Frequently Asked Questions: Access to naloxone in Canada (including NARCAN™ Nasal Spray)

What is naloxone?

Naloxone is a drug that blocks opioid actions and is used to reverse the effects of opioid overdoses. Common signs of overdose include respiratory depression (difficulty breathing), sedation (feeling sleepy) and hypotension (unusually low blood pressure). The World Health Organisation refers to naloxone as "an essential medicine that can save lives in opioid overdose situations".

Naloxone is a safe drug and administering naloxone to a person that is unconscious because of a non-opioid overdose is unlikely to create more harm. However, it will not reverse overdoses that are not caused by opioids. For example, naloxone will not work to reverse overdoses caused by alcohol, benzodiazepines, psychostimulants (e.g. cocaine, amphetamines or methylphenidate), etc.

Is naloxone available without a prescription?

Yes. In March 2016, Health Canada changed the prescription status of naloxone to increase public access. Instead of requiring a prescription for each individual in need of naloxone, pharmacies are now able to proactively give out naloxone to those who might experience or witness an opioid overdose. Additionally, switching naloxone to non-prescription enabled emergency responders to administer naloxone without having to wait for a prescription to be ordered for each individual in need.

What is naloxone nasal spray?

Naloxone nasal spray is a specific format of naloxone which enables it to be sprayed directly into the nose through the nostril. As with other naloxone products, it is used to reverse the effects of opioid overdoses. Through the nasal route of administration, naloxone's effects occur in 2 to 3 minutes.

Are there other formats of naloxone besides the nasal spray?

Yes. In Canada, in addition to the nasal spray format, several versions of naloxone in an injectable format are available. When naloxone is injected intravenously (into veins), its effects occur in less than 2 minutes. When naloxone is injected subcutaneously (into skin) or intramuscularly (into a muscle), its effects occur in 3 to 5 minutes.

Naloxone in any of the formats is effective at reversing the effects of opioid overdoses. However, there may be specific circumstances where one format may be preferred over another for various reasons, such as ease of use, cost etc.

Why did Health Canada issue an Interim Order allowing the importation of NARCAN^®Nasal Spray from the United States (U.S.)?

In light of the alarming increase in opioid-related deaths, the Government of Canada is committed to addressing problematic opioid use, including providing easier access to various formats of naloxone. Prior to the Interim Order, only injectable naloxone products were available in Canada. While all formulations of naloxone are life-saving, Health Canada identified the need to increase Canadian access to an alternative formulation of naloxone that may be easier to administer in some emergency situations.

As an emergency public health measure, the Minister of Health signed an Interim order on July 6, 2016 to allow the importation of NARCAN^®Nasal Spray, the U.S. version of the Canadian NARCAN™ Nasal Spray, into Canada for one year. The signing of the Interim Order was a mechanism to enable Canadians to access the nasal spray, while Health Canada completed an expedited review of the product to grant it normal Canadian market approval.

What is the expiry date of the Interim Order?

Given that the Interim Order is only valid for one year, the expiry date is July 5, 2017. After this date, the importation of NARCAN^®Nasal Spray from the U.S. will no longer be legally permitted.

After the Interim Order expires, can the U.S. NARCAN^®Nasal Spray already obtained under the Interim Order continue to be used in Canada?

After the Interim Order expires, any U.S.NARCAN^®Nasal Spray which has been sold in Canada can continue to be used until its product expiry date.

When will the Health Canada-approved naloxone nasal spray be available for sale in Canada?

In parallel to the Interim Order, Health Canada conducted an expedited review of naloxone nasal spray, and has approved it under the brand name NARCAN™ Nasal Spray. To date, this is the only nasal spray version of naloxone approved in Canada.

To avoid any interruption in supply, the Health Canada-approved NARCAN™ Nasal Spray will be available for sale in Canada by the date of expiry of the Interim Order.

After the Interim Order expires, how can I obtain access to the Health Canada-approved NARCAN™ Nasal Spray?

For more information on how to obtain the Health Canada-approved NARCAN™ Nasal Spray, contact the manufacturer at: Customerservicecanada@ebsi.com or 1-877-870-2726.

What is the difference between the Health Canada-approved NARCAN™ Nasal Spray and the U.S. NARCAN^®Nasal Spray sold under the Interim Order?

To date, Health Canada has approved one naloxone nasal spray under the brand name NARCAN™ Nasal Spray. This product is the same as the U.S. NARCAN^®Nasal Spray sold under the Interim Order. However, the Health Canada-approved NARCAN™ Nasal Spray meets Canadian specific labelling requirements. In general, the Canadian labelling is very similar to the U.S. labelling, although there are some minor differences.

Does Health Canada still require a supplementary information sheet to be included with the Health Canada-approved NARCAN™ Nasal Spray?

As mandated by the Interim Order, any NARCAN^®Nasal Spray imported from the U.S. was required to include a one-page handout from Health Canada entitled Important Supplementary Information for NARCAN^®Nasal Spray 4 mg, in addition to the U.S. packaging and labelling. The Health Canada-approved NARCAN™ Nasal Spray does not require this supplementary handout as the information has been incorporated into the approved Canadian product labelling.

How can I access information on the Canadian labelling of naloxone products?

