TY - JOUR
T1 - Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries
T2 - a perspective on tuberculosis
AU - Tiemersma, Everdina W.
AU - Ali, Ibrahim
AU - Alemu, Asnakech
AU - Avong, Yohanna Kambai
AU - Duga, Alemayehu
AU - Elagbaje, Cassandra
AU - Isah, Ambrose
AU - Kay, Alexander
AU - Mmbaga, Blandina Theophil
AU - Mmari, Elice
AU - Mwamwitwa, Kissa
AU - Nhlabatsi, Siphesihle
AU - Sintayehu, Kassech
AU - Arefayne, Aida
AU - Teferi, Mekonnen
AU - Cobelens, Frank
AU - Härmark, Linda
N1 - Funding Information: This publication was produced by the PAVIA project. This project is part of the EDCTP2 program supported by the European Union (grant number CSA2016S-1627 – PAVIA). The views and opinions of authors expressed herein do not necessarily state or reflect those of EDCTP. Publisher Copyright: © 2021, The Author(s).
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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.
AB - 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.
KW - Health system assessment
KW - Pharmacovigilance
KW - Tuberculosis
UR - http://www.scopus.com/inward/record.url?scp=85116774815&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12913-021-07043-6
DO - https://doi.org/10.1186/s12913-021-07043-6
M3 - Article
C2 - 34625085
SN - 1472-6963
VL - 21
JO - BMC Health Services Research
JF - BMC Health Services Research
IS - 1
M1 - 1062
ER -