Canada Gazette, Part I, Volume 150, Number 29: ORDERS IN COUNCIL
July 16, 2016
DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Interim Order Respecting Naloxone Hydrochloride Nasal Spray
P.C. 2016-684 July 8, 2016
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to paragraph 30.1(2)(a) (see footnote a) of the Food and Drugs Act (see footnote b), approves the Interim Order Respecting Naloxone Hydrochloride Nasal Spray, made by the Minister of Health on July 5, 2016.
EXPLANATORY NOTE
(This note is not part of the Interim Order.)
Proposal
The Order approves the Interim Order Respecting Naloxone Hydrochloride Nasal Spray (the Interim Order) made by the Minister of Health on July 5, 2016. Without this approval, the Interim Order would, in accordance with paragraph 30.1(2)(a) of the Food and Drugs Act, cease to have effect 14 days after it was made.
The Interim Order authorizes the immediate importation and sale of NARCAN® Nasal Spray for use in the emergency treatment of known or suspected opioid overdoses.
In order to be sold in Canada, NARCAN® Nasal Spray will need to be accompanied by the U.S. labelling as well as additional information required by the Minister of Health. This additional information includes instructions for use in French and instructions on how to report adverse drug reactions. This additional information will also be made available on the Health Canada Web site.
The provisions in Part C of the Food and Drug Regulations will not apply to the importation or sale of NARCAN® Nasal Spray, other than the requirements relating to the reporting of serious adverse drug reactions and recall by the manufacturer.
NARCAN® Nasal Spray will be available without a prescription.
As a result of this approval, the Interim Order will, in accordance with paragraphs 30.1(2)(b) to (d) of the Food and Drugs Act, cease to have effect on the day on which it is repealed, on the day on which regulations having the same effect come into force, or one year after the day on which the Interim Order is made, whichever is earliest.
Objective
The objective of this Interim Order is to take immediate action to address the significant risk to the health of Canadians as a result of opioid overdoses. This Interim Order represents one of a number of actions to combat the risks associated with opioid use, announced by the Minister of Health on June 17, 2016, at the Charting the Future of Drug Policy in Canada conference.
Background
Drug overdose deaths as a result of opioid use and abuse are continuing to rise in Canada. Opioids are a class of drugs that include prescription medications such as oxycodone, fentanyl, hydrocodone, and morphine, as well as illegal drugs such as heroin. The continuing rise in drug overdose deaths in British Columbia led to the declaration of a public health emergency on April 14, 2016. In January alone, there were 74 overdose deaths in that province, and if the trend continues, the total number of deaths could far exceed the 474 deaths that occurred in 2015. Similar disturbing increases have been observed across Canada, much of it as a result of the illicit use of prescription medications.
Naloxone hydrochloride is a life-saving medication that can stop or reverse the effects of an opioid overdose. It is currently available in Canada in a form that requires it to be administered by injection. Health Canada has recently taken steps to make naloxone hydrochloride available without a prescription in emergency situations outside of hospitals.
Naloxone hydrochloride is available in the United States (U.S.) in both an injectable form and as a nasal spray sold by the brand name NARCAN® Nasal Spray (National Drug Code 69547-353-02). NARCAN® Nasal Spray is ready-to-use and does not require assembly, can be used on adults or children, and is easily administered by anyone, even those without medical training.
In approving the nasal spray, the U.S. Food and Drug Administration (FDA) noted that many first responders and primary caregivers felt that a nasal spray formulation of naloxone hydrochloride is easier to deliver, and eliminates the risk of a contaminated needle stick.
NARCAN® Nasal Spray is not currently available for sale in Canada. However, its manufacturer, Adapt Pharma Inc., has filed a new drug submission with Health Canada that could eventually allow for its sale in Canada. Until this occurs, the Minister of Health has determined that there is an immediate need for the product to be available in Canada to help address the ongoing health emergency that exists as a result of opioid overdoses.
Implications
This Interim Order will have the effect of providing Canadians with earlier access to a safe and effective drug that is easy to use by persons who are not medically trained and could subsequently save additional lives by reversing the effect of opioid overdose. It could also reduce the risks of infection from contaminated needle sticks to police, first responders, and other health care professionals who may currently be administering naloxone hydrochloride by injection.
Consultation
Representatives of provinces and territories, including chief medical officers of health and other health professionals, have been made aware of the Minister's intent to take action to reduce the risk of opioid overdose in Canada, including measures to make naloxone hydrochloride more accessible to Canadians at risk. They have indicated their support for the Interim Order as a means to provide earlier access to a safer and easier to use nasal formulation.
Contact
Bruno Rodrigue
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Address Locator: 3105A
Holland Cross, Tower B, 5th Floor
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Email: LRM_MLR_consultations@hc-sc.gc.ca
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