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抗生素药物短缺及应对这些短缺所采用策略的系统评价。

A systematic review of antibiotic drug shortages and the strategies employed for managing these shortages.

作者信息

Pandey Avaneesh Kumar, Cohn Jennifer, Nampoothiri Vrinda, Gadde Uttara, Ghataure Amrita, Kakkar Ashish Kumar, Gupta Yogendra Kumar, Malhotra Samir, Mbamalu Oluchi, Mendelson Marc, Märtson Anne-Grete, Singh Sanjeev, Tängdén Thomas, Shafiq Nusrat, Charani Esmita

机构信息

Department of Pharmacology, Clinical Pharmacology Unit, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

The Global Antibiotic Research and Development Partnership, Geneva, Switzerland.

出版信息

Clin Microbiol Infect. 2025 Mar;31(3):345-353. doi: 10.1016/j.cmi.2024.09.023. Epub 2024 Sep 26.

Abstract

BACKGROUND

There is a need to examine the impact of increasingly prevalent antibiotic shortages on patient outcomes and on the emergence and spread of antimicrobial resistance.

OBJECTIVES

To: (1) assess patterns and causes of shortages; (2) investigate the effect of shortages on health systems and patient outcomes; and (3) identify strategies for forecasting and managing shortages.

DATA SOURCES

PubMed/MEDLINE, EMBASE, Scopus, and Web of Science.

STUDY ELIGIBILITY CRITERIA

Studies published in English from January 2000 to July 2023. Participants health care, policy, and strategic teams managing and responding to shortages. Patient populations (adults and children) affected by shortages.

PARTICIPANTS

Healthcare workers responding to and populations affected by antibiotic shortages.

INTERVENTIONS

Strategies, policies, and mitigation options for managing and responding to antibiotic drug shortages.

ASSESSMENT OF RISK OF BIAS

The methodological quality of included studies was reviewed using the most appropriate tool from Joanna Briggs institute critical appraisal tool for each study design.

METHODS OF DATA SYNTHESIS

Data synthesis was qualitative and quantitative using descriptive statistics.

RESULTS

The final analysis included 74 studies (61/74, 82.4% high-income countries). Shortages were most reported for piperacillin-tazobactam (21/74, 28.4%), with most of the reported antibiotics being in the WHO Watch category (27/54, 51%). Frequent cause of shortages was disruption in manufacturing, such as supply of active pharmaceutical ingredients and raw materials. Clinical implications of shortages included increased length of hospital stay, treatment failure after using inferior alternative agents, and a negative impact on antimicrobial stewardship programmes (AMS). Robust economic impact analysis of shortages is unavailable. Successfully reported mitigation strategies were driven by AMS and infectious diseases teams in hospitals.

CONCLUSIONS

Antibiotic shortages are directly or indirectly driven by economic viability and reliance on single source ingredients. The limited data on clinical outcomes indicates a mixed effect, with some infections becoming more difficult to treat, though there is no robust data on the impact of shortages on antimicrobial resistance. The mitigation strategies to manage shortages rely heavily on AMS teams.

摘要

背景

有必要研究日益普遍的抗生素短缺对患者预后以及对抗菌药物耐药性的出现和传播的影响。

目的

(1)评估短缺的模式和原因;(2)调查短缺对卫生系统和患者预后的影响;(3)确定预测和管理短缺的策略。

数据来源

PubMed/MEDLINE、EMBASE、Scopus和Web of Science。

研究纳入标准

2000年1月至2023年7月以英文发表的研究。参与者为管理和应对短缺的医疗保健、政策及战略团队。受短缺影响的患者群体(成人和儿童)。

参与者

应对抗生素短缺的医护人员以及受其影响的人群。

干预措施

管理和应对抗生素药物短缺的策略、政策及缓解措施。

偏倚风险评估

使用乔安娜·布里格斯研究所针对每种研究设计的批判性评价工具中最合适的工具,对纳入研究的方法学质量进行审查。

数据综合方法

采用描述性统计进行定性和定量数据综合。

结果

最终分析纳入74项研究(61/74,82.4%来自高收入国家)。哌拉西林-他唑巴坦的短缺报告最多(21/74,28.4%),报告的大多数抗生素属于世界卫生组织观察类(27/54,51%)。短缺的常见原因是生产中断,如活性药物成分和原材料的供应问题。短缺的临床影响包括住院时间延长、使用劣质替代药物后治疗失败以及对抗菌药物管理计划(AMS)产生负面影响。目前尚无关于短缺的有力经济影响分析。成功报告的缓解策略由医院的AMS团队和传染病团队推动。

结论

抗生素短缺直接或间接由经济可行性和对单一来源成分的依赖驱动。关于临床结局的有限数据表明存在混合效应,一些感染变得更难治疗,不过关于短缺对抗菌药物耐药性影响的有力数据尚不存在。管理短缺的缓解策略严重依赖AMS团队。

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