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      Outpatient Fluoroquinolone Prescription Fills in the United States, 2014 to 2020: Assessing the Impact of Food and Drug Administration Safety Warnings

      1 , 2 , 1 , 2
      Antimicrobial Agents and Chemotherapy
      American Society for Microbiology

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          Abstract

          The impact of United States Food and Drug Administration (FDA) safety warnings on outpatient fluoroquinolone use is unclear. Annual changes in outpatient ciprofloxacin, levofloxacin, and moxifloxacin prescription fills (IQVIA National Prescription Audit databases) were assessed using a regression model.

          ABSTRACT

          The impact of United States Food and Drug Administration (FDA) safety warnings on outpatient fluoroquinolone use is unclear. Annual changes in outpatient ciprofloxacin, levofloxacin, and moxifloxacin prescription fills (IQVIA National Prescription Audit databases) were assessed using a regression model. Monthly fills during baseline (August 2014 to April 2016) and first (May 2016 to June 2018) and second FDA warning periods (July 2018 to February 2020) were compared by interrupted time series analysis. From 2015 through 2019, total fluoroquinolone fills decreased from 35,616,786 (111.1/1,000 persons) to 21,100,050 (64.3/1,000 persons) annually (10.8% annually [ P = 0.001]). Ciprofloxacin, levofloxacin, and moxifloxacin fills decreased annually by 10.4% ( P = 0.001), 11.2% ( P < 0.001), and 17.7% ( P = 0.008), respectively. During the baseline period, there was no significant change in monthly fluoroquinolone fills. In May 2016 and during the first warning period, monthly fluoroquinolone fills decreased significantly ( P < 0.001); the trend of decreased fills was significantly greater than that of the baseline period ( P = 0.02). There was no change in fluoroquinolone fills in July 2018. Monthly fills decreased significantly throughout the second warning period ( P < 0.001), but the trend did not differ from that of the first warning period. Trends for ciprofloxacin, the most commonly prescribed fluoroquinolone, were similar to those for the class. Fills of prescriptions by infectious diseases specialists ( P < 0.005) and nurse practitioners ( P = 0.04) significantly increased during the study. U.S. outpatient fluoroquinolone prescription fills significantly decreased from August 2014 to February 2020, most strongly in association with May 2016 FDA warnings. FDA safety warnings are useful tools for leveraging outpatient antimicrobial stewardship.

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          Oral versus Intravenous Antibiotics for Bone and Joint Infection

          The management of complex orthopedic infections usually includes a prolonged course of intravenous antibiotic agents. We investigated whether oral antibiotic therapy is noninferior to intravenous antibiotic therapy for this indication.
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            Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis

            Patients with infective endocarditis on the left side of the heart are typically treated with intravenous antibiotic agents for up to 6 weeks. Whether a shift from intravenous to oral antibiotics once the patient is in stable condition would result in efficacy and safety similar to those with continued intravenous treatment is unknown.
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              US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014.

              The Patient Protection and Affordable Care Act of 2010 brought attention to adverse drug events in national patient safety efforts. Updated, detailed, nationally representative data describing adverse drug events can help focus these efforts.
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                Author and article information

                Contributors
                (View ORCID Profile)
                Journal
                Antimicrobial Agents and Chemotherapy
                Antimicrob Agents Chemother
                American Society for Microbiology
                0066-4804
                1098-6596
                June 17 2021
                June 17 2021
                : 65
                : 7
                Affiliations
                [1 ]VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA
                [2 ]School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
                Article
                10.1128/AAC.00151-21
                33875430
                f7dd66d9-3ac3-4219-bee9-2d05e952cc0d
                © 2021

                https://doi.org/10.1128/ASMCopyrightv2

                https://journals.asm.org/non-commercial-tdm-license

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