Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA.
BMJ Qual Saf. 2013 Sep;22(9):727-34. doi: 10.1136/bmjqs-2012-001704. Epub 2013 Apr 25.
The official prescribing information document distributed with a prescription drug is a key source of safety information, but it may include excessive or insufficient details.
To compare prescribing information approved by the US Food and Drug Administration with the UK, Canada and Australia to identify content differences in safety warnings.
For 20 top-selling prescription drugs, we used an automated natural language processing tool to calculate the number and severity of reported adverse drug reactions (ADRs). We fit hierarchical Poisson models and included fixed effects for other prescribing information characteristics. Separately, we analysed the appearance and content of 'black box' warnings.
There was substantial variation in safety content of approved prescribing information. Canada had the highest median ADRs per drug (138 (IQR 86-234)) and the UK had the lowest (84 (IQR 51-111)). The number of ADRs reported was on average 50% higher in Canada compared with the USA (ratio of ADRs/document: 1.5, 95% CI 1.4 to 1.6, p<0.001). By contrast, there were on average 15% fewer ADRs listed in the UK compared with the USA (ratio of ADRs/document 0.85 (95% CI 0.78 to 0.93, p<0.001), and 21% fewer ADRs listed in Australia compared with the USS (ratio of ADRs/document 0.79, 95% CI 0.74 to 0.85, p<0.001). There were no variations in ADR severity. The presence and qualitative content of boxed warnings also showed substantial diversity.
International variations exist in the presentation of safety data in drug prescribing information, which may have important implications for patient safety. Better international coordination is necessary to enhance use of this information for patient decision-making.
与处方药一起分发的官方处方信息文件是安全性信息的主要来源，但其中可能包含过多或过少的细节。
将美国食品和药物管理局批准的处方信息与英国、加拿大和澳大利亚进行比较，以确定安全性警告中的内容差异。
对于 20 种最畅销的处方药，我们使用自动自然语言处理工具计算报告的不良药物反应（ADR）的数量和严重程度。我们拟合了分层泊松模型，并包括了其他处方信息特征的固定效应。另外，我们分析了“黑框”警告的出现和内容。
批准的处方信息的安全性内容存在很大差异。加拿大每一种药物的平均 ADR 最高（138（IQR 86-234）），而英国最低（84（IQR 51-111））。与美国相比，加拿大报告的 ADR 数量平均高出 50%（ADR/文件的比值为 1.5，95%CI 为 1.4 至 1.6，p<0.001）。相比之下，与美国相比，英国列出的 ADR 数量平均减少了 15%（ADR/文件的比值为 0.85（95%CI 为 0.78 至 0.93，p<0.001），澳大利亚列出的 ADR 数量平均减少了 21%（ADR/文件的比值为 0.79，95%CI 为 0.74 至 0.85，p<0.001）。ADR 的严重程度没有差异。框警告的存在和定性内容也存在很大差异。
药物处方信息中安全性数据的呈现方式存在国际差异，这可能对患者安全产生重要影响。为了增强患者决策中对该信息的使用，有必要进行更好的国际协调。
