National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities—1995

J P Santell, R F Kamalich
American Journal of Health-system Pharmacy: AJHP 1996 November 1, 53 (21): 2591-605
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.

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