This research was presented previously at the 29th International Conference on Pharmacoepidemiology &Therapeutic Risk Management; August 25–28, 2013; Montreal, Quebec, Canada.
PURPOSE: In February 2010, the US Food and Drug Administration (FDA) issued new recommendations for the safe use of long-acting beta agonists (LABA) in those with asthma. The objective of this study was to determine the impact of the FDA’s 2010 LABA advisory on LABA utilization. METHODS: Using administrative data from the state of 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, prior respiratory controller medication use, and by age. FINDINGS: Of the 8646 study patients, 53% had a diagnosis of asthma, 21% of patients had no respiratory diagnosis, and 32% did not use a respiratory controller medication in the recent past. The trend in new LABA prescriptions declined by 0.09 new starts per 10,000 patients per month (95% confidence interval [CI] -0.19 to -0.01) following 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 following 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. IMPLICATIONS: The FDA’s 2010 advisory was associated with modest reductions in LABA utilization overall and in ways highlighted in their recommendations.
This study was unfunded. During the course of this study, DM was funded through the Oregon Comparative Effectiveness Research K12 Program, grant number 1K12HS019456 (PI JMG) from the Agency for Healthcare Research and Quality.