Notice to interested parties — Proposal to add tramadol to Schedule I to the Controlled Drugs and Substances Act and the Schedule to the Narcotic Control Regulations
This notice provides interested stakeholders with the opportunity to provide comments on Health Canada’s intent to amend Schedule I to the Controlled Drugs and Substances Act (CDSA) and the Schedule to the Narcotic Control Regulations (NCR) to include tramadol, its salts, isomers and derivatives and the salts and isomers of its derivatives.
Tramadol is an opioid analgesic that is used to treat moderate to moderately severe pain. It has been marketed in Canada since 2005, and is available by prescription.
Like many opioids, tramadol can produce dependence and euphoria, and has the potential for problematic use. While tramadol itself is a weak opioid, when taken orally, it is partially metabolized to produce the opioids M1 and M5, with M1 being a much more potent opioid than tramadol itself. There is evidence that high doses of oral tramadol can produce effects similar to some opioids controlled under the CDSA.
Tramadol can also cause adverse effects that may pose serious health risks, including seizures, serotonin syndrome, and respiratory failure. Adverse events related to problematic use and dependence have been reported in many countries, including 14 reported deaths in Canada.
The CDSA and its regulations provide a legislative framework for the control of substances that can alter mental processes and that may produce harm to individuals or to society.
Scheduling tramadol under the CDSA and NCR would help to prevent diversion of tramadol and protect Canadians from the health risks associated with unauthorized use, while maintaining its availability for legitimate medical and scientific use. Pharmacists would continue to be authorized to dispense tramadol to patients with a written prescription from a practitioner, but verbal prescriptions and refills would no longer be permitted.
The publication of this notice in the Canada Gazette, Part I, initiates a 60-day comment period. Anyone interested in this process or who has comments on this notice should contact Legislative and Regulatory Affairs, Controlled Substances Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, by mail at Address Locator: 0302A, 150 Tunney’s Pasture Driveway, Ottawa, Ontario K1A 0K9, or by email at hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca.
Michelle Boudreau
Director General
Controlled Substances Directorate
