Indicator-Based Pharmacovigilance Assessment Tool: Manual for Conducting Assessments in Developing Countries
(2009; 126 pages)

Strengthening Pharmaceutical Systems (SPS) Program. 2009. Indicator-Based Pharmacovigilance Assessment Tool: Manual for Conducting Assessments in Developing Countries. Submitted to the U.S. Agency for International Development by the SPS Program. Arlington, VA: Management Sciences for Health.

IPAT can be used by national medicine regulatory authorities, public health programs, health facilities, and all other stakeholders concerned with pharmacovigilance and medicine safety.

Abstract

Opinions vary about the scope and attributes of an optimally functional pharmacovigilance and medicine safety system. Furthermore, no universally adopted performance or outcome metrics exist for assessing pharmacovigilance systems. These challenges have major implications for low- and middle-income countries where efforts to strengthen pharmacovigilance have been sporadic and uncoordinated. Consequently, a need exists for the development of a monitoring tool for a pharmacovigilance and medicine safety system. Such a tool is needed to benchmark stakeholders’ functions; diagnose system strengths, weaknesses, and gaps; and monitor and evaluate interventions. This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.

IPAT is suitable for evaluating the current state of collection, analysis, and interpretation of data on the safety aspects of medicine regulation as well as to ensure safe use of medicines at public health programs, health facilities, and the health care worker and consumer levels. The analysis of data derived from IPAT could be used to develop recommendations and identify priority interventions to improve critical aspects of the pharmacovigilance and medicine safety system.

 
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