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抗菌药物短缺:传染病医生的新常态。

Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians.

作者信息

Gundlapalli Adi V, Beekmann Susan E, Graham Donald R, Polgreen Philip M

机构信息

University of Utah School of Medicine and VA Salt Lake City Health Care System.

University of Iowa Carver College of Medicine, Iowa City.

出版信息

Open Forum Infect Dis. 2018 Apr 23;5(4):ofy068. doi: 10.1093/ofid/ofy068. eCollection 2018 Apr.

Abstract

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.

摘要

背景

2012年,美国食品药品监督管理局(FDA)要求药品制造商提前通知即将出现的药品短缺情况。开展了一项针对传染病(ID)医生的调查,以确定这一要求的影响,并跟进ID医生此前对抗菌药物短缺的看法。

方法

我们于2016年对新兴感染网络的ID医生成员进行了一项基于网络的调查。

结果

在1597名成员中有701名(44%)回复,70%的人报告称在过去两年中因短缺而需要改变抗菌药物的选择。大多数人(73%)报告称,短缺通过使用更广谱(75%)、更昂贵(58%)、效果较差的二线药物(45%)或毒性更强的药物(37%)影响了患者护理或治疗结果。报告中最常见的供应短缺抗菌药物为哌拉西林-他唑巴坦、氨苄西林-舒巴坦、美罗培南、头孢噻肟和头孢吡肟。受访者通过医院通知、同事、订购短缺药物后药房的联系、FDA或其他网站得知短缺情况。大多数(83%)受访者所在机构的抗菌药物管理项目(ASP)已制定应对短缺的方法。尽管71%的人表示沟通充分,但大多数人(87%)认为自2012年FDA提出要求以来,关于短缺的沟通没有任何改善。

结论

ID医生报告的抗菌药物短缺持续存在令人不安,由此导致需要使用更广谱或毒性更强的药物的情况同样如此。ASP在帮助应对短缺方面的突出作用、有效的沟通渠道以及FDA沟通策略缺乏明显改善值得进一步考虑。

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