- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Mots-clés > adverse drug reactions (ADRs)
- Mots-clés > adverse event (AE)
- Mots-clés > assessment
- Mots-clés > medicine surveillance systems
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > pharmacovigilance
- Mots-clés > pharmacovigilance systems
- Mots-clés > quality assurance system
- Mots-clés > reporting system
- Mots-clés > safety
(2011; 143 pages)
Strengthening Pharmaceutical Systems (SPS) Program. 2011. Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance. Submitted to the US Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health.
With increased access to new essential medicines, such as artemisinin-based combination therapy (ACT) and antiretroviral (ARV) therapy in Africa, there is a greater need to monitor and promote safety and effectiveness of medicines. The burden of adverse events from poor product quality, adverse drug reactions (ADRs), and medication errors may affect achieving the full benefits of these new medicines and pose great challenges to health care systems in Africa. Besides the impact of adverse drug events (ADEs) on morbidity and mortality and the direct cost of managing the events, ADEs also have other associated costs in terms of the loss of confidence in the health system, economic loss to the pharmaceutical industry, non-adherence to treatment, and development of drug resistance. Although it is challenging to measure these costs, it is apparent that they may constitute a profound impact on the resources of the health system.
The pharmacovigilance (PV) system safeguards the public through efficient and timely identification, collection, assessment, and communication of medicine-related adverse events. A comprehensive PV system includes both active and passive surveillance methods, effective mechanisms to communicate medicine safety information to health care professionals and the public, collaboration among a wide range of partners and organizations, and incorporation of PV activities into the various levels of the health system, from the facility to the national levels.
The objectives of this study were to:
- Provide a comprehensive description and analysis of national PV systems in sub- Saharan African (SSA) countries
- Identify replicable and successful experiences and classifying countries based on performance
- Map out how donor agencies and global health efforts are contributing to PV in SSA countries
- Recommend options for enhancing PV systems
The study used 3 methods to assess PV systems and their performance in 46 SSA countries: literature review, mailed survey, and in-depth assessment that was administered by consultants who visited 9 priority countries—Burkina Faso, Democratic Republic of Congo, Ghana, Kenya, Nigeria, Senegal, South Africa, Tanzania, and Uganda. The Indicator-based Pharmacovigilance Assessment Tool (IPAT) was adapted and used for data collection...