Health Canada to fast-track easier access to overdose-reversing drug

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A first-aid drug that reverses the symptoms of an opioid overdose is expected to be available without a prescription in Canada by mid-March in response to an alarming spike in deaths linked to fentanyl.

Health Canada announced on Thursday that it is fast-tracking the process for changing the status of naloxone to a non-prescription drug, a move that would give those at risk of an accidental overdose easier access to the life-saving antidote. Naloxone reverses the effects of an opioid overdose within minutes.

Health-care advocates have been calling on the federal government to address what they describe as an epidemic of opioid overdose deaths.

A bootleg version of fentanyl has been linked to a wave of overdose deaths that have hit British Columbia and Alberta particularly hard. Fentanyl was developed as a prescription painkiller, but gained popularity as a street drug after other opioids, notably OxyContin, were removed from the market. The bootleg version of fentanyl is often made in clandestine labs and smuggled into Canada.

Fentanyl is 50 to 100 times stronger than morphine, and therefore more lethal. Between 2009 and 2014, fentanyl was found to be a cause or a contributing cause in 655 drug overdose deaths in Canada.

As the death toll mounts, health-care advocates have accused the federal and provincial governments of not doing enough to address the problem. In Ontario, for instance, dozens of health-care experts wrote a letter to Premier Kathleen Wynne and Health Minister Eric Hoskins last November, asking them to appoint an official to expedite overdose-prevention and intervention measures, but they have not received a response.

Many of the advocates welcomed Health Canada's decision to make naloxone more readily available.

"We certainly need more access to naloxone," Rosana Salvaterra, medical officer of health for Peterborough, Ont., said in an interview. "We have a crisis on our hands."

In British Columbia, one of the hardest-hit provinces, a take-home naloxone program has been credited with reversing at least 373 opioid overdoses since it began in August, 2012. Drug users with a prescription from their doctor can go to one of 126 sites in B.C., receive training on how to administer the drug and take a kit home with them.

To date, about 5,500 people have been trained – including users' family members and loved ones – and more than 4,400 naloxone kits have been dispensed. Details have not yet been finalized on how the non-prescription version would be dispensed.

Ashraf Amlani, a harm-reduction epidemiologist with the BC Centre for Disease Control, said a change in prescription status would improve access to the life-saving drug – particularly in rural and remote communities.

"In the Lower Mainland, we have a lot of providers and a lot of doctors, but in rural and remote communities, it's actually quite hard for people to travel to a place to connect with a nurse practitioner, or a doctor, to get a prescription," she said.

While naloxone is a safe and effective rescue medicine, Dr. Salvaterra said, making it available on a non-prescription basis is not the only solution. She is urging provincial governments to make naloxone more affordable for those on fixed incomes by including it in their publicly funded drug programs. No province currently pays for it.

Manitoba Health Minister Sharon Blady said she will ask a task force set up this week to tackle the fentanyl problem to look at including naloxone in the province's drug plan.

Health Canada said last July that the process for making naloxone available without a prescription would take 18 months. But on Thursday, the department said it will waive the six-month implementation period that usually follows a change in a drug's status when the consultation period ends in mid-March.

In a statement, Health Canada said it "remains concerned about the growing number of opioid overdoses and deaths occurring across Canada."