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1652. Impact of the 2022-2023 Amoxicillin Shortage on Antibiotic Prescribing for Acute Otitis Media: A Regression Discontinuity Study

BACKGROUND: On October 28th, 2022, the U.S. Food and Drug Administration (FDA) announced a national shortage of amoxicillin powder for liquid suspension. The extent to which drug shortages affect prescribing patterns has been poorly described. To characterize the causal impact of the amoxicillin sho...

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Autores principales: Khazanchi, Rohan, Brewster, Ryan, Butler, Alex, O’Meara, Daniel, Bagchi, Devika P, Michelson, Kenneth
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679135/
http://dx.doi.org/10.1093/ofid/ofad500.1486
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author Khazanchi, Rohan
Brewster, Ryan
Butler, Alex
O’Meara, Daniel
Bagchi, Devika P
Michelson, Kenneth
author_facet Khazanchi, Rohan
Brewster, Ryan
Butler, Alex
O’Meara, Daniel
Bagchi, Devika P
Michelson, Kenneth
author_sort Khazanchi, Rohan
collection PubMed
description BACKGROUND: On October 28th, 2022, the U.S. Food and Drug Administration (FDA) announced a national shortage of amoxicillin powder for liquid suspension. The extent to which drug shortages affect prescribing patterns has been poorly described. To characterize the causal impact of the amoxicillin shortage, we performed a quasi-experimental analysis of antibiotic prescribing for uncomplicated acute otitis media (AOM). METHODS: We retrospectively analyzed encounters for children < 18 years old diagnosed with AOM from May 15th, 2022 to April 14th, 2023 at an urban children's health system. Exclusion criteria included a prior episode of AOM within 30 days, presence of concomitant respiratory infections (sinusitis, pharyngitis, pneumonia, and conjunctivitis), and penicillin or amoxicillin allergy. We used a sharp regression discontinuity design with logistic regressions to evaluate the causal impact of the FDA shortage on the odds of being prescribed amoxicillin, amoxicillin-clavulanate, cefdinir, other antibiotics, or no antibiotic. RESULTS: We identified 3076 encounters with 1677 (54.5%) occurring after the amoxicillin shortage (Table 1). The mean patient age was 4.1 years (SD 3.5), and most patients were male (n=1695, 55.1%), Hispanic (n=1252, 40.7%), and seen in the emergency department (n=1900, 61.8%). The most prescribed antibiotics were amoxicillin (n=1662, 54.0%), amoxicillin-clavulanate (n=671, 21.8%), and cefdinir (n=263, 8.6%). The odds of being prescribed amoxicillin decreased by 91% after the FDA shortage declaration (OR 0.09 [95%CI 0.07-0.12]) (Fig. 1A). The odds of being prescribed amoxicillin-clavulanate or cefdinir increased 7-fold and 9-fold (7.90 [5.59-11.31] and 9.25 [5.27-17.17]), respectively (Fig. 1B/1C). Management without antibiotics (0.82 [0.55-1.23]) and prescriptions for other antibiotics (1.73 [0.96-3.19]) did not significantly change (Fig. 1D/1E). [Figure: see text] [Figure: see text] CONCLUSION: The amoxicillin shortage had an immediate, sweeping impact on prescribing patterns. To mitigate future clinical, economic, and antimicrobial resistance consequences, the FDA should increase oversight of manufacturers responsible for critical medications, require supply issue resolution timelines, and incentivize antibiotic production to mitigate their low profitability. DISCLOSURES: Kenneth Michelson, MD, Moderna: Stocks/Bonds|Pfizer: Stocks/Bonds
