1. Pharmacovigilance of antimalarial drugs in Uganda Hasifa Bukirwa Uganda Malaria Surveillance Project Funded by: CDC/PMI and EDCTP

2. Pharmacovigilance “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug related problem” World Health Organization, The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva 2002

3. Why is pharmacovigilance important? African countries have been encouraged to develop pharmacovigilance systems as ACTs are rolled out But no system of reporting exists Many countries lack capacity for monitoring ACTs appear to be safe and well-tolerated, but the safety of new regimens when used in the ‘real world’ is unclear Drugs used repeatedly Over-the-counter treatment very common Information on safety in vulnerable groups is limited Pregnant women, HIV infected patients, young children In 2005, UMSP began a project to explore methods of drug safety monitoring outside of the clinical trial setting

4. Phase I We conducted FGDs and interviews with community members, health care workers, drug shop owners, and key stakeholders Study objectives To investigate perceptions and experiences with antimalarial drugs To assess current reporting systems in the public and private sectors To develop strategies for establishing a sustainable system for reporting adverse events at the community and health facility levels Phase I of the project was completed at the end of 2006

5. Phase I findings Informal sources of treatment predominate in Uganda A pharmacovigilance system should take this into consideration and incorporate informal sector and community if possible Common effects of treatment (vomiting) were often perceived as signs of healing by community members, rather than adverse reactions Will need to be addressed in sensitization and training Both health care workers and community wished for a formal organized reporting system Most prefer a system that is based within their own communities Training, sensitization, and feedback were felt to be important for a successful reporting system

6. Ongoing activities The information collected in Phase I was used to design a system for collecting adverse event reports from the public health facilities, private sector, and the community Two stakeholders meetings were held to review results, all training materials, and plans for pilot system Pilot system involves enhanced passive surveillance Training HCWs and key community members Distributing and collecting AE report forms Analyzing data, generating reports Providing feedback and support supervision Monitoring and evaluation of system Pilot started in Budondo sub-county, Jinja in September 62 HCWs and community members trained Collection of AE forms starts this month

7. Next steps In 2008, we plan to expand the project to include active surveillance in Jinja Conduct a census and initial survey of households Two parishes will be selected for active surveillance Track ACT treatment at key health facilities Actively follow-up patients to assess for adverse events Pregnancy register to monitor ACT exposure in pregnancy Evaluate maternal and fetal outcomes In 2009, activities will be expanded to Nagongera sub-county, Tororo Establish components of system at additional UMSP sites?

8. Acknowledgments Pharmacovigilance team Sarah Staedke Ambrose Talisuna Hasifa Bukirwa Susan Nayiga Norah Mwebaza Heidi Hopkins Rosalind Lubanga UMSP Fred Wabwire-Mangen Moses Kamya Yeka Adoke Data team National Drug Authority Hellen Ndagije Angella Bonabana Malaria Consortium James Tibenderana Grace Nakanwagi University of Washington/IDI Andy Stergachis