National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals

Abstract

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.