This article discusses the process by which rescue inhalers, inhaled corticosteroids + long
acting B2-agonists or B2 agonists alone, could become available to patients over-the-counter
(OTC). Although some may be unaware, there is currently an epinephrine inhaler (Primatene
Mist) that is already available OTC. This inhaler has been previously discontinued by the Food
and Drug Administration (FDA) due to its lack of therapeutic effects, lack of guidance for use in
the National Institutes of Health’s “Guidelines for the Diagnosis and Management of Asthma”,
and increased risk of adverse effects including cardiac toxicity. This inhaler has since been
reintroduced to the market in 2018. Providing patients with an OTC inhaler has provided access
to those that may be uninsured and/or underinsured. Although the use of Primatene is
potentially better than nothing, this article argues that it would be more appropriate to offer an
inhaled corticosteroid + long acting B2-agonist or B2 agonist alone OTC inhaler to reflect the
recommendations made by the Global Initiative for Asthma guidelines.
Prior to 1972, the FDA required drug companies to submit a new drug application for a
medication to become an OTC product. In 1972, the FDA created a drug monograph system
that allowed for OTC use without specific FDA review. The drug monograph system is a list of
active ingredients that can be sold OTC based on medications that were previously approved
OTC. Just recently in 2020, legislation passed allowing manufacturers to seek out additional
active ingredients that were not on the OTC monograph previously. Although the approval of
an OTC rescue inhaler could potentially reduce the cost and any barriers limiting patients access
to this medication, it doesn’t come without concern. There is concern that these agents will be
used inappropriately to manage symptoms, decrease patient’s knowledge of proper inhaler
technique, and subsequently decreases patient’s awareness of asthma flares. In the future, the
FDA or drug manufacturers could push to make rescue inhalers OTC and creating educational
material to improve patient safety

 

https://jamanetwork.com/journals/jama/fullarticle/2789469

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