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Conference Agenda

Overview and details of the sessions of this conference. Please select a date or room to show only sessions at that day or location. Please select a single session for detailed view (with abstracts and downloads if available).

Session Overview
Date: Monday, 14/Nov/2011
9:00am - 11:30amSatellite: Pharmaceutical System Strengthening: Is There a Need for a New Paradigm?
Jasper Auditorium 

Oral Presentation

Akatari Mamtaz

Ministry of Health and Family Welfare (MOHFW), Bangladesh


Pharmaceutical System Stregthening: Is There a Need for a New Paradigm?

David Ofori-Adjei

Ghana College of Physicians & Surgeons, Ghana


Pharmaceutical System Stregthening: Is There a Need for a New Paradigm?

Andreas Seiter

World Bank, United States of America


Pharmaceutical System Stregthening: Is There a Need for a New Paradigm?

Richard Ogilvie Laing

WHO, Switzerland


Pharmaceutical System Stregthening: Is There a Need for a New Paradigm?

Douglas L. Keene

MSH/SPS Program, United States of America

2:00pm - 3:20pmWelcome Addresses
Session Moderator: Mehtap Tatar, Hacettepe University, Turkey
Jasper Auditorium 

Welcome Address - International Organizing Committee

John Chalker

MSH, United Kingdom


Welcome Address - Minister of Health of the Republic of Turkey

Recep Akdağ

Minister of Health of the Republic of Turkey, Turkey

Welcome Address - General Manager of General Health Insurance, Turkey

Rıza Murat Karaşen

General Manager of General Health Insurance, Turkey

Welcome Address (by video) - Regional Director of EURO, World Health Organization

Zsuzsanna Jakab

Regional Director, EURO, Denmark

Welcome Message from the Regional Director, EMRO, World Health Organization

Hussein Abdel-Razzak Al Gezairy, Mohamed Bin Shahna

EMRO, Egypt

Welcome Address - Minister of Health, Sultanate of Oman

H.E. Dr Ahmed bin Mohamed bin Obaid Al Saidi

Minister of Health, Sultanate of Oman, Oman

Welcome Address- International Scientific Program Committee

Anita Katharina Wagner

Harvard Medical School, United States of America

3:20pm - 4:20pmOpening: Keynote Addresses
Session Moderator: David Ofori-Adjei, Ghana College of Physicians & Surgeons, Ghana
Jasper Auditorium 

From ICIUM2004 to ICIUM2011 - Challenges and Opportunities for Medicines Access and Use

Suwit Wibulpolprasert

Ministry of Public Health, Thailand


Public Policies to Improve Drug Access for Chronic Diseases; the Experience of Mexico

Ricardo Perez-Cuevas

Ministry of Health, Mexico, Mexico


Healthcare Reforms and Pharmaceuticals: Lessons from Turkey

Mehtap Tatar

Hacettepe University, Turkey

4:30pm - 5:00pmEffects of Turkish Health Reform on Pharmaceutical Policies
Session Moderator: AKIF AKBULAT, General Directorate of Pharmaceuticals and Pharmacy, Ministry of Health of Turkey, Turkey
Session Rapporteur: Guvenc Kockaya, General Directorate of Pharmaceuticals and Pharmacy, Turkey
Jasper Auditorium 

To Be Announced

Hüseyin Kiliçaslan

Social Security Institution, Turkey


To Be Announced

Hanefi Ozbek

saglik Bakanligi, Turkey

5:00pm - 5:45pmRational Medicines Use Issues in Turkey - Yesterday, Today, and Tomorrow
Session Moderator: Hanefi Ozbek, saglik Bakanligi, Turkey
Session Rapporteur: Kubilay Oransay, Turkish Ministry of Health General Directorate of Pharmaceuticals and Pharmacy, Turkey
Jasper Auditorium 

Rational Medicies Use Issues in Turkey- Yesterday, Today, and Tomorrow

Ersin Yariş

Turkish Pharmacology Society, Turkey


Rational Medicies Use Issues in Turkey- Yesterday, Today, and Tomorrow

Harun Kızılay

Turkish Pharmacists` Association


Rational Medicies Use Issues in Turkey- Yesterday, Today, and Tomorrow

Burcak Deniz Dedeoglu

Ministry of Health of TURKEY, Turkey


Date: Tuesday, 15/Nov/2011
9:00am - 10:10amPlenary 1: International and Regional Systems, Policies, and Programs
Session Moderator: Sauwakon Ratanawijitrasin, Mahidol University, Thailand
Session Moderator: Andreas Seiter, World Bank, United States of America
Session Rapporteur: Anita Katharina Wagner, Harvard Medical School, United States of America
Jasper Auditorium 

Improving Use of Medicines - Where Are We Today?

Kathleen Anne Holloway

World Health Organization, India


Corporate Responsibility of Pharmaceutical Companies Under Conditions of Market Failure and Failing States

Klaus Leisinger

Novartis Foundation for Sustainable Development Basel Switzerland

10:15am - 11:15am1b. Policy: The Pharmaceutical Policy Process
Session Moderator: Andreas Seiter, World Bank, United States of America
Session Moderator: Regina M Mbindyo, WHO, Kenya
Session Rapporteur: Chiratidzo Ellen Ndhlovu, National Drug and Therapeutics Policy Advisory Committee(NDTPAC)/ c/o University of Zimbabwe, Zimbabwe
Jasper Auditorium 

Improving Access and Quality Use of Medicines in Palliative Care within National Drug Policy, Regulatory, and Funding Frameworks

Debra Rowett1, Tania Shelby-James2, Simon Eckerman2, Janet Hardy3, Lynn Weekes4, David Currow2

1Drug and Therapeutics Information Service, Australia; 2Discipline, Palliative and Supportive Services, Flinders University, South Australia; 3Mater Health Services and Centre for Palliative Care Research and Education, Queensland; 4NPS: Better Choices - Better Health.

Problem statement: There is a growing need for palliative care throughout the world with an ageing world population, an increasing incidence and prevalence of cancer and HIV/AIDS, and progressive advanced chronic illness. However, improving equity of access and quality use of medicines in palliative care is impeded by the limited evidence for efficacy, cost effectiveness, and safety data for medicines commonly used for symptom control.

Objective: Improve access to affordable priority medicines to relieve suffering and symptom burden in palliative care

Methods: Australia has both a National Medicines Policy and a Palliative Care Strategy which provide a policy framework for implementing improved access to and quality use of medicines in palliative care. The work was coordinated by a government auspiced committee, the Palliative Care Medications Working Group. This committee provided a forum for medicines regulators, the pharmaceutical industry, government, policy makers, and clinicians to address the issues of access and quality use of medicines.

Results: A process to support the listing of medicines to manage symptom burden in palliative care through the national public drug reimbursement programme has been established and continues to be expanded where efficacy, safety, and cost-effectiveness criteria are met. Funding has been provided for a national multi-site collaborative clinical study network, the Palliative Care Clinical Studies Collaborative (PaCCSC), to improve the availability of evidence of clinical interventions in the palliative care setting with rigorously designed and performed phase III and IV studies to inform registration and subsidy applications. Symptoms being studied include delirium, complex pain, bowel obstruction, anorexia, breathlessness, constipation, and nausea. The improvement in access has been complemented by strategies to improve quality use through effective industry partnerships, education programs for practitioners (through NPS: Better Choices-Better Health, an independent, not-for-profit organisation), and a broader communication network for the health workforce and community. A rapid reporting pharmacovigilance programme that builds on the work of the PaCCSC has been developed and is being extended into South East Asia and New Zealand.

Conclusion: Regional and global public health programs struggle with the reality of funding disease-modifying therapies and prevention measures while trying to relieve suffering and provide optimal end of life care. This programme of work is contributing to the evidence base to inform policy decisions concerning access and quality use of medicines.

Funding source: Australian Government, Department of Health and Ageing


Use of an Indicator-Based System for Assessing, Monitoring, and Improving Pharmacy Practice

Jennie Lates1, Victor Sumbi2, Dawn Pereko3

1Ministry of Health and Social Services (MoHSS); 2Management Sciences for Health/Strengthening Pharmaceutical Systems (MSH/SPS); 3Management Sciences for Health/Strengthening Pharmaceutical Systems (MSH/SPS)

Problem statement: An assessment by the Ministry of Health and Social Services (MoHSS) in 2004 identified the unavailability of routine data to monitor and improve pharmaceutical services as well as inform decision making and planning at all levels of the health system. The assessment identified a need to empower district and regional management teams to identify and address their shortcomings in the delivery of pharmaceutical services.

Objectives: To implement a Pharmacy Management Information System (PMIS) that can provide data for planning and decision making at hospital, regional, and national levels.

