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 iss 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 and adverse drug reaction (ADR) reporting to the NMRAs among DR-TB healthcare providers.Conclusion: aDSM has created awareness about the importance of pharmacovigilance among NTPs and has increased ADR reporting rates from the NTPs and/or TB healthcare providers to the NMRAs. 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.

Facilitators and barriers in implementation of active TB drug safety monitoring and management (aDSM) in programmatic management of drug resistance TB in Dar es Salaam region

“…From the findings however, almost all health facilities did not have a functional laboratory in site, but there was a sample referral system instead that was coordinated by the program (NTLP). These results are similar to a study done in Tanzania where implementation of aDSM was found to be difficult since most health facilities either lacked the necessary toxicity monitoring equipment like ECG, or had been faulty or HCWs were unable to operate it [13]. Another similar study conducted in India, on adverse events among patients being programmatically treated, found that guidelines, SOPs and aDSM forms were available at the treatment centre; however some toxicity monitoring tests were not done due to absence of machines for the respective tests [14].…”

Pharmacoethics and pregnancy: Overcoming the therapeutic orphan stigma

“…A minority of LMICs have no post‐market safety systems established 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 .…”

Pharmacovigilance in Nigeria: Addressing challenges in ensuring drug safety and monitoring adverse effects

“…The extent of pharmacovigilance among resident doctors in Nigeria underscores the importance of strengthening pharmacovigilance programs across different healthcare sectors (Ohaju-Obodo & Iribhogbe, 2009; Abrahams et al, 2023). Additionally, the assessment of pharmacovigilance activities in sub-Saharan African countries, including Nigeria, emphasizes the necessity of evaluating and addressing the strengths and challenges within existing pharmacovigilance systems (Tiemersma et al, 2021;Ilugbusi et al, 2020).…”

“…The evaluation of pharmacovigilance activities in Nigeria has exposed weaknesses in the system, including limited capacity to monitor the safety of medicines, both registered and unregistered, for the treatment of diseases like drugresistant tuberculosis (Tiemersma et al, 2021). This underscores the importance of strengthening pharmacovigilance systems to ensure the safety of all medications used within the country.…”