OTTAWA – The federal government has rejected provincial pleas to delay or deny approval of the generic form of OxyContin, a highly addictive painkiller that has been widely abused in many small towns and remote First Nations reserves.
Instead, Health Minister Leona Aglukkaq says Ottawa will tighten licensing rules so that distributors of oxycodone have to keep better track of where the drug does. They will now need to report spikes in sales and changes in distribution patterns, in addition to previous responsibilities to report losses and theft.
Aglukkaq is also telling the provinces to use their own power over doctors and pharmacists to crack down on wayward prescriptions.
“Banning a generic version of one drug would do little to solve the actual problem,” Aglukkaq said in a letter to provincial and territorial health ministers. “There are almost 100 authorized drugs in Canada that are in the very same class of drugs as OxyContin.
“Banning all these drugs because they have the potential to be addictive would help dry up the drug supply for addicts, but would lead to pain and suffering for patients who desperately need them.”
Ontario Health Minister Deb Matthews has led a public campaign to pressure Ottawa to reject approval of generic oxycodone, saying failure to ban the drug would lead to a flood of the narcotic and a corresponding surge in addiction.
The generic version is set to win federal approval on Nov. 25, the day the patent expires on Purdue Pharma’s OxyContin.
But the federal government has pushed back, saying a ban on the knock-off drug is too simplistic a response to a complex problem of prescription drug abuse. Ottawa says it does not want to politicize a bureaucratic process that must automatically approve a drug if it is an exact copy of another brand-name drug that has already been approved.
“I do not believe that politicians should pick and choose which drugs get approved,” the minister wrote. “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 also admonished provincial politicians for pumping up the benefits of OxyNeo — Purdue’s new brand-name form of oxycodone that some believe is harder for addicts to abuse because it is not as easily crushed or injected.
“It’s important to remember that OxyNeo is, to date, not authorized to make claims that it is ‘tamper-proof’, ‘tamper-resistant’ or ‘harder to abuse’,” Aglukkaq said.
“As health ministers, I want to stress that it’s very important that we not make health claims that the drug company itself is not legally allowed to say.”
Still, Aglukkaq said she understands why Ontario and other provinces are so concerned about prescription drug abuse.
But she says provinces already have the power to crack down on unscrupulous doctors and pharmacists who allow oxycodone products to flow to abusers
Provinces have jurisdiction over doctors, pharmacists and dentists and are free to discipline them, she said.
“Provinces can implement rigorous controls that could help shut down abuse within the system,” she wrote. “Actions such as prescribing guidelines, trial prescription programs and product assurance agreements all clearly fall under provincial and territorial jurisdiction.”
If the provinces eventually find that they still can’t sufficiently control oxycodone, then Aglukkaq says she would be open to new regulations to further restrict prescribing and dispensing of the drug.
Ottawa could set up a regime that could place extra controls on who can prescribe or dispense potentially addictive drugs. It already has a similar arrangement for methadone.