Tramadol Added to List of M3P Drugs
In the context of the national opioid crisis and recent Health Canada changes, effective March 31, Tramadol has been added to the list of drugs covered by the Manitoba Prescribing Practices Program (M3P).
Tramadol and all tramadol-containing products will now require an M3P approval to prescribe and will be subject to all M3P prescription requirements (including but not limited to Tramacet®, Tridural®, Zytram®).
Health Canada Changes to Legislation
Because of the health and safety risks associated with tramadol, Health Canada has opted to control this opioid more tightly. New Health Canada regulatory changes come into effect on March 31, 2022. Tramadol will be a Schedule I drug under the Controlled Drugs and Substances Act (CDSA) and listed in the Narcotic Control Regulations (NCR). These changes will strengthen the oversight of tramadol, facilitate detection and prevention of diversion, and help to mitigate the risks of tramadol to the public.
When Health Canada changes federal legislation like the CDSA and NCR, provincial regulators need to adapt practice policies accordingly. To incorporate these federal changes and to further mitigate the health and safety risks associated with tramadol, the College of Pharmacists of Manitoba (CPhM) and CPSM have added it to the M3P drug list. Both Councils have approved these changes.
What does this mean for prescribers?
If your last tramadol prescription was written before March 31, 2022, the pharmacy can provide one refill from this prescription, for a maximum of a 1-month supply. After this, a new M3P tramadol prescription will be required. The table below outlines specific M3P requirements.
NECESSARY CHANGES TO TRAMADOL PRESCRIPTIONS AS OF MARCH 31, 2022
|Prescriptions for tramadol-containing products must be written on M3P forms, which must be given to the pharmacy within 3 days. Prescriptions can also be faxed directly to the pharmacy during the COVID-19 pandemic (see below for further guidance on faxing M3Ps).|
|Prescribers must complete all fields as per the M3P form requirements, including: · Patient demographics (name, address, PHIN, DOB) · Name, strength, and dosage form of the tramadol · Total quantity of tramadol to be dispensed (in numbers and words) and the intervals (# of days) at which it is to be dispensed · Therapeutic indication · Directions for use · Date prescribed · Written and signed by an authorized practitioner|
Verbal prescriptions and refills are no longer permitted for tramadol products. Only part fills are allowed if the total quantity and specified time interval between part-fills is clearly indicated.
Prescription transfers are no longer permitted for tramadol products between pharmacies.
Physician Assistants and Clinical Assistants are no longer able to prescribe tramadol, as it is on the M3P drug list.
What about Codeine?
According to the Manitoba Opioid Atlas, the use of tramadol per 1000 persons in Manitoba has increased dramatically since its Canadian market launch in 2005. More than a 400% increase in tramadol users per 1000 persons was reported from 2005 to 2018. CPSM Council approved the motion to add all tramadol formulations to the M3P drug list to protect Manitobans from the potential harms associated with this opioid, as supported by Health Canada’s impact assessment.
Council went on to express grave concern about the harms associated with codeine prescribing. In Manitoba, the prescribing of codeine remains more prevalent than any other opioid and it continues to contribute to more accidental overdose deaths than any other opioid. Tylenol #3 is not currently on the M3P drug list due to a variety of historical reasons. Council feels strongly that this issue needs to be evaluated and addressed in future collaboration with the CPhM. Furthermore, Council was concerned that the regulatory changes around tramadol may create the unintended and erroneous perception that codeine is a safer opioid than tramadol. This is not the case! All opioids have associated benefits and harms.
CPSM advises its registrant to continue treating pain appropriately, including using opioids when indicated. Selecting the opioid prescribed during a trial must be based on clinical factors and collaborative decision-making with the patient. This needs to occur within the safeguards outlined by the Standard of Practice for Prescribing Opioids. As always, a balance between patient needs and public safety must be at the forefront.
CPSM Resources for M3PS
To prevent forgeries, the following two resources are available by request rather than posted online. Please contact the Prescribing Practices Program at (204) 774-4344 to request these resources:
· Ensuring Safe Access to M3P Prescriptions for Patients During COVID-19 (provides details of faxing options and requirements for all M3P prescriptions)
· COVID-19 Guidance Regarding M3P Prescriptions for Palliative Care
As an opioid, tramadol was always subject to the Standard of Practice for Prescribing Opioids and these prescribing and dispensing expectations remain.
Why are these changes occurring?
The opioid crisis is a national concern. According to Health Canada, between 2006 and March 2020, tramadol is suspected of having contributed to 27 reported deaths. While tramadol can provide effective pain relief for some patients, like other opioid analgesics, it also has the potential to cause harm. Chronic use of tramadol can lead to the development of tolerance and physiological dependence. Long-term tramadol use is also associated with a risk of developing serious complications such as opioid use disorder (opioid addiction), respiratory depression, and death.
While the problematic use of tramadol has not contributed significantly to the opioid crisis in Canada, tramadol is a threat to the health and safety of the public.
Tramadol was previously regulated only under the Food and Drugs Act (FDA) Prescription Drug List. Unlike most other opioids, tramadol was not previously controlled under the CDSA or the NCR.
CPSM has managed the prescribing of other CDSA Schedule I drugs by adding them to the M3P drug list. Other Schedule I opioids include morphine, heroin, codeine, hydromorphone, oxycodone, and fentanyl. As a reminder, all single ingredient opioids and all opioid formulations (1 opioid + 1 active non-opioid ingredient) are currently included under the M3P program.
More information about Tramadol changes
· Order Amending Schedule I to the Controlled Drugs and Substances Act (Tramadol)
· Regulations Amending the Narcotic Control Regulations (Tramadol)
· Notice of intent to amend: Prescription Drug List (PDL): Tramadol
The full Health Canada Regulatory Impact Analysis, based on the public and stakeholder consultation held between April and June of 2019, can be found here.