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 tea

SUBMITTER: Tiemersma EW 

PROVIDER: S-EPMC8499544 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature