Stakeholder Perspectives and Experiences on Pharmacovigilance and Adverse Drug Reaction Reporting in Sierra Leone: A Qualitative Study among National-Level Policymakers, Health System Leaders, and Senior Clinicians

Adverse drug reaction (ADR) reporting remains low in many low- and middle-income countries despite efforts to strengthen pharmacovigilance systems. Sierra Leone established a National Pharmacovigilance Centre and joined the WHO Programme for International Drug Monitoring, yet routine ADR reporting remains limited. This study explored national stakeholders' perspectives on pharmacovigilance practices, barriers to ADR reporting, and opportunities to strengthen Sierra Leone's pharmacovigilance system. A qualitative focus group discussion was conducted with nine purposively selected stakeholders, including regulatory officials, programme managers, clinicians, pharmacists, and academics. Discussions were audio-recorded, transcribed verbatim, and analysed using reflexive thematic analysis. Four themes emerged. Participants recognised pharmacovigilance as essential for patient safety, regulatory decision-making, and public trust. Key barriers included limited awareness of reporting tools, increased workload, fear of blame or litigation, lack of facility-level structures, and weak private-sector engagement. Gaps in training, reporting tools, and feedback mechanisms contributed to the underutilisation of VigiFlow and VigiMobile. Stakeholders identified opportunities to strengthen reporting through curriculum integration, the designation of focal persons, automated feedback, community engagement, and integration with national health information systems. Although pharmacovigilance was widely valued, system-level barriers continue to limit ADR reporting. Strengthening pharmacovigilance requires coordinated interventions embedded within routine practice, institutional structures, and national systems. Key recommendations include integrating pharmacovigilance into pre-service curricula, designating facility-level focal persons, supporting the adoption of digital tools such as VigiMobile, embedding pharmacovigilance indicators within District Health Information Software 2 (DHIS2), engaging the private sector, and fostering a non-punitive reporting culture.