Guidance for Feedback on NAPRA Consultation: Compounding Competence

Changes to the requirements for practical knowledge of compounding in Canada has resulted in a change in direction for pharmacy technician education. In October 2024, the National Association of Pharmacy Regulatory Authorities (NAPRA) published the updated Entry to Practice (ETP) Competencies document, which outlines these changes. Pharmacy professionals are required to have practical and theoretical knowledge of non-sterile, non-hazardous compounding at entry-to-practice. Additional education/training and authorization will be required for practicing sterile and hazardous compounding.

The Pharmacy Technician Society of Alberta (PTSA), Pharmacy Technician Society of British Columbia (PTSBC) and Canadian Association of Pharmacy Technicians (CAPT) oppose these changes. Despite providing feedback on behalf of pharmacy technicians, NAPRA continues to move forward with this change and has agreed upon an approach to compounding competence.

A consultation document has been prepared by NAPRA to guide the Pharmacy Regulatory Authorities (PRAs) in each province in ensuring competence in sterile and hazardous compounding. The goal of this consultation is to assess the proposed plan the PRAs will use in implementing the new direction. Requirements may differ across Canada because PRAs will implement the plan in their specific jurisdiction and may formally require completion of, or may recommend, an accredited education/training program.

A working group consisting of representatives from PTSA, PTSBC and CAPT have responded to NAPRA’s consultation survey. Below are the questions you will find in the NAPRA Survey with feedback prepared by the working group to support you in responding as individuals. Downloadable copy of the: Guidance for Feedback on NAPRA Consultation

Copy and paste the feedback into your individual survey response. You may share the feedback in its entirety or select certain points, but your participation is essential to help the PRAs understand the needs and realities of our profession.

The survey closes on Sunday, March 15^th at 9:59pm MDT.

CONSULTATION SURVEY

Survey Questions:

1. Are you responding as an individual/individual pharmacy or on behalf of an organization?

• Choose Individual

2. Please indicate your name. (this is required information)

3. Please select the category that best describes you:

• Choose the best description from many options

4. If you would be willing to discuss any of your responses, please provide your contact information: (this is optional)

5. Please share feedback regarding the proposed Guidance for education accreditors:

I oppose changes that will eliminate opportunities for pharmacy technicians to be prepared with formal practical education in sterile and hazardous compounding at the time of entering practice.

• These changes will result in disparities within the workforce, that may ultimately affect patient care.

I agree that ensuring only individuals with the appropriate competencies are engaged in practicing, and educating about, compounding. As such:

• Pharmacy technicians are compounding experts and should be teaching education/training programs for sterile and hazardous compounding.
• Those teaching the sterile and hazardous compounding programs need to be authorized in the applicable aspect of compounding with a current competency assessment, not simply be experienced in the field.

I agree offering supplemental training/education in modular components is an ideal solution for experienced pharmacy professionals desiring to change their focus in compounding. However, I am concerned about separating sterile from hazardous compounding in supplemental education because:

• Easy access opportunities for pharmacy professionals seeking new training/education beyond ETP may be limited. For consistency, it is recommended that both sterile and hazardous compounding programs be offered from the same purveyors.
• Education/training programs that are developed modularly will need to ensure all components are accredited. Hazardous and non-hazardous skill sets are not easily separated from a practical perspective, and education/training may be redundant impacting individuals’ time and financial resources.

Education/training experiences must be of adequate “intensity, breadth, structure and duration” to ensure individuals are prepared to successfully complete compounding competency assessments. To ensure the quality and precision of supplementary programs:

• There should be a minimum number of hours required to sufficiently achieve the required competencies, that reflects current state ETP program requirements, for individuals seeking education/training beyond ETP.
• Training/education offered beyond ETP programs must reinforce, but not duplicate, the theoretical knowledge already obtained.
• Practicing pharmacy professionals will not require the same approach as individuals new to compounding practice, so consideration should also be given to incorporating a competency-based education (CBE) approach. CBE could distinguish between learners who are new to the activity and those who have experience – focusing on demonstrating proficiency rather than a fixed hour range.
• Individuals should have the opportunity to complete a competency assessment acceptable to the PRA during the program using real working equipment but should also be able to choose to do this in a practice environment. Assessors in both situations should meet national qualifications/criteria.
• Education must be mapped to the NAPRA Model Compounding Competencies for Pharmacists and Pharmacy Technicians in Canada, not just the Professional Competencies for Pharmacists and Pharmacy Technicians at Entry to Practice in Canada (as linked in the consultation document).

6. Please share feedback regarding the proposed National List of Qualifications/Criteria for Assessors (compounding supervisor assessors and third-party assessors):

I agree that assessors must be registered pharmacy technicians or pharmacists authorized to practice in the types of compounding they will be assessing, but I am concerned that the overarching approach will result in an inadequate number of qualified assessors to meet demand, especially during subsequent years of implementation. As a result,

• I strongly urge NAPRA to re-evaluate the exclusion of sterile and hazardous compounding in ETP competencies.

7. Please share feedback regarding the Potential implementation timelines:

The proposed timeline is extremely aggressive. I agree issues will arise if the timeline slips; however, to ensure the approach is effective, introduces the least amount of burden on the profession and practicing professionals, and maintains the integrity and quality of patient care:

• PRAs must not proceed with planning or decision-making regarding the implementation components without the meaningful involvement of pharmacy technicians, whose scope of practice are directly impacted by these decisions. Decisions made without pharmacy technician participation risk overlooking critical practice realities.
• Pharmacy technician ETP program curriculums, and the CCAPP standards for their accreditation, must not be changed to exclude practical training/education components for sterile and hazardous compounding. Rubrics for supplemental training programs should be created separately from ETP program rubrics.
• Schools must ensure that students are made aware that completion of the ETP program may not qualify them to practice sterile or hazardous compounding, and supplemental education may be required. Changes may affect career opportunities in certain practice settings, such as hospital pharmacies, where the majority of pharmacy technicians are required to sterile or hazardous compound.
• Current pharmacy technician programs include education and practical training in sterile and hazardous compounding; therefore, any supplemental education/training and/or authorization, must not be required until such a time this is no longer available.
• While non-regulated pharmacy employees are enabled to complete sterile and hazardous compounding activities in some jurisdictions, they do not have the foundational knowledge and competencies of pharmacy technicians and pharmacists. PRAs must consider how the approach will be applied to registered pharmacy professionals, pharmacy technician/pharmacist candidates, and non-regulated pharmacy employees, recognizing that different approaches are appropriate to reflect different levels of expertise.

8. Submit your responses.

FOR INFORMATION: Various documents are available for your review, should you be interested in further details.

The Model Compounding Competencies for Pharmacists and Pharmacy Technicians in Canada were published in 2022 by NAPRA. Additionally, the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations were published in 2015 and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations were published in 2016.

There is an additional Consultation regarding the Model Document for Pharmacy Regulatory Authority Use – Non-sterile Compounding Standards and Model Document for Pharmacy Regulatory Authority Use – Sterile Compounding Standards. This consultation can be found here: CONSULTATION DOCUMENT for PRAs for Non-sterile and Sterile Compounding Standards. The sterile compounding standards include both non-hazardous and hazardous compounding.