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Health Canada Statement on Change in Federal Prescription Status of Naloxone

Health Canada today proposed a change to make naloxone more widely available to Canadians in support of efforts to address the growing number of opioid overdoses. After taking the unprecedented step of initiating a review of the drug’s prescription status, Health Canada has put forward an amendment to the prescription drug list to allow non-prescription use of naloxone specifically for emergency use for opioid overdose outside hospital settings. The product labelling would be revised and training would be required for those potentially administering the drug. A consultation seeking views on this proposal has been launched.

Naloxone is a drug administered by injection that reverses the effects of opioid medications and can be used to temporarily counteract opioid overdoses. Some provinces have already expanded the availability of naloxone through community-based take-home programs, and others have undertaken regulatory changes to allow use by first responders.

Health Canada’s goal in considering whether to change the prescription status of any drug is to determine whether it can be used safely outside the direct supervision of a health-care practitioner. Working closely with the provinces and territories the Department requested, collected and assessed: the health and safety data, such as the record of adverse reactions associated with naloxone use; the need for immediate follow-up treatment (since the effects of naloxone are temporary); and the requirements for administering the drug.

Health Canada undertakes a public consultation whenever a change is proposed to the prescription status of any drug. Canadians are encouraged to provide comments on the proposal until March 19, 2016. If the change in status continues to be supported by the evidence and input received during the consultation, the change will be finalized. Health Canada intends to waive the usual six-month implementation period that follows such decisions so that the change in status can occur as quickly as possible.

Health Canada remains concerned about the growing number of opioid overdoses and deaths occurring across Canada, and will continue working with the provinces and territories and other stakeholders to address this important issue.