ARCHIVED - Rationale for Class Exemptions under Section 56 of the Controlled Drugs and Substances Act for Paramedics and Designated Administrators

Issue

In most provinces and territories, certain categories of paramedics are authorized under provincial/territorial (P/T) legislation to carry out activities with controlled substances as part of the pre-hospital care for which they are responsible. However, as they are not specifically authorized to do so under the Controlled Drugs and Substances Act (CDSA) and its regulations, these paramedics may face legal risks when conducting these activities.

The purpose of this document is to support the issuance of a series of exemptions under section 56 of the CDSA that will authorize:

1. exempted categories of paramedics across Canada to possess, transport and administer controlled substances, in accordance with established protocols and relevant scopes of practice, when providing pre-hospital care to patients across Canada; and
2. designated administrators employed by emergency medical services to possess and provide controlled substances to exempted categories of paramedics.

Background

Under the Narcotic Control Regulations (NCR) and Benzodiazepines and Other Targeted Substances Regulations (BOTSR), practitioners, e.g., doctors of medicine, dentists and doctors of veterinary medicine, are authorized to prescribe, administer, sell or provide narcotics, benzodiazepines and other targeted substances when treating patients in their professional capacity.

Across Canada, certain categories of paramedics conduct activities with a limited range of controlled substances in the course of providing pre-hospital care. In particular, P/T scopes of practice for the affected paramedics authorize them to possess and transport controlled substances including morphine, fentanyl, ketamine, pethidine, diazepam, midazolam and lorazepam, and administer them in accordance with pre-approved protocols and/or directions from a practitioner. In addition, administrative staff within the individual emergency medical services that employ the affected paramedics are involved in ordering, storing, transporting and providing controlled substances to these paramedics.

As affected paramedics are not considered to be practitioners under the CDSA, and as there are no provisions in the NCR or BOTSR that allow paramedics or any staff working for an emergency medical service to conduct activities with narcotics or targeted substances, their handling of controlled substances is not in compliance with the CDSA, NCR and BOTSR. Therefore, P/T governments have asked Health Canada to examine how their P/T practice of paramedicine can be aligned with the federal legislative framework for controlled substances.

Health Canada Response

Based on recent consultations with its provincial/territorial partners, Health Canada has opted to issue exemptions under section 56 of the CDSA that will authorize the affected paramedics and administrative staff of emergency medical services to carry out activities with controlled substances in accordance with their respective P/T scopes of practice and/or legislation. As the legislative/regulatory schemes governing the activities of affected paramedics vary by province/territory, Health Canada is issuing separate class exemptions for individual provinces/territories.

Relevant Definitions

From the CDSA

Practitioner means a person who is registered and entitled under the laws of a province to practise in that province the profession of medicine, dentistry or veterinary medicine, and includes any other person or class of persons prescribed as a practitioner.

Traffic means, in respect of a substance included any of Schedules I to IV,

1. to sell, administer, give, transfer, transport, send or deliver the substance,
2. to sell an authorization to obtain the substances, or
3. to offer to do anything mentioned in paragraph (a) or (b), otherwise than under the authority of the regulations

From the NCR

Narcotic means any substance set out in the schedule or anything that contains any substance set out in the schedule of the NCR.

From the BOTSR

Targeted substance means

1. a controlled substance that is included in Schedule 1 of the BOTSR; or
2. a product or compound that contains a controlled substance that is included in Schedule 1 of the BOTSR.

Definitions for the purposes of this document

Paramedic means, in general, a person who is registered under the laws or policies of a province/territory to perform duties in providing pre-hospital care in that province/territory, and is authorized to possess, transport and administer controlled substances as set out in the scope of practice under the laws or policies of that province/territory. The exact definition for paramedic varies by exemption for each province/territory.

Designated Administrator means, in general, a person who is in a managerial position within an emergency medical service and is ultimately responsible for ordering, transporting, storing and providing controlled substances to paramedics for their use in pre-hospital care. The exact definition of Designated Administrator varies from one exemption to another, in light of the differing governance frameworks for emergency medical services in each jurisdiction.

Relevant Aspects of the Federal Legislative Framework for Narcotics and Targeted Substances

Controlled Drugs and Substances Act (CDSA)

The CDSA provides for the control of substances that can alter mental processes and that may produce harm to health and to society when diverted or misused. Except as authorized under its related regulations, all activities with controlled substances, e.g., possession, possession for the purposes of trafficking, trafficking, importation, exportation, possession for the purposes of exportation and production of controlled substances, are prohibited under the CDSA.

Subsection 4.(1) of the CDSA prohibits anyone from possessing a substance included in Schedule I, II or III to the CDSA, unless authorized by regulation.

Subsection 4.(1) of the CDSA

Subsection 5 of the CDSA prohibits anyone from trafficking in controlled substances listed in Schedules I to V. By definition in the CDSA, traffic includes the activities of selling, giving, transferring, sending, delivering, transporting, and administering controlled substances.

Subsections 5.(1) and 5.(2) of the CDSA

Narcotic Control Regulations (NCR)

The NCR provide the authority for licensed dealers, pharmacists, hospitals and practitioners to handle narcotics listed in the Schedule to the Regulations. In particular, the NCR authorize a practitioner as defined in the CDSA to prescribe, administer, sell or provide a narcotic to a person or animal who is a patient under the practitioner's professional treatment and requires the narcotic. This authority is dependent on certain requirements pertaining to record-keeping, security, reporting, etc, being met. The NCR also authorize a pharmacist to, among other things, provide or sell a narcotic to a person who is exempted under section 56 of the CDSA with respect to the possession of that narcotic.

Benzodiazepines and Other Targeted Substances Regulations (BOTSR)

Similar to the NCR, the BOTSR provide the authority for licensed dealers, pharmacists, hospitals and practitioners to handle targeted substances listed in Schedule 1 of the Regulations, where these are primarily benzodiazepines listed in Schedule IV of the CDSA. They also allow a practitioner to prescribe a targeted substance for or administer it to an individual or animal, and to sell, provide, send, deliver or transport a targeted substance to or for an individual or for the benefit of an animal, provided that the individual or animal is a patient that the practitioner is treating in their professional capacity and who requires that targeted substance for their care. The BOTSR also authorize a pharmacist to, among other things, provide or sell a targeted substance to a person who is exempted under section 56 of the CDSA with respect to the possession of that targeted substance.

Section 56 of the CDSA

Section 56 of the CDSA provides the Minister of Health with the authority to exempt any person(s) or substance(s) listed in the Schedules to the CDSA from the application of any provisions of the Act or its regulations if the Minister deems it necessary.

Section 56

Questions may be directed to:

Office of Controlled Substances
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Tel: 613-952-2177
Fax: 613-946-4224
E-mail: OCS_Policy_and_Regulatory_Affairs@hc-sc.gc.ca