-oriented’ campaigns that discuss a condition a medicine treats without mentioning a specific brand name. The claimed benefit of disease-awareness campaigns is that the public becomes more aware of untreated health problems and seeks effective care at an earlier stage, leading to better health. However, serious information deficiencies have been identified in campaigns, raising questions about potential benefits versus harm. A key concern is that the context in which this information is provided could be biased towards supporting treatment with the sponsor’s product.

Objectives: To investigate whether advertising of prescription medicines through unbranded condition-oriented campaigns is associated with effects on health services use and health outcomes

Design: Systematic literature review

Setting: Published literature on unbranded advertising of prescription medicines identified by using Medline, Embase, Web of Science, Cochrane Systematic Review, all from January 1980 to December 2010. Searches will be supplemented with grey literature identified by the authors and experts. Data will be independently abstracted and logged into a data extraction form by 2 of the authors and any disagreements will be resolved by consensus.

Study population: Articles published in English, Dutch, French, Spanish, and Portuguese, describing the effects on health services use and health outcomes brought about by condition-oriented advertising campaigns of prescription medicines conducted by or on behalf of pharmaceutical companies and disseminated in any media (broadcast and printed).

Outcome measure(s): Effects on health services use and health outcomes; (1) measures of health service use are rates of first consultations, prescribing and dispensing rates, pharmaceutical expenditures, and sales volume; (2) health outcomes include increases or decreases in the rate of serious adverse events, non-serious, and total adverse events and quality of life, including outcomes associated with the condition being treated and/or drug therapy

Results: Published materials are limited and grey literature resources outweigh peer-reviewed articles. A detailed analysis of the published items will be provided, describing the focus, nature, and methodology of the different studies; in addition, selected outcome measures, academic or industry sponsorship, and type of publication/journal will be provided.

Conclusions: The literature review will inform current policy discussions on the impact of unbranded campaigns by the pharmaceutical industry in the direct provision of information about their medicinal products to the public.

Funding source: HAI receives funding from the Dutch Ministry of Foreign Affairs programme MFS1. HAI Europe has been awarded an operating grant for 2011 by the European Health and Consumers Agency.

Differences in External Price Referencing in Europe—A Descriptive Overview

Christine Leopold1,2, Sabine Vogler1, Aukje Mantel-Teeuwisse2, Kees de Joncheere3, Richard Laing4, Bert Leufkens2

1Gesundheit Österreich GmbH (GÖG), Austria; 2Utrecht Institute for Pharmaceutical Sciences, the Netherlands; 3WHO Regional Office for Europe, Denmark; 4WHO Department of Essential Medicines and Pharmaceutical Policies, Switzerland

Problem statement: Various pricing policies are applied in European countries; external price referencing (EPR)—the mechanism of setting and/or negotiating the price on the basis of the price in other countries—is the most common pricing policy in Europe with many national specifications.

Objective: To provide an up-to-date description as well as comparative analysis of the national characteristics of EPR in Europe.

Design: Cross-country descriptive study; review of the country-specific Pharmaceutical Pricing and Reimbursement Information (PPRI) Pharma Profiles as well as personal contacts with members of the PPRI network

Setting and study population: 27 EU countries as well as Norway

Interventions: N/A

Policy: EPR, the policy under investigation in this study, is defined by the glossary of the European PPRI network as “the practice of using the price(s) of a medicine in one or several countries in order to derive a benchmark or reference price for the purposes of setting or negotiating the price of the product in a given country.”

Outcome measure(s): The outcome was the number of countries that applied EPR in 2010 as well as the number of countries with the most common mechanisms within the EPR methodology.

Results: 24 European countries have implemented EPR in 2010. The majority of countries had statutory rules to enforce EPR. Most countries had less than 10 countries in the reference basket; five countries defined between 10 and 20 countries in their basket, and three countries had more than 20 countries in their basket. Taking the average price of all countries in the basket as the basis to calculate the price was the most common strategy (n=8). The methodology of EPR has changed in most European countries (n=19) over the past 10 years. Two countries have decided to abolish EPR as means of national price setting for medicines, but Malta decided in 2010 to implement EPR for regulating the prices of new medicines.

Conclusions: EPR is a widely used pricing policy. Important differences were observed between countries in the way they carry out this pricing policy. A trend on including more reference countries in the basket was recognised. The widespread use of this policy may serve to save public funds by efficient price setting but may also result in prices tending to converge without taking into account different countries’ ability to pay.

Funding source(s): Self-funded


How Much of the Price Variance of Medicines Can Be Explained by External Price Referencing?—A price Comparison among 15 European Countries

Christine Leopold1,2, Sabine Vogler1, Leonhard Seyfang1, Aukje Mantel-Teeuwisse2, Kees de Joncheere3, Bert Leufkens2, Richard Laing4

1Gesundheit Österreich GmbH (GÖG), Austria; 2Utrecht Institute for Pharmaceutical Sciences; 3WHO Regional Office for Europe, Denmark; 4WHO Department of Essential Medicines and Pharmaceutical Policies, Switzerland

Problem statement: Regulating medicine prices by the implementation of pricing policies such as external price referencing (EPR) is widespread in Europe. The assumption is that countries that apply EPR have lower medicine prices than countries without EPR.

Objectives: To examine the impact of EPR on the average price level of 15 European countries in 2007 and 2008

Design: Cross-country volume-weighted price analysis of a basket with 20 products in 15 countries in 2007 and 2008. Multivariable analysis was performed to account for differences on the gross domestic product, total pharmaceutical expenditure, and the national employment in the pharmaceutical industry.

Setting and study population: 20 products in 15 countries (11 applying EPR and 4 countries without EPR) in 2007 and 2008 were investigated. The unit ex-factory prices of each product were weighted according to their sales volume. The prices were compared between the two groups of countries with and without EPR as well as over time. For some countries, such as the United Kingdom, the prices were adjusted to exchange rate fluctuations.

Interventions: N/A

Policy: EPR, a policy in which the price(s) of a medicine in one or several countries is used to set or negotiate the price of the product in a given country, is only applicable for prescription-only or reimbursable medicines in the majority of EU countries.

Outcome measure(s): The average price level in the countries with and without EPR

Results: Data will be presented showing that, in principle, the average prices were lower in countries with EPR. This outcome was especially true for on-patent reimbursable products, which showed a less erratic picture, although considerable variation was observed between individual products and countries. Regulatory safety discussion (e.g., for Avandia and Actos ) also had an influence on the price development of the products. Products that already had generic alternatives on the market had, in general, lower prices in all countries whether EPR was applied or not.

Conclusions: Countries with EPR seemed to have more erratic prices. More specifically, EPR seemed to be a reasonable pricing policy for on-patent reimbursable medicines to have moderate prices.

Funding source(s): Self-funded


Improving Access to Medical Supplies in Emergency Settings by Preparing Humanitarian Responders with Online Medicine Supply Management Training

Libby Levison1, Monica Onyango2, Leilani Johnson3

1Independent consultant, United States of America; 2Boston University School of Public Health; 3Circle of Health International

Problem statement: When organizations respond to an emergency, one significant determinant of their ability to deliver effective medical care is the robustness of the medicine supply management system. Many relief organizations may not have the time or resources to develop specific training materials. Additionally, responders to humanitarian emergencies are often required to depart immediately, with minimal time for training before departure and limited resources upon arrival. To address this problem, we are developing a set of training modules on medical supply management to be made available online to academic and not-for-profit organizations.

Objectives: To test the feasibility of using an online course to teach medical supply management to potential responders to humanitarian emergencies

Design: Descriptive; before-after study with no control group. Participants were given a written quiz on the management of medical supplies. Participants then followed 4 online modules on medical supplies, quantification, stores management, and the analysis of morbidity and consumption data. After completing the online modules, participants retook the original quiz.

Setting: Online

Study population: Graduate students in public health enrolled in a course on humanitarian emergencies and volunteers preparing to travel to Circle of Health International’s project in Haiti

Outcome measures: Increased scores as measured by comparing the results of the pre- and post-training quizzes.

Results: After taking online lectures, 100% of students increased their knowledge of medical supply management; 64% showed significant increase.

Conclusions: Findings from this study will facilitate the development of additional online training materials on medical supply management in emergency settings. These materials will allow organizations to standardize the management of supplies in their projects and to train responders as part of their preparation to go to the field. Strengthening the management of medical supplies will lead to improved health delivery and more rational use of medicines by guaranteeing that the right medical supplies are available when and where they are needed.

Funding sources: None


Experience with the Global Fund’s revised Quality Assurance Policy for pharmaceutical products

Sophie Logez, Joelle Daviaud, Monika Zweygarth, Carmen Perez Casas, Thuy Huong Ha

The Global Fund to Fight AIDS, Tuberculosis and Malaria, Switzerland

Problem Statement: As a major financing organization in the fight against AIDS, malaria and tuberculosis, the Global Fund is committed to ensure that patients in grant-funded programmes receive quality medicines. In 2007, stakeholders raised concerns about quality criteria for key medicines such as antimalarials and anti-TB medicines which are vulnerable to emerging resistance.

In 2008, the Global Fund reviewed its Quality Assurance (QA) Policy for pharmaceuticals, using a consultative approach. Since July 2009, all funded antiretrovirals, antimalarial and anti-TB medicines must be WHO-prequalified or authorized by a regulatory authority belonging to ICH, or- if fewer than two such finished products are available on the market - have a time-limited recommendation by a WHO-hosted expert review panel. Requirements for quality monitoring in recipient countries were strengthened.

Objective: To monitor the impact of the revised quality policy for ARVs, antimalarial and anti-TB medicines (ATM medicines) procured with Global Fund resources.

Design: Policy implementation is monitored through the Global Fund’s procedures for purchasing ATM medicines with grant funds: recipients must obtain the Global Fund’s approval to procure products which have been reviewed by the Expert Review Panel, and must report all purchases in the online price and quality reporting (PQR) system.

Setting: The Global Fund finances over 600 public and private sector programs in 145 countries. Recipients procure directly from manufacturers or through national or international organizations.

Study Population: Since the implementation of the revised policy, Global Fund grant recipients have reported over 2500 purchases of ATM medicines worth approximately 400 million USD.

Results: PQR reporting indicates that grant recipients have procured exclusively WHO-prequalified or stringently authorized antiretrovirals since July 2009, but challenges remain for anti-TB products and some products for severe malaria. With the implementation of the new criteria prices have increased for some products, while qualified sources are lacking for some antimalarial and anti-TB products. The policy was fine-tuned to ensure the continued supply of products. QA policy harmonization has started with key partners; the Global Drug Facility of the Stop TB Partnership now shares the Global Fund’s standards and assessment procedures.

Conclusion: The revised policy has created incentives for manufacturers of ATM products to meet the required standards for products of which the Global Fund is a major funder. It thus supports procurement of quality-assured medicines at competitive prices in the long term. Harmonization among donors and capacity-building in recipient countries are essential to shape the market and to facilitate implementation by countries. Consultations are under way to strengthen quality requirements for other essential medicines.

Funding Source: The Global Fund to Fight AIDS, Tuberculosis and Malaria


Spillover Effects of Prescribing Restrictions for Trastuzumab in Australia

Christine Y Lu, Preeyaporn Srasuebkul, Anna Drew, Robyn Ward, Sallie-Anne Pearson

Lowy Cancer Research Centre and Prince of Wales Clinical School, University of New South Wales, Australia

Problem statement: Trastuzumab, a recombinant monoclonal antibody, is used routinely to treat HER2+ metastatic and early stage breast cancer worldwide. In Australia, its use in these two settings has been subsidised since 2001 and 2006, respectively. Over this period, there have been ongoing concerns about the medicine’s cardiac safety. Consequently, at the time of listing trastuzumab for the treatment of early stage disease on Australia’s national drug program (October 2006), a requirement for cardiac function assessment before and every 3 months during treatment was introduced.

Objectives: To determine the spillover impact of a policy for “regular” cardiac monitoring in patients treated with trastuzumab for early stage disease on monitoring rates in patients treated with trastuzumab in the metastatic setting

Setting: Australia has a universal health care system. Both the Herceptin Program (a separate program to the national drug coverage program) and the Medicare Benefits Scheme (that covers cardiac function tests) are publicly funded, nationwide programs. The Herceptin Program enrolment data and the medical service claims data were linked via unique person identifier.

Study population: All women treated with trastuzumab for HER 2+ metastatic breast cancer via the Herceptin Program between December 2001 and February 2010 (n=3,779); median age 55 years (range 21–95)

Design: Interrupted time-series analysis

Outcome measure(s): Proportion of patients by quarter receiving cardiac function tests before initiating trastuzumab therapy and receiving cardiac monitoring during therapy

Results: After the policy was introduced, we found an immediate 8% increase (95% CI, 2–14; p=0.02) in cardiac monitoring before initiating trastuzumab therapy without a significant change in the trend. Monitoring rates during therapy increased steadily from early 2005, coinciding with the release of interim results from several trials involving trastuzumab that included data on its cardiac safety. The policy was also associated with an immediate 7% increase (95% CI, 3–10; p<0.01) in cardiac monitoring during therapy, which remained stable till the end of the observation period.

Conclusions: We identified a positive spillover effect of a policy, but our study highlights the need for research to evaluate intended and unintended consequences of prescribing restrictions on patterns of care and patient outcomes.

Funding source(s): Australian National Health and Medical Research Council Public Health Training Fellowship (CL) and Cancer Institute New South Wales Career Development Fellowship (SAP)


Remedies at Home: Evaluating an Innovative Medicines Provision Program

Vera Lucia Luiza1, Rondinelli Mendes Silva2, Angela Esher1, Fernando Avelar1, Samara Ramallho Matta1, Rocha Claudia Rocha2, Ranieri Camuzi3, Egléubia Oliveira4

1NAF/ENSP/Fiocruz, Brazil; 2SMS DC- RJ; 3FF/UFF; 4UFRJ

Problem Statement: Aiming to improve access to hypertension (HT) and diabetes (DM) treatment, and improve health care and enhance the information system, the municipality of Rio de Janeiro, Brazil, in 2002, implemented a public medicines provision program for HT and DM patients that delivered, free of charge, medicines directly to the patients’ homes. This program is named “Remedies at home” (Remédio em Casa or RECASA)

Objectives: Evaluate the RECASA program by considering aspects of structure, activities, and results.

Design: A cross-sectional survey was conducted. Data collection methods included interviews with managers and health professionals, observation of storage conditions, and medical records review. A household survey was also conducted. Indicators were related to financing, human resources, health care, dispensation, adherence to treatment, and patient satisfaction.

Setting: Municipality of Rio de Janeiro, Brazil (about 6 million inhabitants)

Study Population: All 88 health facilities operating the program were visited. A representative (10%) random sample of 580 patients were surveyed at household level.

Outcome Measure(s): Adequacy of structure and process. Outcome approach included patient satisfaction and adherence to treatment.

Results: The program was structured to establish a specific central distribution facility where prescriptions were prepared for delivery. RECASA was given a a specific budget, access to an information system, and limited human resources. Not all procedures were adequately standardized and clearly communicated to professionals involved. There were also inconsistencies between information entered in the computerized system and medical records. Most of patients (91.6%) declared to be satisfied with RECASA but only 1% were found to be totally adherent according to Martín-Bayarre-Grau scale.

Conclusions: Some good results were achieved as a structure was established to operate the program and to provide patient satisfaction. However, the program implementation was not successful due to the major challenge of operating the program in a city with 6.2 million inhabitants; in addition, city violence caused problems with the program’s outreach.

Funding Source: Rio de Janeiro Foundation for Supporting Research (FAPERJ)


A Risk-Based Cost-Effective Approach to Medicines Quality Monitoring in Resource-Limited Countries

Patrick Lukulay1, Veerle Coignez2

1U.S. Pharmacopeia, Washington DC; 2Consultant

Problem statement: The use of substandard and counterfeit medicines (SCM) constitutes an increasing public health problem, especially in low- and middle-income countries (LMIC). A USAID-USP program has documented cases where over 40% of sampled medicines were of poor quality. Medicines regulatory authorities (MRA) in LMIC often cannot assume their medicines quality assurance role, and many do not even monitor the quality of medicines in the supply chain, due to lack of technical, human, financial, and/or legal capacity.

Objective: The study seeks to develop and test a risk-based three-level approach to medicines quality monitoring (MQM) that enables MRAs in LMIC to exercise better oversight over medicines quality in the country. The research questions are (1) can MQM be achieved on a large scale, to the extent it becomes an effective tool to help reduce the availability of poor quality medicines in LMIC? (2) what are the requirements for success?

Design: This is an operational research case study. It examines the introduction of a risk-based three-level approach to MQM in two countries: Cambodia and Ghana.

Setting: The risk-based approach to MQM can be applied at regional as well as national level, covering medicines throughout the supply chain, in the private and the public sectors.

Policy change: Cambodia introduced MQM in 2003 and Ghana in 2009. Both countries used the three-level approach of visual inspection, basic screening tests, and compendial testing. The sentinel sites were carefully selected and the sampling protocol adjusted to national context, allowing the MRAs to spread the net as wide as possible to catch problem medicines with the given resources. The test results were used to take concrete corrective actions, diagnose quality assurance problems, and/or raise public awareness.

Outcome measure(s): (1) Proportion of sampled medicines found to be substandard, (2) number of substandard lots withdrawn, (3) number of operators closed, and (4) other MQA improvement measures

Results: MQM enabled Ghana to identify and take action against specific counterfeits (including Coartem) in both years of operation. In Cambodia, 16.9% of antimalarials, sampled in 4 provinces, failed quality testing from 2003 to 2004. The failure rate dropped to 9.4% of 470 samples from 6-10 provinces (2005–07) and to 3.4% of 1,715 samples from 8-12 provinces (2008–09). In 2010, 728 antimalarials were sampled in the same 12 provinces: less than 1% failed quality control tests. Cambodia has closed over 1,000 illegal operators in 2009–11.

