Researchers concerned about proposal for OTC rescue inhaler availability
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In response to a research group’s proposal for over-the-counter availability of rescue inhalers for asthma, another group advised that the benefits and risks of this recommendation need consideration, according to a letter in JAMA.
“With regard to over-the-counter albuterol, I am fearful this will lead to an increase in mortality,” John J. Oppenheimer, MD, clinical professor of medicine at UMDNJ University School of Medicine, a Healio Allergy/Asthma Peer Perspective Board Member and coauthor of the responding letter along with Kathleen R. May, MD, and Stanley J. Szefler, MD, told Healio.
The American College of Allergy, Asthma & Immunology (ACAAI) and American Academy of Allergy, Asthma & Immunology (AAAAI) collaborated in assigning a work group of their members to submit the letter to JAMA, as both organizations indicated that they felt very strongly about the issue.
Increased availability
The initial proposal by William B. Feldman, MD, DPhil, MPH, associate physician in the division of pulmonary and critical care medicine at Brigham and Women’s Hospital, and colleagues, also published in JAMA in February, called for the FDA to give OTC status to fast-acting beta 2 agonist (FABA) inhalers for treating asthma symptoms.
Feldman and his coauthors called FABA inhalers safer and more effective than current OTC inhaler alternatives that use epinephrine. Further, they wrote, albuterol is widely prescribed while offering greater pulmonary selectivity and less cardiac risk than epinephrine.
OTC availability of combination rescue inhalers that include inhaled corticosteroids (ICS) and FABA would be a better solution, they continued. OTC availability would improve access to this medication for patients in underserved communities as well, they added.
In their response, May, Oppenheimer and Szefler concurred that OTC therapy would provide easy access for patients, who would not need to go through the health care system to get a prescription and could refill as needed based on symptoms.
“I agree that the access for patient is easier. There is no need for an office visit to determine need for a prescription and a diagnosis,” May, Wray chair in pediatrics, department of pediatrics, allergy-immunology and rheumatology at Medical College of Georgia at Augusta University, told Healio.
“This is currently true for inhaled epinephrine and would be true if albuterol were made over the counter,” May, who also is president-elect of ACAAI, continued.
Oppenheimer, however, said that the ability to obtain albuterol without seeing a doctor is not really an advantage.
“Studies have demonstrated that increased use of short-acting beta agonists is a signal of poor outcomes or death, and lower adherence to inhaled corticosteroids among those with moderate to severe asthma is a signal of increased morbidity and mortality,” he said.
“Furthermore, studies have demonstrated that patients underperceive their level of disease,” he added. “Thus, a physician’s evaluation with objective measure of lung function allows intervention before exacerbation.”
For example, May and colleagues cited a small, randomized, double-blind crossover study — published in 1993 in Thorax — that showed regular users of albuterol experienced earlier and more frequent asthma symptoms in addition to decreases in baseline pulmonary function.
Medication overuse
May and colleagues additionally called albuterol overuse common and associated with increased risk for asthma exacerbations and mortality due to asthma. They noted that the Global Initiative for Asthma (GINA) has outlined these risks as well and called for increased awareness of the consequences of inappropriately managed asthma.
For instance, they cited an Australian survey published in BMJ Open where 37% of respondents used more than four puffs of albuterol per day in the previous month, with 74% of them not using a daily asthma preventer medication, and 20% of albuterol users not having a formal asthma diagnosis.
Patients who overuse prescription albuterol have a noted risk for morbidity and mortality, May said.
“Overuse and regular use of albuterol without controller therapies to treat asthma have been linked to harm, including reduced responsiveness to albuterol and risk of more severe exacerbations, especially in adolescents,” May said.
At times, May continued, these patients have even required admission to the pediatric ICU as they feel the results of albuterol more rapidly while other controller prescriptions work best over time.
“Some have borrowed or obtained others’ albuterol inhalers, such as their siblings, in lieu of an office visit. This also happens with adults,” May said. “What would happen to those patients if albuterol were to go over the counter?”
“In pediatrics, we tend to encourage patients to keep contact and for parents to use prescription meds rather than rely on over-the-counter meds for asthma. This may be more of an issue in adults who self-care,” Szefler, director of the Pediatric Asthma Research Program in the Breathing Institute at Children’s Hospital Colorado, told Healio.
Feldman and colleagues wrote that patient education, proper labeling, counseling by pharmacists and ongoing management from physicians could mitigate this misuse, but the respondents did not agree that these strategies would be effective.
“There is a potential disconnect between the patient and provider unless the patient reports use of this medication and frequency,” Szefler said.
