U.S. drug officials are preparing for a flood of generic Canadian oxycodone to make its way across the border after the Canadian government recently approved six generic versions of the widely abused painkiller OxyContin.
Health Canada authorized the sale of the cheaper generic versions of OxyContin in November following the expiration of the patent held by drug maker Purdue Pharma. Because the original formula was so prone to abuse and its patent was expiring, Purdue replaced OxyContin in Canada with a more tamper resistant painkiller called OxyNeo.
In the United States, a reformulated version of OxyContin was introduced in 2010, also designed to make it more difficult for drug abusers to crush into powder for snorting and injecting.
But the generic versions approved in Canada will not be tamper resistant, and that has officials on both sides of the border concerned.
“While Canadian officials are taking steps to address prescription drug misuse and will be monitoring the issue closely, the potential exists for diversion into the United States because the old formulations, which are easier to abuse, are unavailable in the United States,” read a notice issued by the U.S. Office of National Drug Control Policy.
Montana Attorney General Steve Bullock echoed those sentiments, calling on Canada’s Health Minister to reconsider her agency’s decision to allow generic oxycodone to be manufactured and sold in Canada.
“Studies have shown that the tamper-resistant changes OxyContin manufacturers have made to the drug have resulted in less abuse among addicts,” Bullock wrote in a letter to Health Minister Leona Aglukkaq . “I have concerns that allowing easier-to-abuse oxycodone in Canada could undo some of the work that both Canadian and U.S. government and community leaders have accomplished in combating this epidemic.”
Canadian officials and doctors are also concerned and have urged Aglukkaq to conduct more research before going ahead with the plan.
“If there were some foolproof way to stratify patients into low risk vs. high risk, perhaps we could provide the generic versions to low risk patients and reserve the tamper-resistant formulations for the higher risk patients,” reads a letter sent to Aglukkaq endorsed by 34 doctors.
Several provincial Canadian health ministers, as well as the Ontario Association of Chiefs of Police, have also appealed to Aglukkaq to delay approval, but she says her office is compelled by law not to withhold approval for a drug that is otherwise considered safe and effective for its intended use.
“The minister has made it clear that she doesn’t feel it’s the place for politicians to interfere with the scientific review process,” said her spokesperson, Steve Outhouse.
But some doctors say that opening up the market to generics ignores data suggesting that removal of OxyContin from the market led to reduced rates of oxycodone abuse in the U.S.
Dr. Mark Ware, director of clinical research at the Alan Edwards Pain Management Unit at McGill University Health Centre in Montreal, accusees the Canadian government of approving a drug formulation with a known health hazard.
He describes the action as a declaration “that it’s now fair game once again for abuse.”
To monitor illegal activity, Health Canada has introduced new regulations governing the sale of oxycodone, including rules that require pharmacies to report surges in prescriptions.
But Dr. Peter Selby, clinical director of the addictions program at the Center for Addiction and Mental Health, says that isn’t enough.
“We go forward with this policy at our own peril and at the peril of others in society,” said Selby.
OxyContin is a patented time-release formulation of oxycodone hydrochloride. The highly addictive opioid medication is prescribed for moderate to severe pain in adults.
When it was introduced in 1996, OxyContin was heralded as a wonder drug, but soon became known as “hillbilly heroine” for the cheap high it gave to drug abusers in poor rural regions. By some estimates, over half the adults in some Canadian native Indian tribes are addicted to OxyContin and other opioids.