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Conference Agenda

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Session Overview
2e. Child Health: Impact of Interventions to Improve Access to Medicines for Children in LMIC
Time: Tuesday, 15/Nov/2011: 3:15pm - 4:15pm
Session Moderator: Hortensia Reyes-Morales, National Institute of Public Health, Mexico
Session Moderator: Christopher John Gill, Boston University School of Public Health, United States of America
Session Rapporteur: Alexander Rowe, U.S. Centers for Disease Control and Prevention, United States of America
Location: Lal 3-4


Costs and Effects of a Multifaceted Intervention to Improve the Quality of Care of Children in District Hospitals in Kenya

Edwine Barasa1, Philip Ayieko1, Susan Cleary2, Mike English1,3

1KEMRI Centre for Geographic Medicine Research – Coast, and Wellcome Trust Research Programme, Nairobi, Kenya; 2Health Economics Unit, University of Cape Town, Cape Town, South Africa; 3Department of Pediatrics, University of Oxford, Oxford, UK

Problem statement: It is estimated that more than 8.8 million children die globally before they reach the age of 5. In Kenya, the under 5 mortality rate was 74 per 1000 children in 2008. To improve the quality of care for seriously ill children, a multifaceted approach employing clinical practice guidelines, training, supervision, feedback, and facilitation was developed; for brevity, the strategy is called Emergency Triage and Treatment Plus (ETAT+).

Objectives: To assess the costs and efficiency of delivery of the ETAT+ strategy in district hospitals in Kenya

Methods: A cost-effectiveness analysis from the provider’s perspective was conducted alongside a cluster randomized study that compared the delivery of ETAT+ in 4 district hospitals in Kenya to 4 control district hospitals receiving a partial version of the intervention between 2005 and 2009. The 8 rural district hospitals were identified on the basis of district-specific criteria, from 4 of Kenya’s 8 provinces. Effectiveness of the intervention was measured using 14 process measures that capture improvements in quality of care and span the assessment, diagnosis, and treatment on admission for diseases resulting in 60% of inpatient deaths in children under 5. The economic cost of development, implementation, and treatment of sick children in intervention and control hospitals was estimated through interviews with implementers of the intervention, accounting, and clinical record reviews. An annual discount rate of 3% was used and one-way sensitivity analyses were used to assess uncertainty. Incremental cost-effectiveness ratios (ICERs) were defined as the cost per percentage improvement in quality of care as measured from the 14 process measures in control and intervention hospitals.

Findings: The cost per child admission was USD 54.74 in intervention hospitals compared to USD 31.06 in control hospitals, while quality of care as measured by the 14 process measures was 25.01% higher in intervention hospitals than in the control hospitals. These results suggest an additional cost of USD 0.78 per child admitted to achieve a percentage improvement in quality of care.

Interpretation: Our findings indicate that the delivery of ETAT+ as a multifaceted intervention yields significant improvements in quality of care of sick children but at a higher cost. Knowing what value decision makers place on quality improvement and their preferences for attributes of this and similar quality of care interventions would be useful in making decisions about their adoption explicit. Also of importance is assessing the costs of scaling up to assess the feasibility of implementation of ETAT+ on a national scale.

Funding sources: Funds from a Wellcome Trust Senior Fellowship awarded to Dr. Mike English (#076827) made this work possible.


Can the Management of Uncomplicated Diarrhea at the ADDOs in Tanzania be Further Improved?

Edmund R Rutta1, Suleiman Kimatta1, Jafary Liana1, Amani Philip2, Keith Johnson1

1Management Sciences for Health, United States of America; 2Tanzania Food and Drug Authority, Tanzania

Problem statement: The accredited drug dispensing outlet (ADDO) program has increased access to affordable quality medicines and pharmaceutical services in retail drug outlets in underserved areas of Tanzania. Program monitoring and evaluation have showed improved medicine availability and dispensing; however, anecdotal evidence suggested continuing problems with diarrhea management.

