By actively monitoring and collaborating with stakeholders, Canada has managed to mitigate drug shortages more effectively than the U.S., underscoring the benefits of proactive health policy.

Study: Differences in Drug Shortages in the US and Canada. Image Credit: Shutterstock AI / Shutterstock.com

A recent study published in the Journal of American Medical Association reported that drug-related supply chain issues in Canada were 40% less likely to result in significant drug shortages between 2017 and 2021 than in the United States.

Monitoring drug shortages in Canada and the U.S.

Global drug shortages, which are exacerbated by increasingly globalized supply chains, pandemics, and natural disasters, can lead to delayed treatments and adverse outcomes. Both the U.S. and Canada have policies requiring manufacturers to report potential supply chain issues.

The U.S. Food and Drug Administration (FDA) Safety and Innovation Act mandates reporting but lacks penalties for non-compliance. Comparatively, Health Canada has a more proactive approach, as this federal department actively monitors drug supplies and collaborates with stakeholders to prevent shortages.

During the coronavirus disease 2019 (COVID-19) pandemic, both the U.S. and Canada strengthened policies to enhance supply chain transparency and expedite drug production. The U.S. Coronavirus Aid, Relief, and Economic Security (CARES) Act increased FDA authority for priority applications and inspections, whereas Canada implemented competitive bidding, expanded imports, and improved public reporting.

Canada’s system effectively compares to the approach used by the U.S. to evaluate policies aimed at reducing drug shortages. Therefore, the researchers in the current study compared how often drug-related supply chain issues in the U.S. and Canada led to shortages, both overall and during the COVID-19 pandemic.

About the study

The current study obtained data on commonly purchased drugs between 2017 and 2021 from the IQVIA Multinational Integrated Data Analysis (MIDAS) database. Drugs with reported supply chain issues in both the U.S. and Canada were identified through data from the FDA, the American Society of Health-System Pharmacists (ASHP), and Health Canada.
Both the U.S. and Canada mandate the reporting of potential supply issues; however, these nations differ in approach. For example, the FDA receives manufacturer reports with some regulatory flexibility to prevent shortages, whereas Health Canada directly collects public reports and takes proactive measures.

Drugs with reported supply issues in both countries within 180 days were included in the analysis. Of the 5,876 purchased drugs, 1,198 met inclusion criteria, which led to a final sample of 104 reports after filtering for concurrent supply chain issues in both the U.S. and Canada.

The primary outcome was drug shortages, defined as a 33% or greater supply decrease within 12 months of a reported issue. Certain characteristics, such as manufacturing source, pricing, availability of alternatives, essential medicine status by the World Health Organization (WHO), and Canadian tier-3 classification, were considered in this analysis. The researchers aimed to determine whether policy differences impact the likelihood of shortages following reported supply issues.

Statistical analysis involved using Kaplan-Meier curves, unadjusted cumulative incidence estimation, Cox proportional hazards models, interaction terms for pre- and post-COVID-19 periods, and sensitivity analyses with different definitions of drug shortages and durations.

Study findings

Canada had 10,772 reports of supply chain issues, 100% of which provided reasons. Comparatively, the U.S. had 1,018 reports, 24% of which lacked specific reasons. About 49% of U.S. reports of supply chain issues were associated with drug shortages, compared to 34% of those in Canada.

Reports in Canada were about 40% less likely to lead to shortages than those in the U.S. This trend remained consistent before and after the COVID-19 pandemic, with lower risks of shortages in Canada with hazard ratios (HRs) of 0.47 and 0.31, respectively.

Reports issued after March 2020 indicated shifts in the types of issues reported, particularly in the U.S., where manufacturing and shipping issues increased. The frequency of drug shortages was also lower after March 2020 in both countries.

Sensitivity analyses revealed that alternative definitions for drug shortages based on different timeframes supported the primary findings, thus confirming the lower risk in Canada. Drug recalls and discontinuations in the U.S. were less likely to impact shortages than standard reports, while no differences were observed in Canada.

Conclusions

The study findings highlight disparities between Canada and the U.S. regarding the likelihood of supply chain issues potentially leading to drug shortages, thus emphasizing the effectiveness of Canada’s proactive regulatory approach in managing these crises. These observations underscore the importance of international cooperation to address drug shortages and improve supply chain resilience, particularly in the context of ongoing public health challenges.

Importantly, the current study is limited by the analysis of data until 2021, incomplete capture of over-the-counter drugs, potential underestimation of patient impact, possible unaccounted demand-driven shortages, and differences in reporting thresholds between Canada and the US.