High-blood pressure drug shortage highlights wider problem in Canada

There are more than 1,800 current drug shortages in Canada, according to Health Canada's third party reporting website Drug Shortages Canada.

The recent shortage of a medication used to treat high blood pressure and other heart conditions is calling attention to the greater problem of drug shortages in Canada.

In July, pharmaceutical company Bayer Canada reported it was experiencing shortages of its extended-release Adalat XL tablets in the 20 milligram and 60 milligram dosages.

Adalat XL, or nifedipine, belongs to a class of medications called calcium channel blockers that are used to control high blood pressure and prevent chest pain from angina by relaxing the blood vessels.

According to Drug Shortages Canada, a third-party website launched by Health Canada that pharmaceutical manufacturers are required to report their shortages to, Adalat XL is in short supply due to “disruption of the manufacture of the drug.”

There is no other information on the website about what is responsible for the disruption or when the issue might be resolved.

In an emailed statement, Bayer said it received a warning letter from the U.S. Food and Drug Administration (FDA) regarding its supply center in Leverkusen, Germany in January of 2017. The company said the letter concerned “certain items” in their “good manufacturing practices” area.

“Since the routine GMP inspection by the FDA, Bayer has and continues to implement remediation and modernization activities in a timely manner,” the statement read.

Bayer went on to say that remediation efforts may result in “potential disruptions” in supply.

“We are committed to helping patients and healthcare professionals access these products, and will provide updates as new information becomes available,” the company said.

Dr. Jacalyn Duffin, a physician, hematologist, and the creator of canadadrugshortage.com, a website dedicated to tracking drug shortages in Canada, said Adalat XL is representative of a much larger problem and is just one of more than 1,800 current shortages in the country. She said these kinds of disruptions can be incredibly destabilizing for patients, particularly those with long-term conditions.

“It’s very, very upsetting for people to suddenly lose a drug they’ve come to rely on,” she told CTVNews.ca during a telephone interview on Friday. “In conditions like high blood pressure, but also in conditions like epilepsy or arthritis, for example, these are problems that sometimes take a long time to stabilize.”

Even though nifedipine is available from several other manufacturers in Canada, Duffin warns there is a risk those, too, will become in short supply due to the sudden increase in demand. For example, there are currently 10 shortages of nifedipine in Canada, including the ones from Bayer Canada. The affected manufacturers include Apotex, Mylan, AA Pharma, and Pharmascience.

In cases where nifedipine is unavailable, Duffin said patients will have to resort to other “calcium channel blockers” that may not be as effective for them.

“Some medications can’t be tolerated,” she said. “Some medications that the patient has never been exposed to before have to be titrated to find the right dose that’s going to work to control that person’s blood pressure. So you can end up spending weeks chasing your tail trying to find something that will work instead.”

Duffin called the problem “frustrating beyond belief” because it consumes so much time for pharmacists, doctors, and patients to find a solution.

“It strikes me, [as someone] who has been looking at this problem for nine years, that it’s so unnecessary,” she said.

Barry Power, senior director of digital content for the Canadian Pharmacists Association (CPhA), said pharmacists reported spending about 20 per cent of their time dealing with drug shortages according to a recent survey they conducted.

“It’s over a day a week in a typical seven-day pharmacy week,” he told CTVNews.ca on Friday. “It’s taking up a huge amount of time.”

The CPhA also echoed Duffin’s concerns in a letter sent to the prime minister earlier this month.

In the letter, the association warned of “significant increases” in drug shortages in the last three to five years. In some cases, pharmacists have reported not being able to fill 50 per cent of their weekly order, the organization stated.

“This trend has also been confirmed by patients with one in four Canadians saying that they have experienced a shortage, either personally or a family/friend,” the association wrote.

A global problem

When it comes to why these shortages are happening in the first place, Duffin said there isn’t one simple explanation. In fact, on her website, she lists 16 possible causes for the recurring drug shortages in Canada.

These include growing demand for certain drugs, breakdowns in manufacturing or quality control, shortages in raw materials used to make the medications, the pricing of generic drugs, and the competition between big pharmaceutical companies and generics.

Duffin said it’s not as easy as blaming pharmaceutical companies for the disruptions because in actuality, it’s in their best interest to supply these medications if the demand is there.

“It doesn’t make sense because if there’s a desire to have a drug, there’s money to be made by making it,” she said.

Drug shortages aren’t just affecting Canada, either. Duffin said she’s listed more than 100 countries with reported shortages on her website.

“This is a global problem. The problem is not residing here in Canada. The problem is something to do with the international pharmaceutical market well beyond our borders,” she said.

Power said the globalization of manufacturing processes over the last couple of decades means the production of certain ingredients for medication is often concentrated to one or two plants in the entire world.

“The vulnerabilities are more obvious because there isn’t necessarily built-in redundancies in the production chain or the supply chain,” he explained. “So if there’s a problem in one step it can have quite significant consequences downstream that can result in shortages.

As things have become more global we’re starting to see that they’re also becoming more fragile.”

For example, when Puerto Rico was hit with a devastating hurricane in 2017, Power said there was worldwide concern there would be a shortage of Tylenol, or acetaminophen, because a large supply of the drug is manufactured in the country.

As for finding solution, Duffin said she doesn’t think one individual country will be able to fix it and it will require international collaboration. However, that doesn’t mean she doesn’t think the Canadian government should take a more active role in measuring the reasons behind the shortages and trying to find a solution.

“Canada should be standing up and leading the world in investigation to figure it out,” she said.

The Canadian Pharmacy Association is also urging the government to conduct research on the underlying causes of the shortages in Canada and around the world and to take a leadership role in launching a global task force to look at the problem.

“It’s not just a Canada issue,” Power said. “They [affected countries] may have to look at making some changes to some of the regulatory processes that are used to assess the manufacturing plants. They’d have to be done in conjunction with other groups, like the European Medicines Agency, the Food and Drug Administration in the States, so that everybody is in synch.”

CPhA has also asked for more resources and tools to support front-line health-care workers to mitigate the shortages and recalls.

On its website, Health Canada said it’s “working with stakeholders throughout the supply chain to better prevent, mitigate and communicate shortages.” The agency described drug shortages as a “complex, global problem” that may arise from any number of possible causes. These causes include production issues, sole source contracting, unexpected surges in demand for a drug, and difficulties accessing raw supplies.

As of 2016, Health Canada said it introduced new regulations requiring manufacturers to report actual and anticipated drug shortages as well as discontinuations to the website Drug Shortages Canada.

In 2012, the health agency also created the Multi-Stakeholder Steering Committee on Drug Shortages (MSSC), comprised of industry and health-care representatives, which is aimed at working towards a more “rigorous and coordinated approach” to the problem.

Duffin said she’d like to see the government go one step further and study the reasons behind the shortages that are reported on the online database.

“They’ve got this website and it says ‘Oh, there are 1,800 shortages,’ but they aren’t measuring them through time. So they aren’t summarizing how many per month or how many per year. They’re not finding out if they’re seasonal. They’re not finding out if they’re getting worse or getting better. They’re just reporting them.”

To find a solution, Duffin said the number one focus for all countries experiencing drug shortages should be to understand the different causes behind each shortage.

“We can’t fix something if we don’t know what the cause is,” she said.