Health Canada has decided not to require controlled-release opioid painkillers to be tamper-resistant, saying that measure wouldn’t help Canada’s fastest-growing drug problem, which kills hundreds of people across the country each year.
In the summer of 2014 the previous Conservative government launched consultations into whether to require certain drugs, starting with controlled-release oxycodone, the generic version of OxyContin, to be tamper-resistant.
Their Liberal successors have decidedthat wouldn’t be a good idea. It “would not have had the intended health and safety impact,” Monday’s press release stated.
(“Controlled-release” opioids are drugs designed to give their pain-relieving effect over an extended period of time. If they’re abused to get that entire high all at once, it can have serious health consequences, including overdose and death.)
Tamper-resistant formulations, as the name suggests, are designed to make it tougher for people to crush, snort or inject the pill.
Purdue Pharmaceuticals, the maker of OxyContin and other drugs, reformulated the popular opioid painkiller to make it tamper-resistant shortly before its patent on the original drug was set to expire.
The new patented version, called OxyNEO in Canada, is supposed to become a mushy goo if you try to crush it into a powder. A quick online search reveals plenty of ways to circumvent this, however.
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Reviews have been mixed: Some say this formulation at least makes it more difficult to abuse the drug in some of the most destructive ways; others argue it gives a false sense of security, especially given the ability to tamper with it if you try hard enough, and given the drugs’ ability to have deleterious effects even if they’re used as directed.
“You can make a case that any opioid should be tamper-resistant,” David Juurlink, an addictions expert at Toronto’s Sunnybrook Health Sciences Centre, said when Health Canada first floaded the idea in 2014.
But “all that does is discourage the people who want to grind it up and snort or inject it.
“It’s a good idea, but it doesn’t really address the greater problem of opioid misuse and abuse. … The idea that this is going to solve the problem is specious.”
Many provinces used the switch as an opportunity to remove OxyNEO from the list of drugs they’ll pay for. As Global News has documented, that just meant other opioids are prescribed more frequently.
(Purdue, which has vehemently argued its new formulation is much safer, continues to market Hydromorph Contin, a controlled-release opioid that isn’t tamper-resistant, and which has become increasingly popular in Ontario.)
“Requiring tamper-resistant properties on all legitimate preparations of controlled-release oxycodone would have served to eliminate certain lower cost drugs from the market, increasing costs for patients and the health system, while having little to no effect in the fight against problematic opioid use,” Health Canada’s releases states.
Purdue said in a statement it’s “disappointed” in Health Canada’s decision, which it called “fundamentally flawed.”
The pharmaceutical company called on Health Minister Jane Philpott to “accelerate the use of abuse-deterrent formulations across the entire class of opioids.”
Purdue says it’s “actively developing” an tamper-resistant version of its drug Hydromorph Contin, whose use has skyrocketed over the past four years. But the company won’t say when that will happen.
The U.S. Food and Drug Administration recently took a different approach last month, announcing its intention to increase the development of, and access to, “abuse-deterrent” opioids.
“Recent work has suggested that introducing tamper deterrent formulations of only one product (ie oxycodone) won’t solve the issue since people will generally just move on to other alternative opioids (ie hydromorphone). However, [tamper-deterrent] products are certainly one tool that I think have value in addressing this issue.”
The list of things Health Canada is doing to combat the opioid crisis includes “educating prescribers,” whose regulatory bodies have so far been reluctant to mandate continuing education on opioids. A Manitoba study found half of new fentanyl prescriptions don’t follow safety guidelines.
Philpott says she’d like to improve national data collection on opioid deaths, which is largely nonexistent right now.