Drug shortages more common in the US than Canada, study finds

Meaningful drug shortages were less common in Canada than in the US between 2017 and 2021, despite the countries having similar regulatory processes, according to recent research published in JAMA.

“Drug-related reports of supply chain issues were 40% less likely to result in meaningful drug shortages in Canada compared with the US,” Mina Tadrous, of the University of Toronto, and colleagues wrote in their study. “These findings highlight the need for international cooperation between countries to curb the effects of drug shortages and improve resiliency of the supply chain for drugs.”

Tadrous and colleagues performed a longitudinal cross-sectional study of 104 reports of drugs with supply chain issues between 2017 and 2021 that occurred within 6 months of each other in the US and Canada. A drug shortage was defined as a 33% decrease in purchased standardized drug units in a given month within 12 months of a report compared to purchased units within the previous 6 months. They evaluated the rate of shortages by country using the IQVIA Multinational Integrated Data Analysis database as well as the timing of the report relative to the COVID-19 pandemic, supply chain characteristics surrounding the report, drug manufacturing source, therapeutic alternatives, price per unit, and time since drug approval.

Overall, there were 21 reports (20%) of supply chain issues associated with drug shortages in both the US and Canada, 26 reports (25%) of supply chain issues in the US only, and 10 reports (10%) of supply chain issues in Canada only. A majority of reports in both countries concerned drugs approved at least 20 years ago (86% vs. 82%), with generic drugs representing over 90% of reports in both the US and Canada, while drugs with a single source manufacturer consisted of 20% of reports in the US and 28% of reports in Canada.

The researchers found 49.0% of drug-related reports of supply chain issues in the US (95% CI, 39.9-59.7%) were linked to drug shortages within 12 months of the report compared with 34.0% of reports (95% CI, 25.0-45.0%) in Canada (adjusted hazard ratio [HR], 0.53; 95% CI, 0.36-0.79). Compared with the US, Canada had a lower risk of drug shortages both prior to the COVID-19 pandemic (adjusted HR, 0.47; 95% CI, 0.30-0.75) and during the first 2 years of the pandemic (adjusted HR, 0.31; 95% CI, 0.15-0.66). Researchers also noted that drugs with a single manufacturing source were at double the risk for shortage when reports of supply chain issues from both the US and Canada were combined (adjusted HR, 2.58; 95% CI, 1.57-4.24), while the risk was lower for Canadian tier 3 medicines (adjusted HR, 0.56; 95% CI, 0.32-0.98).

Tadrous and colleagues highlighted several reasons why the Canadian system may be better able to mitigate potential drug shortages, such as its ability to coordinate with wholesalers, expedite review for drugs in short supply, allowing private labels to expand the supply chain, limit prescriptions to a 30-day supply, and coordinate drug pricing for public payers.

“During drug shortages in Canada, existing relationships enable established committees and task forces to cooperatively prioritize drugs for mitigation efforts,” they explained. “Although the US has some similar policies in place to address drug shortages, the policies may not be leveraged as effectively due to the lack of close cooperation between regulators and other health system partners that exists in Canada.”

The researchers noted that international cooperation is needed to identify policy strategies for the prevention of drug shortages. “Domestic production of drugs has been proposed as a solution to shortages, but the production of all medications domestically is cost prohibitive and may limit access,” they said. “Importation of drugs on shortage may also decrease access and exacerbate international disparities in drug supply. Thus, coordinated or aligned strategies may prove to be beneficial to the global drug supply chain.”

In a related editorial, K. Jane Muir, of the University of Pennsylvania; Joseph Ross, of the Yale School of Medicine, said the findings by Tadrous and colleagues “have important implications for clinical care.” About half of people living in the US use one or more prescription medication, they explained, and 91% of prescription medications are generics. During drug shortages, clinicians will prescribe alternative medications, if necessary, but they can be unfamiliar or cost more to patients, they said. In addition, they noted there are medical ethics and health equity concerns associated with drug rationing during shortages.

“Although the US and Canada share similar federal regulatory processes for reporting supply chain issues, the findings by Tadrous and colleagues suggest that greater standardization of US reporting systems are needed to prevent future drug shortages, such as consistency in listing specific reasons for supply chain issues. Moreover, international cooperation and coordinated policy response may also prevent drug shortages, mitigating their effect on the care and health of patients,” Muir and Ross concluded.

JAMA Tadrous et al.

JAMA Muir et al.

Drug shortages more common in the US than Canada, study finds

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