Setting: Following a comprehensive consultative process, the PMIS was introduced at all public hospitals in Namibia in October 2007 with the intention of rolling out at a future date to primary health care facilities.

Interventions: The main activities carried out to set up the PMIS were (1) development of the system through an all-inclusive consultative process; data collection tools, data collection and reporting schedules and systems for upward reporting and provision of feedback were established; (2) training regional pharmacists who then trained their pharmacy staff on the PMIS; (3) strengthening therapeutics committees to implement interventions to address gaps identified through PMIS; (4) implementation of the system through on-going data collection, analysis, and use at district, regional, and national levels; and (5) provision of feedback through quarterly PMIS reports at the national level.

Results: The PMIS was formally launched in July 2007; accomplishments to date include (1) all 35 hospitals in the public sector have been producing timely PMIS reports submitted through the 13 regional directorates; (2) a national database has been developed for tracking performance by all hospitals in the various areas of pharmacy service provision since October 2007; (3) PMIS data and results are discussed at district and regional therapeutic committees, and interventions aimed at improving services are designed and implemented. Notable results include development and use of a medicine list that shows brand and generic names of essential medicines has improved generic prescribing in Ohangwena region; rational medicine use trainings carried out in Kunene region to address prescribing problems identified using PMIS data (polypharmacy, inappropriate antibiotic prescribing); improved inventory management across the country as reflected by the increased percentage of stock cards with a balance that is equal to the physical stock (75.6% in December 2007 to 94.5% in April 2010); use of PMIS workload data to successfully advocate for additional pharmacy staff in the Hardap region as well as to guide allocation of dispensing equipment to hospitals.

Conclusions: Implementation of a PMIS leads to availability of critical information that can be used to guide decision making and to improve various aspects of pharmacy service provision including rational medicine use and inventory management.

Funding sources: USAID Namibia and MoHSS, Government of Republic of Namibia


The Volume Share of Generic Medicines in the Retail Market Between 1999 and 2009: a Comparison between Brazil and Mexico

Rene Soria-Saucedo1, Veronika J Wirtz1, Warren A Kaplan2

1Center for Health Systems Research, National Institute of Public Health, Mexico; 2Center for Global Health and Development, Boston University, USA

Problem Statement: Most Latin American countries have implemented some pharmaceutical policies that encourage the use of generic medicines to increase access to pharmaceutical products. Mexico and Brazil are two Latin American countries that decided early on to introduce the concept of bioequivalence to increase confidence in the quality of generic medicines, and hence, promote its uptake. Little comparative analysis has been carried out to study the way policies were implemented.

Objectives: To analyze the relationship between public policies to promote the use of generic medicines and their volume share in the retail market between 1999 and 2009.

Design: Time series analysis of the retail pharmaceutical market volume and analysis of policies to promote the use of generic medicines

Setting: Brazil and Mexico retail sectors

Study Population: Innovator and generic medicines retail sales volume between 1999 and 2009

Intervention: Public policies introduced to promote the use of generic medicines

Outcome: Percentage change in volume share of generic medicines out of total retail market volume between 1999 and 2009

Results: From 1999 to 2009, the percentage volume share of generic medicines increased by more than five fold for Brazil (5% to 27.5%) and nearly four-fold for Mexico (1.8% to 8.5%). In Brazil, the annual increase in generic volume share was relatively constant over the 10 years (annual increase of 2.13%). In Mexico from 1999 to 2004, the annual increase in volume share was minimal (0.16% mean annual increase) and this changed after 2005 when the generic medicines volume increased about 1.31% per year.

Even though the policy objectives in Brazil and Mexico are similar in promoting generic medicines use, they differ largely in strategies and focus of implementation: Brazil enacted a law in 1999 which provided the framework for an explicit pharmaceutical policy largely based on WHO recommendations as well as a norm defining the requirements that generic medicines have to comply with before market authorization (among other bioequivalence tests). A key player in Brazil’s efforts to promote generic medicines was the Medicines Regulatory Agency (ANVISA). In contrast, Mexico lacked a coherent explicit pharmaceutical policy. Even though since 1998, regulations included a list of interchangeable generics, the Mexico’s Medicines Regulatory Authority (COFEPRIS) did not play an active part to promote generic medicine uptake in the private sector. In 2005, it was announced that all generic medicines will require a bioequivalence test similar to standards in Europe and the United States.

Conclusions: The Brazilian pharmaceutical policies were placed high on the political agenda, and ensured the technical, logistical, and financial preconditions for the medium- and long-term implementation since 1999. Mexican policies were targeted more effectively at the public market than the retail market.

Funding Sources: National Institute of Public Health, Mexico.


Health Litigation and New Challenges in the Management of Pharmaceutical Services

Vera Lucia Edais Pepe1, Tatiana de Aragão Figueiredo1, Luciana Simas1, Claudia Garcia Serpa Osorio-de-Castro1, Míriam Ventura2

1ENSP-Fiocruz, Brazil; 2IESC- Universidade Federal do Rio de Janeiro. Brazil

Problem Statement: Health litigation spurs many challenges in the management of pharmaceutical services. Performance of health managers and decision-makers must be adjusted to new administrative and legal boundaries. Their actions must also be efficient in responding to ongoing lawsuits, as well as in avoiding additional litigation and in upholding principles and directives of the Brazilian Health System (SUS).

Objectives: This paper proposes to better understand one of the aspects of health litigation, namely the growing use of lawsuits demanding medicines, and the relationship between this phenomenon and pharmaceutical services management in SUS.

Design and Setting: A review of management and technical procedures related to health litigation of medicines in Brazil was carried out. Through the analysis of available published research on the subject the main elements of "medicines litigation" are presented and examined in light of their interference on the activities of the pharmaceutical services cycle.

Results: Three possible negative effects of judicialization were found: problems with the principles of universal access and equity, difficulties in the management of pharmaceutical services and risks to patient safety, due to misguided prescribing of listed and public-funded medicines, and also of new, innovative medicines without solid established evidence. Moreover, unregistered, unauthorized medicines as well as off label uses may be the target of demands. All technical and operational phases of the pharmaceutical services cycle may suffer disruption by judicial demands. Injunctions can press health system to select medicines in order to adjust the AF cycle to judicial demands, increase the acquisition costs and contribute to the non-rational use of medicines. It is important to develop tools to update information about lawsuits; increase ethical, legal and technical actions and stimulate future innovative actions in different fields of knowledge. A model flow for the analysis of judicial demands in light of the need for evidence-based decision-making was obtained.

Conclusions: The analysis points to possible mechanisms to be adopted by decision-makers in management and in the Judicial System, since the right to health can only be effectively established when management and Justice are predominantly aware and committed to the safety and the protection of patients and users.

Funding Source: National Council for Scientific and Technological Development (CNPq) and Carlos Chagas Filho Research Support Foundation of Rio de Janeiro (FAPERJ)

2:00pm - 3:10pmPlenary 2: National Systems, Policies, and Programs
Session Moderator: Ahmed Mohammed Al Saidi, Ministry of Health, Oman, Oman
Session Moderator: Soonman Kwon, Seoul National University, Korea, South (Republic of)
Session Rapporteur: Richard Ogilvie Laing, WHO, Switzerland
Jasper Auditorium 

National Approach to the Rational Use of Medicines: The Omani Experience

Batool Jaffer Suleiman

Ministry of Health, Oman


Experiences in Implementing a National Medicines Policy Change in China

Jing Sun

China National Health Development Research Center, MoH China, China, Peoples Republic of

3:15pm - 4:15pm2b. Policy: Quality and Safety of Medicines in LMIC
Session Moderator: Andy S Stergachis, University of Washington, United States of America
Session Moderator: Andrea Mant, University of New South Wales, Sydney, Australia, Australia
Session Rapporteur: Andrew Lofts Gray, University of KwaZulu-Natal, South Africa
Jasper Auditorium 

Proposed Set of Indicators for Monitoring and Evaluation of Pharmacovigilance Activities

Ambrose Ohumagho ISAH1, Shanthi PAL2, Sten OLSSON3

1University of Benin, Benin City, Nigeria (INRUD Nigeria), Nigeria; 2World Health Organization, Geneva; 3International Collaborating Centre, Uppsala, Sweden

Problem Statement: The thalidomide tragedy triggered global consciousness regarding the safety of medicines. The need to monitor safety issue s regarding the intake of medicines has resulted in the tremendous growth of pharmacovigilance (PV) structures and activities. However, there are no acceptable standard set of indicators to measure and monitor these activities. Furthermore, there are no indices for comparison of measures in relation to baseline periods or inter- and intra-country, region, and facility comparisons.

Objectives: To outline a set of indicators for monitoring PV activities

Design: A qualitative study with the identification of a set of candidate indicators.

Setting: The envisaged setting for use will include country, regional, and health facilities, and public health programmes.

