March 18, 2022
3 minute read
Disclosures: Feldman reports receiving funding from the NIH and the FDA Sentinel Initiative; consulting for Alosa Health; and receive honoraria from Blue Cross Blue Shield of Massachusetts. Please see the study for relevant financial information from all other authors.
In a viewpoint published in JAMA, the authors propose that the shift to the availability of over-the-counter rescue inhalers would provide asthma patients with access to safer and more effective reliever therapy than is currently available over-the-counter.
“Epinephrine inhalers are now available over-the-counter for the treatment of asthma symptoms in the United States, but these inhalers are not recommended by guidelines,” William B. Feldman, MD, DPhil, MPH, Associate Physician in the Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital and Researcher in the Regulation, Therapeutics and Law (PORTAL) Program in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and the Harvard Medical School, Healio told . “We argue that, if patients have access to over-the-counter rescue inhalers, as they currently do, why not at least ensure they have access to a safer and more effective treatment than epinephrine? inhaled?”
Feldman was a viewpoint writer, 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 over-the-counter inhaler available to manage asthma symptoms is Primatene Mist (Amphastar Pharmaceuticals), an inhaled epinephrine product that was approved in 2018. Inhaled epinephrine is currently only not recommended in guidelines for treating asthma, the authors wrote.
“Asthma disproportionately impacts underserved communities in the United States, and we wanted to explore ways to increase access to guideline-recommended relief therapy,” Feldman told Healio.
The authors say “a positive step forward” for asthma patients is the over-the-counter availability of inhaled albuterol, which they say is widely prescribed and has greater lung selectivity and lower cardiac risk than epinephrine. Additionally, “a potentially better solution” would be the availability of over-the-counter combination rescue inhalers containing inhaled corticosteroids (ICS) and fast-acting beta-agonists (FABA), the authors wrote.
“Switching from albuterol or low-dose ICS-FABA to OCT would be part of a tradition of facilitating access to many commonly used drugs that can be taken safely without a prescription, such as omeprazole, antihistamines, and topical hydrocortisone,” the authors wrote. “A change would also offer patients a safer and more effective lifesaving therapy than is currently available, while helping to ensure access for underserved asthma patients. Three recent developments – tentative approval of generic budesonide-formoterol (an ICS-FABA), full approval of generic albuterol inhalers, and new legislation reforming the OTC system – could help catalyze change.
Editor’s note: On March 15, the FDA announced the approval of the first generic of Symbicort (AstraZeneca) — budesonide and formoterol fumarate dihydrate — for the treatment of asthma and COPD. Read Healio’s cover here.
Additionally, they wrote, “long-standing barriers to over-the-counter lifesaving therapy may now be eroding.”
New legislation passed in 2020 gives manufacturers a new route to switch from prescription to OTC, making it easier to add ingredients to over-the-counter monographs and avoiding 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 path “is not without its challenges,” as the FDA has in the past favored new drug applications for metered-dose inhalers over the monograph system.
“Perhaps the easiest path for a prescription to OTC change in this case would be for a drugmaker to conduct the studies necessary for regulatory approval and submit a new drug application to the FDA,” said Feldman to Healio.
The authors propose that if manufacturers do not pursue the move to OTC status for prescription-only rescue inhalers, “the FDA should consider initiating a change.”
“Switching over-the-counter prescriptions to ICS-FABA combination inhalers as needed may provide an optimal alternative to inhaled epinephrine,” the authors wrote. …”Allowing over-the-counter low-dose inhaled corticosteroids while reserving higher-dose inhaled corticosteroids for prescription-only use (as is the case with topical hydrocortisone) would help reduce adverse events related to to steroids while maintaining the benefits of ICS-FABA as needed.”
A concern about easier over-the-counter access to these drugs is that it could lead to inappropriate use by patients. However, the authors said appropriate education, at least to some extent, could help address these concerns, along with new labeling strategies for patient safety, pharmacist guidance, ongoing management by physicians and in-depth studies of results after switching from prescription to OTC. .
Currently, ICS-FABAs are only approved as maintenance therapy, so a switch to OTC might require labeling changes, the authors wrote.
“In contrast, there are fewer barriers to a switch from prescribing albuterol to OCT, and although ICS-FABAs may be the preferred agent, albuterol would offer an improvement over epinephrine “, wrote Feldman and his colleagues. “Some have gone further, advocating making maintenance inhalers indicated for daily use available over the counter. But at a minimum, because patients already have access to an over-the-counter inhaler for acute asthma symptoms, they should also have access to a safer and more effective therapy than inhaled epinephrine.
For more information:
William B. Feldman, MD, DPhil, MPHcan be contacted at [email protected]