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 OCP 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.
After an assessment, the designated individual receives an email with detailed instructions on how to access the Quill software system to respond to the requested action plan. Each issue identified during the assessment will be presented as an ‘Infraction’.
The action plan submitted must address the issues identified in enough detail, clearly outlining the steps taken to mitigate risk, optimize patient outcomes and sufficiently rectify the infraction. The response to each item should be concise, specific, achievable, and realistic with a defined implementation timeline. If sufficient detail is not provided, the operation advisor will communicate back using Quill requesting further information.
The action plan is required to be submitted 30 days from the date of the assessment; however, an ongoing collaborative dialogue may occur as the operation advisor supports achieving full compliance. It is the responsibility of the pharmacy/organization to continue to review their active infractions and status on an ongoing basis until the issues are appropriately addressed.
The College has oversight of hospital pharmacies and assesses them to ensure that a safe medication management system is in place. The Drug and Pharmacies Regulation Act, s.119, defines a hospital pharmacy as “the primary location or locations in the hospital where drugs are compounded, dispensed or supplied from for hospital patients by a hospital, together with any other location in the hospital where drugs are stored or supplied from.” Therefore, if the hospital has medications for injectable use, then the sterile requirements would apply. If a hospital is receiving any compounded preparations from other sites or external sources, they must ensure that all compounded preparations received meet NAPRA requirements and have been maintained at the proper temperature during transport.
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 NE 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)
