A minority of families and healthcare providers were willing to have pediatric emergency departments (EDs) conduct a direct oral challenge (DOC) to delabel penicillin allergies in children, a cohort study showed.
After considering the child’s risk category, family interest, and clinician willingness, 117 parents had their low-risk child complete the DOC out of the 1,189 initially approached at three urban Midwest teaching pediatric EDs, reported David Vyles, DO, MS, of the Medical College of Wisconsin, and colleagues.
Clinicians were able to delabel 98% of reported penicillin allergy in those low-risk patients. Providers chose not to go forward with a DOC 19 times, most frequently citing worries about time constraints and fear of allergic reaction in patients, according to their researcher letter in JAMA Pediatrics.
The study authors said that DOCs may still make sense in pediatric EDs given the overreporting of penicillin allergies in clinical practice.
About 10% of pediatric patients arriving in the ED have family-reported allergies to penicillin-family antibiotics, making it one of the most common pediatric allergies in the U.S. Most of these individuals are categorized as “low-risk” and, depending on the patient’s age, some symptoms may not even reoccur upon future exposure.
“The fact is that penicillin-based antibiotics are first line for the treatment of many infections — and in some cases, the only or the best, and for a variety of reasons. One is that if you start using either more expensive [antibiotics] or antibiotics with a broader spectrum, then you increase or create resistance,” Maria Garcia-Lloret, MD, of UCLA Health, told MedPage Today.
“In the long run, this is a personal issue as well as a public health issue,” added Garcia-Lloret, who was not involved with the study.
Recently, the PALACE trial showed that a direct oral penicillin challenge sufficed to remove an incorrect penicillin allergy label on low-risk people. Just 0.5% of those with a PEN-FAST score <3 tested positive after either a physician-verified positive immune-mediated penicillin oral challenge alone or the standard practice of a skin test followed by oral challenge.
Vyles and colleagues maintained that the pediatric ED could make sense as a setting for an effective DOC program for penicillin delabeling. Regarding providers’ safety concerns, the authors noted that “severe reaction to amoxicillin is exceedingly rare and should a reaction occur, the [pediatric ED] is an exceptionally safe place to treat any reaction.”
Garcia-Lloret said she agreed, particularly when tools like a prepared, communicative support system for delabeling programs and symptom questionnaires can help those administering the oral challenge to have a deeper and more confident understanding of their patient population. “In a well-selected population, the challenge is safe,” she said.
“We convinced patients that have been allowed in front of us that, ‘OK, we’re gonna do a challenge, if something happens we’ll deal with it,'” she added. “It’s a matter of trust, and you need to know that you’re doing the right thing. And, you need to have everything in your emergency department, just in case of that 1%.”
Study authors suggested that a DOC may be best suited for children needing acute antibiotics. In any case, Vyles and colleagues said more work is needed outside the realm of implementing DOCs in the pediatric ED.
“Integration through a standardized EMR [electronic medical record]-based process is the next step toward expansion of addressing the problem of overreported penicillin allergy. This could include better prevention of allergy labels and a more streamlined process for allergy testing referrals,” they wrote.
The study was conducted at three Midwest, urban pediatric EDs — within a Pediatric Emergency Care Applied Research Network — from March 2019 to November 2020. Researchers gave questionnaires to patients and their families reporting a penicillin allergy so that they could assign them as being low- or high-risk based on symptoms.
Of parents approached to complete questionnaires for 1,189 children age 2-16 years, just 31% completed them.
For this subgroup, the study population was 51.6% boys and the average patient age was 9 years. By race, 58% of the patients were white, 21.5% were African American, and 13.4% were Hispanic.
The proportion of children deemed low-risk ranged from 46% to 69% across the three pediatric EDs. Family interest ranged from 58% to 87%, and clinician willingness to proceed with DOC reached a low of 56% at one site and a high of 94% at another.
One potential limitation to these results is that the questionnaire provided to patients and their families differed from site to site.
This study was supported by funding from the Nodal Pilot Award from Hospitals of Midwest Research Node of the Pediatric Emergency Care Applied Research Network.
Vyles and Garcia-Lloret had no disclosures.
A study coauthor reported relationships with Verve, Janssen, UpToDate, AstraZeneca, and Biocryst; and grants from NIH and Australia’s National Health and Medical Research Council.
Source Reference: Vyles D, et al “Multisite oral amoxicillin challenges during pediatric emergency department visits” JAMA Peds 2023; DOI: 10.1001/jamapediatrics.2023.3659.