Generic Albuterol Inhalers Are Key to Minimizing Shortages Early in Pandemic

As the COVID-19 pandemic began and investigators examined the virus's impact on lung function, shortages of albuterol inhalers became common across the United States. Generic options, therefore, became a priority for the FDA to help individuals with asthma.

Unlike some other drug shortages early in the pandemic, the albuterol shortage was not caused by production interruptions. It occurred because of increased use of albuterol inhalers in hospitals for patients with COVID-19 to help with respiratory issues, according to a statement from the American College of Allergy, Asthma, and Immunology (ACAAI).¹

The demand for inhalers jumped by 400% early in the pandemic, leading to shortages in the United Kingdom and the United States, according to the results of a study published in the journal Respiratory Medicine.² There were early concerns that use of inhalers or nebulizers could increase the risk of transmitting COVID-19 by spreading droplets through the air.¹

Furthermore, according to early World Health Organization guidelines, the steroids used in inhalers and nebulizers could negatively affect the immune system, potentially leading to increased susceptibility to COVID-19.² Despite these concerns, investigators soon confirmed that the benefits outweigh the risks for patients with asthma who properly use their prescriptions.²

Investigators used evidence and findings from different bodies to investigate the use of steroids and the risk of viral infections of the upper respiratory tract. The investigators confirmed the risk of COVID-19 infection and a weakened immune system, but they said patients should continue to use their inhalers and nebulizers as prescribed and not stop steroid use.²

When advising patients about how to handle shortages, the ACAAI emphasized asthma control, saying that well-controlled asthma would not need as much albuterol.

If necessary, the ACAAI said it may be possible to use an expired albuterol inhaler and advised patients to contact their health care providers for other options if a refill was unavailable.¹

Generic options became an especially important way to ensure patients get their medications.

In response to the pandemic and resulting albuterol shortages, the FDA approved the first generic albuterol inhaler on April 8, 2020, for the treatment or prevention of bronchospasm in patients 4 years and older who have reversible airway disease.³

"We learned of possible shortages about a month ago, and with the introduction of this inhaler, we have a generic product to add to the supply," allergist Michael Blaiss, MD, executive medical director of the ACAAI, said in a statement in April 2020. "While shortages may not be occurring in every part of the country, we want patients to know they may have additional options if they are having an issue getting their medicine."¹

This effort to bring more generic albuterol options to market has continued in 2021, with a recent announcement by Sandoz Inc that it has in-licensed commercial distribution rights to the branded and generic Proventil HFA Inhalation Aerosol from Kindeva Drug Delivery.⁴ In a statement, the company cited the surge in demand for albuterol medications over the past year and increased demand at pharmacies after the CDC recommended that Americans stock up on medications.

"With the commercial distribution rights to the brand and authorized generic of Proventil HFA, we are excited to work to increase supply and help ensure patients who need albuterol have access to this important medicine," Keren Haruvi, president of Sandoz, siad in the statement.

REFERENCES

1. A message to asthma sufferers about a shortage of albuterol metered dose inhalers. News release. American College of Allergy, Asthma and Immunology. Updated April 9, 2020. Accessed March 3, 2021. https://acaai.org/news/message-asthma-sufferers-about-shortage-albuterol-metered-dose-inhalers

2. Karlovitch S. Inhalers safe during COVID-19 pandemic, study shows. Pharmacy Times®. July 13, 2020. Accessed March 3, 2021. https://www.pharmacytimes.com/news/inhalers-safe-during-covid-19-pandemic-study-shows

3. FDA approves first generic of a commonly used albuterol inhaler to treat and prevent bronchospasm. News release. FDA. April 8, 2020. Accessed March 3, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm

4. Sandoz in-licenses brand and authorized generic of respiratory medicine Proventil HFA (albuterol sulfate) Inhalation Aerosol from Kindeva Drug Delivery, with immediate generic availability in US. News release. Sandoz. March 16, 2021. Accessed March 17, 2021. https://www.us.sandoz.com/news/media-releases/sandoz-licenses-brand-and-authorized-generic-respiratory-medicine-proventil-hfa