Crawford S Y, Narducci W A, Augustine S C
Scientific Affairs Department, American Society of Hospital Pharmacists, Bethesda, MD 20814.
Am J Hosp Pharm. 1991 Nov;48(11):2398-413.
The results of a survey of pharmacy department activities for quality assurance in the preparation of sterile drug products in short-term, nonfederal hospitals are reported. A questionnaire was mailed in March and April 1991 to pharmacy directors at hospitals that had indicated in ASHP's 1990 national survey of pharmaceutical services that they had formal quality assurance processes for intravenous admixture preparation. The adjusted gross sample size was 465. The net response rate was 71% (330 usable replies). Nearly all respondents indicated that sterile drug products were prepared extemporaneously in their departments; 61% reported batch preparation of such products. Both pharmacists and pharmacy technicians prepared sterile products. Respondents identified which guidelines were used in developing departmental policies and procedures for sterile product preparation. Specific areas were identified in which educational programs for pharmacists are needed; the most frequently indicated area (85%) was principles of aseptic technique. A majority of respondents used the following means for the orientation and training of personnel who prepare sterile products: aseptic technique lectures or videotapes, on-the-job training, written policies and procedures, and direct observation of technique. Almost all of the respondents (99%) had laminar-airflow hoods in their departments. Three fourths of those respondents indicated that laminar-airflow hoods were located in a limited-access room. Half of the respondents reported that laminar-airflow hoods were located certified every six months and that prefilters were changed monthly. Less than one third sampled environmental areas for microbial contamination. Less than one third of the surveyed hospitals routinely sampled sterile products for microbial contamination or pyrogens. Almost half indicated the absence of policies and procedures for testing chemical purity, drug concentration, sterility, pyrogenicity, or the environment for sterile preparations. Few respondents indicated the use of sterilization techniques other than microbial filtration, which was used by 32% of pharmacies involved in extemporaneous preparation and 16% of those involved in batch preparation. About 90% of the respondents used published references and manufacturers' recommendations to determine expiration dating. This survey revealed that certain quality assurance procedures related to pharmacy-prepared sterile products need major improvement.
本文报告了一项针对短期非联邦医院无菌药品制剂质量保证药房部门活动的调查结果。1991年3月和4月，向那些在1990年美国医院药师协会全国药学服务调查中表明有静脉药物混合制剂正式质量保证程序的医院的药房主任邮寄了一份调查问卷。调整后的总样本量为465。净回复率为71%（330份可用回复）。几乎所有受访者表示其所在部门的无菌药品是临时配制的；61%报告称此类产品是批量配制的。药剂师和药房技术员都参与无菌产品的配制。受访者指出了制定无菌产品配制部门政策和程序所依据的指南。确定了药剂师需要接受教育的具体领域；最常提及的领域（85%）是无菌技术原则。大多数受访者采用以下方式对配制无菌产品的人员进行入职培训和培训：无菌技术讲座或录像带、在职培训、书面政策和程序以及对技术的直接观察。几乎所有受访者（99%）所在部门都有层流通风橱。四分之三的受访者表示层流通风橱位于限制进入的房间。一半的受访者报告称层流通风橱每六个月进行一次认证，前置过滤器每月更换。不到三分之一的受访者对环境区域进行微生物污染采样。不到三分之一的被调查医院定期对无菌产品进行微生物污染或热原检测。几乎一半的受访者表示没有针对无菌制剂的化学纯度、药物浓度、无菌性、热原性或环境检测的政策和程序。很少有受访者表示使用除微生物过滤以外的灭菌技术，参与临时配制的药房中有32%使用微生物过滤，参与批量配制的药房中有16%使用。约90%的受访者参考已发表的文献和制造商的建议来确定有效期。这项调查表明，与药房配制的无菌产品相关的某些质量保证程序需要重大改进。
