Dosanjh moves to make MDs report serious side-effects

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Last Updated Wed, 15 Dec 2004 09:16:56 EST

OTTAWA - Federal Health Minister Ujjal Dosanjh wants to make it mandatory for physicians to report adverse drug reactions so that Canadians can have confidence their prescription drugs are safe. INDEPTH: Adverse drug reaction database

Federal Health Minister Ujjal Dosanjh (file photo) At the moment, doctors voluntarily tell Health Canada when they suspect a side-effect from a prescription drug caused a patient to become ill or die. A mandatory drug reaction reporting system was one of the main recommendations of a 2001 coroner's inquest into the sudden death of Vanessa Young, an Ontario teenager who died after taking the stomach pill called Prepulsid.

FROM APRIL 24, 2001: Prepulsid jury wants drug-warning reforms Bureaucrats have long argued that a law making such reports mandatory would be too hard to enforce.

"We have to overcome those obstacles, because even if we save one more life by having mandatory reports, I would do that," Dosanjh told CBC News. "I want this department to be an activist department, an agent of change." Dosanjh has told his officials to start working on the reforms. He said he would put the rule in place right away if he didn't need the co-operation of the provinces and doctors. That might take years of negotiations.

Focus on investigation of current reports: doctor Dr. Bob Burns represents a national coalition of Colleges of Physicians and Surgeons, the groups in each province that would have to ensure doctors comply with a mandatory reporting rule. He thinks it would be more useful to stick with voluntary reporting, but put more Health Canada resources into investigating the reports that are already being filed.

"That's felt to be more consistent with the approach taken with patient safety groups around the world," he said. Making doctors report side-effects could drive information underground, Burns said, if they feel they might be held liable in a lawsuit filed by a patient.

Drug companies are already required to report adverse drug reactions during the testing and approval process. Doctors are in a better position to notice problems once the drug is in widespread distribution and being taken by thousands of people, however. Their information often leads to Health Canada re-evaluating drugs and issuing warnings about previously unknown dangerous side-effects.

Written by CBC News Online staff
Headlines: Canada

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