Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: Prevalence of related drug use
Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: Prevalence of related drug use
复制标题
DOI：
10.1592/phco.28.8.992
复制
发表时间：
2008-08-01
期刊：
影响因子：
4.1
通讯作者：
Lesko, Lawrence J.
中科院分区：
文献类型：
--
作者：
Frueh, Felix W.;Amur, Shashi;Lesko, Lawrence J.
研究目标。审查美国食品和药物管理局 (FDA) 批准的药物标签，以识别那些包含药物基因组生物标志物信息的药物，并收集有关药物标签中包含药物基因组信息的药物的使用流行率信息。回顾性分析。数据来源。使用 Physicians' Desk Reference 网站、Drugs@FDA 网站和制造商网站来识别包含药物基因组信息的药物标签，并使用大型药品福利管理者（为美国超过 5500 万人提供保险）的处方索赔数据库来获取药物利用数据。测量和主要结果。定义了药物基因组生物标志物，确定了 FDA 批准的包含该信息的药物标签，并确定了这些药物的利用。在 1945 年至 2005 年审查的 1200 个药物标签中，有 121 个药物标签包含基于关键词搜索和后续筛选的药物基因组信息。其中，69 个标签涉及人类基因组生物标志物，52 个标签涉及微生物基因组生物标志物。在涉及人类生物标志物的标签中，43 个 (62%) 与细胞色素 P450 (CYP) 酶代谢的多态性有关，其中 CYP2D6 最常见。 2006 年，大型药房福利管理机构处理了 3610 万名患者的处方，其中约 880 万人 (24.3%) 收到了一种或多种药物标签上含有人类基因组生物标志物信息的药物。结论。近四分之一的门诊患者接受了一种或多种药物标签中含有药物基因组信息的药物。应测试药物标签中药物基因组信息的纳入和适当使用是否能够改善美国的药物使用和安全性。
Study Objectives. To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling.Design. Retrospective analysis.Data Sources. The Physicians' Desk Reference Web site, Drugs@FDA Web site, and manufacturers' Web sites were used to identify drug labels containing pharmacogenomic information, and the prescription claims database of a large pharmacy benefits manager (insuring > 55 million individuals in the United States) was used to obtain drug utilization data.Measurements and Main Results. Pharmacogenomic biomarkers were defined, FDA-approved drug labels containing this information were identified, and utilization of these drugs was determined. Of 1200 drug labels reviewed for the years 1945-2005, 121 drug labels contained pharmacogenomic information based on a key word search and follow-up screening. Of those, 69 labels referred to human genomic biomarkers, and 52 referred to microbial genomic biomarkers. Of the labels referring to human biomarkers, 43 (62%) pertained to polymorphisms in cytochrome P450 (CYP) enzyme metabolism, with CYP2D6 being most common. Of 36.1 million patients whose prescriptions were processed by a large pharmacy benefits manager in 2006, about 8.8 million (24.3%) received one or more drugs with human genomic biomarker information in the drug label.Conclusion. Nearly one fourth of all outpatients received one or more drugs that have pharmacogenomic information in the label for that drug. The incorporation and appropriate use of pharmacogenomic information in drug labels should be tested for its ability to improve drug use and safety in the United States.