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Changes to the Drug Schedules Regulation Regarding Codeine, Lisdexamfetamine dimesylate, Nicotine, and Cannabinoids coming into effect soon
Amendments to the Drug Schedules Regulation (DSR) regarding Cannabinoids have been filed with the Ministry of Health and are expected to come into effect in December 2018.
Additional amendments to the DSR regarding Codeine, Lisdexamfetamine dimesylate, and Nicotine have also been submitted for filing with the Ministry and are expected to come into effect on January 22, 2019.
Changes to the Drug Schedules Regulation were approved by the College Board at its November 2018 meeting in order to address a scheduling gap; and improve alignment with the Prescription Drug List under the Food and Drugs Act (Canada) and the Schedules to the Controlled Drugs and Substances Act (Canada) with respect to Cannabinoids, Codeine, Lisdexamfetamine dimesylate, and Nicotine.
The amendments to Codeine, Lisdexamfetamine dimesylate and phyto and synthetic Cannabinoids were made in response to a number of requests from the British Columbia College of Nursing Professionals for them to be added to the DSR so that nurses can legally prescribe them.
Under the Health Professions Act (British Columbia), registered nurses and nurse practitioners may, in accordance with their standards of practice, prescribe drugs that are categorized as Schedule I, IA and II on the DSR.
Amendments to Nicotine were made to improve alignment of the drug with the Prescription Drug List .
Cannabinoids
Phytocannabinoids (s.g. Sativex) and synthetic cannabinoids (e.g. Nabilone) that have been classified as prescription drugs by Health Canada will be added to the DSR in order to align with the Prescription Drug List and the Schedules to the Controlled Drugs and Substances Act (Canada).
It should be noted that the Prescription Drug List only regulates the prescription status of health products containing cannabis and not other types of cannabis products such as cannabis for non-medical purposes.
These amendments have been approved by the Ministry of Health and will come into effect in early December 2018.
Codeine, Lisdexamfetamine dimesylate, and Nicotine
Codeine
Depending on its dosage form, codeine is currently scheduled on the DSR as a Schedule 1A or a Schedule II drug. However, these two categories do not capture the dosages of codeine found in Tylenol #2 and Tylenol #3. Therefore, a separate category, Schedule 1 codeine, will be created to address the scheduling gap.
Lisdexamfetamine dimesylate
Lisdexamfetamine dimesylate will be added to the DSR as a Schedule I drug to align with the Schedules to the Controlled Drugs and Substances Act (Canada).
Nicotine
The nicotine qualifier in the DSR will be amended for alignment with recent changes to the Prescription Drug List.
These amendments have been submitted for filing with the Ministry of Health for a period of 60 days and are expected to come into effect on January 22, 2019.
Summary of Amendments to the Drug Schedules Regulation
| Old Entry | New Entry | Expected In Force Date |
|---|---|---|
| None |
Codeine, except (a) when prescribed as a single entity, (b) when included in a preparation containing 60 mg or more per dosage unit, or (c) in preparations exempted from the Regulations to the Controlled Drugs and Substances Act (Canada) |
January 22, 2019 |
| None | Lisdexamfetamine dimesylate | January 22, 2019 |
|
Nicotine and its salts, for human use, except (a) in natural substances; (b) in the form of a chewing gum containing 4 mg or less of nicotine per dosage unit; (c) in the form of a transdermal patch with a delivery rate of 22 mg or less of nicotine per day; (d) in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit; or (e) in the form of a lozenge containing 4 mg or less of nicotine per dosage unit |
Nicotine or its salts, for human use, except (a) in natural substances; (b) in the form of a chewing gum containing 4 milligrams or less of nicotine per dosage unit, (c) In the form of a transdermal patch with a delivery rate of 22 mg or less of nicotine per day, (d) in a form to be administered into the oral cavity by means of a non-active device (one that operates on energy generated by the human body or by gravity) that delivers 4 mg or less of nicotine per dose for buccal absorption, or (e) in the form of a lozenge containing 4 mg or less of nicotine per dosage unit |
January 22, 2019 |
| None |
Phytocannabinoids produced by, or found in, the cannabis plant and substances that are duplicates of such phytocannabinoids, except (a) derivatives of cannabis as defined in subsection 2(1) of the Cannabis Act (Canada) that are exempt from the application of that Act under the Industrial Hemp Regulations (Canada) and that do not contain an isolated or concentrated phytocannabinoid or a synthetic duplicate of that phytocannabinoid, (b) anything referred to in Schedule 2 to the Cannabis Act (Canada) that contains no more than 10 µg/g delta-9-tetrahydrocannabinol and that does not contain an isolated or concentrated phytocannabinoid or a synthetic duplicate of that phytocannabinoid, or (c) anything referred to in the Cannabis Exemption (Food and Drugs Act) Regulations (Canada) that is exempt from the application of the Food and Drugs Act (Canada) |
December 2018 |
| None | Synthetic cannabinoid receptor type-1 agonists, their salts, derivatives, isomers, and salts of derivatives and isomers, as listed in the schedules to the Controlled Drugs and Substances Act (Canada) and the Narcotic Control Regulations (Canada) | December 2018 |