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

Corine Ekhart (), Sjoerd H. P. Wiarda, Sonja Koppel, Souad Skalli, Waad Alghamdi, Francesca Menniti-Ippolito, Kunwarang Tangchitkhachon, John Samson Mponda, Herman J. Woerdenbag and Florence Hunsel
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Corine Ekhart: Netherlands Pharmacovigilance Centre Lareb
Sjoerd H. P. Wiarda: Netherlands Pharmacovigilance Centre Lareb
Sonja Koppel: Netherlands Pharmacovigilance Centre Lareb
Souad Skalli: Faculty of Science Mohammed V University
Waad Alghamdi: Saudi Food and Drug Authority
Francesca Menniti-Ippolito: Italian National Institute of Health
Kunwarang Tangchitkhachon: Praboromarajchanok Institute Ministry of Public Health
John Samson Mponda: Kamuzu University of Health Sciences
Herman J. Woerdenbag: University of Groningen
Florence Hunsel: Netherlands Pharmacovigilance Centre Lareb

Drug Safety, 2025, vol. 48, issue 1, No 6, 75-86

Abstract: 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.

Date: 2025
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DOI: 10.1007/s40264-024-01480-y

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