Pharmacy compounding of high-risk level products and patient safety.

PURPOSE: Issues surrounding pharmacy compounding as well as patient safety concerns surrounding compounding of high-risk level products are discussed.

SUMMARY: The practice of traditional pharmacy compounding is an established activity of pharmacists that serves a vital function to meet the prescribed medical needs of individual patients. However, legal and regulatory debate concerning the oversight of pharmacy compounding has arisen in recent decades, driven mostly by patient harm that has occurred as a result of compounding errors or deceptive practices. Federal and state government agencies and professional organizations have reported errors in pharmacy compounding, including subpotent and contaminated products that have caused patient harm. The United States Pharmacopeia (USP) chapter 797 serves to protect patients by requiring best practice and quality standards for the safe preparation and handling of compounded sterile preparations (CSPs). High-risk level CSPs pose the greatest risk to patients since non-sterile ingredients or containers are used, which mandates final product sterilization prior to dispensing. Pharmacists should understand and comply with federal, state, and USP chapter 797 requirements when preparing CSPs, particularly high-risk level CSPs. Professional pharmacy organizations, such as the American Society of Health-System Pharmacists (ASHP) and the National Association of Boards of Pharmacy (NABP), continue to support the practice of traditional pharmacy compounding through their guidelines, with patient safety as a central theme.

CONCLUSION: Until the regulatory debate is resolved, pharmacists engaged in pharmacy compounding, particularly in the preparation of high-risk level CSPs, should remain competent in their skills and practice in accordance with federal, state, and USP chapter 797 requirements and, thereby, protect patients and the professionalism of pharmacy.