Side effects reporting improved

Health Canada is ramping up efforts to get more doctors to report when their patients suffer side effects to medications.

The campaign, which the federal regulator hopes will improve drug safety, follows a Toronto Star investigation that revealed problems with Health Canadas monitoring of patient side effects.

The investigation found side effects are under-reported, in part because of a flawed drug safety law that does not require Canadas medical professionals to report serious adverse reactions to drugs.

Though the system remains voluntary, Health Canada is now placing notices in 22 journals for health professionals that explain the process and importance of reporting adverse side effects.

Health Canada also commissioned Accreditation Canada, a nonprofit organization that assesses the performance of many of Canadas hospitals and other health facilities, to develop a new standard on reporting adverse side effects.

The reports, which detail reactions as varied as nausea to convulsions to suicide, are intended to play a pivotal role in regulating drug safety.

While increased reporting is important, the Stars investigation found Health Canada was not alerting the public to the magnitude of these side effects. This is because the regulator has not analyzed the data it collects.

After a controlled-setting clinical trial involving thousands of participants, if a drug is approved for sale, the reports are often the only way a government can monitor how a drug performs in the larger general population. Clinical trials may not reveal serious side effects that take time to materialize or occur infrequently.

Health Canada hopes the new standard and awareness campaign will increase the quantity and quality of side-effect reports it receives from health professionals.

Nearly 73 per cent of the roughly 160,000 side-effect reports filed to Health Canada from 2000 to 2011 came from health professionals, the Star found. Most of the other reports came directly from the public.

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Side effects reporting improved