Methods: The set of indicators were identified from several sources— initially from a detailed review of the established pharmacovigilance process/routine, contributions from pharmacovigilance experts, national pharmacovigilance centres, and groups including Pharmacovigilance sans Frontiers (PVSF), the World Health Organization (WHO) Advisory Committee on Safety of Medicinal Products (ACSoMP), WHO/Uppsala Medical Centre, and literature sources.

Results: A total of 64 candidate indicators were identified. The indicators were categorized into structural (19) which assesses the existence of key PV structures, systems, and mechanisms in the setting; process (26) which assesses the entire mechanisms and degree of PV activities; and outcome/impact (19) which measures the effects (results and changes) of PV activities indicators. A set of background information parameters (10) to put into perspective the PV milieu (demographics, economics, health care system, and pharmaceutical scenario) generating the indicator data was also noted. This will also serve to provide the denominator for measuring the indicators. A further categorization into core and complementary indicators were made. A further subset for use in public health programmes is also highlighted

Conclusions: The set of indicators provide a useful robust tool to monitor and evaluate PV activities at various levels of the healthc are system as well as to provide indices for comparison of PV activities at country, regional, and facility levels, and within public health programmes.

Funding: WHO


Quality of Medicines in South Africa: Perceptions vs. Reality

Aarti Patel1,3, Robin Gauld2, Pauline Norris3, Thomas Rades3

1Health Research for Action (HERA), Belgium; 2Department of Preventive and Social Medicine, University of Otago, New Zealand; 3School of Pharmacy, University of Otago, New Zealand

Problem statement: To date little is known about how consumers and health care providers understand the concept of quality of medicines and/or the extent to which such understandings affect peoples’ procurement and use behaviours. Such knowledge is needed, especially in light of the increasing availability of counterfeit and substandard medicines in low- and middle-income countries. Although these resource-limited countries face many challenges in dealing with this issue, one approach is to increase awareness of consumers and providers of the dangers associated with the use of poor-quality medicines. These awareness campaigns must be informed by local norms and practices.

Objective: To explore perceptions of medicines’ quality from the perspective of consumers and health care providers and to compare these perceptions to the actual quality of selected medicines in South Africa

Design: Qualitative study involving focus group discussions (n=12) and semi-structured interviews (n=15) to gain familiarity with perceptions of quality; in vitro analysis performed on 135 generic and brand name medicines (paracetamol, amoxicillin and hydrochlorothiazide) sourced from both the public and private sectors, to determine actual quality Identification and dissolution tests based on BP and USP methods were used.

Setting: Conducted at the local level in three cities: Johannesburg, Durban, and Cape Town

Study population: Purposive sampling was used to recruit consumer participants (n=73) representing low, middle, and high socioeconomic status (place of residence and type of employment were used as proxy measures of status: formal and informal). Random sampling was used to recruit health care providers from public and private sectors (n=15).

Results: Respondents described drug quality in relation to the effect on symptoms. Consumers preferred getting their medicines from the private sector. They perceived free and generic medicines supplied by the state as inferior, suggesting that their views of the quality of care in general influence their perception of medicines quality. Procurement and use behaviour of health care providers was influenced by prior experience, manufacturers’ names, and consumers’ ability to pay. All formulations passed the in vitro tests for quality.

Conclusion: The study showed a clear difference between how people perceive the quality of medicines and the actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Education and targeted public campaigns specifically addressing the information needs of consumers and health care providers is one solution to addressing the present mismatch between perception and reality.

Funding source(s): University of Otago Grant and School of Pharmacy


Study on Quality Assurance for Essential Medicines other than ARVs, Antimalarial and Antituberculosis Medicines

Joëlle Daviaud1, Jean-Michel Caudron1, Corinne Pouget2, Monika Zweygarth2, Abu Saleh1, Carmen Perez Casas1, Sophie Logez1

1The Global Fund to Fight HIV, Tuberculosis and Malaria, Switzerland; 2Quamed, Institute of Tropical Medicine, Antwerp, Belgium

Problem Statement: The Global Fund’s quality assurance policy for pharmaceutical products requires that ARVs, antituberculosis, and antimalarial medicines procured with grant funds meet internationally recognized quality norms and standards. However, less stringent requirements are in place for other essential medicines, which include life-saving medicines, such as anti-infectives.

Objectives: The study aimed to determine the current quality assurance status of essential medicines other than ARVs, antimalarial, and anti-TB medicines, and to identify areas for improvement to inform policy development.

Design: This descriptive study entailed a questionnaire survey and visits to five recipient countries (Armenia, Burkina Faso, Cambodia, Nepal, and Nicaragua).

Setting: The questionnaire survey was conducted among key donors, grant implementers and organizations with procurement activities. Relevant stakeholders were interviewed during the country visits, including representatives of facilities across levels of health care, regulatory authorities, local manufacturers, recipients of Global Fund grants, WHO country offices, and disease programmes.

Study Population: The questionnaire survey was completed by 27 of 53 organisations contacted. Key informants were interviewed during each of the five one-week country visits.

Results: Based on the outcomes of the study, national regulatory authorization of essential medicines does not by itself give reasonable assurance that pharmaceutical products used in grant-funded programmes meet internationally recognized quality standards. Procurement agencies assume responsibility for quality assurance of the products that they deliver, but many lack the specific pharmaceutical capacity, insight and/or access to information required for this purpose. Quality control testing is overemphasized in relation to more proactive measures such as qualification of sources based on evaluation of product documentation and production sites assessment. Key stakeholders recognize the need for a more stringent approach to quality assurance for essential medicines; however they expressed concerns about possible price increases, reduced access to medicines if the market were to be limited, the impact on local pharmaceutical industries, and the creation of multiple quality standards for these widely-used medicines.

Conclusions: A global harmonized approach is needed to promote adherence to internationally recognized quality norms and standards for essential medicines. Major donors should work together to develop a policy approach and to phase in quality assurance requirements on a risk basis. These donor-driven measures should benefit the wider national health and medicines regulatory systems of recipient countries.

Funding Source: The Global Fund to Fight AIDS, Tuberculosis and Malaria


Interventions to Improve Medication Safety in a University Hospital in Thailand

Wimon Anansakunwatt, Uraiwan Silpasupagornwong, Umporn Yoobang, Nareumon Dhana, Monwarat Laohajeerapan

Pharmacy Department, Siriraj Hospital, Mahidol University, Thailand

Problem statement: Adverse drug events were found to be a major complication for hospitalized patients and most of them were preventable. Several interventions were implemented in Siriraj Hospital during 2000-2010. Medication error (ME) reporting system, drug information service and poison control center (DIS&PCC), adverse drug reaction (ADR) monitoring, and staff and patient education programs were implemented. Some of these interventions are highly accepted and successful, but there is no study to compare and conclude the success factors.

Objectives: To study common success factors of interventions to improve medication safety

Design: Observational descriptive study

Setting: Siriraj Hospital, the 2,300 beds tertiary-care teaching hospital of Mahidol University, Thailand

Study population: Interventions used for medication safety improvement in the hospital during 2000 to 2010

Method: Reports and minutes of team meeting review and discussion with key persons of each team

Policy: Patient safety is a goal of the hospital administration.

Outcome measures: Number of ME reports, ADR prevention reports, phone calls to DIS&PCC, scores of tests in education programs, and factors influenced success of each intervention

Results: ME reporting increased significantly when the manual reporting was changed to an on-line system and manual monthly reports were gathered from nursing and pharmacy departments and sent to the risk management office (p < 0.05). The number of phone calls received by DIS&PCC increased from 2,057 calls to 20,054 calls per year, after the service was changed from 8 hours to 24 hours; the services of toxicologists and staff education programs were also provided. The ADR monitoring team could prevent more repeated known allergy from 152 cases to 3,139 cases per year after a computerized alert in the pharmacy prescription process was implemented and patients were asked a prime question for known allergies. Staff education programs were provided and scores were significantly increased from pre-test to post-test, 68.1% to 88.7% and 63.5% to 81.8% in high-alert drugs and drug administration training, respectively. Patients were empowered to use their medicines correctly and monitor themselves. Patients increased their knowledge scores from 29% to 55% (N = 70, p < 0.05) and from 58.60% to 93.33% (N = 1,502, p < 0.05) in the transplant clinic and anticoagulation clinic drug counseling program, respectively. There were the terms of standards, quality, accreditation survey, multidisciplinary, computer program, counseling, and education in the meeting minutes and discussions. Key persons of each intervention worked after office hours to improve the interventions.

Conclusion: Accreditations from external organizations, multidisciplinary team approach, information technology, patient participation, and devoted personnel are common success factors of interventions to improve medication safety.

