Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis.
Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis.
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DOI：
10.1186/s12913-021-07043-6
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发表时间：
2021-10-08
影响因子：
2.8
通讯作者：
Härmark L
中科院分区：
文献类型：
--
作者：
Tiemersma EW;Ali I;Alemu A;Avong YK;Duga A;Elagbaje C;Isah A;Kay A;Mmbaga BT;Mmari E;Mwamwitwa K;Nhlabatsi S;Sintayehu K;Arefayne A;Teferi M;Cobelens F;Härmark L
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. 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. 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. 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. The online version contains supplementary material available at 10.1186/s12913-021-07043-6.
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DOI：
10.1183/09031936.00125812
发表时间：
2013-06
期刊：
The European respiratory journal
影响因子：
--
作者：
Skripconoka V;Danilovits M;Pehme L;Tomson T;Skenders G;Kummik T;Cirule A;Leimane V;Kurve A;Levina K;Geiter LJ;Manissero D;Wells CD
通讯作者：
Wells CD
影响因子：
4.2
作者：
Abiri, Onome T.;Johnson, Wiltshire C. N.
通讯作者：
Johnson, Wiltshire C. N.
影响因子：
158.5
作者：
Conradie, Francesca;Diacon, Andreas H.;Spigelman, Melvin
通讯作者：
Spigelman, Melvin
影响因子：
3.7
作者：
Avong, Yohanna Kamabi;Isaakidis, Petros;Dakum, Patrick Sunday
通讯作者：
Dakum, Patrick Sunday
影响因子：
3.7
作者：
Nadew, Solomon Shiferaw;Beyene, Kidanemariam G. Michael;Beza, Solomon Worku
通讯作者：
Beza, Solomon Worku