Shortages of Antiseizure Meds Continue, More Common Among Generics: Australian Report

Approximately 1 in 5 patients taking antiseizure medications has been affected by medication shortages in Australia, found a new report, highlighting the commonality of shortages in the country and their impact on patients.

Between 2019 and 2020, there were 97 reported shortages among sponsor-reported antiseizure medications, 93% of which were generic brands. These shortages affected over 240,000 of the 1.2 million (19.5%) patients receiving at least one of these medications. Medications were considered to be in shortage if they were not likely to meet the demand over a 6-month period.

Findings published recently in Epilepsy and Behavior

The researchers noted that the findings of their study, based on data from the Medicine Shortages Reports Database, are in line with those reported around the globe, including in the United States.

“In the United States, the increasing rate of medication shortages has been attributed to the high market concentration of manufacturers, manufacturers having limited capacity for spare production, and ’just in time’ inventory practices, meaning that small changes in supply or demand can result in shortages,” explained the researchers. “An FDA report on US drug shortages identified economic forces, including the limited profitability of producing older generic drugs, as well as increasing complexity of supply and logistics, and regulatory hurdles making global supply chains more vulnerable as root causes for medication shortages.”

Drugs that had the greatest number of shortages included levetiracetam, pregabalin, gabapentin, and topiramate. These shortages resulted in over 230,000 brand or formulation switches. For comparison, 67.6% of patients on levetiracetam switched to a different brand or formulation during shortages compared with 46.6% during nonshortage periods. An exploratory univariate analysis showed a statistically significant, albeit small, increase in mean adherence after a patient switched the brand or formulation of levetiracetam. The researchers cautioned that it’s unlikely this small change is indicative of clinically meaningful adherence changes

The median time of shortage for the medications overall was 109 days. Notably, shortages were more common before the COVID-19 pandemic than after it started, suggesting that shortages are likely to occur even outside of major global events that have an impact on supply chains. Approximately two-thirds of the shortages occurred during the pre–COVID-19 period, with a median shortage length of 129 days. Shortages during COVID-19 lasted a median of 101 days.

“In light of the disruption seen in global supply chains during the COVID-19 pandemic, it is important for policymakers to prioritize further understanding of the vulnerabilities of pharmaceutical supply chains and develop strategies to improve supply chain resilience,” detailed the researchers. “Solutions may include developing redundancy in manufacturing and supply, holding additional stock or production capacity, holding ‘buffer’ stock, or increasing domestic manufacturing capacity.”

The group also highlighted recommendations from the FDA for increasing understanding of these shortages and their consequences, incentivizing manufacturers to improve quality management systems, and fostering sustainable contracting practices.

Reference

Welton J, Stratton G, Schoeninger B, Low M, Moody A, D’Souza W. Shortages of antiseizure medications in Australia and the association with patient switching, and adherence in a community setting. Epilepsy Behav. Published online March 11, 2023. doi:10.1016/j.yebeh.2023.109145