Faculdade de Medicina, Hospital das Clínicas, Universidade Federal de Minas Gerais, Av. Prof. Alfredo Balena, 190, Belo Horizonte, MG 30130-100, Brazil.
Eur J Clin Pharmacol. 2011 Dec;67(12):1301-8. doi: 10.1007/s00228-011-1086-4. Epub 2011 Jun 24.
Detecting potential drug interactions can lead to early interventions that protect patients from serious drug-related problems. The aim of this study was to evaluate the agreement among the lists of warfarin interactions provided by five information sources.
The lists of warfarin interactions and the corresponding severity ratings and documentation levels presented by the three compendia and by the World Health Organization (WHO) Model Formulary were all compared, and each list was compared to that provided on the package insert of Marevan, a brand of warfarin. The compendia used were: Drug Interaction Facts, Drug Interactions: Analysis and Management and DRUG-REAX. A kappa coefficient was used to calculate the agreement among the sources.
A total of 537 interactions were listed. Only 13 (2.4%) were common to the five sources. The global Fleiss' kappa coefficient was -0.0080, which indicated poor agreement. Eleven warfarin interactions appeared only in the Marevan package insert. Importantly, 243 interactions (45.3% of the total) were deemed significant in at least one compendium. Only two warfarin interactions were reported as critical by all three compendia and by WHO. The most critical interactions cited by the compendia were missing from the package insert.
Poor agreement was found among five sources listing warfarin interactions. Potentially severe clinical consequences might occur due to these discrepant recommendations. Finally, the lack of standard terminology and clinical guidance, as well as the possible inaccuracy of severity ratings and documentation might contribute to heterogeneous procedures in clinical practice.
检测潜在的药物相互作用可以促使早期干预,从而保护患者免受严重的药物相关问题的影响。本研究旨在评估五种信息来源提供的华法林相互作用列表之间的一致性。
比较了三种药物手册和世界卫生组织(WHO)示范处方集提供的华法林相互作用列表及其相应的严重程度评级和文件级别,并将每个列表与 Marevan(一种华法林品牌)的包装插页进行比较。所用的药物手册包括:《药物相互作用事实》《药物相互作用:分析与管理》和 DRUG-REAX。使用kappa 系数来计算来源之间的一致性。
共列出了 537 种相互作用。只有 13 种(2.4%)在五种来源中是共同的。全球 Fleiss' kappa 系数为-0.0080,表明一致性较差。有 11 种华法林相互作用仅出现在 Marevan 包装插页中。重要的是,在至少一种药物手册中,有 243 种相互作用(总共有 45.3%)被认为是显著的。只有两种华法林相互作用被三种药物手册和 WHO 都列为关键。在药物手册中引用的最关键的相互作用在包装插页中缺失。
五种列出华法林相互作用的来源之间存在较差的一致性。由于这些不一致的建议,可能会出现严重的临床后果。最后,缺乏标准术语和临床指导,以及严重程度评级和文件准确性可能存在差异,这可能导致临床实践中的程序不一致。