The Canadian Product Monograph (CPM) is part of a drug's labelling and contains important information about the properties and approved use(s) of a drug, and any other information that may be required for optimal, safe and effective use of the drug. The CPMs for naloxone products approved for sale in Canada (including NARCAN™ Nasal Spray and injectable formats of naloxone), can be accessed through the online Drug Product Database.

What is the difference between the information included in the labelling of the Health Canada-approved NARCAN™ Nasal Spray and the U.S. NARCAN^®Nasal Spray imported under the Interim Order?

A minor difference in labelling between the Canadian NARCAN™ Nasal Spray and U.S. NARCAN^®Nasal Spray relates to the recommended sequence for calling 911. The Health Canada-approved User Guide recommends calling 911 prior to administering naloxone nasal spray, while the U.S. User Guide recommends administering the product immediately and calling 911 afterwards. In practice, neither approach is considered wrong.

While it is necessary to call 911 in the event of a suspected opioid overdose, there are differences in opinion among experts as to when the call should be made. Experienced users of naloxone nasal spray may feel comfortable administering the product immediately to avoid wasting time, whereas first-time users may benefit from calling 911 first to receive verbal instruction on how to successfully administer the product. While Health Canada carefully considered the implications of both sequences before providing the recommendation to call 911 first, it should be noted that the optimal approach may vary on a case-by-case basis.

The following points are described in more detail in the Canadian Product Monograph (CPM) of NARCAN™ Nasal Spray If you are using an injectable format of naloxone, please refer directly to its CPM.

CPMs can be found online by searching the Drug Product Database.

When should NARCAN™ Nasal Spray be administered?

NARCAN™ Nasal Spray is indicated for emergency use to reverse known or suspected opioid overdose, as manifested by respiratory and/or severe central nervous system depression.

NARCAN™ Nasal Spray can be administered by a bystander (non-health care professional) before emergency medical assistance becomes available, but it is not intended to be a substitute for professional medical care. Emergency medical assistance (calling 911) should always be requested when an opioid overdose is suspected.

What are the signs of an opioid overdose?

Signs of an opioid overdose include:

• Trouble breathing or no breathing;
• Extreme drowsiness;
• Pale and clammy skin;
• Slow or no heartbeat;
• Passing out;
• Unable to be woken up;
• Pinpoint pupils.

How do I use NARCAN™ Nasal Spray?

NARCAN™ Nasal Spray should be used as described in the product labelling and as indicated by your pharmacist. In an overdose situation:

• Call 911 as soon as you encounter an individual experiencing an overdose;
• Administer NARCAN™ Nasal Spray to the individual experiencing an overdose;
• Be prepared to assist the individual experiencing an overdose for potential side effects;
• Monitor the individual experiencing an overdose until emergency medical help arrives. The duration of action of most opioids may exceed that of NARCAN™ Nasal Spray, therefore symptoms of an opioid overdose may reoccur. In such cases, administering additional doses of NARCAN™ Nasal Spray may be necessary.
• Perform artificial respiration or cardiac massage until emergency help arrives, if you know how and if it is needed.

What are the possible side effects of NARCAN™ Nasal Spray?

NARCAN™ Nasal Spray may cause the following side effects: swelling and/or dryness in the nose, congested and/or runny nose, yawning, nervousness, pain, aggressive behaviors, irritability, restlessness, agitation, blood pressure increased, increased heart rate, nausea, vomiting, diarrhea, abdominal cramps, shivering, chills, tremors, trembling, fever, sweating, weakness, seizures, shaking, muscle spasms, dizziness, headache.

How do I report any side effects with NARCAN™ Nasal Spray?

You can report any suspected side effects associated with the use of NARCAN™ Nasal Spray to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. Health Canada does not provide medical advice.

Are there situations where NARCAN™ Nasal Spray should not be used?

If you find someone unconscious but you are not sure that it is caused by an opioid overdose, the administration of NARCAN™ Nasal Spray is recommended as the outcome will likely be better than not administering it.

The only situation where naloxone should not be used is when a person is known to have a life threatening allergy to naloxone. This is a rare situation and if you do not know whether or not an opioid overdose victim is allergic to naloxone, you should administer NARCAN™ Nasal Spray as the outcome is likely better than not administrating it.

How should I store NARCAN™ Nasal Spray?

• Store NARCAN™ Nasal Spray at room temperature between 15°C and 25°C.
• NARCAN™ Nasal Spray may be stored for short periods between up to 40°C.
• Do not store NARCAN™ Nasal Spray in the car on hot summer days.
• Do not freeze or leave NARCAN™ Nasal Spray in a car during the winter.
  • NARCAN™ Nasal Spray may not be as effective if it is not stored properly. If NARCAN™ Nasal Spray gets frozen or is stored at 40°C for long periods of time, you should replace it. Only discard the NARCAN™ Nasal Spray once you have a replacement for it. If you did not replace NARCAN™ Nasal Spray before it is needed, it is better to use it, even if it hasn't been stored properly.
• Keep NARCAN™ Nasal Spray in the box until ready to use. Protect from light.
• Replace NARCAN™ Nasal Spray before the expiration date on the box.
  • If only expired NARCAN™ Nasal Spray is available, it should be used in an overdose situation.
• Keep out of reach and sight of children.