Section 56 Class Exemption for Designated Administrators of Ambulance Service Operators in Ontario

Pursuant to section 56 of the Controlled Drugs and Substances Act (CDSA), Designated Administrators of certified ambulance service operators in the province of Ontario are exempted for medical purposes from the application of the following provisions of the CDSA and its regulations:

• Subsection 4(1) of the CDSA with respect to fentanyl, ketamine, morphine and pethidine
• Subsections 5(1) and 5(2) of the CDSA with respect to diazepam, fentanyl, ketamine, lorazepam, midazolam, morphine and pethidine
• Subsection 8(1) of the Narcotic Control Regulations (NCR) with respect to fentanyl, ketamine, morphine and pethidine

In respect of this exemption,

• Base Hospital Program means a program defined as a Base Hospital Program under the Ambulance Act (Ontario) and Ontario Regulation 257/00.
• Controlled substance means one of the following substances: diazepam, fentanyl, ketamine, lorazepam, midazolam, morphine and pethidine.
• Designated Administrator means a person who is in a managerial position and is responsible for ordering, transporting, storing and providing controlled substances to paramedics for an ambulance service operator certified under the Ambulance Act (Ontario).
• Medical Director means a person who is defined as a Medical Director under the Ambulance Act (Ontario) and Ontario Regulation 257/00, and who is ultimately responsible for activities conducted by paramedics with respect to controlled substances.
• Paramedic means a person who is registered by the Ontario Ministry of Health and Long-Term Care under the Ontario Regulation 257/00 to practice paramedicine as an Advanced Care Paramedic or Critical Care Paramedic in Ontario and administer controlled substances as part of the practice of paramedicine, and authorized by a Medical Director of a Base Hospital Program to practice paramedicine for that Base Hospital Program.
• Unserviceable controlled substance means a drug product containing a controlled substance that is expired, contaminated or damaged, or any residual controlled substance remaining in a multi-dose vial.

This exemption provides the aforementioned Designated Administrators with the authority to possess, transport and provide controlled substances required by Advanced Care Paramedics or Critical Care Paramedics employed by the certified ambulance service operators to which Designated Administrators are affiliated.

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 Ontario Ministry of Health and Long-Term Care and the Medical Director of a Base Hospital Program, to ensure the security of controlled substances in storage and during transportation;
2. Order controlled substances from a hospital pharmacy or community pharmacy in accordance with orders issued by the Medical Director of the Base Hospital Program with which the certified ambulance service operator is affiliated;
3. Record all transactions involving controlled substances, i.e., date, name and quantity of controlled substances ordered, received, stored in ambulances or aircrafts, and provided to paramedics (to be carried on their person);
4. Maintain all records with respect to controlled substances submitted by paramedics working for their ambulance service operator;
5. Report all incidences of loss or theft of controlled substances in writing to Health Canada within 10 days of discovery; and
6. Keep information specified in (3) and (4) for at least two years and make it available to Health Canada upon request.

This exemption will remain in effect until revoked. 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 the behalf of the Minister of Health

Diane Allan
Director, Office of Controlled Substances
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch

Effective Date: July 12, 2010