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Health Canada to post online summaries of medication safety reviews for public

Health Canada has begun posting summaries of drug safety reviews on its website with the goal of better informing the public about potential harms associated with certain medications — starting with the controversial acne remedy Diane-35.

Federal Health Minister Rona Ambrose announced the program — part of the “regulatory transparency and openness framework and action plan” — Tuesday in Ottawa.

“With this initiative, Canada is now a world leader in the posting of drug-safety reviews and post-market access to this information,” Ambrose said.

Health Canada conducts a review of a drug when a safety issue is red-flagged to the department, said Dr. Supriya Sharma, a senior medical adviser at Health Canada.

“We can get a signal or a sign that something needs to be looked at for a product from anywhere,” Sharma said in an interview from Ottawa. “Sometimes it comes to us from the adverse reactions that are reported to Health Canada. Sometimes it comes from medical and scientific literature. It can come from identification by the company.

“But basically somewhere there’s a signal to say you need to do a reassessment of that product.”

The online summaries, which will be a few pages long, will detail the department’s assessment of a drug and subsequent safety warnings it determines are needed when the medication is prescribed.

“It’s basically taking that assessment and providing the public with plain language descriptions of all the findings and the decisions,” she said, adding that the aim is to help consumers make better-informed decisions about taking a drug.

Dr. Joel Lexchin, a professor of health policy and management at York University in Toronto, called the initiative a good first step, but a ways from full transparency.

“Having done nothing for so long, something is better than nothing. But this still isn’t really enough,” he said.

Dr. David Juurlink, a drug-safety expert at Sunnybrook Health Sciences Centre in Toronto, agreed the program is a good start, but he questions how complete and “open” the information will be.

“For years, Health Canada has been hammered over its lack of transparency, and specifically doctors and patients have had no idea how they decide whether a drug should be allowed on the market or not,” Juurlink said.

“So it really has been a black box and I think this announcement is a response to that criticism.”

However, Juurlink is concerned that posted summaries will not include key details from drug safety reviews that Health Canada has redacted to protect pharmaceutical companies’ proprietary information.

“So I think in keeping the reviews secret, they’re actually hiding information that doctors and patients need to make informed decisions.”

The first summary to go public outlines the risks of Diane-35, which can cause potentially fatal blood clots in some patients.

While approved in Canada for the treatment of severe acne, Diane-35 is often prescribed to women “off-label” as a contraceptive because it halts ovulation. The online synopsis says the drug has been deemed a “possible” cause in the deaths of 10 women in Canada since 1998. At least a score of other women’s deaths worldwide have been linked to the medication.

The summary of Health Canada’s 2013 safety review of the Bayer drug and its generic equivalents includes a checklist, a guide to help health providers when considering whether to prescribe the drug to an individual patient.

“The safety issue was not something that would warrant taking the product off the market,” said Sharma. “We summarized all the information that we had and then we put a practical tool (the checklist) in place so people can use that information.”

Lexchin said whether such summaries end up helping Canadians and their doctors to make safer prescription decisions will depend on how complete the information is that they contain.

“Hopefully the summaries will update the information about the safety of products that wasn’t apparent when those products came on the market,” he said. “So hopefully, it will lead to both better prescribing and better use of the drugs.”