Funding source: No funding for this study


Date: Wednesday, 16/Nov/2011
8:45am - 9:00amDaily Summary
Session Moderator: Dennis Ross-Degnan, Harvard Medical School, United States of America
Jasper Auditorium 

Daily Summary - 2

Tienie Stander

heXor, South Africa

9:00am - 10:10amPlenary 3: Health Care and Financing Institutions
Session Moderator: Alexander Nii Oto Dodoo, University of Ghana Medical School, Ghana
Session Moderator: Socorro Zarate Escalante, World Health Organization, Viet Nam
Session Rapporteur: John Chalker, MSH, United Kingdom
Jasper Auditorium 

Win-Win or Lose-Lose? Why is multi-stakeholder involvement essential?

Saul Sebastian Walker

Department for International Development, United Kingdom


Universal Health Coverage and Access to Medicines: Golden Ring or Trojan Horse?

Jonathan Dickinson Quick

Management Sciences for Health, United States of America


A System Framework for Access to Medicines - Implications for Research and Policy

Maryam Bigdeli

World Health Organization, Switzerland

10:15am - 11:15am3b. Policy: Policy Interventions to Improve Rational Use of Medicines in LMIC
Session Moderator: Ambrose Ohumagho Isah, University of Benin, Benin City, Nigeria (INRUD Nigeria), Nigeria
Session Moderator: Liliya Eugenevna Ziganshina, Kazan Federal University, Russian Federation
Session Rapporteur: Elizabeth E Roughead, University of South Australia, Australia
Jasper Auditorium 

New Performance-Based Reward Strategy to Improve Pharmacy Practices, Financial Management, and Appropriate Medicines Use in the Public Sector in Uganda

Birna Trap1, Richard Semakula1, Martin Oteba2, Kate Kikule3, Belinda Blick1

1Management Sciences for Health, Uganda; 2Ministry of Health,Pharmacy Division, Uganda; 3National Drug Authorities. Uganda

Problem statement: Ensuring availability and appropriate use of essential medicines is crucial if limited resources are to be used optimally. Although training of health workers has been underway for a long time, taken since long, significant and sustainable improvements in availability and medicines management have not been achieved, and new interventions are needed. Increasingly, countries are finding it difficult to ensure sufficient funding for medicines; at the same time, the financial management (FM) capacity among pharmaceutical staff is weak. The use of a performance-based reward strategy (PBRS) has proven successful in strengthening vaccine management. The effect of capacitating pharmaceutical staff in FM and applying PBRS still needs to be assessed in regard to improving medicines management.

Objective: To assess impact of PBRS and FM in improving pharmacy practices (PP) and appropriate medicines use (AMU), implemented by trained medicines management supervisors (MMSs)

Design: A randomized longitudinal intervention study with randomization by districts; 25 indicators will be applied to assess good PP and AMU after educational, managerial, regulatory, and financial (reward) interventions were implemented. Data collection is undertaken as baseline at the initial facility visit, and several follow-up supervisory visits will also be made. Prior to each supervisory visit, performance will be assessed; this information will become part of the data along with the information collected during the visit. Supervisory visits are expected to continue for up to 2 years.

Setting: The study includes 45 intervention and 15 control districts with 1,482 public and 443 private not-for-profit, all-level health facilities; on average, 39 (11-105) facilities per district.

Intervention: The intervention districts are randomly assigned to 1 of 3 intervention groups: (1) supervision in supply chain management targeted at accreditation in good PP, (2) additional supervision in FM targeted at certification in good FM, and (3) additional stores computerization—all compared to a control group of facilities. Accreditation in good PP is undertaken by the national drug authority and harmonized with the licensing criteria applied in private sector pharmacies; 146 MMSs will be trained as district and health subdistrict supervisors. The reward system for MMSs comprises items such as motorbikes, computers, Internet access, personal training, and e-based learning, and for the facilities, accreditation, certification, technical manuals, continued education, and computerization, all with community involvement.

Policy: The strategy is built on the basis of the essential medicines concept with development of essential medicines, supplies, and the laboratory supplies list, classified according to health impact and importance in saving lives, which will guide procurement at all levels.

Outcome measures: The primary outcome measures included PP, FM, and AMU.

Results: Method description and baseline date available for ICIUM 2011. Results will only start to become available from mid 2011.

Funding source: United States Agency for International Development through Securing Ugandans’ Right to Essential Medicine (SURE) Program.


The Irrational Use of Drugs in Rural China: Evidences from Two Provinces

Qiang Sun, Jia Yin, Genyong Zuo, Qingyue Meng

Center for Health Management & Policy, Shandong University, Peoples Republic of China

Problem statement: Irrational use of drugs is a severe problem in China. The overuse, under use, or misuse of drugs has resulted in wastage of scarce resources, poor-quality treatment, and unnecessary costs of health care.

Objectives: To evaluate the basic situation of rational use of drugs in rural China by studying the behavior and perception of health care providers and rural residents

Design: It was a policy evaluation study. A cross-sectional study was designed to evaluate the use of drugs in rural China.

Setting: This study was conducted in Shandong and Ningxia provinces. In each province, the public hospitals and rural community were the basic study sites.

Study population: In each province, 3 counties, 9 towns, and 18 villages were randomly sampled according to the economic level, and in each villages, 30 household were randomly sampled. In total, 13,481 rural residents were investigated. 3,000 prescriptions were randomly sampled and collected at county hospitals, township health centers, and village clinics. 49 health care providers from county, town, and village health institutions were interviewed.

Policies: The Ministry of Health has issued policies and carried out health promotion activities for improving the rational use of drugs in hospitals and communities, but the effects of these policies and activities on use of drugs, especially in the rural area in China, are unclear.

Outcome measure(s): Primarily, the behavior and perception of health care providers and rural residents on use of drugs were measured.

Results: The results showed that 75.3% and 66.2% of prescriptions sampled from the village clinics have antibiotics in Shandong and Ningxia, respectively, and the antibiotic utilization rate in the village clinics is significantly higher than that in county hospitals and township health centers (χ2=123.659, p<0.001; χ2=12.735, p= 0.005). Accustomed prescription practices of rural health providers and economic incentives from selling drugs are the main reasons for the high antibiotic utilization; meanwhile over 50% of surveyed populations don’t know consequence of irrational use of antibiotics in the two provinces. Over 50% of prescriptions have the injections in the township health centers and village clinics, which is significantly higher than that in the county hospitals. Our study found that the rural patients actively require using the injections as they believe the effect of injections is better than oral drugs. 54.6% and 60% of the rural patients cannot comply with medical advice to take drugs in Shandong and Ningxia, respectively.

Conclusions: The policies and health promotions do not play certain roles in improving the rational use of medicines in rural China. Implementing trainings on the rational use of drugs and reforming the incentive mechanism for rural health providers are urgent and essential for improving the rational use of drugs in rural China.

Funding source(s): The study is part of a project entitled "Bringing Health Care to the Vulnerable: Developing Equitable and Sustainable Rural Health Insurance in China and Vietnam (RHINCAV)" funded by the European Commission (Specific Targeted Research Project).


Financial Impact of Judicious Use of Medicine in Primary Care

Yeqin Zuo, Stephen Morrell, Jonathan Dartnell, Lynn Weekes

NPS:Better Choices, Better Health, Australia

Problem statement: Many policies and guidelines have been developed to promote the judicious use of medicines. Funding large-scale programs to implement these policies remains challenging. NPS has worked at the national level to address quality use of medicine in the last 12 years.

Objectives: To assess the financial impact of NPS programs on expenditures by the Australian Pharmaceutical Benefit Scheme (PBS) between 2007 and 2009

Design: Time series modeling was used to assess the association between general practitioner (GP) participation in NPS programs and PBS expenditures, controlled for underlying trends, seasonality, autocorrelation, and medicine price changes. PBS monthly time trends over 1999–2009 in utilization of antithrombotics, antihypertensives, analgesics, antidepressants, and proton pump inhibitors (PPI) were analyzed.

Setting: Primary care

Study population: All Australians entitled to PBS subsidies

Intervention(s): The interventions aimed at GPs included educational visits, case studies, clinical audits, and group discussions. Key messages relevant to reducing suboptimal use of medicines included the following: (1) reserve clopidogrel for those unable to take aspirin; (2) avoid fixed-dose combination products in the initiation of antihypertensives; (3) limit the role of tramadol for mild to moderate pain management; (4) use psychological therapies as first-line treatments in mild depression; and (5) step down the dosage of PPIs to intermittent, symptom-driven therapy.

