Abstract
BackgroundNew 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.MethodsAssessment 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.ResultsMost 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.ConclusionaDSM 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.
Highlights
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
In NTPs there has been ample attention for the management of Adverse drug reaction (ADR) in individual patients caused by anti-TB medicines, but until recently there was no attention to the importance of reporting ADRs to the National medicines regulatory agency (NMRA) to improve medicine safety on a population level [5, 6]
Until shorter treatments with new medicines became available, ADRs did occur regularly in the recommended 18- to 24-months, multiple-medicine regimens used for the treatment of multi-drug resistant (MDR) TB, [7] including hearing loss caused by aminoglycosides [8]
Summary
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 key to better understand the safety of medicines with the aim to prevent or minimize adverse drug reactions (ADRs), a major cause of morbidity and mortality [1,2,3]. National Tuberculosis Programs (NTPs) have a major role in the end-to-end care for TB patients, including diagnosis, treatment provision, and patient management and monitoring, usually in TB-specialized health facilities or TB units within general health facilities. Until shorter treatments with new medicines became available, ADRs did occur regularly in the recommended 18- to 24-months, multiple-medicine regimens used for the treatment of multi-drug resistant (MDR) TB, [7] including hearing loss caused by aminoglycosides [8]. The need for adequate pharmacovigilance has become pressing with the introduction of new and re-purposed medicines for the treatment of (M)DR-TB which, because of the high clinical need, received accelerated or conditional regulatory approval from stringent regulatory authorities based on limited trial data [9,10,11]
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