Changes in Long-acting β-agonist Utilization After the FDA’s 2010 Drug Safety Communication Public Deposited

http://ir.library.oregonstate.edu/concern/articles/p5547t10h

This research was presented previously at the 29th International Conference on Pharmacoepidemiology &Therapeutic Risk Management; August 25–28, 2013; Montreal, Quebec, Canada.

This is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by Elsevier and can be found at:  http://www.clinicaltherapeutics.com/

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  • Changes in Long-acting Beta Agonist Utilization Following the FDA’s 2010 Drug Safety Communication
  • Changes in Long-acting beta-agonist Utilization After the FDA's 2010 Drug Safety Communication
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  • 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.
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  • Hartung, D. M., Middleton, L., Markwardt, S., Williamson, K., & Ketchum, K. (2015). Changes in Long-acting β-agonist Utilization After the FDA’s 2010 Drug Safety Communication. Clinical Therapeutics, 37(1), 114-123. doi:10.1016/j.clinthera.2014.10.025
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  • description.provenance : Submitted by Deanne Bruner (deanne.bruner@oregonstate.edu) on 2015-06-09T23:45:51Z No. of bitstreams: 5 HartungDanielPharmacyChangesLongActingBetaAgonistUtilization.pdf: 361846 bytes, checksum: ca2be88ed35a7e6de8c3cee8665b5087 (MD5) HartungDanielPharmacyChangesLongActingBetaAgonistUtilization(Tables).pdf: 44297 bytes, checksum: 1a747f23090807a013e13119c5d43579 (MD5) HartungDanielPharmacyChangesLongActingBetaAgonistUtilization(Figure1).jpg: 1040337 bytes, checksum: 213859303c1434dbdc0566f45c9b8aad (MD5) HartungDanielPharmacyChangesLongActingBetaAgonistUtilization(Figure2).jpg: 1208683 bytes, checksum: 17bba67ebfcf01e6576484aa815abc3b (MD5) HartungDanielPharmacyChangesLongActingBetaAgonistUtilization(Figure3).jpg: 1020241 bytes, checksum: ea5e38b88264842400fd5485d1c77204 (MD5)

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