(P-029) Assessment of the National Pharmacovigilance System in Nepal Using the Indicator Based Pharmacovigilance Assessment Tool (IPAT)

Background: Nepal, a South Asian country (population approximately 29 million) instituted a national pharmacovigilance system in 2006. There are 14 regional pharmacovigilance centers reporting to the national pharmacovigilance center. During the past 15 years the country underwent tremendous political changes and a major earthquake (in 2015), affecting the progress and sustainability of healthcare initiatives. A systematic analysis of the national pharmacovigilance system has not been conducted so far and can provide useful insights for improvements.

Objectives: To assess the national pharmacovigilance system in terms of functionality, strengths, and limitations.

Methods: After ethical approval from the Nepal Health Research Council, a descriptive cross-sectional study was conducted during January 2021 amongst 14 respondents, 12 from regional pharmacovigilance centers (2 centers did not respond), and one each from the national pharmacovigilance center 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 the national pharmacovigilance program was used following the standard scoring system. The score was calculated by dividing the total score of core and supplementary indicators and multiplied by 100 for obtaining the percentage values and if this was more than 60% then it was concluded that the component met the specific needs. The assessment period was two years since 2020 was affected by the Covid-19 pandemic.

Results: The national pharmacovigilance program is functional with limitations mentioned below. The national pharmacovigilance center scored 46.1%. Of the 12 regional centers, adverse drug reaction (ADR) reporting was actively carried out in five (41.6%) centers. The regional center scores for core indicators ranged from 26.3% to 52.6%.and supplementary indicator scores ranged from 0.16% to 0.66%. The scores were relatively better for two regional centers (core-20, supplementary-8; core-20 and supplementary 7), started in 2010 and 2018 respectively. The values were less than 60% highlighting the need for improvement in functioning of these centers.

Conclusions: A functional national pharmacovigilance system exists with underreporting and less equipped regional centers. Resources, manpower and expertise at regional centers needs strengthening. Experience from the two regional centers with better pharmacovigilance can be shared with other centers. The program can be strengthened by trainings, resource allocation and regulatory interventions.