Trip Report: Africa Pharmacovigilance Meeting 2012

The meeting was organized by Systems for Improved Access to Pharmaceuticals and Services (SIAPS) and Management Sciences for Health (MSH) to present the findings of a pharmacovigilance (PV) assessment in Sub-Saharan Africa (SSA). The assessment was conducted by SPS and SIAPS, and it used three methods to evaluate PV systems and their performance in 46 countries in SSA. The PV assessment found that the pharmaceutical market size of SSA is estimated to be between $3.7 and 4.7 billion USD. Pharmaceutical manufacturing capacity exists in 80% of the countries in SSA, and 74% of SSA countries have national medicines regulatory authorities (NMRAs). However, less than 50% of surveyed countries monitor product quality, medication errors, and treatment failures through existing PV systems. Only 2 out of 46 countries collected more than 100 reports per million population in 2010. The meeting brought together more than 100 participants from over 30 countries, representing various stakeholders, including MSH, US FDA, CDC, USAID, WHO, pharmaceutical industry, international NGOs, and academia. The agenda included presentations on PV assessment findings, medicines regulatory harmonization initiatives in Africa, WHO PV tool kit, global stakeholders' perspectives on PV systems, and current PV practices in Africa. Dr. Abdelkrim Smine, a consultant for the Promoting the Quality of Medicines (PQM) program, represented PQM at the meeting and gave a presentation on "The Link between the Quality and the Safety of Medicines." The presentation focused on the skills and resources needed to implement effective medicine quality assurance systems and emphasized the importance of safety in medicine quality. The meeting highlighted the need for new approaches, tools, and regulations to improve the safety of medicines in SSA. The findings of the PV assessment were presented, and the participants discussed the need for improved PV systems, including the development of priority PV tools and the implementation of active surveillance activities. The meeting also included a workshop on vaccine safety and a summary of priority PV tools and plans for their development. The PQM presentation and other workshop activities emphasized the importance of quality and safety in medicines. The presentation highlighted the skills and resources needed to implement effective medicine quality assurance systems and emphasized the importance of safety in medicine quality. The meeting provided a platform for stakeholders to share information and discuss the need for improved PV systems in SSA. The meeting was funded by USAID core funding for Common Agenda. The Promoting the Quality of Medicines (PQM) program, funded by USAID, is the successor of the Drug Quality and Information (DQI) program implemented by the United States Pharmacopeia (USP). PQM provides technical assistance to developing countries to build local capacity in medicine quality assurance systems, increase the supply of quality medicines to priority USAID health programs, and ensure the quality and safety of medicines globally. The meeting was a significant event in the field of pharmacovigilance in SSA, and it provided a platform for stakeholders to discuss the need for improved PV systems. The findings of the PV assessment and the PQM presentation highlighted the importance of quality and safety in medicines and emphasized the need for new approaches, tools, and regulations to improve the safety of medicines in SSA.