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

Project Title Long Acting Beta2-Agonists (LABA) Policies and Drug Utilization Patterns
Date Posted
Thursday, January 9, 2014
Status
Complete
Deliverables
Related Links
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.

Medical Product
long-acting beta2 agonist (LABA)
Health Outcome
change in drug utilization patterns
Population / Cohort
All individuals 65 years of age or younger
Time Period
2004 - 2011
Assessment Type
Exploratory Analyses
Study Type
Protocol/Surveillance Plan
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

Data Sources
Mini-Sentinel Distributed Dataset (MSDD)
FDA Center
CDER
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