Ekhart Corine, Wiarda Sjoerd H P, van de Koppel Sonja, Skalli Souad, Alghamdi Waad, Menniti-Ippolito Francesca, Tangchitkhachon Kunwarang, Mponda John Samson, Woerdenbag Herman J, van Hunsel Florence
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH's, Hertogenbosch, The Netherlands.
Department of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Groningen, The Netherlands.
Drug Saf. 2025 Jan;48(1):75-86. doi: 10.1007/s40264-024-01480-y. Epub 2024 Sep 12.
The use of herbal products globally is substantial, but varying definitions and regulatory frameworks have led to differences in their status as medicinal products and in approaches to monitoring their safety. This article explores the current landscape of herbal pharmacovigilance, drawing insights from interviews with global experts in the field, and offers recommendations for best practices to enhance the safety and benefit-to-harm balance of herbal products.
This study comprised semi-structured interviews with members of the International Society of Pharmacovigilance-Herbal and Traditional Medicines Special Interest Group and the Nutrivigilance Information Exchange Network, recruited using purposive sampling. Data were stored and coded using NVIVO and analysed thematically using a qualitative inductive approach.
Sixteen participants from 11 countries were interviewed, revealing diverse regulatory approaches and challenges in herbal pharmacovigilance. Key themes included legal status, awareness, identification and coding of herbal products, pre-/post-marketing product control, reporting of adverse drug reactions, causality assessment and signals of herbal products. This study yielded five general recommendations to further improve herbal pharmacovigilance worldwide.
This study offers an overview of the global landscape of herbal pharmacovigilance, highlighting challenges in monitoring herbal products and presenting universal recommendations. These recommendations encompass increasing awareness, enhancing education and improving legislative frameworks. Given the growing use of herbal products, the implementation of strong pharmacovigilance practices is crucial to ensure consumer safety.
全球范围内草药产品的使用十分广泛，但不同的定义和监管框架导致其作为药品的地位以及监测其安全性的方法存在差异。本文通过采访该领域的全球专家，探讨了草药药物警戒的现状，并为提高草药产品的安全性以及效益与风险平衡提供了最佳实践建议。
本研究采用目的抽样法，对国际药物警戒协会草药与传统药物特别兴趣小组以及营养药物警戒信息交流网络的成员进行了半结构化访谈。数据使用NVIVO存储和编码，并采用定性归纳法进行主题分析。
对来自11个国家的16名参与者进行了访谈，揭示了草药药物警戒中不同的监管方法和挑战。关键主题包括法律地位、认知度、草药产品的识别与编码、上市前/后产品控制、药品不良反应报告、因果关系评估以及草药产品的信号。本研究提出了五项一般性建议，以进一步改善全球范围内的草药药物警戒。
本研究概述了全球草药药物警戒的现状，强调了监测草药产品的挑战并提出了通用建议。这些建议包括提高认知度、加强教育以及完善立法框架。鉴于草药产品的使用日益增加，实施强有力的药物警戒措施对于确保消费者安全至关重要。
