Vanessa's Law not helping boost drug safety, ER doctor says
Health-care institutions now mandated to report serious drug reactions but not document them
Canada's new drug safety law mandates hospitals to report serious drug reactions, but it needs to be strengthened because fewer than five per cent of the reports are ever filed, doctors say.
A commentary in Monday's issue of the Canadian Medical Association Journal is titled "Can reporting of adverse drug events create safer systems while improving health data?"
The answer is yes, says Dr. Corinne Hohl, an emergency-room physician at Vancouver General Hospital and her co-authors. They set out why and how the law could be more effective.
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In November, the federal government passed Bill C-17, Vanessa's Law. It aims to strengthen the government's power to recall drugs with harmful effects, from changing the label to taking a drug off the market. The bill also mandates health-care institutions to report serious drug reactions.
But the law misses the first key step, Hohl says, adding it doesn't require health-care providers to document serious drug reactions such as those that lead to hospitalization, deaths, near fatalities and congenital malformations.
"There's far less than five per cent of adverse drug reactions that are reported," she says.
To illustrate the scale of underreporting, Hohl says Health Canada received about 9,004 adverse event reports in 2014. At her hospital alone, she said there's probably at least 3,000 such reports every year.
The law is named in honour of Conservative MP's Terence Young's daughter, Vanessa. The 15-year-old died in 2000 after suffering complications while taking the drug Prepulsid, or cisapride, which was prescribed for gastrointestinal symptoms like heartburn.
A new vision
Hohl envisions how she would like the law applied.
If Vanessa had gone to an emergency department and had an ECG that showed the heart rhythm disorder called long QT, a health-care provider would enter the high-risk condition in an electronic system. Anyone who tried to prescribe or dispense a medication that could exacerbate the heart condition would be stopped automatically.
"We need to completely redesign reporting," Hohl says. "We know based on our qualitative work that clinicians seem very motivated to report if we make it about the patient rather than about generating data."
Health-care providers have no obligation to report data that seems to disappear into a black box at the regulator, says Hohl, who is also a researcher at the Vancouver Coastal Health Research Institute.
But adverse events are sometimes repeated because information isn't communicated between health-care providers.
Hohl gave the example of a diabetic man who was comatose, taken to one hospital and started on a new medication. A community pharmacist added the new drug on top of the old one instead of replacing it, which led the man to lapse into a coma again and be taken to her hospital.
Health Canada is seeking public feedback on the new drug safety law until May 25.
'Up against an unmovable force'
Young called the commentary helpful in ensuring Vanessa's Law is implemented correctly.
Doctors often fail to report suspected reactions in part because of their fear of being sued, Young says. Other times, physicians aren't sure they've identified an adverse drug reaction.
"I've been working on this for 14 years," Young says.
"I've been up against an unmovable force, which is the doctors that frankly don't like being told what to do and the irresistible force in the pharmaceutical companies who are one of, if not the, most influential industries in the world who don't like to be told what to do either."
Young and her co-authors, Ellen Balka from Simon Fraser University in Vancouver and Dr. Joel Lexchin of Toronto's York University, say the reports to Health Canada also need to be less onerous and time consuming to complete.
Physicians, pharmacists and nurses should be able fill in a report over time as more information becomes available instead of the current system that only allows one person to enter the information just once.
Alan Cassels, a pharmaceutical policy researcher at the University of Victoria who wasn't involved in the commentary, says: "I don't think Vanessa's Law on its own is going to fix this."
First, the culture of medicine itself needs to change, he says.
The way to fix it, Cassels suggested, is to institute regulations in hospitals and clinics so doctors learn to spot adverse drug events and then have a quick and seamless way to report them.
"Physicians prescribe based on information they get from clinical trials, and sometimes that information is not useful enough," he says. "When drugs are tested in very unique populations but then get used in everyone, that's really when we find out who's benefiting and who's being harmed."
One of the most common reasons for hospitalization in the elderly, Cassels says, is how they're often taking multiple medications that interact and can lead to harm.
Prepulsid was pulled from the market in Canada in August 2000. Young settled an individual lawsuit with Johnson & Johnson in 2006.
With files from CBC's Kelly Crowe