Tory government looks to improve drug safety at Health Canada

The Conservative government will be looking at better ways to collect reports of negative side effects Canadians experience from taking prescription drugs.

OTTAWA—The Conservative government will be looking at better ways to collect reports of negative side effects Canadians experience from taking prescription drugs, the Star has learned.

Federal Health Minister Leona Aglukkaq will outline Tuesday morning new priorities for the Conservative government when it comes to the safety of food, consumer products and prescription drugs.

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“Our government will be taking concrete action to improve drug safety, which is an important way we can support the health and safety of Canadian families,” a government source familiar with the plans said in an emailed statement Monday.

“These new initiatives will improve safety and quality of life of Canadians by making it easier for Canadians to understand what they’re taking, and how they should take it,” said the government source.

A Star investigation into the safety of prescription drugs shone a light on problems with the way Health Canada collects and analyzes reports of adverse drug reactions, as well as the secrecy surrounding what the regulator learns about whether the drugs are harmful, even fatal, or do not work for some patients.

Health Canada approves new medications without being certain about how people will react to them once doctors start prescribing them, especially when it comes to children, seniors and pregnant or nursing women.

This is because pre-market clinical trials, no matter how well-designed, provide drug manufacturers with limited information about potential side effects, due to the sample size being relatively small compared to the general population.

Health Canada has traditionally relied upon manufacturers, doctors and ordinary Canadians to submit adverse drug reaction reports, but a report from the Senate social affairs committee published last month notes they likely represent no more than 5 per cent of the total side effects experienced by patients outside clinical trials.

The auditor general found in 2011 it can also take more than two years for Health Canada to assess a potential safety issue, update the product label and then issue a warning about it, which does not even necessarily reach consumers.

The Star revealed last year the adverse reaction reporting database contained information about nearly 600 cases of Canadian children — including seven who committed suicide — suffering serious side effects suspected to have been caused by ADHD medications in the past decade, but Health Canada was not alerting the public about them.

The priorities to be unveiled Tuesday will include plans to look at ways to improve the collection of adverse reaction reports as part of an overall push to improve drug safety.

The speech is not expected to provide a detailed a policy map or even specify timelines and funding levels, but will involve the Conservative government clearly signalling its intent to take action on an issue that a government source said both Aglukkaq and Prime Minister Stephen Harper have been hearing about from Canadians.

The source said the federal government is open to all options, including introducing new legislation.

That could also include reintroducing elements of the bill formerly known as C-51, which was set to modernize the Food and Drugs Act for the first time in half a century before it died when Harper called the 2008 federal election.

Other drug safety measures to be discussed Tuesday will include something on “plain language” on prescription drug labels to help avoid confusion that can lead to medications being taken incorrectly.

Aglukkaq will also discuss how Health Canada is working with industry to figure out a way to avoid having pharmaceuticals with similar names.

Health Canada already took steps to boost the number and quality of adverse reaction reports earlier this year.

The federal regulator commissioned Accreditation Canada, a non-profit organization monitoring the performance of more than 700 health care facilities, to develop a new standard on reporting adverse side effects.

It also placed advertisements explaining the process and importance of reporting adverse drug reactions in academic journals read by health professionals.

© The Toronto Star