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A lab technician prepares a prescription at a pharmacy Thursday, March 8, 2012 in Quebec City. (Jacques Boissinot/THE CANADIAN PRESS)
A lab technician prepares a prescription at a pharmacy Thursday, March 8, 2012 in Quebec City. (Jacques Boissinot/THE CANADIAN PRESS)

Globe Editorial

Lack of research tracking the risks of prescribing drugs "off-label" in Canada Add to ...

Prescribing drugs “off-label” – for an ailment or condition they were not meant for – is a quite common practice that has sparked worries about harm to patients and doubts whether they are aware of the risks. Immediate steps need to be taken to make sure doctors have access to a database educating them about what they prescribe.

A study by McGill University researchers in Montreal has concluded that 11 per cent of prescriptions are off-label, used to treat a condition other than one that has been approved by Health Canada for safety and efficacy. Only one in five of the drugs prescribed off-label had some scientific support.

In other words, 79 per cent of such prescriptions lacked strong scientific evidence, according to the study published online last week in Archives of Internal Medicine by Tewodros Eguale, Robyn Tamblyn and their colleagues. It should not only prompt patients to be more aware of their medical conditions but also to discuss their prescriptions with their doctors, said Dr. Eguale.

“What we need are more informed physicians, but at the same time, we need to inform patients,” said Dr. Eguale, who analyzed electronic health records of 113 primary-care physicians treating 50,823 patients in Quebec cities between 2005 and 2009.

The drugs most frequently prescribed off-label include anti-psychotics, antidepressants and anti-epilepsy drugs. Anti-infective agents that kill germs or stop their spread were also prescribed in this way, as were ear, nose and throat medications. Women tended to receive them more than men.

This is no neutral matter. Antipsychotics, for example, have been prescribed broadly in nursing homes as a form of chemical restraint for dementia patients. Consequently, Health Canada has issued a warning they can be deadly for that group.

With so many medications on the market – there are about 1,000 of them – it can be challenging for physicians to stay on top of all their uses and guidelines. For that reason, a computerized system that can inform doctors of the best drugs for a given condition should be created and made available across Canada.

As the United States does, Health Canada should move to track off-label use of drugs, with an eye to educating both the profession and patients on these worrisome prescribing patterns.

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