Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs


Gagne JJ, Popovic JR, Nguyen M, Sandhu SK, Greene P, Izem R, Jiang W, Wang Z, Zhao Y, Petrone AB, et al. Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs. Drug Saf. 2018;41 (12) :1313-1323.

Date Published:

2018 12


INTRODUCTION: Nearly 90% of drugs dispensed in the US are generic products. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.