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Pharmacogenomic biomarker information on drug labels of the Spanish Agency of Medicines and Sanitary products: evaluation and comparison with other regulatory agencies

The Pharmacogenomics Journal volume 24, Article number: 2 (2024) Cite this article

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Abstract

This work aimed to analyse the pharmacogenetic information in the Spanish Drug Regulatory Agency (AEMPS) Summary of Products Characteristics (SmPC), evaluating the presence of pharmacogenetic biomarkers, as well as the associated recommendations. A total of 55.4% of the 1891 drug labels reviewed included information on pharmacogenetic biomarker(s). Pharmacogenomic information appears most frequently in the “antineoplastic and immunomodulating agents”, “nervous system”, and “cardiovascular system” Anatomical Therapeutic Chemical groups. A total of 509 different pharmacogenetic biomarkers were found, of which CYP450 enzymes accounted for almost 34% of the total drug-biomarker associations evaluated. A total of 3679 drug–biomarker pairs were identified, 102 of which were at the 1A level (PharmGKB® classification system), and 33.33% of these drug-pharmacogenetic biomarker pairs were assigned to “actionable PGx”, 12.75% to “informative PGx”, 4.9% to “testing recommended”, and 4.9% to “testing required”. The rate of coincidence in the assigned PGx level of recommendation between the AEMPS and regulatory agencies included in the PharmGKB® Drug Label Annotations database (i.e., the FDA, EMA, SWISS Medic, PMDA, and HCSC) ranged from 45% to 65%, being ‘actionable level’ the most frequent. On the other hand, discrepancies between agencies did not exceed 35%. This study highlights the presence of relevant pharmacogenetic information on Spanish drug labels, which would help avoid interactions, toxicity, or lack of treatment efficacy.

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Fig. 1: Analysis of biomarker distribution and pharmacogenomics in Spanish drug labels.
Fig. 2: Ratio of active substances and pharmacogenomic biomarkers in drug labels across ATC categories.
Fig. 3: Prevalence of key pharmacogenetic biomarkers in Spanish drug labels across ATC categories.

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Data availability

The datasets generated and/or analysed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors would like to acknowledge the funding received from the Spanish Agency of Medicines and Sanitary Products (AEMPS), as well as from the Ministry of Economy and Competitiveness / Instituto de Salud Carlos III (ISCIII) to carry out this work with funding from Projects Biofram22 (PMP22/00099) and Impact (IMP/000009).

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Authors and Affiliations

  1. INUBE Extremadura Biosanitary Research Institute, Badajoz, Spain

    María Estévez-Paredes, M. Carmen Mata-Martín, Fernando de Andrés & Adrián LLerena

  2. CICAB Clinical Research Centre, Pharmacogenetics and Personalized Medicine Unit, Badajoz University Hospital, Extremadura Health Service, Badajoz, Spain

    María Estévez-Paredes, M. Carmen Mata-Martín, Fernando de Andrés & Adrián LLerena

  3. Department of Analytical Chemistry and Food technology, Faculty of Pharmacy, University of Castilla-La Mancha, Albacete, Spain

    Fernando de Andrés

  4. Faculty of Medicine, University of Extremadura, Badajoz, Spain

    Adrián LLerena

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  1. María Estévez-Paredes
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Contributions

Conceptualization: ALL. Methodology: ALL, FdA. Data retrieval, analysis, and curation: MEP, FdA, MCMM. Resources: ALL. Writing-original draft: FdA, MEP. Writing-review and editing: MEP, FdA, MCMM, ALL. Project administration: ALL. Funding acquisition: ALL. All authors have read and agreed to the published version of the paper.

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Correspondence to Adrián LLerena.

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Estévez-Paredes, M., Mata-Martín, M.C., de Andrés, F. et al. Pharmacogenomic biomarker information on drug labels of the Spanish Agency of Medicines and Sanitary products: evaluation and comparison with other regulatory agencies. Pharmacogenomics J 24, 2 (2024). https://doi.org/10.1038/s41397-023-00321-y

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