Mark Kulakowski, who takes narcotic pain killers for a back injury that occurred more than three decades ago, reaches for a bottle of OxyContin at his home in Peabody, Mass., May 25, 2012.GRETCHEN ERTL/The New York Times
The federal government is introducing new tamper-resistance rules for opioid painkillers aimed at reducing prescription-drug abuse.
On Friday, Health Canada announced draft regulations that would require all oxycodone products to be "tamper-resistant" before they can be sold. Tamper-resistant refers to drugs that are difficult to crush, snort or inject as a way of preventing people from getting high. The new rules are designed to help combat the growing problem of opioid misuse and abuse in Canada, which has the world's second-highest per capita consumption of the drugs, which include oxycodone, fentanyl and morphine.
"Prescription-drug abuse is a significant public-health and safety concern," Health Minister Rona Ambrose said in a statement. "Adding tamper-resistant properties to drugs at high risk of abuse is an important component of our government's comprehensive approach to fighting prescription-drug abuse."
The proposed rules include a three-year phase-in period to allow companies to reformulate products. If companies do not reformulate products in that time period, they will not be allowed to sell them in Canada.
But prominent Canadian medical organizations and experts are concerned the government's push toward tamper-resistance is deeply flawed. The scientific evidence defining tamper resistance and whether it actually works at reducing rates of abuse is still relatively new. And the regulations would apply only to one type of opioid, which could simply shift the problem elsewhere.
The only way the government's new rules will have any impact is if the tamper-resistance requirements are extended to all opioids, said Dr. Chris Simpson, president of the Canadian Medical Association.
"If you create a deterrent for one drug, then people just move to other drugs that don't have that technology," he said in an interview.
In its official submission to Health Canada last year on the proposed new rules, the Canadian Pharmacists Association urged the federal government not to single out a single drug category for tamper-resistance requirements, in order "to prevent drug abusers from switching to another" drug.
And tamper-resistance targets only a subset of opioid users, namely those who abuse drugs by snorting, chewing or injecting.
"That's the only element that tamper resistance addresses," said Phil Emberley, director of pharmacy innovation at the Canadian Pharmacists Association. "Those people that get large quantities of this drug and take it by mouth, tamper-resistance is not going to change that."
In addition to the new regulations, the federal government has also launched a national marketing campaign to help parents talk to their children about prescription-drug abuse and has set aside funds to address the problem, including $13.5-million over five years to help First Nations communities and $8-million for prescriber education programs and the development of a national monitoring and surveillance program.
With a report from Karen Howlett
Carly Weeks