Experts urge national pharmaceutical security strategy amid drug shortage concerns

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A national strategy is needed to address drug shortages in Canada, according to experts who warn that the country is too reliant on foreign imports for critical medicines.

In an analysis published by the Canadian Medical Association Journal (CMAJ) Monday, health-care professionals wrote that pharmaceutical security, which ensures Canadians have access to critical drugs at all times, should become “a national priority.”

Drug shortages in the country are caused by the Canadian pharmaceutical supply’s reliance on foreign imports and vulnerable supply chains, they wrote.

“Establishing a critical drug’s list, stockpiling essential medications and strengthening domestic manufacturing capacity for active pharmaceutical ingredients and drugs are actions that should be taken urgently,” the report said.

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Dr. Shoo Lee, one of the article’s co-authors, says drug shortages have been an ongoing issue that “is getting worse.”

“Even before the pandemic, one-quarter of all the drugs used in Canada experienced some kind of shortage,” said Lee. “The pandemic, of course, worsened and aggravated the situation.”

“And we — those of us who are in health care — felt that it was time for the government to actually deal with this in a comprehensive manner, so that we can protect our pharmaceutical supplies for the public in Canada when there is a crisis like that,” he added.

Over the past 10 years, imports as a percentage of total domestic drug expenditures increased to 93 per cent from 74 per cent, according to the analysis citing industry reports on pharmaceutical manufacturing in Canada.

Of all types of shortages, Tier 3 shortages are considered to have “the greatest potential impact on Canada’s drug supply and health care system,” Health Canada states on its website.

Canada currently has 16 types of drugs that have been designated as Tier 3 shortages, including Lohexol Injection, Sterile Water for Injection and Asparaginase – Erwinase.

Click to play video: 'A look at drugs that are considered ‘essential’ to Canada’s health care system'
A look at drugs that are considered ‘essential’ to Canada’s health care system

Lee said the first step is to maintain a list of essential drugs that are important to the health-care system, like the U.S. list of 227 essential medicines and medical countermeasures in 2020.

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The U.S. also produces reliable, long-term domestic supply chains for medications essential to public health, he said.

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The second thing that Canada needs to narrow down are the drugs with limited manufacturers, said Lee.

“If a drug is manufactured by only one or two manufacturers, it becomes very vulnerable because if one of those manufacturers is unable to supply when we are in trouble, you cannot get access to them,” said Lee.

Canada also needs to have a backup plan for accessing to those essential drugs should the need arise, according to Lee.

“In other words, either we have the ability to manufacture them, or we have stockpiles of them for emergencies,” he said.

In Canada, there is the the National Emergency Strategic Stockpile (NESS), which is a federally-owned inventory of medical assets managed by the Public Health Agency of Canada (PHAC).

According to PHAC, provinces and territories may request medical assets “during public health emergencies or events when their own resources are depleted or not immediately available.”

“However, when COVID struck, we discovered that in fact, NESS did not stockpile many things that are essential, and also did not stockpile them in sufficient quantities,” said Lee.

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According to Lee, Canada should have an inventory list of medication supplies that’s “updated,” which includes information such as expiry dates, holding locations, quantities, so that health-care professionals and Canadians know where the medications are, how they can access and track them in real time.

Dr. Joel Lexchin, an emergency physician at the University Health Network, said he hopes this report serves as a caution to the government and Canadians about “the kind of situation that we encountered early on in the COVID-19 pandemic” when there was a global rush to get vaccines.

“Although Canada is a rich country and struck deals or had contracts with companies to supply the vaccine, that vaccine just wasn’t forthcoming because it wasn’t made in Canada,” said Lexchin, who is also the co-author of the analysis.

Lexchin said if certain essential drugs are being made by just one or two companies, Canadians have reason to worry about the availability of those products.

He said although Canada could solve the problem by making deals with several manufacturers, the most effective way to address the problem is for the government to invest in local manufacturers.

But how much money the government is willing “to throw at the problem in terms of constructing manufacturing facilities, putting money into doing research, new vaccines and training people,” depends on their “political will” to make actual changes, Lexchin said.

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According to Lee, Canada should create a Crown Corporation to manufacture essential drugs or subsidize domestic firms.

“Or we could create a nonprofit consortium that either manufactures or subcontracts for for generic pharmaceutical to be made in this country,” said Lee. “There are different options that can be used to ensure that drugs can be made available in this country when we need them.”

“The other piece of the puzzle,” says Lee, are the components that go into the making of a drug, also known as active pharmaceutical ingredients (API).

“Supplies of API have been a problem for some time, because in more recent years, most of the API production has shifted to low-cost manufacturing countries like India and China,” he said. “So, even if you have the facilities to manufacture the drugs, you cannot produce them when you don’t have the APIs.”

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“Drug shortages are something that happens often behind the scenes,” said Dr. Danielle Paes, the chief pharmacist officer at the Canadian Pharmacist Association. “One in four Canadians has been impacted by or affected by a direct shortage, and pharmacists can spend up to 20 per cent of their day, which for typical shift is about two hours, managing drug shortages.”

Paes said the shortage of any drugs could impact patients, regardless of how common or rare the disease is.

Enabling health-care providers to manage drug shortage situations would be a huge help alleviate some of the strain on the health-care system, according to Paes.

“Not all pharmacists have the ability to make therapeutic substitutions, or modify drug therapy and make adaptations in the moment,” said Paes. “Even though we have the information and the knowledge at the counter, in certain jurisdictions, pharmacists need to get approval from the prescriber.

She said this “back and forth” could cause delays in therapy and ultimately impact the patient.

“It would be really valuable to enable pharmacists to be able to make therapeutic substitutions and manage drug shortages,” said Paes.

According to Lexchin, one of the main lessons that we need to learn from the COVID-19 pandemic is that drug supply shortages are not a one-time situation.

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“This is going to happen again at some point, we don’t know when,” he said. “We need to remember that this is not something that we can say ‘we’re done’ or ‘it’s under control, and we can move on now.’

“We need to be always on the alert for this kind of situation.”

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