The College of Pharmacists of Manitoba (CPhM) Council, and the College of Physicians and Surgeons of Manitoba (CPSM) have approved the addition of all single-entity tramadol products and tramadol preparations (tramadol + 1 active non-narcotic ingredient) to the M3P list.
This decision is a result of the federal scheduling changes to tramadol announced by Health Canada. Tramadol will be removed from the Prescription Drug List (PDL) and listed in Schedule I of the Controlled Drugs and Substances Act (CDSA). Tramadol will also be listed as item 19 in the Schedule of the Narcotic Control Regulations (NCR) and therefore subject to all the regulatory requirements set out in the CDSA and NCR.
Both federal scheduling changes, and the provincial addition to the M3P list, are effective March 31, 2022.
CPhM, in collaboration with CPSM, and the College of Registered Nurses of Manitoba (CRNM) have developed a Q & A for the public, to help address some of the most anticipated common questions.
For all prescriptions written BEFORE March 31, 2022, patients may be provided with only ONE additional refill for a maximum of a 1-month supply. After that, all patients must acquire a new prescription that follows the new legislated requirements.
All prescriptions written ON OR AFTER March 31, 2022, must follow the new rules.
The following prescribing and dispensing changes will be applicable for all tramadol products and tramadol preparations:
- All prescribers must have authority from their professional regulatory authorities to prescribe M3P medications.
- If prescribers are from another province, they must have authority to prescribe CDSA drugs.
- Physician Assistants or Clinical Assistants can no longer prescribe these medications (refer to the Prescribing Authority Table).
- All prescriptions must be written on a compliant M3P form and presented to the pharmacy within 3 days (in addition to the day the prescription was written). Alternatively, the prescription can be faxed directly to the pharmacy, following the joint guidance document entitled “Ensuring Safe Access to M3P Prescriptions for Patients During the COVID-19 Outbreak” (please login to your member portal for access to the full document).
- Repeats are not permitted, but part fills are allowed if the prescriber states in writing the total quantity to be dispensed, the quantity of each fill, and the specific dispensing time interval.
- Verbal prescriptions are no longer permitted.
- Transferring of prescriptions is no longer permitted.
- As already established, all prescriptions written by members of CPSM and CRNM must follow the corresponding Standards of Practice for Prescribing Opioids (including the CPSM Standard of Practice for Prescribing Opioids, and CRNM RN(NP) Opioid Prescribing to Treat Non-Cancer Pain). Please also refer to the CPhM Companion Document for more guidance.
- Prescriptions can only be written for a maximum of a three-months supply, which can only be dispensed one-month at a time.
- Most recently, the Manitoba Veterinary Medical Association (MVMA) has also announced the same standards to the practice of veterinarians (see By-law 4-6-10 and 4-6-11)
The following record keeping requirements will be applicable for all single entity tramadol products and tramadol preparations:
- Pharmacists are responsible for the security of all tramadol products under their care. All reasonable steps must be taken to protect tramadol from against loss and theft.
- As required by the Pharmacy Facilities Practice Direction all tramadol products must be stored in the narcotic safe.
- Pharmacists will be responsible for maintaining, in an auditable manner, all the records required by the NCR and the Manitoba Pharmaceutical Regulation regarding their activities with tramadol for a minimum of five years. This includes, but is not limited to the following records:
- Purchase records
- Records of receipt
- Sale/Provision records
- Emergency transfer records
- Records of returns to licensed dealers
- Destruction records
- Furthermore, pharmacists must include all tramadol prescriptions dispensed on or after March 31, 2022, in their special narcotic prescription file. This includes part-fills of tramadol that may be dispensed after March 31, 2022, pursuant to a prescription received or partially filled prior to the scheduling change.
- Per the Drug Distribution and Storage Practice Direction, and the CPhM Narcotic and Controlled Drug Accountability Guidelines, pharmacists must perform inventory counts and reconciliations on a regular basis (at minimum, every three months per provincial requirements, after a pharmacy move, and after a change in pharmacy manager or owner) to ensure all controlled substances, including tramadol, are accounted for.
- If discrepancies are discovered, they must be investigated. Any theft or unexplained loss of any narcotic, controlled and or/targeted substance must be reported to Health Canada and the College of Pharmacists of Manitoba within 10 days of discovery. Additionally, local police must be informed of any theft without delay.
For additional information, please see the related Controlled Substances Bulletin.
Should you have any questions regarding the above, please contact CPhM at info@cphm.ca.