Drug makers must report shortages or risk fines
Health advocates, industry members welcome changes
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 toward 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.
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 toward 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 products in February 2012, where it was later revealed company executives knew of the issue three months earlier but took no action, said Dr. Douglas DuVal, vicepresident of the Canadian Anesthesiologists’ Society. Health Canada also sent letters to drug companies that withheld timely information about shortages of nitroglycerine.
But health advocates said more work is necessary to solve the predicament that is 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.
Some members of the industry say they’ll support the plan, though they would have “preferred voluntary,” said Russell Williams, president of Rx&D, a national association representing 50 pharmaceutical companies in Canada.