31 Oct UPitt Study Compares Supply Chains and Drug Shortages Between US and Canada
MedicalResearch.com Interview with:
Dr. Suda
Katie J. Suda, PharmD, M.S., FCCP
Professor of medicine with tenure
Associate Director, Center for Pharmaceutical Policy and Prescribing
University of Pittsburgh School of Medicine
MedicalResearch.com: What is the background for this study?
Response: Our pharmaceutical supply chain is global where the manufacturing process for one drug may occur in multiple countries. Sometimes there are breakdowns in the pharmaceutical supply chain which may threaten access to medicines. Breakdowns in the supply chain occur for medicines manufactured in the U.S. and by international partners. While breakdowns in the supply chain occur for hundreds of drugs each year, not all result in a decrease in available supply (a “drug shortage”) because of action taken by manufacturers, pharmacies and drug regulators (e.g., the U.S. Food and Drug Administration [FDA]).
Drug shortages are a critical concern to public health as pharmacies, clinicians, and patients struggle to identify safe and effective alternatives. In addition, drug shortages have been associated with adverse patient outcomes and medication safety events. Recently, drug shortages have gotten worse with shortages occurring with increasing frequency and lasting longer. There has also been a shift in the types of medicines in shortage from drugs primarily used in hospitals, such as injectables, to oral medicines frequently used to manage outpatient conditions.
Countries have different regulatory authority and policy which may impact how drug supply chain breakdowns result in drug shortages. We wanted to know if there are differences between the U.S. and Canada in the frequency that national drug shortages occur after supply chain breakdowns are reported in both countries. Canada is a good comparator to the U.S. because Canada has similar drug regulatory standards and manufacturing inspections. Prescription drug coverage is also similar for the two countries where half of prescriptions are reimbursed through public insurance and half through private insurance and out-of-pocket.
MedicalResearch.com: What are the main findings?
Response: From 2017-2021, 104 supply chain breakdowns were common between the U.S. and Canada. After linking reports of supply chain breakdowns from the American Society of Health-Systems Pharmacists (ASHP), FDA, and Health Canada to drug purchase data to determine national decreases in supply, 49% of reports of supply chain breakdowns were associated with drug shortages in the US versus 34% of reports of supply chain breakdowns in Canada were associated with shortages. Reports of supply chain breakdowns were 47% less likely to be associated with drug shortages in Canada compared with the U.S.
When we combined reports of supply chain breakdowns from both the U.S. and Canada, medicines with a sole-source manufacturer were more than twice as likely to go into shortage. Canadian Tier 3 medicines, which are drugs with the greatest impact on Canada’s health care system, were almost half as likely to go into shortage. Another important finding is that some previously reported characteristics associated with supply chain breakdowns were not associated with shortages: formulation, time since drug approval, and drug price per unit.
MedicalResearch.com: What should readers take away from your report?
Response: We can learn from other countries’ health policy to improve access to supply of medicines for our communities. We also need to work collaboratively with other countries to improve our drug supply chain for medicines made domestically and by international partners. It is important to note that even medicines made in the U.S. are not immune from shortages; a single natural disaster (Hurricane Helene) closed the manufacturer of 60% of IV fluids in the U.S.!
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: There is still a lot we don’t know. Because our research focused on the U.S. and Canda, we don’t know how other countries compare. We also don’t know if results are different for specific therapeutic categories (e.g., oncology agents) or specific patient groups.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: There are important limitations to consider in the results. The data ended in 2021 so we could not fully assess the impact of policies implemented during COVID-19 in both countries. Canada had many more reports than the U.S. due to differences in regulations. Lastly, this analysis studied national shortages and not shortages that may impact specific health-systems. Local shortages are important as well, but we were not able to detect local shortages with the dataset used in this study.
Disclosures: Dr. Tadrous has received support from Health Canada. Dr. Hernandez has received personal fees from Pfizer and Bristol Myers Squibb.
Funding: The study was funded through a research grant awarded to Dr. Suda by the U.S. Agency for Healthcare Research and Quality (AHRQ), a federal agency within the Department of Health and Human Services.
Citation: Tadrous M, Callaway Kim K, Hernandez I, et al. Differences in Drug Shortages in the US and Canada. JAMA. Published online October 31, 2024. doi:10.1001/jama.2024.17688
https://jamanetwork.com/journals/jama/article-abstract/2825535
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Last Updated on October 31, 2024 by Marie Benz MD FAAD