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Navigating Drug Supply Challenges: Why the US Faces Greater Shortage Risks than Canada

Reports indicating issues in the drug supply chain were found to be 40% less likely to lead to drug shortages in Canada compared to the United States, according to a recent study.

A recent study conducted by researchers at the University of Pittsburgh and published today in JAMA revealed that reports of supply chain disruptions in the drug industry were 40% less likely to result in drug shortages in Canada than in the U.S.

The study analyzed drug disruption reports from 2017 to 2021 in both Canada and the U.S. It was found that within a year after an initial report in the U.S., nearly 50% of cases led to drug shortages, in contrast to about one-third of cases in Canada. Moreover, Canada consistently demonstrated a lower risk of experiencing shortages in the subsequent months following the reports.

“Drug shortages have a significant impact on patients, often causing interruptions or delays in their treatment,” said senior author Dr. Katie J. Suda, Pharm.D., M.S., a professor at the Pitt School of Medicine and associate director at the Center for Pharmaceutical Policy and Prescribing. “We can gain insights from other nations effectively reducing the impact of drug shortages on patients.”

The research utilized supply chain issue reports from the U.S. Food and Drug Administration, the American Society of Health-System Pharmacists, and Health Canada. The team then examined these reports alongside actual drug usage trends, defining a drug shortage as a reduction in monthly purchased units by at least 33% compared to the average in the six months prior to the report.

The majority of supply-chain issue reports stemmed from manufacturing or shipping problems, with one-quarter of U.S. reports lacking a specific cause. Reports concerning generic drugs constituted 95% of cases in both nations, while sole-sourced drugs represented one in five cases. Notably, factors such as administration method, time since U.S. Food and Drug Administration (FDA) approval, and drug pricing per unit did not seem to predict shortages.

Lead author Mina Tadrous, Pharm.D., PhD, an assistant professor at the University of Toronto’s Leslie Dan Faculty of Pharmacy, stated, “The pharmaceutical supply chain is global, and every individual involved in the process—from manufacturers to port workers to pharmacists—is vital. Supply chain disruptions are likely to occur, making it essential to collaborate internationally to formulate strategies that minimize the impact on patients.”

While the research did not delve into the reasons for the varying drug shortage rates in Canada and the U.S., the authors suggested that Canada’s stronger cooperation among regulatory bodies, health systems, public payers, and key stakeholders such as manufacturers and wholesalers plays a role. Moreover, Canada employs its pharmaceutical stockpile to handle shortages, unlike the U.S., which reserves its stockpile for emergencies like terrorism or mass casualty events. The authors also proposed that policymakers might encourage the production of lower-profit-margin generic drugs.

The study involved additional contributions from Katherine Callaway Kim, M.P.H., Scott D. Rothenberger, Ph.D., Tina B. Hershey, J.D., M.P.H., Lisa M. Maillart, Ph.D., and Walid F. Gellad, M.D., M.P.H., all affiliated with Pitt; Inmaculada Hernandez, Pharm.D., Ph.D., from the University of California San Diego; and Joshua W. Devine, Pharm.D., Ph.D., from Des Moines University.

This research was funded by the Agency for Healthcare Research and Quality (R01 HS027985). Dr. Hernandez has disclosed receiving consulting fees from Bristol Myers Squibb and Pfizer, unrelated to this study. Dr. Tadrous has also received consulting fees from Health Canada and the Canada Drug Agency (CDA).