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Update from council

December 14, 2016

Council convened December 5-6, 2016 in Edmonton and will reconvene again on March 2-3, 2017. Following are highlights of council’s December deliberations:

Model Compounding and Repackaging Agreement – The agreement required between Compounding and Repackaging Pharmacies was further amended by replacing reference to the narcotic control regulation with reference to the Controlled Drugs and Substances Act. Except in emergencies, a compounding and repackaging pharmacy MUST NOT compound or repackage any drug, or combination of drugs, listed in the schedules or regulations to the Controlled Drugs and Substances Act. Council extended the deadline for when Compounding and Repackaging Pharmacies must establish new agreements with licensed pharmacies, to whom they provide services, to February 1, 2017.

Vision 2025 – ACP and RxA have worked over the past year to develop a vision for pharmacy practice in Alberta over the next 10 years. The DRAFT vision was further amended to incorporate suggestions received from CSHP-AB branch. Prior to finalizing the document, we will be incorporating suggestions received from external stakeholders. ACP, RxA, PTSA, and CSHP-AB branch look forward to socializing this vision with pharmacists, pharmacy technicians and other key audiences in 2017.

Budget and Business Plan 2017 – council approved the budget and business plan for 2017, taking into consideration projections for 2018-19. There will be no increases to ACP’s fee schedules, meaning that registration and annual permit renewal fees remain at 2016 levels. Priorities ACP will address in 2017 include:

  • Implement a new information management system to administer/manage basic requirements for core programs: registration, competence, professional practice, complaints resolution; o Pilot and be prepared to implement an audit process for the pharmacy technician competence program; o Receive council approval on proposed amendments to the Pharmacist and Pharmacy Technician Regulation and the Pharmacy and Drug Regulation; o
  • Develop program content, develop delivery polices and strategies, pilot and receive council approval for a pharmacy licensee program (watch for more information to come);
  • Implement phase one and phase two of Standards for Compounding Sterile NonHazardous Preparations; o Engage with at least 500 registrants, either through in-person meetings and/or through electronic solutions that facilitate dialogue and discussion about selected subjects.
  • Watch in early 2017 for a copy of ACP’s Strategic Plan, and the five strategic goals of council. 

Appointment to PEBC Board of Directors – Kaye Moran was appointed for a second three-year term, as ACP’s appointee to the PEBC Board of Directors. Kaye currently sits on the Executive Committee of the Board.

Model Standards for Pharmacy Compounding Hazardous Sterile Preparations – council approved NAPRA’s Model Standards for Compounding Hazardous Sterile Preparations, with the following amendments: 

  • Page 37 – Table 5 – that an N95 or N100 NIOSH approved mask is not required when compounding hazardous products in a biological safety cabinet or compounding aseptic containment isolator. REASON: council felt that USP 800 was not specific enough respecting when such masks were required, and was satisfied that when compounding in a BSC or CACI, that adequate protection was provided to pharmacy personnel.
  • Page 38 – Section 5.5.3 (Uniform) –pharmacy personnel compounding hazardous products in compliance with these standards, are not required to wear clean room scrubs. REASON: council could not find evidence to support the need for wearing clean room scrubs.

    Council determined the timeframe for implementing this standard, along with the approved standard for Compounding Sterile Non-hazardous products should be the same. Therefore, the new timelines for complying with the standards for Compounding Sterile Hazardous and Non-hazardous Products are:

    • Phase 1 – July 1, 2018
    • Phase 2 – January 1, 2019
    • Phase 3 – To be determined. 

      Model Standards for Pharmacy Compounding Non-sterile Preparations – council received and reviewed comments received in a consultation process with registrants, stakeholders, Alberta Health, and Alberta Health Services. Comments have been forwarded to NAPRA’s National Advisory Committee on Pharmacy Practice charged with developing a national model standard. The committee will consider comments from across Canada, and will provide recommendations to the NAPRA Board in 2017. Once a national model is approved, ACP’s council will deliberate adopting the model as approved, or in an adapted form.

      Naloxone – council supported a proposal from the Minister to reschedule Naloxone to unscheduled status. This will make Naloxone more readily accessible to first responders, community support groups, other health professionals, and families. Please watch for further notice should rescheduling occur.

      Medical Assistance in Dying (MAID) – the MAID protocol for euthanasia recommends that pharmacists provide the drugs in a ready-to-use format. Council approved the following guidance for pharmacists and pharmacy technicians who pre-fill syringes for the MAID euthanasia protocol

  • Whenever possible, the pre-filling of syringes with drugs for the euthanasia protocol should occur in a sterile environment;
  • If a sterile environment is not accessible, then aseptic technique may be used
  • If aseptic technique is used, then: Syringes should be pre-filled as close to the arranged, pick-up time by the prescribing physician or nurse; and, Syringes MUST not be filled more than 24 hours in advance of the planned time of administration
  • Pharmacists and pharmacy technician must ensure that filled syringes are securely stored in an appropriate environment to ensure stability

    CPSA Standards for Safe Prescribing and Supervising Restricted Activities – council supported DRAFT standards proposed by CPSA for safe prescribing and supervising restricted activities. The DRAFT standards introduce requirements ACP already expect of pharmacists. CPSA council consider feedback received during the spring of 2017, prior to approval and implementation.

    NAPRA Governance – council received a presentation from Anjli Acharya, NAPRA president, proposing changes to NAPRA’s governance structure. The recommendations resulted from an external governance review conducted by NAPRA, including a review of structures used by other national coalitions of health regulators. NAPRA will be deliberating changes to its governance structure in April 2017.

    Discussion with Deputy Minister Carl Amrhein – council was privileged to have a 90- minute discussion with Dr. Amrhein. In his opening comments, Dr. Amrhein paraphrased a speech made by the Minister of Health to the Accelerating Primary Care Conference in November. While many topics were covered, some of the sentinel topics were:

  • Government welcomes new ideas and alternatives for improving access to health services, within the constraints of a restricted budget;
  • The future of healthcare is in community practice;
  • Pharmacy needs to contextualize its role in health promotion, disease prevention, and the delivery of care, as it would be seen and consistently experienced by Albertans in an integrated, community based system.

Originally published in the December 14, 2016 issue of The Link