Mssusa Alambo K, Holst Lone, Maregesi Sheila, Kagashe Godeliver
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
J Pharm Policy Pract. 2024 Dec 24;18(1):2438223. doi: 10.1080/20523211.2024.2438223. eCollection 2025.
The increase in the consumption of herbal medicines and their documented adverse reactions (ARs) necessitate countries to have good pharmacovigilance (PV) systems at all levels. PV systems should be frequently assessed in a systematic manner with available harmonised tools to monitor the implementation of efforts, strengthen the systems and identify areas for improvement.
This study aimed to assess the performance of pharmacovigilance and its quality systems for monitoring herbal medicine safety at the National PV Centre at the Tanzania Medicines and Medical Devices Authority (TMDA), manufacturers and herbal medicine marketing authorisation holders (MAHs) to identify gaps, challenges and opportunities for improvement.
A descriptive cross-sectional study was conducted using structured interviews with key informants, questionnaires administered by the researchers and document analysis. A retrospective study of suspected ARs to herbal medicines received via the TMDA was also performed.
Policies and a legal framework for regulatory control and safety monitoring of herbal medicines were in place with a well-established and functional PV system at the TMDA. However, some gaps and challenges in the safety monitoring of herbal medicines, such as underreporting, lack of training, and dissemination of PV information, have been identified. A total of 18 reports containing 40 suspected herbal medicine ARs were received at the TMDA. Among the MAHs, only 64% had PV systems, with only 29% having mechanisms for the collection of ARs from their products. Only a few MAHs (39%) had a qualified person in the PV. The majority of the MAHs (64%) had established a quality system for PV; however, the systems were inadequate.
Deliberate efforts need to be made to strengthen herbal medicine safety monitoring at the regulatory level. MAHs need to develop efficient PV systems and recruit qualified persons to identify safety issues related to herbal medicines.
草药消费的增加及其已记录的不良反应促使各国在各级建立完善的药物警戒（PV）系统。应使用现有的统一工具对PV系统进行定期系统评估，以监测工作的实施情况、加强系统并确定改进领域。
本研究旨在评估坦桑尼亚药品和医疗器械管理局（TMDA）国家PV中心、制造商和草药营销授权持有人（MAH）在监测草药安全性方面的药物警戒及其质量体系的表现，以识别差距、挑战和改进机会。
采用对关键信息提供者的结构化访谈、研究人员发放的问卷以及文件分析进行描述性横断面研究。还对通过TMDA收到的疑似草药不良反应进行了回顾性研究。
已制定了草药监管控制和安全监测的政策及法律框架，TMDA拥有完善且运行良好的PV系统。然而，已发现草药安全监测存在一些差距和挑战，如报告不足、缺乏培训以及PV信息传播等问题。TMDA共收到18份包含40例疑似草药不良反应的报告。在MAH中，只有64%拥有PV系统，只有29%具备从其产品中收集不良反应的机制。只有少数MAH（39%）在PV方面有合格人员。大多数MAH（64%）已建立了PV质量体系；然而，这些体系并不完善。
需要在监管层面做出刻意努力以加强草药安全监测。MAH需要建立高效的PV系统并招聘合格人员，以识别与草药相关的安全问题。
