National survey of quality assurance activities for pharmacy-compounded sterile preparations

The compliance of hospitals' quality assurance practices for pharmacy-compounded sterile preparations with the American Society of Health-System Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products was studied. A survey based on the 2000 ASHP guidelines was developed to determine current practices for compounding sterile preparations in hospital pharmacies. Practices were compared with those identified in a 1995 ASHP survey. The survey was mailed in July 2002 to a stratified random sample of 600 hospital pharmacy directors. There were a total of 182 usable responses, for a net response rate of 30.3%. Quality assurance practices for some quality domains showed low compliance with the 2000 ASHP guidelines. Only 5.2% of pharmacies that compounded risk level 1 preparations were compliant with garb requirements. Only 4.7% of pharmacies compounding risk level 3 preparations were compliant with recommendations for documentation. Compliance with guidelines on the use of resources to determine expiration dates was high (95.5%). Hospitals were moderately compliant with guidelines related to personnel training (62.7%) and labeling (61.1%). Although some improvements were observed, hospital pharmacies in 2002 were still not fully compliant with the ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.