Board Highlights – April 21, 2017
Highlights from this meeting include the establishment of an Application Committee; approval of a four-year recommended implementation plan for new compounding standards for pharmacies; changes to both Health Professions Act and Pharmacy Operations and Drug Scheduling Act fee schedules; bylaws that address telepharmacy; committee appointments and terms of reference; a Governance Committee update; and a presentation on the scope of the work being done to bring in the new pharmacy ownership requirements.
You can re-watch all the April Board meeting presentations through the College’s Periscope Channel.
GOVERNANCE COMMITTEE UPDATE
Public Board Member and Chair of the Governance Committee, Norm Embree provided an update on the activities of the Governance Committee since the previous Board meeting.
The Governance Committee met by teleconference on March 22 where they discussed the following items:
- The effectiveness of existing committee structures and the recruitment of new registrant and public members as well as a desire to move towards Board members chairing all committees in an effort to streamline communication back to the Board.
- Initiating a Board self-evaluation to begin in 2018 and continue on an annual basis with the results provided at each June Board meeting. It was agreed that Phase 2 of the Ernst & Young review will serve as the self-evaluation for 2017.
Norm Embree - Chair of the Governance Committee also notified us that Ernst & Young’s survey of the Board had been completed and that they are currently working on analyzing the data to formulate key themes and findings. It is anticipated a draft will be ready for review by early May.
Committee Appointments and Terms of Reference
The College Board approved the committee appointments recommended by the Governance Committee.
College committees are a vital resource to the Board that provide essential advice, expertise, and recommendations that ultimately inform Board policies and decisions. This year the College issued a call for applications from pharmacists, pharmacy technicians and the public and received an overwhelming response of over 75 applications.
Volunteers were reviewed by the Governance Committee and the following factors were considered in recommending appointments:
- Composition requirements from terms of reference
- Type of practice (community/hospital/others)
- Previous/type of volunteer experience
- Geographic area of practice
- Specialty areas of practice
- Relevant education
- Technician and pharmacist balance
- Continuing and new member balance
Appointments will be announced on the College’s website. The College would like to thank everyone who applied for their interest contributing in to the College’s committees.
Updates to the Committee Terms of Reference
In addition to the committee member appointments, an amendment to the terms of reference for all committees was approved by the Board. The change is minor and consistent with previous Board direction to change terms of office to three years from two years and remain at a maximum of six years in total.
The Board also approved changes to the Drug Administration Committee Terms of Reference to align with what already exists in legislation under section 18 of the Health Professions Act bylaws. Previously, legislation was passed that expanded drug administration to include by intranasal route, however, the terms of reference was not updated to reflect that change.
The Board approved the allotment of $50,000.00 to hire an external consultant to work with the Registrar to develop a comprehensive evaluation of his performance. This will begin an annual evaluation process for the Board to assess the Registrar’s performance.
The Board approved the four-year recommended implementation plans to adopt the model standards for pharmacy compounding, recently released by NAPRA: the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.
In order to officially adopt the new model standards, the Board directed the Registrar to draft bylaws to adopt the Model Standards which will establish minimum requirements for compounding sterile preparations in BC.
The new bylaws will come into effect in May 2021. However, pharmacies and pharmacy professionals who compound sterile preparations will want to follow the four-year phased approach to ensure they meet the new requirements by May 2021.
Compounding, with respect to drugs and medications, is defined as the mixing together of individual ingredients in personalized strengths and dosage forms. Evolving practice as well as the increased awareness of the risks of compounding sterile preparations on the health of both patients and compounding personnel led the National Association of Pharmacy Regulatory Authorities (NAPRA) to develop new model standards for pharmacy compounding. These model standards will set national standards for pharmacy compounding and are expected to be adopted by pharmacy regulatory authorities across Canada.
To inform the adoption and implementation of the two released Model Standards, the College developed a multi-step engagement process. This included:
- An online survey sent to pharmacy managers to determine how many pharmacies (community and hospital) were engaged in non-hazardous sterile compounding, hazardous sterile compounding and non-sterile compounding.
- A Gap Analysis Survey sent to pharmacy managers, pharmacists and pharmacy technicians to determine any gaps in practice in meeting the minimum Model Standards. The Gap Analysis Survey allowed pharmacy managers, pharmacists and pharmacy technicians to determine how their current-day practice meets or does not meet the standards indicated in the model standards.
- A workshop style engagement session with pharmacy managers, pharmacists and pharmacy technicians that included a review of the Gap Analysis Survey results and a series of questions to understand where potential barriers and challenges to meeting the Model Standards may exist.
- A survey for each of the Model Standards sent to pharmacy managers, pharmacists and pharmacy technicians who are involved in compounding sterile preparations (non-hazardous and hazardous). The survey was designed to understand what knowledge gaps front-line compounders might be facing and also to understand challenges and barriers from their perspective.
