‘Off-label’ drugs need scrutiny
Six years ago, Ellyn Braun’s doctor told her that the acne medication she was taking could double as birth control, even though Health Canada doesn’t regulate it as a form of contraception.
The drug, Diane-35, is regulated for temporary acne treatment, but Braun has been using it on a permanent basis as a birth control pill — even though it’s been linked to the deaths of nine Canadians since 2000.
That doesn’t faze Braun. “I think there’s a place for it, but you just have to be careful about it,” says the 28-year-old medical student at McMaster University in Hamilton, Ont.
She’s far from alone. “Off-label” prescriptions — using drugs to treat illnesses for which they haven’t been approved by Health Canada — is a growing practice that demands more careful scrutiny, experts say.
Canada needs a national monitoring system, said Dr. Robyn Tamblyn, scientific director with the Canadian Institutes of Health Research.
A study Tamblyn co-authored last year found 11 per cent of prescriptions in Canada are off-label; in 79 per cent of those cases, there was no evidence to back up the doctor’s decision.
Tamblyn proposed the idea of a monitoring system to the Senate committee on Social Affairs, Science and Technology last week, and intends to pitch Health Canada on the same idea later this month. Health Canada has historically rejected the idea of regulating drugs, saying it can’t control what doctors prescribe. With the exception of Quebec, most provinces don’t require doctors to say why they prescribed a certain drug.
Dr. Joel Lexchin, a professor at York University in Toronto, said he agrees in principle with the idea of monitoring off-label drugs. But he thinks a national system is unlikely.
Besides the health benefits of a national system, Tamblyn said, there may be financial upsides for the provinces since they foot most of the bill for prescriptions.
“If a drug is prescribed 99 per cent of the time in cases where it hasn’t been studied, you either are getting a benefit you don’t know, or you are paying for something that either is doing nothing or doing damage.”
Ontario Ministry of Health spokesman David Jensen wouldn’t speculate about if the province would welcome a national monitoring system, but said it “continues to explore new ways to monitor prescription drug use to enhance patient safety.”