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228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk
BACKGROUND: Fluoroquinolones were commonly prescribed for hospitalized patients with diabetic foot infection (DFI) at our institution, included in 69% of empiric antibiotic regimens from 2011–2014. On December 20, 2018, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication r...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7776833/ http://dx.doi.org/10.1093/ofid/ofaa439.272 |
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author | Li, Catherine Mercuro, Nicholas J Chapin, Ryan Gold, Howard McCoy, Christopher |
author_facet | Li, Catherine Mercuro, Nicholas J Chapin, Ryan Gold, Howard McCoy, Christopher |
author_sort | Li, Catherine |
collection | PubMed |
description | BACKGROUND: Fluoroquinolones were commonly prescribed for hospitalized patients with diabetic foot infection (DFI) at our institution, included in 69% of empiric antibiotic regimens from 2011–2014. On December 20, 2018, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding the risk of aortic aneurysm with fluoroquinolones. The objective of this study was to assess the impact of the FDA Communication on antibiotic prescribing for DFI. METHODS: This was a single-center quasi-experimental study of hospitalized patients initiated on antibiotics for DFI before (February-December 2018) and after (February-December 2019) the 2018 FDA Communication. Patients with concomitant infections or documented beta-lactam or fluoroquinolone allergies were excluded. The primary outcome was inpatient days of fluoroquinolone therapy. Secondary outcomes included days of beta-lactam therapy and Outpatient Parenteral Antibiotic Therapy (OPAT) enrollment. Variables were compared using the Pearson’s chi square, Fisher’s exact, and Mann Whitney U tests, as appropriate. A logistic regression was performed to identify predictors for inpatient receipt of fluoroquinolones. RESULTS: A total of 198 patients were included. Baseline characteristics were similar between groups (Table 1). After the FDA Communication, the median duration of inpatient fluoroquinolones decreased from 3 [0–5.5] to 0 [0–1] days (p< 0.001). The duration of antipseudomonal beta-lactams increased from 0 [0–2] to 2 [0–6] days (p< 0.001). OPAT enrollment increased from 16.5% to 29.7% (p=0.028), with a corresponding increase in peripherally inserted central catheter placement (15.5% to 25.7%, p=0.074). There was no difference in outpatient fluoroquinolone prescribing over time. Incidence of re-infection, readmission for DFI, and antibiotic adverse events were similar between groups (Table 2). Table 1 [Image: see text] Table 2 [Image: see text] CONCLUSION: Inpatient fluoroquinolone prescribing for DFI decreased significantly following the 2018 FDA Communication, followed by an increase in antipseudomonal beta-lactam use and OPAT enrollment. FDA statements can influence institutional antibiotic prescribing and transitions of care decisions, representing an opportunity for education by Antimicrobial Stewardship programs. DISCLOSURES: All Authors: No reported disclosures |
format | Online Article Text |
id | pubmed-7776833 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-77768332021-01-07 228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk Li, Catherine Mercuro, Nicholas J Chapin, Ryan Gold, Howard McCoy, Christopher Open Forum Infect Dis Poster Abstracts BACKGROUND: Fluoroquinolones were commonly prescribed for hospitalized patients with diabetic foot infection (DFI) at our institution, included in 69% of empiric antibiotic regimens from 2011–2014. On December 20, 2018, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding the risk of aortic aneurysm with fluoroquinolones. The objective of this study was to assess the impact of the FDA Communication on antibiotic prescribing for DFI. METHODS: This was a single-center quasi-experimental study of hospitalized patients initiated on antibiotics for DFI before (February-December 2018) and after (February-December 2019) the 2018 FDA Communication. Patients with concomitant infections or documented beta-lactam or fluoroquinolone allergies were excluded. The primary outcome was inpatient days of fluoroquinolone therapy. Secondary outcomes included days of beta-lactam therapy and Outpatient Parenteral Antibiotic Therapy (OPAT) enrollment. Variables were compared using the Pearson’s chi square, Fisher’s exact, and Mann Whitney U tests, as appropriate. A logistic regression was performed to identify predictors for inpatient receipt of fluoroquinolones. RESULTS: A total of 198 patients were included. Baseline characteristics were similar between groups (Table 1). After the FDA Communication, the median duration of inpatient fluoroquinolones decreased from 3 [0–5.5] to 0 [0–1] days (p< 0.001). The duration of antipseudomonal beta-lactams increased from 0 [0–2] to 2 [0–6] days (p< 0.001). OPAT enrollment increased from 16.5% to 29.7% (p=0.028), with a corresponding increase in peripherally inserted central catheter placement (15.5% to 25.7%, p=0.074). There was no difference in outpatient fluoroquinolone prescribing over time. Incidence of re-infection, readmission for DFI, and antibiotic adverse events were similar between groups (Table 2). Table 1 [Image: see text] Table 2 [Image: see text] CONCLUSION: Inpatient fluoroquinolone prescribing for DFI decreased significantly following the 2018 FDA Communication, followed by an increase in antipseudomonal beta-lactam use and OPAT enrollment. FDA statements can influence institutional antibiotic prescribing and transitions of care decisions, representing an opportunity for education by Antimicrobial Stewardship programs. DISCLOSURES: All Authors: No reported disclosures Oxford University Press 2020-12-31 /pmc/articles/PMC7776833/ http://dx.doi.org/10.1093/ofid/ofaa439.272 Text en © The Author 2020. 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 | Poster Abstracts Li, Catherine Mercuro, Nicholas J Chapin, Ryan Gold, Howard McCoy, Christopher 228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk |
title | 228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk |
title_full | 228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk |
title_fullStr | 228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk |
title_full_unstemmed | 228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk |
title_short | 228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk |
title_sort | 228. fluoroquinolone prescribing for diabetic foot infections following an fda drug safety communication for aortic aneurysm risk |
topic | Poster Abstracts |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7776833/ http://dx.doi.org/10.1093/ofid/ofaa439.272 |
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