Evaluation of Warfarin Drug Interaction Listings in US Product Information for Warfarin and Interacting Drugs
Evaluation of Warfarin Drug Interaction Listings in US Product Information for Warfarin and Interacting Drugs
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DOI：
10.1016/j.clinthera.2011.01.021
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发表时间：
2011-01-01
影响因子：
3.2
通讯作者：
Malone, Daniel C.
中科院分区：
文献类型：
--
作者：
Hines, Lisa E.;Ceron-Cabrera, Diana;Malone, Daniel C.
背景：由于与华法林的相互作用对患者构成严重风险，临床医生使用的药物信息源应该包含准确、及时和实用的药物相互作用信息。目的：本研究的目的是评估与华法林相互作用的处方药官方标签中包含的信息。方法：我们检查了美国食品和药物管理局批准的50种药物、生物制品和药物类别的官方标签信息，这些药物、生物制品和药物类别通常被临床药理学、Epocrates(R)和Micromedex(R)识别为与华法林相互作用的美国处方信息(PI)。每种产品的等电点都被评估为可能提到与华法林的相互作用。数据由1名调查员收集并制表。临床研究人员对数据的准确性和一致性进行了评估。与第三名调查员讨论了尚未解决的问题，并以协商一致的方式作出决定。结果：在73种产品的标签中，62种(85%)提到了与华法林的相互作用。那些没有提到华法林相互作用的药物是旧的仿制药或流感疫苗。在列出与华法林相互作用的标签中，信息的位置、使用的术语以及相互作用的证据都不一致。当考虑所有73种产品的等电点时，根据Landis和Koch法，Fleiss‘kappa系数(kappa=0.467)建议了中等一致性。结论：这项对50种已知与华法林相互作用的药物、生物制品和药物类别的美国官方产品标签的评估发现，15%的产品没有提到这种相互作用，即使在华法林标签中提到了这种相互作用。(CLIN THER.2011；33：36-45)(C)2011爱思唯尔HS期刊，Inc.
Background: Because interactions with warfarin represent a serious risk to patients, drug information sources used by clinicians should contain accurate, timely, and practical drug interaction information.Objective: The aim of this study was to assess the information regarding warfarin interactions that is included in the official labeling of prescription products that interact with warfarin.Methods: We examined the official labeling information approved by the US Food and Drug Administration for the 50 drugs, biologics, and drug classes that were commonly identified by 3 drug information compendia-Clinical Pharmacology, ePocrates (R), and Micromedex (R)-and the warfarin US prescribing information (PI) as having an interaction with warfarin. The PI of each product was assessed for possible mention of an interaction with warfarin. The data were collected and tabulated by 1 investigator. A clinical investigator evaluated the data for accuracy and consistency. Unresolved issues were discussed with a third investigator and decided by consensus. The interaction listings were compared to determine similarities, differences, and inconsistencies and analyzed by 5 investigators.Results: Of the labeling for 73 products evaluated, 62 (85%) included mention of an interaction with warfarin. Those failing to mention the warfarin interaction were for older generic drugs or influenza vaccine. Among the labels listing an interaction with warfarin, the location of the information, the terminology used, and the inclusion of evidence for the interaction was inconsistent. When considering the PI for all 73 products, Fleiss' kappa coefficient (kappa = 0.467) suggested moderate concordance according to the method of Landis and Koch.Conclusion: This assessment of official US product labeling for 50 drugs, biologics, and drug classes known to interact with warfarin, comprising 73 distinct agents, found that 15% failed to mention the interaction, even though the interaction was mentioned in the warfarin labeling. (Clin Ther. 2011;33:36-45) (c) 2011 Elsevier HS Journals, Inc.