Warner Travis, Nishi Cesilia, Checkowski Ryan, Hall Kevin W
, BSP, ACPR, is a Staff Pharmacist with St. Boniface General Hospital, Winnipeg, Manitoba.
Can J Hosp Pharm. 2009 May;62(3):192-203.
The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its "General Chapter <797> Pharmaceutical Compounding-Sterile Preparations", which set a more rigorous and enforceable standard for sterile compounding in the United States.
To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards.
An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies.
A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. The survey methods for this study and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments were reported in Part 1. Part 2 reports results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It also highlights some of the key areas where there is considerable opportunity for improvement.
This survey identified numerous deficiencies in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.
1996年加拿大医院药师协会（CSHP）发布的《药房无菌产品配制指南》代表了加拿大当前无菌配制的实践标准。然而，这些指南是实践建议，而非可强制执行的标准。先前对无菌配制实践的调查表明，实际操作明显偏离了自愿性实践建议。2004年，美国药典（USP）发布了其《通则<797>药品配制——无菌制剂》，该通则为美国的无菌配制设定了更严格且可强制执行的标准。
评估加拿大医院药房的无菌配制实践，并将其与当前CSHP的建议以及USP通则<797>标准进行比较。
基于先前对无菌配制实践的研究、CSHP指南和<797>通则标准，创建了一项在线调查，并分发给193家加拿大医院药房。
共有133家药房至少完成了部分调查，回复率为68.9%。所有受访者均报告了无菌产品的配制情况。在CSHP指南和USP标准的几乎所有领域都发现了与实践建议存在不同程度的偏差。在设施与设备、工艺验证和产品检测等方面，合规水平较低最为明显。<797>通则标准要求中心药房具备符合或超过国际标准化组织（ISO）8级标准的洁净室设施，但超过40%的回复药房报告称他们没有这样的设施。在政策与程序、着装要求、无菌技术以及危险产品处理方面，合规水平较高。本研究的调查方法以及与政策、人员、原材料、储存与处理、设施与设备以及服装相关的结果在第1部分中进行了报告。第2部分报告了与无菌产品配制、有效期标注、标签、工艺验证、产品检测与放行、文件记录、记录以及危险药品处置相关的结果。它还突出了一些有很大改进空间的关键领域。
本次调查发现加拿大医院药房的无菌配制实践存在诸多不足。认识到这些不足可能会促使对实践进行批判性评估并加以改进。
