Public Consultation: Amendments to Accredited Facilities Bylaw

This consultation is now closed. 

CPSM Requests feedback on amendments to the Accredited Facilities Bylaw (the Bylaw).

Background

The Bylaw applies to:

1)     Diagnostic facilities in Manitoba that are not operated by the provincial or municipal government and those designated as hospitals and;

2)     Non-hospital medical or surgical facilities in which procedures with a sufficient risk of potential harm to a patient are performed.

Three proposed amendments require public consultation to the Accredited Facilities Bylaw. 

The amendments

1. Intravenous Ketamine Administration

Intravenous administration of ketamine will be added to the list of procedures in the Bylaw that are required to be performed in an accredited facility. With this change, the administration of ketamine for off-label purposes is now only permitted in CPSM-accredited Non-Hospital Medical Surgical Facilities (NHMSF), or in hospitals. 

CPSM has become aware that ketamine is increasingly being prescribed for off-label purposes, including for depression not adequately treated with conventional pharmacological and psychotherapeutic options. Additionally, ketamine prescribing has become a regulatory concern in several other jurisdictions, particularly ketamine prescribed via the parenteral (IV) and intramuscular (IM) routes of administration. 

In Manitoba, IV vials of ketamine are being prescribed to patients for self-administration via oral or sublingual routes. The unsupervised use of ketamine carries a risk of diversion. Patients may also self-administer prescribed ketamine via the intravenous or intramuscular routes, which carries significant cardiovascular, neurological, and psychiatric risks. These risks are magnified when IV ketamine is prescribed without the implementation of universal safety precautions.

Health Canada has approved ketamine for use as an anesthetic. Ketamine is also used in the management of acute and chronic pain. It is also a controlled substance under Schedule I of the Controlled Drugs and Substances Act, meaning that it has been classified as having a high potential for harm and abuse. The off-label use of ketamine is regulated by provincial Colleges, and in many jurisdictions, its use falls under the regulations and guidelines for Alternative and Complementary Medical Treatments (guidelines vary by medical regulatory authorities).

2. MDMA

The amendment will add MDMA (3,4-methylenedioxymethamphetamine) administration to the list of procedures required to be performed within Non-Hospital Medical Surgical Facilities (NHMSF) in Manitoba. The purpose of including MDMA administration in the Bylaw is to protect patients in Manitoba by providing a safe environment for the controlled use of MDMA.

Manitoba is among several provinces seeing growing interest in the use of MDMA-assisted psychotherapy for treatment-resistant Post Traumatic Stress Disorder (PTSD), complicated by suicidality. The use of psychedelic agents to enhance psychotherapy is currently an active area of clinical and scientific interest. CPSM’s role is not to endorse any specific emergent psychiatric treatment modalities, nor do we wish to stand in the way of innovation in medicine. However, we must meet our mandate of public protection by ensuring patient safety remains the focus as new clinical services are developed.

MDMA can have significant emotional and physical effects, including effects on the heart and brain. Using it requires careful evaluation, patient preparation, and monitoring during and after treatment. Additionally, MDMA-assisted psychotherapy may use gentle touch or bodywork, which raises the risk of boundary violations. The effects of MDMA can magnify these risks and could expose patients to undue harm. Therefore, it is crucial to have a regulatory framework that enforces strict boundaries and a standardized approach to managing medical risks.

Consistent with other jurisdictions, a regulatory accreditation framework is essential to ensure patient safety as interventional psychiatry evolves.

3. Requiring anesthesiologists working in dental clinics to report Adverse Patient Outcomes

The CPSM Accreditation Facilities Bylaw ensures all levels of care and quality are maintained in a non-hospital setting. In working closely with the Manitoba Dental Association (MDA), CPSM identified a gap in reporting Adverse Patient Outcomes (APO) between anesthesiologists working in dental facilities and anesthesiologists reporting APOs in Non-Hospital Surgical Medical Facilities. CPSM has a responsibility to adhere to patient safety and quality care and ensure all APOs are reported accordingly.

Currently sec. 13.4.  in the bylaw states,

“CPSM registrants providing anaesthesiology services for dental procedures undertaken by members of the MDA in dental surgery clinics, must comply with the Pharmacologic Behaviour Management Bylaw of the Manitoba Dental Association.”

The proposed amendment 13.4.1. states,

“In addition to complying with the Pharmacologic Behaviour Management Bylaw of the Manitoba Dental Association, CPSM registrants providing these services must notify the Assistant Registrar within one working day of becoming aware of any major adverse patient outcome resulting from the anaesthesiology services provided in the dental surgery clinic.”

Request for Feedback

The Bylaw is being distributed to the public, CPSM registrants, and other stakeholders for 30 days for feedback and public input, as required by regulations.

CPSM Council will review and consider the feedback gathered during the consultation before approving the Bylaw amendments. 

How to Submit Your Feedback

1.     Review the Accredited Facilities Bylaw amendments.

2.     Share your feedback by completing this survey or submit your comments in writing by email to: CPSMconsultation@cpsm.mb.ca

You can also mail or submit your comments in person (post-marked August 29) to:

1000 – 1661 Portage Ave, Winnipeg MB R3J 3T7

The deadline for feedback is August 29, 2024