Conclusions: MQM based on the three-level approach enables an MRA to identify poor quality medicines in a country’s supply chain, without overwhelming scarce financial, human, and laboratory resources. The prerequisites are careful selection of sentinel sites and samples, appropriate use of screening technology, and an operational basic quality control laboratory. To have impact on the ground, timely reporting, political will, and a legal basis for corrective actions are key. To sustainably reduce SCM availability, other MQA activities will likely be required (see also abstract 219).

Funding source(s): Promoting the Quality of Medicines (PQM) Program, a USAID cooperative agreement implemented by USP


The Plague of Substandard Medicines in Developing Countries: Evidence for Policy Change

Christophe Luyckx, Jean-Michel Caudron, Raffaella Ravinetto

Institute of Tropical Medicine, Belgium

Problem statement: The global pharmaceutical market is characterized by multiple qualitative standards. Although the quality of medicines is generally assured in wealthy, strictly regulated countries, many resource-limited countries are still permeable to poor quality medicines. This North-South gap is caused by multiple factors, including the lack of awareness of key-actors, the increasing complexity of the global market, the lack of public information on the quality of essential medicines, the insufficient regulatory safeguards, the ever-increasing pressure on prices, and the insufficient political will to address the problem. Various international initiatives have been created to fight counterfeit medicines, whereas the problem of substandard medicines, which has an at least equally deleterious impact to the health of populations in resource-poor countries, is insufficiently addressed.

Objectives: To document the extent of the problem of substandard medicines in resource-poor countries and to develop guidance for corrective measures, with the ultimate objective of fostering universal access to quality medicines. Since most current initiatives aiming at strengthening pharmaceutical quality assessment focus solely on HIV/AIDS, malaria, and tuberculosis, we will look especially at medicines for other infective and chronic diseases.

Design, setting, and methods: The QUAMED Network , created at the end of 2010, brings together partners from Belgium, the Democratic Republic of Congo, France, Kenya, Madagascar, Togo, and the UK to develop operational, policy research, and advocacy activities. The core operational activities consist of technical assessments of finished pharmaceutical products, manufacturers, and procurement agencies, whose findings will be used through an innovative database for improving the procurement strategies of the partners in sub-Saharan African and for developing evidence-based policies to improve the quality of medicines in public health programs worldwide.

Results and policy: We will present the preliminary findings from the first year of activities of QUAMED, and we will discuss their possible short- and long-term implications, with special focus on the impact of quality of medicines on the performance of health systems. Policy changes could be envisaged both at the procurement level (for operational actors, such as procurement agencies, NGOs, and donors) and at regulatory level.

Funding source(s): QUAMED core activities are funded by the Belgian Directorate General for Development Cooperation (DGDC).


2006 Medicare Part D Benefit: Evaluating a Major Expansion of Medicines Insurance for Vulnerable Americans

Jeanne Marie Madden

Harvard University & Harvard Pilgrim Health Care, United States of America

Problem statement: In the US, health care and its access via insurance has been notoriously uneven and reliant on the private marketplace. With health spending at 17% of GDP, reforms are slow and contentious, despite widely acknowledged problems. National health insurance established in 1965 for elderly and disabled Americans did not include medication insurance. In 2006, a medicines benefit finally became available, Medicare Part D. A balanced evaluation of this major policy shift requires application of multiple, carefully selected approaches.

Objectives: To evaluate the impact of Medicare Part D for elderly and disabled persons in the United States, with focus on medicines affordability from the patient perspective, particularly for those burdened with chronic illness and for the poor

Design: Interrupted time series analysis

Setting: National samples from the United States, including (1) a representative panel survey of Medicare beneficiaries, and (2) insurance claims and enrollment data on 5% sample of persons dually enrolled in Medicare (for the elderly and disabled) and Medicaid (for the poor)

Study population: (1) approximately 15,000 survey participants per year (2000 to 2007), stratified by income, with subgroups defined by hypertension and diabetes diagnoses; (2) approximatedly 10,000 continuously dually enrolled individuals (2004 to 2007) with severe mental illness (schizophrenia or bipolar disorder)

Outcome measures: Study outcomes include type and generosity of medication insurance if any; annual prescription fills; annual out-of-pocket spending; costs of disease treatment; cost-related medication nonadherence; and adverse events (psychiatric hospital and ER admissions).

Results: After implementation of the new benefit in 2006, among the overall beneficiary population, we saw increases in total annual fills (+1.8 fills in 2006, +3.4 by 2007) and modest decreases in self-reports of cost-related nonadherence (relative decline about 15%). Decreases in annual out-of-pocket spending on medications were substantial (overall, 23% in first year), especially for those with no prior source of medicines insurance who enrolled in the new benefit (-37%). The new benefit reduced disparities among income subgroups, as intended. However, because of the benefit structure, chronic disease sufferers still faced large cost-sharing burdens and saw fewer improvements as compared with healthier beneficiaries.

Conclusions: These interrelated studies demonstrate the power of insurance reform to effect major changes for patients, even in the context of relative wealth. Moreover, these studies demonstrate the necessity of longitudinal data to accurately measure change and the importance of multiple measures and subgroup analyses in constructing a complete story. The presentation will focus on methods messages applicable in other settings with a broad range of developmental levels.

Funding sources: US National Institute on Aging and US Agency for Healthcare Research and Quality


Monitoring Medicine Prices with WHO/HAI Surveys: Upsides, Downsides, and Forward-Thinking Strategies

Jeanne Marie Madden

Harvard University & Harvard Pilgrim Health Care, United States of America

Problem statement: In the past decade, WHO/HAI medicine price surveys have been conducted in dozens of countries. The surveys represent snapshots of pharmaceutical prices and availability, based on limited samples, which can support policy reforms to increase patient access. The value of this information has great potential to multiply if surveys are conducted at regular intervals, such as quarterly. Several countries have implemented monitoring of medicine prices and availability using the WHO/HAI approach, including Kenya where monitoring continued for 4 years. Longitudinal monitoring poses both opportunities and pitfalls for local teams, but accumulated experiences and various tools are on hand to assist.

Objectives: To review the utility of medicine price surveys, particularly as part of a longitudinal activity; to explore design options for price monitoring and the consequences of design choices; to describe data patterns from actual practice in the field, trouble spots to be aware of, and analytic approaches that will get the most out of monitoring

Design: Price monitoring in general will be reviewed, with particular reference to the Kenyan experience, in which data was collected quarterly on the price and availability of targeted medicines (lowest priced version, regardless of manufacturer).

Setting: Examples will be drawn especially from monitoring in Kenya from 2006 to 2009.

Study population: Analyses for the Kenya monitoring were conducted at the level of medicines (N = up to 36 per survey round) and survey round (N =12 rounds representing calendar quarters). Approximately 15 rural and 15 urban outlets were covered in each survey round and sector (public, private retail, and mission).

Outcome measures: The presentation will cover the key WHO/HAI measures of percentage availability across outlets and median medicine price. An array of analyses were undertaken to aggregate data across medicines and assess changes over time. Price distribution and outlier observations were assessed, and results compared to an earlier snapshot survey.

Results: In the Kenya monitoring activity, several scheduled rounds were skipped, the targeted medicines list was updated twice, and the public sector exhibited a rapid shift toward zero-priced medicines, posing substantial challenges for comprehensive analysis. Nevertheless, the data were of generally good quality and a clear picture of changes in Kenya emerged, both at the aggregate level and in finer detail.

Conclusions: Price monitoring can be extremely useful in terms of enhancing our confidence around survey results, tracking important trends over time, and evaluating effects that may be attributable to specific policy changes. Attention must be paid particularly to the consistency of methods over time, so that data are comparable among rounds. Techniques are available to adjust for inconsistent data and to quantify both gradual and sudden changes over time.

Funding sources: WHO and Health Action International


Medicine Prices in Peru: Validation of the Sampling Approach Used in WHO/HAI Surveys

Jeanne Marie Madden, Edson Meza, Margaret Ewen, Richard O. Laing, Peter Stephens, Dennis Ross-Degnan

Harvard University & Harvard Pilgrim Health Care, United States of America

Problem statement: WHO/HAI medicine price surveys describe pharmaceutical prices and pricing problems in support of policy reforms to increase access to essential medicines. The survey methodology relies on data collectors to obtain prices for a defined basket of medicines (up to 50) from a sample of 30 outlets per sector (e.g., public clinics, private retailers). The sampling of medicines, outlets, and geographic regions is designed to balance representativeness and pragmatic concerns. However, such rapid sample methodologies involving only a small numbers of selected facilities and case types may mask potential biases.

Objectives: In a special validation activity, we sought to determine if: WHO/HAI survey results differed in the more remote areas typically excluded from sampling; medicines on the core target list reflected overall medicine availability and prices; limiting data to the originator brand and the lowest price generic version accurately captured a medicine’s price range; and WHO/HAI survey prices agreed with independent estimates.

Design: To investigate the extent of potential sampling biases, a survey was carried out that expanded the sampling frame of outlets and medicines in specific ways. Remote regions of the country and remote outlets within catchment areas were added. Comprehensive data were gathered on medicines within 3 therapeutic classes. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health.

Setting: 6 regions in Peru, South America, in 2005

Study population: Analyses were conducted at the level of outlets (N = 52 public sector facilities and 96 private pharmacies) and medicines (N = 38 using standard outcomes, plus detailed investigations within 3 therapeutic classes: 6 ACE inhibitors, 7 anti-ulcerants, and 8 oral anti-diabetic agents).

Outcome measures: Study measures included product availability, price distributions, retail and wholesale price medians, brand premiums, and treatment costs.

Results: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of ACE inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher-priced products, and weakly correlated for lower-priced products (which had higher estimated retailer markups).

Conclusions: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

Funding sources: WHO and Health Action International


An Action Plan for the Selection of Essential Medicines

Rachel Magarinos-Torres1,2, Vera Lucia Edais Pepe2, Claudia Garcia Serpa Osorio-de-Castro2

1Faculdade de Farmácia - Universidade Federal Fluminense, Brazil; 2Escola Nacional de Saúde Pública - Fiocruz, Brazil

Problem statement: The essential medicines list (EML) is a tool for guiding the clinical and administrative proceedings on medicines in certain political and clinical settings. Its adoption promotes access and contributes to rational use, to the extent that only essential medicines with verified efficacy, safety, lower cost of treatment per day, and the most appropriate dosage forms are included.

Objectives: The study aimed to present a process for the preparation of the EML for the State of Rio de Janeiro, Brazil, including a detailed plan of action for the process.

Design and setting: A review of management and technical procedures related to medicines selection in the State of Rio de Janeiro was carried out. Legal documents and meeting minutes were consulted. Other methods of data collection included observation and meetings with the responsible departments. Simultaneously, the review process of the Brazilian EML was analyzed. A plan of action for preparation of the final product was formulated.

Results: The plan was organized in three parts, according to the framework of health services evaluation. The first stage was structuring necessary planning activities for the review process, followed by the actual evidence-based review of medicines, seen as the core of the selection process. Finally, the results were worked upon, represented by the actions of promoting and monitoring adherence to the list. Intended objectives, goals, and procedures for each step were drafted, totaling 16 objectives, 8 goals, and 16 sequential and coordinated procedures. Every action was detailed in regard to its contribution to the objective, its implementation methodology and required resources, the estimated period for implementation, and the indicators to measure whether the objectives were achieved.

Conclusions: The EML should include medicines for all levels of health care, which should be made available by the health system. It is estimated that the action plan can support regular reviews of the list, as well as the selection processes in municipalities and state health units.

Funding source: Secretaria de Saúde e Defesa Civil do Estado do Rio de Janeiro–SESDEC RJ


What Do Managers and Prescribers of the Brazilian Health System Think of Essential Medicines? Preliminary Results of a Nationwide Qualitative Study

Rachel Magarinos-Torres1,2, Vera Lucia Edais Pepe2, Claudia Garcia Serpa Osorio-de-Castro2

1Faculdade de Farmácia - Universidade Federal Fluminense, Brazil; 2Escola Nacional de Saúde Pública - Fiocruz, Brazil

Problem statement: The adoption of the concept of essential medicines by health systems starts with the development and use of essential medicines lists (EML). In Brazil there are legal provisions for the development of EMLs in the health sector of the three levels of government and in health institutions. Studies have pointed to a low level of adherence to the EML, however, by managers and by prescribers.

Objectives: To describe, analyze, and discuss the knowledge and perceptions of managers and prescribers of the Brazilian Health System (SUS) in regard to the essential medicines concept and to the national, state, and local EMLs

Design: We present an exploratory qualitative study.

Setting and study population: 20 state and federal managers and 60 SUS prescribers from the five administrative regions of the country were sampled through a national health facilities database. Data were collected during the second semester of 2010 by means of participants’ responses to a questionnaire and interviews. Interviews were recorded and transcribed, with informed consent from interviewees. Analysis was done using content analysis technique.

Results: 30 health facilities were visited, in 15 different municipalities. Of these, 15 were hospitals of different levels of care, and 15 were primary health care units. Five state managers and 15 municipal managers were interviewed. Prescribers totaled 11 in the state of Rio Grande do Norte (Northeast), 13 in Acre (North), 12 in Goiás (Mid-west), 12 in Minas Gerais (Southeast), and 12 in Santa Catarina (South). All participants gave informed consent. Managers and prescribers associate essential medicines with primary health care, especially for treatment of hypertension and diabetes. Managers have some knowledge regarding the Brazilian national EML, but the importance given to essential medicines is mainly related to their financing quotas. Prescribers apparently do not employ the EML in their daily practice and do not recognize its value. Perceptions are that the lists are a restriction to prescribing, with perceived gains only for management and not for clinical practice.

Conclusions: Great effort has been channeled into the development and review of EMLs and to the adoption of the essential medicines concept throughout Brazil in the past 12 years. Nevertheless, adherence to these is still lacking. The results indicate that either these efforts have not been sufficient or strategies must be redirected. Further analysis is needed to understand which strategies have been useful and whether the relationship between levels of government and between prescribers and managers may enhance adherence to the list, fostering more positive attitudes and gains for the health system and for users.

Funding source: CAPES—Programa de Excelência Acadêmica PROEX/CAPES


Assessment of the Impact of Market Regulation in Mali on the Price of Essential Medicines Provided through the Private Sector


University of Montreal, Canada

Problem Statement

In Mali, public access to generic essential medicines and other prescription drugs occurs both through publicly subsidised institutions (“the public sector”) and the private sector.

Partly as a means of responding to public concerns about skyrocketing costs of prescription drugs and the negative impact on access to essential medicines, in 2003, the government passed a decree regulating retail prices of essential medicines in public institutions. This measure was partially undermined by the private sector, which purchased from the public wholesaler large quantities of drugs at competitive prices, creating a shortage in the public sector, and then resold the drugs to consumers at higher prices than were permitted in the public sector.

Consequently, in 2006, the government sought to further constrain the private sector and fixed maximum prices for 107 generic essential medicines.


The current study assessed the impact of this intervention on the evolution of market prices (wholesale and retail), and the subsequent availability and public access to essential medicines in Mali.


A cross-sectional descriptive survey was conducted in February and May 2006, and January 2009, with 16 wholesalers and 30 private drugstores in Bamako, Mali.

Our sample of drugs included 49 of the 107 highest selling generic essential medicines.

The variables collected were the availability of the 49 medicines and their wholesale and retail prices.


The overall availability of essential medicines at private wholesalers (p=1) and pharmacies (p=0.53) was identical before and after the enforcement of the 2006 decree fixing maximum drug prices. In private pharmacies, availability of the 49 drugs was estimated to be 66.1% in February 2006, dropping to 58.8% in May 2006, but returning to pre-enforcement levels (66.6%) by January 2009. Median wholesale prices in 2009 were 25.6% less than those fixed by the decree. In private pharmacies, retail prices were only 3% more expensive than the recommended prices, compared with being 25.5% more expensive prior to enforcement of the decree.

Before enforcement of the decree, the prices of only six out of 49 drugs (12.2%) accorded with the prices set by the decree; for all the other products the prices were more expensive. In May 2006, however, 85.4% of the drugs respected the maximum price limits. By January 2009, 63.8% of the drugs met the maximum prices.


The study shows that prices of essential medicines in Mali have evolved favorably towards the prices recommended by the government decree. Further, the study contributes to mounting evidence that market regulation by governments does not necessarily negatively affect drug availability; in fact, given the reduction in prices, the study shows that Malians arguably have better access to more affordable essential medicines.

Funding Source:

This study was funded by the Ministry of Health of Mali.


Pharmacovigilance Reporting in Kwazulu-Natal—Evaluation of a Solicited System of Reporting

Viloshinie Krishna Manickum1, Fatima Suleman2

1Strengthening Pharmaceutical Systems/Management Sciences for Health; 2University of KwaZulu-Natal, South Africa

Problem Statement: The high burden of HIV in KwaZulu-Natal resulted in an increase in the numbers of patients being initiated on HAART. However, very little information on adverse events was forthcoming from facilities. Therefore a solicited system of reporting was established to facilitate the reporting of adverse drug reactions (ADRs) from all accredited sites.

Objectives: To evaluate the effect of the solicited reporting system on ADRs reported.

Design: A retrospective audit was performed on forms that were received from 1 May 2007 to 31 May 2008 for all patients on HAART who experienced ADRs.

Setting: The study was conducted at provincial level. All public sector facilities that were issuing antiretrovirals were included in this study.

Study Population: The following patients were included in this study: (1) patients that were on HAART and experienced ADRs for which regimen changes were requested (n=3,534); (2) patients who required non-standard regimens (n=216); and (3) high-risk patients who were survivors of sexual assault and required post-exposure prophylaxis (n=173). Non-serious (Grade 1 and 2) adverse drug reactions that did not require a change of regimen were not considered in this study.

