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Health Canada considers mandatory reporting of adverse drug reactions

  1. BitterSweet
    19365.jpg Health Canada is taking a serious look at making the reporting of negative side effects Canadians experience after taking prescription drugs mandatory.

    OTTAWA—The Conservative government could require doctors to report negative side effects that Canadians experience from prescription drugs as part of efforts to increase the oversight mediations after they hit the market.

    “We’re looking at whether or not we need to make some regulatory or legislative changes to mandate or compel information to come in,” Dr. Supriya Sharma, a senior medical adviser and assistant deputy minister at Health Canada, told the Star in an interview Tuesday.

    A Star investigation into the safety of prescription drugs highlighted problems with the way Health Canada collects and analyzes reports of adverse drug reactions, as well as the secrecy surrounding what the regulator learns about whether the drugs are harmful, or if they work for some patients.

    Health Canada has traditionally relied upon manufacturers, distributors, doctors and ordinary Canadians to submit adverse drug reaction reports, but government studies have suggested it captures only a tiny fraction of the total side effects experienced by patients outside clinical trials and it can take up to two years for the federal regulator to issue a warning about it.

    Still, there is a lack of consensus over whether extending legal requirements to report adverse drug reactions to health-care practitioners — it is currently voluntary for everyone but drug manufacturers and distributors — is a good idea.

    Conservative Senator Kelvin Ogilvie, who chairs the committee conducting a series of studies on prescription pharmaceuticals, said numerous expert witnesses said legislating mandatory reporting of adverse drug reactions does not boost the numbers.

    “What it does is it strikes terror in the minds of the average medical practitioner,” Ogilvie said by telephone Tuesday.

    Dr. Anna Reid, president of the Canadian Medical Association, said Health Canada should consider making the existing adverse drug reaction reporting system more user-friendly and responsive before it looks at forcing physicians to fill out reports.

    “What we would like to see happen is that Health Canada actually allocate enough resources so that it can effectively analyze and respond to the adverse drug reports that they are actually already getting,” Reid said in a telephone interview Tuesday.

    “There is actually no point (making it mandatory) until you put those elements in place, because really it is just going into this big black hole,” Reid said.

    Sharma said Health Canada is already planning to receive and process adverse reaction reports electronically beginning early next month and is looking at eventually integrating them with electronic health records so physicians can enter information in real time.

    Sharma also said legislation on mandatory reporting is still a theory at this time, as Health Canada first wants to monitor the effectiveness of its decision to commission Accreditation Canada, a non-profit organization monitoring the performance of more than 700 health-care facilities, to develop a new standard on reporting negative side effects.

    “That’s just coming into place. We need to see what that help yields us and then we’re working with our counterparts to see (if there are) other parts of the system that would benefit from putting something in legislatively, but we’re not quite there yet,” Sharma said.

    “In order to put in the legislation, we want to make sure it’s possible and it will actually work to get more information in.”

    Sharma also said increasing the quantity of reports is just the beginning.

    “We are looking at more sophisticated ways to mine that data and to look at those signals,” said Sharma, adding that includes more co-operation with international partners and giving themselves clear deadlines for analyzing reports for risks.

    Author: Joanna Smith
    Source: Ottawa Bureau Reporter
    Date: April 16th, 2013
    http://www.thestar.com/news/canada/...hildrens_products_and_prescription_drugs.html

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