Notice of Consultation on the Prescription Drug List (PDL): Epinephrine chloride (topical solution)

August 12, 2019
Our file number: 19-114682-132

This Notice of Consultation provides an opportunity to comment on the proposal to add Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000) to the Prescription Drug List (PDL). Only the Human part of the PDL is proposed to be revised.

The proposed listing is:

Drugs containing any of the following:	Including (but not limited to):	Qualifier:	Effective Date:
Epinephrine or its salts	no data	Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000)	to be determined

Rationale:

Epinephrine (often referred to as 'adrenalin') as a topical solution is used as a hemostatic agent in mucosal and sinus surgery. It is applied topically during endonasal surgeries or endodontic mini-surgeries when a reduction of local hemorrhage is indicated.

Epinephrine has been marketed in Canada since 1951. Epinephrine has been regulated as a Natural Health Product (NHP) since 2004 when the Natural Health Products Regulations (NHPR) came into force. Prior to 2004 it was considered a drug.

Health Canada has received a drug submission for topical epinephrine that contains sufficient information to demonstrate that topical epinephrine solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000) meets the PDL factors and that the PDL should be modified accordingly. It has been determined through the review of the submission that:

• Practitioner supervision is necessary for treatment and/or monitoring;
• The use of the drug requires complex or individualized instructions;
• Practitioner expertise is necessary to administer the drug or oversee the drug's administration;
• The drug has a narrow margin of safety;
• Medication errors occurred with the use of topical epinephrine as an injectable; and,
• Practitioners are needed to administer the product in a hospital or clinic.

As a result of this PDL amendment, products containing "Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000)" will be considered prescription products under the Food and Drugs Regulations (FDR), and as such, would no longer be considered NHPs.

The following products will be affected by this switch:

• Adrenalin (Erfa Canada 2012 Inc.)
• Racemistat (Pascal International Corporation)

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 Prescription Drug List should be provided to Health Canada, preferably in electronic format, within 75 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

Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca
Telephone: 343-998-9304
Facsimile: 613-941-1812

If all comments not in favour of this change can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. The Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL. The actual revision to the PDL would be made six months from the date of the Notice of Intent to Amend and communicated to stakeholders through a Notice of Amendment.