Laboratory of Drug Development, Centre for Training, Research and Expertise in Drug Sciences, Doctoral School of Sciences and Health, Joseph Ki-Zerbo University, 03 BP 7021, Ouagadougou, Burkina Faso.
EA7307, Centre for International and European Studies, Faculty of Pharmacy, University of Strasbourg, 74, route du Rhin, 67400, Illkirch, France.
Pharmaceut Med. 2023 Jul;37(4):305-318. doi: 10.1007/s40290-023-00478-8. Epub 2023 May 22.
West African Economic and Monetary Union (UEMOA) countries are characterised by a high prevalence of informal use of medicinal plants and traditional medicines by their population for health care, requiring the establishment of pharmacovigilance, in order to monitor the associated health risks. However, the state of implementation of pharmacovigilance for traditional medicines in UEMOA countries is not known.
This study aimed to assess the state of implementation of pharmacovigilance for traditional medicines in the eight UEMOA countries, describing the relevant community provisions, assessing the integration of traditional medicines monitoring into national pharmacovigilance systems and identifying related national challenges.
This was a cross-sectional study using questionnaires, conducted between 1 May and 31 August 2022. A face-to-face questionnaire was administered to officials responsible for the issue within UEMOA and the West African Health Organisation (WAHO). A second online questionnaire was specifically sent to the pharmacovigilance focal points of the eight UEMOA countries. Questionnaires were designed using the WHO indicators for pharmacovigilance. The face-to-face questionnaire collected two types of data, namely community policies and regulations on pharmacovigilance and technical and financial support from sub-regional organisations to countries. The online questionnaire sent to countries collected four categories of data on the study issue: structural data, process data, impact data and data on national challenges.
As a community provision, WAHO has a harmonised regulatory framework for phytovigilance. The monitoring of traditional medicines is not effectively implemented in the pharmacovigilance systems of UEMOA countries. Only two reports of adverse events due to traditional medicines have so far been recorded in the Union. The countries have neither funding nor sufficient human resources for pharmacovigilance in general. Monitoring of traditional medicines in the unregulated market, training of stakeholders, risk communication, and integration of traditional health practitioners in reporting systems are the main challenges of countries for the development of pharmacovigilance for traditional medicines.
The effective compliance of WAHO's harmonised phytovigilance regulatory framework by UEMOA countries and addressing the challenges identified by the countries constitute the basis for the development of pharmacovigilance for traditional medicines within UEMOA.
西非经济和货币联盟（UEMOA）国家的特点是其民众大量非正式地使用药用植物和传统药物进行医疗保健，因此需要建立药物警戒制度，以监测相关的健康风险。然而，目前尚不清楚 UEMOA 国家传统药物药物警戒的实施情况。
本研究旨在评估 UEMOA 八个国家传统药物药物警戒的实施情况，描述相关社区规定，评估将传统药物监测纳入国家药物警戒系统的情况，并确定相关国家挑战。
这是一项 2022 年 5 月 1 日至 8 月 31 日期间进行的横断面研究，使用问卷进行。面对面地向 UEMOA 和西非卫生组织（WAHO）负责该问题的官员发放问卷。第二份在线问卷专门发给 UEMOA 八个国家的药物警戒联络点。问卷采用世界卫生组织药物警戒指标设计。面对面问卷收集了两类数据，即社区药物警戒政策和法规以及次区域组织向国家提供的技术和财政支持。发给国家的在线问卷收集了与研究问题相关的四类数据：结构性数据、过程性数据、影响数据和国家挑战数据。
作为一项社区规定，WAHO 拥有一个统一的植物药物警戒监管框架。传统药物监测尚未在 UEMOA 国家的药物警戒系统中得到有效实施。迄今为止，该联盟仅记录了两起因传统药物引起的不良事件报告。各国既没有用于药物警戒的资金，也没有足够的人力资源。对不受监管市场的药物监测、利益攸关方的培训、风险沟通以及将传统卫生从业人员纳入报告系统，是各国发展传统药物药物警戒的主要挑战。
UEMOA 国家有效遵守 WAHO 统一的植物药物警戒监管框架，并解决各国确定的挑战，是在 UEMOA 内发展传统药物药物警戒的基础。
