Notice: Prescription Drug List (PDL): Naloxone

March 22, 2016
Our file number: 16-103373-445

The purpose of this Notice of Amendment is to notify that as a result of consultation Health Canada has revised the listing for naloxone on the Prescription Drug List (PDL). Health Canada has conducted a scientific review of naloxone against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which remains unchanged from what was proposed in the January 14, 2016 Notice of Consultation, is:

Drugs containing the following:
Naloxone or its salts
Including (but not limited to):
Naloxone hydrochloride
Except when indicated for emergency use for opioid overdose outside hospital settings
Effective Date:

Consultation summary

Over 130 responses on the proposal of removing prescription status for naloxone when used outside hospital settings were received and all were in favour. Amongst those heard from were social services and community health groups, nurses, doctors, pharmacists, patient and parent organizations affected by a death from opioid overdose, as well as individuals from across Canada with no identified affiliation. Although all responses encouraged the switch, other comments received were more general and outside the scope of the switch consultation.

The most common comment was the need for a more user-friendly dosage form, since the use of a syringe by a person trained but not familiar with administering the drug under emergency situations is awkward, risky and may reduce its effectiveness. One comment stated that the current formulation for injection should not be switched because the significant risks involved when a layperson administers the drug. These risks were taken into account in Health Canada's assessment which concluded the benefit of having naloxone, even in the injectable form, available as soon as a potential over-dose is observed outweighed the risks. Health Canada cannot stress enough of the importance of appropriate training of potential administrators of the drug before distribution. Many commented that the nasal formulation would be a better alternative, which Health Canada would agree with if one were approved and available at this time. It should be noted that approval of alternative dosage forms of naloxone must be initiated by a sponsor of such a formulation, such that Health Canada can assess its safety, effectiveness and quality.

The second most common comment was with respect to the importance of training the administrator since they often may be an untrained medical professional. It was suggested that pharmacists can play a major role when naloxone is purchased in a pharmacy; however, this training will take a significant amount of the pharmacist's time. Other distributors such as "take home programs" commented they have had a very high success rate of overdose reversal when they train potential administrators.

Other comments were more general in nature and themed around the issue that wider availability of naloxone is not the cure to the opioid abuse problem and we must not lose sight of the underlying causes of drug addiction. Training and funding of treatment and support programs must be maintained if not increased.

Should you have any questions on this update to the Prescription Drug List, please contact:

Prescription Drug Status Committee
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9

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