Tramadol Added to Narcotics Schedule

Summary#

These final rules add the pain medicine tramadol and two of its main breakdown products — O-desmethyltramadol (M1) and N,O-didesmethyltramadol (M5) — to the list of narcotics regulated in Canada. The change makes tramadol subject to the Narcotic Control Regulations and the Controlled Drugs and Substances Act, and it came into force one year after publication (on March 31, 2022).

What it does#

• Adds tramadol, its salts, isomers and related derivatives M1 and M5 to the schedule to the Narcotic Control Regulations and to Schedule I of the Controlled Drugs and Substances Act.
• Brings tramadol under the same rules that already apply to other prescription opioids. That includes requirements for:
  • written prescriptions (no verbal prescriptions and no automatic refills for listed tramadol products);
  • record-keeping and reporting by pharmacies and licensed dealers;
  • licences and permits for manufacturers, importers and exporters; and
  • secure storage and other physical-security rules for licensed sites.
• Allows for narrow medical or special-use exceptions (Health Canada can issue exemptions where needed, for example for wildlife care).

Who's affected#

• Patients who take tramadol. They will still be able to get tramadol by prescription, but some may need to see their prescriber more often because refills and verbal prescriptions are no longer allowed.
• Health workers: doctors, nurse practitioners, pharmacists, and veterinarians will follow the new record‑keeping and reporting rules.
• The pharmaceutical industry: an estimated 19 Canadian companies supply 35 tramadol products and will face licensing, security and paperwork requirements. Health Canada’s analysis estimates incremental industry costs of about $1,058,142 (present value) over 10 years.
• Pharmacies: the government estimated pharmacy administrative costs in present value at about $3,186,149 over 10 years (annualized about $453,636).
• Wildlife rehabilitators and some animal-care providers: they raised concerns about access for injured animals; Health Canada said exemptions (under subsection 56(1) of the Act) can be used where needed.
• Law enforcement and regulators: gain clearer authority to seize unauthorized tramadol shipments and to act against diversion.

(If any group’s exact impact is unclear from the government’s material, that is noted in the analysis.)

Why it matters#

• Public health: tramadol can cause dependence, serious side effects (including seizures and serotonin syndrome), and has been linked to reported harms in Canada (about 94 adverse events and 27 suspected deaths from 2006 to March 2020 in the government’s review). Putting tramadol under narcotics rules aims to reduce diversion and problematic use.
• Access and care: patients may need more frequent contact with prescribers to maintain treatment. That could be a small inconvenience for many, but may affect some people more (for example those with mobility or access issues). Health Canada says it does not expect major interruptions to access.
• Costs and paperwork: companies and pharmacies face new compliance costs. The government estimated total quantified costs to stakeholders at about $4,257,041 in present value over 10 years (annualized $606,107), while also concluding the changes are expected to produce net public‑health benefits overall.
• Practical effect for everyday life: the change strengthens monitoring and enforcement around tramadol, which could reduce misuse and related health harms — but it also adds administrative steps for health professionals and businesses that handle the drug.