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PRP INSIGHTS: Sterile Compounding Mini-Series - Policies and Procedures
The College standards for sterile compounding came into effect on July 4, 2022. Pharmacy professionals involved in sterile compounding are expected to know, understand, and be in full compliance with the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations, and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.
The purpose of the Model Standards is to provide pharmacy professionals with the guidance necessary to evaluate their practice, develop service-related procedures and implement appropriate quality controls for both patients and compounding personnel.
As of September 2022, the College has been reviewing sterile compounding services under the Practice Review Program using the Sterile Compounding Review Form. During sterile compounding reviews, Compliance Officers may identify areas of non-compliance, for which they will then work with pharmacy staff to ensure deficiencies in their practice are addressed through establishment and implementation of corrective measures. This article is the first of a series that will highlight areas of non-compliance that have been observed during sterile compounding reviews. This installment discusses the development and application of written sterile compounding policies and procedures.
When conducting sterile compounding reviews, Compliance Officers have observed that policies and procedures were not established or documented, were not updated or were incomplete.
Sections 5.2 and 7 of the Model Standards for Pharmacy Compounding of Non-hazardous and Hazardous Sterile Preparations state the requirements for establishing and following written sterile compounding policies and procedures. The standards require that:
- The sterile compounding supervisor must establish the content of policies and procedures, providing detailed descriptions of all activities in the pharmacy’s compounding of nonhazardous sterile preparations. The supervisor must also ensure application of and compliance with these policies and procedures.
- The procedures must be clear, must follow a standard format and must include an index for easy access to information when it is needed.
- The sterile compounding supervisor must ensure that all established policies and procedures are promptly updated whenever there is a change in practice or in standards. In addition, policies and procedures must be reviewed at least every 3 years.
- The drafting and revision dates, the date of each change and the names of authors and reviewers must be included in each policy or procedure.
- Where compounding is undertaken by another pharmacy, as permitted by provincial/territorial legislation, the pharmacist or pharmacy technician at the dispensing facility should include in its general procedures manual information about policies and procedures for acquiring compounded sterile preparations for patients (originating pharmacy, entry in the file, delivery, etc.).
- The sterile compounding supervisor must establish a quality assurance program to ensure that sterile preparations are compounded in compliance with established procedures.
Written procedures for all sterile compounding activities must be available to compounding personnel who perform sterile compounding tasks. For example, when aseptically compounding, personnel are expected to follow a compounding procedure that includes clear, step-by-step directions. The implementation of standardized procedures is critical to ensure the consistent execution of sterile compounding activities. This practice not only upholds uniformity but also contributes to the overall quality of preparations and end product safety for patients. The absence of clear compounding procedures can cause confusion amongst staff and subsequently can increase the chances of an error occurring.
When performing any sterile compounding activity, pharmacy professionals must do so in accordance with the site-specific procedures. If a pharmacy professional identifies a deficiency in procedure or a potential area for improvement, this information should be brought to the attention of the sterile compounding supervisor so they can consider updating the procedure, when necessary.
The quality, efficacy and absence of contamination of the final compounded sterile preparation depends upon, among other standards, full compliance with appropriate procedures. It is the responsibility of the sterile compounding supervisor to establish written policies and procedures for all sterile compounding activities and it is pharmacy professionals’ responsibility to follow them.
Pharmacy professionals are encouraged to review their sterile compounding practice using the ”Policies and Procedures”section of the Sterile Compounding Review Form to identify gaps or areas for improvement.
Stay tuned for the next PRP Insights Sterile Compounding Mini-Series article – Gloved Fingertip Sampling and Media Fill Testing.
To learn more about the Practice Review Program, including how to prepare for your review, visit: