Santell J P, Kamalich R F
Center on Pharmacy Practice Management, ASHP, Bethesda, MD 20814, USA.
Am J Health Syst Pharm. 1996 Nov 1;53(21):2591-605. doi: 10.1093/ajhp/53.21.2591.
The results of a survey of hospital pharmacy and home infusion facility activities for quality assurance in the preparation of sterile drug products are reported, and the hospital results are compared with those of a 1991 ASHP survey. A questionnaire was mailed in May and June 1995 to 778 hospital pharmacy directors and 203 home infusion pharmacy directors. Usable questionnaires were returned by 547 hospitals and 111 home infusion facilities, for an overall response rate of 67%. The percentages of hospitals with pharmacists involved in extemporaneous (70%) and batch (28%) preparation of sterile drug products have decreased since 1991, while the percentage with technicians who are not limited as to the types of sterile products they may prepare has increased. Some 16% of all sterile products compounded in hospitals were prepared by nonpharmacy personnel. Few respondents contracted with outside sources for compounding of sterile products. A need for educational programs on aseptic technique was identified by 83% of hospitals, and 84% of home infusion facilities indicated a need for education on environmental monitoring. Three fourths of respondents used the ASHP Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products in developing their policies and procedures. Significant improvements in orientation and training techniques have occurred since 1991. Use of a laminar-airflow hood in a limited-access room has increased. The aspects of sterile product compounding most often modified since 1991 were, for hospitals, personnel training and evaluation (74%), facilities and equipment (48%), and garb policies (36%); for home infusion facilities, personnel training and evaluation (76%), facilities and equipment and garb policies (both 69%), and end-product testing and evaluation (66%). There have been advances in quality assurance procedures related to pharmacy-prepared sterile products, but opportunities for improvement remain.
本文报告了一项关于医院药房和家庭输液机构在无菌药品配制过程中质量保证活动的调查结果，并将医院的调查结果与1991年美国卫生系统药师协会（ASHP）的调查结果进行了比较。1995年5月和6月，向778名医院药房主任和203名家庭输液药房主任邮寄了调查问卷。547家医院和111家家庭输液机构返回了可用问卷，总体回复率为67%。自1991年以来，参与无菌药品临时配制（70%）和批量配制（28%）的药师所在医院的比例有所下降，而可以配制任何类型无菌产品的技术人员所在医院的比例有所增加。医院配制的所有无菌产品中，约16%是由非药学人员配制的。很少有受访者与外部机构签订无菌产品配制合同。83%的医院认为需要开展无菌技术教育项目，84%的家庭输液机构表示需要开展环境监测教育。四分之三的受访者在制定政策和程序时参考了ASHP关于药房配制无菌产品质量保证的技术援助公告。自1991年以来，入职培训和培训技术有了显著改进。在有限进入的房间内使用层流通风柜的情况有所增加。自1991年以来，医院最常修改的无菌产品配制方面是人员培训和评估（74%）、设施和设备（48%）以及着装政策（36%）；家庭输液机构最常修改的方面是人员培训和评估（76%）、设施和设备以及着装政策（均为69%）以及成品检测和评估（66%）。与药房配制无菌产品相关的质量保证程序有了进展，但仍有改进的空间。