Intervention(s): The completion of the ADR form by clinicians, when they requested a change in antiretroviral/regimen. This form was then evaluated by a pharmacist at pharmaceutical policy and systems development in collaboration with consultants. Specific forms and guidelines were developed for the reporting process, and health care workers were trained with respect to the guidelines and the completion of the forms.

Policy(ies): Results generated by the solicited reporting system were disseminated to the National and Provincial Authorities resulting in the recommended adult dose of stavudine being decreased from 40 mg twice daily to 30 mg twice daily; and amending the South African National Guidelines in April 2010 to include newer antiretrovirals such as tenofovir.

Outcome Measure(s): Increase in number of reports submitted to the province; increase in the number of adverse events reported

Results: The total numbers of reports received from 77 hospitals were 3,923. Of the 3,322 reports that indicated patients were on stavudine, lamivudine and efavirenz/ nevirapine, 2,946 (88.7%) reports documented stavudine as the possible cause of the ADR. The proposed new regimen in 73.6% of the reports was zidovudine, lamivudine, and efavirenz/nevirapine.

Conclusions: The system of centralized system of solicited reporting looks intensively at the reporting of adverse drug reactions, and provides results rapidly. It can be incorporated into a systematic, continuous risk assessment system in a resource constrained setting for the monitoring and evaluating of adverse drug reactions.

Funding Source(s): SPS, Department of Health (KZN)


Comparison of the National List of Essential Medicines (India) with the WHO Model Lists of Essential Medicines and Essential Medicines for Children

S. Manikandan1, Gitanjali Batmanabane2

1Indira Gandhi Medical College & Research Institute, India; 2World Health Organization, Regional Office for South East Asia

Problem statement: Essential medicines lists (EML) have been proven to improve access to medicines and facilitate rational use. The Ministry of Health, Government of India, revised the National List of Essential Medicines of India (NLEMI) in June 2011, 8 years after the previous list was published. This list was found to have improper selection, significant errors, and omissions. Because the EML is also advocated to be used for procurement of drugs in the public sector, there is an immediate need to analyse the lacunae in the present NLEMI so that these can be rectified.

Objectives: To review NLEMI in comparison with the 17th Model WHO EML and 3rd WHO Model EML for children (EMLc) and to identify areas of discordance and list major errors

Design: Descriptive study comparing NLEMI with WHO EML and EMLc in terms of proper selection, suitability of dose, and dosage forms

Methodology: The 17th Model WHO EML and 3rd EMLc were taken as basic templates, and NLEMI was compared to them. A table was prepared to permit easy comparison.

Outcome measures: Areas of discordance between NLEMI and WHO EML and EMLc

Results: There is evidence that the selection criteria of essential medicines as defined by WHO and the methods used to develop a list were overlooked when NLEMI was prepared. Obsolete medicines such as ether and tincture benzoin are included in NLEMI. Pantoprazole and famotidine have been added when omeprazole and ranitidine are already on the list; 5 antihistamines are listed in NLEMI whereas WHO EML and EMLc list 1. There are 7 iodine containing radiocontrast media in NLEMI, but 1 in WHO EML and none in EMLc. For many drugs, the information provided is incomplete. The strength of oral rehydration salts is mentioned as ‘As per IP’. Similarly, for premix insulin, it is not specified which of the 2 insulin preparations are mixed. There are also significant omissions of medicines which are listed in the national programmes (e.g., fixed dose combinations of antituberculosis medicines, iron and folic acid). Many drugs do not have either the dose or dosage form appropriate for children. Spelling mistakes in the name of the drugs and the more serious errors in the dose and factual errors are plenty. Inadequate formatting and lack of an index adds to the issues in NLEMI.

Conclusion: The basic considerations of efficacy, safety, suitability, and cost were not rigorously applied when the NLEMI was prepared. Greater accountability of those involved in its preparation is called for and an immediate revision is warranted.

Funding sources: World Health Organisation - SEARO


Selection of Essential Medicines

Aukje Kaija Mantel-Teeuwisse1, Rianne van den Ham1, Richard Laing2

1Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; 2World Health Organization, Geneva, Switzerland

Problem statement: Essential medicines are defined as those that satisfy the priority health care needs of the population. Since 1977, a WHO expert committee has developed a Model List of Essential Medicines every 2 years (Model EML). The Model EML serves as a tool for countries to develop their own essential medicines list (EML).

Objectives: To describe the evolution of the Model EML over time (1977–2009) and to compare national EMLs and the Model EML to verify how countries use the Model EML for their own decision making

Design: Descriptive study

Setting: International (Model EML) and national (EML) level

Study population: WHO Model EMLs between 1977 and 2009 were assessed. In addition, 12 national EMLs (equal representation of the 6 WHO regions) from the year 2006 and 2007 were selected and compared to the 2005 Model EML.

Intervention(s): N/A

Policy: An EML is a helpful tool to achieve better health care, better drug management, and lower costs. The contents of the WHO Model EML and the selection process itself should serve as model. Over the years, the selection process used by WHO changed fundamentally over time. Selection is based on the underlying evidence rather than experience of committee members.

Outcome measure(s): WHO Model EML: both the quantitative (e.g., number of molecules and formulations, dosages, and their ratio) and qualitative changes (e.g., additions and deletions of specific medicines). Differences in medicines included in the Model EML and the 12 national lists.

Results: The number of molecules listed on the Model EML increased between 1977 and 2009 from 204 to 355 molecules, excluding duplicates. The list expanded mainly due to the growth of specific sections and the incorporation of the EML for children. Comparison with national EMLs showed that 42% of these EMLs contained fewer medicines than the 312 medicines that were present on the WHO Model List of 2005. The ratio of dosage forms to medicines ranged from 1.2 to 2.1 for national EMLs compared to a ratio of 1.7 in the WHO Model EML 2005. Examples of medicines that appeared on none of the national EML’s were anti-infectives such as triclabendazole and levofloxacin, cytotoxic medicines such as chlormethine and levamisole, and the combination mifepristone-misoprostol, used for early pregnancy termination. Alternatively, some medicines that appeared on the national EMLs but not on the 2005 Model EML, did appear on the 2009 Model EML, such as omeprazole.

Conclusions: The WHO Model EML expanded considerably between 1977 and 2009. Undesirable differences between the Model EML and national EMLs were observed. Reasons for countries not to include specific medicines may be the variety in burden of disease costs, unavailability, or cultural unacceptability of the medicine. The selection process should not be determined by an expert’s opinion and experience but should be the result of a systematic review of the underlying evidence.

Funding source(s): None


Conflict of Interest Policies: Do Academic Medical Centers Make the Grade?

Christopher Manz1,3, Timothy Anderson2,3, Gabriel Silverman3,4, Allan Coukell5

1Duke University, United States of America; 2Case Western School of Medicine, United States of America; 3American Medical Student Association, United States of America; 4University of Pittsburgh, United States of America; 5The Pew Charitable Trusts, United States of America

Problem: Conflicts of interest can distort physician prescribing practices, resulting in inappropriate prescribing, increased reliance on expensive brand name drugs and increased utilization of healthcare resources. Appropriate institutional policies can mitigate the negative impact of conflicts of interest on prescribing practices and patient care in industrialized and non-industrialized countries.

Objective: This survey examined the quality of conflict of interest policies at all academic medical centers in the United States, with the intent of promoting policy transparency and encouraging schools to implement stronger policies.

Design/Intervention/Policies: The American Medical Student Association administers an annual PharmFree Scorecard survey. The survey evaluates academic medical centers on 11 metrics related to conflict of interest: gifts, consulting relationships, industry-funded speaking relationships, disclosure, pharmaceutical samples, purchasing and formularies, industry sales representatives, on and off site educational activities, industry support for scholarships and funds for trainees, and medical school curriculum. Each policy is evaluated on a 3 point scale according to standards widely used and established by literature, and schools are assigned a letter grade of A through F.

Setting/Population: The Scorecard surveys all 152 allopathic and osteopathic medical schools in the US.

Outcome Measure: The quantity and quality of conflict of interest policies at academic medical centers.

Results: From 2008 to 2010, the Scorecard has documented a large increase in the number of schools with strong conflict of interest policies (rated A or B), from 19% of schools in 2008 (29 out of 149 schools) to 52% of schools in 2010 (78 out of 152). The Scorecard has seen a consistent rise in strength of policies across all 11 metrics and a participation rate of 92%.

Conclusions: Since the Scorecard was instituted in 2007, the number and quality of conflict of interest policies at medical schools has increased substantially. That the Scorecard campaign has played an active role in this process is evidenced by coverage from major media outlets, including CNN, Fox News, the New York Times and the Wall Street Journal. In 2009, when 18 schools refused to respond to the survey, US Senator Grassley required that they submit policies to the US Senate instead, highlighting the importance of the Scorecard in promoting conflict of interest polices. The Scorecard has empowered medical students at institutions across the country (most visibly at Harvard Medical School) to push their institutions to improve their policies, underscoring the utility of the survey to drive policy change at an institutional level. Strong policies may reduce the negative impact of conflicts of interest, improve prescribing practices and lower cost of care in both developed and developing countries.

Funding: The Scorecard is supported by funding from Pew Charitable Trusts.


Improving Access to Routine Medication from a Revolving Drug Fund for Chronic Patients in Rural Cambodia

Ngeav MAO, Maurits VAN PELT

MoPoTsyo patient information centre, Cambodia

Problem Statement : A structured 1,023-chronic-patient-membership community, consisting of diabetic mellitus (DM) and high blood pressure (HBP) patients, has formal arrangements with the public hospital services to prescribe the medicines for these chronic conditions and with the private sector to dispense the prescription medicines in their districts. The patient network facilitates access to prescription medication through a revolving drug fund (RDF) having contracted with one private pharmacy. In the first 6 months of 2010, this private pharmacy underperformed, leaving uncertainties about adherence and medicine use by the members. Besides, inconsistent health education messages from different sources reaching HBP patients compromised access and their adherence to the continuum of care.

Objectives : To document how both access and adherence to routine prescription medicines from an RDF were improved using a comprehensive set of specific measures. These measures include expanded roles of chronic patients and peer educators (PE) and also supply-side measures, notably increasing the number of pharmacies and agreeing with service providers on harmonization of specific health education messages.

Design : Before-After Study of Intervention effects

Setting : In a rural Cambodian district of 133,000 people, mostly served by private and to lesser extent by public health services, a community-based peer educator network (PEN) operates. The 9 PEs is all diabetic themselves and some of them also have HBP. The network facilitates access to health services for DM and HBP patients registered as members of the network and access to an RDF by dispensing from contracted private pharmacies.

Study Population : 1,023 chronic patients, among whom 448 DM and 575 HBP.

Intervention : During the second half of 2010, three more pharmacies were contracted: one was located near the existing central one, one was in the eastern part of the district, and one was in the southern part. Specific measures were introduced throughout the whole operational district such as reinforcing Health education messages and increasing the number of specialised consultation sessions and the level and type of PE incentives for follow-up and for monitoring the RDF.

Outcome Measures : (1) Comparing the RDF sales during first half of 2010 to and by the one pharmacy to the RDF sales to and by the four pharmacies in the first half of 2011, detailing RDF revenue and costs, including PEN incentive costs; (2) number of dispensing to members by gender and age group compared with their prescriptions in periods before and after the introduction of the measures; and (3) health expenditures, monthly prescription costs, and the numbers of molecules prescribed.

Results : Among 1,023 registered members, 65% are women, and 29% are DM patients older than 60 years indicating relatively good access to the organisation's membership status by these groups. After introducing the special measures, out of 448 DM members the proportion of those with prescription for using the RDF increased from 58% (260 DM) to 67% (302 DM) (p<0.001). The proportions of men and women having used medical consultation remained unchanged and relatively proportionate: 73% women and 27% men. Among the DM patients older than 60 years, the proportion with prescriptions remained unchanged: 29%. The average monthly prescription cost increased from USD 4.36 to USD 5.44 (median from 3.66 to 4.94). The number of dispensing invoices by contracted pharmacies tripled from 345 invoices in first half of 2010 to 1,059 invoices in the first half of 2011. The average number of invoices per DM patient with prescription increased from 1.30 in the first half of 2010 to 3.51 in the first half of 2011. In the first half of 2010, only 11 of the 575 registered HBP members had a prescription, but this increased to 63 HBP patients in the same group in the first half of 2011. Invoice-based dispensing for them rose from 2 (0.18 times per patient) to 250 (3.97 times per patient) in the first half of 2011. The RDF gross revenue from drug sales to pharmacies rose from USD 2,817 in the first half of 2010 to USD 6,156 in the first half of 2011. The intervention’s main costs in first half 2010 and first half 2011 were USD 1,087 and USD 2,401 respectively for the RDF, and USD 1,117 and USD 1,359 respectively for the PEN suggesting increased activity. Both the costs of organising medical consultation and local supervision remained unchanged at USD 936 and USD 708 respectively. Costs and revenue related to the laboratory service provision are excluded from these financial figures to show the dynamics related to the RDF in particular.

Conclusions : The utilisation figures suggest that an intervention combining low-cost measures and pulling together demand and service supply sides can significantly improve access to routine medication for a structured rural membership community of chronic DM patients and has potential to serve an even larger group of HBP patients in the same area, simultaneously improving financial sustainability of the RDF.


Teaching Critical Appraisal of Medicinal Drug Promotion (CADP) in 3 Latin American Countries: A Network Initiative

Benoit Marchand1, Carlos Fuentes1, Martín Cañás2,3, Claudia Vacca4,5

1Acción Internacional Para la Salud (AIS) Nicaragua; 2Federación Médica de la Provincia de Buenos Aires (FEMEBA), Argentina; 3Grupo Argentino Para el Uso Racional de los Medicamentos (GAPURMED); 4Red para el uso Adecuado de Medicamentos (RAM), Colombia; 5Universidad Nacional de Colombia

Problem statement: Health workers utilize drug promotional materials from pharmaceutical companies as a major source of information, which can induce unnecessary drug consumption and/or misuse. WHO and HAI have identified this risk and have developed documents and material to make this problem known. Such documents were used as a reference by HAI-Nicaragua to develop and implement a CADP teaching module, which was presented as a network initiative to the Drug Utilization Research Group (DURGLA) and implemented in Argentina in 2006-2010 and Colombia in 2008-2010.

Objectives: To promote a critical attitude towards medicinal drug promotion , implementing CADP teaching module with health workers and medicine and pharmacy students

Design: Intervention to improve critical appraisal of medicinal drug promotion cross-sectional study

Setting: Medicine and pharmacy schools from Nicaragua, Argentina, and Colombia

Study population: Students from these universities

Intervention(s): Application of a CADP teaching module with doctors and pharmacy and medicine students that contained introductory material (PowerPoint and paper) about relevance of independent information and critical appraisal of drug information, pharmaceutical advertising pieces from each country, tools to evaluate advertising pieces agains the WHO Ethical Criteria, workshop support material (videos especially in Colombia and Nicaragua), and workshop evaluation. In Nicaragua, the impact was evaluated through a pre – post workshop survey.

Results: The CADP module was applied to 1,762 medicine students, 213 pharmacy students, and 30 doctors and pharmacists from Nicaragua, Argentina (3 universities of 3 great cities), and Colombia (biggest university in the capital). In Argentina and Columbia, the activities were developed in medicine and pharmacy degree courses, respectively. The participants and students considered the inclusion of CADP teaching module important and useful in their education. The module was considered pertinent by the majority of professionals and they would recommend it to their colleagues. When the module was evaluated for Nicaragua, knowledge and critical perceptions about industry/health professionals’ interactions, pharmaceutical sale representatives, and printed advertising material showed improvement.

Conclusions: The CADP teaching module is pertinent and useful for developing a critical attitude towards medicinal drug promotion. The contents could be incorporated into a degree curriculum of health professionals (Rosario University in Argentina will do it with a formal, 80-hour course at medical school) including impact studies, standardized materials, and experiences. These results are a concrete output of the complementarity of different networks in the region (DURG-LA, HAI/AIS-LAC, ISDB) and experiences of groups at the national level (GAPURMED, RAM). In 2009, the HAI/WHO guide Understand Pharmaceutical Promotion and Respond to it was published and it is now proposed to validate and evaluate the manual in the different universities of Latin America.

Funding source(s): Acción Internacional para la Salud /Drug Utilization Research Group


Access to Medicines in Guatemala, Honduras, and Nicaragua: The Challenge of Adapting Methodologies

Nelly Marin1, Cecilia Acuña1, Adriana Mendoza1, Vera Luiza2, Emmerick Isabel2

1Pan American Health Organization; 2National School of Public Health/Oswaldo Cruz Foundation, Brazil

Problem statement: Equitable access to medicines is one of the greatest challenges in the Americas. The 45º Directing Council of PAHO/WHO urged member states to address it as a priority, with emphasis on poor and marginalized populations. A better understanding on access (ATM), quality, and rational use of medicines (RUM) can support policing making to face problems related to these aspects.

Objectives: Describe the pharmaceutical situation in 3 Central American countries and identify the barriers related to ATM and RUM, comparing the pharmaceutical status of the related indicators in each country with the proposed standards.

Design: Approach based on the WHO Pharmaceutical Situation Level II package. Additional questions and performance reference were proposed. Each country was a unit of study and results compared among them. Indicators reorganized according to the dimensions of ATM adapted from Penchansky (1981).

Setting: Guatemala, Honduras, and Nicaragua

Study population: An average of 36 public health care facilities with their respective pharmacies, 5 public warehouses, and 30 private pharmacies were surveyed per country.

