评估美国华法林药品信息中关于华法林和相互作用药物的药物相互作用列表。

Evaluation of warfarin drug interaction listings in US product information for warfarin and interacting drugs.

机构信息

Center for Health Outcomes and PharmacoEconomic Research, The University of Arizona College of Pharmacy, Tucson, Arizona 85721-0202, USA.

出版信息

Clin Ther. 2011 Jan;33(1):36-45. doi: 10.1016/j.clinthera.2011.01.021.

DOI:10.1016/j.clinthera.2011.01.021

PMID:21397772

Abstract

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(®), and Micromedex(®)--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 (κ = 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.

摘要

背景

由于与华法林相互作用会对患者造成严重风险，因此临床医生使用的药物信息来源应包含准确、及时且实用的药物相互作用信息。

目的

本研究旨在评估包含于与华法林相互作用的处方产品官方标签中的华法林相互作用信息。

方法

我们检查了美国食品和药物管理局批准的 50 种药物、生物制剂和药物类别（这些药物是由 3 种药物信息手册——临床药理学、ePocrates（®）和 Micromedex（®）——和华法林美国处方信息（PI）共同确定的，这些药物被认为与华法林有相互作用）的官方标签信息。评估了每种产品的 PI 是否可能提到与华法林相互作用。由一名调查员收集和制表数据。一名临床调查员评估数据的准确性和一致性。未解决的问题与第三名调查员讨论并达成共识。通过 5 名调查员对相互作用清单进行比较，以确定相似性、差异和不一致性，并进行分析。

结果

在所评估的 73 种产品的标签中，有 62 种（85%）包含提到与华法林相互作用。未提及华法林相互作用的药物是一些较老的仿制药或流感疫苗。在标签中列出与华法林相互作用的产品中，信息的位置、使用的术语以及相互作用证据的纳入并不一致。考虑到所有 73 种产品的 PI，Fleiss'kappa 系数（κ=0.467）根据 Landis 和 Koch 的方法表明中度一致性。