The second Sterile Compounding Advisory Group meeting focused on a more in-depth exploration of the discussion topics and challenges identified in the preceding session. The group actively deliberated on significant challenges associated with achieving compliance with the NAPRA compounding standards and evaluated commonly available public resources and their utility in practice. Notable discussion points and salient feedback garnered during this meeting are presented below.
- Training and competency assessment
The group discussed concerns pertaining to the lack of clarity surrounding training requirements for pharmacy managers, the Sterile Compounding Supervisor (SCS), pharmacy staff, and the role of a third-party evaluator (TPE). The group noted the importance of using the title “third-party evaluator” (a pharmacy professional with expertise in sterile compounding, positioned at arm’s length from the facility/pharmacy and free of any real or perceived conflict of interest when performing training and/or competency assessments), versus “third-party certifier” for alignment with the nomenclature in the Standards.
The group examined the NAPRA standards, which stipulate that a SCS undergo formal training (i.e., certificate courses) in the compounding of sterile preparations, and maintains the competency to supervise the sterile preparation compounding practice according to the standards. To this end, the SCS is responsible for overseeing the initial training and competency assessment program; the SCS can assign the training portion of the program to a pharmacy professional on the team while continuing to perform the assessment portion or, alternatively, assign both the training and assessment of personnel to a TPE. There was consensus among the group, that while the NAPRA compounding standards provide a robust framework of the competency assessment program, the training provided at each facility should be tailored to meet the needs of the specific compounding services offered at the practice site.
The significance of having the SCS’s competencies evaluated by a TPE was also discussed. Group members raised concerns about SCSs who may not be directly involved in day-to-day compounding but are still expected to undergo a competency assessment. Questions regarding the relevance of certain assessment (quality assurance) activities, such as media fill tests and glove fingertip sampling were posited, accompanied by considerations of the associated time and cost implications.
The group evaluated the utility of related OCP resources, such as articles and FAQs, to help the College ensure they are meeting the needs of pharmacy professionals. The group acknowledged their use of the College’s existing FAQs regarding training and competency assessments; however, the group maintained that additional clarity or re-circulation is needed on some topics.
Members discussed the challenges with the delegation of compounding in different practice settings, examining the role of the pharmacist as the ‘authorizer’ of the delegation and emphasizing the need for clarity on the OCP Policy- Medical Directives and the Delegation of Controlled Acts within the context of compounding. There was consensus that the definition of the term “regular practice” as defined in the Policy is subject to interpretation, creating uncertainty about how it can be practically quantified and applied. The group acknowledged that although the NAPRA standards indicate technical tasks related to sterile compounding can be assigned to unregulated staff using a formal delegation process, a pharmacy technician is prohibited by legislation from delegating a controlled act. The group noted that many practice sites face challenges with this, particularly in remote areas where there may be a lack of pharmacists and pharmacy technicians. The group further highlighted that in certain practice environments, pharmacists have limited day-to-day involvement in the physical, ‘hands-on’ act of compounding, creating uncertainty as to the appropriateness of delegating. The discussion highlighted the need for collaborative approaches and potential consideration of a Policy review and re-circulation of the Pharmacy Connection article entitled “Navigating Delegation of Controlled Acts”.
Members acknowledged that while the NAPRA standards provide extensive guidance on beyond-use dates (BUDs), extending the BUD necessitates the consultation of additional resources. The group discussed the extent to which pharmacy professionals rely on internal or external testing and data interpretation to establish or extend BUDs. While there was consensus that Table 7 in the standards is commonly used for ‘default’ BUDs, members also highlighted their selection and use of other resources. A notable concern was raised regarding the interpretation of the BUD definition, particularly in relation to infusion end times and storage times. A key insight from the discussion emphasized the importance of providing pharmacy professionals with the necessary training and resources to effectively establish BUDs and the need to achieve clarity and consistency when interpreting the NAPRA standards and the current OCP Guideline – Extending the Beyond-Use Dates for Sterile Preparations.
The group also delved into the skill set required for interpreting stability data and establishing BUDs. While the majority disagreed with the notion that only pharmacists possess the scientific knowledge required for this task, some members noted that pharmacists have traditionally taken on this responsibility in clinical settings. However, it was acknowledged that with the right training and resources, pharmacy technicians could play a more active role in determining BUDs, working in collaboration with pharmacists.
- Closed system drug transfer devices
The meeting provided valuable insights into the potential benefits and challenges associated with closed system drug transfer devices (CSTD). It was acknowledged that NAPRA compounding standards do not currently address this topic in great detail and that there is a need for additional guidance; some public resources were referenced, including the CDC, NIOSH, CADTH, and Cancer Care Ontario.
The group discussed using CSTD to extend beyond-use dates (BUDs) in addition to their primary role in ensuring the safe handling of hazardous drugs. The group noted that a CSTD should be used in conjunction with, and not a replacement for, other engineering controls to reduce risk to the compounder. Concerns were raised about the applicability of CSTDs in high-risk compounding scenarios (e.g., making sterile preparations from non-sterile ingredients or when ingredients not initially present within the closed system). The group speculated on a cost-savings potential in certain hospital settings, particularly for partially used vials of costly drugs.
Members also discussed challenges related to testing these devices in different ‘clean room’ settings. The group shared insights on conducting sterility testing and expressed concerns about non-compliant clean rooms affecting testing validity. The group suggested that there may be a need to establish guidelines for testing quantities, timelines, and limits.