Policy: Evidence-based prescribing

Outcome measure(s): Difference in PBS expenditure on targeted medicines attributable to the intervention

Results: The GP participation rates were between 29% (5,956) and 52% (8,358) of all GPs. We found a significant correlation between GP participation and decreased PBS expenditures on targeted medicines (p <0.0001 to <0.05). We noted a significant increase in the effect of interventions in the initial period following implementation. For example, the annual PBS expenditure saving on antidepressants increased from 7% in 2008 to 12% in 2009 (last GP enrollment in May 2008); however, 2 years after implementation, the PPI program showed signs of waning. Annual cost savings decreased from 13% in 2008 to 12% in 2009 (last GP enrollment in April 2007). Overall, we estimate a mean annual PBS expenditure reduction of 16% (AU $18.4 million) per program per drug group attributable to NPS interventions.

Conclusions: Comprehensive programs in primary care can reduce inappropriate prescribing and lead to substantial national cost savings. Program for some drug groups may need refresher interventions every 2–3 years to sustain the impact.

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


Effects of Listing and Delisting in National Essential Medicine List on Utilization Patterns

Sauwakon Ratanawijitrasin1, Sanita Hirunrassamee2

1Faculty of Social Sciences and Humanities, Mahidol University, Thailand; 2Pharmacy division, Phramongkutklao Hospital, Thailand

Problem statement: The National Essential Medicine List (NEML) has been a major policy instrument that the Thai Government has employed to regulate the use of medicines in government health facilities since 1982. Recent changes made in the 2008 NEML, from the previous 2004 edition, include addition and deletion of a number of medicines.

Objectives: This study examines the effects of NEML listing and delisting on utilization patterns and compares delisted drugs with remaining or added medicines and, where applicable, “non-essential” medicines (NEM; not listed in both NEML editions) in the same pharmacological category.

Methodology: Comparisons were made on 3 groups of medicines: (1) statins: Atorvastatin (delisted), Simvastatin (listed 2004 and 2008), and Rosuvastatin (NEM); (2) ACEIs and AIIAs: Enalapril and Losartan (listed 2004 and 2008) and Valsartan (delisted); and (3) antiepileptics: valproic acid (listed 2004 and 2008), Gabapentin (indication changed), and Levetiracetam (added 2008). Outpatient electronic dispensing databases from 9 government hospitals were used. Segmented regression analysis of interrupted time-series data was employed. The number of patients prescribed each of the medicines 14 months before and 10 months after the policy change were traced. This comprises a total of 24 months of time-series data points, with 130,287 patients in this dataset prescribed the statins, 85,349 patients prescribed the ACEIs and AIIAs, and 31,739 patients prescribed the antiepileptics. Comparisons of the percentages of patients in the 3 major health insurance schemes prescribed the delisted medicines were also conducted.

Results: Time-series plots of the number of patients prescribed each studied medicine per month exhibit no apparent change in the utilization patterns for all the items before and after the switch from 2004 to 2008 NEML. The statistical analyses of the listed, delisted, and non-listed medicines showed no significant difference before and after the introduction of the 2008 NEML. Further examination of utilization patterns among beneficiaries of the 3 major health insurance schemes revealed differences in the percentage of patients in different groups being prescribed these medicines. Before the new NEML, Atorvastatin was prescribed to 31.5%, 3.8%, and 0.6% of patients in the Civil Service Medical Benefits Scheme, Social Security Scheme, and the 30-Baht Scheme, respectively. After the new NEML, these numbers changed only slightly to 31.1%, 3.3%, and 0.6%. Similar discrepancies among schemes were also found in the prescribing patterns of Losartan, Valsartan, and Gabapentin.

Conclusion: No statistical significant changes in the utilization patterns of the listed, delisted, and non-listed medicines occurred after the introduction of the 2008 NEML. Discrepancies in utilization were found among patients in different health insurance systems. It appears that health insurance policy exerts greater influence on utilization patterns than essential medicine policy.

Funding source: Information not provided

2:00pm - 3:10pmPlenary 4: Health Care Providers
Session Moderator: Hortensia Reyes-Morales, National Institute of Public Health, Mexico
Session Moderator: Göran Bengt Tomson, Karolinska Institutet, Sweden
Session Rapporteur: Keith William Johnson, Management Sciences for Health, United States of America
Jasper Auditorium 

Improving Mental Health in Low- and Middle-Income Countries

Robert Sebbag

Sanofi-aventis Groupe, France


Promoting Adherence to Antiretroviral Therapy Through System Inverventions - The INRUD-IAA Experience

John Chalker

MSH, United Kingdom


Chronic Diseases in Low and Middle Income Countries: A Framework for Long-term Pharmacotherapeutic Care

Veronika J. Wirtz

National Institute of Public Health, Mexico, Mexico

3:15pm - 4:15pm4b. Policy: Providers and Promotion
Session Moderator: Batool Jaffer Suleiman, Ministry of Health, Oman
Session Moderator: Kumud Kumar Kafle, INRUD Nepal, Nepal
Session Rapporteur: Brian Conroy Gunn, Ministry of Health, Sultanate of Oman, Oman
Jasper Auditorium 

Marketing and Promotion of the Pharmaceutical Industry: Snapshot of Current Practice Within, or With Possible Implications In, Low- and Medium-Income Countries

Suzanne Elizabeth Edwards1, Afshin Mehrpouya2, Frans Westerbos1

1Access to Medicine Foundation, Netherlands, The; 2MSCI Group - ESG Research

Problem statement: Developing countries often have more constrained regulatory enforcement, information systems, and consumer protection. These countries’ health care professionals and patients can be more dependent on medical information from and the self-regulation of companies themselves. Stakeholders, including the WHO, have highlighted concern over the possible risks this situation may pose for rational prescription and use of medicines.

Objectives: To use data from the Access to Medicine Index 2010, a bi-annual pharmaceutical industry benchmarking tool, to provide a baseline snapshot of current average and leading sector practice in the area of marketing and promotion (M&P) in index countries (ICs).

Design: A sub-analysis of 7 qualitative indicators relating to M&P. Data was obtained through public and engagement-based disclosure for the 2008 and 2009 financial years. Analysis focused on governance, policies, and operations in or with impact on ICs—88 countries based on the UN HDI list of low- and medium-income countries and for products targeting 33 high-priority diseases (in ICs).

Study population: 20 largest originator pharmaceutical companies in 2009

Policy change: By transparently measuring and benchmarking companies we aim to build a deeper and broader understanding of the current situation and practice in this area. The bi-annual nature of the survey and the use of consistent metrics will, in the future, allow evaluation of changes over time to facilitate policy development and evaluation both within and external to the industry.

Results: Currently 100% (20) of companies analysed commit to adherence with at least 1 recognised global M&P code and also have an employee code of conduct which includes M&P. Seven companies do not currently demonstrate evidence of the existence of mechanisms to monitor and ensure compliance in IC markets. Eight companies commit to demanding ethical marketing from their third parties. Of these, 4 currently ensure this by either making it contractual or by providing evidence of compliance mechanisms. Of the 12 companies with no commitment, 5 have general recommendations in place. At present, not one company analysed discloses or reports their approach, the nature of the M&P activities, or resources dedicated to M&P in ICs. During the period of analysis, no major litigation in the ICs was found regarding M&P activities. All companies disclose this information to a level legally mandated.

Conclusions: Currently, no company discloses any information regarding their M&P approach, activities, or financing in ICs. Internal governance of M&P appears less robust for companies’ IC operations, with robustness lower still for M&P occurring through third parties. Examples of leading practice are found, which may indicate growing company attention to these issues and stimulate more rapid sector-wide adoption. The index has an ongoing role in policy development and evaluation in this area by facilitating greater transparency, communicating clear stakeholder expectations, and evaluating behaviour change over time.

Funding sources: Bill & Melinda Gates Foundation, UK Department for International Development, Dutch Ministry of Foreign Affairs


CEMA-Community to Improve Knowledge and Skills in Evaluating Medicine Advertisements

Chairun Wiedyaningsih1, Nunung Priyatni2, Siti Munawaroh3, Sri Suryawati4

1Faculty of Pharmacy, Gadjah Mada University, Yogyakarta, Indonesia; 2Magister of Medicine Management and Policy, Faculty of Medicine, Gadjah Mada University, Yogyakarta, Indonesia; 3Agency for Women and Community Empowerment, Yogyakarta Province, Indonesia; 4Centre for Clinical Pharmacology and Medicine Policy Studies, Gadjah Mada University, Yogyakarta, Indonesia

Problem statement: Since objective information on medicine advertisements is often scarce, medicine advertisements may affect the community’s perception and health. The Critical Evaluation Medicine Advertisement by the community (CEMA-community) is a strategy that may empower a community in evaluating medicine advertisements. It was developed based on the previous study targeted at medical students with modifications on the content and the inclusion of local regulation on medicine promotion.

Objectives: To evaluate the effectiveness of CEMA-community to improve knowledge and skills of participants in critically evaluating medicine advertisements

Design: An intervention study used pre and post in time series with control group design

Setting: The study was conducted in collaboration with Family Empowerment and Welfare Organization (PKK) in Yogyakarta municipality, Indonesia.

