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

Project Title Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs
Date
Friday, August 17, 2018
Location

Drug Saf. 2018 Aug 17. doi: 10.1007/s40264-018-0709-4

Description

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.

Corresponding Author

Joshua J. Gagne; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA. Email: jgagne@bwh.harvard.edu

Authors

Joshua J. Gagne, Jennifer R. Popovic, Michael Nguyen, Sukhminder K. Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B. Petrone, Anita K. Wagner, Sarah K. Dutcher

Related Assessments
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel
2018 ICPE Presentation: Evaluation of Switching Patterns in FDA’s Sentinel System – A New Tool to Assess the Substitutability of Generic Drugs
Publication Type
Publication
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