Data from: Building functional and sustainable pharmacovigilance systems - an analysis of pharmacovigilance development across high-, middle- and low-income countries

<p>Background</p> <p>Pharmacovigilance (PV) is an essential component of health systems. Functional PV systems protect and promote public health by supporting the safe and effective use of medicinal products through the prevention and mitigation of harm. With increased simultaneous introduction of innovative products in high-, middle- and low-income countries, e.g., COVID-19 vaccines, or solely in low- and middle-income countries (LMIC), e.g., malaria vaccines, PV systems in LMIC must be able to detect safety signals and ensure adequate safety surveillance. This research aims to analyse the development of PV systems across high-, middle- and low-income countries and to carve out essential elements for implementing functional and sustainable PV systems in LMIC.</p> <p>Methods</p> <p>A convergent parallel mixed-methods design, consisting of qualitative and quantitative methods was used. Qualitative research consisted of semi-structured interviews. To expand the breadth and range of the study, a quantitative survey was conducted, focusing on the same thematic questions as the semi-structured interviews.</p> <p>Results</p> <p>Twelve key informants from nine countries were interviewed and 52 respondents from 36 countries completed an online questionnaire. Four major themes consisting of 12 categories emerged from the data. Based on these, the following elements essential for building functional and sustainable pharmacovigilance systems in LMIC were identified: understanding the drivers of PV development; adequately resolving core system challenges; implementing an efficient organisational structure and procedures for PV; investing in activities beyond reporting of adverse drug reactions; identifying alternate sources of financing; having a national strategy with a vision and mission for PV; adequately leveraging the health system; and effectively integrating the pharmaceutical sector in the national PV system.</p> <p>Conclusions</p> <p>Findings from this research revealed progress in PV systems in LMIC in the last decade, though significant efforts are still needed to develop these systems to meet global standards. Developing the different areas emerging from this research, which necessitates implementing functional PV structures and processes, adequately leveraging the health system and effectively engaging the pharmaceutical sector, through the mechanisms proposed, would enable a comprehensive progression from basic to stable, functional and thus sustainable PV systems in LMIC.</p>