Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, Michigan.
Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Pharmacogenet Genomics. 2022 Feb 1;32(2):51-59. doi: 10.1097/FPC.0000000000000452.
Evaluations from pharmacogenetics implementation programs at major US 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 US 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, US Food and Drug Administration drug labels and clinical practice guidelines from US professional medical organizations across therapeutic areas.
We analyzed clinical pharmacogenetics recommendation elements within Clinical Pharmacogenetics Implementation Consortium guidelines, US 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.
On the basis of 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.
美国主要医疗中心的药物基因组学实施计划的评估报告显示，治疗领域之间药物基因组学的临床应用存在差异。这种差异的一个潜在原因可能涉及到临床医生接受的药物基因组学建议在治疗领域的特异性差异。然而，到目前为止，还没有评估过来自美国主要指导来源的治疗领域之间临床药物基因组学建议的差异。因此，我们的目的是全面比较临床药物基因组学实施联盟指南、美国食品和药物管理局药物标签以及美国专业医疗组织的临床实践指南中包含的治疗领域内临床药物基因组学建议的基本要素。
我们通过 05/24/19 分析了临床药物基因组学实施联盟指南、美国食品和药物管理局药物标签和专业临床实践指南中的临床药物基因组学建议要素。
我们确定了 606 个独特的临床药物基因组学建议，其中涉及肿瘤学（217 个建议）、血液学（79 个）、精神病学（65 个）、心血管（43 个）和麻醉学（37 个）药物的建议最多。在我们的分析中，我们观察到在以下基本药物基因组学建议要素方面，治疗领域之间存在相当大的差异：推荐的临床管理策略；相关的遗传生物标志物；提供药物基因组学建议的组织；是否推荐常规基因筛查；以及建议发布后的时间。
根据我们的结果，我们推断治疗领域之间临床药物基因组学建议的差异可能是由于与特定疾病状态、相关遗传生物标志物以及提供建议的组织特征相关的具体因素所致。
