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加拿大医院药房无菌产品配制实践调查。

Survey of sterile product compounding practices in Canadian hospital pharmacies.

作者信息

Fitch D P, Hall K W

机构信息

Health Sciences Centre, Winnipeg, Manitoba.

出版信息

Can J Hosp Pharm. 1993 Dec;46(6):249-60.

Abstract

Improper preparation of sterile products by hospital or community pharmacies may have serious consequences. Recent reports of deaths or injury to patients as a result of receiving products that were contaminated during their preparation in a pharmacy have highlighted the importance of maintaining good sterile compounding practices. Efforts are now underway to develop revised guidelines for the compounding of sterile products in order to minimize the potential for future recurrence of similar incidents. This survey study was undertaken to provide background data on current sterile products compounding practices and procedures in Canadian hospital pharmacies. It was also anticipated that these data would be helpful in identifying issues that needed to be addressed in the new guidelines. Surveys were distributed to 700 Canadian hospitals with 50 or more beds. Responses from returned surveys were entered into and analyzed using the database program RBase. A total of 306 hospital pharmacies responded, with 200 indicating that sterile products were compounded within their department. The information provided by respondents provides insight into the types of sterile products being prepared in Canadian hospitals, the training background of staff involved in sterile product preparation, the type of facilities and equipment used for compounding these preparations, and the quality control/quality assurance procedures that are in place in hospital pharmacies. The information arising from this survey underscores the need for comprehensive guidelines or standards with respect to sterile product compounding, and the need for improved training of personnel involved in sterile product compounding. The results should be of interest to hospital pharmacy administrators, pharmacy regulatory bodies, and government agencies responsible for assuring the safety of pharmaceutical products used in patient care.

摘要

医院药房或社区药房对无菌药品制备不当可能会造成严重后果。近期有报告称,患者因使用在药房配制过程中被污染的药品而死亡或受伤,这凸显了保持良好无菌配制规范的重要性。目前正在努力制定无菌药品配制的修订指南,以尽量减少未来类似事件再次发生的可能性。这项调查研究旨在提供有关加拿大医院药房当前无菌药品配制规范和程序的背景数据。预计这些数据将有助于确定新指南中需要解决的问题。调查问卷被分发给700家拥有50张或更多床位的加拿大医院。回收调查问卷的回复被录入数据库程序RBase并进行分析。共有306家医院药房做出回应,其中200家表示其科室会配制无菌药品。受访者提供的信息有助于深入了解加拿大医院配制的无菌药品类型、参与无菌药品配制人员的培训背景、用于配制这些制剂的设施和设备类型,以及医院药房现行的质量控制/质量保证程序。这项调查得出的信息强调了制定有关无菌药品配制的全面指南或标准的必要性,以及加强对参与无菌药品配制人员培训的必要性。医院药房管理人员、药房监管机构以及负责确保用于患者护理的药品安全的政府机构可能会对这些结果感兴趣。

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