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An ongoing shortage of liquid albuterol, a medicine commonly used for breathing problems like asthma, is expected to get worse as there is only one domestic supplier left.
Akorn, an Illinois-based specialty drug company, filed for bankruptcy on Feb. 23 after years of trying to work through regulatory and financial troubles. It also closed down all its factories in the United States, including the Illinois plant that produces liquid albuterol used in nebulizers, a machine that turns liquid medicine into a fine mist that reaches the lungs faster.
The closure made Nephron Pharmaceuticals, a drug maker in South Carolina, the last remaining U.S.-based supplier of albuterol inhalation solution. As on March 1, Nephron is still having a backorder of the drug “due to a manufacturing issue,” according to the American Society of Health-System Pharmacists’ drug shortage website.
“This will likely exacerbate some existing shortages and could leave some single-source products completely unavailable,” Dr. Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, wrote on Twitter.
Akorn had stopped making liquid albuterol several months before eventually ceasing all U.S. operations, but its shutdown may prolong the nation’s albuterol shortage, according group purchasing company Premier, The Washington Post reported.
Dr. Angela Folger, director of pharmacy for Nemours Children’s Hospital in Orlando, Florida, described the ongoing albuterol shortage as “the worst it’s ever been in [her] almost 20-year career.” She told the Post that the lack of Akorn’s 20-mL product is forcing her staff to extract 40 0.5-mL containers to make one batch. The process is tedious, but it is the only way the hospital can work around the problem and meet the patients’ needs.
Albuterol has been on the U.S. Food and Drug Administration (FDA) drug shortage list since October 2022. According to the FDA, less profitable generic drugs are generally more vulnerable to shortages because manufacturers lack the economic incentive to produce them, improve their quality, or detect early signs of supply chain issues. The logistical and regulatory complexities also make it harder for manufacturers to restore supply after a disruption.
The FDA said in a statement that it is reviewing the impact Akorn’s closure has on the nationwide supply of albuterol, as well as other drugs the company was producing.
While the FDA can’t require other firms to increase production, it can accelerate the typically months-long review and approval process in case a new supplier wants to acquire the technology from Akorn, start new production lines, or needs new raw material sources to help increase supplies.
According to the American College of Allergy, Asthma and Immunology, parents could potentially cope with the shortage by contacting their allergist or health care provider, as there are other options available that they can prescribe, and by not overusing an albuterol inhaler, as one canister should last for months. They’re also advised to use expired inhalers that may still at least be partially effective.
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