Feedback for Seeking Feedback on Proposed Implementation Timeline for NAPRA's Sterile Compounding Standards

Canadian Society of Hospital Pharmacists - Ontario Branch  ·  June 30, 2016

The Ontario Branch of the Canadian Society of Hospital Pharmacists (CSHP-OB) welcomes the opportunity to provide feedback regarding the proposed two-year timeline to implement the National Association of Pharmacy Regulatory Authorities (NAPRA) national standards for pharmacy compounding of hazardous and non-hazardous sterile preparations. CSHB-OB both welcomes and fully supports the Ontario College of Pharmacists (OCP) adoption of the national standards for pharmacy compounding, as this would enhance patient safety. CSHB-OB further would like to recognize OCP for providing a reasonable proposed timeline for all pharmacies to be fully compliant with the national standards for compounding of sterile preparations. CSHB-OB concurs with OCP that additional time will be required to become fully compliant with these standards. From the hospital pharmacy perspective, CSHP-OB agrees that the proposed 2-year timeline from the date the NAPRA standards are adopted by OCP council is reasonable for hospital pharmacies to identify any gaps in current practice, establish an action plan, and implement process and procedural changes to meet the requirements. CSHP-OB has also reached out to its members for their feedback on the proposed timeline. Our members have expressed some concerns which CSHP-OB feels we should share with OCP.

Feedback from CSHP-OB members:

Any structural changes to meet standards may not be possible in many cases within the 2 year proposed timeline. The contract to make structural changes will have to go out for tender which could take 6-8 months to be awarded through the procurement process before any renovation or construction begins. Securing capital for major structural changes may also be challenging within this time frame. The Request for Proposal (RFP) process along with capital approval will likely not leave adequate time for planning, designing, construction and implementation.  Hospital pharmacies and facilities that do not have a strong pharmacy presence or leadership may have a more difficult time meeting the timelines Architectural standards for designing sterile compounding facilities are developing and may be misinterpreted if the process is hurried. The NAPRA national standards are functional standards. To help facilitate the transition to meet the NAPRA national standards for pharmacy compounding, CSHB-OB recommends the following: 1. Require all pharmacies to ensure process/procedures in preparing sterile preparations meet NAPRA national standards within the 2 year proposed timeline. OCP can require pharmacies to provide: a. Evidence of staff being trained/certified and meeting NAPRA compounding competencies b. Documentation of process compliance and appropriate sterility testing to show compliance with NAPRA national standards for compounding 2. Require all pharmacies to have, at minimum, a detailed action plan in place with secured funding for implementing structural changes within the 2-year proposed timeline. 3. Provide additional time beyond the 2-year proposed timeline for structural changes to be completed. This extended timeline can be site specific depending on the complexity of the changes required.

CSHP-OB will continue to work with provincial partners to advocate to the Ministry of Health and Long Term Care to make this issue a provincial priority and for increased funding for hospital pharmacies to meet the NAPRA national standards for pharmacy compounding. There will be a huge financial impact for the entire province at a time when hospital funding is not increasing. CSHP-OB also believes this is an opportunity for the Local Health Integration Networks to regionally support hospital pharmacies by securing services of experts in NAPRA national standards for pharmacy compounding and design/implementation of sound architectural sterile compounding rooms to cohesively meet the timelines. We hope our feedback will be of value to OCP. Please do not hesitate to reach out for further questions or clarifications regarding our feedback.

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