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855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals

BACKGROUND: Many antimicrobial stewardship programs have set goals to reduce the use of fluoroquinolones because of risks of causing C. difficile and other adverse safety events. The US Food and Drug Administration issued a black box label warning for fluoroquinolones in June 2016 recommending avoid...

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Autores principales: Yarrington, Michael, Anderson, Deverick J, Ashley, Elizabeth Dodds, Jones, Travis, Johnson, Melissa, Lokhnygina, Yuliya, Sexton, Daniel, Moehring, Rebekah W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252437/
http://dx.doi.org/10.1093/ofid/ofy209.040
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author Yarrington, Michael
Anderson, Deverick J
Ashley, Elizabeth Dodds
Jones, Travis
Johnson, Melissa
Lokhnygina, Yuliya
Sexton, Daniel
Moehring, Rebekah W
author_facet Yarrington, Michael
Anderson, Deverick J
Ashley, Elizabeth Dodds
Jones, Travis
Johnson, Melissa
Lokhnygina, Yuliya
Sexton, Daniel
Moehring, Rebekah W
author_sort Yarrington, Michael
collection PubMed
description BACKGROUND: Many antimicrobial stewardship programs have set goals to reduce the use of fluoroquinolones because of risks of causing C. difficile and other adverse safety events. The US Food and Drug Administration issued a black box label warning for fluoroquinolones in June 2016 recommending avoidance of this class for treatment of uncomplicated infections. METHODS: We performed a retrospective cohort study of antimicrobial use (AU) data in 29 southeastern United States hospitals from 2013 to 2017. An interrupted time series approach with segmented negative binomial regression modeling was used to estimate the longitudinal trend and effect of the FDA safety announcement on AU rates. Fluoroquinolone and alternative antibiotic agent use rates were measured as days of therapy (DOT) per 1,000 patient days. Alternative antibiotics were analyzed individually or in groups (e.g., community-onset agent group included ceftriaxone, cefotaxime, and ertapenem). RESULTS: Hospital AU data for the 60-month period included a total of 6,685,950 patient days; 8 to 29 hospitals contributed AU data to estimates each month. FQ use rates declined at a consistent rate of approximately 1 DOT/1,000 patient days per month resulting in an overall 10% decrease prior to the FDA warning. A significant drop in FQ use rates occurred at the time of the announcement (P = 0.002), but there was no significant change in trend [rate ratio (RR) 0.89, 95% CI 0.79–1.01, P = 0.07, Figure 1]. Alternative antibiotic use significantly increased for the following antibiotic groups after the warning: community-onset agents (RR 1.24, 95% CI 1.11–1.38), atypical agents (RR 1.40, 95% CI 1.19–1.66), and third-generation cephalosporins (RR 1.54, 95% CI 1.19–1.65). Antipseudomonal β-lactam use remained stable (RR 0.96, 95% CI 0.88–1.05, P = 0.3). CONCLUSION: Fluoroquinolone use was declining in our network prior to the FDA announcement and continued to decline after 2016. This is likely due to stewardship activities focusing on quinolone-sparing treatment guidelines. AU shifted away from FQ toward third-generation cephalosporins and atypical agents. DISCLOSURES: All authors: No reported disclosures.
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spelling pubmed-62524372018-11-28 855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals Yarrington, Michael Anderson, Deverick J Ashley, Elizabeth Dodds Jones, Travis Johnson, Melissa Lokhnygina, Yuliya Sexton, Daniel Moehring, Rebekah W Open Forum Infect Dis Abstracts BACKGROUND: Many antimicrobial stewardship programs have set goals to reduce the use of fluoroquinolones because of risks of causing C. difficile and other adverse safety events. The US Food and Drug Administration issued a black box label warning for fluoroquinolones in June 2016 recommending avoidance of this class for treatment of uncomplicated infections. METHODS: We performed a retrospective cohort study of antimicrobial use (AU) data in 29 southeastern United States hospitals from 2013 to 2017. An interrupted time series approach with segmented negative binomial regression modeling was used to estimate the longitudinal trend and effect of the FDA safety announcement on AU rates. Fluoroquinolone and alternative antibiotic agent use rates were measured as days of therapy (DOT) per 1,000 patient days. Alternative antibiotics were analyzed individually or in groups (e.g., community-onset agent group included ceftriaxone, cefotaxime, and ertapenem). RESULTS: Hospital AU data for the 60-month period included a total of 6,685,950 patient days; 8 to 29 hospitals contributed AU data to estimates each month. FQ use rates declined at a consistent rate of approximately 1 DOT/1,000 patient days per month resulting in an overall 10% decrease prior to the FDA warning. A significant drop in FQ use rates occurred at the time of the announcement (P = 0.002), but there was no significant change in trend [rate ratio (RR) 0.89, 95% CI 0.79–1.01, P = 0.07, Figure 1]. Alternative antibiotic use significantly increased for the following antibiotic groups after the warning: community-onset agents (RR 1.24, 95% CI 1.11–1.38), atypical agents (RR 1.40, 95% CI 1.19–1.66), and third-generation cephalosporins (RR 1.54, 95% CI 1.19–1.65). Antipseudomonal β-lactam use remained stable (RR 0.96, 95% CI 0.88–1.05, P = 0.3). CONCLUSION: Fluoroquinolone use was declining in our network prior to the FDA announcement and continued to decline after 2016. This is likely due to stewardship activities focusing on quinolone-sparing treatment guidelines. AU shifted away from FQ toward third-generation cephalosporins and atypical agents. DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2018-11-26 /pmc/articles/PMC6252437/ http://dx.doi.org/10.1093/ofid/ofy209.040 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Abstracts
Yarrington, Michael
Anderson, Deverick J
Ashley, Elizabeth Dodds
Jones, Travis
Johnson, Melissa
Lokhnygina, Yuliya
Sexton, Daniel
Moehring, Rebekah W
855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals
title 855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals
title_full 855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals
title_fullStr 855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals
title_full_unstemmed 855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals
title_short 855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals
title_sort 855. impact of fda black box warning on fluoroquinolone and alternative antibiotic use in southeastern us hospitals
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252437/
http://dx.doi.org/10.1093/ofid/ofy209.040
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