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Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians

BACKGROUND: In 2012, the US Food and Drug Administration (FDA) required drug manufacturers to give advance notice of impending drug shortages. A survey of infectious diseases (ID) physicians was undertaken to determine the impact of this requirement and to follow-up on prior perceptions of ID physic...

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Autores principales: Gundlapalli, Adi V, Beekmann, Susan E, Graham, Donald R, Polgreen, Philip M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5917774/
https://www.ncbi.nlm.nih.gov/pubmed/29732380
http://dx.doi.org/10.1093/ofid/ofy068
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author Gundlapalli, Adi V
Beekmann, Susan E
Graham, Donald R
Polgreen, Philip M
author_facet Gundlapalli, Adi V
Beekmann, Susan E
Graham, Donald R
Polgreen, Philip M
author_sort Gundlapalli, Adi V
collection PubMed
description BACKGROUND: In 2012, the US Food and Drug Administration (FDA) required drug manufacturers to give advance notice of impending drug shortages. A survey of infectious diseases (ID) physicians was undertaken to determine the impact of this requirement and to follow-up on prior perceptions of ID physicians on shortages of antimicrobial agents. METHODS: We used a web-based survey of ID physician members of the Emerging Infections Network in 2016. RESULTS: Of the 701 of 1597 members (44%) who responded, 70% reported the need to modify their antimicrobial choice because of a shortage in the prior 2 years. A majority (73%) reported the shortages affected patient care or outcomes by the use of broader-spectrum (75%), more costly (58%), less effective second-line (45%), or more toxic agents (37%). The most commonly reported antimicrobials in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, and cefepime. Respondents learned of shortages from hospital notification, from a colleague, contact from pharmacy after ordering the agent in short supply, or FDA or other website. The antimicrobial stewardship programs (ASPs) of a majority (83%) of respondents’ institutions had developed approaches to deal with shortages. Although 71% indicated that communications were sufficient, most (87%) did not perceive any improvement in communications about shortages since the 2012 FDA requirement. CONCLUSIONS: The persistence of antimicrobial agent shortages reported by ID physicians is disturbing as is the resulting need to use broader-spectrum or more toxic agents. The prominent role of ASPs in helping to deal with shortages, effective communication channels, and the lack of perceived improvement in FDA’s communication strategy merit further consideration.
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spelling pubmed-59177742018-05-04 Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians Gundlapalli, Adi V Beekmann, Susan E Graham, Donald R Polgreen, Philip M Open Forum Infect Dis Major Article BACKGROUND: In 2012, the US Food and Drug Administration (FDA) required drug manufacturers to give advance notice of impending drug shortages. A survey of infectious diseases (ID) physicians was undertaken to determine the impact of this requirement and to follow-up on prior perceptions of ID physicians on shortages of antimicrobial agents. METHODS: We used a web-based survey of ID physician members of the Emerging Infections Network in 2016. RESULTS: Of the 701 of 1597 members (44%) who responded, 70% reported the need to modify their antimicrobial choice because of a shortage in the prior 2 years. A majority (73%) reported the shortages affected patient care or outcomes by the use of broader-spectrum (75%), more costly (58%), less effective second-line (45%), or more toxic agents (37%). The most commonly reported antimicrobials in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, and cefepime. Respondents learned of shortages from hospital notification, from a colleague, contact from pharmacy after ordering the agent in short supply, or FDA or other website. The antimicrobial stewardship programs (ASPs) of a majority (83%) of respondents’ institutions had developed approaches to deal with shortages. Although 71% indicated that communications were sufficient, most (87%) did not perceive any improvement in communications about shortages since the 2012 FDA requirement. CONCLUSIONS: The persistence of antimicrobial agent shortages reported by ID physicians is disturbing as is the resulting need to use broader-spectrum or more toxic agents. The prominent role of ASPs in helping to deal with shortages, effective communication channels, and the lack of perceived improvement in FDA’s communication strategy merit further consideration. Oxford University Press 2018-04-23 /pmc/articles/PMC5917774/ /pubmed/29732380 http://dx.doi.org/10.1093/ofid/ofy068 Text en © Infectious Diseases Society of America 2018. 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 Major Article
Gundlapalli, Adi V
Beekmann, Susan E
Graham, Donald R
Polgreen, Philip M
Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians
title Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians
title_full Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians
title_fullStr Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians
title_full_unstemmed Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians
title_short Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians
title_sort antimicrobial agent shortages: the new norm for infectious diseases physicians
topic Major Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5917774/
https://www.ncbi.nlm.nih.gov/pubmed/29732380
http://dx.doi.org/10.1093/ofid/ofy068
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