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A New Analytic Tool Developed in the Sentinel System to Assess Safe Use Recommendations

Basic Details
Date
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Description

The purpose of this manuscript was to develop a flexible analytic tool for the Food and Drug Administration's (FDA's) Sentinel System to assess adherence to safe use recommendations with two capabilities: characterize adherence to patient monitoring recommendations for a drug, and characterize concomitant medication use before, during, and/or after drug therapy. The tool has two key capabilities: (a) characterize adherence to patient monitoring recommendations for a treatment; and (b) characterize concomitant medication use before, during, and/or after a drug therapy.

Materials
Related Assessment(s)
Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case
Author(s)

Noelle M. Cocoros, Anita Wagner, Kevin Haynes, Andrew B. Petrone, Elnara Fazio‐Eynullayeva, Yulan Ding, Rima Izem, Joo‐Yeon Lee, Jacqueline M. Major, Michael Nguyen, Jing Ju

Corresponding Author

Noelle M. Cocoros, Department of Population Medicine, Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, MA, USA. Email: noelle_cocoros@harvardpilgrim.org