Switching to Over-the-Counter Availability of Rescue Inhalers for Asthma

Switching to Over-the-Counter Availability of Rescue Inhalers for Asthma
Kristopher Nguyen, PharmD, New Ulm Medical Center

As it stands, epinephrine inhalation aerosol (Primatene Mist) is the only over-the-counter (OTC) inhaler approved to manage asthma symptoms. Currently, there are no clinical guidelines that recommend inhaled epinephrine to manage and treat asthma. Guideline-recommended rescue inhalers are only available with a prescription and prices of these inhalers can make accessibility an issue for many patients with asthma. Historically, inhaled albuterol has been recommended as rescue therapy for patients with asthma. More recently, however, the Global Initiative for Asthma recommends low-dose inhaled corticosteroid - long-acting beta agonist (ICS-LABA) for rescue therapy which marks a change in clinical prescribing. Recently, the Food and Drug Administration approved the first generic of budesonide/formoterol (Symbicort), ICS/LABA, in March 2022, and there are generic versions of albuterol inhalers on the market currently. Because of these generics, prescription-to-OTC switches can have up to three years of OTC exclusivity which provides another revenue option for manufacturers. In addition, legislation passed in 2020 offers a new path for prescription-to-OTC switches which avoids the new drug application while still maintaining product exclusivity. Another avenue for this change could come from the FDA itself in initiating this switch. There has only been one instance of this happening. In 1982, another nonselective β-agonist was made OTC but was switched back to prescription status following negative feedback from physician groups. If manufacturers do not plan on pursuing OTC status for these inhalers, it would behoove the FDA to exercise this authority again in order for patients to have an affordable and efficacious option to help manage their asthma.

With these changes and an increasing need for accessible asthma management, manufacturers and the FDA have a plethora of options to make the switch from prescription to OTC for these rescue inhalers. One argument against making these inhalers OTC could stem from the potential for inappropriate and inaccurate use without proper counseling. However, with any medication, OTC or prescription, proper education can assuage these doubts. As mentioned, these changes can occur either directly from the FDA, from the manufacturer, or from pressure from the FDA. Either way, healthcare professionals should advocate for this change to not only help get their patients the medications they need but a safer and more effective option.


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  2. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2021. Available from: www.ginasthma.org
  3. Kahn J. FDA approves first generic of Symbicort to treat asthma and COPD. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-g.... Published March 15, 2022. Accessed April 28, 2022.