Department of Clinical Pharmacy, Medication Outcomes Center, University of California, San Francisco, 94143-0622, USA.
Am J Health Syst Pharm. 2011 Sep 1;68(17):1626-31. doi: 10.2146/ajhp110025.
Inconsistencies in boxed warnings between drug information resources and the manufacturer's prescribing information (PI) were evaluated.
This study was a cross-sectional evaluation of boxed warnings in Black-BoxRx, DrugDex, Facts and Comparisons, Epocrates, Lexicomp, and PDR.net conducted in June 2010. New molecular entities with boxed warnings and PI that conformed to current Food and Drug Administration labeling requirements were included. Each resource was reviewed for warnings that appeared verbatim with the full boxed warning in the PI. Two drug information pharmacists independently reviewed the remaining nonverbatim boxed warnings to determine concordance with the boxed warning summary in the "highlights" section of the PI. Tests of proportions were used to examine differences among resources in the proportion of warnings concordant with the PI. Interrater reliability was assessed with the kappa statistic.
A total of 71 drugs with unique boxed warnings were included in the evaluation. Resources revealed varying degrees of discordances with the boxed warning in the PI. The resource with the lowest number of verbatim warnings contained a significantly higher percentage of warnings with discordant information when compared with all other resources (p < 0.0001 for all paired comparisons). Interrater reliability was excellent (kappa = 0.86).
Boxed warning information presented in major drug information resources may be missing key elements of the official boxed warning in the current PI. The current PI may be the most reliable approach to accessing the complete, up-to-date boxed warning for a given drug.
评估药品信息资源与制造商的处方信息（PI）之间的盒装警告不一致情况。
本研究是 2010 年 6 月对 Black-BoxRx、DrugDex、Facts and Comparisons、Epocrates、Lexicomp 和 PDR.net 中包含盒装警告和符合当前食品和药物管理局标签要求的 PI 的新分子实体进行的横断面评估。每个资源都审查了与 PI 中完整盒装警告完全一致的警告。两名药物信息药师独立审查其余非完整盒装警告，以确定与 PI“重点”部分的盒装警告摘要的一致性。使用比例检验来检查资源之间与 PI 一致的警告比例的差异。使用κ统计评估组内可靠性。
共有 71 种具有独特盒装警告的药物被纳入评估。各资源与 PI 中的盒装警告存在不同程度的不一致。与 PI 中的盒装警告相比，包含较少完全一致警告的资源具有更高比例的不一致信息（所有配对比较的 p < 0.0001）。组内可靠性非常好（κ=0.86）。
主要药品信息资源中呈现的盒装警告信息可能缺少当前 PI 中官方盒装警告的关键要素。当前 PI 可能是获取特定药物完整、最新盒装警告的最可靠方法。
