Expanding Canada’s Drug Manufacturing May Ease Shortages

Canada’s pharmaceutical supply has become highly dependent on imports, leading to calls to increase domestic manufacturing in the long term and to manage vulnerable supply chains better in the short term.

The pandemic worsened an already fragile supply of medicines in Canada, write Shoo K. Lee, MBBS, PhD, principal investigator of the Maternal-Infant Care Research Center, and co-authors in an editorial published August 22 in CMAJ.

The nation has experienced persistent pharmaceutical shortages for more than a decade. Nearly one quarter of all marketed pharmaceuticals were in short supply at some point between March 2017 and September 2018, according to the authors.

“A secure drug supply is critical for high-quality health care and ensuring the health of all people in Canada,” they write. “When supplies of medicines are compromised, clinicians might be forced to choose second-line therapies, pharmacists spend unnecessary time procuring supplies, and, most critically, patients’ health may be compromised.”

Forgoing Price Reduction

Shortages of epinephrine autoinjectors in Canada over the past 5 years, for example, caused stressful and even potentially life-threatening consequences for people at risk of anaphylaxis. Supplies of drugs such as hydroxychloroquine, which is used for rheumatoid arthritis and inflammatory bowel disease, suddenly became strained during the pandemic as clinicians began using these drugs to treat COVID-19, the authors write.

Imports as a percentage of total Canadian drug expenditures rose in the past decade from 74% to 93%. This heavy reliance on pharmaceutical imports makes Canada vulnerable to disruptions in global supply chains.

The current situation reflects trends in drug manufacturing that have evolved over decades, the authors note. There has been a shift toward imports from China and India, especially for raw materials, such as active pharmaceutical ingredients (APIs).

“Consequently, increasing production within Canada to mitigate shortages is not a viable solution, at least at this time,” the authors write. “Finally, shortages for generic drugs have also been attributed to their low price points, which have caused firms to exit the market. This becomes problematic when only one or two manufacturers of a generic drug exist, limiting redundancy in supply chains.”

Globalization has been considered a way to bring down costs. People will as a rule try to find the lowest prices for many products, but that approach should be reconsidered when it comes to medicines, Lee told Medscape Medical News.

“You may have to forgo some of your price reduction to maintain a secure supply,” Lee said. “There are some things that you simply cannot trade off.”

In their editorial, the authors offer several suggestions for increasing Canada’s domestic production of medicines. They refer to a University of Montreal project in which researchers are investigating a technique that requires a substantially smaller industrial plant footprint in making APIs. The authors suggest using government-owned entities, known as Crown corporations, to increase the manufacture of essential drugs.

Another recommendation is to follow the example of Civica RX, a US organization created to increase the supply of critical generic medicines. Establishing a public manufacturer of generic medicines to work in tandem with current manufacturers will help curb future shortages, according to the authors. They suggest picking an organization that could function “as a small but fully scalable operation, or it could provide a constant supply of essential drugs.”

They also propose that to incentivize Canadian production, public procurement could include reserving partial tenders for companies that manufacture products in Canada. “To support constant production, public group-purchasing organizations should be mandated to purchase entirely from the entity. To further promote pharmaceutical industry growth in Canada, incentives for venture capital should be provided.”

Another alternative is to actively contract with existing commercial firms to produce pharmaceuticals, including vaccines, only in the event of shortages or other emergencies, the authors suggest. “Higher pricing may result, but society could likely accept a trade-off between pricing and a secure supply,” they write.

Near-Term Solutions

The authors also offer suggestions for near-term fixes to better manage the Canadian drug supply. Some of these echo recommendations made by the Ontario Medical Association (OMA) in a 2021 article on drug shortages. Among the points of agreement are the need for better coordination among healthcare organizations regarding the state of the current pharmaceutical supply.

The authors call for a central inventory management system that tracks the details of all pharmaceuticals in Canada’s National Emergency Strategic Stockpile. This system should include expiration dates, holding locations, and quantities, they write.

In its report, OMA recommends that federal, provincial, and territorial governments work with it and other key players, such as the Canadian Association of Pharmaceutical Distribution and the Canadian Generic Pharmaceutical Association, to develop and implement a centralized drug supply monitoring system. This system would provide real-time updates on community drug supply and distribution and should specify reasons for and the anticipated durations of shortages, OMA says.

Rose Zacharias, MD, president of OMA, told Medscape that redistributing unused drugs and considering appropriate substitutions or alternatives are other steps to be considered in the short term.

Canada has already had to employ some of these methods. In 2020, for example, Health Canada issued an interim order allowing the import and sale of international versions of certain critically needed drugs, even though these products may not have met the nation’s regulatory and labeling requirements, CMAJ reported. In the case of the sedative propofol, Health Canada expedited imports from the European Union, and clinicians can use alternatives such as ketamine, although there also are concerns about the supply of this medicine.

In addition to her work with OMA, Zacharias has practiced as an emergency department physician for about 20 years. Shortages of staple medicines for hospitals, such as propofol, ketamine, and succinylcholine, are extremely concerning, she said. Without an adequate supply of these medicines, some procedures must be delayed.

“You cannot do surgery like this. It just seems like such a horrific statement to make, but you cannot do surgery on someone who’s awake,” Zacharias said.

Lee receives grant support for the Maternal-Infant Care Research Center team from the Canadian Institutes of Health Research. Zacharias has disclosed no relevant financial relationships.

CMAJ. Published online Aug. 22, 2022. Full text

Kerry Dooley Young is a freelance journalist based in Washington, DC. She also serves as the core topic leader for patient safety for the Association of Health Care Journalists (AHCJ). Follow her on Twitter at @kdooleyyoung.

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