Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Corine Ekhart, Sjoerd H. P. Wiarda, Sonja van de Koppel, Souad Skalli, Waad Alghamdi, Francesca Menniti-Ippolito, Kunwarang Tangchitkhachon, John Samson Mponda, Herman J. Woerdenbag, Florence van Hunsel
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Abstract

Background and Objective

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.

Methods

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.

Results

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.

Conclusions

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.

Abstract Image

对草药药物警戒相关人员的定性访谈以及对全球适用的最佳做法的建议
背景和目的草药产品在全球范围内的使用量很大,但不同的定义和监管框架导致草药产品的药用地位和安全性监测方法存在差异。本文通过对该领域全球专家的访谈,探讨了草药药物警戒的现状,并提出了最佳实践建议,以提高草药产品的安全性和效益与危害之间的平衡。方法这项研究包括对国际药物警戒学会-草药和传统药物特别兴趣小组和营养警戒信息交流网络成员的半结构式访谈,访谈采用有目的的抽样方式。采用 NVIVO® 对数据进行了存储和编码,并采用定性归纳法对数据进行了专题分析。结果 来自 11 个国家的 16 位参与者接受了访谈,揭示了草药药物警戒方面的不同监管方法和挑战。关键主题包括草药产品的法律地位、认识、识别和编码、上市前/后产品控制、药物不良反应报告、因果关系评估和信号。本研究提出了五项一般性建议,以进一步改善全球草药药物警戒工作。 结论 本研究概述了全球草药药物警戒工作的现状,强调了草药产品监测工作面临的挑战,并提出了普遍性建议。这些建议包括提高认识、加强教育和改进立法框架。鉴于草药产品的使用日益增多,实施强有力的药物警戒措施对确保消费者安全至关重要。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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