Objective: To determine how ADDO dispensers manage uncomplicated diarrhea in children under age five

Design: Quantitative data collection was performed in 2010 using a mystery shopper scenario in the Ruvuma region, where the program had operated for seven years, in the Singida region with one year of ADDO operations, and in the Mara region, which had no ADDOs (control). Ruvuma data from 2004 came from a retrospective record review.

Setting: 30 randomly selected ADDOs from Ruvuma, 60 each in Singida and in Mara

Intervention: Ruvuma and Singida dispensers received training in 2003 and 2009, respectively, on how to manage uncomplicated diarrhea in children under five as part of ADDO accreditation. ADDO dispensers in both regions received supportive supervision on diarrhea management. Drug shop workers in Mara received no training or supervision.

Outcome measures: Percentage of uncomplicated diarrhea encounters in which either antibiotics or appropriate treatment using oral rehydration solution were dispensed.

Results: In Ruvuma in 2010, cases managed according to treatment guidelines did not change from the 2004 levels of 29%; in Singida, the percentage of encounters in which uncomplicated diarrhea was managed appropriately rose from 20% at baseline in 2009 to 42% at end-line; no change was observed in Mara (25% at baseline compared with 27% at end-line). The percentage of uncomplicated diarrhea encounters that included dispensing of an antibiotic declined from 98% at baseline to 76% at endline in Singida, while it remained constant in Mara (87% at baseline and 84% at endline). The percentage of diarrhea cases in which metronidazole was dispensed by ADDOs in Ruvuma declined from 53% in 2004 to 42% in 2010.

Conclusions: Managing uncomplicated diarrhea with oral rehydration solution increased and antibiotic dispensing decreased after the ADDO intervention in Ruvuma and Singida; however, practices still fall well short of the recommended national treatment guidelines. Qualitative research suggests that other factors beyond ADDO dispensing skills and knowledge may fuel these practices, such as the prescribing practices at public and private health facilities, consumer pressure and preference for metronidazole, and profit motive. Stakeholders recommended further assessments to understand the ADDO dispenser/health facility prescribers and consumer dynamics and its impact on antibiotics use in diarrhea management.

Funding source: Management Sciences for Health/East African Drug Seller Initiative, funded by a grant from the Bill & Melinda Gates Foundation


Is Performance-Based Reward the Strategy of the Future for Strengthening the Quality of Reporting and Immunization Systems?—Experiences from GAVI

Rete Trap1,2, Birna Trap3,2, Torsten Wind Hansen2, Ebba Holme Hansen4

1Aabenraa University Hospital, Denmark; 2Euro Health Group, Denmark; 3Management Sciences for Health, SURE Program, Kampala, Uganda; 4Faculty of Pharmaceutical Sciences, Department of Pharmacology and Pharmacotherapy, University of Copenhagen

Problem statement: Global coverage of childhood diphtheria-tetanus-pertussis (DTP3) immunization increased to 80% in 1990, after which immunization rates declined considerably in many countries. Several initiatives have been introduced to strengthen immunization. The Global Alliance for Vaccines and Immunization (GAVI), a public-private global health partnership, was established in 1999 for strengthening immunization service support (ISS). The GAVI initiative has been introduced in over 75 countries and is linked to performance-based reward strategy, a scheme that pays a fixed fee for children immunised with DTP3 as reported by the country. The effectiveness of this costly initiative, however, needs to be further investigated.

Objectives: To assess whether linking the GAVI ISS with performance-based interventions has improved immunization reporting and system quality

Design: A retrospective study based on immunisation data quality following a combined managerial and reward based strategy

Method: We used a data quality audit (DQA), a validated standardized indicator-based performance assessment, to evaluate reporting consistency and accuracy and the quality of the immunisation system, with the aim of improving immunisation coverage.

Study population: Nine developing countries having had two consecutive DQA’s in the period 2002 to 2005

Interventions: GAVI ISS including a performance assessment (i.e., DQA) and system improvement recommendations and implementations support, combined with financial reward

Outcome measure(s): Reporting quality (verification factor) and system set-up quality (quality scores).

Results: Both reporting and system quality improved following the GAVI ISS intervention. Immunisation coverage improved in all but one of the nine countries from the initial DQA to the following DQA. The improved reporting quality was associated with improved overall quality of the immunisation system. Correlation was found between verification factor and immunisation coverage.

