Auditor general slams Health Canada for failing to monitor drug safety

The federal auditor general is raising red flags about how government ensures the safety of drugs.

John Wiersema says Canada has an archaic system of monitoring that can take years to tell the public that some drugs come with significant risks.

In one case, a drug that was being prescribed for epilepsy, migraines, psychiatric conditions or weight loss was found to be linked to birth defects.

But it took six months for the brand-name drug to include a warning, and almost two years for generic producers to be told they had to change their labels and warnings.

In another case, the United States was already warning in 2006 that the benefits of low-dose ASA could be eroded by taking ibuprofen at the same time.

But in Canada, a review took more than three years, and orders to change labelling for the public are still not fully in place for several hundred products that are affected.

“Health Canada is slow to act on potential safety issues related to drugs already on the market,” Wiersema said in a release. “It needs to get safety information out to Canadians more quickly, and address the potential for conflict of interest.”

The auditor general also raised concerns about Health Canada failing to say why it rejected certain drugs, or required changes. But since doctors can prescribe drugs for conditions that have not been authorized, they need to have this information to keep their patients safe.

“It is important that they be informed when the department rejects a marketed drug for a new use, so they understand the department’s concerns,” says the audit, tabled in Parliament on Tuesday.

The fall report also highlight problems in other departments:

— Canada’s visa officers are failing to screen applicants for dozens of diseases, concentrating instead on just two diseases that were prevalent 50 years ago.

— The government has failed to properly monitor how effectively funds were spent under the recession-fighting Economic Action Plan, including information about just how many jobs were created.

— The military is doing a poor job of predicting its maintenance needs and costs over the long haul.

But the report on Health Canada raises the most disturbing issues. It found there is poor communication about clinical trials, pointing out that Health Canada was not disclosing information about authorized trials — depriving some Canadians with life-threatening diseases of a chance to participate in new treatment options.

The department is also turning a blind eye to unauthorized trials, making it impossible for participants to make informed decisions.

“This increases the risk that Canadians may be unaware of new treatment options or may unknowingly participate in an unauthorized trial.”

In one case, a child was involved in an unauthorized experiment, but did not realize it until his parents contacted Health Canada with concerns about safety. Only then did Health Canada conduct an investigation.

The audit shows a department overwhelmed with a mounting pile of information about thousands of drugs that are increasingly central in how Canadians manage their health care.

The department often receives crucial information about adverse reactions by fax or courier, and has to enter the information manually into a database. With the number reports of adverse reactions skyrocketing in the past few years, the backlog is growing and Health Canada has not found a way to prioritize, the audit says.

The department is also falling behind on its inspections of clinical trial sites.

And its reviews of drugs for safety, efficiency and quality drag on, especially for generic drugs, over-the-counter medications and other drugs that are adjusted after they hit the market.

As for conflict-of-interest, the audit says Health Canada should beef up its requirements and actively make sure its employees are in compliance.

Health Canada has agreed to all of the auditor general’s recommendations, and in some cases has already begun implementing them.

The drug market in Canada is enormous, as Canadians have become more dependent on pharmaceuticals to treat their ailments. In 2008, there were 13,000 different kinds of prescription and non-prescription drugs sold in Canada for about $28 billion. Prescription drugs are generally 84 per cent of that.

In 2010, doctors issued 505 million prescriptions.