NAPRA interim recommendations: low concentration brimonidine tartrate eye drops okay on retail shelves

New interim recommendations by the National Drug Scheduling Advisory Committee have brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025% as an unscheduled drug. As an unscheduled drug, it could be sold anywhere in the pharmacy and could be carried by any retail store. The eye drops are used for relieving redness of the eye due to minor irritations that are brought on by environmental allergies, dryness or fatigue. They’re for adults 18 years and older. Other preparations of brimonidine or its salts will remain as schedule I drugs, which require a prescription. Brimonidine tartrate is a highly selective imidazoline alpha-2 adrenergic receptor agonist that causes vasoconstriction. Brimonidine tartrate eye drops in concentrations higher than 0.025% are used for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension, according to the U.S. Food and Drug Administration.In May 2022, Health Canada revised the presence of brimonidine tartrate ophthalmic solution in concentrations up to 0.025% on the prescription drug list, deciding it was safe for non-prescription use. Pediatric use of brimonidine tartrate products still requires a prescription.In Nov. 2022, National Association of Pharmacy Regulatory Authorities (NAPRA) recommended it as a schedule III drug, meaning it could be self-selected by clients, but in an area under the direct supervision of the pharmacist. The new interim recommendations suggest it can be kept anywhere in the pharmacy.The National Drug Scheduling Advisory Committee also made the interim recommendation that packages of acetaminophen and ibuprofen in oral, fixed-dose combinations that have 20,000 mg or less of acetaminophen and less than 6,000 mg or less of ibuprofen remain as schedule III drugs. For packages that have more than 20,000 mg of acetaminophen or more than 6,000 mg of ibuprofen stay as schedule II drugs. Schedule II drugs don’t require a prescription but must be dispensed by the pharmacist at the point of sale. Any objections to the interim recommendations must be sent to NAPRA by the end of the day on January 11, 2023. Contact the National Drug Scheduling Advisory Committee Secretariat at ndsac@napra.ca with any comments or questions. Read: Ontario pharmacists, RPhTs granted new immunization, treatment authorities

NAPRA interim recommendations: low concentration brimonidine tartrate eye drops okay on retail shelves

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