Drug supply chain issues more likely to result in shortages in US than Canada
University of Pittsburgh
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Katie J. Suda, Pharm.D., M.S., professor in the University of Pittsburgh School of Medicine and associate director of the Center for Pharmaceutical Policy and Prescribing
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Reports of drug-related supply-chain issues were 40% less likely to result in drug shortages in Canada versus the United States, according to a new study from University of Pittsburgh researchers and published today in JAMA.
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 unit did 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).
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About the University of Pittsburgh Schools of the Health Sciences
The University of Pittsburgh Schools of the Health Sciences include the schools of Medicine, Nursing, Dental Medicine, Pharmacy, Health and Rehabilitation Sciences, and Public Health. The schools serve as the academic partner to UPMC. Together, their combined mission is to train tomorrow’s health care specialists and biomedical scientists, engage in groundbreaking research that will advance understanding of the causes and treatments of disease, and participate in the delivery of outstanding patient care. Pitt has ranked among the top recipients of funding from the National Institutes of Health since 1998. For additional information about Pitt Health Sciences, please visit www.health.pitt.edu.
About the Leslie Dan Faculty of Pharmacy, University of Toronto
The Leslie Dan Faculty of Pharmacy at the University of Toronto is Canada's top-ranked faculty of pharmacy, offering cutting-edge undergraduate and graduate programs. We are globally recognized for impactful pharmaceutical sciences research and fostering expert and innovative clinical practice. Our scientific research focuses on the role of pharmacists in the health care system, and the full scope of drug discovery and delivery. We advance education programs that develop leaders in science and clinical practice and work to strengthen the link between research, education, and patient care. For more information visit pharmacy.utoronto.ca
Differences in Drug Shortages in the US and Canada
JAMA Network
About The Study: Drug-related reports of supply chain issues were 40% less likely to result in meaningful drug shortages in Canada compared with the U.S. These findings highlight the need for international cooperation between countries to curb the effects of drug shortages and improve resiliency of the supply chain for drugs.
Quote from corresponding author Katie J. Suda, PharmD, MS:
“Our U.S. drug supply chain is linked globally – shortages in one country can happen in another country – presenting an opportunity to compare and contrast how different countries are affected. When we compared the U.S. to Canada for drugs with the same supply chain issues, Canada was 40% less likely to experience national drug shortages than the U.S.
“The U.S. can learn from other countries’ pharmaceutical policy to mitigate the impact of shortages on access to essential medications. We also need to cooperate locally and globally to strengthen our pharmaceutical supply chain and regionally to recognize the interconnectedness of supply chains essential for North American health security.”
Contact information for Katie J. Suda, PharmD, MS: email Liz Reid at reide4@upmc.edu.
To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/
(doi:10.1001/jama.2024.17688)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.
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