Conclusions: The study indicates that the combined GAVI ISS performance-based reward intervention strategy is effective, resulting in increased immunization coverage, improved reporting quality, and improved quality of the immunizations system set-up at all levels of health care. High-quality reporting with accurate and consistent data is instrumental in targeting and focusing immunization management toward increased coverage, demonstrated by the correlation between increased reporting quality and immunization coverage. To ensure sustainable immunisation system improvements, repeated assessments are recommended. To further explore the applicability of the performance-based reward system in other areas of supply chain and medicines managements, the SURE project in Uganda has applied a performance assessment reward project, in an attempt to strengthen medicines management. The applicability of the performance-based reward system to other areas of supply chain and medicines management needs to be explored.

Funding source(s): Aabenraa Regional Hospital, Denmark, Euro Health Group, Denmark and Pharmaceutical Univercity of Copenhagen, Denmark


Factors Associated to Medicine Use Among Children from the 2004 Pelotas Birth Cohort (Brazil)

Edilson Almeida Oliveira1, Marlos Rodrigues Domingues2, Alicia Matijasevich Manitto2, Iná S Santos2, Aluísio J D Barros2, Andréa Dâmaso Bertoldi2

1Universidade do Vale do Rio dos Sinos; 2Universidade Federal de Pelotas, 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, National Research Council, and the Ministry of Health.


Analysis of Clinical Trials in Children Registered in the Clinical Trials Registry of India

S. Manikandan1, M. Jayanthi1, B. Gitanjali2, G. Sivagnanam1

1Indira Gandhi Medical College & Research Institute, Pondicherry, India; 2Technical Officer - Essential Drugs and Other Medicines (EDM), World Health Organisation - Regional Office for South East Asia, New Delni, India.

Problem statement: India launched a freely accessible online ‘Clinical Trials Registry – India’ (CTRI) in 2007 to inform the public and health professionals about the clinical trials being conducted in India. Pediatric clinical trials are scarce because of the inherent difficulties involved in conducting studies in children. It has been observed that the information provided in trial registries is insufficient and out of date, thus undermining the expected benefits of trial registration.

Objectives: To analyse clinical trials in children registered in CTRI with regard to completeness, transparency, currency of information, concordance of data with WHO’s Trial Registration Data Set (TRDS) and to suggest measures to improve the CTRI

Design: Descriptive study of clinical trials in children registered in CTRI

Setting: Conducted at a national level because the CTRI permits registration of clinical trials conducted all over India

Study population: Children up to 18 years; all clinical trials conducted on children registered in the CTRI were included

Intervention: The trials conducted on children (up to 18 years) from its inception until August 15, 2010, were retrieved from the CTRI website and included in the analysis. All the eligible 81 trials were scrutinized by 2 independent observers who scored each of the 36 items requested in the CTRI portal. The method of scoring was defined a priori for each of the items.

Outcome measures: The completeness of reporting, appropriateness, and degree of concordance of CTRI data with WHO-TRDS items were analyzed.

Results: The CTRI portal has 36 items, of which 23 are marked as WHO portal items. However, only 20 of them qualify as WHO-TRDS. All 20 are considered mandatory in the WHO International Clinical Trial Registry portal, though only 7 items are marked as mandatory in CTRI. Out of the 36 items, only 9 have 100% and 4 have near complete (99%) concordance. In 43 trials, the date of last update is mentioned even before the date of registration. Regulatory approval is needed for 41 trials of which 9 (22%) have not obtained it. There are 23 placebo controlled trials of which 7 (30%) could be considered unethical because the control arm were/are denied active or most appropriate intervention. The results and adverse events of the trials are not provided.

Conclusion: The level of concordance of WHO-TRDS and non-WHO-TRDS items in CTRI is unsatisfactory and the quality of information available in the registry is poor. An urgent revision and modification of CTRI and stricter scrutiny of applications prior to registration are required. The registration of trials in children which are overtly unethical raises serious doubts over the competence of the ethics committees that has approved these projects and whether such trials should be banned from being conducted

Funding source: World Health Organization, SEARO