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

Basic Details
Date Posted
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.

Deliverables (2)
Mini-Sentinel Impact 2010 FDA Regulatory Actions LABA Medication Use Mini-Sentinel Impact FDA Regulatory Policies LABAs Protocol
Additional Details
FDA Center
CDER
Time Period
2004 - 2011
Analysis Type
Mini-Sentinel
Population / Cohort
All individuals 65 years of age and younger
Data Sources
Mini-Sentinel Distributed Dataset (MSDD)
Related Links
Changing Patterns of Asthma Medication Use Related to US Food and Drug Administration Long-Acting β2-Agonist Regulation from 2005-2011
The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011
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