Intervention(s): Data collected from December 2007 to April 2008; observations were guided by checklists, documents consultation, patient exit interview, and secondary database consultation. Stakeholders of all 3 countries and local PAHO officers were identified and involved in all phases.

Policy(ies): Access to medicines

Outcome measure(s): Dimensions of ATM: availability, affordability, acceptability, and geographical accessibility

Results: The results shown poor ATM in all dimensions—prices are much higher in the private sector than the international reference prices (IRPs); shortages of medicines in both the public and private sectors; geographical access difficulties; no pharmacist in almost half of the pharmacies; high proportion of prescribers without training in RUM. Results were acceptable in regards to adherence to the prescription, prescriptions using generics, and the percentage of medicines dispensed in the public sector. There was a lack of uniformity of international standards and recommendations for comparing results, which made it difficult to qualify the situation in some dimensions, such as availability, IRPs, and percentage of antibiotics prescribed.

Conclusions: The comparison of results in these countries was facilitated because of their similarities in geographical area and socioeconomic status. The presentation of the results sensitized the national authorities on the need to review public policies and strengthen public pharmaceutical services, health and economic regulation of medicines, as well as human resources. Based on the results, Nicaragua already decided to review its National Drug Policy, which was started in 1996. Another lesson learned was the need to review the appropriateness of the WHO indicators for measuring different dimensions of ATM and to standardize the criteria and expected performance for indicators.

Funding sources: Pan American Health Organization


Using Routine Information for Improving Rational Prescribing

Abdullah Masoud, Mohammad Zafar, Mohammad Fahim, Paul Ickx

Management Sciences for Health, Afghanistan

Problem statement: Routine health information systems often do not contain the detailed information needed for analyzing irrational prescribing. In Afghanistan, the morbidity data in the HMIS is limited to several priority conditions, and medicine use data is limited to reported stock-outs of tracer medicines. In 13 of the 34 provinces, quantities distributed on a quarterly basis to each province are available.

Objectives: To improve rational use of antibiotics by regularly tracking distributed quantities against general patient load in different facilities

Design and setting: The USAID-funded Tech-Serve Project, through the Ministry of Public Health (MoPH), ensures pooled procurement of essential medicines for organizations that are contracted by the government to implement the Basic Package of Health Services in 13 of the 34 provinces of Afghanistan. Medicines are distributed quarterly, based on quantifications made by the NGOs implementing the contracts. Ad hoc reports mention gross overprescribing of antibiotics, but the available routine data does not allow a straightforward prescription analysis and, until very recently, available funding did not allow regular field assessments.

Intervention: Once every quarter, the total number of full-course antibiotic treatments distributed to each NGO is compared with total patient visits reported through the routine HMIS of the MoPH, allowing an estimate of what proportion of the patients might have gotten a full treatment of antibiotics. This provides a rough estimate of the degree of overprescribing of antibiotics at health facilities based on readily available data. The findings are analyzed by the NGO managers and possible actions for improvement are identified. In the process, NGO managers learn how to apply the same analysis to each facility.

Outcome measure(s): Over a two year period, by using this process, we observed a remarkable decline in irrational prescribing.

Results: The calculation method most likely underestimates the actual overprescribing. However, the high level of overprescribing identified in the last quarter of 2006 made it clear that something needed to be done. The results are now being discussed routinely with the NGOs and, as a result, they are now analyzing prescribing practices in all their facilities. The data for monitoring overprescribing is readily available from the routine HMIS, and thus the same approach is used by the MoPH’s Health Economics and Finance Department during their routine performance monitoring of the contracted NGOs.

Conclusions: In spite of the absence of detailed, disease-specific or actual prescribing data, overall improvement in prescribing practices can be made by drawing attention to the overprescribing of antibiotics by using data that are easily available.

Funding source: Activities were funded by USAID through the Associative Cooperative Agreement No. 306-A-00-06-00522-00 Technical Support to the Central and Provincial Ministry of Public Health (Tech-Serve) under the Leader Cooperative Agreement No. GPO-A-00-05-00024-00 Leadership and Management Sustainability (LMS) Project.


Evaluating the Impact of a Public-Private Partnership for the National Introduction of a New Rotavirus Vaccine: Evidence from a Case-Control Study in Nicaragua (2006–2009)

T. Christopher Mast1, Felix Espinoza2, Leonel Palacio del Carmen3, Shazia Khawaja1, Anna Cardellino1, Edmundo Sanchez4

1Merck Research Laboratories, United States of America; 2Leon University, Leon, Nicaragua; 3Manuel de Jesús Rivera Hospital, Managua, Nicaragua; 4Ministry of Health, Managua, Nicaragua

Problem Statement: Rotavirus causes over 500,000 annual deaths globally among children aged <5 years; 80% of deaths are in the developing world. In 2006, a highly efficacious rotavirus vaccine (RV5; RotaTeq™ [rotavirus vaccine, live, oral pentavalent] ) was licensed in the United States and Europe but its effectiveness in low-income countries was unknown. In addition, it has historically taken up to 20 years for a new vaccine to be available in developing countries.

Objectives: The Merck and Nicaragua RotaTeq™ Partnership was established in 2006 to provide: (1) free vaccinations against rotavirus gastroenteritis to all eligible infants born in Nicaragua; (2) a scientific evaluation to measure the public health impact of the three-year partnership; and (3) planned programmatic sustainability.

Design: A matched case-control design evaluated vaccine effectiveness (VE) between February 2007–October 2009. A surveillance program assessed vaccination coverage.

Setting: Six hospitals in Nicaragua and the surrounding communities

Study Population: The surveillance program enrolled 6,174 children with acute gastroenteritis (GE). Of these, 1,082 children had rotavirus RGE and 300 met the protocol definition of RGE for inclusion in the VE analysis. Cases were age-matched with 1,685 community controls and 1,894 hospital controls.

Intervention: The partnership provided over 1.3 million RV5 doses to infants in Nicaragua. Vaccine introduction and administration was implemented by the Ministry of Health through its routine vaccination program.

Policy: The study evaluated the policy impact of adopting a new vaccine into the routine national immunization delivery system.

Outcome Measures: (1) Extent of vaccination coverage, (2) public health impact assessmentof the partnership, and (3) sustained national vaccination with RV5 after completion of the partnership.

Results: The partnership resulted in a three-dose RV5 vaccine coverage rate of 92% among age-eligible children within the study period. Using conditional logisic regression, the adjusted VE against severe rotavirus disease in children receiving three doses was 87% (95% confidence interval [CI]:74,93) using community controls; 64% (95% CI:44,78) using hospital controls; and 76% (95% CI:63, 84) using combined control groups. In children at highest risk (<12 months old at the time of RGE onset), VE was 85% (95% CI:66,93) for the combined groups (all results p<0.05). After the completion of the partnership, Nicaragua continues vaccination with RV5 in 2011 and the sustainability of rotavirus vaccination has been ensured by a commitment from the GAVI Alliance.

Conclusions: The partnership demonstrated a feasible and sustainable model to reduce the delay in introducing a measurably effective new health intervention into a GAVI-eligible country.

Funding Source: Merck Research Laboratories.


Assessing the Readiness of Pharmacy Outlets to Support Chronic Care: Results from a National Assessment in Kenya

Josephine Maundu, Peter Nguhiu, Charles Ouma

Management Sciences for Health/Strengthening Pharmaceutical Systems (MSH/SPS) Program, Nairobi, Kenya

Problem statement: Pharmacy services are an underutilized resource that could contribute more to improving access to medicines and health care in developing countries. In Kenya, little is known about the scope and quality of pharmacy services, particularly in private sector outlets, and their potential contributions to patient-centered care, especially those on prolonged treatment for chronic diseases.

Objectives: To determine readiness and willingness of pharmacy outlets in the private, public, and faith-based sectors to provide pharmaceutical care; specific objectives were to determine readiness in terms of staff skills, qualifications, and perceptions and facility infrastructure.

Study design: Cross-sectional observational study conducted in August 2009; self-administered questionnaire based on key indicators was used to obtain data, which was analyzed using SQL Server Views and Stata Version 11

Setting: 501 study sites were selected to represent a wide range of pharmacy practice centers including public, private, and faith-based health facilities, retail pharmacies, and pharmacy training institutions in rural and urban settings in all 8 provinces

Study population: 469 pharmacy staff sampled from the selected study sites

Outcome measure: Percentages of the study population responding to questions related to readiness to provide pharmaceutical care

Results: Apart from routine dispensing, staff also offered clients drug information and patient education. Most of the respondents (92.9%) stated that, in their opinion, they provided pharmaceutical care with 82.3% indicating that they had adequate skills and knowledge to provide the service. However, perception of what constitutes this service varied; 80.0% were either pharmacists or pharmaceutical technologists. Almost all respondents (97.3 %) indicated that they felt pharmaceutical care was important in the current pharmacy practice environment in Kenya. Most (89%) of the practice facilities had a sizeable waiting area for patients at the pharmacy; 62% had private patient counseling areas, of which 84% were considered appropriate for confidential medicine counseling; 62% of the respondents stated that they used computers at their workplace. However, only 29.8% of the facilities had specialized dispensing software installed.

Conclusions: The basic elements required for pharmacy services to support chronic care are in place. The majority of dispensing staff are in pharmaceutical cadres who have the required knowledge and skills.. Readiness to provide pharmaceutical care is further evidenced by positive attitudes, willingness, and availability of suitable infrastructure. In Kenya, provision of chronic care services can be enhanced by fully utilizing the capacity of pharmacy to support the service and strengthened by addressing specific gaps in health worker skills as well as improving institutional capacity to provide an optimum standard of care.

Funding source: USAID-Kenya



Theeraya Mayakul

Siriraj Hospital, Thailand

Problem Statement:

Medication errors frequently occurred in surgical wards due to several transitions in hospital care. Medication reconciliation (MR) was an effective tool to reduce and prevent errors. MR process consisted of verification, clarification and reconciliation patients’ medication. These processes were successful by co-operation of multidisciplinary team including physicians, nurses and pharmacists.

Objective: To assess the compliance of multidisciplinary team on MR policy implementation.

Design: Retrospective descriptive study

Setting: Twelve surgical wards, Siriraj Hospital, Mahidol University

Study population: Medical Records of Patients admitted in 12 surgical wards during Oct.1st, 2009 to Sep. 30th, 2010

Interventions:On admission, nurses and pharmacists interviewed patient’s current medications including OTC medications, herbs and other supplements then recorded on MR form. Pharmacists reviewed medication history and completed list of medications. These medication lists would be considered by physicians before the first order. During hospitalization, pharmacists reconciled, identified medication discrepancies and also searched for drug related problems. Nurses could also compare medication lists to medication orders and identify discrepancies. They rechecked all medications before patients were discharged.

Policy: Medication reconciliation should be done for all patients

Outcome measures: The compliance of multidisciplinary team was assessed by nurse records, pharmacist reviews and physician signatures on MR form. Incompleteness of nurses’ interview and pharmacists’ interventions were measured.

Results: There were 8,882 cases admitted which 5,893 cases (66.35%) were conducted MR, by nurses alone 224 cases (4.1%), nurses and pharmacist 1,622 cases (24.5%) and pharmacists alone 4,027 cases (68.1%). There were few (0.12%) physicians signed on MR form. From 1,622 cases of nurses MR with pharmacist double checks, there were 507 cases (31.3%) found incomplete lists which incomplete in item was 65.5%, regimen was 17.5% and both item and regimen was 17.0%. Of those 1,581 medication errors found, there were omission (68.2%), commission (3.5%), difference of dose frequency (22.4%), and medication change within the same class (5.9%). Of 1,043 pharmacist interventions 83.2% were completely accepted, 8.0% partial accepted and 8.8% not accepted.

Conclusion: MR process could prevent medication errors. Pharmacists had major role on MR. The main problems of non-compliance of nurses and physicians on MR policy were a lot of work load and limited access to sources of medication information. These problems led us to develop a computerized program which will support patient’s medication profile, and also improve compliance of multidisciplinary team on medication reconciliation.

Authors: Mayakul T., Thummawut W., Kulabusaya B.,., Promraj R., Thammatinno V., and Yoobang U.


Measuring Access to Essential Medicines in Kenya Using the Standardized WHO Level II Household Survey

Regina M MBINDYO1, Fred M SIYOI2, Christa CEPUCH3, Njeri MUCHERU4, Joan WAKORI5

1WHO, Kenya; 2Pharmacy & Poisons Board; 3Health Action International-Africa; 4Ministry of Medical Services; 5Kenya Medical Supplies Agency

Problem Statement: Access to essential medicines (EMs) is a stated goal for Kenya’s health system. There is little evidence on access to and use of medicines in households (HHs) in Kenya. This is critical in determining the extent to which existing policies are contributing to access for policy development and strategic planning. A household survey was undertaken in Kenya in October 2008.

Objectives: To investigate household situations with regard to (1) how they access the medicines they need (where they obtain medicines and how much they pay for them), (2) barriers to medicines affordability, and (3) examine access and use of medicines in specific situations of acute and chronic diseases.

Design: Cross–sectional study; adapted WHO Level II Household Assessment tool

Setting: National survey covering households in 18 districts from 6 of the 8 provinces.

Study Population: 1,069 HHs with 5,955 household members. HHs purposively sampled with reference to 6 public facilities in each province, 30 HHs per facility, selecting 3 clusters of 10 HH within 5, 10, and 15 kilometers respectively of each of 6 public facilities per region. Analysis of HHs within 5 self–selected socioeconomic categories, with A=lowest and E=highest.

Policy Change: National Drug Policy 1994 under review. Health sector–wide approach implemented within the second National Health Sector Strategic Plan. Public supply of EMs being integrated centrally, with partial roll–out of the inventory–based ordering (pull) system. Some increase in public and donor medicines financing.

Outcome Measure(s): Access, use, affordability

Results: Percentage of health expenditures spent on medicines: A–95%, E–50%. Prevalence of chronic conditions in HHs: A–38%, E–13%; in women: >50% except diabetes and tuberculosis. Of medicines in HH: analgesics, antipyretics, non-opioids and nonsteroidal anti-inflammatory medicines,and disease modifying anti-rheumatic medicines: 31%; anti-infectives–28%. Percentage of HHs taking longer than 1hour to reach nearest public facility: A–67, E –47. HHs with medicines at home: A–41, E–74. Percentage of HHs obtaining medicines from public facilities for acute illness: A–54, E–18. Percentage of medicines for chronic illness obtained from public facilities: A–45, E–2.8. Percentage of HHs that disclosed at least one chronic illness: A–23%, E–35%. Percentage of HHs with chronic illness and medicines for chronic illness at home: overall 75%. Percentage of HHs that experienced catastrophic expenditure on medicines: A–2%, E–0%. Percentage of HHs that borrowed money to buy medicines: A–70%, E–2%. Percentage of HH with full insurance coverage for medicines: A–1%, E–1%.

Conclusions: Public facilities are a major source of medicines for poor HH

Poor HH spend more time travelling to a public hospital than wealthy HH

Chronic conditions are more likely found in wealthier HHs and in women. The wealthiest HHs are more likely to keep medicines at home. Medicines are a significant part of HH health expenditure; and they take up virtually all HH health expenditure for the poorest HH. Overall, non–public sources were the most frequent medicines sources in HHs. The majority of HHs took medicines as prescribed for chronic illnesses but the poorest HHs were more likely to fail to take prescribed medicines for chronic illness because they could not afford them. Insurance coverage for medicines is practically nonexistent for poorest HHs.

Funding Source: The survey was conducted with financial support through WHO from the UK Department for International Development (DFID) project on Access to Essential Medicines; and the European Commission’s EC/ACP/WHO Partnership on Pharmaceutical Policies. WHO provided technical support in collaboration with HAI-Africa, in the context of the DFID-supported WHO/HAI Collaboration project on Access to Essential Medicines.


Measuring Access to Essential Medicines in Kenya Using the Standardized WHO Level II Health Facility Assessment

Regina M MBINDYO1, Fred M SIYOI2, Njeri Mucheru3, Christa Cepuch4, Joan Wakori5

1WHO, Kenya; 2Pharmacy and Poisons Board - Kenya; 3Ministry of Medical Services, Department of Pharmacy - Kenya; 4Health Action International-Africa; 5Kenya Medical Supplies Agency

Problem statement: Access to essential medicines (EMs) is a stated goal for Kenya’s health system. Pharmaceuticals are complex, and multiple and cross-cutting factors influence access. A pharmaceutical situation assessment was undertaken in Kenya in October 2008, as a critical tool in determining the extent to which existing policies are contributing to access and providing evidence for policy development and strategic planning.

Objectives: To determine whether EMs to treat common conditions at primary care level (1) are available and affordable in facilities, (2) are properly managed, and (3) are prescribed and dispensed appropriately and by qualified personnel

Design: Cross-sectional study; adapted WHO Level II Health Facility Assessment tool; before-and-after comparison of public sector findings with similar 2003 study

Setting: National survey covering public facilities, faith-based health services (FBHS) facilities, and private sector facilities in 18 districts from 6 of the 8 provinces. Survey sites were hospitals, health centers and dispensaries, central warehouses, and retail pharmacies.

Study population: 108 facilities (36 per sector) and two central warehouses. Sampling of facility records and patients followed standard INRUD methodology.

Policy change: National Drug Policy 1994 under review. Health sector SWAp implemented within the second Health Sector Strategic Plan. Public supply of EMs being integrated centrally, with partial roll-out of the inventory-based ordering (pull) system. Some increase in medicines financing from the government and donors.

