Open Forum Infectious Diseases · 2021 · 23 citations · 25 references
PharmacyPharmacologyDrug Utilization ReviewHealth AssessmentPublic Health SurveillanceDrug Safety MonitoringDrug Utilization EvaluationMedication UsePharmacoepidemiologyAlertsAmbulatory Medication UseDrug Use Trend MonitoringDrug Utilization AnalysisDrug Utilization MetricsDrug Utilization SurveillanceFda RegulationSafety Advisories
Abstract Background Frequently used fluoroquinolones have been subject to increasing safety concerns and regulatory alerts. This study characterized ambulatory fluoroquinolone utilization in the United States and evaluated the impact of 2016 Food and Drug Administration (FDA) safety advisories on its use. Methods We used IQVIA’s National Disease and Therapeutic Index to quantify adult outpatient fluoroquinolone use (“treatment visits”). Descriptive statistics and segmented regression were used to report trends and quantify the varied use before and after FDA’s 2016 alerts. Results Between 2015 to 2019, fluoroquinolone use decreased by 26.7% (18.7 million treatment visits in 2015 to 13.7 million treatment visits in 2019). Annual use declined by 44%, 24%, and 24% for respiratory, urogenital, and gastrointestinal conditions, respectively; and by 66% among providers ≤44 years old vs negligible decline among those ≥65 years old. Before 2016 FDA advisories, there were approximately 4.8 million fluoroquinolone treatment visits/quarter, which had a statistically significant immediate drop by 641035 visits (95% confidence interval [CI], –937368 to –344702; P=.000) after FDA’s 2016 advisories. A statistically significant difference of approximately 45000 visits/quarter (95% CI, –85956 to –3122; P=.036) was observed after the advisories. Conclusions Large reductions in ambulatory fluoroquinolone use in the United States have coincided with increasing evidence of safety concerns and FDA advisories. However, fluoroquinolone use varies significantly based on patient and provider characteristics, suggesting heterogeneous effects of emerging risks on clinical practice.
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