Canada: Passage Of Bill 21 Brings Significant Changes To Hospital Pharmacy And Health Professional Regulation

Bill 21, the Safeguarding Health Care Integrity Act, 2014  received Royal Assent on December 11, 2014 bringing about significant changes to the oversight of hospital pharmacies and regulated health professionals. The Bill amended a number of key statutes and also created the Voluntary Blood Donations Act, 2014.

Regulation of Hospital Pharmacies by the Ontario College of Pharmacists

Bill 21 amends the Drug and Pharmacies Regulation Act ("DPRA") to expand the oversight authority of the Ontario College of Pharmacists ("OCP") to include hospital and institutional pharmacies. While future regulations will designate premises "in or associated with one or more health custodial institutions" as an "institutional pharmacy," the recent amendments deem the following locations to be a "hospital pharmacy" for the purpose of the DPRA:

...where drugs are compounded, dispensed or supplied for hospital patients by a hospital in premises located in a hospital, the primary location or locations in the hospital where drugs are compounded, dispensed or supplied from, together with any other locations in the hospital where drugs are stored or supplied from and any other location prescribed in regulations...

In order to continue operating, a hospital pharmacy must be accredited by the OCP. The OCP will monitor compliance with DPRA provisions and any terms and conditions of licence through its authority to enter, search and examine (under warrant) areas deemed to be a hospital pharmacy.

It should be noted that only certain provisions of the DPRA apply to a hospital pharmacy and some provisions do not apply in the same way to hospital and other (community) pharmacies. The OCP also has authority to make regulations in respect of a hospital pharmacy, including with regard to inspections, operations and standards.

By giving the OCP authority to licence and inspect hospital and institutional pharmacies, the amendments have effectively implemented a key recommendation made by Dr. Thiessen in his report A Review of the Oncology Under-Dosing Incident, following his investigation into the March 2013 discovery of diluted chemotherapy drugs at a number of Ontario hospitals. We provided an overview of the report in a previous Health Communiqué.

Amendments to the DPRA will not come into force until supporting regulations regarding inspection criteria and operation and licensing standards of hospital and institutional pharmacies are developed.

Expanded Oversight of Regulated Health Professionals

Bill 21 also increases the oversight of regulated health professionals by introducing new mandatory reporting requirements to health regulatory colleges in the Public Hospitals Act and the Health Professions Procedural Code, Schedule 2 to the Regulated Health Professions Act ("RHPA"). Combined with amendments to the RHPA that expand exceptions to a health regulatory college's duty of confidentiality, these amendments are expected to support colleges in more efficiently identifying and effectively responding to issues regarding a member's professional practice. The expanded exception in the RHPA now permits health regulatory colleges to communicate otherwise confidential information to a hospital, as well as others prescribed by legislation, in the course of investigating a complaint about a member. These provisions are not yet in force.

Voluntary Blood Donation System in Ontario Maintained

The Voluntary Blood Donations Act, 2014 ("VBDA") preserves the public and voluntary blood donation system in Ontario and specifically prohibits payment (including reimbursement for expenditures of any kind) for blood and blood constituents (i.e. plasma) except in exceptional circumstances. The VBDA makes it an offence punishable by significant fines to pay or offer an individual payment for blood and for a donor to accept any payments. Canadian Blood Services ("CBS") and its donors are explicitly exempted from the payment prohibition. Where it is deemed necessary, CBS donors may be paid for blood donations. Blood donated "solely for the purpose of research" as defined in the VBDA is also excluded from the payment prohibitions.

Inspectors appointed under the VBDA have broad authority to enter, inspect and remove records or other items from a blood collection facility, any place perceived to be one, and any business that owns or operates such a facility. Compliance orders may be issued for not complying with the payment prohibitions.

Related amendments were made to other legislation, including the following:

  • The general entitlement under the Laboratory and Specimen Collection Centre Licensing Act to be issued a licence to establish, operate or maintain a laboratory or specimen collection centre subject to meeting statutory requirements, will not apply where the laboratory or specimen collection centre will operate as a blood collection facility within the meaning of the VBDA and the Minister is of view that issuing a licence is not in the public interest; and
  • The Trillium Gift of Life Network Act, which prohibits the sale or purchase of any tissue for a transplant of any body part or parts thereof for therapeutic purposes, medical education or scientific research, was amended to exclude "blood and blood constituents" from the definition of tissue. The impact of this amendment is that any payment prohibition for blood and blood constituents is exclusively governed by the VBDA.

The VBDA came into force on December 11, 2014, the day Bill 21 received Royal Assent.

Practical Implications

The passing of Bill 21, the Safeguarding Health Care Integrity Act, 2014 has broad implications for health industry clients. From a risk management perspective, hospitals and other entities that employ or offer privileges to a regulated health professional should establish clear protocols for meeting the new mandatory reporting requirements to health regulatory colleges, and for acting upon confidential information provided by college investigators.

Public and private hospitals and organizations likely to be deemed an institutional pharmacy will need to review their medication management processes to determine the legal and operational implications of these changes.  Given the broad definition of "hospital pharmacy", the legislation extends well beyond what might traditionally be thought of as a "pharmacy".  It extends to locations in the hospital where drugs are compounded, dispensed, stored or supplied, whether or not the activity is being carried out by pharmacists or other regulated health professionals such as registered nurses.  Even if a hospital does not operate a pharmacy or employ a pharmacist, the OCP may still consider whether the hospital has safe medication practices in place in relation to these premises.

Hospital Boards of Directors and senior leadership will need to consider the broader systemic implications of these changes, recognizing the obligation to ensure that appropriate systems are in place for safe medication management.  The legislation provides an excellent opportunity for hospitals to take an enterprise risk approach to identify, review and prioritize potential risks and to develop strategies to eliminate, manage or transfer risk, where possible. 

The OCP has circulated draft inspection criteria for hospital pharmacies which will be used for conducting baseline assessments of pharmacy practices and medication management.  They will be visiting all Ontario hospitals to conduct the baseline assessments.  In addition, the OCP is in the process of drafting the regulations to support Bill 21, which will be followed by a public consultation process.  It is anticipated that regulations will be in place by the end of the year.

We encourage hospitals to actively participate in the assessments, processes and consultations that are taking place to ensure there will be consideration of the unique environment in which hospital pharmacies operate.   

We will be following the process closely and invite you to contact us if you have questions about the Safeguarding Health Care Integrity Act, 2014, how it may impact your organization, and for assistance and advice with addressing the changes.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Kathryn M. Frelick
Sarah Virani (Student at Law)
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