Prevalence and types of inconsistencies in clinical pharmacogenetic recommendations among major U.S. sources.
Prevalence and types of inconsistencies in clinical pharmacogenetic recommendations among major U.S. sources.
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DOI：
10.1038/s41525-020-00156-7
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发表时间：
2020
影响因子：
5.3
通讯作者：
Luzum JA
中科院分区：
文献类型：
--
作者：
Shugg T;Pasternak AL;London B;Luzum JA
药物基因组学（PGx）的临床应用进展缓慢。先前的研究已经确定了临床PGx建议之间的一些不一致性，但尚未在美国临床药物遗传学实施联盟，美国食品药品监督管理局药物标签和美国主要专业医疗组织的主要PGx指南来源中全面分析不一致性的发生率和类型。在以下要素中分析了胰岛素：推荐类别;是否推荐常规筛查;以及涉及的特定生物标志物，变体和患者组。我们确定了606个临床PGx建议，其中包含267种独特的药物。总体而言，48.1%的临床PGx建议和93.3%的三个来源的建议发生了复合不一致。在推荐类别（29.8%）、患者组（35.4%）和常规筛选（15.2%）中发生了异常。总之，来自美国主要指南来源的近一半的临床PGx建议包含不一致性，这可能会减缓临床实施。
Clinical implementation of pharmacogenomics (PGx) is slow. Previous studies have identified some inconsistencies among clinical PGx recommendations, but the prevalence and types of inconsistencies have not been comprehensively analyzed among major PGx guidance sources in the U.S. PGx recommendations from the Clinical Pharmacogenetics Implementation Consortium, U.S. Food and Drug Administration drug labels, and major U.S. professional medical organizations were analyzed through May 24, 2019. Inconsistencies were analyzed within the following elements: recommendation category; whether routine screening was recommended; and the specific biomarkers, variants, and patient groups involved. We identified 606 total clinical PGx recommendations, which contained 267 unique drugs. Composite inconsistencies occurred in 48.1% of clinical PGx recommendations overall, and in 93.3% of recommendations from three sources. Inconsistencies occurred in the recommendation category (29.8%), the patient group (35.4%), and routine screening (15.2%). In conclusion, almost one-half of clinical PGx recommendations from prominent U.S. guidance sources contain inconsistencies, which can potentially slow clinical implementation.