Questions and Answers - Naloxone
1. What is naloxone?
Naloxone is a drug that prevents or reverses the effects of opioids, including respiratory depression, sedation, and hypotension. It can be used in emergency situations to reduce opioid overdose (OD) deaths.
2. How is naloxone administered?
Naloxone can be injected intravenously (into veins), and its effects occur in less than 2 minutes. Naloxone can be injected subcutaneously (into skin) or intramuscularly (into a muscle), and its effects occur within 3-5 minutes. Naloxone can also be sprayed into the nose, and its effects occur in 2 to 3 minutes.
If an opioid overdose is suspected, 911 (Emergency Services), should be called immediately. Following administration of naloxone, the individual should be monitored. If the effects of naloxone wear off, the administration of naloxone should be repeated until Emergency Services arrive. Repeated naloxone administration is often needed because the effects of most opioids last longer than the effects of naloxone.
3. What is the Prescription Drug List?
The Prescription Drug List is a list of medicinal ingredients that, when found in a drug, require a prescription. The list has two sections: one that pertains to human use and the other to veterinary use. The Prescription Drug List includes listings of ingredients, their salts and derivatives when appropriate, examples of these ingredients, any applicable qualifiers, and the effective date the listing came into effect. Updates to the list are published regularly on Health Canada's website.
4. Why did Health Canada change naloxone's prescription status?
With the dramatic increase in opioid use and opioid related deaths, in June 2015, the provinces and territories (P/Ts) requested that Health Canada make naloxone available without a prescription for use in emergency situations.
In March 2016, Health Canada changed the prescription status to increase public access to naloxone. 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.
5. How did the process for changing naloxone's prescription status differ from the usual process?
The market authorization holder (sponsor) of a drug would normally file a submission with Health Canada to request a switch in its product's prescription status. The submission would typically include data from various sources, as well as a Benefit-Harms-Uncertainties assessment to support the request and it would be reviewed by Health Canada. If the benefits of changing the prescription status outweigh the harms, then Health Canada forwards the switch recommendation to Health Canada's Prescription Drug Status Committee (PDSC). The PDSC comprises a group of Health Canada officials whose role is to consider whether or not the prescription status change recommendation aligns with the Prescription Drug List's pre-established criteria.
Given the serious and urgent nature of the opioid public health crisis, Health Canada conducted the Benefit-Harms-Uncertainties assessment during the Summer-Fall of 2015, and made its recommendation in early 2016 to change naloxone's prescription status.
6. What other actions did Health Canada take to make it easier to access naloxone?
In early 2016, P/Ts, first responders and the public requested access to easier-to-use formats of naloxone, since the injection format was the only available naloxone product in Canada. As a public health emergency measure in July 2016, Health Canada issued a Federal Interim Order to allow Adapt Pharma's prescription naloxone nasal spray, NARCAN, to be imported from the United States and sold in Canada without a prescription for up to one year.
In parallel, Adapt Pharma applied for Health Canada approval of their naloxone nasal spray as a non-prescription product. Health Canada's review was expedited due to the opioid crisis, and was completed quickly. Adapt Pharma's naloxone nasal spray was approved for sale in Canada in October 2016, and is expected to be available for sale in Canada before the Interim Order expires, to avoid any disruption in supply.
7. Why did Health Canada revise naloxone's Prescription Drug List Qualifier?
In early 2017, stakeholders contacted Health Canada to request clarity around who can administer naloxone and under what conditions/settings. The Prescription Drug List (PDL) qualifier caused confusion especially within some hospital settings. Health Canada clarified that non-prescription naloxone can be administered by anyone who witnesses an opioid overdose regardless of the setting. As a result, on February 2, 2017, following a brief consultation, Health Canada revised naloxone's PDL qualifier by removing "outside hospital settings", to reflect Health Canada's original intent of increasing access to naloxone.
8. What are the provincial/territorial considerations around naloxone?
The National Association of Pharmacy Regulatory Authorities (NAPRA) provides a recommendation on drug scheduling to all P/Ts except for Quebec, which falls under the authority of the Ordre des pharmaciens du Québec. NAPRA's National Drug Schedules (NDS) consist of three schedules and one category: Schedule I requires a prescription for sale; Schedule II requires pharmacist intervention for sale; Schedule III requires the option to consult a pharmacist for sale; and the Unscheduled category requires no professional supervision for sale.
NAPRA scheduled both non-prescription injectable naloxone and naloxone nasal spray as Schedule II.
It is important to note that P/Ts may differ in the way they follow NAPRA's NDS. Some automatically adopt NAPRA's NDS, while others may implement different conditions or restrictions than those recommended. These must be the same as, or more stringent than, the Prescription Drug List.
For further information or detail about provincial or territorial differences on how to access naloxone in your region, contact your provincial or territorial Ministry of Health.
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