Section 56 Class Exemption for Designated Administrators of Emergency Health Service Operators in Nova Scotia

Pursuant to section 56 of the Controlled Drugs and Substances Act (CDSA), Designated Administrators of emergency health service operators contracted by the Nova Scotia Department of Health under the Emergency Health Services Act (Nova Scotia) 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, pethidine and hydromorphone
• - Subsections 5(1) and 5(2) of the CDSA with respect to diazepam, fentanyl, ketamine, lorazepam, midazolam, morphine, pethidine and hydromorphone
• - Subsection 8(1) of the Narcotic Control Regulations with respect to fentanyl, ketamine, morphine, pethidine and hydromorphone

In respect of this exemption,     

• Controlled substance means one of the following substances: diazepam, fentanyl, ketamine, lorazepam, midazolam, morphine, pethidine and hydromorphone.
• Designated Administrator means a person who is in a managerial position and is ultimately responsible for ordering (with the approval of a Medical Oversight Physician), transporting, storing and providing controlled substances for an emergency health service operator contracted by the Nova Scotia Department of Health under the Emergency Health Services Act (Nova Scotia).
• Medical Oversight Physician means a registered practitioner in the province of Nova Scotia who is contracted by the Nova Scotia Department of Health to provide medical direction to paramedics and is responsible for approving orders for controlled substances for an emergency health service operator contracted by the Nova Scotia Department of Health under the Emergency Health Services Act (Nova Scotia), with which he/she is affiliated. 
• Paramedic means a person who is registered by the Nova Scotia Department of Health under the Emergency Health Services Act (Nova Scotia) to practice paramedicine as a Primary Care Paramedic, Intermediate Care Paramedic, Advanced Care Paramedic or Critical Care Paramedic, and who is authorized by the Nova Scotia Department of Health to administer controlled substances as part of the practice of paramedicine.
• System Support Technician means a person who is responsible for transporting, storing, destroying and providing controlled substances from the Emergency Health Services main storage facilities to designated hospitals for an emergency health service operator contracted by the Nova Scotia Department of Health under the Emergency Health Services Act (Nova Scotia).
• System Support Transporter means a person who is responsible for transporting, destroying and providing controlled substances between ambulances for an emergency health service operator contracted by the Nova Scotia Department of Health under the Emergency Health Services Act (Nova Scotia).
• Unserviceable controlled substance 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 the aforementioned Designated Administrators with the authority to possess, transport, and provide controlled substances required by paramedics in accordance with relevant policies established by the Nova Scotia Department of Health, 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 policies established by the Nova Scotia Department of Health, to ensure the security of controlled substances in storage and during transportation;
2. Order, with the approval of a Medical Oversight Physician, controlled substances from the Nova Scotia Provincial Drug Distribution Program;
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, System Support Technicians and System Support Transporters;
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 behalf of the Minister of Health

Original signed by

Julie Thompson
Director, Office of Controlled Substances
Controlled Substances Directorate
Healthy Environments and Consumer Safety Branch

Effective Date: June 14, 2016