Canada is less likely to experience significant drug shortages due to supply chain issues

A new study published in found that the United States is more affected by supply chain problems when it comes to drug shortages JAMA.¹ Because Canada is less likely to experience drug shortages, collaboration between the two countries is important to mitigate the impact of shortages.

Drug-related supply chains are globalized, which can lead to global drug shortages depending on the country's policies and regulators. The FDA requires drug manufacturers to report any problems that could lead to a drug shortage. If manufacturers report problems, the FDA can work with manufacturers to prevent shortages.² Canada has similar regulations to address drug shortages, making it a reasonable comparison, especially after both countries adopted new measures to address shortages during the pandemic. The aim of this study was to assess the frequency of drug-related reports of supply chain issues related to drug shortages overall in the pre-pandemic (2017 to 2020) and during the pandemic (2020 to 2021) periods.

To conduct the population-based study, a longitudinal sample of medications used in both the United States and Canada during this period was used. The definition of a drug shortage was taken from the FDA and Health Canada definitions. This was understood to mean any event in which the supply of medication does not match demand. Any supply chain issues should be reported to either the FDA or Health Canada, depending on the location.

This study used IQVIA's Multinational Integrated Data Analysis (MIDAS) data, which includes 89% of drug purchases in the United States and 100% of drug purchases in Canada. All medicines purchased in either country and with at least one incident of supply chain problems between January 2017 and September 2021 were eligible for this study. All medications were reported in standardized total units. Medications that were not recorded in the MIDAS database were not included in the study.

Drugs with 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 within 180 days of each other in both countries. All recalls and discontinuations were not taken into account. The primary outcome was drug shortages within 12 months of reporting drug supply chain issues. Drug formulation, number of manufacturers, and number of alternatives served as covariates.

The analysis of drug shortages between 2017 and 2021 was conducted between January 2023 and March 2024. 96 medicines were identified that had at least one report of supply chain issues in both countries, resulting in a total of 104 medicine-related reports. A total of 24% of reports in the United States had no reason or no specific reason, while all reports in Canada had a reason listed. This included a disruption in the manufacturing of the drug (51%).

Most reports involved medications approved for use at least 20 years ago (USA, 86%; Canada, 82%). Overall, one in five reports involved medicines from only one manufacturer, whereas in both countries more than 90% of reports concerned generics.

Drug shortages were reported in 25% of reports in the United States alone, only 10% of reports in Canada, and 20% of reports in both countries. At 12 months, a total of 49.0% (95% CI, 39.3%-59.7%) of drug shortage reports were associated with drug shortages in the United States, compared to 34.0% (95% CI, 25. 0%-45.0%) in Canada. Reports of supply chain issues were 40% less likely to be associated with Canada than in the US (adjusted HR 0.53; 95% CI 0.36-0.79). The risk of a shortage doubled for drugs that had a single manufacturer (adjusted HR, 2.58; 95% CI, 1.57-4.24), but only half for Canadian Tier 3 drugs (adjusted HR , 0.56; 95% CI, 0.32–0.98). .

Reports of supply chain issues during the pandemic were more likely to affect manufacturing, packaging or shipping (50% after March 2020 vs. 37% before) in the US. Disruptions in drug manufacturing (63% after March 2020 versus 46% before) were reported more frequently in Canada. Both countries were less likely to experience drug shortages due to supply chain issues (U.S., 27.5%; 95% CI, 14.8%-47.7% vs. Canada, 29.1%; 95% CI, 14.7% –52.3%). Compared to the United States, Canada had both before (adjusted HR 0.47; 95% CI 0.30-0.75) and after the pandemic (adjusted HR 0.31; 95% CI 0.15-0) 66) a lower risk of drug shortages.

This study has some limitations. The full implementation of the measures related to the pandemic could not be assessed in this study as the data extended up to 2021. Over-the-counter medicines were not included in the MIDAS database, which may underestimate overall medicine shortages. It is unknown whether the thresholds for publishing reports of supply chain issues were different in the United States and Canada.

The researchers concluded that Canada is 40% less likely to report supply chain issues that lead to significant drug shortages. This highlights the need for collaboration between the two countries to reduce the impact of supply chain issues on drug shortages.

References

1. Tadrous M, Kim KC, Hernandez I, et al. Differences in drug shortages in the United States 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.