Seeking Feedback on Proposed Implementation Timeline for NAPRA's Sterile Compounding Standards
Following an extensive consultation process, the National Association of Pharmacy Regulatory Authorities (NAPRA) has approved national standards for pharmacy compounding of hazardous and non-hazardous sterile preparations. The Ontario College of Pharmacists is expected to adopt these standards at their September 2016 Council meeting.
Current pharmacy practice for the preparation of sterile products in Canada includes many of the same patient safety and quality assurance requirements as these new standards. However, there are some additional requirements in the new standards, including an onsite quality assurance program, increased oversight, beyond-use-dates, recall procedures, and more.
Since some pharmacies may require additional time to become fully compliant with these new standards, the College is proposing a two-year implementation timeline. Assuming Council approves the adoption of the standards in September 2016, all pharmacies in Ontario that are engaged in compounding hazardous and/or non-hazardous sterile preparations would be required to be fully compliant with the NAPRA standards by September 2018.
Pharmacies currently engaged in sterile compounding are expected to review these new standards, identify any gaps in current practice and establish an action plan to ensure full compliance on or before the proposed timeline.
The College is currently seeking your feedback regarding the proposed two-year implementation timeline.
To help ensure feedback is focused and constructive, please read the “Points to Consider” and ”Common Questions” sections below prior to responding. For easy reference, links to the NAPRA standards are provided:
- Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations
- Standards for Pharmacy Compounding of Hazardous Sterile Preparations (approved but still in draft form awaiting French translation)
Points to Consider
The College is seeking feedback with regard to the two-year implementation timeline only. The NAPRA standards for pharmacy compounding of hazardous and non-hazardous sterile preparations are finalized. No further feedback or changes to the standards are being sought.
- Is two years enough time for pharmacies engaging in compounding hazardous and/or non-hazardous sterile preparations to:
- Review the NAPRA standards and identify any gaps in the pharmacy’s current practice
- Establish an action plan to become fully compliant
- Implement the plan and meet the NAPRA standards
- If two years is not enough time to complete these tasks, why? How much time would be required?
- What challenges would pharmacies face in order to meet the proposed implementation timeline of two years?
Would the pharmacy have to demonstrate that we are working toward compliance within the two-year period?
Yes. When College practice advisors visit the pharmacy for routine assessments, they will ask for details about the plans and progress the pharmacy has made in becoming fully compliant with the standards.
What if the pharmacy determines we can’t meet the NAPRA standards?
Any pharmacy that determines they are unable to meet the NAPRA standards should create a plan to discontinue the service in a way that ensures patients have continuity of care.
Will pharmacy assistants be permitted to work in this area?
Yes, it is recognized that well-trained and experienced pharmacy assistants may continue to work in this area and participate in compounding activities. As unregulated health professionals, however, it is expected that the pharmacist in charge of compounding will ensure that the assistant is sufficiently qualified and supervised, and that the assistant does not perform any activities which fall within a regulated health professional’s scope of practice.
Will office use preparation be permitted?
Yes. Any sterile compounding practice that currently prepares substances for office use can continue to do so within the context of these standards and the federal legislation.
Is any training required?
It is expected that any pharmacy providing sterile compounding will employ pharmacy professionals whose education, training and/or experience have prepared them to offer this practice and that restricted activities are performed by pharmacy professionals within their scope of practice. Pharmacy professionals are not required to register training with the College. The process of identifying national compounding competencies is underway, and will eventually lead to the accreditation of continuing education in this specialized area by the Canadian Council on Continuing Education in Pharmacy (CCCEP).
An Ontario Expert Working Group comprised of pharmacy professionals currently working within the area of sterile compounding met recently to discuss the implementation of the standards. The working group proposed that the NAPRA standards be adopted and implemented in Ontario, in parallel with the official implementation of USP 800 in the United States. The group also recommended that the College consult with pharmacy professionals on the time required to implement the standards.