Navigating the albuterol shortage for patients with asthma

In late October 2022, the FDA declared a shortage of albuterol sulfate inhalation solution 0.5%, and as of early April the shortage is still in effect, according to the administration’s website.

This dosage of albuterol, which is usually found in hospitals, is the only dosage currently in shortage; patients who use albuterol inhalers are not affected by this shortage, according to tweets from the FDA.

“There are great concerns surrounding this shortage,” Clifford Bassett, MD, FAAAAI, FACAAI, medical director of Allergy and Asthma Care of New York, member of the AAFA medical scientific council and clinical assistant professor at NYU Grossman School of Medicine, told Healio. “Many concerns are about patient safety since this drug has many asthma prescribers. Patients with asthma using albuterol are accustomed to having it available for an ‘as needed’ quick onset bronchodilator.”

As noted on the FDA’s drug shortage list, there has been “no new manufacturing” of albuterol sulfate inhalation solution 0.5% 20 mL from Akron Pharmaceuticals, the main manufacturer, as of March 16. Nephron Pharmaceuticals is in the process of allocating the drug but it is currently still on the shortage list.

Notably, this nearly 6-month shortage period has overlapped with the tripledemic in the U.S. of the flu, respiratory syncytial virus (RSV) and COVID-19. According to the American Lung Association, albuterol is used to treat several diseases other than asthma, such as COPD, COVID-19 and RSV, making it even more difficult to obtain during this vulnerable time.

“I have found the most reliable option for our practice is the neighborhood pharmacy, as many of the larger distributors were not willing to process orders for smaller medical groups,” Bassett, also the author of The New Allergy Solution, told Healio.

During this crucial time, there is a close watch on hospital stock levels to make sure they can continue treating patients, according to the American Lung Association. However, as the duration of the shortage lengthens and more patients are in need, the albuterol supply will lower.

For patients who have been or might soon be affected by this shortage, Bassett recommends that they meet with their provider and/or respiratory specialist to go over other prescription options that will help them manage their disease.

Two notable alternatives are levalbuterol and formoterol, according to Bassett.

“If hospitals are unable to source albuterol, levalbuterol is another option,” he told Healio. “According to Drugs.com, the median time of levalbuterol HFA to onset is 4.5 minutes for a 15% increase in FEV₁. Formoterol was also found to have similar efficacy and safety in ED studies in a systematic review and meta-analysis (Rodrigo GJ, et al)."

As of March 8, the FDA tweeted a reminder that “outsourcing facilities may compound the specific product that’s in shortage to help increase supply.”

“Although, I have not experienced our asthma patients attempting to ‘ration’ their albuterol inhaler, the asthma care team must provide proper guidance for any patient that may be impacted by this serious supply problem,” Bassett told Healio.

For more information:

Clifford Bassett, MD, FAAAAI, FACAAI, can be reached at drbassett@allergyreliefnyc.com.

References:

• FDA Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Albuterol%20Sulfate%20Inhalation%20Solution,%200.5per&st=c. Updated March 16, 2023. Accessed April 3, 2023.
• How the albuterol shortage will impact your chronic lung disease. https://www.lung.org/blog/albuterol-shortage-lung-health-impacts. Published March 13, 2023. Accessed April 3, 2023.
• Rodrigo GJ, et al. Ann Allergy Asthma Immunol. 2010;doi:10.1016/j.anai.2009.11.064.
• Twitter. U.S. FDA. https://twitter.com/US_FDA/status/1633649230144237569. Published March 8, 2023. Accessed April 3, 2023.
• Twitter. U.S. FDA. https://twitter.com/US_FDA/status/1633649223936753665. Published March 8, 2023. Accessed April 3, 2023.
• Xopenex HFA Prescribing Information. https://www.drugs.com/pro/xopenex-hfa.html. Updated May 23, 2022. Accessed March 31, 2023.