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

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.
Competing Interests: Declarations. Funding: This study received no additional funding. Conflicts of interest/competing interests: The authors have no conflicts of interest that are directly relevant to the content of this article. Some of the authors were also interviewees. Statements about opinions are those of the interviewees alone, and not necessarily reflecting their institution. Disclaimer: The views expressed in this paper are those of the authors and not do not necessarily reflect those of the authors’ institutions or their stakeholders. Guaranteeing the accuracy and the validity of the data is a sole responsibility of the research team. Ethics approval: If a study in the Netherlands is subject to the Medical Research Involving Human Subjects Act (WMO), it must undergo a review by an accredited Medical Research Ethics Committee or the Central Committee on Research Involving Human Subjects (CCMO). This study does not fall under the WMO. Consent to participate: Participants in the study were informed in writing of the study purposes, including publication of the results, and provided a statement of informed consent prior to participating in the study. Consent for publication: All participants were provided with the finalised version of the results. Feedback of the participants on the results was incorporated. Availability of data and material: The data for this article (transcribed interviews and NVIVO coding) are not publicly available because of the Lareb data protection policy. Requests to access the datasets should be directed to the corresponding author and will be granted upon reasonable request. Code availability: The NVIVO coding for the data used in this article is not publicly available because of the Lareb data protection policy. Requests to access the datasets should be directed to the corresponding author and will be granted upon reasonable request. Authors’ contributions: The original study protocol was designed by FvH, SHPW, SvdK and HJW. The study protocol was reviewed by SS. Interviews were held by SHPW. Data analysis was performed by SHPW, FvH and CE. The first draft of the manuscript was written by CE. All authors contributed to manuscript drafting and revision. All authors approved the final version to be published.
(© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)