Health Canada mulls stripping off naloxone’s prescription-only status

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Like people in many other regions in the world, Canadians too are getting addicted to opioids and with a spurt in the number of overdose related deaths, Health Canada is looking to review the prescription only status of naloxone in a bid to increase its accessibility across the country.

Naloxone is a drug that temporarily reduces the effects of opioid overdose and has been in use in Canadian hospitals for over 40 years. It is currently available in the country by prescription only, which limits its availability.

Several provinces have recently requested that it be made available without requiring a prescription in order to facilitate broader access by first responders as well as friends and family members to help them deal with emergency situations.

To improve accessibility, Health Canada will have to remove naloxone from its list of ingredients that require a prescription. This would allow access similar to epi-pens and insulin.

In normal conditions, manufacturers request a change of status and provide Health Canada with evidence to support the change. However, if there are specific health and safety needs, Health Canada may itself initiate a review at any time.

As a first step in its risk assessment, Health Canada has requested that the provinces and territories gather and share the evidence in their possession about the use of naloxone. Some provinces have already taken steps to expand the accessibility and use of the drug, such as by allowing injection of naloxone to patients by a wider range of professionals including first responders. A number of cities and provinces have also implemented programs to provide opioid users with take-home naloxone kits and training for their families and friends in how to inject it in case of an opioid overdose.

Health Canada’s risk assessment would examine all elements, including the risks of use in the initial absence of a health professional.

In the event Health Canada’s initial assessment finds that the benefits of expanding access appear to outweigh potential risks, the next step would be a public consultation on its website. The full process would be expected to wrap up in about 18 months.