Alatawi Y, Rahman Md M, Cheng N, Qian J, Peissig P L, Berg R L, Page C D, Hansen R A
Department of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, Auburn, AL, USA.
Biomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, WI, USA.
J Clin Pharm Ther. 2018 Jun;43(3):327-335. doi: 10.1111/jcpt.12646. Epub 2017 Nov 1.
Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases.
Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends.
Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01).
Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported.
在品牌药和仿制药是否产生相同疗效方面，公众存在一些怀疑。本研究以授权仿制药（AGs）作为可能的仿制药认知偏差的对照，探讨品牌药和仿制药的不良事件（AE）报告模式是否相似。
分析了2004年至2015年向美国食品药品监督管理局不良事件报告系统报告的事件。根据药品和制造商名称，将药品分类为品牌药、AG或仿制药。如果氨氯地平、氯沙坦、缓释美托洛尔（ER）或辛伐他汀被列为主要或次要可疑药物，则纳入报告。使用报告比值比（ROR）进行不成比例分析，评估与用所有其他药物报告这些AE相比，报告标签AE的相对率。Breslow-Day检验比较了品牌药、AG和仿制药的ROR。中断时间序列分析评估了仿制药进入对报告趋势的影响。
仿制药在美国报告总数中占很大比例，但AGs在报告中所占比例较小，包括氨氯地平（14.26%）、氯沙坦（1.48%）、美托洛尔ER（0.35%）和辛伐他汀（0.70%）。虽然多个品牌药与仿制药比较的ROR有显著差异，但AG与仿制药比较产生的统计学显著结果较少。具体而言，只有AG与仿制药在氨氯地平伴外周水肿方面的ROR不同（P <.01）。
与AG和仿制药相比，品牌药和仿制药之间观察到更多不一致的报告模式。使用AGs作为针对仿制药认知偏差的对照是有用的，但这种方法可能会受到AG报告数量少的限制。要求在药瓶或包装上打印制造商名称可以提高报告产品的分类准确性。
