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监测医院药剂科危险药物配制表面的污染。共识声明。西班牙医院药师学会(SEFH)的实践指南。

Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. A consensus Statement. Practice guidelines of the Spanish Society of Hospital Pharmacists (SEFH).

机构信息

Pharmacy Department. Instituto de Investigación Sanitaria La Fe. Valencia. España..

Pharmacy Department. Hospital Universitario Gregorio Marañón. Madrid. España..

出版信息

Farm Hosp. 2021 Mar 11;45(2):96-107. doi: 10.7399/fh.11655.

Abstract

OBJECTIVE

To establish a series of recommendations based on available evidence for monitoring surface contamination in the areas devoted to compounding hazardous drugs in pharmacy departments.

METHOD

Based on a literature search in the Medline and Embase databases (search period: January 2009 to July 2019), as well as on a review of standards and recommendations issued by different healthcare organizations, a committee of experts from the Spanish Society of Hospital Pharmacists defined a series of safe practices for handling hazardous drugs and monitoring compounding work surfaces. Recommendation decisions were adopted by consensus among the members of the expert group, considering the recommendations reviewed, the monitoring situation in Spanish hospital departments, and the associated costs.

RESULTS

Ten recommendations were formulated, structured into eight sections. They include aspects related to the drugs to be monitored; the  areas to be monitored; when samples should be taken; risk determination and preparation of a sampling protocol; analytical techniques; contamination thresholds; and design of an action plan based on the sampling and decontamination results obtained.

CONCLUSIONS

Surface monitoring allows hazardous drugs detection and evaluation of the effectiveness of current protocols for the safe handling of such drugs in hospital pharmacy departments. The evaluation should include an analysis of the efficacy of engineering controls, work practices and cleaning and decontamination processes.

摘要

目的

根据现有证据,为药剂科调配危险药物的区域建立表面污染监测的一系列建议。

方法

基于 Medline 和 Embase 数据库的文献检索(检索时间:2009 年 1 月至 2019 年 7 月),以及对不同医疗机构发布的标准和建议的审查,来自西班牙医院药剂师学会的专家委员会为处理危险药物和监测调配工作表面确定了一系列安全操作实践。建议决策由专家组的成员通过共识达成,考虑到所审查的建议、西班牙医院部门的监测情况以及相关成本。

结果

制定了十条建议,分为八个部分。它们包括与要监测的药物相关的方面;要监测的区域;应采集样本的时间;风险确定和采样方案的准备;分析技术;污染阈值;以及根据采样和去污结果制定行动计划。

结论

表面监测可检测危险药物,并评估医院药剂科中当前安全处理此类药物的方案的有效性。评估应包括对工程控制、工作实践以及清洁和去污过程的有效性进行分析。

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