Subsection 56(1) Class Exemption for Designated Administrators of the Prince Edward Island Ambulance Service

Pursuant to subsection 56(1) of the Controlled Drugs and Substances Act (CDSA), Designated Administrators of ambulance services operators contracted by the Prince Edward Island Department of Health and Wellness under the Ambulance Services Act (Prince Edward Island), are exempted for medical purposes from the application of the following provisions of the CDSA:

• Subsection 4(1) of the CDSA with respect to fentanyl, hydromorphone, ketamine and morphine.
• Subsections 5(1) and 5(2) of the CDSA with respect to diazepam, fentanyl, hydromorphone, ketamine, lorazepam, midazolam and morphine.

In respect of this exemption,

• Controlled substance means one of the following substances: diazepam, fentanyl, hydromorphone, ketamine, lorazepam, midazolam and morphine.

• Designated Administrator means a person who is in a managerial position (Operations Manager and/or General Manager) and is ultimately responsible for ordering, transporting, storing and providing controlled substances for an ambulance services operator contracted by the Prince Edward Island Department of Health and Wellness under the Ambulance Services Act in the province of Prince Edward Island.

• Emergency Medical Technician means a person who is registered and entitled under the Emergency Medical Technicians Act and Emergency Medical Technicians Regulations to practice as an Emergency Medical Technician licensed in the category of Primary Care Paramedics (EMT-I); Intermediate Care Paramedics (EMT-II); and Advanced Care Paramedics (EMT-III) in the province of Prince Edward Island and to administer controlled substances as part of the practice of paramedicine.

• Unserviceable stock means a drug product containing a controlled substance that is expired, contaminated, damaged, or any residual controlled substance remaining in a multi-dose vial.

This exemption provides Designated Administrators with the authority to order, possess, transport, store and provide controlled substances required by paramedics (Emergency Medical Technicians) employed by an ambulance services operator contracted by the Prince Edward Island Department of Health and Wellness under the Ambulance Services Act, in accordance with relevant policies established by the ambulance services operator contracted by the Prince Edward Island Department of Health and Wellness under the Ambulance Services Act (Prince Edward Island) and subject to the terms and conditions of this exemption.

The exemption is only applicable if the following conditions are met. Designated Administrators must:

1. Take necessary steps, in accordance with guidelines established by the ambulance services operator contracted by the Prince Edward Island Department of Health and Wellness, to ensure the security of controlled substances in storage and during transportation;
2. Order controlled substances from the Queen Elizabeth Hospital pharmacy (60 Riverside Dr, Charlottetown, PE C1A 8T5) in Prince Edward Island.
3. Record all transactions involving controlled substances, i.e., date, name and quantity of controlled substances ordered, received and stored in ambulances or provided to paramedics (Emergency Medical Technicians) (to be carried on their person) and returned to originating hospital pharmacy for destruction.
4. Record the name and address of the person from whom the controlled substance was purchased, received and returned to;
5. Maintain all records submitted by paramedics (Emergency Medical Technicians) working for the ambulance services operator contracted by the Prince Edward Island Department of Health and Wellness with which they are affiliated and for which the Designated Administrator is ultimately responsible;
6. Report all incidences of loss or theft of controlled substances in writing to Health Canada within 10 days by emailing ocs.reporting-rapporter.bsc@hc-sc.gc.ca; and
7. Keep information specified in (3) to (5) for at least two years and make it available to Health Canada upon request.

This exemption will remain in effect until the date on which this exemption has been replaced or the date on which this exemption is revoked.

The Minister may at any time and for any reason revoke or change the terms and conditions of this exemption. Should this be the case, you will be informed in writing and reasons for the revocation or changes will be provided.

A suspension of this exemption without prior notice may be ordered if the Minister deems that such a suspension is necessary to protect public health, safety or security.

Failure to comply with the terms and conditions of this exemption may, among other things, result in immediate suspension of this exemption, and ultimately, in its revocation.

Signed for and on behalf of the Minister of Mental Health and Addictions and Associate Minister of Health.

Carol Anne Chénard
Acting Director General
Controlled Substances Directorate
Health Canada

Effective Date: January 19, 2024