Philip J Schneider
Clinical Professor and Director Latiolais Leadership Program
College of Pharmacy Ohio State University USA
More than 10 years ago there were several highly publicised cases where patients were harmed by improperly compounded sterile preparations, including both injectable and ophthalmic doses. There were errors in both the content and sterility of these final preparations, resulting in toxicity and infections. A baseline survey published in the American Journal of Hospital Pharmacy in 1991 confirmed the suspicion that there were significant discrepancies between proper and actual procedures.(1) The results were responses from the US Federal Government, the United States Pharmacopoeia,(2) State Boards of Pharmacy and the American Society of Hospital Pharmacists(3) (now American Society of Health-System Pharmacists) to strengthen regulations and standards related to pharmacy-compounded sterile preparations in the name of improving patient safety. A follow-up survey in 1995 to assess the impact of stronger standards documented that there were improvements in quality assurance procedures used by pharmacists for compounding sterile preparations(4).
In May 2001 the use of a contaminated sterile preparation resulted in several patient deaths in California. This, along with increased activity by pharmacists who are compounding larger quantities of sterile preparations, some of which are made from nonsterile ingredients, has prompted renewed public fears regarding medication safety. The Food and Drug Administration has expressed concern about pharmacists engaging in the manufacturing of larger quantities of doses, particularly when prepared from nonsterile ingredients, or in large quantities without a prescription in hand, or those prepared when there is a commercially available product. Pharmacists in the USA have asserted their right to compound sterile preparations without Federal oversight, which would necessitate meeting stringent manufacturing standards. The United States Pharmacopoeia (USP) has published for comment a proposed standard, Pharmaceutical Compounding – Sterile Preparations.(5) Its adoption would significantly affect how pharmacists compound sterile preparations. While the proposed standard is currently under revision based on comments received, it is expected to increase the standards of practice for pharmacists. Some areas where improvements might be needed include personnel education, training and evaluation, facilities and equipment, cleanroom garb, aseptic techniques, validation of technique and end-product evaluation. A survey is currently being conducted to assess compliance with current standards of practice by hospital pharmacists.(6)
Patient safety is at the centre of healthcare issues in the USA. Pharmacists have often focused on the drug itself, including dose, interactions, drug administration errors, and proper monitoring for side-effects and therapeutic response. Perhaps we have overlooked an important component of the medication use process that also contributes to patient safety, and is one of the most traditional and basic responsibilities of the pharmacist – competently preparing the dose.
- Crawford SY, Narducci WA, Augustine SC. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals. Am J Hosp Pharm 1991;48:2398-413.
- Sterile products for home use. In: United States Pharmacopoeia, 24th national formulary. 19th ed. Rockville, MD: United States Pharmacopeial Convention; 2000. p. 2130-43.
- ASHP guidelines on quality assurance of pharmacy-prepared sterile products. Am J Health-Syst Pharm 2000;57:1150-69.
- Santell JP, RF Kamalich. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities – 1995. Am J Health-Syst Pharm 1996;53:2591-603.
- Pharmaceutical compounding – sterile preparations. Pharmacopeial Forum 2002;28(2):498-534.
- Morris A, Schneider PJ, Pedersen CA, Mirtallo JM. National survey of quality assurance activities for pharmacy-prepared sterile products. ASHP Midyear Clinical Meeting, Atlanta, GA; 11 December 2002.