Evidence map›Paper›PMID 39266812›Full record

ArticleDrug safety2025

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

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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Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Analysis of Adverse Reactions Associated with the Use ofPharmaceuticals (Basel, Switzerland) · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Corine EkhartNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH's, Hertogenbosch, The Netherlands. c.ekhart@lareb.nl.ORCID 0000-0002-2252-0467
Sjoerd H P WiardaNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH's, Hertogenbosch, The Netherlands.
Sonja van de KoppelNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH's, Hertogenbosch, The Netherlands.
Souad SkalliFaculty of Science Mohammed V University, Rabat, Morocco.
Waad AlghamdiPharmacovigilance Directorate, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Francesca Menniti-IppolitoItalian National Institute of Health, Rome, Italy.
Kunwarang TangchitkhachonPraboromarajchanok Institute Ministry of Public Health, Nonthaburi, Thailand.
John Samson MpondaPharmacy Department, Kamuzu University of Health Sciences, Blantyre, Malawi.
Herman J WoerdenbagDepartment of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Groningen, The Netherlands.
Florence van HunselNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH's, Hertogenbosch, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe 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.

methodsThis 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

resultsSixteen 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.

conclusionsThis 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.

Indexed as

Adverse Drug Reaction Reporting SystemsPharmacovigilanceDrug-Related Side Effects and Adverse ReactionsHumansInterviews as TopicPlant PreparationsPlants, MedicinalPlant Preparations

Identifiers

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.