Drug supply chain issues more likely to result in shortages in US than Canada

The analysis looked at drugs that had reports of supply-chain disruptions between 2017 and 2021 in both countries and found that within 12 months of an initial U.S. report, nearly half resulted in drug shortages in the U.S. versus about one-third in Canada. There was also a consistently lower risk of shortage in Canada at each month after the reports.

"Drug shortages cause real disruptions in patients' lives, often resulting in interrupted or delayed treatment," said senior author Dr. Katie J. Suda, Pharm.D., M.S., professor in the Pitt School of Medicine and associate director of the Center for Pharmaceutical Policy and Prescribing. "We can learn from other countries that are having success in mitigating the effects of drug shortages on patients."

The researchers used supply chain-issue reports drawn from the U.S. Food and Drug Administration, the American Society of Health-System Pharmacists and Health Canada. They then compared these reports to actual drug usage in both countries, defining a drug shortage as a decrease in monthly purchased units of at least 33% relative to average units in the six months before the report.

Most reports of supply-chain issues were due to manufacturing or shipping problems. However, one-quarter of the U.S. reports did not specify a reason. Generic drugs accounted for 95% of reports in both countries, and sole-sourced drugs made up one in five. However, the route of administration, time since approval by the Food and Drug Administration (FDA) and drug price per unitdid not predict drug shortages.

"The pharmaceutical supply chain is global, and every single person who touches a drug is essential, from manufacturers to port workers to pharmacists," said lead author Mina Tadrous, Pharm.D., PhD, assistant professor at the University of Toronto's Leslie Dan Faculty of Pharmacy. "Shocks to the supply chain will happen, and it's important to cooperate internationally to develop strategies for minimizing disruptions for patients."

While the paper did not explore the reasons behind the differences in drug shortages in the two countries, the authors note that Canada has more cooperation between regulatory agencies, health-systems, public payers and other important players like manufacturers and wholesalers. Canada also uses its pharmaceutical stockpile mechanisms to address drug shortages, whereas the U.S. stockpile is for acute events, such as terrorism or mass casualty. The authors also said policymakers should consider incentivizing manufacture of lower profit margin generic drugs.

Additional authors are 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 of Pitt; Inmaculada Hernandez, Pharm.D., Ph.D., of the University of California San Diego; and Joshua W. Devine, Pharm.D., Ph.D., of Des Moines University.

This research was supported by the Agency for Healthcare Research and Quality (R01 HS027985). Dr. Hernandez has received consulting fees from Bristol Myers Squibb and Pfizer, outside of the reported work. Dr. Tadrous has received consulting fees from Health Canada and Canada's Drug Agency (CDA).