Health Canada seeking feedback on proposal for stricter control of tramadol

Health Canada is inviting comments on a proposal to add tramadol to Schedule I of the Controlled Drugs and Substances Act (CDSA) and the Schedule to the Narcotic Control Regulations (NCR).(1,2)Tramadol, an opioid analgesic used to treat moderate to moderately severe pain, has been marketed in Canada since 2005. It is currently classified as a prescription drug and is available in single-entity products, as well as in combination products with acetaminophen.(1)In a “notice to interested parties,” Health Canada notes that like many opioids, tramadol can produce dependence and euphoria, and has the potential for misuse. Tramadol is a weak opioid, but one of its metabolites is a much more potent opioid than tramadol itself. Oral tramadol in high doses can produce effects similar to some opioids controlled under the CDSA.(1)Tramadol can also cause other potentially serious adverse effects, including seizures, serotonin syndrome and respiratory failure. Problematic use of tramadol and dependence have been reported in several countries; 14 deaths have been reported in Canada.(1)A 2017 report from the Canadian Institute for Health Information stressed the significant (30%) increase in tramadol prescriptions in Canada from 2012 to 2016.(3) The report also highlighted an escalation in the number of emergency department visits involving tramadol abuse or misuse in the United States—an approximate 250% increase from 2005 to 2011.(3)Health Canada is proposing to schedule tramadol under the CDSA and NCR to help prevent diversion and protect the public from the risks associated with unauthorized use of tramadol. If this stricter control is approved, pharmacists would still be authorized to dispense tramadol to patients with a written prescription, but verbal prescriptions and refills would no longer be permitted.(1)Comments on the proposal must be submitted within 60 days to Legislative and Regulatory Affairs, Controlled Substances Directorate, Healthy Environments and Consumer Safety Branch, Health Canada. Comments can be sent by mail at Address Locator: 0302A, 150 Tunney’s Pasture Driveway, Ottawa, Ontario K1A 0K9, or by email (hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca).(2)ReferencesBoudreau M. Health Canada. Controlled Substances Directorate. Controlled Drugs and Substances Act. 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. Canada Gazette, Part I;152(24): June 16, 2018. http://www.gazette.gc.ca/rp-pr/p1/2018/2018-06-16/html/notice-avis-eng.html#ne2 (accessed June 18, 2018).Health Canada. Consultation on regulatory amendments regarding tramadol. https://www.canada.ca/en/health-canada/programs/consultation-amendments-tramadol.html (accessed June 18, 2018).Canadian Institute for Health Information. Pan-Canadian trends in the prescribing of opioids, 2012 to 2016. Ottawa, ON: CIHI; 2017. https://www.cihi.ca/sites/default/files/document/pan-canadian-trends-opioid-prescribing-2017-en-web.pdf (accessed June 18, 2018).

Health Canada seeking feedback on proposal for stricter control of tramadol

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