“Prescription drugs can’t be viewed as commodities; just because a patent expires doesn’t mean we should give the go-ahead to generics”
— Allan Malek, Senior Vice President, Ontario Pharmacists’ Association
The federal government’s approval of generic versions of OxyContin is a matter of great concern to the Ontario Pharmacists’ Association (OPA), which fears it will worsen the public health crisis related to narcotic abuse and misuse, and lead to a resurgence in pharmacy armed robberies and break-ins.
Health Canada approved 6 generic versions of the drug on November 27, 2012 — just one day after the expiration of Purdue Pharma’s patent for oxycodone, the active ingredient in OxyContin. All the provincial and territorial premiers, along with many health professionals, the Ontario Association of Chiefs of Police and the OPA, had urged the federal government to delay such authorization until a complete review of the risks could be undertaken.
However, the federal minister of health, Leona Aglukkaq, said she is required by law not to withhold approval for a drug otherwise considered safe and effective for its intended use. To do so, she said, would undermine the integrity of Health Canada’s scientific review process.
That view is narrow and short-sighted, says Allan Malek, Senior Vice President, Professional Affairs, Drug Information & Continuing Education with the OPA. “Prescription drugs can’t be viewed as commodities; just because a patent expires doesn’t mean we should give the go-ahead to generics.
“The OPA believes the review process should be overhauled to take a more holistic view,” he adds. “There are social impacts from these kinds of drugs and that should be part of the consideration.”
Concerns about safety of pharmacists
Earlier this year, Purdue Pharma began phasing out OxyContin in Canada and replaced it with OxyNEO, a formulation considered more difficult to abuse. Since the change, there has been a decline in robberies and break-ins at pharmacies in many Ontario communities.
“We would anticipate that with a re-introduction of oxycodone to the market, we are going to see a resurgence in robberies,” says Mr. Malek. “The OPA advocates for the best quality care for patients but we also have to look at representing the interests of our members, and that includes their safety and security in the workplace.”
Ontario’s planned regulations not a solution
Ontario Health Minister Deb Matthews quickly responded to the federal announcement of approval — by revealing plans to regulate limited access to generic OxyContin. The Ontario Drug Benefit (ODB) plan would only fund the generics if they were in a tamper-resistant form, the minister said.
The Ontario government is attempting to do what it can with the tools it has available, says Mr. Malek, but the OPA is not confident that Matthews’ plan will do much to mitigate the risks.
“Tamper-resistant does not mean tamper-proof; we saw that with OxyNEO,” he says. “Almost before the new drug hit the market, we saw websites popping up that gave tips on how to break down the OxyNEO formulation.
“I don’t believe making it tamper-resistant is going to solve anything,” he adds. “And these new generics will be coming into the market at 25% of the brand price — which makes them more accessible and cheaper on the street.”
Health care professionals, addiction specialists and all levels of government need to come together to develop broad solutions to deal with widespread abuse and misuse of narcotics, according to Mr. Malek.
“This goes well beyond oxycodone. We need to address all the issues — drug abuse, drug diversion, prescribing habits and better approaches to managing patients’ chronic pain.”