Canada Less Likely to Have Meaningful Drug Shortages Due to Supply Chain Issues

The United States was found to be more affected by supply chain issues when it came to drug shortages in a new study published in JAMA.¹ With Canada less likely to be affected by drug shortages, collaboration between the 2 countries is important to mitigate the effects of shortages.

Drug-related supply chains are globalized, which can lead to global drug shortages based on the policy and regulatory authority of the country. The FDA requires drug manufacturers to report any issues that can lead to a drug shortage. Should the manufacturers report issues, the FDA can work with the manufacturers to try to prevent shortages.² Canada has similar regulations for addressing drug shortages, which makes it an appropriate comparison, especially after both countries passed new shortages policies during the pandemic. This study aimed to assess the frequency of drug-related reports of supply chain issues being related to drug shortages overall in the time periods before the pandemic (2017 to 2020) and during the pandemic (2020 to 2021).

Drug shortages due to reports of supply chain issues were less likely in Canada compared with the US | Image credit: wacomka - stock.adobe.com

A longitudinal cross-section of drugs that were used in both the US and Canada during this time period was used to conduct the population-based study. The definition of a drug shortage was taken from the FDA and Health Canada’s definitions, which was indicated as any event where the supply of the drug does not meet the demand. All issues in the supply chain should be reported to either the FDA or Health Canada, depending on location.

IQVIA’s Multinational Integrated Data Analysis (MIDAS) data were used for this study, which includes 89% of US drug purchases and 100% of Canadian drug purchases. All drugs that were purchased in either country that had at least 1 incident report of supply chain issues between January 2017 and September 2021 were eligible for this study. All drugs were reported in total standardized units. Any drug that was not captured in the MIDAS database was not included in the study.

Drugs that had supply issues in both countries were identified using data from the FDA, Health Canada, and the American Society of Health System Pharmacists (ASHP). Supply chain issues were included if they occurred in both countries within 180 days of each other. All recalls and discontinuations were not included. A drug shortage within 12 months of a report of supply chain issues related to drugs acted as the primary outcome. Drug formulation, number of manufacturers, and number of alternatives acted as covariates.

The analysis of drug shortages between 2017 and 2021 was conducted between January 2023 and March 2024. There were 96 drugs that were identified that had at least 1 report of supply chain issues across both countries, which came out to 104 reports related to drugs. A total of 24% of the reports had no reason or no specified reason in the US whereas all reports in Canada had a reason listed. These included disruption of manufacture of the drug (51%).

Most of the reports were made regarding drugs that were approved for use at least 20 years ago (US, 86%; Canada, 82%). A total of 1 in 5 reports were made up of drugs with only 1 manufacturer whereas more than 90% of the reports in both countries were made up of generic drugs.

Drug shortages were reported in the US alone in 25% of the reports, Canada only in 10% of the reports, and both countries in 20% of the reports. A total of 49.0% (95% CI, 39.3%-59.7%) of drug shortage reports were associated with drug shortages in the US compared with 34.0% (95% CI, 25.0%-45.0%) in Canada after 12 months. Reports of supply chain issues were 40% less likely to be associated with Canada compared with the US (adjusted HR, 0.53; 95% CI, 0.36-0.79). The risk of shortage was doubled in drugs that had a sole source manufacturer (adjusted HR, 2.58; 95% CI, 1.57-4.24) but only half for Canadian tier 3 medicines (adjusted HR, 0.56; 95% CI, 0.32-0.98).

Reports of supply chain issues during the pandemic were more likely to involve manufacturing, packaging, or shipping (50% after March 2020 vs 37% before) in the US. Disruptions of the manufacture of the drug (63% after March 2020 vs 46% before) were more likely to be reported in Canada. Both countries had a lower frequency of drug shortages due to supply chain issues (US, 27.5%; 95% CI, 14.8%-47.7% vs Canada, 29.1%; 95% CI, 14.7%-52.3%). Canada had a lower risk of drug shortages compared with the US both before (adjusted HR, 0.47; 95% CI, 0.30-0.75) and after (adjusted HR, 0.31; 95% CI, 0.15-0.66) the pandemic.

There were some limitations to this study. The full implementation of policies related to the pandemic could not be assessed in this study due to the data ending at 2021. Over-the-counter drugs were not included in the MIDAS database, which could underestimate the drug shortages overall. It is unknown if the thresholds for making reports of supply chain issues public were different between the US and Canada.

The researchers concluded that Canada was 40% less likely to have reports of supply chain issues that resulted in meaningful drug shortages, which highlights the need for cooperation between the 2 countries to reduce the effects of supply chain issues on drug shortages.

References

1. Tadrous M, Kim KC, 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
2. Drug shortages. FDA. Updated October 3, 2024. Accessed October 31, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages