Who's minding the store of drug safety

A new federal law aims to make prescription drugs safer. I'll explain why it may not work.
Bill C17 is a new federal law that gives the government stronger powers to protect the public from prescriptions that have deadly side-effects. But success depends on getting reluctant doctors to report them. A commentary in the Canadian Medical Association Journal (behind a paywall) says keep it simple. Knowing what I know about how doctors think, I'll tell you why even that bit of advice may not be enough.

Bill C17 - passed by the federal government in November 2014 - gives the federal regulator Health Canada the power to compel health care institutions to share information with the government and with other stakeholders on adverse drug effects.  The law would give Health Canada the authority to change prescription drug product labels and when warranted, the power to recall drugs.  In an article in the National Post, noted drug regulations watcher Matthew Herder from Dalhousie called it the most promising rewrite of Canadian drug safety laws since the thalidomide disaster of the early 1960s.

In Canada, doctors are responsible for the vast majority of prescriptions to patients.  As such, they are in the catbird seat in monitoring the safety of prescription drugs - especially new ones that have just arrived on pharmacy shelves.  If a patient has a horrendous side effect, there's a good chance the prescribing doctor will be one of the first to know.

The question is, do they tell authorities?  Right now, the answer is a resounding no.  The existing system of reporting deadly side effects is voluntary.  And right now, fewer than five per cent of adverse drug events are reported to Health Canada.  To make things safer for patients, that number has to come up dramatically.

I suspect many doctors see the voluntary reporting system as too daunting or too much of a bother.  The commentary in CMAJ recommends making it easy and quick to file a report.  One way is to build reporting into the electronic health record. So, if you're  entering a note in the chart that the patient had a drug side effect, a message could pop up asking if you want to send a report to Ottawa.  

Whatever reporting methods the government selects will be new and unfamiliar to health care providers.  That means the government will have to send out lots of reminders across all platforms - by mail, by fax, by email, and by social media. Then, there's motivation.  Bill C17 calls for mandatory  reporting of side effects. Knowing the culture of medicine, I suspect that my colleagues  don't report adverse drug effects because they aren't paid to. I say pay them - and pay them well for a high quality report.  

In his National Post article, Matthew Herder said it's easy to pass a law that demands transparency in reporting and dealing with unsafe prescription drugs - a lot harder to change the culture from which the need for tougher laws arises. Right now, we have a  cozy culture of secrecy between Health Canada and drug companies. Health Canada is not nearly as transparent as the US Food and Drug Administration or the European Union - both of which are far more likely than Canada to put on its website the evidence  why it approves and why it withdraws a drug from the market.

Recently, as reported in the Toronto Star, when Dr. Nav Persaud asked for the evidence behind Health  Canada's approval of the drug Diclectin for morning sickness, the information he got back was heavily redacted.

At stake is nothing less than the health of Canadians. Remember that Bill C17 is also known as "Vanessa's Law."  It's named after Vanessa Young, the daughter of Oakville Conservative MP Terence Young.  Vanessa died back in 2000 of a lethal heart rhythm disturbance caused by Prepulsid, a drug used back then to treat gastrointestinal symptoms like nausea. The death was entirely preventable.  Vanessa was just 15 at the time.  Terence Young said he introduced the Bill so that other families would not have to suffer such a devastating loss.  The case of Vanessa Young is hardly a one off. Many patients have side effects that go unreported.  Some - like Vanessa, lose their lives.  

From now until May 25, the government seeking public input on drug safety in connection with the new law. If you have strong opinions about the safety of prescription drugs, now is the time to make your voice heard. You can learn more about that here.


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