Rita Daly

Staff Reporter

Toronto Star May 26^th 2005

Patients and doctors can now learn more about possible side effects of medicines. Access to that information, restricted for years by Health Canada, was opened to the public for the first time yesterday through the Health Ministry's website.

With a few clicks of a mouse, anyone can now view Health Canada's national database of reported adverse reactions - minor or serious - that patients have suffered while taking a prescription drug.

The reports cover everything from cancer treatments to heartburn pills, as well as non-prescription drugs and. natural health products.

With some 5300 prescription drugs on the Canadian market and roughly 9000 adverse drug reactions, reported annually, critics applauded the move as a victory for patient safety and government. They also urged the lilberal government not to stop, there.

Dr. Joel Lexchin, a drug policy expert and professor at York University, said that the federal health ministry must take a more active role in drug-safety monitoring and demand that pharmaceutical firms do follow-up safety studies after drugs are approved for public use.

The government now relies on periodic reports from drug manufacturers and voluntary. reporting of adverse events from doctors and hospitals for its data. Experts estimate only 1 to 10 per cent of adverse drug reactions am ever reported.

This is a good first step. The database provides. a small window into what's going on," Lexchin said.

But without putting more money aid resources into this entire process we’re not going to get the picture of what really goes on with adverse drug reactions.

Called the Canadian Adverse Drug Reaction Information System (CADRIS), the online database can be searched by the name of the product or active ingredient, the date a report was received, the patient's age and gender, and the outcome of the adverse reaction.

The entire database will be updated quarterly and can be downloaded. Data does not include confidential information such as patient identity.

For years Health Canada refused to release the CADRIS database, arguing it was too complex and incomplete for the public to draw accurate conclusions about drug safety.

Patients could request information on an individual drug, but often waited weeks for it.

The Canadian Association of Journalists gave Health Canada its satiric Code of Silence award last year for denying access to the database, a distinction that did not go unnoticed by Health Minister Ujjal Dosanjh. CBC radio eventually obtained access - as did the Toronto Star, which ran a series on drug safety last December.

CAJ president Paul Scluieidereit applauded Health Canada’s move.

The industry association for Canadian research-based pharmaceutical companies yesterday supported publication of the database.

"Safety and transparency have always been fundamental to our member companies'" Rx&D president Russell Williams said in a published statement

"Well-informed patients have a better understanding of their condition, treatment and can make well-informed decisions about their health care."

A report of a reaction doesn't necessarily mean it was caused by the suspected drug, and patients are asked to consult a health care professional before stopping any medication.

Dr. Bob James, a family physician 'in Dundas, Ont, said the database may actually promote greater dialogue about drug safety between doctor and patient, although there is a risk some people may stop taking their medication after reviewing the information .

"Overall, I think more information is better than less information;" he said.

"Maybe this will give us an opportunity to raise with patients the need for taking the drug. . . and the fact that everything has side effects, including Tylenol and your vitamin C tablets"

The database can be accessed at Health Canada’s website at www.hc-sc.gc.ca.

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