Date: August 27, 2021
Our file number: 21-115489-476

This Notice of Consultation provides an opportunity to comment on the proposal to revise the listing for brimonidine or its salts, by adding a qualifier to the human and veterinary parts of the Prescription Drug List (PDL).

The current listing is:

The proposed listing is:

Rationale

Brimonidine tartrate is a highly selective imidazoline alpha-2 adrenergic receptor agonist, a chemical class known to cause vasoconstriction (narrowing of blood vessels). Currently, drug products containing brimonidine or its salts as a medicinal ingredient require a prescription for human and veterinary use. Health Canada received a new drug submission for a brimonidine tartrate ophthalmic solution 0.025% (weight-volume, w/v), for the non-prescription relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue, for adults 18 years and older.

Health Canada's review of the submission's safety, efficacy and quality evidence revealed that this new brimonidine tartrate ophthalmic product did not meet any of the criteria for addition to the PDL outlined in section C.01.040.3 of the Food and Drug Regulations (FDR). Clinical and consumer use studies confirmed that this product would be suitable for non-prescription use. It should also be noted that should this PDL amendment proceed, use of this brimonidine tartrate ophthalmic product in children would continue to require a prescription.

The following is a brief summary of how the submission does not meet any of the prescription criteria:

1. Supervision by a practitioner is necessary (i) for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or (ii) to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug.

No. As evidenced by the approval of similar non-prescription ophthalmic vasoconstrictor drugs, the indication for brimonidine tartrate ophthalmic solution 0.025% is a well-established, self-diagnosed and self-treated condition which does not require a practitioner's involvement. The product is only recommended to be used for a short duration (not more than 3 days). As such, while other diseases may present with similar symptoms, it would be unlikely that the product's short duration of use would mask such diseases.

Additionally, the technique of applying eye drops topically is not complex. It has been demonstrated that this product can be used safely in a self-care environment, which further supports that practitioner supervision for treatment or monitoring is not necessary. The active ingredient, brimonidine tartrate, has been safely and effectively used globally and in Canada for more than 20 years as a prescription topical ophthalmic product, and at concentrations up to 6- to 8-fold higher (0.15% to 0.20%) than the proposed product's concentration. Finally, brimonidine tartrate does not possess abuse potential or dependence that would lead to non-medical use.

2. The level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner.

No. In 2017, the US-FDA authorized brimonidine tartrate ophthalmic solution 0.025% as a non-prescription product, to relieve redness of the eyes for children 5 years and older and adults. Overall, the product's post-market data revealed a favourable safety profile.

3. Use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner's supervision.

No. Brimonidine tartrate is a third generation alpha-2 adrenergic receptor agonist that was approved in Canada in 1997 for the control of intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension. With two decades of marketing experience, there is no evidence of harm to public health associated with use of brimonidine tartrate ophthalmic solutions (0.15- 0.2%). Brimonidine tartrate ophthalmic solution 0.025%, at a 6- to 8-fold lower concentration than the prescription solutions, would have a more favourable safety profile, and is unlikely to cause any risk to public health. Finally, post-market evidence has not identified any misuse or abuse potential associated with brimonidine tartrate ophthalmic solutions.

In conclusion, Health Canada's review revealed that none of the PDL criteria outlined in section C.01.040.3 of the FDR apply to brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025%, used for the relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue for adults of 18 years and older.

No currently marketed product would be affected by this amendment.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs .

Comments on this proposed change to the PDL should be provided to Health Canada in writing, preferably in electronic format, within 60 days from the date of this notice.

Please send your comments to:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

E-mail: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca

Next steps

All comments will be reviewed and summarized. Should Health Canada proceed with the amendment, a Notice of Intent to Amend the PDL will be posted on the Health Canada website.