TORONTO – With only a few weeks until the original patent expires in Canada, a new study says OxyContin prescriptions increased significantly near the Windsor-Detroit border following its replacement with a tamper-resistant formula in the U.S.
“There is only one plausible explanation for this finding, and it’s the diversion of huge quantities of the original OxyContin formulation from Ontario into the United States,” said Dr. David Juurlink, co-author and scientist at the Institute for Clincial Evaluative Sciences (ICES).
Due to its high risk of addiction, OxyContin manufacturer Purdue Pharma took the drug off the U.S. market in August 2010, and replaced it with OxyNEO, a new formula that is considered tamper-resistant and therefore less prone to abuse.
OxyContin was not taken off the Canadian market until March 1, 2012. During the time that it was still available in Canada and not the U.S., the ICES study looked at retail pharmacies in the three cities with the highest volume of U.S.-Canada border crossings in Ontario.
Findings of the ICES study
• A 390 per cent increase in OxyContin dispensing from pharmacies close to the Detroit-Windsor Tunnel.
• Almost 250,000 excess OxyContin tablets were dispensed in Windsor near the Detroit-Windsor Tunnel between August 2010 and October 2011.
• OxyContin prescribing near border crossings in Niagara Falls and Sarnia remained stable.
Juurlink told Global News that the amount of drug being dispersed from pharmacies close to the Detroit-Windsor Tunnel was upwards of a quarter million dollars in tablets, worth millions of dollars on the street. After studying multiple border crossings, the spike was only seen in that particular area and the pharmacies operating in its vicinity.
“It’s not difficult to speculate that this is actually the product of organized crime… diverting huge amounts of OxyContin into the U.S.,” he said.
After warnings to prescribers and pharmacies regarding “drug-seeking behaviour” were issued in April 2011, dispensing declined and returned to baseline rates by November 2011 in the area.
The study results suggest a variable availability of opioids like OxyContin can impact cross-border trafficking. While notification of this drug-seeking behaviour to prescribers and dispensers may help control the problem, Juurlink emphasizes the potential for widespread abuse.
“If generic OxyContin is made available in Canada, we will see this same phenomenon across the country, perhaps with the drug going into the U.S. on a massive scale,” said Juurlink. “And any advance that was accomplished by the introduction of OxyNeo earlier this year will be erased.”
Patent to expire
Now, with the patent expiring on the original drug in two weeks in Canada, some provincial health ministers have made an unprecedented request of the federal government: Prohibit generic versions of the prototype from coming on the market and opening up a new, far-cheaper supply of the highly addictive drug.
Ontario health minister Deb Matthews warns that approving generic Oxy would be a “tragedy,” leading to more addiction and death just as the problem is beginning to wane.
Some experts argue the government cannot ignore well-entrenched patent laws to block one version of a drug, but not another.
Some competitors, meanwhile, suggest the provinces are playing into the hands of a manufacturer that has used the purportedly tamper-proof tablet chiefly to stave off generic competition.
And there are pain physicians who say there may be other reasons to allow the original OxyContin back on the market.
Peter Watson, a Toronto neurologist, said two thirds of the 50 chronic, non-cancer pain patients he has surveyed report the new pill is not as effective as the original, with a few even saying it does not work at all, causing them to become suicidal with the unmitigated pain.
“Every day in my office I see several patients who are now in bed or in much worse pain after they’ve had good control for years on OxyContin,” Dr. Watson said. “It’s a real problem for me.”
He recommends that the generic versions be approved, but that they be made subject to the same kind of restrictions imposed on methadone, with authorities licensing certain specialists to prescribe the drugs.
Juurlink says he knows the patent expires at the end of November, but that he doesn’t know when he will hear from Health Canada on their decision.
“As a physician, if the generic formulation makes it to market, my suggestion to physicians is simply not to prescribe it,” he said.
“The concern is unambiguous, this drug will end up on the streets, it will be sold for 20, 40 or more dollars a tablet and people will be back to snorting and injecting and smoking a drug that was a plague on society for the past 10 or 15 years.”
With a report from Jennifer Tryon and files from the National Post