The input received through the engagement process and the results of the Gap Analysis Surveys, informed the recommendations, timelines and mitigation strategies for successful implementation of the Model Standards.
Approach to Implementing New Model Standards for Sterile Compounding in BC
A four-year phased implementation is recommended to bring in the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations. Each phase includes specific groupings of standards from the Model Standards.
— BC Pharmacists (@BCPharmacists) April 21, 2017
The College’s existing bylaws and policies will remain in place until May 2021 (i.e. after the four-year implementation period is complete). Once these new bylaws come into effect, all existing references to compounding standards will be repealed.
The Model Standards for Non-Sterile Preparations are still under development by NAPRA.
Stay tuned for more updates and resources coming from the College on the new Model Standards for Compounding.
HPA and PODSA Fee Changes
The Board approved amendments to the Health Professions Act Bylaws Schedule D – Fee Schedule in accordance with the College’s 2017/2018 budget.
The fee increases were approved at the February 2017 meeting as part of the 2017/2018 budget in order to meet the needs of the College.
The amended fee schedule and accompanying forms will be sent to the Ministry of Health for filing. The Health Professions Act does not require the fee schedules to have a public posting period.
The College seeks to have the majority of these HPA fee changes take effect for the January 1 – December 31, 2018 pay period. Student fee changes will come into effect for the September 2017 – August 2018 pay period in order to remain consistent with the school calendar.
Amendments to PODSA Bylaws Schedule A – Fee Schedule
The Board approved amendments to the Pharmacy Operations and Drug Scheduling Act (PODSA) Bylaws Schedule A – Fee Schedule and related forms for public posting in accordance with the College’s 2017/2018 budget.
Comments on the PODSA Bylaws Schedule A - Fee Schedule and related forms should be submitted not later than July 23, 2017.
The Board had previously reviewed these fee increases as part of their approval of the 2017/2018 budget.
In light of the loss of revenue from the Ministry of Health’s decision to transfer the College’s two PharmaNet contracts back to the Ministry of Health, the College has developed a multi-year plan that draws on reserves to help manage the immediate impact, followed by replenishment of those reserves through fee increases.
The College worked with the Audit and Finance Committee to develop a budget that allows the College to maintain momentum in implementing the 2017/18 – 2019/20 Strategic Plan, improving legislation, improving IT infrastructure, and planning for and implementing business process improvements.
In addition, at the April meeting, the College Board also approved additional changes to fees and forms with respect to telepharmacies in light of the proposed bylaw amendments to officially license telepharmacies.
Unlike the Health Professions Act (HPA), PODSA does not exempt particular bylaws (e.g. fee schedules) from the 90 day public posting period requirement. Additionally, in contrast to the HPA, PODSA does not authorize the Registrar to establish forms.
Once the 90 day public posting period is completed, both the bylaws and forms will be brought to the Board at their September 2017 meeting for filing approval. These fee increases will come into effect for the February 2018 – January 2019 pay period.
PODSA Bylaws – Public Posting (Telepharmacy)
The Board approved bylaw amendments to the Pharmacy Operations and Drug Scheduling Act bylaws regarding telepharmacies, for a 90-day public posting period. In addition, the College will also post the proposed new Telepharmacy Standards of Practice.
Comments on the draft bylaws should be submitted no later than July 23, 2017.
Telepharmacy is the delivery of traditional pharmacy services, including the dispensing of medications and providing patient counselling, via telecommunications to patients in locations where they may not have local access to a pharmacist. Telepharmacy is designed to provide access to pharmacy services in rural and remote communities by allowing pharmacies to operate, without requiring a pharmacist to be physically present.
There are currently just over 10 community telepharmacy sites in British Columbia. The first telepharmacies were developed in 2007 as part of a pilot project to increase access to pharmacy care in rural areas of BC.
Proposed Bylaw Amendments for Telepharmacy
The proposed bylaws regarding telepharmacy significantly amend the current requirements. It is important to note that these provisions apply only to community telepharmacies.
The proposed bylaws regarding telepharmacy require a pharmacy technician to staff the telepharmacy site. Existing sites will be ‘grandfathered’ to continue to allow a pharmacy assistant staffing model in order to maintain the level or pharmacy services currently in place in BC’s rural and remote communities. To address concerns regarding unregulated staffing of these pharmacies, the bylaws have been strengthened with new requirements that aim to increase the security of drugs and confidential health information, and include additional requirements for ‘grandfathered’ sites.
Existing sites would need to meet all new requirements, with these exceptions:
- Existing sites would not have to meet two pharmacy premise requirements (i.e., the dispensary area being at least 160 square feet, and having a dispensing counter with at least 30 square feet of clear working space).
- Four existing sites would be permitted to have a license as a telepharmacy and community pharmacy. These sites would be able to switch from a traditional community pharmacy to a telepharmacy, at times (e.g., switch into “telepharmacy mode”). However, all other telepharmacies must only hold one license type (i.e., a community pharmacy or telepharmcy license).
