Pharmacogenomic drug labels in the Summary of Product Characteristics (SmPC) provide an instrument for clinical implementation of pharmacogenomics. We compared pharmacogenomic guidance by Clinical Pharmacogenetics Implementation Consortium (CPIC), Dutch Pharmacogenetics Working Group (DPWG), the US Food and Drug Administration (FDA), and by the European agencies the European Medicines Agency (EMA), College ter Beoordeling van Geneesmiddelen Medicines Evaluation Board (CBG-MEB), and Federal Institute for Drugs and Medical Devices (FIDMD), collectively assigned as EMA/FIDMD+MEB shortened as EMA/FM. Of 54 drugs with an actionable gene-drug interaction in the CPIC and DPWG guidelines, only 50% had actionable pharmacogenomic information in the SmPCs and the agencies were in agreement in only 18% of the cases. We further compared 450 additional drugs, lacking CPIC or DPWG guidance, and found 126 actionable gene-drug labels by the FDA and/or the EMA/FM. Based on these 126 drugs in addition to the 54 above, the consensus of actionable pharmacogenomic labeling between the FDA and the EMA/FM was only 54%. In conclusion, guidelines provided by CPIC/DPWG are only partly implemented into the SmPCs and the implementation of pharmacogenomic drug labels into the clinics would strongly gain from a higher extent of consensus between agencies.

中文翻译：

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药物基因组药物标签现行法规和指南的评估：改进的机会。

产品特征摘要（SmPC）中的药物基因组药物标签为临床应用药物基因组学提供了一种工具。我们比较了临床药物遗传学实施联合会（CPIC），荷兰药物遗传学工作组（DPWG），美国食品和药物管理局（FDA）以及欧洲机构欧洲药品管理局（EMA），贝奥德尔丁·范·Geneesmiddelen医学院的药物基因组学指导评估委员会（CBG-MEB）和联邦药品和医疗器械研究所（FIDMD），统称为EMA / FIDMD + MEB，简称为EMA / FM。在CPIC和DPWG指南中具有可操作的基因-药物相互作用的54种药物中，只有50％的药物在SmPC中具有可操作的药物基因组学信息，而且只有18％的病例与该机构达成了一致。我们还比较了450种其他药物，缺乏CPIC或DPWG指导，并发现了FDA和/或EMA / FM的126种可行的基因药物标签。除上述54种药物外，基于这126种药物，FDA与EMA / FM之间可操作的药物基因组学标记的共识仅为54％。总之，CPIC / DPWG提供的指南仅部分实施到SmPC中，而在机构之间达成更高程度的共识，则将极大地受益于在诊所中使用药物基因组学药物标签。