Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan
Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan
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DOI：
10.1111/jcpt.12089
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发表时间：
2013-12-01
影响因子：
2
通讯作者：
Ikeda, M.
中科院分区：
文献类型：
--
作者：
Shimazawa, R.;Ikeda, M.
药物基因组学信息在药品说明书（PI）中的提供近年来变得越来越普遍。PI的内容可以定制，以满足目标人群的具体要求。我们的目的是确定，评估和报告的差异，在药物基因组学信息的PI从美国（美国），英国（英国）和Japanes.MethodsPackage插页获得美国食品和药物管理局（FDA）的药物标签中的药物基因组学生物标志物表2012年10月1日。同时从日本和英国获得相应的PI。我们比较了药物基因组学的信息，信息所在的位置，药物的治疗类别，生物标志物的类型和目的，以及最初的美国批准year.Results和discussionOne一百一十八PI包括在FDA表中。在118个PI中，29个PI提供了药物靶点信息，69个PI提供了代谢酶信息，20个PI提供了其他方面信息。在来自英国的71个PI和来自日本的44个PI中描述了基因组生物标志物。三个司法管辖区的标签一致性在PI的适应症章节中高于注意事项章节。适应症章节中生物标志物信息的国家间一致性（相对于美国信息，英国为65%，日本为48%）似乎高于注意事项章节中的一致性（英国为41%，日本为17%）。新内容和结论美国、英国和日本PI中包含的药物基因组学信息存在实质性差异。差异根据PI部分以及生物标志物的类型和目的而变化。差异似乎根据支持使用生物标志物的证据的强度而变化。有必要进一步分析，以确定这些差异的原因。
What is known and objectiveThe provision of pharmacogenomic information in drug package inserts (PIs) has become more common in recent years. The content of PIs can be tailored to meet specific requirements of the target populations. Our objective was to identify, assess and report on differences in pharmacogenomic information in PIs from the United States (USA), the United Kingdom (UK) and Japan.MethodsPackage inserts were obtained from the US Food and Drug Administration (FDA) Table of Pharmacogenomic Biomarkers in Drug Labels on 1 October 2012. Corresponding PIs were obtained concurrently from Japan and the UK. We compared the pharmacogenomic information included, where the information was located, the therapeutic class of the drug, the type and purpose of the biomarker and the initial US approval year.Results and discussionOne hundred eighteen PIs were included in the FDA table. Of the 118 PIs, 29 provided information on drug targets, 69 on metabolizing enzymes and 20 on other aspects. Genomic biomarkers were described in 71 PIs from the UK and 44 from Japan. Consistency in labelling across the three jurisdictions was greater in the Indications' section of the PIs than that in the Precautions' section. There appears to be greater concordance across countries for the biomarker information in the Indications' sections (UK 65% and Japan 48% relative to the US information) than that in the Precautions' sections (UK 41% and Japan 17%).What is new and conclusionThere are substantial differences in the pharmacogenomic information included in PIs from the USA, the UK and Japan. The differences varied according to the PI sections, and type and purpose of the biomarkers. The differences appeared to vary according to the strength of the evidence supporting use of the biomarkers. Further analyses are necessary to determine the causes of these differences.