A call for switching to OTC availability of asthma rescue inhalers

In a viewpoint published in JAMA, authors propose that switching to over-the-counter availability of rescue inhalers would offer patients with asthma access to safer and more effective rescue therapy than what is currently available OTC.

“Epinephrine inhalers are now available over-the-counter for the treatment of asthma symptoms in the U.S., but these inhalers are not guideline-recommended,” William B. Feldman, MD, DPhil, MPH, associate physician in the division of pulmonary and critical care medicine at Brigham and Women’s Hospital and research fellow in the Program On Regulation, Therapeutics and Law (PORTAL) in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, told Healio. “We argue that, if patients have access to reliever inhalers over-the-counter, as they now do, why not at least ensure that they have access to safer and more effective therapy than inhaled epinephrine?”

Feldman was an author of the viewpoint, along with Jerry Avorn, MD, and Aaron S. Kesselheim, MD, JD, MPH, both also with PORTAL and Brigham and Women’s Medical School and Harvard Medical School.

Currently, the only FDA-approved OTC inhaler available to manage asthma symptoms is Primatene Mist (Amphastar Pharmaceuticals), an inhaled epinephrine product that was approved in 2018. Inhaled epinephrine is not currently guideline-recommended to treat asthma, the authors wrote.

“Asthma has a disproportionate impact on underserved communities in the U.S., and we wanted to explore ways of increasing access to guideline-recommended reliever therapy,” Feldman told Healio.

The authors argue that “one positive step forward” for patients with asthma is OTC availability of inhaled albuterol, which they note is widely prescribed and has greater pulmonary selectivity and less cardiac risk than epinephrine. Further, “a potentially better solution” would be OTC availability of combination rescue inhalers that contain inhaled corticosteroids (ICS) and fast-acting beta agonists (FABA), the authors wrote.

“Switching albuterol or low-dose ICS-FABAs to OCT would fit within a tradition of facilitating access to many commonly used medications that can be taken safely without a prescription, such as omeprazole, antihistamines and topical hydrocortisone,” the authors wrote. “A switch would also offer patients a safer and more effective rescue therapy than the one currently available, while helping to ensure access to underserved patients with asthma. Three recent developments — the tentative approval of generic budesonide-formoterol (an ICS-FABA), the full approval of generic albuterol inhalers and new legislation reforming the OTC system — may help catalyze a switch.”

Editor’s note: On March 15, the FDA announced approval of the first generic of Symbicort (AstraZeneca) — budesonide and formoterol fumarate dihydrate — for the treatment of asthma and COPD. Read Healio’s coverage here.

Further, they wrote, “the long-standing barriers to OTC rescue therapy may now be eroding.”

Newer legislation that was passed in 2020 provides a new path for manufacturers to pursue a switch from prescription to OTC that makes it easier to add ingredients to OTC monographs and avoids the requirement for a new drug application but still qualifies for 18 months of product exclusivity, the authors wrote. However, they noted that the new pathway “is not without challenge,” as the FDA has in the past favored new drug applications for metered-dose inhalers over the monograph system.

“Perhaps the simplest path for a prescription to OTC switch in this case would be for a drug manufacturer to conduct the studies needed for regulatory approval and submit a new drug application to the FDA,” Feldman told Healio.

The authors propose that if manufacturers do not pursue a switch to OTC status for prescription-only rescue inhalers, “the FDA should consider initiating a switch.”

“A prescription-to-OTC switch for as-needed combination ICS-FABA inhalers could offer an optimal alternative to inhaled epinephrine,” the authors wrote. ... “Permitting low-dose inhaled corticosteroids OTC while reserving higher-dose inhaled corticosteroids for prescription-only use (as is done with topical hydrocortisone) would help reduce steroid-related adverse events while preserving the benefits of as-needed ICS-FABAs.”

A concern about easier OTC access to these medications is that it could lead to inappropriate use by patients. However, the authors said proper education, at least to an extent, could help address these concerns, as well as novel labeling strategies for patient safety, counseling from pharmacists, ongoing management by physicians and careful studies of outcomes following a switch from prescription to OTC.

Currently, ICS-FABAs are approved only as maintenance therapy, so a switch to OTC could require labeling changes, the authors wrote.

“By contrast, fewer hurdles exist for an albuterol prescription-to-OCT switch, and even though ICS-FABAs may be the preferred agent, albuterol would offer an improvement over epinephrine,” Feldman and colleagues wrote. “Some have gone further to advocate making maintenance inhalers indicated for daily use available OTC. But at a minimum, because patients already have access to an OTC inhaler for acute asthma symptoms, they should also have access to therapy that is safer and more effective than inhaled epinephrine.”

For more information:

William B. Feldman, MD, DPhil, MPH, can be reached at wbfeldman@bwh.harvard.edu.