CAROLYN ABRAHAM
From Thursday's Globe and Mail Published on Thursday, Dec. 16, 2004 7:18AM EST Last updated on Thursday, Apr. 09, 2009 1:23AM EDT
Now, it appears Mr. Young has a powerful ally in his bid to keep better tabs on the dangers of medications.
Federal Health Minister Ujjal Dosanjh said this week that he wants a drug-monitoring system in which doctors and other health professionals would be legally bound to report serious adverse drug reactions.
"This is wonderful news if they can make it happen," said Mr. Young, a former Ontario MPP. "Nothing significant has changed in the drug-monitoring system in this country since Vanessa's death."
Mr. Dosanjh said yesterday that he wants to compel physicians and other health-care professionals to report adverse drug side effects to Health Canada so the public can feel confident that drugs on the market are safe.
"I think it's important that we mandate this so that we have more significant data on an ongoing basis on all drugs that enter the market to assess whether or not the drugs are having adverse effects," Mr. Dosanjh said in an interview with The Globe and Mail.
As things stand now, doctors and pharmacists report troubling side effects of prescription drugs on a voluntary basis. But Health Canada estimates only 10 per cent of incidents are actually reported, leaving no reliable way to spot harmful, or even deadly trends with medications.
The minister's announcement, which is winning little support among doctors themselves, follows years of calls for mandatory reporting, particularly from patient advocacy groups and the families of those who have lost loved ones due to bad drug reactions, which are estimated to kill 10,000 in Canada every year.
"I call it the conspiracy of silence," Mr. Young said. "You have the drug companies, the doctors and the regulators."
During the inquest into his daughter's death in 2001, Mr. Young said it was clear that the drug company had far more information about adverse reactions, even deaths, associated with Prepulsid than had ever been shared with authorities.
In the end, after hearing the tragic circumstances that led to Vanessa's death, the Ontario coroner's jury recommended that doctors be required to report adverse drug reactions within 48 hours of learning of them.
As well, Mr. Young noted that this spring the parliamentary standing committee on health compiled a report entitled Opening the Medicine Cabinet that also called for mandatory reporting of adverse drug reactions.
But doctors are less convinced this is the answer to ensure drug safety.
Albert Schumacher, president of the Canadian Medical Association, said compelling physicians to report all adverse drug reactions would be an ineffective means of tracking problem medications.
"Adverse drug reactions are frequent, but the majority are trivial . . . we're going to flood the federal government with trivia," Dr. Schumacher said. He noted that the CMA has for years urged the federal government to create a program to review many issues related to drugs, including dosing, off-label uses and adverse reactions.
"I'm surprised [the minister] announced this without consulting us first," Dr. Schumacher said.
He said that unless the federal government is willing to put resources into truly analyzing and sharing the information it receives, the process could be pointless.
Jack Uetrecht, a professor of pharmacy and medicine at the University of Toronto and Canada Research Chair in Adverse Drug Reactions, agreed. He said forcing doctors to file reports "won't improve safety at all."
"There would be a million of these reports -- where would you find the time to go through all of these?"
Dr. Uetrecht explained that the reports would need to have very detailed information on patients and their medical history in order to distinguish true cases of adverse events.
"With the reports that Health Canada gets now, it's almost always impossible to tell what's really going on."
Dr. Uetrecht suggested that Canada follow the example of France and set up a highly trained investigative squad independent of Health Canada that tracks new drugs on the market, and those known to have certain problems.
Dr. Schumacher said a mandatory reporting system would also raise serious issues about patient privacy and the role of provincial jurisdictions.
Doctors are governed by the provinces and officials at Health Canada have no jurisdictional power to compel physicians to do anything. Mr. Dosanjh said yesterday that he plans to consult provincial governments on the plan.
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