Long Acting Beta2-Agonists (LABA) Policies and Drug Utilization Patterns

    Basic Details
    Date Posted
    Wednesday, January 8, 2014
    Status
    Complete
    Medical Product
    long-acting beta2 agonist (LABA)
    Health Outcome(s)
    change in drug utilization patterns
    Description

    Protocol and report for a project to assess the impact of the 2010 FDA regulatory action on long acting beta2 agonists (LABAs) on drug utilization patterns. The protocol represents a customized study design.

    Additional Details
    FDA Center
    CDER
    Time Period
    2004 - 2011
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals 65 years of age and younger
    Data Sources
    Mini-Sentinel Distributed Dataset (MSDD)
    Workgroup Leader(s)

    Melissa Butler PharmD, MPH, PhD; Kaiser Permanente of Georgia, Center for Health Research Southeast, Atlanta, GA

    Esther Zhou MD, PhD; Center for Drug and Evaluation Research, FDA, Silver Spring, MD

    Workgroup Members

    Meghan A. Baker MD, ScD; Brigham and Women's Hospital, Boston, MA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Monika Houstoun PharmD; Solomon Iyasu MD, MPH; Mark Levenson PhD; Marsha Reichman PhD; Sally Seymour MD; Yu-te Wu PhD; Center for Drug and Evaluation Research, FDA, Silver Spring, MD

    Darren Toh ScD; Fang Zhang PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Ann Wu MD, MPH; Boston Children's Hospital, Boston, MA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Pingsheng Wu PhD; Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN