Federal government to require drug industry to report shortages

Shortages of critically important drugs have become a serious, ongoing issue for people across the country. At any given time, there are dozens of drugs in short supply in Canada. Often, these drugs are older, inexpensive generic treatments that many rely on to manage health conditions. In an attempt to help better inform the public of looming problems, the federal government announced Thursday it is moving ahead with plans to require the drug industry to report when shortages are going to occur.

The new system, which will eventually be housed online, will replace the current website, drugshortages.ca, which is managed by the pharmaceutical industry on a voluntary basis. Experts who have been following the drug shortage issue say the current website, while better than nothing, has major flaws. For instance, it's not uncommon for reports of new shortages to be posted with little or no notice before the drug becomes unavailable.

The question now is whether the federally mandated website will make a meaningful difference.

Drug shortages 101

Shortages have become a big issue in the last decade in Canada. Although the exact reasons vary, common factors are often cited, such as problems at production facilities, particularly in countries that struggle with quality-control issues and availability of raw materials used to make drugs. Many experts also believe shortages could stem from the fact the inexpensive drugs generate so little profit that there is no motivation to produce them. The drug industry disputes that suggestion. In many cases, there are alternative drugs that can be used when one is in short supply, but they may not be as effective or may cause side effects.

For several years, the federal government has been promising to take action, with former health minister Rona Ambrose announcing last year a mandatory reporting structure. The new rules didn't take effect before last year's election, however.

Now the Liberals have promised to finish the job.

Will mandatory reporting help?

Dr. Richard Hall, an anesthesiologist based in Halifax, said the federal plan to mandate shortage reporting is "long overdue" and is likely to have some benefit.

"To the extent that there has been a reluctance to report the issue because it was voluntary, it will eliminate that," said Hall, professor of anesthesiology, critical care medicine and pharmacology at Dalhousie University.

But mandatory reporting won't fix the problem. In many cases, shortages happen "out of the blue," Hall said, meaning there is no way to inform the public and health-care professionals well in advance so they can make alternative plans. In some cases, companies may not even realize certain inexpensive, infrequently prescribed drugs are facing a shortage until it happens because they aren't paying attention to that particular agent. Also, it's still possible that drug companies will delay reporting of shortages, as it puts them at a competitive disadvantage to disclose problems well in advance, Hall said.

Dr. Jacalyn Duffin, Hannah Chair of history of medicine at Queen's University in Kingston, agrees. She also asked why the federal government isn't tracking and reporting on the extent of the problem, as they do in the United States.

"We need to measure it and we need to understand why we have this problem," Duffin said.

Duffin said she also has concerns about how the new shortage website will work. In its announcement, Health Canada said that it is requesting prequalified contractors to submit proposals for developing and maintaining a reporting website. If a private contractor is in charge of this enormous venture, the public needs to be assured it is going to get accurate, up-to-date information. She said the government itself should be running the website to make sure the public's best interests are served.

Moving forward

It doesn't appear the issue of drug shortages will go away any time soon. A website isn't going to fix the problem, Dr. Hall said, but Canada could be taking a proactive role by creating a stockpile of essential medicines.

"I don't see any other solution to the situation because, to some extent, it's market driven," Hall said. "The only way we can guarantee those drugs are going to be available for Canadians is to ensure we can independently supply them."