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

WWLHIN Pharmacy Council  ·  June 27, 2016

WWLHIN Pharmacy Council response for feedback to NAPRA standards implementation by September 2018

Feedback deadline: June 30, 2016 Background Summary from OCP 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:


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. 1. Is two years enough time for pharmacies engaging in compounding hazardous and/or non-hazardous sterile preparations to: o Review the NAPRA standards and identify any gaps in the pharmacy’s current practice GRH has been working on addressing the NAPRA standards since the renovation of our inpatient pharmacy sterile room. Meeting the NAPRA standards for the inpatient pharmacy sterile room would be possible by the proposed September 2018 timeline as many of the NAPRA standards have been implemented. Work is in progress that includes post-construction sterile room remediation, additional training of personnel involved in sterile compounding, enhanced environmental cleaning and environmental and personnel testing. With the experience gained from the inpatient pharmacy and with the NAPRA and USP <800> standards approved, a two year timeline to identify gaps for the preparation of hazardous products in the Grand River Regional Cancer Centre (GRRCC) Pharmacy is feasible.

o Establish an action plan to become fully compliant GRH has a plan to addressing the existing gaps for the NAPRA standards for our inpatient pharmacy sterile room. Work is in progress that includes post-construction sterile room remediation, additional training of personnel involved in sterile compounding, enhanced environmental cleaning and environmental and personnel testing. We have encountered some challenges in sourcing, at a reasonable cost to the operating budget, the required supplies to support the standards. As more sites are required to meet these standards, it is anticipated that more vendors will be available on the Canadian market to provide supplies to meet the standards, at a more competitive price. With the experience gained from the inpatient pharmacy and with the NAPRA and USP <800> standards approved, a two year timeline to develop an action plan for the preparation of hazardous products in the Cancer Centre Pharmacy is feasible. o Implement the plan and meet the NAPRA standards Since a lot of work has been done on the inpatient pharmacy non-hazardous sterile compounding, two years is feasible to meet the NAPRA standards. However, GRH also has the regional Cancer Centre. The sterile room in the Cancer Centre will require extensive renovations to meet NAPRA and USP <800> standards. A two year timeline for meeting these standards is not sufficient for several reasons: - Capital has already been approved for the 16/17 fiscal year. The call for 17/18 capital will not occur until the fall of 2016 and Board approval will not occur until March 2017. - The hospital must replace its hospital information system. This replacement will require a significant capital investment which will make it difficult to fund other capital requests. - Work on the hospital HIS replacement is the most critical project to be completed by the pharmacy before April 2018. Many resources will be dedicated to this project which will be difficult to resource for the Cancer Centre Pharmacy renovations and NAPRA standard implementation. - Implementation of other OCP hospital pharmacy standards requires resources, whether personnel or minor capital. - Once capital is approved, extensive consultation will be required to determine appropriate facilities design to meet the standards. Due to BPSA, procurement for consultants will take several months. - Renovation plans need to be approved by the MOHLTC due to the anticipated dollar cost involved. From experience, this approval may take several years, even if no funding from the MOHLTC is requested. - Once renovation approval is granted from the MOHLTC, a tender needs to be created for the renovation work. This takes several months. - Renovation planning will be required to maintain service to the Cancer Centre patients while decanting production elsewhere, potentially to other WWLHIN partners. If all sites are working towards the same timelines, it may reduce capacity to assist. - Other priority projects and medication safety initiatives as well as hospital OCP and Accreditation Canada work will be required during this timeline. - Even if a pharmacy decided to completely outsource the sterile compounding, due to the BPSA, this process would require up to a year to procure and complete a contract. GRH is working on this process at present for a subset of products and it has been very difficult and time-consuming in working with Purchasing to determine the best process under BPSA.

  1. If two years is not enough time to complete these tasks, why? How much time would be required? For the reasons outlined above two years would not be enough time to complete the hazardous drug compounding action plan for the Grand River Regional Cancer Centre Pharmacy. Five years is a more reasonable timeline for GRRCC.
  2. What challenges would pharmacies face in order to meet the proposed implementation timeline of two years? Pharmacies face the following challenges in meeting the proposed two-year timeline:
  3. Time required for capital approval, procurement, consultation, and implementation
  4. Competition for scarce resources (e.g capital budget, personnel)
  5. Competition for other medication safety improvements/initiatives (e.g. implementation of other OCP hospital standards, Accreditation Canada Managing Medication standards and Required Organizational Practices, etc)
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