Comparison of clinical pharmacogenetic recommendations across therapeutic areas.
Comparison of clinical pharmacogenetic recommendations across therapeutic areas.
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DOI：
10.1097/fpc.0000000000000452
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发表时间：
2022-02-01
影响因子：
2.6
通讯作者：
Luzum JA
中科院分区：
文献类型：
--
作者：
Shugg T;Pasternak AL;Luzum JA
来自美国主要医学中心的遗传药理学实施项目的评估报告了遗传药理学在各治疗领域的临床应用的差异。这种变异性的一个潜在原因可能涉及已发表的药物遗传学推荐给临床医生的治疗区域特异性差异。然而，迄今为止，尚未评估来自美国主要指南来源的治疗领域的临床药物遗传学建议的差异。因此，我们的目标是全面比较临床药物遗传学实施联盟指南、美国食品药品监督管理局药物标签和美国专业医疗组织跨治疗领域的临床实践指南中包含的临床药物遗传学建议的基本要素。我们分析了2019年5月24日之前临床药物遗传学实施联盟指南、美国食品药品监督管理局药物标签和专业临床实践指南中的临床药物遗传学建议要素。我们确定了606项独特的临床药物遗传学建议，其中大多数建议涉及肿瘤学（217项建议），血液学（79项），精神病学（65项），心血管（43项）和麻醉（37项）药物。在我们的分析中，我们观察到以下基本药物遗传学建议要素中的治疗领域存在相当大的差异：推荐的临床管理策略;相关遗传生物标志物;提供药物遗传学建议的组织;是否推荐常规遗传筛查;以及自建议发表以来的时间。根据我们的研究结果，我们推断，在不同治疗领域的临床药物遗传学建议中观察到的差异可能是由与个体疾病状态相关的特定因素、相关的遗传生物标志物以及提供建议的组织的特征引起的。
Evaluations from pharmacogenetics implementation programs at major U.S. medical centers have reported variability in the clinical adoption of pharmacogenetics across therapeutic areas. A potential cause for this variability may involve therapeutic area-specific differences in published pharmacogenetics recommendations to clinicians. To date, however, the potential for differences in clinical pharmacogenetics recommendations by therapeutic areas from prominent U.S. guidance sources has not been assessed. Accordingly, our objective was to comprehensively compare essential elements from clinical pharmacogenetics recommendations contained within Clinical Pharmacogenetics Implementation Consortium guidelines, U.S. Food and Drug Administration drug labels, and clinical practice guidelines from U.S. professional medical organizations across therapeutic areas. We analyzed clinical pharmacogenetics recommendation elements within Clinical Pharmacogenetics Implementation Consortium guidelines, U.S. Food and Drug Administration drug labels, and professional clinical practice guidelines through 05/24/19. We identified 606 unique clinical pharmacogenetics recommendations, with the most recommendations involving oncology (217 recommendations), hematology (79), psychiatry (65), cardiovascular (43), and anesthetic (37) medications. Within our analyses, we observed considerable variability across therapeutic areas within the following essential pharmacogenetics recommendation elements: the recommended clinical management strategy; the relevant genetic biomarkers; the organizations providing pharmacogenetics recommendations; whether routine genetic screening was recommended; and the time since recommendations were published. Based on our results, we infer that observed differences in clinical pharmacogenetics recommendations across therapeutic areas may result from specific factors associated with individual disease states, the associated genetic biomarkers, and the characteristics of the organizations providing recommendations.