Strengthening signal detection in pharmacovigilance by using international nonproprietary name (INN) stems

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dc.contributor.authorMalan, Sarel
dc.contributor.authorBalocco, Raffaella
dc.contributor.authorAronson, Jeffrey
dc.date.accessioned2025-11-25T10:20:17Z
dc.date.available2025-11-25T10:20:17Z
dc.date.issued2025
dc.description.abstract‘Stems’, which mark pharmacological relationships between substances, form the backbone of the International Nonproprietary Name (INN) system, developed by the WHO in the 1950s. In this paper, we propose using the INN stems to enhance pharmacovigilance signal detection. After analysis of historical cases and current pharmacovigilance practices, we discuss how stem-based classification could facilitate understanding of the adverse-effects profile of each stem, to be used as a benchmark for early identification of adverse drug reactions that deviate from expected class effects, in other words signals associated with newly marketed medicines or different uses of well-known medicines. We propose a potential framework for integrating stem-based analysis into existing pharmacovigilance databases, supplemented by artificial intelligence approaches, such as machine learning. While acknowledging limitations, such as stem variability and reporting bias, we suggest that this approach offers potential advantages for regulatory authorities and healthcare professionals in post-marketing surveillance. Implementation of stem-based post-marketing surveillance could enhance signal-detection efficiency and contribute to improved patient safety through earlier identification of unexpected adverse effects and adverse reactions.
dc.identifier.citationBalocco, R., Aronson, J.K., Malan, S.F. and Figueras, A., 2025. Strengthening Signal Detection in Pharmacovigilance by Using International Nonproprietary Name (INN) Stems. Drug Safety, pp.1-7.
dc.identifier.urihttps://doi.org/10.1007/s40264-025-01620-y
dc.identifier.urihttps://hdl.handle.net/10566/21472
dc.language.isoen
dc.publisherSpringer Nature Link
dc.subjectDrug Regulation
dc.subjectPlant Signalling
dc.subjectPlant stem cell
dc.subjectStem Cell Biotechnology
dc.subjectDrug Safety and Pharmacovigilance
dc.titleStrengthening signal detection in pharmacovigilance by using international nonproprietary name (INN) stems
dc.typeArticle

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