- Mots-clés > adverse drug reactions (ADRs)
- Mots-clés > adverse event (AE)
- Mots-clés > drug safety
- Mots-clés > management information system (MIS)
- Mots-clés > medicine safety
- Mots-clés > national pharmacovigilance system
- Mots-clés > pharmacovigilance reporting system
- Mots-clés > pharmacovigilance systems
- Mots-clés > post marketing surveillance
- Mots-clés > safety and efficacy
(2011; 37 pages)
Nyawakira, Anicet, Nyirimigabo, Josbert. 2011. Initiation and Implementation of a Pharmacovigilance System in Rwanda. Submitted to the US Agency for International Development and Rwanda Ministry of Health by the Strengthening Pharmaceutical Systems (SPS) Program. Kigali Office: Management Sciences for Health.
Rwanda, like most developing countries, benefits from the increased availability and accessibility of new medicines and fixed-dose combination formulations to treat epidemic diseases (HIV/AIDS, malaria, and tuberculosis [TB]) and the use of other essential medicine through community health programs and other health facilities. However, the lack of experience with these products creates concerns about medicine safety. This highlights the need to identify and evaluate adverse events (AEs) and product quality to better understand and prevent possible risk, improve treatment protocols and patient safety. This concern was expanded to other essentials medicines and vaccines which are need also a close safety monitoring. Rwanda had planned to address these issues through a PV and medicine information (MI) system...
In many countries, the National Medicine Regulatory Authority (NMRA) is responsible for ensuring the quality, safety, and efficacy of the medicines available in the country through activities such as medicine registration, quality control testing, and PV.
Despite the fact that Rwanda does not have an NMRA, the Pharmacy Task Force (PTF) within the Ministry of Health (MoH) temporarily performs those activities by elaborating pharmacy policies and monitoring their implementation. This task force has a desk that coordinates PV, MI, and rational medicine use activities.
In 2009, a midterm PV diagnostic assessment was conducted to provide evidence-based options analysis and feasible recommendations that reflect local realities, priorities, and resource availability. These recommendations have been used to orient system implementation.