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[抗生素使用监测:根据《药品法》第23条第4款第2句对“医院抗生素使用性质和范围数据的定义”进行澄清]

[Surveillance of antibiotic consumption : clarification of the "definition of data on the nature and extent of antibiotic consumption in hospitals according to § 23 paragraph 4 sentence 2 of the IfSG"].

作者信息

Schweickert B, Kern W V, de With K, Meyer E, Berner R, Kresken M, Fellhauer M, Abele-Horn M, Eckmanns T

机构信息

Fachgebiet Nosokomiale Infektionen, Surveillance von Antibiotikaresistenzen und -verbrauch, Robert Koch-Institut, DGZ-Ring 1, 13086, Berlin, Deutschland.

出版信息

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2013 Jul;56(7):903-12. doi: 10.1007/s00103-013-1764-8.

DOI:10.1007/s00103-013-1764-8
PMID:23807401
Abstract

According to § 23 paragraph 4 of the German Infection Prevention Act (IfSG; July 2011), hospitals and clinics for ambulatory surgery are obliged to establish a continuous monitoring system of antibiotic consumption. This is aimed at contributing to an optimization of antibiotic prescription practices in order to confine the development and spread of resistant pathogens. The general requirements (restricted to hospitals) on the method and extent of data collection are provided by the national public health institution after discussion with representatives of various professional societies (Robert Koch-Institut, Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 59, 2013). The article aims to clarify these specifications and to provide background details. In agreement with national and European surveillance systems, the Anatomical Therapeutic Chemical (ATC)/Defined Daily Dose (DDD) classification system recommended by the WHO should be used as reference standard. Antibiotic consumption should be expressed as the number of DDDs per 100 patient days and per 100 admissions. The categories of antimicrobials and hospital organizational units to be monitored and the time intervals in which analyses should be conducted are determined. Furthermore, various approaches of data assessment are described.

摘要

根据德国《感染预防法》(IfSG;2011年7月)第23条第4款,医院和门诊手术诊所必须建立抗生素使用情况的持续监测系统。这旨在促进抗生素处方行为的优化,以限制耐药病原体的产生和传播。国家公共卫生机构在与各专业协会(罗伯特·科赫研究所,《联邦健康报 健康研究 健康保护》59,2013年)的代表进行讨论后,规定了数据收集方法和范围的一般要求(仅限于医院)。本文旨在阐明这些规范并提供背景细节。与国家和欧洲监测系统一致,应使用世界卫生组织推荐的解剖治疗化学(ATC)/限定日剂量(DDD)分类系统作为参考标准。抗生素使用情况应以每100患者日和每100次住院的DDD数来表示。确定了要监测的抗菌药物类别、医院组织单位以及进行分析的时间间隔。此外,还描述了各种数据评估方法。

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