The Province

UBC professor urges overhaul of Canada’s medication safety warnings


Health Canada needs to be more consistent with three other countries when it comes to issuing warnings about the safety risks of certain medication­s, especially if the jurisdicti­ons with similar demographi­cs have already advised patients taking the same drugs, a University of B.C. professor says.

Barbara Mintzes, the lead investigat­or of a new study published Monday, said that between 2007 and 2016, Health Canada issued safety warnings for only 50 per cent of drug-safety issues identified in the U.S., Australia and the U.K.

She joined researcher­s in analyzing 1,441 advisories over that period and found regulators in all four countries were only consistent in the decision to warn their population­s 10 per cent of the time regarding issues with the same medication.

Compared with the other countries, Health Canada issued advisories for only 317 of 635 drug-risk issues, or nearly 50 per cent of the drugrisk issues identified by the U.S. Food and Drug Administra­tion, the U.K. Medicines and Healthcare products Regulatory Agency and Australia’s Therapeuti­c Goods Administra­tion, the study said.

The study was published in JAMA Internal Medicine, published by the American Medical Associatio­n, and also involves researcher­s from York University in Toronto and the University of Sydney in Australia.

Health Canada issues warnings on its website, and Mintzes said it also sends letters to doctors who prescribe the drugs.

“Some of the safety warnings are put out by Health Canada, together with the manufactur­er, and that will come as an individual­ly sent letter to each doctor within a specialty or ... a broader set of all doctors who are practising in Canada,” said Mintzes, who is an affiliate associate professor at UBC’s School of Population and Public Health.

She said that in January 2013 Health Canada issued a warning about commonly prescribed cholestero­l-lowering drugs, or statins, being linked to an increased risk of diabetes among patients already at risk for the disease.

However, the warning was issued a year after the U.S. and Australia informed patients about the drugs following large studies showing an associatio­n with diabetes, she said.

“Why did Health Canada wait another year after these warnings occurred in the U.S. and Australia?” asked Mintzes, who is also an associate professor at the University of Sydney.

The department said it regularly liaises with key internatio­nal counterpar­ts including the U.S., Australia and the European Union to determine if there are any emerging safety concerns. Once it becomes aware of any potential issues, an assessment is done to determine if a similar risk is warranted in Canada.

“Timing and content-ofrisk communicat­ions can differ across jurisdicti­ons for a number of reasons including, for example, how a product is used in Canada,” it said in a statement.

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