Health Canada 'gutting' law to detect dangerous medicines, with possible deadly consequences, advocates warn

Health Canada 'gutting' law to detect dangerous medicines, with possible deadly consequences, advocates warn
From Global News - August 17, 2017

After Vanessas Law successfully navigated Parliament and became the law of the land, then Conservative MP Terence Young felt a sense of relief, able to breathe believing hed finally won his 14-year battle.

Parliament had passed, without a single dissenting vote, a government bill that had started as his own; a bill to protect patients from potentially dangerous prescription drugsto protect Canadians from suffering the agony his family suffered when his daughter, 15-year-old Vanessa, died of a heart attack after taking a prescribed drug.

But now, almost three years later, Youngs battle continues as a handful of measures he says are critical to the bills efficacy have yet to be enacted.

Specifically, Young says Health Canada is not going to require the reporting of all serious adverse drug reactions, a measure at the heart of the bill Parliament passed. Scaling back that requirement, he said, means Health Canada wont be in any position to better understand what prescription drugs are harmingand killingCanadians.

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These fears stem from a recent discussion paper Health Canada published. The 37-page document details where the department is leaning now in terms of developing the remaining regulations.

Health Canada has written a guidance document which basicallyis the exact opposite of the intent of Vanessas Law, Young said in a recent interview.

A crumbling pillar

As is the case with many bills that pass through Parliament, when Vanessas Law was passed in November 2014, some of its provisions were immediately enacted, while others requiring new regulations were not.

Today, Health Canada is in the process of designing those regulations, publishing papers hinting at the direction the department is thinking, and taking advice and input from pharmaceutical companies, safety advocates, the provinces and territories and others.

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The stated goal of this process, according to Health Canada, is to improve the quality and increase the quantity of reports of adverse reactions to prescribed medication, in an effort to ensure the department always has enough data to spot and react to safety problems.

But reading between the lines, says Young, paints a different picture.

One fundamental pillar of the lawthat every serious drug reaction occurring at every health-care institution in the country is reportedis being gutted, he says.

Getting that evidence is absolutely crucial to keeping patients safe, Young said. Every serious adverse drug reaction can provide very important data that can lead to saving patients lives.

Burdening the system

It appears, however, as though Health Canada is poised to regulate only acute-care hospitalsrather than including long-term care facilities and clinics, for exampleand require them to report only unexpected adverse reactions to prescription drugs, rather than all.

In other words, the reports wont include anything the drug manufacturer includes on the drug label, which often featurea laundry list of symptoms and reactions.

With these caveats, theyre only going to get a fraction of the real number of adverse drug reactions, said Young, who has chaired Drug Safety Canada since 2001.

If a drug is harming patients, if its an unsafe drug, you want to get all serious adverse drug reactions reported as early as possible. And the proposal made under [Health Canadas] white paper would make sure you dont.

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David Lee, chief regulatory officer at Health Canada, told Global News that, in designing and implementing new regulations, the burden on hospital staff and the usefulness of the data also have to be taken into consideration.

Were trying to get safety information about drugs, but we also have to remember its a hospital. And so you want the health-care professionals spending their time on care, he said.

Tracking known reactions to prescription drugs


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