Outcome measure(s): Availability, affordability, prescribing, dispensing, health professional profiles

Results: For public, FBHS, private indicators: (1) percentage of availability of 15 basic EMs: 87 (93), 93, 93; (2) percentage of availability of 36 EMs: 67 (n/a), 66, 8; (3) stock-out days of 15 basic EMs (central): 0 (n/a)-0; (4) stock-out days of 15 basic EMs (facilities): 46 (25), 14; (5) centralized procurement MPR: 0.44 (n/a), 0.61, (n/a); (6) percentage of medicines issued for free: 89 (n/a), 15, 0; (7) affordability of selected individual treatments: <1 days’ reference wage (all sectors) (<1); (8) percentage of adequacy of storage (central): 50 (n/a), 100 (n/a); (9) percentage of adequacy of storage (facilities): 60 (75), 75, 80; (10) percentage of adequacy of labeling: 5 (13), 21, 40; (11) percentage of antibiotics prescribing: 77 (78), 68 (n/a); (12) percentage of prescribing according to EML: 93 (81), 79, (n/a); (13) percentage of facilities complying with dispensing law: 38 (n/a), 31, 81; (14) percentage of unqualified personnel dispensing: 42 (n/a), 25, 14; and (15) percentage of untrained staff prescribing: 14 (n/a), 6 (n/a).

Conclusions: (1) Basic EMs are available in all sectors; a broader scope of EMs is less available. (2) Public and FBHS centralized procurement systems are price-efficient; they procure almost exclusively generics. (3) Frequent, sometimes critical stock-outs occur in public facilities. (4) Public sector has low or no price barriers to accessing EMs. (5) Public sector medicines storage infrastructure is critically deficient. (6) Critical shortage of pharmaceutical personnel hinders services. (7) The mixed performance on RUM may reflect lack of clear strategies. (8) Regulatory requirements are not effectively enforced in public and FBHS facilities. (9) Public sector indicators show stagnation or deterioration compared to 2003. (10) Pharmaceutical services are poorly integrated in health sector coordination mechanisms.

Funding source(s): The survey was conducted with financial support—through WHO—from the UK Department for International Development (DFID) project on Access to Essential Medicines and the European Commission’s EC/ACP/WHO Partnership on Pharmaceutical Policies. WHO provided technical support in collaboration with HAI-Africa, in the context of the DFID-supported WHO/HAI collaboration project on Access to Essential Medicines.


Availability of Paediatric Medicines and Factors Impacting Availability in Faith-Based Health Facilities in Chad

Anke Meiburg, Donna Asiimwe Kusemererwa

Ecumenical Pharmaceutical Network, Kenya

Problem statement: The majority of deaths among children under 5 could be prevented or treated if paediatric medicines were available and accessible. MDG 4 on reducing child mortality and 6 on combating HIV/AIDS, malaria, and other diseases will not be attained if children’s medicines are not available. Although paediatric medicines increasingly figure on essential medicines lists, little is known whether these medicines are available at the facility level.

Objectives: To determine the level of availability of selected paediatric medicines in faith-based health facilities in Chad and investigate factors impacting availability

Design: Exploratory descriptive study; data collection was done in July and August 2010

Setting: Faith-based health facilities in 6 regions in Chad

Study population: 31 institutions were selected from 117 existing faith-based facilities through convenience sampling, including 7 hospitals and 24 health centres

Intervention: Face-to-face interviews were conducted with facility and/or pharmacy in charge; availability of 28 medicines in 34 dosage forms was physically verified

Results: Average availability of general medicines (excluding ARVs, TB, and malaria medicines) was 44% for all facilities (range 0–90%). Only 5 medicines were available in more than 50% of institutions, namely oral rehydration salt (90%), mebendazole 100 mg chewable tablet (87%), salbutamol 2 mg tablet (87%), diazepam 10 mg injection (81%), and tetracycline 1% eye ointment (68%). Medicines with an availability of less than 10% were ceftriaxone 250 mg injection (7%), vitamin A capsule 100,000 IU (7%), and chlorpheniramine syrup 2 mg/5 mL (0%). Availability of antibiotic syrups was 45% for amoxicillin 125 or 250 mg/5 mL, 39% for cotrimoxazole 240 mg/5 mL, and 13% for metronidazole 200 mg/5 mL. Zinc 20 mg tablet was only found in 10 facilities (32%). Average availability of medicines for priority diseases was 43% for ARVs (range 0–86%), 21% for TB medicines (range 0–43%), and 16% for malaria medicines (range 7–39%). Only 11 respondents (36%) reported that their facility had received medicines via national programmes; 19 institutions (61%) purchased 100% of the medicines they supplied with their own funding. Reasons for not being able to procure paediatric medicines were lack of funds (58%), availability of adult formulation to substitute (48%), and unavailability at the supplier (36%). Management tools for medicines like stock cards were only used in 19 institutions (61%). Only 2 facilities (7%) had pharmaceutically trained staff employed.

Conclusion: Availability of paediatric medicines was rather low. The study identified factors at facility and policy level that might have contributed to the low availability. Facilities should strive to improve management of medicines and policymakers should consider subsidizing paediatric medicines and ensure national programmes reach all facilities.

Funding sources: ICCO, WEMOS, and UCC



Peter Memiah1, Martine Etiene1, Kristen Stafford1, Eva Karorero1, Mwansa Mulenga1, Francesca Odhiambo1, Ruth Atukunda1, Solomon Agbor1, Ian Wanyeki2

1University of Maryland,; 2Futures Group

Problem Statement:

Quality improvement measures have been proven to be highly effective in the poorest health systems, but they often are not applied appropriately. There is therefore need to focus on building the capacity of health care workers to deliver quality services at primary health care facilities through the promotion of data use for decision making, building QI teams and carrying out STOCs’


To create site ownership and build sustainable teams that focus on data to improve processes and outcomes


A descriptive before–after study with no control group was used to evaluate the impact of the interventions. Time series designs were used for comparing trends


40 rural health Facilities in Kenya, Uganda, Tanzania and Rwanda

Study Population:

The sample included 40 rural health facilities with 160 health care workers providing HIV care and treatment to approximately 12,000 patients.


Through CQI training, each HF is represented by a 3 - 4 person team, members learn improvement techniques, exchange insights and advice, and have a shared sense of commitment to achieving common improvement goals and outcomes. Back at the HF level they conduct repeated cycles of interpreting data, problem diagnosis, development and implementation of small-scale improvement efforts, assessment of effects, and refinement and expansion of effective actions until desired outcomes are achieved.

Policy :

Advocacy for health facilities to form functional CQI teams to focus on data to improve processes and outcomes.

Outcome Measures:

Mortality rates, Lost to Follow up rates, Reduction in missed appointments and increase in pediatric enrollment


Four participants each came from the 40 facilities and went through a comprehensive quality improvement training package for 3 days. Topics discussed included(1) problem/issue identification from collected data (2) interpreting data trends (3) developing a small scale improvement effort (STOC) (4) How to engage other providers in the intended small change (5) Refining and expanding effective actions (6) providing effective feedback to the rest of the team. Individuals were asked to form QI teams at their various facilities and implement STOC


To achieve continuous quality improvement a new culture of quality has to be established at all levels of the health system whereby all staff are engaged in and take responsibility for maintaining and improving the quality of care that they deliver; where clients are equal decision-makers in the care process; and where the focus of the entire system is on problem resolution, rewarding good performance, and improving health outcomes.

Funding Sources:




Peter Memiah, Martine Etiene, Mian Hossain, Kristen Stafford, Mercy Niyang, Patience Mnjala, Anthony Amoroso, Solomon Agbor, Robert Redfield

University of Maryland, United States of America

Problem Statement:

Several indicators have been identified as impacting adherence to antiretroviral therapy (ART) in resource limited settings. Distance to clinic has been often cited as an important factor; however this indicator has not been thoroughly investigated in the rural African setting.


The objective of this analysis is to examine the relationship between distance from patients’ home to clinic and adherence to ART


A cross-sectional analysis .The dependent variable is adherence to ART. Adherence is measured using three questions from the validated Institute of Human Virology Adult Adherence Survey—doses missed in last week, last month and appointment missed in past three months. Age, gender, baseline CD4, opportunistic infections, ARV knowledge, and total months on therapy are used as controls in the multivariate analysis. Crude and adjusted logistic regression models are used to estimate the relationship between distance to clinic and adherence to ART treatment.


Rural health Facilities in Nigeria, Uganda and Tanzania

Study Population:

The sample included 1258 HIV AIDS patients in Nigeria, Uganda and Tanzania.


A cross-sectional retrospective review of patient health information documented in patient medical charts is conducted annually in AIDSRelief supported sites as part of the quality improvement program. Nigeria, Uganda and Tanzania conducted this on-treatment review on its adult population in 2008.

Policy :

Advocacy for health facilities to form satellite sites ; and community-based organizations have emerged to provide essential services in HIV-related prevention, care and treatment.

Outcome Measures:

The primary variable of interest is patients’ reported distance to clinic


Crude logistic regression results show that the odds of adherence to ART respectively is 1% (p<0.960), 20% (p<0.199) and 45% (p<0.001) less when a patient comes from 5-10km, 11-20km and more than 20km compared to a patient who comes from 5km or less. The trend in odds of adherence to ART remains consistent when the effect of other covariates in the model including baseline CD4 and number of months on ART are controlled for. Adherence to ART does not show any significant difference between males and females.


Simulation analysis show adherence to ART could be improved if distance to clinic could be minimized. Findings suggest that bringing care closer to patients and their communities through mobile or satellite clinics should be increased in order to improve the adherence to ART

Key Words:

Adherence, HIV, Access

Funding Sources:



Risk of Anemia Associated with Zidovudine (AZT)-based HAART in Namibia

Assegid Tassew Mengistu1, Ishmael Katjitae1, Catherine Corbell3, Johannes Gaeseb1, Jennie Lates1, Evans Sagwa2, David Mabirizi2, Jude Nwokike2, Francis Kalemeera1, Andy Stergachis3

1Ministry of Health and Social Services; 2Management Sciences for Health/ Strengthening Pharmaceutical Systems; 3University of Washington

Problem Statement: Anemia among AZT-based antiretroviral therapy users was the most commonly reported adverse event to Namibia’s Therapeutics Information and Pharmacovigilance Center (TIPC), accounting for 41% (106/256) of total adverse events reported in 2009. This generated a safety signal, which led to conduct of a pharmacoepidemiologic study to establish the incidence rate and risk factors of anemia among AZT users.

Objectives: To determine the incidence of and risk factors for anemia in adults on AZT-based HAART and to demonstrate the feasibility of using linked automated databases as a sustainable platform for assessing the safety and use of HAART to support evidence-based decision making in Namibia.

Design: A cohort of HIV adult patients newly initiated on AZT and d4T-based HAART from January 2007 to June 2008 were followed retrospectively using linked data from three automated data sources: (1) the ART electronic dispensing tool (EDT), a pharmacy-based database; (2) the electronic Patient Management System (ePMS), a clinical database; and (3) MEDITECH, a laboratory database from the Namibia Institute of Pathology. The paper-based clinical records stored at health facilities was used to validate the linked electronic data and to obtain additional information on risk factors of anemia for the nested case-control study.

Study Population: A total of 12,365 persons aged 19 to 65 years started on HAART between January 2007 and June 2008 whose unique person-records were identified from EDT and matched to ePMS and MEDITECH database.

Outcome Measure: Anemia, hemoglovin (Hb) value < 7.0 g/dl, diagnosed at least 30 days after starting HAART

Results: The adjusted relative risk (ARR) of severe anemia 29.76 (95% CI: 2.87,308.86) was highest during the first three months of AZT use compared to non-use. The risk dropped after the first three months of AZT use (ARR: 1.09 ) (95% CI: 0.17, 7.05) compared to non-use. In persons with baseline Hb values available, the incidence rate of developing severe anemia was 2.28 per 100 PY in the AZT cohort (95% CI: 1.81, 2.87). There was no significant difference in the incidence rate of severe anemia between the AZT and d4T cohorts during the entire period of follow-up among this subset of persons with baseline Hb values available. The incidence rate of severe anemia was similar to the incidence rate reported in South Africa and in Haiti but lower than the incidence rate reported in the Ivory Coast.The median number of Hb measurements during the first year was 2 for both AZT and d4T cohorts. Furthermore, the median time to a first Hb measurement was 37 days in the AZT cohort and 146 days in the d4T cohort.

Conclusions: Risk of severe anemia associated with AZT-based HAART was highest during first three months of AZT use and diminished thereafter. This study successfully demonstrated the benefit of records linkage in the examination of incidence rate and risk factors of adverse events and compliance with treatment guidelines.

Funding Source: USAID-funded Strengthening Pharmaceutical Systems


Pharmacoepidemiologic Study of Potential Drug Interactions in Hospital Inpatients

Dolores Mino1, Eugenia Galván-Plata2, Svetlana Vladislavovna Doubova2, Sergio Flores-Hernandez2, Hortensia Reyes-Morales3

1Instituto de Geriatría. Institutos Nacionales de salud, Mexico; 2Centro Médico Nacional Siglo XXI, IMSS; 3Instituto Nacional de Salud Pública

Problem statement: Prescribing more than one drug increases the risk of potential drug-drug interaction (pD-DI), therapeutic failure, high pharmacological effect, or adverse events.

Objectives: To estimate the frequency of drug-drug interactions in prescriptions for hospitalized patients and to identify the associated factors for these prescriptions

Setting: Mexico City

Study population and method: A secondary data analysis of a cohort was carried out, including 284 patients at the internal medicine ward in a third level hospital in Mexico City (from July 2003 to February 2004). Age, gender, diagnosis at admission, days of hospitalization, prescription, and administration of the drugs were analyzed. The pD-DI were identified and registered according to the severity by using the program Micromedex® DrugReax® System (Healthcare series 2007). Descriptive and crude association including the outcome variable and co-variables, and Poisson regression analyses were performed.

Results: The median of age was 53 ± 18 years old; 53% of the patients were women, and 34% were older than 65 years of age. 63% of the patients received one prescription identified as pD-DI, and 33.5% of these prescriptions were “major pD-DIs.” The most frequently paired drugs prescribed were fluoroquinolones and hypoglycemics (20.5%); enoxaparin, a nonsteroidal anti-inflammatory drugs, or anticoagulants (18.1%); furosemide, an angiotensin converting enzyme inhibitors (ACE inhibitor) (12.2%); allopurinol, also an ACE inhibitor (9%), and spironolactone, another ACE inhibitor (9%). A positive correlation between the number of potential DD-Is and the number of drugs (r=0.469; p<0.001, 95% CI: 0.34-0.55) was observed. The regression analysis showed that men have a 20% higher chance of receiving a prescription with the potential for pharmacological interactions than women (95% CI: 1.01–1.45) and that for each additional drug a patient is prescribed, that patient has a 9% higher chance of receiving a prescription with the potential for pharmacological interactions (95% CI: 1.07–1.12), independent of factors such as being older than 65 years, having a diagnosis of AIDS, days of hospital stay, and number of diagnoses at hospital admission.

Conclusions: The high percentage of prescriptions with pD-DI makes necessary to implement educational programs or alert strategies, including the identified associated factors, aimed at improving the quality of prescriptions and reducing the risks for hospitalized patients.

Funding source(s): Instituto Mexicano del Seguro Social


Predictors of Switching Antiretroviral Regimen Among Clients Attending TASO Jinja, Uganda

Justine Mirembe1, Sarah Khanakwa1, Vincent Batwala2

1The AIDS Support Organisation (TASO) Jinja Centre, Uganda; 2Mbarara University of Science and Technology

Problem statement: The Uganda Ministry of Health recommends AZT/3TC or TDF/3TC or TDF/FTC or D4T/3TC + NVP or EFV as first-line antiretroviral drug combinations for treatment of HIV. Information from clinical practice indicates that HIV positive clients are switched onto these drugs without following guidelines.

Objective: To assess the predictors of switching antiretroviral drug combinations among clients attending The AIDS Support Organisation (TASO) Jinja centre

Design: This was a policy evaluation that assessed the predictors of switching antiretroviral drug combinations in facility-based and home-based intervention models in August-December 2008.

Setting: TASO Jinja centre is located in eastern Uganda and serves a catchment population of 1.5 million. As of July 2008, the total number of active HIV positive clients was 9,068. The Jinja centre is one of the branches of TASO with headquarters in Kampala. This is a local, private, not-for-profit organization, providing HIV services using facility-based and home-based models.

Study population: A computer-generated random sample of 326 HIV positive registered clients on antiretroviral drugs was retrieved.

Policy: TASO follows the national guidelines on antiretroviral therapy (ART). Clinicians are encouraged to make a collective decision regarding replacement of 1 or 2 component drugs within the combination on a case-by-case basis. The current study reports that some of the replacements/switches did not meet the guidelines, resulting in abuse of antiretroviral drugs.

Outcome measures: Switching antiretroviral regimen

Results: 31 (11.4%) clients were in WHO clinical stage 4, 115 (35.3%) in stage 3, 126 (38.7%) in stage 2, and 1 (0.3%) in stage 1; 150 (46.0%) received drugs under the home-based model; the proportion of clients on first-line ART was 325 (99.7%); 142 (43.6%) were started on AZT, 3TC, and NVP; 132 (40.4%) on d4T, 3TC, and NVP; 26 (8.0%) on d4T, 3TC, and EFV; 24 (7.4%) on AZT, 3TC, and EFV; and 2 (0.6%) on TDF, 3TC, and NVP. About 60.3% developed side effects (peripheral neuropathy 93 [28.5%], anemia 27 [8.3%)], skin rash 10 [3.1%], lipodystrophy 5 [1.5%]) following ART initiation; 63 (19.3%) had their first antiretroviral drug combinations switched either by clinicians (48; 14.3%), pharmacy technicians (1; 0.3%), nurses (3; 0.9%), or field officers (5; 1.8%); 22 (6.7%) had their antiretroviral drugs switched for the second time, 7 (2.1%) for the third time, and 3 (0.9%) for the fourth time. All switches were within the first-line ART combinations. The antiretroviral drug combination that the client was started on (d4T/3TC/NVP; p = 0.002), development of side effects (p < 0.001) and lack of a medicine companion or treatment supporter (p = 0.039) were associated with switching of antiretroviral drugs.

