Administration of medications not approved by Health Canada

Health Canada has adopted guidelines for the importation of health products under the Food and Drugs Act (the “Guidelines”) which allow Canadian citizens to import a variety of health products for their personal use.¹ Under the Guidelines, Canadians may be able to import health products not otherwise authorized by Health Canada, which may include human drugs, natural health products, medical devices, among other things. Occasionally, nurses may be asked to administer medications imported under these guidelines.

Nurses should be aware that the personal importation guidelines set a few requirements for individual importation. Importation can occur either by personally bringing in a substance following travel outside of Canada or, in some cases, by other means, such as courier or mail. The following are important requirements:

1. Importation for personal use is subject to Health Canada’s discretion. Health Canada may or may not approve the importation.
2. Canadians who import medications from abroad cannot bring more than either a single course of treatment or a 90-day supply (whichever is shortest).
3. The imported medication must be for personal use by the individual or someone for whom they are legally responsible. It cannot be sold or provided to another person.
4. The medication must be in the packaging dispensed by the hospital or pharmacy, the original retail packaging, or have the original label identifying the substance and its contents.

Nurses may be asked to administer a medication imported under the Guidelines that has not been otherwise approved as a prescription medication by Health Canada. This is especially likely when the route of the drug does not lend itself to self-administration. For example, edaravone is an intravenous medication that can be imported under the Guidelines but is not on the list of prescription medication approved by Health Canada although it has been approved in a few countries for patients with Amyotrophic Lateral Sclerosis (ALS). A nurse who is asked to administer a drug that is not approved by Health Canada, but was imported under the guidelines, should consider the following risk management issues:

1. Is there a prescription or directive from an authorized (Canadian) prescriber approving the controlled or restricted act?
2. Can the substance be authenticated and has it been appropriately handled?
3. Does the nurse’s employer have a policy permitting the administration of the substance to patients?
4. Is the administration of the substance in keeping with an evidence-based nursing practice?
5. Does the nurse have the necessary experience, training and competence to administer the substance?
6. Does the nurse have the knowledge, skill, and judgement to recognize and manage any potential adverse outcomes from the administration of the substance?
7. In administering the substance, is the nurse following other applicable nursing standards (i.e. medication, documentation, etc.)?

If a nurse is asked to administer a medication that has been internationally obtained through the Guidelines, the appropriateness of the administration can be complex. Nurses should ensure that they follow the practice standards of nursing in their jurisdiction before they administer medication. They can also discuss the matter with a CNPS legal counsel member, who is a lawyer, to better assess the legal risk of administration to their practice.

CNPS beneficiaries can contact CNPS at 1-800-267-3390 to speak with a member of CNPS legal counsel. All calls are confidential.

1.  Health Canada, Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0084), issued June 1, 2010. Health Canada, Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations (POL-0060), issued, June 1, 2010.

Published May 2018

THIS PUBLICATION IS FOR INFORMATION PURPOSES ONLY. NOTHING IN THIS PUBLICATION SHOULD BE CONSTRUED AS LEGAL ADVICE FROM ANY LAWYER, CONTRIBUTOR OR THE CNPS. READERS SHOULD CONSULT LEGAL COUNSEL FOR SPECIFIC ADVICE.