Health Canada Allowing Immediate Access to Naloxone Nasal Spray

A new step in Health Canada’s work to address opioid misuse.

July 6, 2016 – Ottawa, ON – Health Canada

As an emergency public health measure in response to the current opioid crisis, the Minister of Health has signed an Interim Order to temporarily allow naloxone in nasal spray form to be imported from the U.S. and sold in Canada. Until now, only the injectable format of the drug has been available in Canada.

Health Canada received an application for a nasal version of naloxone in May 2016, and is currently conducting an expedited review for authorization in Canada. The Interim Order allows the product, which has been approved by the U.S. Food and Drug Administration, to be temporarily sold in Canada.

An English and French instruction sheet will be provided together with the nasal spray distributed in Canada to ensure that health-care providers, first responders, patients and their families are able to administer the drug safely and effectively.

Allowing immediate access to naloxone nasal spray is one of a series of new actions announced recently by the Minister of Health to address opioid misuse. The new actions focus on better informing Canadians about the risks of opioids, supporting better prescribing practices, reducing easy access to unnecessary opioids, supporting better treatment options, and improving the national evidence base.

These new actions build on work already underway in this area, including:

  • educating consumers on the safe use, storage and disposal of prescription medication;
  • increasing inspections to minimize diversion of prescription drugs from pharmacies;
  • improving surveillance data on prescription drug abuse in Canada;
  • working with our First Nations partners to enhance prevention and treatment services, given the federal government’s role in providing health care services to First Nations communities; and,
  • increasing access to naloxone for emergency treatment to temporarily reverse the effects of an opioid overdose.

The Government of Canada will continue to work with health professionals, addiction experts, stakeholders and provinces and territories to implement the action plan and regularly assess rates and impacts of problematic substance use across Canada.

Quotes

“The number of opioid overdoses in Canada is nothing short of a public health crisis. First responders, police and family members need immediate access to formats of naloxone that are easy to use so that needless deaths can be prevented.  Extraordinary measures are required to address this crisis, so I have asked my department to conduct an expedited review of nasal naloxone for sale in Canada, and to enact this temporary measure that allows access to a product from the US while our review is underway.”

The Honourable Jane Philpott
Minister of Health

Related Products
Health Canada Statement on Change to Prescription Drug List for Naloxone

Health Canada’s Action on Opioid Misuse

Associated Links
Industry Notice on Change to Prescription Drug List for Naloxone

Contacts

Christina Lazarova
Office of Jane Philpott
Minister of Health
613-957-0200

Media Relations
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866 225-0709

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