Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case

Project Title Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case
Date Posted
Monday, February 12, 2018
Status
Complete
Description

This project will develop a reusable program to identify and characterize the occurrence of a procedure, dispensing, laboratory test or result, or diagnosis before, during, or after a particular treatment episode and “in the context of a treatment episode" before, during, or after some recommendation or warning has been made by FDA on a particular calendar date.

Workgroup Leader(s)

Noelle Cocoros, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Michael Nguyen, MD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Yulan Ding, MS, Jacqueline Major, PhD; Division of Epidemiology, Office of Surveillance and Epidemiology, FDA, Silver Spring, MD

April Duddy, MPH; Elnara Fazio-Eynullayeva, MA; Timothy Glavin; Sandra Feibelmann, MPH; Genna Panucci, MPH; Andrew Petrone, MPH; Anita Wagner, PharmD, MPH, DrPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Kevin Haynes, PharmD; HealthCore, Inc., Alexandria, VA

Wei Hua, MD, PhD; Office of Surveillance and Epidemiology, FDA, Silver Spring, MD

Rima Izem, PhD; Joo-Yeon Lee, PhD; Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Julia Ju, PharmD, PhD; Division of Risk Management Office of Medication Error Prevention and Risk Management, FDA, Silver Spring, MD

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