Evolving national pharmacovigilance systems in Africa

Abstract

Introduction: Various authors have described the challenges associated with African pharmacovigilance systems. However, the last decades have seen growth of these systems. The thesis provides insight into the emergence and growth of African pharmacovigilance systems by looking at different elements of the system. Focus will be on examining the role of the national pharmacovigilance centre, the participation and awareness of reporters and evaluators and lastly, the feasibility of generating evidence on the safety and use of medicines in low resource settings in Africa. Results:Chapter 2.1 characterized Adverse Drug Reaction (ADR) reporting activities in Africa and compared them with the rest of the world. We found that ADR reporting in Africa has grown from 25,000 in 2010to 103,499 in 2015. The characteristics of African ADRs are different from the rest of the world in terms of products and ADRs reported. In Chapter 2.2 we provided a broader view on the functioning of national pharmacovigilance centres in Africa by examining their resources, relationships and organisational capacity. We found that strategic leaders of national centres often attributed successful pharmacovigilance activities to availability of political and technical resources, while unsuccessful activities were often attributed to a lack of financial and human resources. In order to increase reporting of ADRs to the national centre, we assessed the awareness of Ghanaian patients about ADRs and ADR reporting (Chapter 3.1) which revealed that of the 491 participants in our study, 38% had experienced an ADR of which 67% reported the ADR to someone, 68% of them reported it to a doctor. However, only 3% of the 491 participants were aware of the Ghana-Food and Drug Authority’s patient reporting system. There is limited knowledge on the use of local data for decision making in Africa. In Chapter 3.2 through literature review we showed that no major drug safety decisions have been taken by public health programmes based on data collected in Africa. Data on the use and safety of medicines may be needed to make decisions for products used in Africa hence in Chapter 4.1 we applied a cohort event monitoring methodology to assess the ADRs of Injectable Artesunate (Inj AS) and found that,the overall incidence of ADRs was 17.9% (197/1103) which is similar to that listed in the public assessment reports published by the WHO. In Chapter 4.2 the data collected through the cohort event monitoring was used to assess prescribing practices of African health care professionals and investigate if these are in line with the WHO treatment guidelines. We found that Inj AS is the most commonly prescribed medicine in the management of severe malaria in Ghana and Uganda. However, only 27.6% (329 out of 1191) of patients received at least three doses if Inj AS followed by a full course of oral ACT as recommended by WHO. Conclusion: Most African countries have met the WHO minimum requirements for formal national pharmacovigilance systems. However, with pharmacovigilance activities expanding, various system structures and relationships between system participants need to be further strengthened.