Recommendations on strengthening pharmacovigilance in Africa

Excerpt

The pharmacovigilance (PV) meeting of the members of the WHO Programme for Internaional Drug Monitoring and partners in Africa, held in Morocco in 2023, included five working groups which discussed various issues and made recommendations which have been reported in the WHO Pharmaceutical Newsletter .The working group (WG) on PV training recommended that a repository of all existing training materials and courses should be standardised and shared; all courses and documents should be available in English, French and Portuguese; and existing training should be coordinated and conducted by trainers with necessary qualifications and experience.The WG on increasing African reports of adverse events, and adverse events following immunisation, in VigiBase made recommendations to enhance reporting tools and resources including supporting countries to get free access to VigiFlow and other electronic reporting tools; supporting evaluations of PV systems and training of national PV centres in each country; and recommended that PV centres contact WHO to allow VigiFlow access and also harmonise databases and reinforce regulations.The WG on harmonising methods between PV and epidemiology (causality assessment) made recommendations such as creating an international working group on harmonisation; analysing similarities between methods; and collecting investigation reporting forms to propose harmonisation.The WG on better collaboration between the national regulatory authority and national immunisation programme (NIP) recommended that African countries promote establishment of a centralised safety review committee; and use VigiFlow as a platform to decentralise PV activities, giving access to NIPs. This WG also recommended that WHO should advocate with donors and partners for better coordinated PV activities, and establish a regional network for information and learning sharing.The WG on active surveillance made recommendations for the WHO HQ and regional offices such as adapting existing tools for active surveillance, engaging market authorisation holders in active surveillance planning, and provide guidance on protocol. The group also recommended that PV centres increase public awareness of active surveillance; collaborate with the Public Health Programme and Ministry of Health to train practitioners in conducting active surveillance; and ensure timely interim analysis of data by an expert committee. …