Notice: Prescription Drug List (PDL): Naloxone

January 14, 2016
Our file number: 16-100479-342

The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Naloxone on the Prescription Drug List (PDL) to allow the non-prescription use of Naloxone for the conditions listed below.

The proposed wording of the new listing is:

Drugs containing the following: Naloxone or its salts

Including (but not limited to): Naloxone hydrochloride

Qualifier: Except when indicated for emergency use for opioid overdose outside hospital settings

Effective Date: to be determined

Rationale

Naloxone, an opioid antagonist, is indicated for the complete or partial reversal of opioid depression, including respiratory depression induced by an overdose of an opioid (natural and synthetic). It is also indicated for the diagnosis of suspected acute opioid overdose. Both the 0.4 milligram/millilitre and the 1 milligram/millilitre strengths are proposed to switch.

Opioid overdose is a very serious and often life-threatening condition. Loss of life due to opioid overdoses - both accidental and voluntary - constitutes a serious public health concern. The large increase in opioid overdose episodes has prompted the provinces to design programs to provide greater access to naloxone at the site of the overdose, either through first responders or “take-home programs”. These programs are hindered by the prescription status of naloxone. The provinces and territories have collectively asked Health Canada to re-evaluate the status of naloxone.

In response to the request, Health Canada undertook a Benefit-Harm-Uncertainty (BHU) assessment of naloxone. This assessment recommended that naloxone could safely be administered without the direct supervision of a physician if the person administering the drug has appropriate training.

The main risks associated with the unsupervised use of the drug are:

• the administrator may have difficulty filling the syringe and administering the drug under pressure in an emergency situation;
• the administrator may not seek professional care for follow-up of the patient after injection;
• chance of the patient relapsing since the effects of naloxone may only last for up to one hour depending on amount and type of opioid causing the overdose;
• that the patient may become very agitated and aggressive after coming out of the opioid depression (Acute Opioid Withdrawal Syndrome).

These risks can be mitigated with appropriate training of the potential administrator before naloxone is distributed. The benefit of quickly responding to an overdose far outweighed these risks. Evidence from provincial take-home programs indicates that naloxone can be administered (intramuscularly or subcutaneously) by a layperson and its effects monitored successfully without practitioner supervision. Although an opioid overdose might be mistakenly diagnosed by a layperson, the injection of naloxone in a person not overdosing on an opioid will cause no serious harm.

Drug Identification Numbers (DINs) potentially affected by this proposal are:

• 02148706, 02148714 and 02382601 held by Sandoz Canada Incorporated;
• 02393034 and 02393042 held by Omega Laboratories Ltd;
• 02382482 held by Alveda Pharmaceuticals Inc.

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.

Please send your comments within 65 days from the date of this posting to:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C1
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

or

Telephone: 613-957-1058
Facsimile: 613-941-1812
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

If all comments not in favour of this proposed revision can be addressed, a Notice of Amendment will be posted on the Health Canada website. This Notice will address comments received and inform stakeholders of Health Canada’s revision to the PDL. Please note there will not be a delayed implementation of this switch.