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

    Basic Details
    Date
    Tuesday, February 12, 2019
    Type
    Publication
    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.

    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