Study population: Women who are involved in the family welfare movement team of the PKK organization

Method: The CEMA-community method consisted of two sessions: the first was a brief lecture lasting 45 minutes, and the second involved small-group discussions using printed and audiovisual medicine advertisements in problem-oriented approach for 60 minutes. An activity guide was provided. Recorded radio and television advertisements were displayed by means of portable computer. Data on knowledge were obtained by questionnaires. Data on skills were assessed by the number of inappropriate claims participants could identify the advertisements. All data were collected before intervention, right after intervention, and 2 and 4 weeks after intervention. Effectiveness of the approach was shown by the significance of the increasing level of knowledge and skills after intervention. In-depth interviews with participants indicated feasibility of the approach.

Policy: The CEMA-community strategy can be used to empower the communities in critically evaluating medicine advertisements through any possible channel.

Outcome measure(s): Scores of knowledge and skills in assessing medicine advertisements

Results: Participants’ knowledge and skills in the CEMA-community group improved significantly (Wilcoxon test, p< 0.05) right after intervention and was maintained at the 2 and 4 weeks follow-up. Score of knowledge in the CEMA-community group (means: 13.9±2.52, 18.0±2.72, 19.0±3.10, 18.3±3.74, respectively before intervention, right after intervention, and 2 and 4 weeks after intervention) improved significantly (Mann-Whitney, p<0.05) as compared to the control group. Similarly, scores of skills in the CEMA-community group (means: 7.8±6.05, 16.5±10.01, 32.6±12.89, 32.2±13.06, respectively before intervention, right after intervention, and 2 and 4 weeks after intervention) also improved significantly (Mann-Whitney, p<0.05) as compared to the control group.

Conclusion: CEMA-community was effective in increasing knowledge and skills to critically evaluate medicine advertisements. CEMA-community also feasible to be implemented among Yogyakarta PKK organization members.

Funding source(s): Information not provided


“Under the Radar”: Nurse Prescribers and Pharmaceutical Industry Promotions

Elissa Ladd1, Diane Mahoney1, Emani Srinivas2

1MGH Institute of Health Professions, United States of America; 2Brigham and Womens Hospital

Problem statement: Multiple studies have shown that physicians’ prescribing decisions are affected by non-scientific factors such as patients’ requests for medications as well as pharmaceutical company promotions (i.e., gifts, meals, and continuing education programs). Although there has been extensive research on the effect that pharmaceutical promotions have on physician prescribing, there has been a paucity of empirical data on nurse prescribing behaviors in relation to pharmaceutical marketing.

Objectives: To assess nurse interactions with pharmaceutical industry promotions and evaluate the effect of an educational intervention on the perception of industry sponsored drug information and self-reported prescribing behaviors

Design: Randomized baseline, post 1 and post 2 intervention without control

Setting: National online survey of public and private sector nurse prescribers

Study population: Nationally representative randomized sample of 263 nurse prescribers at baseline and 208 at post-intervention

Intervention: Web-based educational intervention on pharmaceutical marketing, conflicts of interest, and evidence-based prescribing

Outcome measure(s): Change in perceptions and attitudes regarding pharmaceutical marketing; self-reported changes in prescribing behaviors

Results: Almost all of the respondents (96%) reported regular contact with pharmaceutical sales representatives, and the majority (71%) reported receiving information on new drugs directly from pharmaceutical sales representatives some or most of the time. A large portion (66%) gave out drug samples regularly to their patients, and 73% felt that samples were somewhat or very helpful in learning about new drugs.

Post-intervention there was a statistically significant (p<.01) increase between baseline and post 1 for prescribers who reported challenging information provided by pharmaceutical representatives, the use of evidence-based drug information, and the use of generic drugs. There was also a statistically significant decrease (p<.01) in the acceptability of the use of sample medications, the reported use of highly marketed drugs and the favorable perception of the reliability of information provided at industry sponsored meal and continuing education events.

Conclusions: Nurse prescribers had extensive contact with the pharmaceutical industry’s sponsored promotional activities. The educational intervention resulted in a significant change in attitudes and self-reported prescribing behaviors. The findings of this study demonstrate that nurse prescribers and/or nurses who recommend drugs for their patients are shown to be as susceptible to pharmaceutical industry promotions as their physician colleagues. This finding is significant because nurses represent the largest segment of the global health care workforce and therefore can have substantial influence on rational medication selection.

Funding source(s): Attorneys General Consumer and Prescriber Grant Program


Date: Thursday, 17/Nov/2011
8:45am - 9:00amDaily Summary
Session Moderator: Tienie Stander, heXor, South Africa
Jasper Auditorium 
9:00am - 10:10amPlenary 5: Consumers, Patients, and Community Systems
Session Moderator: Celestino Obua, Makerere University, College of Health Sciences, Uganda
Session Moderator: Klara Tisocki, Results in Health, United Kingdom
Session Rapporteur: Catherine E. Vialle-Valentin, Harvard Medical School, United States of America
Jasper Auditorium 

Can Markets Work to Scale up Rational Drug Use?

Anthony D. So

Duke University, United States of America


Scaling up community management of malaria - challenges and successes in EMRO countries

Hoda Atta



Access/rational Use to TB Treatment Issues and Interventions

Samiha Baghdadi, Khaled Khalil



Expanding Regulated Private Sector Medicines Access - Experiences with Accredited Drug Dispensing Outlets

Romuald Mbasi

Apotheker Consultancy (T) Ltd


Medicines Need and Access: Are there Gender Inequities?

Anita Katharina Wagner

Harvard Medical School, United States of America

10:15am - 11:15am5b. Policy: Consumers and Good Governance for Medicines
Session Moderator: Natalia Cebotarenco, CoRSUM - Coalition for Rational and Safe Use of Medicines, Moldova, Republic of
Session Moderator: Mohamed Ramzy Ismail, WHO-EMRO, Egypt
Session Rapporteur: Jing Sun, China National Health Development Research Center, MoH China, China, Peoples Republic of
Jasper Auditorium 

Transparency Monitoring Study: A Rapid Assessment of Transparency in Key Functions of Pharmaceutical Services in 15 Countries

Rasha Saadi Hamra, Alessandra Ferrario, Maryam Bigdeli, Guitelle Baghdadi-Sabeti

World Health Organization/Alliance for Health Policy and Systems Research, Lebanon

Problem statement: WHO launched Good Governance for Medicine program with goal to contribute to health system strengthening and prevent corruption by promoting good governance: 26 countries joined since 2004. First step was to conduct a national assessment of level of transparency and potential vulnerability to corruption in pharmaceutical sector. A standardized instrument was designed to measure transparency in 8 functions of medicine chain: registration, licensing, inspection, promotion, clinical trials, selection, procurement and distribution. The assessment provides a baseline for countries to revise, adjust their laws, policies, administrative structures and processes. It measures vulnerability in systems at time of assessment and vulnerability scoring can be used to monitor progress over time.

Objectives: Analyze data on transparency for baseline and 2010 status; provide recommendations for improving GGM policies

Design: Comparative analysis between baseline transparency indicators with 2010 status. Indicators checklist was developed to collect data for 2010 based on the original Transparency Assessment Instrument indicators.

Setting: Public pharmaceutical sector.

Study population: All 26 countries that conducted Transparency assessment initially, were asked to participate on voluntary basis and were sent checklist to fill, but some choose not to participate in 2010 analysis for various reasons; not a priority, short time given to fill the checklist, change of focal points. Data were received from 15 countries: Benin, Bolivia, Cameroun, Costa Rica, Indonesia, Jordan, Lao, Lebanon Macedonia, Malaysia, Moldova, Mongolia, Philipine, Thailand, and Zambia.

Policies: Initial findings of assessments enabled ministries of health and national regulatory authorities to identify weaknesses and gaps in systems and develop strategies to address them. Current study will show which policies were addressed most and which were given least attention.

Outcome measures: Improvement in indicators across the 8 pharmaceutical functions and overall improvement in transparency and vulnerability to corruption of a given function.

Results: Improvement in pharmaceutical functions was most seen in selection, procurement and registration. Some improvement was seen in inspection and promotion as well. Improvement in licensing and control of clinical trials cannot be seen since we had complete data for baseline and status only for 3 countries to compare. Countries’ efforts to improve good governance consisted in making information publicly available, accountability of committee members, and participation of different stakeholders in various committees. Many pre-existing written documents, procedures and guidelines were made publicly available to increase transparency. Some countries worked on developing detailed terms of reference and guidelines for different committees.

Conclusions: Transparency assessment had power to initiate change at different levels and across various functions of the public pharmaceutical sector. Findings of this analysis gave a clear visualization of policy changes in different functions of pharmaceutical systems. The change introduced and documented will lead countries to further acknowledge importance of good governance. Results of this analysis and future ones will help in identifying agendas for policy change and setting realistic priorities for action in the pharmaceutical sector.

