Given the ever-rising toll of opioid overdose deaths, the move by Health Canada to switch the status of the anti-overdose drug naloxone to be an over-the-counter medication from a prescription drug is a welcome development.
But the celebratory headlines that naloxone is "now available without a prescription in Canada" are a bit premature.
Health Canada, under orders from Health Minister Jane Philpott, moved with record speed to make the switch, but that is only one step in a tediously bureaucratic process.
The National Association of Pharmacy Regulatory Authorities (NAPRA) must approve the "rescheduling" – moving naloxone from schedule I (prescription drug) to schedule II (no prescription required, by behind-the-counter).
NAPRA does not meet again until early June, and it requires a 60-day notice to consider a change. Usually, that request is from a drug maker, but, in Canada, naloxone is not a big-selling generic drug. It is unlikely that a manufacturer would pay the $44,870 fee for a review and NAPRA seems to be taking a "no request, no change" approach.
This being Canada, with its decentralized health regulatory system, the college of pharmacy in each province must, after NAPRA makes its final ruling, also approve the switch to behind-the-counter status. The exception is Quebec, where Health Canada's decision moves naloxone directly to schedule II and the life-saving drug is now available for purchase in pharmacies.
In the rest of the country, naloxone probably won't be available without prescription until after Canada Day, at the earliest.
This is simply not acceptable. (There are other prescription drugs, such as birth control pills, that should be available over-the-counter too, and it is not acceptable that the stifling bureaucracy makes this difficult, either.) As Health Canada noted in its decision to remove naloxone from the prescription drug list, there were 130 submissions – from doctors, nurses, pharmacists, patients, parents, community health and social services groups – and they were unanimous in saying the drug needs to be more widely available, and quickly.
Naloxone has been used for decades in emergency rooms to reverse opioid overdoses. It blocks opiate receptors and essentially reverses the effects of drugs such as heroin and fentanyl.
Administering naloxone is simple – at least in theory. In the United States, it can be purchased in auto-injector form, where you stick the needle into a muscle as you do with an EpiPen, and as a nasal spray. However, in Canada, it is available only in injectable form, and administering it requires some training.
Paramedics carry naloxone (also sold under the brand name Narcan) and so do firefighters and police in many cities. But if we want to have a real impact on reducing ODs, it has to be in a user-friendly form, and affordable. (Naloxone costs about $12 per ampoule and there are two per kit. As a non-prescription drug, there will no longer be a dispensing fee, but pharmacists may require a consultation fee to teach users proper technique.)
Research shows that about 85 per cent of intravenous drug users who overdose do so in the presence of others. But, because their activities are often illegal, there is a reluctance to call 911 for help. Studies have found that making naloxone available to regular opioid users is effective, and can save on health and policing costs, not to mention prevent deaths.
In New York City alone, more than 20,000 kits a year are distributed, and about 500 overdoses are reversed. (And that doesn't count all the other ODs reversed by paramedics and firefighters.) Community groups in Toronto, Ottawa, Edmonton and Vancouver already distribute take-home naloxone kits, and others are considering doing so.
But let's not forget that people at risk of overdoses are not just stereotypical "junkies," but people such as cancer patients and your grandmother. There is a good argument to be made for having naloxone in the homes of patients taking powerful painkillers such as fentanyl.
In Ontario alone, 614 people are known to have suffered fatal opioid overdoses in 2014. Canada-wide, the death toll is probably three times that number. There is no formal data collection in this country but, in the United States, there are more the 16,000 fatal opioid ODs a year.
Making naloxone more readily available can put a dent in those numbers. Of course, that is just one small part of what needs to be done to tackle the opioid epidemic, beginning with reining in gross overprescription of narcotic painkillers.
Right now, naloxone is not easy to get, and paper pushers are to blame. We should not tolerate that petty bureaucracy be allowed to kill people.