The effect of a peer-support collaboration among local pharmaceutical manufacturers in Uganda in strengthening pharmacovigilance systems: a qualitative case study

Introduction In low-income countries, the contribution of local pharmaceutical manufacturers to national pharmacovigilance (PV) databases is significantly lower than in high-income countries. There is a paucity of evidence on the state of PV in local pharmaceutical manufacturers in low-income countries even when domestic pharmaceutical production is growing rapidly post-Covid-19. In 2022, six (out of nine) licensed local drug manufacturers in Uganda voluntarily established a peer-support collaboration to promote the reporting of ADRs to the national pharmacovigilance centre (NPC). The objective of this study is to explore facilitators and barriers to reporting of ADRs among local pharmaceutical manufacturers in Uganda following implementation of a peer-support intervention in 2022. Methods We adopted a qualitative case-study research design. We purposively sampled two large, two medium-sized and two small-scale local pharmaceutical manufacturing firms which participated in a peer-support collaboration in Uganda. In-depth interviews were held with 36 participants involving personnel assigned pharmacovigilance roles, upper and middle-level managers of case-study manufacturers and Ugandan regulatory officials . Data were analyzed thematically based on an established Level of Institutionalization theoretical framework. Results We found wide variations in the presence of PV systems across the six case-study manufacturers in Uganda. The presence of PV systems appeared to be associated with the size of the manufacturing firm. The two largest manufacturers by industry revenue had well established internal PV systems compared to small and medium-sized manufacturers which are yet to achieve scale and optimum plant utilization. Identified facilitators to reporting include the availability of convenient digital platforms such as the Med Safety App, the availability of peer-support in reporting of ADRs and the availability of pharmacovigilance-capable personnel. Barriers include the lack of feedback to manufacturers post-reporting, financial difficulty in retaining full-time PV personnel in medium and small-sized firms, inability to conduct causality assessments due to incomplete ADRs reports which are received principally from manufacturers’ distribution agents, limited investment in information systems for data capture of received ADRs reports among small and medium-size manufacturers. Conclusion We found that small and medium-sized manufacturing firms face multiple barriers in reporting ADRs due to their relatively low investment in pv infrastructure owing to their financial circumstances. We recommend that interventions be devised by the NPC in strengthening feedback mechanisms to local pharmaceutical manufacturers to enhance motivation for reporting ADRs.