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Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel

Basic Details
Date Posted
Status
Complete
Medical Product
Lamictal XR
lamotrigine extended-release (ER)
metoprolol extended-release (ER)
Toprol XL
Description

The Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER) is interested in exploring the potential for the Sentinel System to support investigations of manufacturer-level product switching. The aims of this project are: 

  1. Design, develop, test and evaluate a flexible and reusable prototype analytic tool that could be used to conduct rapid population-based assessments on new generic products in the future; and
  2. Use the Sentinel System to characterize utilization and switching patterns associated with two use-cases: Toprol XL (metoprolol ER) and Lamictal XR (lamotrigine ER). 
Deliverable(s) (1)
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel Protocol
Information
Time Period
2016 - 2017
Data Source(s)
Sentinel Distributed Database (SDD)
Related Links
Related Link(s)
Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs
2018 ICPE Presentation: Evaluation of Switching Patterns in FDA’s Sentinel System – A New Tool to Assess the Substitutability of Generic Drugs
Workgroup Leader(s)

Jennifer Popovic, DVM, MA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Sarah Dutcher, PhD; Office of Research and Standards/Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Joshua Gagne, PharmD, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston

Michael Nguyen, MD; Sukhminder Sandhu, PhD, MPH, MS; Joel Weissfeld, MD, MPH; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Member(s)

Rima Izem, PhD; Yueqin Zhao, PhD; Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Wenlei Jiang, PhD; Zhong (John) Wang, PhD; Office of Research and Standards/Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Patty Greene, PharmD; Aaron Niman, Simone Pinheiro, ScD, MSc; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Timothy Glavin; Adee Kennedy, MS, MPH; Andrew Petrone, MPH; Darren Toh, ScD; Anita Wagner, PharmD, MPH, DrPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA