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TORONTO: FEBRUARY 20, 2012-- Prescription painkiller OxyContin, which will be delisted from Ontario's drug benefit program, at the in-patient pharmacy at Sunnybrook Health Sciences Centre in Toronto on Monday, February 20, 2012. (Michelle Siu for The Globe and Mail) [For News] ((Michelle Siu For The Globe and Mail)
TORONTO: FEBRUARY 20, 2012-- Prescription painkiller OxyContin, which will be delisted from Ontario's drug benefit program, at the in-patient pharmacy at Sunnybrook Health Sciences Centre in Toronto on Monday, February 20, 2012. (Michelle Siu for The Globe and Mail) [For News] ((Michelle Siu For The Globe and Mail)

Addiction experts leery of generic version of OxyContin Add to ...

When OxyContin was replaced by a tamper-resistant substitute in the United States, prescriptions for the original drug at one of Canada’s highest-traffic border cities quadrupled.

That’s a quarter of a million pills prescribed by doctors in Windsor, Ont., in excess of previous levels.

A study published Tuesday in Open Medicine tracked OxyContin prescriptions in Ontario communities on the Canada-U.S. border. It found that prescriptions for OxyContin, one of the most popular drugs behind a wave of prescription-opioid abuse, skyrocketed in Windsor at the same time the drug became unavailable in the U.S.

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Researchers argue the findings indicate the degree to which the drug is being used for illicit purposes. And, they say, it should be reason for the federal government not to allow a generic version of OxyContin on the market when Purdue Pharmaceuticals’ patent expires Nov. 25.

Purdue replaced OxyContin with OxyNEO, which is supposed to be more difficult to crush and therefore harder to snort or inject. OxyNEO was introduced in August, 2010, in the U.S., and in Canada this past spring.

The study found prescription rates in Sarnia and Niagara Falls held steady while Windsor’s OxyContin prescriptions soared, suggesting a much more organized acquisition of drugs to sell on the street, said Tara Gomes, a scientist at the Institute for Clinical Evaluative Sciences and the study’s primary author.

“The fact that it was so specific to the Detroit-Windsor tunnel indicates there was a select group of people,” she said. “It’s a unique situation, where we’ve seen a drug so prone to addiction so popular for resale.”

Most provinces have placed tighter restrictions on OxyNEO. And while there are still questions as to whether this tamper-resistant variation is really safer, many addiction experts are leery of allowing generic versions of the original OxyContin onto the market.

“I think we need to just really, seriously consider what impact generic OxyContin could have on the safety of residents of Canada,” Ms. Gomes said. “This is a highly sought-after drug, and people will undertake a lot in order to get access to the original OxyContin formulation.”

Provincial and territorial health ministers have asked Health Canada to at least defer its decision on generic OxyContin until new research determines whether the tamper-resistant drug, OxyNEO, is any better. But a spokesman for federal Health Minister Leona Aglukkaq said she has no intention of intervening in the drug-approval process. “That’s a decision that firmly rests with Health Canada,” said Steve Outhouse. “You can only imagine what would happen in a drug-approval system where you only need to lobby politicians who go under pressure from constituents who want the newest experimental drug released to them before [it has] been shown to be safe.”

Mr. Outhouse said Health Canada evaluates drugs for their addiction risk, but makes that evaluation based on the drug being used as prescribed.

As far as Jack Kay is concerned, this is a moot issue. His company, Apotex, has spent years, and close to $3-million, on a generic OxyContin formula. “We expect our approval Nov. 25,” he said. “We have shown [Health Canada] that our product is safe and effective for the indications that the molecule is approved for.”

And, Mr. Kay added, Apotex has received documentation that would legally bind Health Canada to grant their final approval.

But if this regulatory framework leaves the federal government’s hands tied, argues Ontario Health Minister Deb Matthews, “then change the legislation. … That’s why we’re in government – to make the laws work for the people we serve.

“Allowing generic Oxy onto the streets … would be a huge step backwards.”

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