BUSINESS

Companies Will Be Named And Shamed For Failing To Post Drug Shortages: Minister

02/10/2015 01:04 EST | Updated 04/12/2015 05:59 EDT
VANCOUVER - A federal scheme that puts the onus of reporting drug shortages on pharmaceutical firms is being endorsed by a chorus of Canadian health professionals who say it's a good first step towards remedying a life-or-death problem.

Health Minister Rona Ambrose announced the government is moving from an industry-run, voluntary system to regulated, mandatory reporting of medicine scarcity with the creation of an independent website and online non-compliance registry.

Companies that fail to publicly post anticipated and actual drug shortages, including discontinuation of their products, risk fines in the millions of dollars and the threat of being "named and shamed," Ambrose told a gathering Tuesday at Vancouver General Hospital.

"We want to know exactly when they know when that's going to happen," said Ambrose, explaining that advance warning — six months would be ideal — will allow Health Canada to attempt to arrange substitutes. "It's really about timely and accurate information."

A long lineup of health advocates support the plan, saying measures to prevent surprise drug shortfalls are essential to ensuring patients aren't left hanging when their health depends on pharmaceuticals most.

The Canadian Medical Association lauded the move towards strengthening the notification system with a third-party website.

"Persistent shortages in the supply of drugs pose a serious disruption to clinical treatment, increase medical error and put unhelpful pressure on the entire health-care system," Dr. Chris Simpson, the association's president, said in a release.

Recent examples of drug disruptions include shortfalls of a number of products in February 2012, where it was later revealed company executives knew of the impending issue three months earlier but took no action, said Dr. Douglas DuVal, vice-president of the Canadian Anesthesiologists' Society.

Another firm refused public notification when it was running out of a cancer drug, said Ambrose. Health Canada also sent letters to drug companies that withheld timely information about shortages of nitroglycerin, which is used to treat a heart condition.

But health advocates said there's still more work necessary to solve the predicament that's often influenced by global factors.

The risks for impending shortages must still be better identified, such as sole sourcing key medications, and there's a need to improve how information is exchanged between hospitals, clinics and across provincial boundaries, said DuVal.

"It really depends on how the information will be utilized," added Suzanne Nurse, chair of the Drug Shortages Committee for the Canadian Epilepsy Alliance.

She said advanced warning is crucial for people who can't make abrupt changes in their medication, but even better would be preventing any shortage in the first place.

A model worth striving towards is embodied by a task force within the U.S. Federal Drug Administration, which endeavours to avert shortages as soon as a pharmaceutical company reveals there's a dearth, she added.

Some members of the industry say they'll support the plan, even though they would have "preferred voluntary," said Russell Williams, president of Rx&D, a national association representing 50 "innovative" pharmaceutical companies in Canada.

"We believe it's our responsibility, we're taking it seriously. My association has a code of ethics. ... We believe in self-regulation," he said, noting all members of his group are already complying with the voluntary requirement.

Williams said drug shortages are a legitimate issue for people to get emotional over, and cautioned the government's plan is most likely to be successful if it's not "draconian."

"I'm approaching the next few months in good faith we'll come up with a model that's more or less the voluntary model, but part of law."

Health Canada began requesting voluntary reporting in March 2012. The ministry is still drafting the final regulations for the new plan.

Both the federal Liberals and NDP supported the registry's creation while claiming that idea as their own.

Liberal health critic Hedy Fry said in an interview that under the new system the government should be "working with, not beating up on" the industry to influence what drugs are produced.

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