Funding source: AHPSR-WHO


Corruption and High Medicine Prices in Vietnam: A Qualitative Study

Tuan Anh Nguyen1,2, Rosemary Knight1, Andrea Mant1, Minh Quang Cao3, Husna Razee1

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

Problem statement: Medicine prices in Vietnam were unreasonably high. Adjusted for Purchasing Power Parity in 2005, the prices to patients in the public sector were 46.58 and 11.41 times the international reference price for originators and lowest priced generic equivalents, respectively.

Objective: To identify the main reasons for high medicine prices in Vietnam

Method: Semi-structured questionnaires were used to conduct 43 interviews with different stakeholders including pharmaceutical companies’ representatives, Ministry of Health officials, and prescribers in Vietnam from April 2008 to December 2009. The interviews were all recorded, transcribed, and coded using NVivo8 software. Ethics approval was obtained from the University of New South Wales.

Results: According to participants’ responses, originator medicines in Vietnam were too expensive due to a supplier monopoly. Prices of generic medicines were set at around 80%, sometime even higher than those of corresponding originator medicines due to informal payment to authorities, commissions for prescribers, and kickback to hospital pharmaceutical departments. Pressures for survival arising from an imperfectly competitive pharmaceutical market, among other reasons, were believed to force pharmaceutical companies to be inextricably linked to prescribers. Salary pressures and the perpetual corruption in the absence of penalties in Vietnam were given as the main motives for prescribers to collude with the pharmaceutical industry. The magnitude of reported corruption varied across geographic regions, sectors, and prescriber’s specialties. In addition, overreliance on the international market, poor market intelligence, failure to achieve economies of scale due to duplication in drug production and distribution, too many layers in the distribution network, and malfunctioning pricing policies were reported to be non-corruption related causes for the high medicine prices in Vietnam.

Conclusions: Corruption was reported as a main driver for high medicine prices in Vietnam. Although individual factors such as professional ethics and personal value influenced physician behaviours and their response to corruption, entrenched or intractable systemic issues including lack of transparency and accountability and poor legislation enforcement emerged as important factors perpetuating corruption. Addressing the widespread issue of corruption, both individual and systemic factors, is necessary in developing sound medicine pricing policies in Vietnam. Interventions to relieve dependencies for survival of health care services on the corrupt system are needed. Rationalization of the domestic drug production and distribution to achieve economies of scale and reduce wasteful uneconomic competition might be a solution that Vietnam needs to achieve soon.

Funding source(s): The Ministry of Education and Training, Government of Vietnam


Active Enforcement to Code of Conduct and Conflict of Interest Policies Based on Transparency Assessment Study in Jordan

Sana Naffa, Adi Nseirat

World Health Organization, Jordan

Problem Statement: Transparency assessment survey showed that there are different levels of vulnerability to corruption, these levels are classified into; minimally vulnerable, marginal, , moderate, very and extremely vulnerable, in six key functions in the pharmaceutical sector.

Objectives: To assess the level of transparency and potential vulnerability to corruption of six essential functions in the pharmaceutical sector; and to develop a framework for improving the good governance in medicine practices within pharmaceutical sector.

Study Design: The assessment instrument contains three questionnaires, one for each function. Each questionnaire is used with key informants selected according to explicit criteria. Sixty-one key informants were selected.

Results: (1) Registration: 7.52—marginally; (2) promotion 1.88 —extremely; (3) inspection 5.79—moderately; (4) selection 7.71—marginally; (5) procurement 8.59—minimally; distribution 8.41—minimally. The total was 6.65—marginally.

Interventions: A national workshop was conducted. Two committees have been formed by ministerial decree—a task force to follow up on study findings and recommendations leading to developing a framework for implementing and socializing the framework; and a steering committee to approve and set policies for reform in the pharmaceutical sector. A national Framework for Good Governance in Medicine was developed to activate the integrity system, which includes a code of conduct, policies on conflict of interest, whistle blowing mechanisms, sanctions, and reprehensible acts. Information on the framework was distributed through a national workshop. The Code of Ethics and conduct was enforced in the civil servants practice. Conflict of interest policy and contest was enforced in all committees working at Jordan Food and Drug Administration. Guidelines regarding medicine promotion control have been issued. Other laws and guidelines are now under revision.

Outcome Measures: Improve performance in transparency in six functional areas in the ph. sector. In medicine registration, the clear written criteria for selecting members of the committee scored 0.6 in the baseline assessment but was raised to 0.83; in the terms of reference for the committee was raised from 0.62 to 0.88. In inspection and market control, the baseline was 0.83 in 2007 and increased to 1.0 in 2010. In promotion control, the provision on medicine promotion and advertising included explicit mention of the different forms of promotion increased from 0.4 in 2007 to 0.9 in 2010 and the provision foresaw an enforcement mechanism stating sanctions, increased from 0.2 in 2007 to 1.0 in 2010. In selection of medicines, use of clear criteria for selection of members of the selection committee increased from 0.53 in 2007 to 0.86 in 2010.

Conclusions: The transparency assessment survey set the guidelines and a baseline for measuring six key functions in the pharmaceutical sector. Sector. Follow up on these measurable indicators in the assessment tool showed remarkable improvement in performance; setting the stage for new guidelines, policies, and reform.

Funding source: WHO


Tsunami Drug Donations in Sri Lanka: Have the WHO Guidelines on Drug Donations been Effective in Meeting Public Health Pharmaceutical Needs in Times of Disaster?

Rohini Fernandopulle1, Hemantha Beneragama2, Priyadarshini Gallappatthy1, Nilesh Fernandopulle2

1Faculty of Medicine, University of Colombo, Sri Lanka; 2Ministry of Health

Problem statement: Noncompliance with WHO good donation practices resulted in inappropriate donations

Objective: To determine compliance with WHO guideline for donations received by the Ministry of Health (MOH) following the tsunami in Sri Lanka in 2004

Design: Pharmaceutical policy analysis

Setting: State sector; private organizations were excluded.

Methodology: Data was collected using investigator administered questionnaires from March to July 2005. A product that had the same drug substance, in the same dosage form and in the same strength irrespective of their brand name and package size, was classified as a ‘unique drug product’ (UDP). The UDPs were then classified according to the 4 categories of the donation guideline (selection, quality assurance and shelf life, presentation packing and labelling, and information and mangement). Selection was determined on the Anatomical Therapeutic Chemical classification status in the WHO model list of essential drugs (2003), the MOH expressed list, the hospital formulary list (2004), the WHO/UNICEF emergency list , Sri Lanka registered medicines list and the British National Formulary (March 2005). Destroying costs were calculated using documents available.

Outcome measure(s): Percentage compliance with WHO guideline

Results: Of all the UDPs, 80% were unsolicited and arrived unannounced in unsorted boxes, 86% of which were under an individual’s name or donated to international focal points (~50%). The balance was donated by governments (8.4%) or national or multinational pharmaceutical firms (5.6%); 53% of UDPs belonged to the ‘non-list’ category; 38% of INNs were unregistered in the country; 50.5% (28 metric tons) did not have expiry dates. Among those with an expiry date, 6.5% had expired on arrival and only 67% complied with the guideline of a remaining shelf life of at least 1 year; 62% of UDPs were labelled in a non-understandable language, 81% were without package inserts, and 15% were without generic names. Medicines purchased after consulting with the MOH and over 90% of the donations sent directly by governments had the required shelf life of over 1 year and were 100% utilized. The value of 1 donation claimed by the donor was 50% of the public sector drug budget, but the budget for 2005 was reduced only by 4%. Cost of destruction of unwanted medicines was approximately SLR 2.5 million and was borne by Sri Lanka.

Conclusions: The WHO guidelines are comprehensive and would have prevented the burden of useless donations if adhered to, but total reliance on donor compliance resulted in inappropriate donations. The lack of a policy on acceptance of donations was a major contributory factor. Donors failed to comply with the guidelines on matters of selection, quality assurance and shelf-life, presentation, packaging, labelling, language, information and disposal.

Recommendations: MOH should have a written policy on drug donations based on the WHO drug donation guidelines and should strictly enforce adherence to the guidelines when donations are received.

