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

The aim of this study was to develop and implement a tool for analyzing manufacturer-level drug utilization and switching patterns within the U.S. 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. 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.