“If there is a disconnect between patient and provider, it puts the burden on the patient to understand how much is too much and to detect when they are getting worse and need a more careful review,” he added.
Also, physicians themselves often misdiagnose asthma, Oppenheimer said, where cardiac, reflux, upper airway and other pulmonary diseases may be the actual cause of illness.
“Finally, it is easy to imagine that without a need to see a doctor, many patients will simply obtain their albuterol without involving a caregiver. What will they do when faced with an asthma exacerbation?” Oppenheimer said.
“I fear that allowing albuterol to go over the counter will be a recipe for disaster,” Oppenheimer said. “I am hopeful that regulatory agencies will consider our letter to the editor and consider what the literature indicates will occur with an OTC switch.
“As outlined in our letter, patients generally underestimate the level of their disease control,” he added. “Without physician oversight, there is a missed opportunity to ensure control, stress adherence and review an emergency plan. You can clearly see the potential for disaster.”
Alternative solutions
Acknowledging that access to asthma care does need improvement, Oppenheimer said that advanced care integration needs consideration.
“Maintenance-to-reliever therapy ratios as an indicator for poor outcomes would make the most sense,” he said. “This has been validated by the work of the Kaiser group.”
OTC availability also is no guarantee of low costs, Szefler added, as health care plans will not cover this medication.
Overall, May and colleagues wrote, better solutions would involve improving awareness of the risk of excessive inhaler use, increasing access to health care for those diagnosed with asthma, and reducing the costs of prescription medications.
“I certainly have patients who are unable to obtain prescriptions, though we work with them via patient assistance programs to obtain prescriptions,” May said.
“National societies should hold discussions with regulatory bodies and consumer groups to determine next steps,” Szefler said. “If this does come to pass, then more emphasis on public patient education should take place about appropriate use of over-the-counter and prescription medications.”
“An ongoing discussion is necessary with all involved stakeholders, including our specialty societies, to determine the safest path forward and with consideration of what is best for our patients,” May said.
References:
- Azzi EA, et al. BMJ Open. 2019;doi:10.1136/bmjopen-2019-028995.
- Feldman WB, et al. JAMA. 2022;doi:10.1001/jama.2022.1160.
- Taylor DR, et al. Thorax. 1993;doi:10.1136/thx.48.2.134.
For more information:
John J. Oppenheimer, MD, can be reached at nallopp22@gmail.com.
Perspective
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William B. Feldman, MD, DPhil, MPH
One of the key concerns with OTC albuterol rescue therapy is that beta-agonist overuse can lead to adverse outcomes. This is, in part, why GINA guidelines recommend as-needed ICS FABAs as the preferred, first-line rescue agent for asthma.
Inhaled corticosteroids treat the underlying inflammation that drives exacerbations. We believe, in keeping with GINA guidelines, that OTC ICS-FABAs would be preferable to OTC albuterol. May and colleagues raise concerns about OTC albuterol but do not address the case for OTC ICS-FABAs.
In addition, as my coauthors and I highlighted, we worry about a key piece of evidence cited by May and colleagues. That study surveyed patients in Australia, where OTC albuterol has been available for decades, and found that a high percentage of patients picking up OTC albuterol at pharmacies had been overusing their rescue inhalers.
But a key limitation of this study is that there is no comparison group. The study does not compare OTC albuterol users with prescription-only users, matched on asthma severity, to understand the effects of OTC availability on utilization patterns. Other studies from Australia that compare OTC-albuterol to prescription-albuterol users find no differences in clinical outcomes.
Last month, the FDA released a proposed rule to further streamline prescription-to-OTC switches, indicating that such switches are a priority for the agency moving forward. The question of whether rescue inhalers should be OTC is a difficult one, and I’m glad that we are having a discussion in the pulmonary and allergy communities about strengthening access to therapy.
In a different context, where all people had access to affordable health care and where prescription medications were cheap, the case for OTC rescue therapy may not be as compelling. But in a country like ours, where millions are uninsured or underinsured, and where another (inferior) product is already available OTC (inhaled epinephrine), we think the case for OTC albuterol or ICS-FABAs is strong. We see this as an equity issue facing our patients with asthma.
References:
The FDA announces proposed rule: Nonprescription drug product with an additional condition for nonprescription use. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/fda-announces-proposed-rule-nonprescription-drug-product-additional-condition-nonprescription-use. Published June 27, 2022. Accessed July 20, 2022.
Feldman WB, et al. JAMA. 2022;doi:10.1001/jama.2022.8775.
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