Funding source(s): World Health Organization

2:00pm - 3:10pmPlenary 6: Strategies and Methods
Session Moderator: Peter Memiah, University of Maryland, United States of America
Session Moderator: Sallie-Anne Pearson, University of New South Wales, Australia
Session Rapporteur: Dennis Ross-Degnan, Harvard Medical School, United States of America
Jasper Auditorium 

Key Strategies for Improving Use of Existing and New Antibiotics - the European Experience

Otto Gunnar Cars

ReAct/Uppsla University, Sweden


Key Strategies for Developing and Facilitating Appropriate Use of New Antibiotics - Toward a New Business Model

Richard Bergstrom, Brendan Barnes

EFPIA, Sweden


Strengths and Challenges of Data for Medicines Use Research: Electronic Hospital Prescribing Data

Inthira Kanchanaphibool

Silpakorn University, Thailand


Strengths and Challenges of Data for Medicines Use Research: Pharmaceutical Sales Data in Brazil

Andréa Homsi Dâmaso

Universidade Federal de Pelotas, Brazil


Strengths and Challenges of Data for Medicines Use Research: Self-reported Medicines Information in Household Survey Data

Brian Serumaga

University of Nottingham, United Kingdom

3:15pm - 4:15pmMethods 1: Longitudinal Methods for Pharmaceutical Policy Evaluation
Session Moderator: Dennis Ross-Degnan, Harvard Medical School, United States of America
Session Moderator: Michael R Law, The University of British Columbia, Canada
Session Rapporteur: Stephen Bertram Soumerai, Harvard Medical School, United States of America
Jasper Auditorium 

Use of Routine Data for Monitoring or Evaluating a Policy Change

Dennis Ross-Degnan

Harvard Medical School, United States of America


Changes in Use of Antidiabetic Medications Following Price Regulations in China (1999-2009)

Christine Y Lu

Harvard Medical School and Harvard Pilgrim Health Care Institute, United States of America

See poster number 878


Effects of Listing and Delisting in National Essential Medicine List on Utilization Patterns

Sauwakon Ratanawijitrasin

Mahidol University, Thailand

See poster number 811


Evaluating the Quality of Care for Patients with Type 2 Diabetes Using Electronic Medical Record Information in Mexico

Ricardo Perez-Cuevas

Ministry of Health, Mexico, Mexico

See poster number 1118


Collection and analysis of longitudinal pharmacy refill data from manual registers: Experiences from Ugandan public health systems

Joshua Kayiwa

Joint Clinical Research Centre, Uganda


Longitudinal Methods for Pharmaceutical Policy Evaluation - Common Analytic Approaches

Michael R Law

The University of British Columbia, Canada


Date: Friday, 18/Nov/2011
8:45am - 9:00amDaily Summary
Session Moderator: Ramachandran Murali, Chettinad Hospitals and Research Institute, India
Jasper Auditorium 

Daily Summary - 1

Dennis Ross-Degnan

Harvard Medical School, United States of America

9:00am - 11:00amMethods 5: Using Market Intelligence Information for Pharmaceutical Policy Analysis
Session Moderator: Veronika J. Wirtz, National Institute of Public Health, Mexico, Mexico
Session Moderator: Murray Aitken, IMS Institute for Healthcare Informatics, United States of America
Session Rapporteur: Laura Faden Garabedian, Harvard Medical School and Harvard Pilgrim Health Care Institute, United States of America
Jasper Auditorium 

Evolution of the Generic Medicines Market in Brazil, 1998-2010: Antihypertensives, Antidiabetics, and Antibiotics

Andréa Dâmaso Bertoldi1, Peter Stephens2, Anita K. Wagner3, Dennis Ross-Degnan3

1Universidade Federal de Pelotas. Pelotas, RS, Brazil; 2IMS Health. London, UK; 3Harvard Medical School and Harvard Pilgrim Health Care Institute. Boston, US

Problem Statement: Generic medicines were launched in Brazil in February 2000 after implementation of the Generic Medicines Policy in 1999. Since then, three types of medicines have been available in the market: originator brands, unbranded generics, and similares (non-originator brands). In Brazil, all generic medicines must be commercialized with no brand and they are the only group of medicines which are considered interchangeable with the originator brand; similares are all the other brand medicines available in the market.

Objectives: To describe changes in market share of selected originator products, similares’ and generics over time, following the 1999 Brazilian generics law.

Design: Interrupted time series.

Setting: Longitudinal data on sales by wholesalers to retail pharmacies in Brazil of antihypertensives, antidiabetics, and antibiotics collected by IMS Health between 1998 and 2010.

Policies: Generics policy (February 1999).

Outcome Measures: Proportion, by originator, similares, and generic products within three therapeutic classes (antihypertensives, antidiabetics, and antibiotics), of the total volume sold by quarter (unit sales volume divided by the total volume of units sold in the market) from the second quarter of 1998 (period 1) through the first quarter of 2010 (period 48).

Results: We analyzed 8,559 products marketed in Brazil between 1998 and 2010; 448 medicines used in diabetes, 2,113 medicines used to treat hypertension and 2,825 systemic antibacterials. Antidiabetics—Starting in period 1, the number of manufacturers producing similares rose rapidly, but this changed at period 30. From the introduction of generics in the market (period 14), the number of manufacturers producing them constantly increased. At period 1, originator brands corresponded to around 85% of the volume of sales. From period 1 to period 14, the volume of similares sales rose and originator brands sales declined. The sales volume of originator brands continued to decline, and he sales volume of similares no longer increased. At the end of the period, generics made up half of the sales, similares accounted for just over 30%, and originator brands to just below 20%. Antibiotics—At any point in time, there were more manufacturers producing similares than any other type of medicine. The number of manufacturers producing generics, on the other hand, rose during the whole period under study. The volume of sales changed very rapidly after the introduction of generics in the market. In period 9, the first generic antibiotics became available in the market. In about one year, generics overtook originator brands and similares in terms of market share. The market share of originator brands declined over time. The market shares of generics and similares in period 48 were about 60% and 35%, respectively. Antihypertensives—In period 9, the first generics were launched in the market, and the number of manufacturers producing generics increased over time. However, the number of manufacturers producing ‘similares’ was consistently higher than that of generics. The volume of sales of both similares and generics tended to increase until period 32. From that period onwards, volume of generics sales continued to increase while similares sales tended to stabilize.

Conclusions: Using data from IMS Health, it is possible to evaluate the impact of the Generic Medicines policy in the Brazilian market share. Sales of similares and particularly originator brands decreased substantially following the launch of generics in the Brazilian market.

Funding Source:

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.


Gender and Access to Medicines in 15 Low- and Middle-Income Countries: Does Physician Prescribing for Men and Women Differ?

Peter Neil Stephens

IMS HEALTH, United Kingdom

See poster number 954


Strengths and Limitations of Market Intelligence Data for Pharmaceutical Policy Analysis in LMIC

Stefan Ziegele1, Peter Stephens2

1IMS Health, Germany; 2IMS Heatlh, UK

11:30am - 1:00pm6b. Policy: Track Summary Preparation
Jasper Auditorium 
2:15pm - 3:45pmPlenary Presentations of Track Summaries
Session Moderator: Birna Trap, Management Sciences for Health, Uganda
Jasper Auditorium 

Access to Medicines Track Summary

Maryam Bigdeli

World Health Organization, Switzerland


Policy Track Summary

Aukje Kaija Mantel-Teeuwisse

Utrecht University, WHO Collaborating Centre for Pharmacoepidemiology and Pharmaceutical Policy Analysis, Netherlands, The


Chronic Care Track Summary

Ricardo Perez-Cuevas1, Veronika Wirtz2, David Beran3

1Ministry of Health, Mexico, Mexico; 2National Institute of Public Health, Mexico; 3International Insulin Foundation, UK


Malaria Track Summary

Evelyn Korkor Ansah1, Kojo Yeboah-Antwi2, Charles Ezenduka3, David Ofori-Adjei4

1Ghana Health Service, Ghana; 2BU School of Public Health; 3Health Policy Research Group; 4Ghana College of Physicians & Surgeons


HIV/AIDS & TB Track Summary

Peter Memiah

University of Maryland, United States of America


AMR Track Summary

Cecilia Stålsby Lundborg

Karolinska Institutet, Sweden

1324-Stålsby Lundborg-_b.pptx
1324-Stålsby Lundborg-_c.pdf

Economics Track Summary

Tienie Stander

heXor, South Africa


Child Health Track Summary

Alexander Rowe

U.S. Centers for Disease Control and Prevention, United States of America

4:15pm - 5:30pmClosing: Keynote Addresses
Session Moderator: Andrew Jack, Financial Times, United Kingdom
Jasper Auditorium 

Summary of Key Conference Findings and Recommendations

Hans V. Hogerzeil

ex-WHO, Switzerland


Creating Policy Change - ICIUM Messages for Policy Makers

Martha Gyansa-Lutterodt

Ministry of Health, Ghana


Generating Evidence for Change - Considerations for Implementing the Post-ICIUM Research Agenda

Dennis Ross-Degnan

Harvard Medical School, United States of America

5:30pm - 5:45pmClosing Remarks
Jasper Auditorium 

Closing Remarks

Richard Ogilvie Laing

WHO, Switzerland