Conclusion: The first antiretroviral drug combination, development of side effects, and lack of a treatment supporter were significantly associated with switching of antiretroviral drugs within the first-line regimen. To control the switching of drugs, ART team members should be involved in decision making.

Funding source: TASO Uganda


Controlling Medicine Prices in Sudan: The Challenge of a Recently Established Medicines Regulatory Agency

Gamal Khalafalla Mohamed Ali1, Ahmed Yagoub2

1Central medical Supplies Public Corporation, Sudan; 2National Medicines and Poisons Board

Problem statement: The price of medicines is one of several reasons for lack of access to essential medicines. Medicine prices in Sudan have been among the highest in the East Mediterranean Region. According to the Pharmacy and Poisons Act 2001, final consumer prices (retail price) are generally determined by National Medicines and Poisons Board (NMPB)—the medicine regulatory agency of Sudan—committee on medicine pricing. The prices are made up of a combination of the price charged by the manufacturer, pre-shipment inspection fees, freight (C&F) costs, import tariffs, port charges, insurance and clearance costs, a pharmacy board fee, and wholesalers’ and retailers’ mark-up.

Objectives: The aim of this study is to evaluate the efficiency current drug pricing system applied by the NMPB in controlling medicine prices. To do so we have checked the conformity of the C&F, whole, and retail prices of medicines with those approved by NMPB. We have also compared prices of generic medicines with those of branded medicines. Finally, prices of selected medicines were compared with those that have been published in the international price indicator guide and BNF (September 2008).

Design: The whole and retail prices, which are usually written on the invoice issued by the wholesalers, were evaluated. The actual price displayed on studied products by pharmacy was also reviewed. This evaluation study was based mainly on the records at selected pharmacies, NMPB, and interviews with key informants.

Setting: This study was conducted in Khartoum State between July and September 2008. The data were collected by the researchers from the records of 5 pharmacies that purposively selected.

Study population: We selected the most sold 50 medicines in 2007 (regardless of their dosage-form, strength, and brands). These medicines have market authorization in Sudan. We ended up with 174 items. The total number of imported medicines that were included in the study was 135 products. 120 (89%) items either generic or branded generics, and 20 products (11%) were innovator brand medicines

Intervention(s): NMPB appointed a committee to thoroughly examine the findings of this study and to report back to the board. The NMPB finally has passed new regulations on medicines price, which became in effect since August 2010.

Policy: It is now the policy of the government that drug companies charge equal medicine prices for all community pharmacies throughout the country regardless of the distance from their warehouses (i.e., there is a cross-subsidy from closer pharmacies to more remote ones).

Outcome measure(s): Enforcement of the medicine price regulations is expected to reduce cost of medicines by up to 50%. This reduction will enhance affordability and thereby access to essential medicines. It will also improve the use of medicines by enabling patients to obtain a complete course of treatment.

Results: The C&F prices of 23% of selected medicines were more than 10 times the International Reference Price. Surprisingly, 71% of these items were generics. The whole price of almost 40% of studied medicines was less than that has been approved by the NMPB. Again, 88% of these medicines were generics. Conversely, the retail price of 47% of drugs was less than that approved by the regulatory authority of Sudan. One of the most striking findings was the fact that the retail price of 7% of the items was three or more times their registered or approved C&F price (i.e., 300% mark-up on the C&F). The retail price of 11 out of 12 originator brands in Sudan was found equal to or more than their prices published in the British National Formulary (BNF, September 2008 edition). The selling price to the public of 82% of these brand medicines was two or more times their prices in the BNF. The actual retail prices of 46% of the selected medicines were twice or more their C&F prices. The price of the medicines distributed by Central Medicines Supplies (a government organisation), on average, was twice their C&F. The mark-up of CMS on the C&F price of selected items ranges from 71 to 2096%.

Conclusions: Price regulation should be considered to avoid stretching what are already inadequate household resources. Lower prices at CMS do not help much in controlling of prices in private sector because retail pharmacies sell the low-cost tender items from CMS at the retail price set by their wholesalers.

Funding source(s): NMPB

220-Mohamed Ali-_a.doc
220-Mohamed Ali-_b.ppt

Impact of Visualizing Performance in Improving Medicines Management in Public Health Sector Facilities in Uganda

Khalid Mohammed, Victoria Nakiganda, Dorthe Konradsen, Richard Semakula, Birna Trap

Management Sciences for Health, Uganda

Problem statement: Pharmaceutical supervision has been practiced in Uganda for a long time. Though effectiveness of supervision in improving medicines management has been documented, Uganda continues to struggle with weak medicines management. Although a performance-based reward system has proven successful in strengthening vaccine management, its efficiency in improving medicines management is not known. The impact of supervision much depends on implementation modality. To strengthen the effect of supervision and improve medicines management, trained medicines management supervisors (MMSs) applied an indicator-based data collection and assessment tool to assess good pharmacy practices. The tool visualises performance in a spidograph, allowing the health worker to better see performance and assess progress. The impact of the standardised, indicator-based performance assessment and visualising tool combined with supervision is not known.

Objective: To establish the impact of performance assessment and visual feedback on medicines management implemented by trained supervisors

Design: A controlled, pre-post intervention study with randomisation by facility; performance assessment is based on a set of 25 qualitative and quantitative indicators covering medicines management. Data collection is undertaken as baseline at the initial facility visit and at each of the following 2 supervisory visits at least a month apart.

Setting: The study is implemented in 9 districts (December 2010– September 2011) situated in the central region including 60 (83%) public and 12 private not-for-profit health intervention facilities covering all levels of care and in 12 control districts (March–August 2011) in the eastern region including 61 control facilities.

Intervention: All 72 facilities (level II to hospital) within each of the 15 health subdistricts are randomly assigned to 1 of 2 intervention groups—1 group (35) having performance assessment, visual feed back and supervision and the other group (37) having performance assessed and supervision. Performance was assessed in the control facilities only once.

Outcome measures: The primary outcome measures include assessment of stock and storage management, ordering and reporting quality, and dispensing and prescribing quality.

Results: Results will become available for ICIUM 2011

Funding sources: United States Agency for International Development through Securing Ugandans’ Right to Essential Medicine program


Cost as a Barrier to Access: Availability, Affordability, and Identifying Component Cost of Essential Medicines

Mohammedsied Nuru Mohammednur1, Teferi Gedif2, Damen Hailemariam2

1Mekelle university, Ethiopia; 2Addis Ababa university,Ethioipia

Problem statement: WHO reported that one-third of the world’s population lacks reliable access to required medicines. The situation is even worse in developing countries, and price is one of the factors that hinder access to essential medicines.

Objectives: To identify barriers in accessibility, availability, affordability, and component cost of essential medicines

Design: A descriptive cross-sectional study design was used. Quantitative methods involved the use of checklist; an exit interview and structured questionnaire were also employed.

Setting: The study was conducted in Addis Ababa (AA), capital city of Ethiopia, and Benishangul Gumuz regional state (BGRS), one of the nine regions in the country. The study included hospitals, health centers, and pharmacies from public, private, and other sectors.

Study population: From the two selected regions, a list of hospitals, health centers, and pharmacies were recorded, and 150 participants were interviewed using an exit interview. Furthermore, from 10 facilities (from each public, private, and other sector), data on availability and price of medicines were collected. For convenience, public health facilities were used to anchor the sample, with other types of medicine outlets chosen by their proximity to these facilities.

Results: In private pharmacies, innovator brand (IB) prices were 27 times higher than the international reference price (IRPs) in AA, whereas generics were 2.7 and 3.6 times higher in AA and BGRS, respectively. In other sector retail outlets, the figures were 2.52 and 4.9 times higher for generics than the IRPs in AA and BGRS, respectively. Add-on costs had a substantial impact on medicine prices in all sectors. Retail pharmacy markups were 25–55% and 25–247% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the national essential drugs list. For a month’s treatment for peptic ulcer disease and arthritis, people have to pay more than a month’s wages when IB was used. In the study of the exit interviews, around 61% of the respondents were able to pay for the prescribed medicines. The most important predictors of ability to pay (ATP) for the prescribed medicine found in this study are type of organization (p<0.015), educational status of the head of the household (p<0.01), amount of payment for the prescribed medicines, and estimated average income of the household (p=0).

Conclusions: The availability of lowest price generics was low in the public sectors and prices of IB were very high in the private sector of AA. Markups for generic products are greater than for IBs. Reducing the base price without controlling mark-ups may increase profits for retailers and wholesalers without reducing the price paid by end users. To increase accessibility and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required.

Funding source(s): School of Graduate Studies, Addis Ababa University


Newspaper Column for Consumer Education on Medicine Use—An Indian Columnist’s Experience

Guru Prasad Mohanta

Annamalai University, Department of Pharmacy, India

Problem statement: It has been reported that around 50% consumers do not take medicines appropriately. The studies have shown that the consumers in general know very little about the medicines. The regular print media usually focuses on diseases or health conditions and very little on the appropriate use of medicines. Whether the consumers use a formal health care channel or decide to self medicate, they are the ultimate decision makers. Public education has an important role to play to influence these decisions positively.

Objective: To educate the consumers on medicine use through a column in newspaper

Method: Because newspapers are read by average consumers (though literacy level is poor in India), I wrote consumer education materials in my column in one of the widely circulated and read English dailies, The New Indian Express’s fortnightly supplement “The Health.” A new column “Know Your Medicine” was initiated and covered around 76 articles in a period of around 4 years from 2004 to 2008. The column covered a wide range of themes ranging from consumers’ rights on medicine use to storing medicine at home to clinical trials to the use of individual medicine. Articles were written in a simple, user-friendly style.

Results: The articles have been widely accepted and appreciated by various sections of the society. The appreciation and enquiry ranged from asking me to continue to seek information on various aspects of medicines and their use. Some of the inquiries were answered in the column itself. One of the district collectors and joint director of public health, government of India, called me for encouragement and information. The general readers used to provide feedback and sought more information through postcards, telephone calls, and e-mail. The readers’ queries were answered through the column using a theme. The pensioner’s association asked permission to reproduce one of the articles relating the use of medicines in elderly in their newsletter.

Conclusion: The newspaper itself (the editor) was apprehensive about the need of such column during the beginning, but the readership’s survey proved the column’s popularity, and the newspaper then expressed the desire to continue the column. Despite of problems associated with publishing a regular column, because of its popularity among the readers, with support from editor, I continued my effort for around four years attempting to empower the public and promote appropriate use of medicines through public education. The continuation of the column for four years itself is a success and signifies its usefulness among the public.

Funding source(s): No funding


Monitoring the Safety of Medicines in Kyrgyzstan

Saltanat Moldoisaeva, Ashirali Zurdinov

Kyrgyz State Medical Academy, NGO "For rational and safety use of the medicines", Kyrgyzstan

Problem statement: This research concerns the problem of monitoring the safety of medicines in Kyrgyzstan. The mortality rate connected with use of medicines all over the world remains high, and consequently, timely detection of adverse drug reactions (ADRs) has great value. Kyrgyzstan has been a full participant in the safety of medical products monitoring program since 2003; however, the gathering of spontaneous reports has still not been adequately implemented.

Objectives: We investigated the level of activity of doctors in the safety monitoring system.

Design: The type of study was pharmacovigilance policy evaluation. The specially developed questionnaires were sent out to 1195 doctors in Bishkek City and the regions. The findings were worked up with the SPSS for Windows 13.00 statistical program.

Setting: The study was conducted at the national level and involved a variety of specialized practitioners in the city’s and regions’ government hospitals.

Intervention(s): It was anonymous, confidential questioning on a voluntary basis. The study was conducted from April to October 2010.

Results: Our research has shown that 2/3 of doctors observed ADRs in their practice. These doctors were then asked whether they registered ADRs in medical cards. Only 49 % of the doctors answered yes, and thus more than half of respondents, 51 %, answered that they seldom or do not register in general. Doctors were also asked if they filled out yellow cards upon the development of ADRs; only 9 % answered positively; 72 % of doctors do not fill out these cards and 17 % refrained from answering. According to doctors, the principal causes of the low level of ADR registration are (1) a lack of information for detecting the relationship of cause and effect between use of medical products and development of ADRs; (2) the erroneous opinion that all medical products registered in our state medical system are safe; and (3) the fear of having to answer to the hospital administration.

Conclusions: The problem of monitoring ADRs in our country remains unresolved. As shown by our research, doctors have a serious deficiency of knowledge about ADRs, which is the principal cause of the low level of registration. From this, it follows that measures directed toward improving the knowledge of medical workers in clinical pharmacology must be implemented, that motivation of workers in public health services must be increased, and that information transfer mechanisms must be reformed.

Funding source(s): Kyrgyz State Medical Academy, NGO “For Rational and Safety Use Of the Medicines”


Evaluation of Prescribing Pattern of Physicians in Various Health Care Facilities in Turkey with Respect to the Rational Use of Medicines Principles

Salih Mollahaliloglu1, Ali Alkan1, Senay Ozgulcu1, Basak Donertas2, Ahmet Akici2

1School Of Public Health,Ankara, Turkey; 2Marmara University School of Medicine Department of Pharmacology, Istanbul, Turkey

Problem statement: Irrational use of medicines is regarded as a severe health problem in Turkey. The Turkish Ministry of Health (MoH) is planning to conduct a series of activities for the purpose of rolling out rational use of medicines (RUM).

Objectives: Prior to the national campaign, this study aimed to evaluate the prescribing performance of physicians, who practice in various health care facilities, within the framework of RUM principles.

Design: Prescriptions were retrospectively collected in the randomly selected pharmacies, servicing in selected 10 provinces across Turkey.

Setting: Collected prescriptions were written out by physicians practicing in 5 different health care facilities (family health centers [FHCs], health centers [HCs], public hospitals, private hospitals, and university hospitals [UH]). Approximately 100 prescriptions per each facility were collected. The list of gold standard (GS) medicines, which are based on the standard treatment guidelines and expert views for 10 pre-identified diagnoses, were prepared. The prescribed medicines for these indications were checked for compatibility with GS. Average medicine cost per prescription was calculated according to the retail sales price of the drugs.

Study population: There were not HCs and UHs in 8 provinces and there were not FHCs in 2 provinces when the survey was conducted. A total of 3201 prescriptions covering all indications were reviewed.

Intervention: No interventions were made into physicians’ prescriptions.

Policy: It is expected that the results of this survey paves the way for a national program for rolling out RUM.

Outcome measure: Average number of medicines and average medicine cost per prescription (NMPP and MCPP), pharmaceutical categories of prescribed medicines, and GS-compatibility of these medicines were evaluated for each health care facilitiy.

Results: It was found that the most commonly prescribed medicines were respiratory system medicines (ATC code R) in HCs and FHCs, and musculoskeletal system medicines and alimentary tract and metabolism (ATC codes M and A) at hospitals. NMPP was 2.8 ± 1.1 and the highest average was for prescriptions written out for A. Sinusitis in HCs (3.8 ± 0.4). MCPP was found to be USD 54.9; 39.8% of medicines prescribed for 10 indications in all health care facilities were GS-compatible. It was noted the physicians prescribing GS-compatible medicines differed by health care facilities and UHs had the highest ratio (50.6%) in prescribing GS-compatible medicines.

Conclusions: This study made clear the types of medicines being prescribed by physicians in primary care or hospitals did not follow the goals of RUM and that physicians did not necessarily respect GS medicine lists when prescribing, which indicates the urgent need for RUM promotion. In addition, major differences were noted among diagnoses reviewed for RUM. As a result, our findings may serve as a guide for the development of prescription audit systems.

Funding source: Turkish MoH


Standardization of Prescribing and Using Oral Liquid Dosage Forms (OLDFs)

Moslem Movahed

Department of Medical Management of Province of Qom’s,social security organization, Iran, Islamic Republic of

Problem statement: Various factors affect the correct dosing and measuring of OLDFs, excluding drops, thereby leading to adverse effects or preventing the desired results to be obtained in treatment.

Objective: This study aims to evaluate the current situation in dosing OLDFs in Qom, Iran.

Study population: Includes all oral liquid products manufactured in Iran; 20 physicians (16 GPs and 4 pediatricians), 2000 OLDF prescriptions, 20 community pharmacists, and 60 literate mothers

Results: (1) Only 60% of the oral liquid products (including antibiotics, even those presented as powder for suspension) are offered with a measure; 8 kinds of medicine (33 products) come with varying measures, of which some are a spoon with a capacity of 5 mL and others are in a cylindrical shape, with 4 capacities ranging from 5 to 20 mL. (2) Many physicians and pharmacists are not aware of the current diversity in measures whereas nearly all the physicians and pharmacists conventionally and practically presume a 5 mL measure. (3) In the group of mothers, 50% fill 10 mL measures completely and 10% fill 20 mL measures up to 15 mL when they are advised to use 1 measure of the drug; 5 mL measures pose no problems. (4) Although 5 sizes of domestic spoons are used by patients, prescribers ignore this diversity by reducing it to 3 sizes only. (5) Although pediatricians have a good knowledge of domestic spoon capacities, many GPs and most of the pharmacists overestimate them, leading to underdosage for adults, especially in cough preparations with low drug content. (6) Less than 10% of adults’ prescriptions come with precisely specified dosages in mL whereas 90% have unclear volume. For children, 27% of the dosages are clear and 73% remain unclear.

