New opioid standards to tackle widespread, serious abuse in Canada

In a bid to curb Canada's widespread prescription-drug abuse problem, Ottawa is moving to force the makers of all opioids – not just the well-known painkiller oxycodone – to render their products resistant to crushing, snorting or injecting for a quick high.

Health Canada recently published a notice of intent to regulate that mentions only slow-release oxycodone by name, but Health Minister Rona Ambrose said in an interview with The Globe and Mail that she hopes to set tamper-resistance standards for all opioids, a change that would make Canada's anti-abuse regime one of the strictest in the world.

"Oxy is not the only problem here from a public health point of view," Ms. Ambrose said. "We want to look at the broader class of opioids and, really, we're leaving it to industry to come up with how they're going to manage and innovate to address the regulation around tamper resistance.... That's an aggressive step, I recognize."

Opioid addiction has become a major public-health crisis in the last 15 years, with Canadians consuming more of the morphine-like drugs per capita than the citizens of any country except the United States.

A new study published Monday in the journal Addiction found that opioid overdoses killed nearly 6,000 people in Ontario between 1991 and 2010, half of them under the age of 42. The study's findings were in keeping with past research laying bare the toll of opioid addiction in Canada.

Reducing that toll will require much more than new tamper-resistance rules, according to public health experts who pointed to two key shortcomings in Ms. Ambrose's plan. The first is that tamper-resistant formulations are relatively new and there is not yet enough solid evidence to prove they deter abuse.

The second is that the majority of opioid addicts swallow the medication as directed; they just take much more than they need for much longer than they should.

"There's nothing bad about this plan per se, but it is illusionary to assume that [tamper-resistance] will make a significant impact in reducing harm outcomes like death," said Benedikt Fischer, a professor in the faculty of health sciences at Simon Fraser University in British Columbia. "If we want to reduce opioid-related problems like abuse, dependence and overdose deaths, we need to reduce the amounts of opioids that physicians dispense to people."

Ms. Ambrose acknowledged that deterring street abuse of opioids is only one piece of a larger puzzle.

"Some people will argue it's a small piece," she said. "But it's one piece and every piece matters because this is about saving lives."

Ms. Ambrose's approach to the problem is a marked departure from that of her predecessor, Leona Aglukkaq, who came under fire in late 2012 for refusing to intervene in Health Canada's decision to approve oxycodone, the generic version of the blockbuster painkiller OxyContin.

By that time, the pharmaceutical company that makes OxyContin had replaced it with OxyNeo, a retooled pill that is more difficult to crush and inhale or inject for the rapid high that gave the drug its infamous nickname, hillbilly heroin.

The U.S. Food and Drug Administration blocked the sale of generic oxycodone on public health grounds. Provincial health ministers in Canada begged Ottawa to do the same, but Ms. Aglukkaq refused, saying it would be inappropriate for a health minister to meddle in the drug approval process.

It was not long before old-fashioned oxy began pouring south across the border, prompting first the U.S. drug czar and then two American senators to chastise Canada for permitting the easier-to-crush pills on the market.

Despite its high public profile, oxycodone is far from the only opioid being misused in Canada, which is why Ms. Ambrose said she is targeting the full range of opioids. Other popular opioids include hydromorphone and fentanyl.

OxyNeo, which turns into a jellylike substance rather than a powder when crushed, is not approved in Canada on tamper-resistance grounds. The notice of intent to regulate seeks advice on what properties a medication should have to count as tamper resistant.

"Patient safety is a priority for our industry and tamper resistant technologies have an important role to play in this complex, multi-faceted issue," Russell Williams, president of the industry association representing brand-name drug companies in Canada, said by e-mail. "How 'tamper resistance' is defined will be important, and a question currently under consultation."

He added that it is "important that any new regulations in Canada align well with those of our major trading partners," a reference to the challenge multinational drug companies could face in producing one version of a drug for Canada and another for the U.S. and other countries. A spokesman for the association representing generic drug makers declined to comment.

Tara Gomes, a scientist with the Institute for Clinical Evaluative Sciences in Toronto, called the proposed tamper-resistance regulations a good first step, one that could help deter street abuse of opioids. She is one of the co-authors of the new Ontario study, which drew on coroners' records to conclude that opioid-related deaths rose 242 per cent between 1991 and 2010, from 12.2 deaths per million in the first year of the study to 41.6 deaths per million in its last.

"This seems to be an issue that's particularly concerning in younger populations," Dr. Gomes said. "For me, that's particularly troublesome because these are people who have a really long life expectancy and their lives are being cut short because of overdosing on these prescribed medications."