title: Changes in long-acting β-agonist utilization after the FDA's 2010 drug safety communication.
abstract: OBJECTIVE
  In February 2010, the US Food and Drug Administration (FDA) issued new recommendations for the safe use of long-acting β-agonists (LABAs) in patients with asthma. The objective of this study was to determine the impact of the FDA's 2010 safety advisory on LABA utilization.
  
  
  METHODS
  Using administrative data from the Oregon Medicaid program, we performed an interrupted time series regression to evaluate changes in the trend in new LABA prescriptions before and after the FDA's 2010 advisory. Trends in incident fills were examined among those with and without an asthma diagnosis code and previous respiratory controller medication use; trends were also assessed according to patient age.
  
  
  RESULTS
  The average age of the 8646 study patients was 37 years, 53% had a diagnosis of asthma, 21% had no respiratory diagnosis, and 32% had not used a respiratory controller medication in the recent past. The trend in new LABA prescriptions declined by 0.09 new start per 10,000 patients per month (95% CI, -0.19 to -0.01) after the FDA's advisory. Among those with a diagnosis of asthma, there was an immediate drop of 0.48 (95% CI, -0.93 to -0.03) and a 0.10 (95% CI, -0.13 to -0.06) decline in the monthly rate of new starts per 10,000 patients. Immediately after the FDA's advisory, we observed a statistically significant 4.7% increase (95% CI, 0.8 to 8.7) in the proportion of new LABA starts with history of previous respiratory controller medication use. Utilization of LABAs did not change in those without a diagnosis of asthma.
  
  
  CONCLUSIONS
  The FDA's 2010 advisory was associated with modest reductions in LABA utilization overall and in ways highlighted in their recommendations.
authors.affiliation: Oregon State University/Oregon Health & Science University, College of Pharmacy, Portland, Oregon. Electronic address: hartungd@ohsu.edu.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Hartung
authors.affiliation: Oregon State University/Oregon Health & Science University, College of Pharmacy, Portland, Oregon.
authors.forename: Luke
authors.initials: L
authors.lastname: Middleton
authors.affiliation: Oregon Health & Science University, Department of Public Health & Preventive Medicine, Portland, Oregon.
authors.forename: Sheila
authors.initials: S
authors.lastname: Markwardt
authors.affiliation: Oregon State University/Oregon Health & Science University, College of Pharmacy, Portland, Oregon.
authors.forename: Kaylee
authors.initials: K
authors.lastname: Williamson
authors.affiliation: Oregon State University/Oregon Health & Science University, College of Pharmacy, Portland, Oregon.
authors.forename: Kathy
authors.initials: K
authors.lastname: Ketchum
mesh_terms: D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D001249:Asthma / Q000188:drug therapy; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D061214:Patient Safety; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D007166:Immunosuppressive Agents
keywords: Medicaid; US Food and Drug Administration; adrenergic β(2)-agonists; utilization