Situation analysis of the pharmacovigilance system in Nepal using the indicator-based pharmacovigilance assessment tool (IPAT)

Objectives: The aim of this study was to assess the national and regional pharmacovigilance centres in Nepal in terms of their policy frameworks, structure and functioning. Methods: A descriptive cross-sectional study was conducted during January 2021 among regional pharmacovigilance centres, and the national pharmacovigilance centre and the Ministry of Health and Population. The indicator-based pharmacovigilance assessment tool (IPAT) consisting of 43 indicators (26 core and 17 supplementary) assessing different aspects of pharmacovigilance was used. Key findings: Of a total of 14 candidates representing regional pharmacovigilance centres, 12 agreed to participate. The national pharmacovigilance centre located at the Department of Drug Administration had an acceptable level of infrastructure and manpower but poor functioning and weak collaboration with regional centres. There are no policies and procedures specifically related to pharmacovigilance and no requirement for pharmaceutical companies to report adverse drug reactions (ADRs). The national centre received only 42 ADR reports during the evaluation period. The regional centres are mostly located (10 out of 14) in the Kathmandu Valley and had qualified manpower and basic resources. There were poor process indicators suggesting problems with functioning in terms of ADR reporting, signal generation and drug safety communication. Conclusions: Underreporting of ADRs, weak processes and poor coordination among centres limit functioning of the system. Creating more awareness, involving consumers and pharmaceutical companies in the reporting process, and conducting more training programmes are needed for the proper functioning of pharmacovigilance services in Nepal.