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

Aisha M. Morris, Philip J. Schneider, Craig A. Pedersen, Jay M. Mirtallo

Research output: Contribution to journalReview article

37 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)2567-2576
Number of pages10
JournalAmerican Journal of Health-System Pharmacy
Issue number24
StatePublished - Dec 15 2003



  • American Society of Health-System Pharmacists
  • Clothing
  • Compliance
  • Compounding
  • Control, quality
  • Data collection
  • Documentation
  • Education
  • Expiration dates
  • Guidelines
  • Labeling
  • Personnel, pharmacy
  • Pharmacy, institutional hospital
  • Quality assurance

ASJC Scopus subject areas

  • Pharmacology
  • Health Policy

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