Outpatient Fluoroquinolone Prescription Fills in the United States, 2014 to 2020: Assessing the Impact of Food and Drug Administration Safety Warnings - PubMed (original) (raw)

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

Deanna J Buehrle et al. Antimicrob Agents Chemother. 2021.

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.

Keywords: FDA; Food and Drug Administration; fluoroquinolone; outpatient.

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Figures

FIG 1

FIG 1

Trends in outpatient fluoroquinolone prescription fills in the United States, August 2014 through February 2020. From August 2014 through May 2016 (baseline period), there were no significant changes in monthly prescription fills per 1,000 persons (y axes) of ciprofloxacin, levofloxacin, and total fluoroquinolones; there was a significant decrease in monthly moxifloxacin fills (P = 0.009). There were significant reductions in monthly prescription fills in May 2016 (indicated by first vertical dashed line) of ciprofloxacin (P = 0.001), levofloxacin (P = 0.006), moxifloxacin (P = 0.04), and total fluoroquinolones (P < 0.001). Throughout the first warning period (May 2016 to June 2018), there was a significant decrease in monthly prescription fills of total fluoroquinolones (P < 0.001), ciprofloxacin (P < 0.001), and moxifloxacin (P = 0.001); there was no change in prescription fills of levofloxacin. Prescription fill trends during the first warning period of total fluoroquinolones (P = 0.02) and ciprofloxacin (P = 0.001) were significantly greater than corresponding trends during the baseline period; there was no change in the trend of prescription fills of levofloxacin and moxifloxacin. There were no significant changes in monthly prescription fills in July 2018 (indicated by second vertical dashed line) of total fluoroquinolones, ciprofloxacin, levofloxacin, and moxifloxacin. Throughout the second warning period (July 2018 to February 2020), there was a significant decrease in prescription fills of total fluoroquinolones (P = 0.001) and ciprofloxacin (P < 0.001), but this trend did not significantly differ from the trend during the first warning period. There was no change in monthly prescription fills of levofloxacin and moxifloxacin during the second warning period, and trends did not differ from corresponding trends during the first warning period. Note that scale on the y axis differs by agent. Monthly prescription fill data are presented as filled black circles. Predicted trends of prescription fills of each antibiotic are presented as solid black lines.

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References

    1. Almalki ZS, Yue X, Xia Y, Wigle PR, Guo JJ. 2017. Utilization, spending, and price trends for quinolones in the US Medicaid programs: 25 years' experience 1991–2015. Pharmacoecon Open 1:123–131. doi:10.1007/s41669-016-0007-y. - DOI - PMC - PubMed
    1. Suda KJ, Hicks LA, Roberts RM, Hunkler RJ, Matusiak LM, Schumock GT. 2018. Antibiotic expenditures by medication, class, and healthcare setting in the United States, 2010–2015. Clin Infect Dis 66:185–190. doi:10.1093/cid/cix773. - DOI - PMC - PubMed
    1. Kabbani S, Hersh AL, Shapiro DJ, Fleming-Dutra KE, Pavia AT, Hicks LA. 2018. Opportunities to improve fluoroquinolone prescribing in the United States for adult ambulatory care visits. Clin Infect Dis 67:134–136. doi:10.1093/cid/ciy035. - DOI - PMC - PubMed
    1. Sanchez GV, Fleming-Dutra KE, Roberts RM, Hicks LA. 2016. Core elements of outpatient antibiotic stewardship. MMWR Recomm Rep 65:1–12. doi:10.15585/mmwr.rr6506a1. - DOI - PubMed
    1. Lin K, Zahlanie Y, Ortwine JK, Mang NS, Wei W, Brown LS, Prokesch BC. 2020. Decreased outpatient fluoroquinolone prescribing using a multimodal antimicrobial stewardship initiative. Open Forum Infect Dis 7:ofaa182. doi:10.1093/ofid/ofaa182. - DOI - PMC - PubMed

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