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
Thursday, June 15, 2017
Status
In progress
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

Related Links