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Drug shortages in Canada, which grew worse during the initial months of the COVID-19 pandemic, improved in 2020 after the federal government introduced new measures to help, according to a new report.

The improvements plateaued in 2021, however, and shortages began to increase again by the end of March 2022. The measures should be maintained and built upon to create long-term change and minimize harm to patients, the study authors wrote.

“Drug shortages have wide-ranging impacts across many clinical areas and types of clinical care — everything from primary care and prevention treatments to ICU drugs and contrast dye, plendil side effects liver ” Mina Tadrous, PharmD, PhD, one of the study authors and a scientist at Women’s College Hospital Institute for Health System Solutions and Virtual Care in Toronto, Ontario, Canada, told Medscape Medical News.

“Most importantly, many patients will be affected, and potential clinical consequences could occur,” he said. “This adds extra strain to our already stretched healthcare systems — imagine the time and effort of switching patients already stable on drugs or finding alternatives or even further delaying procedures.”

The study was published online June 13 in the Canadian Medical Association Journal.

Progress and Plateau

Drug shortages have become a persistent problem in Canada and around the world in recent years, and the pandemic exposed vulnerabilities as supply chains halted from countries that produced pharmaceutical products and raw ingredients, the study authors wrote.

In March 2020, the Canadian government introduced new measures to address those shortages, including an amendment to the Patent Act that allowed manufacturers to make, use, or sell versions of patented drugs without needing to negotiate with patent holders. The federal government also issued an interim order for certain drugs that faced high risks for shortages, which allowed them to be imported from other countries. The interim measures were made permanent in March 2022.

Using a cross-sectional design, the researchers analyzed information from the Drug Shortages Canada database to track changes in drug shortages over time by calculating a 30-day moving average from April 2017 to April 2022.

They found that of the 13,329 drug products at risk for shortage, nearly 45%, or 5953 products, had at least one shortage event in the past 5 years.

Of the 5953 products that had a shortage, many had multiple events during the 5-year period, with an average of 2.1 reports per affected drug identification number. About 88% of shortages were resolved after about 140 days, or nearly 5 months. About 11% of shortages remained unresolved and had been ongoing for an average of 2.5 years.

Average daily shortage prevalence rates rose from 901 in April 2017 to a peak of 2345 by April 2020. Shortages significantly declined after that, dropping to a rate of 1611 by the end of the first year after the new policy measures were implemented.

There was no significant reduction in shortage rates in the second year, however. Rates reached a plateau of around 1500 and then rose above 1600 by the end of March 2022.

“Although COVID shone a light on the issue of drug shortages, they have been an ongoing problem in Canada for many years,” Lorian Hardcastle, SJD, one of the study authors and an assistant professor of community health sciences at the University of Calgary, Alberta, Canada, told Medscape.

“Although manufacturers report shortages, patients and health professionals are often caught off guard by shortages, and the response by policymakers has typically been reactive,” she said. “This suggests that a better systemic response is necessary, whereby policymakers closely follow and act on shortage reports to better minimize disruption to the care received by patients.”

International Collaboration Needed

Future research should focus on specific types of drugs that face shortages, as well as potential measures for improvement, the study authors wrote.

In the current study, all therapeutic classes were affected by shortages, with the highest mean daily shortages rates in the sensory organ, cardiovascular, and dermatological classes.

Hardcastle and others are now examining shortages in veterinary drugs, which often share raw ingredients with drugs for humans, as well as shortages in antimicrobial drugs, which could play a role in antimicrobial resistance.

“Although our paper focused on the domestic impact of shortages, it is also important for Canadian policymakers to collaborate on this issue internationally, given that many of our pharmaceutical products or their raw ingredients come from abroad,” Hardcastle said. “As we saw during COVID, there can be fairness issues to how scarce pharmaceutical products are allocated globally.”

Public health experts and lawmakers also need a better understanding of drug shortage data, causes, and whether new policies help.

“We need more information like this. The government should be producing annual reports on the numbers of shortages through time. There is no other way to assess the impact of changes in policy without measurement,” Jacalyn Duffin, MD, PhD, professor emerita who held the Hannah Chair in the History of Medicine at Queen’s University, Kingston, Ontario, Canada, told Medscape.

Duffin, who wasn’t involved with this study, started a website in 2012 to track drug shortages in Canada and worldwide, called CanadaDrugShortage.com. She continues to update the website, including more than a dozen possible causes for shortages related to supply, demand, pricing, quality control, raw ingredients, and worldwide crises.

“Drug shortages are a longstanding and serious problem that have made many negative impacts on both human and animal health, including disease and death,” she said. “To solve it, we need to understand the causes.”

The authors received no direct financial support for the development of the manuscript. Tadrous has received a grant from the Canadian Institutes of Health Research and consultant fees from the Canadian Agency for Drugs and Technologies in Health and Green Shield Canada. Hardcastle and Duffin reported no relevant disclosures.

CMAJ. Published online June 13, 2022. Full text.

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