Abstract：
Healthcare professionals need a clear understanding of information about gene-drug interactions in order to make optimal use of pharmacogenetic (PGx) testing. In this report, we compare PGx information in the US Food and Drug Administration (FDA) Table of Pharmacogenetic Associations with information presented in Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines.
Information from CPIC guidelines and the FDA Table of Pharmacogenetic Associations do not have a high level of concordance. Many drugs mentioned in CPIC guidelines are not listed in the FDA table and vice versa, and the same gene-drug association and dosing recommendation was reported for only 5 of the 126 drugs included in either source. Furthermore, classification of drugs in specific sections of the FDA table does not correlate well with CPIC-assigned or provisionally assigned clinical actionability levels. The Pharmacogenomics Knowledge Base (PharmGKB) clinical annotation levels are generally high for drugs mentioned in CPIC guidelines. PharmGKB clinical annotation levels are often unassigned or are lower level for drugs listed on the FDA table but not in CPIC guidelines. These differences may be due in part to FDA having access to PGx information that is unavailable in published literature and/or because PGx classifications are based on criteria other than clinical actionability.
There are important differences between the PGx information presented in the FDA Table of Pharmacogenetic Associations and in CPIC guidelines. FDA and CPIC have different perspectives when evaluating PGx associations and use different approaches and information resources when considering clinical validity related to specific medicines. Understanding how information sources developed by each group differ and can be used together to form a holistic view of PGx may be helpful in increasing adoption of these information sources in practice.
Information from CPIC guidelines and the FDA Table of Pharmacogenetic Associations do not have a high level of concordance. Many drugs mentioned in CPIC guidelines are not listed in the FDA table and vice versa, and the same gene-drug association and dosing recommendation was reported for only 5 of the 126 drugs included in either source. Furthermore, classification of drugs in specific sections of the FDA table does not correlate well with CPIC-assigned or provisionally assigned clinical actionability levels. The Pharmacogenomics Knowledge Base (PharmGKB) clinical annotation levels are generally high for drugs mentioned in CPIC guidelines. PharmGKB clinical annotation levels are often unassigned or are lower level for drugs listed on the FDA table but not in CPIC guidelines. These differences may be due in part to FDA having access to PGx information that is unavailable in published literature and/or because PGx classifications are based on criteria other than clinical actionability.
There are important differences between the PGx information presented in the FDA Table of Pharmacogenetic Associations and in CPIC guidelines. FDA and CPIC have different perspectives when evaluating PGx associations and use different approaches and information resources when considering clinical validity related to specific medicines. Understanding how information sources developed by each group differ and can be used together to form a holistic view of PGx may be helpful in increasing adoption of these information sources in practice.
摘要：
医疗保健专业人员需要清楚地了解有关基因-药物相互作用的信息，以便最佳地利用药物遗传学（PGx）测试。在这份报告中,我们将美国食品和药物管理局(FDA)药物遗传学关联表中的PGx信息与临床药物遗传学实施联盟(CPIC)指南中的信息进行了比较.
来自CPIC指南和FDA药物遗传学关联表的信息不具有高水平的一致性。CPIC指南中提到的许多药物未在FDA表格中列出，反之亦然，在这两种来源的126种药物中,仅有5种报告了相同的基因-药物关联和给药推荐.此外，FDA表格中特定部分的药物分类与CPIC指定或临时指定的临床可操作性水平没有很好的相关性.对于CPIC指南中提到的药物，药物基因组学知识库（PharmacogenomicsKnowledgeBase，PharmGKB）临床注释水平通常较高。PharmGKB临床注释水平通常是未分配的，或者是FDA表格中列出但CPIC指南中没有列出的药物的较低水平。这些差异可能部分是由于FDA可以访问已发表文献中无法获得的PGx信息和/或由于PGx分类基于除临床可操作性之外的标准。
FDA药物遗传学关联表和CPIC指南中的PGx信息存在重要差异。FDA和CPIC在评估PGx关联时具有不同的观点，并且在考虑与特定药物相关的临床有效性时使用不同的方法和信息资源。了解每个小组开发的信息源如何不同，并且可以一起使用以形成PGx的整体视图，可能有助于在实践中增加对这些信息源的采用。
来自CPIC指南和FDA药物遗传学关联表的信息不具有高水平的一致性。CPIC指南中提到的许多药物未在FDA表格中列出，反之亦然，在这两种来源的126种药物中,仅有5种报告了相同的基因-药物关联和给药推荐.此外，FDA表格中特定部分的药物分类与CPIC指定或临时指定的临床可操作性水平没有很好的相关性.对于CPIC指南中提到的药物，药物基因组学知识库（PharmacogenomicsKnowledgeBase，PharmGKB）临床注释水平通常较高。PharmGKB临床注释水平通常是未分配的，或者是FDA表格中列出但CPIC指南中没有列出的药物的较低水平。这些差异可能部分是由于FDA可以访问已发表文献中无法获得的PGx信息和/或由于PGx分类基于除临床可操作性之外的标准。
FDA药物遗传学关联表和CPIC指南中的PGx信息存在重要差异。FDA和CPIC在评估PGx关联时具有不同的观点，并且在考虑与特定药物相关的临床有效性时使用不同的方法和信息资源。了解每个小组开发的信息源如何不同，并且可以一起使用以形成PGx的整体视图，可能有助于在实践中增加对这些信息源的采用。
