Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Drug Saf. 2018 Dec;41(12):1313-1323. doi: 10.1007/s40264-018-0709-4.
Nearly 90% of drugs dispensed in the US are generic products.
The aim of this study was to develop and implement a tool for analyzing manufacturer-level drug utilization and switching patterns within the US Food and Drug Administration's Sentinel system.
A descriptive tool was designed to analyze data in the Sentinel common data model and was tested with two case studies-metoprolol extended release (ER) and lamotrigine ER-using claims data from four Sentinel data partners. We plotted initiators of each brand and generic product over time. For metoprolol ER, we evaluated rates of switching from generics around the time of manufacturing issues. For lamotrigine ER, we examined rates of switching back to the brand among those who switched from brand to generic.
We identified 1,651,285 initiators of metoprolol ER products between July 2008 and September 2015. We observed a large decrease in monthly metoprolol ER initiators (from 25,465 in December 2008 to 13,128 in February 2009), corresponding to recalls by generic manufacturers. We observed simultaneous increases in utilization of the authorized generic and brand products. We identified 4266 initiators of lamotrigine ER with an epilepsy diagnosis between January 2012 and September 2015. Among those who switched from brand to generic, the cumulative incidence of switching back was close to 20% at 2 years. Switchback rates were higher for the first available generic products.
This developed tool was able to elucidate novel utilization and switching patterns in two case studies. Such information can be used to support surveillance of generic drugs and biosimilars.
美国配发的药品近 90%为仿制药。
本研究旨在开发并应用一种工具，分析美国食品和药物管理局监测系统内的制造商层面药物利用和转换模式。
设计了一种描述性工具来分析监测通用数据模型中的数据，并使用来自四个监测数据合作伙伴的索赔数据，通过两个案例研究（美托洛尔缓释剂和拉莫三嗪缓释剂）对其进行了测试。我们按时间绘制了每个品牌和仿制药的启动者。对于美托洛尔缓释剂，我们评估了在出现生产问题时从仿制药转换为通用药物的比例。对于拉莫三嗪缓释剂，我们研究了从品牌转换为通用药物的患者中，有多少人转换回品牌药物。
我们确定了 2008 年 7 月至 2015 年 9 月间有 1651285 名美托洛尔缓释剂的启动者。我们观察到每月美托洛尔缓释剂启动者数量大幅减少（从 2008 年 12 月的 25465 人减少到 2009 年 2 月的 13128 人），这与仿制药制造商的召回相对应。我们观察到授权仿制药和品牌产品的使用率同时增加。我们确定了 2012 年 1 月至 2015 年 9 月间有 4266 名患有癫痫症的拉莫三嗪缓释剂启动者。在从品牌转换为通用药物的患者中，2 年内转换回品牌药物的累积发生率接近 20%。转换回品牌药物的速度与首批可用的仿制药有关。
该工具能够阐明两个案例研究中的新的利用和转换模式。此类信息可用于支持对仿制药和生物类似药的监测。