Conclusion: A number of dosing problems in manufacturing, prescribing, and using OLDFs cause overdosing or underdosing which can lead to adverse effects or treatment failure in children; for example, if the intended prescription is 5 mL 3 times a day (but written as "3 measures a day") and the consumer is given a 20 mL measure. In addition, treatment fails in many cases due to underdosing of cough preparations and acetaminophen elixirs. To improve the current situation and prevent problems, it is suggested that (1) OLDFs be offered with a syringe (the best choice), or uniform and/or unisize (preferably 5 mL) measures, or even no measure at all; (2) physicians be advised to prescribe the OLDFs in exact volumes (mL or cc) and avoid prescribing in terms of “measure” or domestic spoons (this should be included in physicians’ and pharmacists’ education); (3) cough preparations be produced in higher concentration and volume for adults; and (4) parents be advised to use appropriate syringes (without a needle) instead of spoons or other measures.

Funding source: Department of Medical Management of Province of Qom’s (Iran) Social Security Organization


Draft South African Marketing Code—A New Model for Marketing Ethics

Kirti Narsai

PIASA, South Africa

Problem Statement: Pharmaceutical marketing has long been criticised both in the media and in medical communities in many countries, and developing countries are no exception. The pharmaceutical industry has responded by focusing on ethical marketing practices and making this core to the way they do business. This has resulted in the development of marketing codes both at industry and company levels. In South Africa, a broader focus has emerged bringing together stakeholders from different parts of the health sector, not only pharmaceuticals.

Objective: To share South Africa's model, as proposed, in the draft South African Code, which has a broader focus than just pharmaceuticals. The development of the Code has been driven by industry associations in South Africa representing pharmaceuticals (prescription, OTC and generics), medical devices, diagnostics and animal health products. Logistics service providers and pharmaceutical professionals society have endorsed the Code.

Design: The SA Code consists of the following parts: Part A—Marketing and promotion of health products to healthcare professional; Part B—Marketing and Promotion of health products directly to the consumer; Part C—Medical Devices; and Part D—Provision for the enforcement of the Code.

Policy: The Medicines Act, which regulates medicines in South Africa, makes provision for a marketing code. The industry was tasked with developing the code as well as establishing a Marketing Code Authority for the enforcement of the Code. Sanctions have been developed after careful analysis of international best practice, in both developed and developing markets. The sanctions will be applied for breaches of the Code by the Marketing Code Authority.

Methods: The methodology used in establishing the code and sanctions has been through detailed analysis of existing codes of practice in approximately 13 countries, both developing and developed. The task team then extracted the most appropriate aspects to developing the standards. This was debated extensively to gain consensus amongst all stakeholders.

Outcome Measure: It is expected that initially there might be an increase in the number of complaints, though not all valid, with companies testing the new system followed by a decline in complaints, once a code use has been embedded in the industry. A pilot phase of implementation, including intensive training of relevant staff across organisations, has already begun. The Marketing Code Authority, managed by an executive officer, has also been established after an memorandum of understanding was signed by all associations.

Conclusion: The health products industry has an important role to play in both business and society. In countries like South Africa, where the target audience for marketing activities is small, it is important that common standards of practice are used because of overlap in marketing and promotional activities. Therefore, collaboration amongst different industry stakeholders is important in establishing standards, even though the time to gain consensus might be significantly longer. The benefits of collaboration outweigh the increase in implementation time.

Funding Source: PIASA


Impact of Regulatory Requirements on Medicine Access in African Countries: Perceptions and Experiences of Pharma Companies in South Africa

Kirti Narsai

PIASA, South Africa

Problem statement: The impact of varied medicine registration policies in African countries poses a challenge for market access in these countries, although little is known about this from a pharma company viewpoint. The recent African Medicines Registration Harmonisation Initiative has increased the focus on the need for harmonisation of regulatory requirements to improve resource utilisation and operational efficiency. The South African pharma industry is well established with a broad representation of local, multinational, and generic companies. Many of these companies have started supplying medicines to African countries, therefore increasing the focus on regulatory requirements in these countries.

Objective: To determine the nature and extent of regulatory hurdles experienced by pharma companies that wish to register and supply medicines to African countries by looking at the nature of regulatory requirements, implementation, and impact on access to medicines

Design: Study was descriptive, qualitative, and conducted using an online survey tool, viz. SurveyMonkey.

Setting: Pharma companies (local, multinational, innovator, and generic) based in South Africa with responsibilities for African markets, supplying both public and private sectors

Study population: Employees of PIASA member companies with medicine registration or commercial responsbilities in African countries

Intervention: Survey was formulated using SurveyMonkey and distributed to relevant employees of PIASA member companies via email. Questions focused on general regulatory requirements and regional and country-specific requirements across SADC, EAC, ECOWAS, and ECCAS. Open-ended questions were included to allow respondents to express their views freely.

Outcome measure: Impact of medicine registration policies across African countries on pharma companies in registering and marketing medicines

Results: 33 responses were received, including 26 regulatory respondents; 1 response per company was allowed. In particular, GMP inspections, GMP inspection fees, and country- specific labeling requirements were cited as key problems; 89.5% of respondents indicated that country-specific requirements are problematic to implement. Of the respondents, 57-86% stated GMP inspection requirements are a barrier to medicine registration; 46-70% believe GMP inspection fees are too high; and 50-62.5% stated that international standards were sometimes recognised.

Conclusion: Country-specific regulatory requirements are probelmatic and impede market access of medicines. Recognition of international standards is important in countries with resource constraints and contribute to companies’ ability to comply. Harmonisation should be preceded by interim agreements between regulators in Africa to facilitate medicine registration and access.

Funding sources: PIASA


Regionalisation of Pharmacovigilance in Uganda

Helen Byomire Ndagije, Huldah Nassali, Victoria Nambasa Bukenya, Evans Kato Tusubira, Angela Bonabana

National Drug Authority, Uganda

Problem statement: Uganda is the 57th country worldwide with a critical shortage of health service providers. There is one doctor for every 8,400 Ugandans and one nurse or midwife for every 36,000 Ugandans. The few health workers are overloaded and leave a service delivery gap that is often filled by unqualified personnel, especially in the rural areas. The National Drug Authority (NDA) is mandated by the National Drug Policy and Authority Act (Cap. 206) to ensure that all medicines, medical devices, and supplies entering Uganda are of good quality and are safe and efficacious. The performance of the over 500 drugs registered in Uganda and especially the newer molecules such as the artemisinin-based combination therapies as well as the highly active antiretroviral therapies need to be closely monitored.

Objectives: In an effort to monitor these drugs, a National Pharmacovigilance Centre (NPC) was started in 2005. This centre acquired full membership of the WHO Programme of International Drug Monitoring in 2007. Regional pharmacovigilance centres were established in the national and regional referral hospitals. The primary objectives of regionalizing pharmacovigilance was to increase the number and quality of reports received at the national centre and contribute to improved quality of health service delivery.

Design: This was an intervention study conducted to assess the status of pharmacovigilance before and after regionalization.

Setting: The regionalisation of pharmacovigilance was introduced in the National and Regional Referral hospitals, where core teams were established and trained in pharmacovigilance and were designated the Regional Pharmacovigilance Centres (RPC). Other regional centres that were a useful resource for the private sector and worked closely with these RPCs were the NDA regional offices.

Intervention: Regionalisation involved training core teams of health workers in the regions on the importance of pharmacovigilance, equipping them with Vigiflow skills to report adverse events online and also receiving their workplans. Sensitization meetings held by the NDA regional officers as part of their routine support supervision activities for the private sector facilities (pharmacies and drug shops) also began to include pharmacovigilance.

Outcome measure(s):. Reporting rates, average time taken to report ADRs, type and seriousness of reports, and number of collaboration on ADR issues

Results: By the end of 2010, we had received over 500 suspected reports of ADRs. The time to enter reports into Vigiflow reduces from 31 months to 3 months. Partnerships with various stakeholders have been built; NPC worked with Soroti RPC to investigate cases of suspected disability due to quinine administration. The change in administration site of quinine to the thigh was accommodated in new malaria treatment guidelines.

Challenges: Poor quality of reports. There is still underreporting.

Conclusion: More collaboration is needed to institutionalize pharmacovigilance in routine health care delivery. Pharmacovigilance must be perceived and implemented as a way of improving quality of care. Enabling laws should be enacted to make reporting compulsory.

Funding source(s): National Drug Authority


Assessing the Extent of Pharmaceutical Care Provision in Kigali Community Pharmacies

Morris Ndekwe1, M.Monique Rwabuhungu1, Patrick Gaparayi2, Ntokamunda Kadima1

1National University of Rwanda, Rwanda; 2Management Sciences for Health, Strengthening Pharmaceutical Systems- Rwanda

Problem statement: Despite the fact that Rwanda currently has health policies and health insurance schemes that ensure access to essential medicines, there is no published data about the level of pharmaceutical care services provision in community pharmacies to ensure that patients are receiving intended quality care and services.

Objective: To establish the extent to which each of the formal elements in the pharmaceutical care process is practiced and to determine the evolution of the role of pharmacist toward patient-centred care

Design: An observational study was conducted in 31 private community pharmacies after receiving their voluntary agreement to participate. Using a standardized checklist adapted from the patient care process by R. Cipolle et al. (2004), we observed pharmacist-patient interactions to acquire data as it actually happened. To avoid biases due to our presence in the pharmacy, we eliminated the first 5 interactions per pharmacy. Using an open ended questionnaire, we also conducted in-depth interviews with pharmacists to obtain their opinions about pharmaceutical care as well as information about available resources facilitating patient-centered care.

Setting: 31 randomly selected, private community pharmacies located in all 3 districts of Kigali City

Study population: In total, 279 patients with prescriptions who interacted only with the pharmacist during the medicine dispensing time were included in our study.

Results: In general, the study showed that pharmaceutical care services were provided at an extent of 23.7%, concentrating more on basic pharmaceutical care. Taken individually, patient care elements were performed at different levels—building therapeutic relationship between patient and pharmacist (50.4%), assessing drug therapy needs (19.8%), developing a care plan (29.4 %), communicating with patients (18.7%), and follow-up evaluation (0.4%). The average pharmacist-patient interaction time was 2 minutes 23 seconds, less than the recommended 5–10 minutes for basic pharmaceutical care provision. Moreover, none of the respondents documented pharmaceutical care provided to their patients whereas 48.4% of the pharmacies did not have any private area to facilitate pharmaceutical care provision. Finally, 93.6% of the respondents stated that they did not provide any service to their patients beyond medicine dispensing.

Conclusion: The provision of pharmaceutical care in community pharmacies in Kigali City is not formalized; to fill the identified gaps to optimize patient-centered care, policy makers need to (1) prioritize pharmaceutical care as an urgent interventional area for investing resources, (2) incorporate pharmaceutical care into the pharmacy practice policy, (3) establish strategies to foster adoption (acceptance and demand creation) of pharmaceutical care practice, and (4) capacitate community pharmacists to provide pharmaceutical care.

Funding source: National University of Rwanda


Medicine Prices, Availability, and Affordability in Vietnam

Tuan Anh Nguyen1,2, Rosemary Knight1, Andrea Mant1, Minh Quang Cao3, Martin Auton4

1School of Public Health and Community Medicine, University of New South Wales, Australia; 2Department of Pharmaco-economics and Pharmaceutical Management, Hanoi University of Pharmacy, Vietnam; 3Ministry of Health of Vietnam, Hanoi, Vietnam; 4Health Action International, Amsterdam, the Netherlands

Problem statement: Ensuring the availability of affordable medicines is a precondition to realizing the fundamental human right of access to essential health care. Yet, medicine prices are often high and unaffordable for a large segment of the world’s population.

Objective: To assess the price, availability, and affordability of a sample of medicines in Vietnam

Methods: Data on the price and availability of 42 medicines were collected in November 2005 using the standard World Health Organization/Health Action International methodology in 5 geographical areas in Vietnam. The median price of these medicines was compared with the Management Science for Health international reference prices, expressed as median price ratios. Affordability was measured as the number of days’ wages required for the lowest paid unskilled government worker to purchase one course of therapy. Of the 42 medicines studied, 15 were chosen for international comparison, which were included in at least 80% of other country surveys using this methodology.

Results: Generic medicines were found in 33.6% of public medicine outlets. The median public procurement price was 1.82 times the international reference prices for generics, but for some individual medicines it was less than half of that. The price to patients in public outlets was higher than in private pharmacies. Adjusted for Purchasing Power Parity in 2005, the lowest generic prices in private pharmacies were still 8.3 times higher than the benchmark. Despite the markedly lower prices, medicines in Vietnam were much less affordable than in the comparable Western Pacific Region.

Conclusions: Medicines in Vietnam were high in price, and low in both availability and affordability, especially in the public sector. Access to medicines, therefore, remains a challenge for the Vietnamese Government. To make public facilities a primary treatment option for the poor, Vietnam needs to reduce medicine prices in this sector by improving procurement efficiency, ensuring and promoting low-priced generics, and regulating reasonable mark-ups.

Funding source(s): The World Health Organization (Vietnam Office)


Transparency, Governance and Regional Collaboration in Pharmaceutical Procurement in Kenya, Tanzania, and Uganda

YK {Yvonne} Nkrumah1, WJ {Wilbert} Bannenberg2, EM {Marianne} Schuermann2, AC {Ed} Vreeke2, VS {Tina} Patel3, J {Joseph} Mhando3, JW {James} Tamale3

1World Bank Institute (WBI); 2Health Research for Action (HERA); 3Independent consultant

Problem Statement: Poor governance in pharmaceutical procurement undermines access tomedicines of good quality that are reasonable priced and suppliedin sufficient quantities for those most in need. Poor governance can result in product specifications that limit competition, biased quantification and supplier selection decisions, manipulation of orders to increase quantities of certain items, skewed award of contracts or other circumventions of tenders, and poor knowledge of end-user needs. Ultimately, poor governance contributes to the inability to of service providers to fulfill the demandfor essential medicines.

Objective: To strengthen and institutionalize accountability and transparency in government pharmaceutical procurement and supply chain management policies, practices and procedures.

Design: Literature review, institutional assessment, capacity building events, use of information and communication technology (ICT) for data collection, and public feedback.

Setting: Regional multiple stakeholders initiative being piloted in Kenya, Tanzania, and Uganda

Study Population: Public sector and non-profit private sector procurement agencies, ministries of health, and civil society organizations (CSO) in Kenya, Tanzania, and Uganda

Interventions: Literature review, followed by interviews of procurement agencies and their stakeholders on issues around procurement and transparency. An assessment tool was applied to benchmark the performance of the procurement agencies. Draft country reports were discussed at national validation workshops and a national coalition made up of multiple stakeholders has been established in each country to drive procurement reforms. Three priority areas have been identified by countries and translated into action plans to address poor governance: CSO empowerment, improved access to procurement and supply chain information, and use of ICT to generate and analyze data to inform policy reform. The coalitions are linked at the regional level through a regional online platform (www.enepp.net) where they share information on the implementation of their action plans. Members also exchange information on essential medicines selection, quantification, prices and quality obtained, and supplier performance.

Policy: The initiative seeks to determine whether a multi-stakeholder group working together to facilitate information sharing, leverage technical expertise, and monitor procurement and supply chain functions could improve the systems for procuring and supplying medicines, as well as contribute to increased access to medicines.

Outcome Measures: benchmark assessments, capacity development, country multi-stakeholder coalitions, country action plans, regional comparative data on prices, use of ICT tools, and efficiency and transparency of procurement agencies.

Results and Conclusions: (1) Creation of active country multiple stakeholder coalitions in Kenya, Tanzania, and Uganda that focus on pharmaceutical procurement and supply chain management; (2) development and implementation of country action plans with a focus on CSO empowerment, use of ICT, and improved access to information on procurement; (3) design and establishment of an online social networking platform (www.enepp.net) to facilitate and sustain peer-to peer learning and problem solving, and provide access to comparative medicine price data for the three countries; and (4) developed a regional training of trainers manual to enhance capacity and credibility of CSOs.

Funding Sources: World Bank Institute, Irish Aid Trust Fund


Strenghtening Pharmacovigilance at the National Level: Development of an Indicator-Based Pharmacovigilance Assessment Tool to Assess Medicines Safety System at the Level of the Pharmaceutical Industry in Developing Countries

Jude Nwokike1, Caroline Adam2

1Management Sciences for Health, Strengthening Pharmaceutical Systems (SPS) Program, South Africa; 2Management Sciences for Health, Strengthening Pharmaceutical Systems (SPS) Program, South Africa

Problem statement: There are no universally accepted performance metrics for determining optimally functioning pharmacovigilance (PV) and medicines safety systems in the pharmaceutical industries in developing countries. PV activities required by regulations and routinely adhered to by pharmaceutical companies operating in stringent, regulatory environments are rarely implemented in developing countries where the burden of adverse reactions may be more and regulatory systems are often weak.

Objectives: To develop a performance monitoring and diagnostic assessment tool for monitoring PV activities within the pharmaceutical industry in developing countries

Design: We adapted the indicator-based pharmacovigilance assessment tool (IPAT) earlier developed by the MSH/SPS program. These indicators were reviewed and compared with post-authorization safety responsibilities from the pharmaceutical regulations of selected countries. Forty four indicators (32 core and 12 supplementary) were developed that address 5 PV and medicine safety systems components that represent the elements of a functional PV system and are applicable to medicinal products under development and drugs during all life-cycle management. The IPAT is modular and the evaluation is conducted through a series of assessment questions reflecting on structures, processes, and outcomes of medicines safety systems. We pilot-tested the pharmaceutical industry IPAT on 4 companies: 2 multinational, 1 generic, and 1 local-owned agency in South Africa. The tool was subsequently used for a comprehensive assessment of selected pharmaceutical companies.

Outcome measure(s): Performance assessment tool; reliable assessment and diagnosis of status of PV systems within a pharmaceutical company

Results: The post-pilot assessment showed that the pharmaceutical industry IPAT was a useful and reliable tool for assessing PV systems across different levels and types of pharmaceutical companies including branded, multisource, contract research organizations. The tool is able to generate both quantitative and qualitative data on medicines safety systems and practices.

