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抗菌药物管理、制药行业与联邦立法的交叉点

The Intersection of Antimicrobial Stewardship, the Pharmaceutical Industry, and the Federal Legislature.

作者信息

Gregory Eric, Martin Craig

机构信息

Department of Pharmacy, University of Kansas Health System, Kansas City, Kansas, USA.

Department of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, Kentucky, USA.

出版信息

Open Forum Infect Dis. 2022 Aug 5;9(8):ofac404. doi: 10.1093/ofid/ofac404. eCollection 2022 Aug.

DOI:10.1093/ofid/ofac404
PMID:36046701
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9423378/
Abstract

To mitigate the dangers of inappropriate antimicrobial use leading to increased multidrug-resistant organisms and mortality, antimicrobial stewardship programs have become a mainstay in many health systems. Unfortunately, some pharmaceutical manufacturers simultaneously have ended antimicrobial research and development efforts altogether due to suboptimal return on investments. An optimal and sustainable antimicrobial armamentarium requires a broad alliance between antimicrobial stewardship programs, the pharmaceutical industry, the legislature, and federal and state agencies. Public-private relationships such as the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and legislative policies creating push and pull incentives, including the Generating Antibiotic Incentives Now (GAIN), Developing an Innovative Strategy for Antimicrobial-Resistant Microorganisms (DISARM), and Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Acts, are each a step in the right direction, but more work remains. Understanding these legislative actions is imperative for all clinicians, as is teamwork from those involved in the antimicrobial field to develop and maintain the life cycle of each drug that harbors societal value.

摘要

为降低不当使用抗菌药物导致多重耐药菌增加和死亡率上升的风险,抗菌药物管理计划已成为许多医疗系统的支柱。不幸的是,由于投资回报率不理想,一些制药商已完全停止了抗菌药物的研发工作。一个最佳且可持续的抗菌药物库需要抗菌药物管理计划、制药行业、立法机构以及联邦和州机构之间建立广泛的联盟。公私合作关系,如抗击抗生素耐药性细菌生物制药加速器(CARB-X)以及制定推拉激励措施的立法政策,包括《立即产生抗生素激励法案》(GAIN)、《制定抗微生物耐药微生物创新战略法案》(DISARM)和《开创抗菌药物订阅以终结耐药性激增法案》(PASTEUR),都是朝着正确方向迈出的一步,但仍有更多工作要做。所有临床医生都必须了解这些立法行动,参与抗菌领域的人员开展团队合作以开发和维持具有社会价值的每种药物的生命周期同样至关重要。

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本文引用的文献

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Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis.2019 年全球细菌对抗菌药物耐药性的负担:系统分析。
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Open Forum Infect Dis. 2020 Jan 28;7(1):ofaa001. doi: 10.1093/ofid/ofaa001. eCollection 2020 Jan.
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The Role of Pharmaceutical Companies in Antimicrobial Stewardship: A Case Study.制药公司在抗菌药物管理中的作用:案例研究。
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What Is the More Effective Antibiotic Stewardship Intervention: Preprescription Authorization or Postprescription Review With Feedback?哪种抗生素管理干预措施更有效:处方前授权还是处方后反馈审查?
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