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Causality Assessment in Pharmacovigilance for Herbal Medicines

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Pharmacovigilance for Herbal and Traditional Medicines

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Abstract

Herbal medicines, including traditional herbal medicines, are commonly used throughout the world in developed and developing countries despite persistent questions on their efficacy and safety. Of importance are pharmacovigilance approaches on how to detect adverse reactions and how to validly assess causality. Detection of adverse reactions can be straightforward if clinical signs are visible within a few minutes or hours, such as exanthema due to an allergic reaction. More difficult is the recognition of adverse reactions affecting other systems/organs, such as the heart, liver, blood, kidney, immune system, or brain, that require clinical experience and systematic approaches to establish the diagnosis of organ injury. Pharmacovigilance for herbal medicines is challenging because of specific issues for these products, such as the precise ingredients and quality of the product. As for conventional medicines, pharmacovigilance depends primarily on the quality of reports submitted by healthcare providers and patients/consumers. Pharmacovigilance perspectives should focus on analyses of cases with good data quality, rather than on large numbers of poorly documented case reports. For suspected general adverse effects, causality for herbal medicines should be assessed using the Naranjo scale, despite some shortcomings, or any other scale scoring key elements, and providing a final objective causality level for the suspected herbal product/ingredient. Use of the WHO method, based on global introspection, is discouraged (by these authors) as it lacks defined key elements with individual scores and provides merely subjective and non-transparent results. Cases involving liver injury require specifically the use of RUCAM (Roussel Uclaf Causality Assessment Method) in its updated version, which is based on defined key elements with individual scores and provides objective and transparent causality levels for each suspected herbal product/ingredient. In conclusion, pharmacovigilance evaluation for herbal medicines requires complete data sets and sophisticated causality assessment methods, such as RUCAM for cases involving liver injury, and the Naranjo scale, or another diagnostic scale, for other suspected adverse reactions.

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Department of Internal Medicine II, Klinikum Hanau, Hanau, Teaching Hospital of the Medical Faculty, Goethe University, Frankfurt/Main, Germany

    Rolf Teschke

  2. Pharmacovigilance Consultancy, Paris, France

    Gaby Danan

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  1. Rolf Teschke
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  1. School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand

    Joanne Barnes

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Teschke, R., Danan, G. (2022). Causality Assessment in Pharmacovigilance for Herbal Medicines. In: Barnes, J. (eds) Pharmacovigilance for Herbal and Traditional Medicines. Adis, Cham. https://doi.org/10.1007/978-3-031-07275-8_10

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