Doctors raise concerns over Ottawa's hands-off stance on generic Oxy
Published Tuesday, November 20, 2012 9:04AM EST
Ottawa’s recent decision not to block generic OxyContin from entering the Canadian market has raised concern among some medical professionals who say the move will lead to a spike in addiction rates.
Health Minister Leona Aglukkaq announced Monday that it isn't part of the federal government's role to tell the provinces which drugs they can and can't approve. If the formula is considered "safe and effective" when taken as recommended, there's nothing Ottawa can do under the Food and Drugs Act to block the approval of the generic drug.
However, Dr. David Juurlink, of Toronto’s Sunnybrook Health Sciences Centre, said generic Oxy is much more dangerous than the current version available in Canada -- and the government needs to take action.
"What's different about the generics and the reason why so many people are concerned is, just like the original formula of OxyContin … the generics are going to be easily crushed, snorted and abused," he told CTV's Canada AM on Tuesday. "And there's going to be a huge black market for that sort of drug."
OxyContin was developed to alleviate chronic pain by releasing a dose of oxycodone into the body over several hours, but soon became popular among drug addicts who altered it to become more potent. The original drug was discontinued early this year and replaced with a drug called OxyNEO, and the tablets are intended to be tougher to crush and extract oxycodone from.
Allowing the generic version to go ahead in Canada will essentially render that measure obsolete, Juurlink said.
"I think no one would have a concern about this if we knew every tablet of OxyContin was going to be taken intact on the prescription of a doctor," he said. "But we know that's just not going to happen. We know there are people out there who want to abuse the drug."
Aglukkaq's provincial counterparts had asked her to intervene last September by delaying the approval of a generic Oxy to allow for more research on the discontinued drug. The current patent by Purdue Pharma Canada expires on Nov. 25.
Ontario Health Minister Deb Matthews was among the provincial health ministers championing calls to block the production of the generic drug. In her view, the emergence of an Oxy alternative would be “tragic,” leading to widespread abuse all over again.
Reaffirming a position she's held throughout the generic Oxy debate, Aglukkaq said politicians should not weigh in on decisions that should be made by medical experts.
"While intentions may be noble in this circumstance, what stops future politicians from caving into public pressure and allowing unproven, unsafe drugs on the market once political pressure starts to mount?" Aglukkaq said in a letter to her provincial counterparts.
But Juurlink said the minister actually has a responsibility to step in and block the approval of the drug if it poses a risk to public safety. He acknowledged, though, that's not likely the legal advice Aglukkaq is receiving.
"This is a national problem and it requires national action and with respect I think the minister is hiding behind processes and hiding behind laws which the government creates. And if Health Canada was compelled to approve this product based upon laws, then those laws have to be changed."
He added: "There's no reason why the law needs to stay the way it is, the government makes the laws."
Dr. Paul Gully, a senior medical advisor to Health Canada, defended Aglukkaq's position, saying the minister had to walk a fine line.
"It's a balance in terms of trying to prevent use and misuse of the drugs, but on the other hand to responding to the needs of those individuals who require the drug, who the drug works for and is effective for, because she's heard from those individuals that they'd like that access to continue," Gully said.
If generic OxyContin is permitted to hit the market, it will be available by prescription only and it will be up to provinces, territories and medical professionals to regulate use of the drug.
Pharmacists will also face tougher requirements for reporting any evidence of theft or loss of the drug.
And, according to Gully, Health Canada would put even tighter restrictions on the drug in areas with high addiction rates, such as First Nation communities.