A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators

Abstract

Abstract Background In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries’ PV systems’ performance. Methods EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries’ PV performance. Results Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0–26). Higher average scores were obtained in the ‘Core’ (9.27/27) compared to ‘Complementary’ (5.59/36) indicators. Overall performance for ‘Process’ and ‘Outcome’ indicators was lower than that of ‘Structural’. Conclusion This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.