Approximately 2% of adults and 4% to 8% of children have food allergies in the U.S., with food-induced anaphylaxis resulting in roughly 30,000 emergency department visits, 2,000 hospitalizations, and 150 deaths each year.
While epinephrine has vastly improved the lives of those with severe food allergies since its creation in the 20th century, there is still a ways to go in managing anaphylaxis.
Currently there are no nationwide laws that stipulate that public spaces are required to stock, administer, and educate staff on epinephrine. Laws vary from state to state, with some passing legislation stating that public venues, including day camps, daycare centers, and sports arenas, are allowed to, but not necessarily required to, stock epinephrine for use in cases of dangerous allergic reactions.
While all states allow primary schools to stock epinephrine, it is also not required, and there are variations in the level of training required for school staff on epinephrine use. However, all 50 states have legislation that protects the rights of individuals to self-carry their epinephrine on their person as treatment for anaphylaxis.
Findings from a survey of five school nurses and 25 school health assistants indicated that the majority performed well on knowledge tests and received updates to their allergy training plans once a year. The most common barriers that limited training in the school setting were a lack of time in order to complete the training, as well as staff resistance, limited staffing, and funding.
Julie Wang, MD, of Mount Sinai in New York City, told MedPage Today that one factor that can make treating anaphylaxis easier is identifying it in the first place, since symptoms can vary from patient to patient.
“There is not one definitive set of symptoms that defines anaphylaxis and so that’s complicated for families and for non-healthcare providers,” she said. “Anaphylaxis does not always look the same in every single person, every single time.”
Data from the “A Shot-to-Live” program showed that providing training to school faculty increased their comfort with recognizing anaphylaxis. Prior to training, only 38% of participants reported feeling “comfort in awareness of general signs/symptoms of anaphylaxis,” which jumped to 98% following training. Confidence in the ability to distinguish anaphylaxis from other types of food reactions increased from 17% to 96%.
In an emergency situation, the number of participants who felt comfortable administering epinephrine rose from 26% to 92%, while the number who could correctly identify the steps of administering the drug increased from 43% to 98%.
Lorie-Mae Nicolas, MD, of Penn State Health Children’s Hospital in Hershey, Pennsylvania, who presented these findings at the American College of Allergy, Asthma & Immunology annual meeting said that limitations on school staff can put students at risk of delayed treatment.
Similarly, another study suggested that maintaining knowledge on identifying anaphylaxis could be just as useful as introducing the skills in the first place.
In this study, providing participating residents with a 24-minute online teaching module improved their confidence and understanding of anaphylactic procedures. Notably, the ability to identify the correct steps of using an EpiPen increased from just 10% to 73% following the module. Comfort in educating patients about both anaphylaxis and EpiPen use also rose from 50% to 78%.
Wang pointed to a COVID-19-era challenge to current practices during emergency department visits following a reaction, as well as a common misconception that could be prevented by thorough, up-to-date education.
“So, historically, all plans state that as soon as epinephrine is given that one should call 911 and have medical attention in case more medications or more treatments are required, or to watch for a recurrence of symptoms,” she said. “What many of us had noticed was that many families linked those two — use epinephrine, call 911 — so tightly that there was a misunderstanding that if you didn’t want to call 911, then you don’t use epinephrine. But, in fact, those are two separate decision points. If the reaction is worrisome, meaning severe symptoms are happening, or the family is worried, or the patient is worried, epinephrine should be given.”
She explained that recent research indicated that, depending on the type and severity of the reaction, patients could consider being monitored at home following administration of epinephrine if they aren’t in need of further medical attention. However, she stressed that the choice is “situation-dependent,” and there are a number of factors to be considered — including whether or not the individual has access to a second dose of the drug should a biphasic reaction occur, which could then warrant an emergency department trip.
Ruchi Gupta, MD, MPH, of Northwestern University Feinberg School of Medicine in Chicago, told MedPage Today that access to medication isn’t enough in terms of treating anaphylaxis, and patients need to be trained in administering epinephrine so as not to delay treatment.
“We have more options now, more epinephrine, but some of the generics are not easy to use,” she said. “And even if you get it, being trained on it and feeling comfortable using it, and getting all that education is really important. So, we’ve noticed that doesn’t always happen. People still fear it.”
New methods of epinephrine administration currently in development may help simplify this process for patients.
Last year, the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended that the agency approve ARS-1, or neffy, an intranasal form of epinephrine used to treat type I allergic reactions, including anaphylaxis, despite concerns about the lack of clinical efficacy data. Speakers at the meeting cited fear of needles, particularly among pediatric patients.
While the nasal spray was ultimately rejected by the FDA, the manufacturer, ARS Pharmaceuticals, announced plans to submit a formal dispute resolution request in order to try and appeal the decision.
Additionally, data from a recent preclinical study indicated that a sublingual film that delivers epinephrine for the treatment of type I allergic reactions demonstrated favorable responses in healthy patients, with no significant treatment-emergent adverse events reported.