Practice Topics > Compounding – Sterile Practice Topic
PRACTICE TOPIC

Compounding – Sterile Practice Topic

The College adopted the NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations, following approval at the September 2016 Board meeting with an implementation date of January 1, 2019.

These standards apply to all pharmacy professionals in all practice settings that engage in sterile compounding in any capacity and are an important way to ensure patient safety and protect pharmacy personnel.

Pharmacy compounding of sterile preparations is a high risk activity which requires comprehensive standards to ensure overall quality and safety. The Designated Manager/department head must ensure, with the best interest of the patient in mind, that the pharmacy has the resources necessary to compound a preparation of good quality in a safe and appropriate manner. Knowledge of the environment in which these preparations are compounded, training of personnel, policies, procedures and quality assurance processes, as well as standards for facilities and equipment are required to protect patients.

STANDARDS, POLICIES AND GUIDANCE

COLLEGE RESOURCES

FAQs

  • A third party evaluator (TPE) must meet the criteria set out in section 5.1.2.4 of the NAPRA Model Standards for Pharmacy Compounding Sterile Preparations.

    The College does not evaluate or approve pharmacists or pharmacy technicians who wish to take on this role. It is the responsibility of the sterile compounding supervisor and Designated/pharmacy manager to do their due diligence and ensure the TPE meets the NAPRA Standards. To effectively “fulfill the mandate” and achieve the intended outcome of the standards, the TPE should possess knowledge and skills which correspond with the nature of the compounding practices being evaluated (e.g., experience with high-risk levels of contamination, handling of volatile drugs, with any specialized equipment or technology used, etc.).

  • Determining the specific details of policies and procedures is the responsibility of the sterile compounding supervisor and Designated/pharmacy manager. The College does not approve a pharmacy’s operational procedures and policies.

    Registrants are encouraged to collaborate with other pharmacy professionals in their region to share best practices and operational advice. Other resources include the references provided in the Standards, other reputable/recognized organizations and professional associations. During an assessment, College operations advisors will identify and discuss any concerns. The College’s approach focuses on achieving intended outcomes using risk mitigation strategies.

  • Continuing education providers are listed on the College's website as a courtesy; the list is not exhaustive and does not imply the program and its content have been reviewed or endorsed by the College. The Designated/pharmacy manager and/or sterile Compounding Supervisor should confirm that any training or certification program completed by compounding personnel meets the competencies needed for their specific practice.

  • The College collaborated with the North East LHIN ’s Hospital Pharmacy Peer Group to develop an integrated strategy for hospital pharmacy medication management services as a region. The North East LHIN Regional Pharmacy Strategy was published on July 2018 and provides a framework to guide LHINs and hospitals to work together to make regional decisions that will ensure hospitals, as a region, collectively provide medication management services according to standards. The strategy acknowledges the importance of broader medication management practices but focuses on sterile compounding and prioritizes patient safety through the critical elements, patient access to services and optimizing volume of service delivery as a region. LHINs and hospitals may choose to use this framework to inform a coordinated regional approach to capital funding requests that accurately reflect the needs of the region. If LHINs and hospitals determine that there is a need for capital investments after going through the process outlined in the strategy, a LHIN-coordinated submission to the Ministry of Health for funding is recommended. 
     
    (LHIN = Local Health Integration Network. As of April 2021, Ontario’s LHINs have transitioned to Ontario Health as Home and Community Care Support Services)

EXTERNAL RESOURCES

Print page