Reclassification of Tramadol to a Schedule 1 narcotic under the Controlled Drugs and Substances Act

The Canadian Department of Health has ordered changes to the Controlled Drug and Substance Act to include Tramadol and its salts. This is a necessary change in the public interest and our fight against the nation wide opioid crisis.

Unlike most opioid analgesics, tramadol is not controlled under the Controlled Drugs and Substances Act (CDSA) or regulated under the Narcotic Control Regulations (NCR). Controlling tramadol would strengthen Health Canada’s (HC or the Department) oversight of legitimate activities with tramadol, and facilitate detection and prevention of diversion. It would also enable Canadian law enforcement agencies to take enforcement action against a broader range of unauthorized activities with tramadol, such as the seizure of unauthorized shipments of tramadol. This would help to mitigate the risk of problematic tramadol use emerging as a significant threat to the health and safety of Canadians.

There is now more evidence that high doses of tramadol could have potential for problematic use comparable to some opioids controlled under Schedule I to the CDSA, such as meperidine (marketed as Demerol®). Between 2006 and 2017, tramadol is suspected to have contributed to 71 adverse events related to problematic use, dependence or withdrawal reported in Canada, and to over 7 000 reported internationally. Problematic tramadol use is also reported to be a serious and growing public health concern for many countries.

Order Amending Schedule I to the Controlled Drugs and Substances Act (Tramadol)

Amendment

1 Schedule I to the Controlled Drugs and Substances Act is amended by adding the following after item 26:

• 27 Tramadol (2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol), its salts, isomers and salts of isomers and the following derivatives of tramadol and the salts, isomers and salts of isomers of these derivatives:
  • (1) O-desmethyltramadol (3-[2[(dimethylamino)methyl]-1-hydroxycyclohexyl]-phenol)
  • (2) N,O-didesmethyltramadol (3-[1-hydroxy-2-[(methylamino)methyl]cyclohexyl]-phenol)

Coming into Force

2 This Order comes into force on the first anniversary of the day on which it is published in the Canada Gazette, April 30, 2020.

For more information: Regulatory Impact Analysis