Researchers compared the issue of drug shortages and supply chain challenges between the US and Canada.
From 2017 to 2021, supply chain issues regarding drug shortages were 40% more likely to occur in the US compared with Canada. With similar procedures and standards set in place for both countries, but different results regarding supply chain issues, researchers suggest that countries work together to address drug shortage complications going forward.
“There are persistent global drug shortages, in part because drug-related supply chains are increasingly globalized; these drug shortages are associated with delayed or missed treatment and adverse outcomes. In addition, pandemics and natural disasters disrupt global drug production, further affecting supply chains. However, countries differ in policy and regulatory authority, which may affect whether supply chain issues develop into drug shortages,” wrote authors of the study published in JAMA.1
In the US, the FDA is the main regulator of drug supply chain issues or shortages, while in Canada, drugs are regulated through Canada’s regulatory agency Health Canada. The FDA works with manufacturers to address product quality, monitor applications to restore production, extend expiration dates, and relax import regulations. Similarly, Health Canada is even more proactive about its regulatory approach, according to the authors.
While Canada and the US align on much of the regulatory actions necessary within the drug supply chain, they’ve both identified unprecedented occurrences that can negatively impact the way these agencies are able to regulate. One of those instances, and a key event determining each country’s handling of drug shortages in this study, was the COVID-19 pandemic.
This population-based study focused on reports of drug-related supply chain issues in both the US and Canada from 2017 to 2021. | image credit: M. Schuppich / stock.adobe.com
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“Both the US and Canada passed new shortage policies during the COVID-19 pandemic that have not yet been assessed or compared. For example, the Coronavirus Aid, Relief, and Economic Security Act enhanced the authority of the FDA to prioritize applications and inspections for drugs during shortages, and requires greater transparency of the supply chains and the sources of the ingredients. The pandemic-related shortage policies implemented in Canada include competitive government bidding, improved importation regulations, and supply chain expansion,” they continued.1
This population-based study focused on reports of drug-related supply chain issues in both the US and Canada from 2017 to 2021. A shortage was defined as “a decrease of ≥33% in monthly purchased standardized drug units.” Specifically, a “drug-related supply chain issue” was included in the study if a drug shortage was reported within 12 months following a supply chain issue. Researchers also compared both countries’ reports of drug shortages for before and after the COVID-19 pandemic to understand its overall impact on the supply chain.
“In this study comparing the US and Canada, 1 in 12 drugs (8%) purchased in both countries experienced at least 1 report of supply chain issues from 2017 to 2021. Reports were approximately 40% less likely to be associated with drug shortages in Canada within 12 months vs in the US both before and during COVID-19,” wrote the authors.
Based on 104 drug-related reports of supply chain issues, 49% were due to US drug shortages and only 34% were associated with shortages in Canada. Researchers say the difference between drug shortages in the US and Canada may be owed to better cooperation between Canadian regulators and public payers.
“This cooperation builds on regulatory frameworks similar to those in the US but allows for some additional unique features such as coordinated discussions with wholesalers, the ability to limit prescriptions to a 30-day supply, coordinated drug pricing for public payers, expedited review of drugs in shortage, and expansion of the supply chain by allowing private labels,” they wrote.1
Canada’s ability to curb issues within the supply chain has been shown throughout the past few years. From 2022 to 2023, just 0.4% of all marketed drugs were considered to be at a shortage with the highest potential for patient impact. A total of 34 drugs were at a shortage with the highest potential for patient impact, but 23 of those shortages were resolved.2
In the US, however, drug shortages have reached an all-time high. According to American Society of Health-System Pharmacists data, drug shortages in the US have been on a steady increase since 2021, peaking at 323 shortages in 2023. They have since gone down to 277 drug shortages, but US statistics continue to dwarf that of Canada’s drug shortages.3
“Drug-related reports of supply chain issues were 40% less likely to result in meaningful drug shortages in Canada compared with the US. 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,” concluded authors of the study.1
READ MORE: Pharmacist Strategies for Mitigating Patient Harm, Inequities During Drug Shortages
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