A heart patient is rationing his drug supply after his life-sustaining medication was abruptly discontinued with no warning to doctors.
Gary Piniach, a 57-year-old father of two in Regina, halved his dosage of the low-cost generic disopyramide after hearing a few weeks ago that the manufacturer stopped production in February and informed Health Canada around the same time. The situation reveals a troubling policy gap, and has patients and doctors calling for the federal agency to overhaul the way it handles the discontinuation of a drug, especially when there is no alternative therapy.
“The onus is on Health Canada,” Mr. Piniach said. “The manufacturer notifies Health Canada that in 30 days they’re not going to make it anymore. But what does Health Canada do with this information? My doctor didn’t know about it. My pharmacist didn’t know about it.”
The Globe and Mail recently reported that about 1,000 heart patients were in treatment limbo – some facing complex, open-heart surgery – after Sanofi Canada discontinued disopyramide, citing weakened demand. The drug is used to treat hypertrophic cardiomyopathy, a condition in which the heart muscle becomes abnormally thick and narrows the passageway through which blood leaves the heart.
Bowing to public pressure, Sanofi Canada plans to resume production sometime next year. In the meantime, it is importing the drug from Europe and is offering it for free under Health Canada’s special-access program (SAP) until it resumes production.
Mr. Piniach, who cut his dosage from 600 milligrams a day to 300 milligrams so that he could stretch his limited supply, is still waiting for his paperwork to be processed to receive the drug under SAP. He’s prepared to travel out of country to procure the drug.
“I’m managing the best I can,” he said. “I don’t want to be cut off completely because that’s dangerous.”
A bigger issue is at play. Health Canada requires pharmaceutical companies to give it 30 days’ notice, and says it has no authority to force a drug-maker to continue to manufacture a medication. Cardiologists, however, say the notice period should be lengthened and a process needs to be put in place to evaluate the impact of withdrawing a drug – and, if there aren’t any alternative therapies, develop a plan to keep it on the market.
Health Canada indicated that it is considering a report by the House of Commons standing committee on health to expand the notice time – from 30 days to six months – before a company discontinues a drug. Health Minister Leona Aglukkaq said in an e-mail statement that the government will respond to the recommendation in “due course.”
In the case of disopyramide, patients only learned this summer of the drug discontinuation when they went to their pharmacists for refills. Some faced surgery, while others scrambled to locate the medication as their own supplies dwindled.
Sanofi Canada said it believed there were other options for patients using disopyramide before it halted production. Cardiologists disagreed, and said they should have been consulted.
Cardiologist Rodney Zimmermann, with the Regina Qu’Appelle Health Region, said he has two patients on the drug, including Mr. Piniach. Usually, Dr. Zimmermann said, there is an alternative when a drug is discontinued. But not in this case.
“With a limited group of patients on it, you’d think it would be relatively easy to notify those patients well in advance rather than when the supply runs out and now you’re left running and scrambling,” he said.
Liberal health critic Hedy Fry said the government needs to increase the notice time for when a drug is discontinued, and inform the health community. Physicians, she said, will then have a chance to at least move their patients to an alternative therapy or petition Health Canada to seek out another manufacturer.
“If Health Canada doesn’t move on it,” Ms. Fry said, “we will continue to have the kinds of problems that are going on.”