(2009; 50 pages)
A Pharmacovigilance system includes all organizations, institutions and resources that contribute to ensuring medicines safety. Ensuring medicines safety includes any effort, whether in personal health care, public health services or intersectoral initiatives to protect the public from harm related to the use of medicines. The implementation of a comprehensive pharmacovigilance and medicine safety system requires efforts beyond adverse events data collection and should include risk evaluation, risk mitigation, and communication. Spontaneous reporting and other forms of data collection for early warning on safety are part of the risk identification. Risk mitigation and communication are the preventive part of pharmacovigilance and includes strategies for mitigating known risks, communication of drug safety information, and the promotion of rational use of medicines. There is a lack of consensus on what constitutes a well functioning pharmacovigilance system. There is currently no performance monitoring tool for assessing where a country stands in achieving a functional pharmacovigilance system. The MSH/SPS program developed an indicator-based pharmacovigilance assessment tool (IPAT) that will guide countries in monitoring their pharmacovigilance and medicine safety system from regulatory pharmacovigilance to safe use of medicines. The IPAT will be useful for addressing the gap created by the current lack of medicine safety performance metrics and will be essential in the diagnostic assessment of pharmacovigilance systems in developing countries. It will support evidence-based options analysis and development of relevant and feasible recommendations reflecting each country’s local realities, existing regulatory capacity and priorities, identified system gaps, and resource availability. Additionally, the standardized and indicator-based approach included in the tool will allow longitudinal measurement of progress after the recommended interventions are implemented. The indicator-based assessment tool will complement other MSH/SPS support for in-country capacity-building and system strengthening for monitoring and addressing medicines safety, therapeutic ineffectiveness, and pharmaceutical product quality issues. The purpose was to conduct a diagnostic assessment of Rwanda pharmacovigilance and medicine safety system using Indicator-based Pharmacovigilance Assessment Tool (IPAT) developed by MSH/SPS and provide feasible recommendations for improvement.