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1f. Malaria: Scaling up Access to New Antimalarials - Challenges
Mapping the Private Sector Distribution Chain to Understand Barriers and Opportunities for Improved Access to Antimalarials in Six Low-income Countries in Africa and South-East Asia
1London School of Hygiene & Tropical Medicine, United Kingdom; 2Kenya Medical Research Institute-Wellcome Trust Research Programme; 3Population Services International; 4Population Services International (Benin); 5Association de Santé Familiale (DRC); 6Population Services International (Cambodia); 7Society for Family Health (Nigeria); 8PACE (Uganda); 9Society for Family Health (Zambia)
Problem statement: In many low-income settings, the private sector plays a crucial role in the delivery of antimalarials, although numerous regulatory challenges have been documented. The operation of the private sector has important implications for antimalarial availability, affordability, quality, and rational use. In the context of the introduction of a global subsidy to improve access to artemisinin-based combination therapies (ACTs), it is particularly important to understand how the private sector operates and how it varies across countries, because this will affect the success of such interventions and, therefore, equitable access.
Objectives: To describe the structure of the private commercial sector distribution chain for antimalarials and the characteristics of wholesale suppliers and to document the availability and mark-ups for antimalarials along the distribution chain
Design: Descriptive cross-sectional study
Setting: Multi-country study in Benin, Cambodia, DR Congo, Nigeria, Uganda, and Zambia
Study population: A key challenge in investigating private sector medicine distribution chains is the lack of an accurate sampling frame from which to draw a representative sample. Within each country, a census of antimalarial retailers was conducted in 19–76 randomly selected geographic areas, and an innovative bottom-up sampling approach was used to trace wholesale suppliers back from their retail customers, with this process repeated until only manufacturers and importers were reached. Across the 6 countries, 688 wholesalers and 7,048 retailers were included in structured surveys.
Outcome measure(s): Structure of private sector antimalarial distribution chain; antimalarial availability and price mark-ups along the chain
Results: We will present maps of the private sector antimalarial supply chains in each country, descriptions of their composition and characteristics, and estimates of availability and price mark-ups for antimalarials. For example, 93.0% of Zambian wholesalers had antimalarials available, but only 72.1% had an ACT in stock—51.2% had an artemisinin monotherapy and 76.7% had a non-artemisinin therapy (e.g., chloroquine). In terms of price mark-up on ACTs, median wholesaler mark-ups (26.7%) were generally lower than median retail mark-ups, which ranged from 42.9% in private pharmacies to 150% in grocery stores. Although nearly all antimalarial wholesalers (97.5%) reported a visit by an inspector over the past 12 months, a smaller proportion (86.1%) was observed to store medicines in appropriate conditions.
Conclusions: Results across countries will be contrasted and implications for interventions to improve ACT access, such as the Affordable Medicines Facility for Malaria, will be explored.
Funding source(s): Bill & Melinda Gates Foundation
Pharmacovigilance of Antimalaria Drug Treatment in Enugu State, Nigeria: Community and Health Workers’ Perceptions and Suggestions for Reporting Adverse Drug Events
1HEALTH POLICY RESEARCH GROUP, ENUGU NIGERIA.; 2DEPARTMENT OF COMMUNITY MEDICINE, COLLEGE OF MEDICINE, UNIVERSITY OF NIGERIA ENUGU CAMPUS, NIGERIA; 3DEPARTMENT OF COMMUNITY MEDICINE, ENUGU STATE UNIVERSITY TEACHING HOSPITAL, PARKLANE CAMPUS, ENUGU STATE NIGERIA
Problem statement: Pharmacovigilance of antimalarial treatment is important to both the individual and the community. Detecting, assessing, understanding, and preventing the adverse reactions of antimalarial medicines are crucial because these medicines are so frequently used because of malaria’s endemnicity in Nigeria.
Objectives: To determine the communities’ level of awareness of adverse drug reactions (ADRs) in malaria treatment and the reporting systems available; the communities’ attitudes; and their problems in reporting adverse events so that suggestions can be provided to alleviate these problems
Design: Cross-sectional descriptive study
Setting: Community based
Study population: 422 mothers and 60 health workers in Enugu South local government area of Enugu State, Nigeria
Outcome measure(s): Community and health workers’ perceptions of pharmacovigilance for antimalarial treatment in Enugu and suggestions for reporting adverse events
Results: All the respondents have had malaria once. Most people (97.2%) have heard of ADRs—42.2% heard through friends, 29.3% through a doctor. Most respondents (54.7%) used chloroquine; others used sulfadoxine-pyrimethamine, ACTs, and halfan. The most common adverse effect was itching (35.6% mainly with chloroquine), and the least noticed adverse effects were blurred vision, rashes, and fainting (1.7%). Most respondents (47%) did nothing about the adverse effects and very few (1.7%) reported to a doctor. The popular reasons for doing nothing were lack of funds (38.8%) and ignorance (36.5%). Problems that affected reporting of ADR included ignorance (55.5%), lack of funds (26.3%), lack of access to health centers (14.9%), and self medication (3.3%). Community suggestions for solving the problems were public awareness (58.8%), provision of accessible health centers (23.2%), provision of free treatment (13.8%), and prevention of self medication (4.2%). For the health workers, about 80% had knowledge of ADRs and the spontaneous reporting system. Most of our respondents (43.3%) each reported only one case of ADRs to antimalarials in the past 1 year; 13.3% reported 2 cases; 5.0%, 3 cases; and 1.9%, 4 cases. A spontaneous reporting system was used for these cases. Problems that affected reporting the adverse effects were ignorance (75%), lack of access to health centers (15%), lack of funds (6.7%), and stress (3.3%). Suggestions for solutions included ensuring public awareness (83.3) and provision of accessible health centers (16.7%).