- All existing sites would be permitted to staff telepharmacies with pharmacy assistants instead of pharmacy technicians, but will be required to meet additional requirements.
New requirements for all telepharmacies to enhance public protection:
- The proposed amendments to change telepharmacy from a service to a distinct license type. Potential telepharmacy operators will be required to provide fulsome information about the proposed telepharmacy during the application process, and will be expected to meet licensure requirements. Currently, quite limited information is requested for community pharmacy owners requesting to operate a telepharmacy service.
- Requiring that the new pharmacy security provisions apply to telepharmacies. These pharmacy security provisions are outlined in s.11.1 of the PODSA-Bylaws, and include requirements for security cameras, motion sensors, and time-delay safes, etc. When the telepharmacy is not being directly supervised by a pharmacist and the premise is accessible to non-registrants (e.g., in locations where the pharmacy is not 100% of the premise), monitored alarms will be required in the dispensary and physical barriers will be required around Schedule I and II drugs, controlled drug substances and confidential health information.
- Increased number of inspections and audits from three to four times per year. This is consistent with Professional Practice Policy-65: Narcotic Counts and Reconciliations. In addition, these inspections and audits must occur at intervals of not less than two months, to avoid inspections and audits only being done at certain times of the year (e.g., all four inspections being done in the summer months).
- The draft Telepharmacy Standards of Practice requires that all prescription processing be completed at the central pharmacy, unless a pharmacist is physically present and on duty at the telepharmacy. This will require the pharmacist to be involved with the processing of all prescriptions received at the telepharmacy, as well as being involved in all aspects of the prescription processing where a pharmacist is required.
- To ensure that the full pharmacist has access to, and oversight of, all patient records and related documentation, the draft Telepharmacy Standards of Practice requires that all original and stamped prescriptions, patient records, invoices and documentation in respect of prescriptions, be stored at the central pharmacy, not at the telepharmacy.
- The draft Telepharmacy Standards of Practice requires that the pharmacist at the central pharmacy must be able to directly supervise the telepharmacy, even if the staff person at the telepharmacy has not requested this supervision.
The Board approved amendments to the Health Professions Act bylaws, for filing with the Ministry of Health, to establish an Application Committee.
This comes after amendments to the Pharmacy Operations and Drug Scheduling Act were approved by the Provincial Government in May 2016. These amendments permit the College to know the identity of all pharmacy owners, determine their suitability for pharmacy ownership and hold them accountable for providing safe and effective care by ensuring their pharmacies are compliant with legislative requirements for pharmacies in British Columbia.
If an application for a pharmacy licence does not meet the eligibility criteria in the Pharmacy Operations and Drug Scheduling Act and the requirements in the College's bylaws, the Registrar must refer the application to the Application Committee.
The Application Committee can:
- request additional information or evidence from the direct owner, indirect owner and proposed manager
- issue, renew or reinstate the pharmacy licence
- issue, renew or reinstate the pharmacy licence with conditions
- refuse to issue, renew, or reinstate the pharmacy licence
(See Section 4(2)(3)(4) of the amendments to Pharmacy Operations and Drug Scheduling Act)
The amendments to the Health Professions Act bylaws include the definition of the new Application Committee, as well as an outline of its powers and duties. However, the committee’s composition is determined under of the Health Professions Act bylaws section 19(1)(t).
The bylaws will now be filed with the Minister of Health and the amendments will be in effect by mid-June 2017. The College will be recruiting volunteers for the Application Committee following the filing period.
New Pharmacy Ownership Requirements and Scope of PODSA Modernization
Doreen Leong, Director of Registration, Licensure, and PharmaNet presented to the Board the scope of the Pharmacy Operations and Drug Scheduling Act bylaw modernization needed to support the new pharmacy ownership requirements.
In May 2016, the Provincial Government approved amendments to the Pharmacy Operations and Drug Scheduling Act permitting the College to know the identity of all pharmacy owners, determine their suitability for pharmacy ownership and to hold them accountable for providing safe and effective care by ensuring that their pharmacies are compliant with legislative requirements for pharmacies in BC.
The Provincial Government and the College identified a gap in the College’s ability to identify pharmacy owners, and when needed, involve non-registrant owners in the Inquiry/Discipline processes to better protect patient safety.
In July 2016, the College began determining what would be required to bring the new pharmacy ownership requirements into effect and developed a detailed project plan to support the change. Work needed to bring the new requirements into effect by March 1, 2018 is on track.
The College is also actively conducting stakeholder engagement to help inform the new draft bylaws for pharmacy ownership. See our Engagement Process for an overview of how we are engaging with stakeholders on the new pharmacy ownership requirements.
Learn more about the new requirements for pharmacy ownership in BC through the amendments to the Pharmacy Operations and Drug Scheduling Act and College bylaws at bcpharmacists.org/ownership.