6 research outputs found
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Changes in Long-acting β-agonist Utilization After the FDA’s 2010 Drug Safety Communication
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 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/ This research was presented previously at the 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25–28, 2013; Montreal, Quebec, Canada.Keywords: Medicaid, Utilization, United States Food and Drug Administration, Adrenergic beta2-agonists (adrenergic β₂-agonists)Keywords: Medicaid, Utilization, United States Food and Drug Administration, Adrenergic beta2-agonists (adrenergic β₂-agonists
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HartungDanielPharmacyChangesLongActingBetaAgonistUtilization(Figure2).jpg
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.Keywords: United States Food and Drug Administration, Medicaid, Utilization, Adrenergic beta2-agonists (adrenergic β₂-agonists)Keywords: United States Food and Drug Administration, Medicaid, Utilization, Adrenergic beta2-agonists (adrenergic β₂-agonists
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HartungDanielPharmacyChangesLongActingBetaAgonistUtilization(Figure3).jpg
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.Keywords: United States Food and Drug Administration, Utilization, Medicaid, Adrenergic beta2-agonists (adrenergic β₂-agonists)Keywords: United States Food and Drug Administration, Utilization, Medicaid, Adrenergic beta2-agonists (adrenergic β₂-agonists
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HartungDanielPharmacyChangesLongActingBetaAgonistUtilization(Figure1).jpg
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.Keywords: United States Food and Drug Administration, Adrenergic beta2-agonists (adrenergic β₂-agonists), Utilization, Medicai
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HartungDanielPharmacyChangesLongActingBetaAgonistUtilization.pdf
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.Keywords: Utilization, Medicaid, Adrenergic beta2-agonists (adrenergic β₂-agonists), United States Food and Drug AdministrationKeywords: Utilization, Medicaid, Adrenergic beta2-agonists (adrenergic β₂-agonists), United States Food and Drug Administratio
Improving outpatient warfarin use for hospitalized patients with atrial fibrillation.
Atrial fibrillation affects an estimated 5 million Americans and accounts for approximately 15% of all strokes. Few studies have successfully addressed patient screening, assessment, and introduction of appropriate antithrombotic therapy in patients with atrial fibrillation.
Objective: To assess whether an intervention improved planned antithrombotic prescribing at the time of discharge in hospitalized patients.
Methods: The study was a prospectively designed, retrospectively evaluated, non-blinded, historical control study of a pharmacist-initiated intervention. The intervention, consisting of pharmacist review and assessment of antithrombotic prescribing in patients with non-valvular atrial fibrillation, was conducted in an urban teaching hospital.
Results: Although antithrombotic prescribing was not significantly higher at discharge in the 252 enrolled subjects (control 67.3% vs. intervention 70.8%; p = 0.58), a significantly greater number of patients had a written discharge plan for antithrombotic therapy (control 73.5% vs. intervention 88.3%; p < 0.01). The adjusted odds ratio that the study group was associated with an improvement in planned or actual warfarin use was 2.46 (95% CI 1.63-3.74). In addition, clinicians adhered to guidelines for antithrombotic therapy in patients with atrial fibrillation more frequently in the intervention group (control 70.4% vs. intervention 88.2%; p < 0.01).
Conclusion: A program designed to identify hospitalized patients with non-valvular atrial fibrillation, assess their need for stroke prophylaxis, and initiate appropriate antithrombotic therapy led to an increase in planned antithrombotic, and most importantly, warfarin use upon discharge from the hospital. Confirmation that an increase in planned antithrombotic use upon discharge results in an actual increase in use after discharge is needed to determine the true effectiveness of this intervention