Conclusion: The major problems that affected the reporting of adverse drug events were ignorance, lack of funds, and lack of access to the health centers. Information, education, and communication programs in the communities and among the health workers should be improved. Funds should be made available to health workers to enable timely reporting of adverse events. Community surveillance is necessary to ensure timely reporting by the community.
Funding source(s): This study was self funded and was carried out as a medical school project.
Priority Setting for Implementation of Artemisinin-Based Combination Therapy Policy in Tanzania: Evaluation against Accountability for Reasonableness Framework
Muhimbili University of Health and Allied Sciences, Tanzania, United Republic of
Problem statement: Malaria case management by pharmaceuticals is a major challenge in many malaria endemic countries. Old but cheap and effective medicines are increasingly facing resistance, and it is no wonder that by 2009, nearly all P. falciparum malaria endemic countries, most of them in sub-Saharan Africa, had changed their treatment policies to artemisinin-based combination therapies. Rapidly raising pharmaceutical expenditures, by contrast, pose another major obstacle and have led to an increased need for prioritization in pharmaceuticals worldwide since not all the available choices can be provided for all who need them. Artemether-lumefantrine was, therefore, prioritized as the first-line drug for management of uncomplicated malaria in Tanzania.
Objective: To analyze and evaluate whether the prioritization decision of artemether-lumefantrine satisfies the four conditions of fair process as suggested in the ethical framework of accountability for reasonableness
Design: This was a descriptive, cross-sectional study in which data were collected by in-depth interviews with key informants and treatment guideline review.
Study setting and population: The study examined the policy decision-making process in the public sector at the national level. We selected the sample of 15 participants from the acknowledgement list in the treatment guideline. Sampling was purposeful to explore the perceptions of people with different backgrounds and perspectives. Key informants represented the national government hospital, National Malaria Control Programme, WHO country office, Ministry of Health and Social Welfare Headquarters, Tanzania Food and Drugs Authority, Medical Stores Department, and Muhimbili University of Health and Allied Sciences.
Results: Publicity: The decision, but not its rationales, was publicized by radio, television, and newspaper. There was no explicit mechanism to involve the stakeholders, and as a result, the task force lacked professional, institutional, and countrywide representation. Public representation within the task force was insufficient. Relevance: The decision was grounded on relevant evidence of clinical efficacy and adequate safety and formulation profile. Appeals and revision: There is neither a reliable appeal and revision mechanism to challenge the outcomes of the policy decision nor Enforcement mechanisms to ensure the other three conditions are met.
Conclusions: The prioritization decision of artemether-lumefantrine as a first-line antimalaria drug failed to fully satisfy the four conditions of the accountability for reasonableness framework. In addition to the demand for enhanced stakeholder involvement, publicity, and transparency, the study also calls for the institution of formal appeals and revision, and regulatory mechanisms in future implementation of health policy change processes.
Funding source(s): This was a master’s thesis research funded by the Norad’s Programme for Masters Studies (NOMA).
Treating Acute Fever with Artemisinin-Based Combination Therapy: Prevalence and Predictors in Five African Household Surveys
Harvard Medical School, United States of America
Problem statement: In recent years, national policies have endorsed Artemisinin-based Combination Therapy (ACT) in countries at high risk of malaria.
Objectives: To generate reliable evidence on the adoption of ACT by the community. Specific aims are to describe how households treat acute fever and to identify predictors of ACT at the consumer level
Design: Descriptive, cross-sectional analysis of household survey data
Setting: Surveys conducted in five African countries (2007-2008) with an instrument developed by WHO to monitor country pharmaceutical situations at community level.
Study population: Households were selected by multistage cluster sampling (900 to 1,080 households per country). Study population consisted of 2,000 household members experiencing fever in the two weeks preceding the survey: data were collected on all sick members in three surveys (Ghana, Kenya, Uganda) or only on the youngest sick member in two surveys (Nigeria, Gambia).
Outcome measures: Treatment of acute fever with ACT vs. other therapy.
Results: The estimate percentage of fevers treated in the public sector ranged from 44.8% in Ghana to 65.0% in Gambia, while estimated percentage of fevers treated with ACT varied from none in Gambia to 26.3% in Uganda and 26.6% in Ghana. Artemisinin combinations reported to be used were usually consistent with national policies. In adjusted multivariate analyses, determinants of seeking care in the public sector varied across countries. The likelihood was significantly (p<0.05) higher when the public facility was close by (Kenya, Nigeria, Uganda), when respondents had a favorable opinion of the facility (Kenya, Nigeria), when respondents could not get credit in a private pharmacy (Ghana, Kenya), when the closest retail medicines outlet was far away (Kenya), and when medicines were obtained free-of-charge (Uganda). Public sector treatment was also significantly higher when the household was poor (Ghana), when respondents were male (Nigeria), and when patients were under 5 (Nigeria) or had severe fever (Ghana).Seeking care in the public sector was a strong predictor of ACT use in all four countries (p<0.05 in Ghana, Kenya, Uganda, p=0.053 in Nigeria). Other determinants of ACT use varied across countries; the likelihood was significantly higher when respondents were more educated (Ghana, Kenya, Nigeria), when households were not poor (Ghana), and if the fever was not considered severe (p<0.05 in Nigeria).
Conclusions: Our results highlight the importance of the public sector in the treatment of fever and in the diffusion of ACT. They indicate that the subgroup of individuals seeking care for fever who were treated with ACT soon after the implementation of ACT national policies tended to be more educated, wealthier, and with illness that was perceived as less severe.
Funding sources: WHO Department of Essential Medicines in Geneva organized and funded data collection with support from the Medicines Transparency Alliance. Harvard Pilgrim Health Care Institute funded the study.