Canada's proactive policies are far more effective at reducing drug shortages than those of the United States

Through active monitoring and collaboration with stakeholders, Canada has managed to mitigate drug shortages more effectively than in the United States, highlighting the benefits of proactive health policies.

Study: Differences in drug shortages in the United States and Canada. Image source: Shutterstock AI / Shutterstock.com

A recent study published in the Journal of the 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 United States

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

The U.S. Food and Drug Administration (FDA) Safety and Innovation Act requires reporting but does not provide penalties for noncompliance. In comparison, Health Canada takes a more proactive approach, as this federal department actively monitors drug supplies and works with stakeholders to prevent shortages.

During the coronavirus disease 2019 (COVID-19) pandemic, both the United States and Canada tightened policies to improve supply chain transparency and accelerate drug production. The U.S. Coronavirus Aid, Relief, and Economic Security (CARES) Act expanded FDA's authority for priority applications and inspections, while Canada introduced competitive bidding, expanded imports, and improved public reporting.

Canada's system compares well with the approach the United States uses to evaluate measures to reduce drug shortages. Therefore, in the current study, researchers compared how often drug-related supply chain issues led to shortages in the United States and Canada, both overall and during the COVID-19 pandemic.

About the study

For the current study, data on commonly purchased medications between 2017 and 2021 were obtained from the IQVIA Multinational Integrated Data Analysis (MIDAS) database. Drugs with reported supply chain issues in both the United States and Canada were identified using data from the FDA, the American Society of Health System Pharmacists (ASHP), and Health Canada.

Both the United States and Canada require reporting of potential supply problems. However, these nations differ in their approach. For example, the FDA receives manufacturer reports with some regulatory flexibility to prevent shortages, while Health Canada collects public reports directly and takes proactive action.

Medicines for which supply problems were reported within 180 days in both countries were included in the analysis. Of the 5,876 drugs purchased, 1,198 met the inclusion criteria, resulting in a final sample of 104 reports after filtering for concurrent supply chain issues in the United States and Canada.

The primary outcome was drug shortages, defined as a decrease in supply of 33% or more within 12 months of a reported problem. Certain characteristics such as source of manufacturing, 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 find out whether political differences affect the likelihood of shortages following reported supply problems.

Statistical analysis included the use of Kaplan-Meier curves, an unadjusted cumulative incidence estimate, Cox proportional hazards models, interaction terms for periods before and after COVID-19, and sensitivity analyzes with different definitions of drug shortages and duration.

Study results

In Canada, there were 10,772 reports of supply chain issues, 100% of which were substantiated. In comparison, there were 1,018 reports in the US, 24% of which did not contain specific reasons. About 49% of U.S. reports of supply chain issues were related to drug shortages, compared to 34% in Canada.

Reports in Canada were about 40% less likely to cause shortages than in the United States. This trend remained consistent before and after the COVID-19 pandemic, with the risk of shortages being lower in Canada with hazard ratios (HRs) of 0.47 and 0.31, respectively.

Reports published after March 2020 suggested shifts in the types of issues reported, particularly in the United States, where manufacturing and shipping issues increased. The frequency of medication shortages was also lower in both countries after March 2020.

Sensitivity analyzes found that alternative definitions for drug shortages based on different time frames supported the primary results, thereby confirming the lower risk in Canada. Drug recalls and discontinuations had less impact on shortages than standard reports in the United States, while no differences were observed in Canada.

Conclusions

The study results highlight the differences between Canada and the United States in the likelihood of supply chain issues potentially leading to drug shortages, underscoring the effectiveness of Canada's proactive regulatory approach in addressing these crises. These observations highlight the importance of international collaboration to address medicines shortages and improve supply chain resilience, particularly in the context of ongoing public health challenges.

Importantly, the current study is limited by analysis of data through 2021, incomplete coverage of OTC medications, possible underestimation of patient impact, possible unaccounted for demand-related shortages, and differences in reporting thresholds between Canada and the United States.