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spelling pubmed-106791352023-11-27 1652. Impact of the 2022-2023 Amoxicillin Shortage on Antibiotic Prescribing for Acute Otitis Media: A Regression Discontinuity Study Khazanchi, Rohan Brewster, Ryan Butler, Alex O’Meara, Daniel Bagchi, Devika P Michelson, Kenneth Open Forum Infect Dis Abstract BACKGROUND: On October 28th, 2022, the U.S. Food and Drug Administration (FDA) announced a national shortage of amoxicillin powder for liquid suspension. The extent to which drug shortages affect prescribing patterns has been poorly described. To characterize the causal impact of the amoxicillin shortage, we performed a quasi-experimental analysis of antibiotic prescribing for uncomplicated acute otitis media (AOM). METHODS: We retrospectively analyzed encounters for children < 18 years old diagnosed with AOM from May 15th, 2022 to April 14th, 2023 at an urban children's health system. Exclusion criteria included a prior episode of AOM within 30 days, presence of concomitant respiratory infections (sinusitis, pharyngitis, pneumonia, and conjunctivitis), and penicillin or amoxicillin allergy. We used a sharp regression discontinuity design with logistic regressions to evaluate the causal impact of the FDA shortage on the odds of being prescribed amoxicillin, amoxicillin-clavulanate, cefdinir, other antibiotics, or no antibiotic. RESULTS: We identified 3076 encounters with 1677 (54.5%) occurring after the amoxicillin shortage (Table 1). The mean patient age was 4.1 years (SD 3.5), and most patients were male (n=1695, 55.1%), Hispanic (n=1252, 40.7%), and seen in the emergency department (n=1900, 61.8%). The most prescribed antibiotics were amoxicillin (n=1662, 54.0%), amoxicillin-clavulanate (n=671, 21.8%), and cefdinir (n=263, 8.6%). The odds of being prescribed amoxicillin decreased by 91% after the FDA shortage declaration (OR 0.09 [95%CI 0.07-0.12]) (Fig. 1A). The odds of being prescribed amoxicillin-clavulanate or cefdinir increased 7-fold and 9-fold (7.90 [5.59-11.31] and 9.25 [5.27-17.17]), respectively (Fig. 1B/1C). Management without antibiotics (0.82 [0.55-1.23]) and prescriptions for other antibiotics (1.73 [0.96-3.19]) did not significantly change (Fig. 1D/1E). [Figure: see text] [Figure: see text] CONCLUSION: The amoxicillin shortage had an immediate, sweeping impact on prescribing patterns. To mitigate future clinical, economic, and antimicrobial resistance consequences, the FDA should increase oversight of manufacturers responsible for critical medications, require supply issue resolution timelines, and incentivize antibiotic production to mitigate their low profitability. DISCLOSURES: Kenneth Michelson, MD, Moderna: Stocks/Bonds|Pfizer: Stocks/Bonds Oxford University Press 2023-11-27 /pmc/articles/PMC10679135/ http://dx.doi.org/10.1093/ofid/ofad500.1486 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Abstract
Khazanchi, Rohan
Brewster, Ryan
Butler, Alex
O’Meara, Daniel
Bagchi, Devika P
Michelson, Kenneth
1652. Impact of the 2022-2023 Amoxicillin Shortage on Antibiotic Prescribing for Acute Otitis Media: A Regression Discontinuity Study
title 1652. Impact of the 2022-2023 Amoxicillin Shortage on Antibiotic Prescribing for Acute Otitis Media: A Regression Discontinuity Study
title_full 1652. Impact of the 2022-2023 Amoxicillin Shortage on Antibiotic Prescribing for Acute Otitis Media: A Regression Discontinuity Study
title_fullStr 1652. Impact of the 2022-2023 Amoxicillin Shortage on Antibiotic Prescribing for Acute Otitis Media: A Regression Discontinuity Study
title_full_unstemmed 1652. Impact of the 2022-2023 Amoxicillin Shortage on Antibiotic Prescribing for Acute Otitis Media: A Regression Discontinuity Study
title_short 1652. Impact of the 2022-2023 Amoxicillin Shortage on Antibiotic Prescribing for Acute Otitis Media: A Regression Discontinuity Study
title_sort 1652. impact of the 2022-2023 amoxicillin shortage on antibiotic prescribing for acute otitis media: a regression discontinuity study
topic Abstract
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679135/
http://dx.doi.org/10.1093/ofid/ofad500.1486
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