When a heart medication was abruptly discontinued earlier this year with no warning to doctors, it left more than 1,000 Canadian patients in treatment limbo. Now, the vice-president of the drug company says it could happen again unless public policy is strengthened.
"[The] Canadian system of product discontinuation in general … is currently not set to prevent such situations from occurring in the future," said the VP of evidence, value and access at Sanofi Canada, the company that discontinued the heart drug.
"We are dealing with the process that is suboptimal in Canada and multiple parties need to work together to reach a consensus on how it could possibly be improved," Stan Glezer said in an e-mail.
Health Canada is in the process of considering a report that would require pharmaceutical companies to provide it with six months notice, up from the current 30 days, when they discontinue a drug. Some question whether that would go far enough.
The Globe and Mail recently reported that Sanofi Canada discontinued the low-cost generic disopyramide in February, 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.
Patients and cardiologists only learned of the discontinuation of the drug – for which there is no alternative – in recent weeks. Health Canada requires companies to give it 30 days notice. At least three patients face complex, open-heart surgery as a result of increased risk, while others scrambled to locate the medication as supplies dwindled.
Bowing to concerns raised by cardiologists and patients, Sanofi Canada plans to resume production, but provided no firm date. In the meantime, it is importing the drug from Europe and plans to offer it for free under Health Canada's special-access program until it resumes production here.
The issue, however, revealed a troubling public policy gap.
Health Canada indicated that it is considering a report by the House of Commons standing committee on health to expand the notice time before a company discontinues a drug. The U.S. Food and Drug Administration requires pharmaceutical companies to inform it six months in advance if they plan on halting production on a "sole-source, medically necessary" drug so it can work on developing an alternative plan for patients, a spokeswoman said.
Health Canada has no authority to make a company continue to manufacture a medication. It's up to drug makers to consider the needs of their product before discontinuing it, said spokesman Gary Holub.
Sanofi Canada said it believed there were other options for patients using disopyramide before it halted production. Cardiologists disagreed, and said that they should have been consulted.
Cardiologist Harry Rakowski, director of the hypertrophic cardiomyopathy clinic, Peter Munk Cardiac Centre at Toronto General Hospital, said three of his patients are opting for surgery rather than waiting for the drug to arrive. Dr. Rakowski has witnessed first-hand just how devastating it can be to pull a drug off the market for which there is no alternative, and with no warning to doctors and patients.
He said Ottawa needs to put a process in place to evaluate the impact of withdrawing a drug, consider alternative therapies, and, if there aren't any, develop a plan to keep the drug on the market.
"Just increasing the notification without then improving the process of allowing appropriate parties to comment is inadequate," Dr. Rakowski said. "If no alternatives are available, there is an obligation to develop a plan to retain availability."
John Haggie, president of the Canadian Medical Association, echoed the sentiment.
"I think it's going to keep happening, quite honestly," Dr. Haggie said. "There should be some mechanism for a health impact assessment."