Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis

Abstract

Background New medicines have become available for the treatment of drug-resistant tuberculosis (DR-TB) and are introduced in sub-Saharan Africa (SSA) by the national TB programs (NTPs) through special access schemes. Pharmacovigilance is typically the task of national medicines regulatory agencies (NMRAs), but the active drug safety monitoring and management (aDSM) recommended for the new TB medicines and regimens was introduced through the NTPs. We assessed the strengths and challenges of pharmacovigilance systems in Eswatini, Ethiopia, Nigeria and Tanzania, focusing on their capacity to monitor safety of medicines registered and not registered by the NMRAs for the treatment of DR-TB. Methods Assessment visits were conducted to all four countries by a multidisciplinary team. We used a pharmacovigilance indicator tool derived from existing tools, interviewed key stakeholders, and visited health facilities where DR-TB patients were treated with new medicines. Assessment results were verified with the local NMRAs and NTPs. Results Most countries have enabling laws, regulations and guidelines for the conduct of pharmacovigilance by the NMRAs. The relative success of NTP-NMRA collaboration is much influenced by interpersonal relationships between staff. Division of roles and responsibilities is not always clear and leads to duplication and unfulfilled tasks (e.g. causality assessment). The introduction of aDSM has increased awareness among DR-TB healthcare providers. Conclusion aDSM has created awareness about the importance of pharmacovigilance among NTPs. In the future, a push for conducting pharmacovigilance through public health programs seems useful, but this needs to coincide with increased collaboration with between public health programs and NMRAs with clear formulation of roles and responsibilities.

Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

“…Pharmacovigilance (Pv) is a science dealing with the continuous identification, assessment, evaluation, and prevention of acute and chronic adverse reactions caused by newly launched and already marketed medicines [5][6][7][8][9][10]. Pv these days also covers drug therapy-related problems (DTRPs) shown by herbals, traditional, complementary, and alternative medicines (TCAMs), biologicals and blood products, medical devices, and vaccines [6,11,12].…”

Clinical standards for the management of adverse effects during treatment for TB

“…This also helps with making reporting more efficient as duplication of efforts in reporting AE was considered a major hurdle by HCWs. 59 When reporting a case, the information outlined in Table 6 should be included; person characteristics, event characteristics, seriousness of the event, actions taken and outcome. 52…”

Pharmacoethics and pregnancy: Overcoming the therapeutic orphan stigma

“…55 The legal framework for post-market safety surveillance is lacking in some sub-Saharan African countries, but there has been slow progress in that. 56 It is worth noting the participation of developing countries in drug trials conducted in pregnant women, most notably the WOMAN/WOMAN2 trial. 57,58 We hope that with the increase in virtual platforms, having regulatory reviews or data safety monitoring committees from outside country members can be more easily attained and help in overcoming some of the obstacles.…”