Consistency in the safety labeling of bioequivalent medications
Consistency in the safety labeling of bioequivalent medications
复制标题
DOI：
10.1002/pds.3351
复制
发表时间：
2013-03-01
影响因子：
2.6
通讯作者：
Li, Xiaochun
中科院分区：
文献类型：
--
作者：
Duke, Jon;Friedlin, Jeff;Li, Xiaochun
目的美国食品和药物管理局要求生物等效性药物的标签上有相同的警告。这一要求具有临床和法律重要性，但从未得到验证。我们试图确定来自不同制造商的生物等效药物电子标签的真实世界一致性。方法采用自然语言处理方法，对9105个结构化产品标签中药品不良反应和上市后药品不良反应进行检索。我们计算了每种生物等效药的ADR标签的标准偏差以及每种仿制药标签与其对应品牌的百分比偏差。我们还分析了个别仿制药制造商的表现。对于标签ADR中差异最大的25种药物，我们进行人工审查以确定不一致的原因。结果68%的多厂家药品在ADR标签上存在差异。对于给定的药物，标记的ADR数量的平均偏差为4.4，中位数为0.8(IQR 0~3.2)。标记ADRs的平均范围为12+/0.9，中位数为2(IQR0~9)。总体而言，77.9%的仿制药制造商生产的标签与品牌不同。不一致的原因包括表格丢失、过时的上市后报告和格式问题。结论尽管FDA授权，生物等效药在安全性标签上往往不同。医生应该意识到这种差异，监管机构应该考虑协调生物等效性标签的新策略。版权所有(C)2012 John Wiley&Sons，Ltd.
Purpose Bioequivalent medications are required by the Food and Drug Administration to have identical warnings on their labels. This requirement has both clinical and legal importance, yet has never been validated. We sought to determine the real-world consistency of electronic labeling for bioequivalent drugs from different manufacturers. Methods Using natural language processing, we indexed the adverse drug reactions (ADRs) found in the Adverse Reactions and Post-Marketing sections of 9105 structured product labels. We calculated the standard deviation in ADR labeling for each bioequivalent drug and the percent deviation of each generic label from its corresponding brand. We also analyzed the performance of individual generic manufacturers. For the 25 drugs with the greatest discrepancy in labeled ADRs, we performed manual review to identify causes of inconsistency. Results 68% of multi-manufacturer drugs had discrepancies in ADR labeling. For a given drug, the mean deviation in number of labeled ADRs was 4.4, and the median was 0.8 (IQR 0 to 3.2). The mean range in number of labeled ADRs was 12 +/ 0.9, and the median was 2 (IQR 0 to 9). Overall, 77.9% of generic manufacturers produced labels differing from brand. Causes of inconsistency included missing tables, outdated post-marketing reports, and formatting issues. Conclusions Despite FDA mandate, bioequivalent drugs often differ in their safety labeling. Physicians should be aware of such differences and regulators should consider new strategies for harmonizing bioequivalent labels. Copyright (c) 2012 John Wiley & Sons, Ltd.