Conclusions: The pharmaceutical industry IPAT provides reliable baseline data and informs the development of interventions for improving PV in the industry setting. The use of the pharmaceutical industry IPAT is feasible in a developing country. The tool can also be used for longitudinal measurement of progress after the recommended interventions are implemented.

Funding source(s): United States Agency for International Development


Actions of the National Regulatory Authorities in Developing Countries Following US FDA and EMA Safety Alerts on Rosiglitazone

Jude Nwokike1, Andy Stergachis2

1Management Sciences for Health (MSH), United States of America; 2Global Medicines Program, University of Washington

Problem statement: On September 23, 2010, the US FDA announced that it will require a restricted access program as part of a risk evaluation and mitigation strategy for the elevated risk of cardiovascular events associated with rosiglitazone. On the same day, the EMA recommended the suspension of the marketing authorizations for rosiglitazone-containing anti-diabetes medicines. Before these regulatory actions, safety concerns had caused global sales of rosiglitazone to slide dramatically from $2.2 billion in 2006 to $1.2 billion in 2009. One of the core indicators of the indicator-based pharmacovigilance assessment tool (IPAT) used for assessing pharmacovigilance systems in developing countries is the average time lag between the identification of safety signal of a serious ADR or significant medicine safety issue and communication to health care workers and the public.

Objectives: To identify the time lag between the announcements on rosiglitazone by stringent regulatory authorities (SRA), as represented by the FDA and EMA, and actions by national regulatory authorities (NRA) from selected developing countries.

Design: We reviewed the Global Regulatory Activity Digest that contains global regulatory updates. We also searched the websites of 12 NRAs including their lists of registered medicines, where available, and followed up with key-informant interviews to validate responses and collect additional information, as appropriate. We calculated the average lag time in days from the date of the first announcement by the SRAs (September 23, 2010, used as the index date) to the date of regulatory action by the NRAs. We considered actions as any communication related to safety of rosiglitazone.

Study population: NRAs

Outcome measure(s): Safety alerts and related communications pertaining to rosiglitazone

Results: We studied regulatory actions related to the safety of rosiglitazone from the FDA, EMA, and 10 national regulatory authorities; 3 NRAs from outside Africa and 7 NRAs from Africa. The NRAs outside of Africa had all taken regulatory actions related to the safety alert to rosiglitazone. Of particular interest, Saudi Arabia took regulatory action to suspend rosiglitazone on March 17, 2010, approximately 190 days before the SRAs. Indonesia took regulatory action a day after the SRAs and India 14 days after. For the 7 African NRAs that registered rosiglitazone, we could confirm regulatory action only for those from Namibia and Kenya. From the index date until December 2, 2010, when the most recent information was collected, only 2 out of 7 (29%) African NRAs had taken regulatory action or reacted to that of the SRAs.

Conclusions: The average lag time between the identification of safety signal of a serious ADR or significant medicine safety issue and communication to the public is shorter for NRAs outside of Africa. Even after 70 days from the index date, many African NRAs had no communication to consumers or health care providers pertaining to the safety of rosiglitazone. This IPAT indicator provides a way for assessing timely communication of safety information.

Funding source(s): The authors were supported by the USAID-funded Strengthening Pharmaceutical Systems program.


Plasma Drug Level Validation of Self-Reported Adherence Predicts Limited Specificity for Intrinsic Poor Adherence in Resource-Limited Settings

Celestino Obua1, Robert Balikuddembe1, Joshua Kayiwa2, Muhammad Ntale1, David Musoke3, Paul Waako1

1Makerere University, College of Health Sciences, Uganda; 2Data Department, Joint Clinical Research Center, Kampala Uganda; 3Department of Pharmacology and Therapeutics, Gulu University, Uganda

Problem statement: Adherence to antiretroviral therapy (ART) in low-income countries is mainly assessed by self-reported adherence (S-RA) because drug-level determination is expensive. Non-adherence is an important factor in the emergence of resistance to ART, presenting a need for drug-level analysis.

Objective: We set out to establish the relationship between plasma drug levels of stavudine and S-RA among patients on a stavudine-containing regimen. The secondary aim was to validate S-RA against the actual detected plasma drug concentrations.

Design: Cross-sectional investigation involving 234 patients; demographic characteristics, treatment history, and 3 months of S-RA levels were extracted from patient records. Good adherence was defined as S-RA ≥ 95%. Plasma stavudine concentrations were determined from venous blood drawn at least 1.5 hrs after the last dose and analysed by high-performance liquid chromatography. Stavudine concentration values in plasma samples were categorized as below, above, or within the normal therapeutic range (36-2400 nM/mL).

Setting: Patients were recruited from the Mengo HIV/AIDS clinic of the Joint Clinical Research Centre in Uganda between June 2006 and June 2007.

Study population: A total of 248 clients consented to participate. However, 14 were excluded because of insufficient clinical and/or S-RA data. Recruited patients were aged 18-50 years, had been on a stavudine-containing regimen for at least 3 months, and were willing to give written consent.

Interventions: No interventions were implemented in this study.

Outcome measures: In this population, we compared plasma levels of stavudine with S-RA using multivariable logistic regression models. The primary exposure was the stavudine plasma concentrations. The sensitivity and specificity of S-RA in predicting actual drug administration was also computed.

Results: Of the 234 patients, 194 (82.9%) had good S-RA with a median [IQR] stavudine concentration of 640.1 [66.1, 1331.1] nM/mL, while 40 (17.1%) had poor S-RA with median [IQR] plasma stavudine levels of 0 [0, 397.7] nM/mL. Patients with good S-RA were almost 7 times more likely to have stavudine levels within normal therapeutic range (adjusted odds ratio: 6.72, 95% confidence interval: 3.2 to 14). S-RA had high (91.6%) sensitivity for adherence, but limited (38.2%) specificity for intrinsic poor adherence.

Conclusions: Self-reported adherence is a good tool for assessing adherence, but has low specificity in detecting non-adherence (intrinsic non-adherence), which has implications for emergence of resistance.

Funding sources: This work was made possible through support provided by the World Health Organization and the Department of Pharmacology and Therapeutics, Makerere University.


Improving Adherence to Antiretroviral Treatment in Uganda: Facility-Based Minimal-Input Intervention

Celestino Obua1, Joshua Kayiwa2, Paul Waako1, Göran Tomson3, Hudson Balidawa4, John Chalker5, Dennis Ross-Degnan6, Rolf Wahlstrom3

1Makerere University, College of Health Sciences, Uganda; 2Data Department, Joint Clinical Research Centre, Kampala Uganda; 3Karolinska Institutet, Department of Public Health Sciences, Division of Global Health, Stockholm, Sweden; 4The AIDS Control Programme, Ministry of Health, Kampala Uganda; 5Centre for Pharmaceutical Management, Management Sciences for Health, Arlington Virginia, USA; 6Department of Population Medicine, Harvard Medical School, Boston USA

Problem statement: Adherence to antiretroviral therapy (ART) is crucial to successful treatment outcomes. Initiatives to address the factors influencing adherence in resource-limited settings often rely on heavy financial inputs, which may be unsustainable.

Objective: To determine if reducing facility congestion by using minimal-input interventions improves ART adherence in Uganda

Design: This was a facility-based interventional, longitudinal, staggered-entry, no-control, pre- and post-intervention assessment of two patient cohorts. Demographic and treatment history were retrospectively extracted from medical records for 6 months pre- and 11 months post-intervention.

Setting: Six district-level public facilities providing ART, ranked with poor adherence in a previous national survey were included.

Study population: Records for 720 experienced patients who had been on treatment 6 months prior to baseline and 761 newly treated patients who initiated treatment 6 months after baseline onward were examined.

Interventions: An appointment system was introduced, under which refill-only patients would be fast-tracked through the facilities’ workflows. We also recommended that clinicians increase the dispensed medication days for patients whom they deemed to be stable and reliable from the traditional 30 days to either 60 or 90 days.

Outcome measures: We determined (1) the percentage of patients who missed scheduled visits and had medication gaps of 3 or more days over time, using mixed-effects models; (2) the percentage of experienced patients with increased days of dispensed medicines; and (3) the events of having a medication gaps of 7 or more and 14 or more days during the first 120 days of treatment in the newly treated cohort, using Cox proportional hazards models.

Results: Among the experienced and newly treated cohorts, there were significant percentage reductions of 5.6% [95% Confidence Interval (CI): 3.8–7.4% decrease] and 6.3% (95% CI: 2.2–10.4% decrease) in missed scheduled visits; 5.0% (95% CI: 3.2–6.9% decrease) and 7.2% (95% CI: 3.0–11.8% decrease) among patients with medications gaps of 3 days or more. The interventions led to significant 4.6% increase (95% CI: 3.4–5.9% increase) in the percentage of experienced patients receiving more than 30 days of dispensed medication; significant 44% [hazard ratio (HR): 0.56, 95% CI: 0.42–0.74] and 38% (HR: 0.62, 95% CI: 0.45–0.85) reductions in the hazards of experiencing a medication gap of 7 or more and 14 or more days, respectively, among the newly treated cohorts.

Conclusions: This study demonstrated that minimal-input interventions designed to reduce crowding at public health facilities are effective in improving ART adherence among patients in Uganda.

Funding source(s): Swedish International Development Cooperation Agency and World Health Organization through Management Sciences for Health.


Access to Medicines in Nigeria – Gender Perspective

Ukamaka Gladys Okafor1, Olanike Adedeji2

1Pharmacists Council of Nigeria; 2Sky Sea and Sand Ltd Nigeria

Problem statement: In a country of over 100 million people (2005), Nigerian women are approximately 49% of the population, most of whom are poor, uneducated, reside in rural areas and have limited access to basic health care.

Objectives: This study focuses on Nigerian women’s access to medicines and explores how gender influences access to malaria management, HIV treatment, and reproductive health including family planning techniques. Disparities between different parts of the country and between rural versus urban populations were also explored.

Design: The study was exploratory in nature and based on an extensive review of literature because of the large pool of primary data available in the country. The main sources of information were the 1990, 2003, and 2008 Nigeria Demographic Health Survey (NDHS). Attempts were made to compare the statistics on access from 1990-2008 to determine if there had been any significant differences.

Settings: The study was limited to internationally accepted research work conducted in Nigeria between 1990 and 2008 with particular reference to malaria, HIV/AIDS and reproductive health

Study population: The 2003 and 2008 NDHSs were based on a nationally representative samples of over 7000 and 34,070 households, respectively.

Results: Access to reproductive health was measured by antenatal clinic attendance and household wealth in 1990 and was compared to 2008. In 2008, only 42% of women who did not participate in any decision in the household accessed antenatal care from a health worker whereas 73.4% of women who participated in at least 3 key decisions in the household had accessed antenatal care from a health worker. According to the 2008 NDHS results, prompt treatment of fever increases with wealth quintile. The NARHS 2007 report shows that more females (4.0%) were infected than males (3.2%). Barriers to preventive and curative health especially for Nigerian women include, but are not limited to, low income and poverty, long geographical distances to health facilities, less education (affecting health seeking behavior), rural locations (unequal distribution of health resources and concentration in urban locations), cultural barriers, attitudes of health workers, ratio of health workers to population [leading to burnout]), inadequate Government funding for health, and decline in use of maternal services following introduction of user fees in 1994.

Conclusions: Poor access to health services including medicines for women is mostly due to low income and poor level of education. Lack of awareness of their rights and poverty makes it even less possible for women to assert such rights in a society where wealth and power are inexorably linked. Recommendations include increased Government funding for health, health insurance/subsidies for women and children, increased community awareness and age appropriate reproductive health education for women and girls, domestication of CEDAW into the Nigerian system, and deliberate policies to promote female participation in decision making.

Funding sources: Pharmacists Council of Nigeria, the Society for Family Health and Women’s SocioEconomic Rights Agenda (WOSERA) provided data and technical support.


Medicine Use from Birth to Two Years of Age: The 2004 Pelotas (Brazil) Birth Cohort Study

Edilson Almeida Oliveira1, Marlos Rodrigues Domingues2, Iná S Santos2, Aluísio J D Barros2, Andréa Dâmaso Bertoldi2

1Universidade do Vale do Rio dos Sinos; 2Universidade Federal de Pelotas, Brazil

Problem statement: According to data from the World Health Organization (WHO), over 50% of medicines are improperly prescribed or sold, approximately one-third of the population do not have access to essential medicines, and 50% of patients do not take their medicines correctly. International studies indicate that medicine use is high during childhood, especially among children younger than age two years. WHO restricts the use and indication of a number of medicines widely in use by Brazilian children.

Objective: To describe medicine use by children at 3, 12 and 24 months of age

Methods: We used a prospective birth cohort study in southern Brazil using cross-sectional data collected at the mean ages of 3 months (N=3,985), 12 months (N=3,907), and 24 months (N=3,868). The outcome variable was medicine use in the 15 days prior to the interview, irrespective of reason, indication, or therapeutic group. In all visits, we asked mothers whether the child had received any medicines in the last 15 days. We then asked for the names of the medicines used and for the packages and prescriptions if available. Information on independent variables (e.g., who indicated the medicine, how it was obtained, periodicity of use, and therapeutic group) were collected using a standardized questionnaire administered during a home interview with the child’s parents.

Results: Prevalence of medicine use at 3, 12, and 24 months were 65.0% (95% CI: 63.5; 66.5), 64.4% (95% CI: 62.9; 65.9), and 54.7% (95% CI: 53.1; 56.2), respectively. As age increased, there was a reduction in the total number of medicines used and an increase in self-medication, which reached 34% at 24 months. Furthermore, frequency of sporadic medicine use increased, whereas that of continuous use decreased. Medicines were purchased mainly using private resources, with roughly 10% of drugs being purchased through the Brazilian National Health Care System. The profile of medicine types used also changed with age. The type of medicine most frequently used were dermatological products (36%) at 3 months; respiratory system drugs (24%) at 12 months; and analgesics (26%) at 24 months of age. Compared to use at 3 months, medicine use at 24 months was characterized by decreased use of digestive tract and metabolism drugs, drugs for the sensory organs, cardiovascular system drugs, and dermatological products, and an increase in systemic anti-infectious drugs, medicine for the skeletomuscular and respiratory systems, analgesics, insecticides, and repellents.

Conclusions: The high prevalence of medicine use among children indicates a need for promoting rational use (i.e., use that takes into account cost-benefit relationships) in this age group. Knowledge of the profile of medicine use in a population-based study of longitudinal design may contribute to the establishment of public policies in this area, aimed at ensuring access to necessary medicines and reducing inappropriate usage.

Funding source(s): World Health Organization, the National Council for Scientific and Technologic Development, the Fundação Nacional de Saúde, and the Pastoral da Criança.


Inappropriate Provision and Treatment of Malaria in Public and Private Sectors in Nigeria: Threat to Malaria Elimination Efforts

Obinna Emmanuel Onwujekwe1, Lindsay Mangham2, Bonnie Cundhill2, Ogochukwu Ezeoke1, Benjamin Uzochukwu1, Virginia Wiseman2

1University of Nigeria, Nigeria; 2London School of Hygiene and Tropical Medicine

Problem statement: Since June 2006, many brands of artemisinin-based combination therapies (ACTs) have been deployed unsystematically in Nigeria by both the government and pharmaceutical companies through a broad spectrum of public and private providers. There is lack of information about the extent that the drugs have been appropriately used and whether providers are adhering to treatment guidelines.

Objective: The study examined the current malaria treatment provision and utilization practices and patterns in Nigeria, especially the pattern of diagnosis, prescribing, and dispensing of malaria treatment of febrile patients for whom treatment was sought at the different types of health facilities.

Design: A cluster survey was conducted with 2089 patients (or caregivers) exiting public and private health facilities. Data was also collected from providers at 20 public primary health care centres, 25 pharmacies, and 55 patent medicine dealers.

Study setting: The study was undertaken at 2 local government areas (LGA) in Enugu state, southeast Nigeria. These were Enugu LGA (urban) and Udi LGA (rural).

Study population: All eligible health workers at public primary health centres and dispensaries plus public health posts and private pharmacies and patent medicine dealers (PMD) were interviewed. The study population for the patient exit surveys was individuals seeking treatment for fever and/or malaria or individuals receiving an ACT. This included individuals seeking treatment for themselves or for someone else.

Data collection: Data was collected using a provider survey questionnaire and a patient exit questionnaire.

Policy context: The need to ensure that ACTs that are the new first-line drugs and other antimalarials are used appropriately so as to improve treatment outcomes and decrease treatment failures and the burden of malaria.

Outcome measure: Appropriate provision and use of ACTs and other antimalarials by a broad spectrum of providers and consumers at the primary health care level.

Results: 78.4% of facilities had first-line ACT (AL) in stock, 88.3% had any ACT in stock; many facilities had artemisinin monotherapy (AMT) and sulfadoxine-pyrimethamine (SP) in stock; 65.4% of health workers reported that the nationally recommended treatment for uncomplicated malaria was an ACT. Very little laboratory diagnosis of malaria (3%) was done in public facilities). There were low levels of use of ACTs among febrile patients (28.8% of patients visiting pharmacies compared to 22.8% in public facilities and 19.0% of patients attending PMDs). Also, 14.8% of patients at pharmacies received an ACT in the correct dose, and for patients attending a public facility, it was 11.1% and attending a PMD, 9.0%. Many febrile patients received SP and AMT.

Conclusion: There are still very high levels of inappropriate provision and consumption of malaria treatment, even with the ready availability of ACTs.

Funding sources: ACT consortium, LHSTM, through a grant from Bill & Melinda Gates Foundation