Allergy Questionnaire: Spotlighting Results of Delabeling Penicillin Allergy with Direct Oral Challenge


This study looked at results of DOC, allergy risk level risk distinctions, and rationale for families and physicians to move forward with DOC.

There are large variations in reasons for families’ interest in direct oral challenge (DOC) for penicillin allergy, according to recent findings, with reasons such as fears of severe allergic reactions and constraints on time highlighted among them.1

These findings also indicated that time constraints are the most common reason for clinicians not to proceed with DOC. These data were the results of new research on DOC, conducted to assess a penicillin delabeling program carried out in a multicenter study.

The investigators of this study noted prior research on positive implications for health in delabeling an allergy to penicillin through DOC, adding that around 10% of children admitted to pediatric emergency departments are shown to report a penicillin family antibiotic allergy.2,3

The research was authored by David Vyles, DO, MS, from the Medical College of Wisconsin in Milwaukee.

“This study implemented a penicillin allergy delabeling program across 3 sites to evaluate differences in allergy risk level designation, clinician and family willingness to proceed with DOC, and results of a DOC,” Vyles and colleagues wrote.

Background and Findings

The investigators used 3 different sites used as teaching Pediatric Emergency Departments (PEDs) in urban areas found in the Midwest. These centers were within a Pediatric Emergency Care Applied Research Network node, and the children had been admitted to these sites between March 2019 - November 2020.

These younger patients in the age range of 2 - 16 years were assessed by the research team, and the participants were included provided they had a parent-reported allergy to penicillin. The team’s analysis of their data took place in the period between November 2020 - December 2020, following institutional review board approval.

The parents of these children were instructed by the investigators to work on a penicillin allergy symptom questionnaire. This survey categorized the children into groups separated into low-risk or high-risk, and the distinction was based upon their childrens’ symptoms.

Written consent for DOC was given to the team by the families investigated, and approval for amoxicillin administration was sought among doctors. The research team decided that they would use previously-established criteria for inclusion for their allergy patients.2

The investigators used REDCap for their management of patient information. They implemented descriptive statistics to better summarize data on demographics, the allergy questionnaire, and DOC results.

Among the 1189 parents who were approached by the research team across the 3 sites, the team found that 31% had filled out the questionnaires for their children (mean [SD] age, 9.03 [4.40] years; 191 [51.6%] boys).

The team reported that, following the application of their criteria for exclusion and following physician approval, there were 117 total subjects who had done the DOC. A major finding by the investigators among those surveyed was that a wide variation was seen and different trends were reported over sites A, B, and C.

These variations were seen in terms of the respondents’ designation of low-risk (57%, 69%, and 46%; P < .001). Variations were also seen by the investigators in terms of familial interest in using DOC (87%, 75%, and 58%; P < .02).

Lastly, the research team reported substantial variation among physicians in their willingness to go forward with DOC (85%, 94%, and 56%; P < .001). Clinicians were shown to have decided not to move forward with DOC in 19 reported instances, and the team noted their main reason had been listed as time constraints.

The investigators later noted in their summary of the findings that a penicillin delabeling initiative through a DOC could potentially prove helpful within PEDs, and this could especially be the case for children in need of urgent antibiotic treatment.

“Integration through a standardized EMR-based process is the next step toward expansion of addressing the problem of overreported penicillin allergy,” they wrote. “This could include better prevention of allergy labels and a more streamlined process for allergy testing referrals.”


  1. Vyles D, Hoganson G, McAneney C, et al. Multisite Oral Amoxicillin Challenges During Pediatric Emergency Department Visits. JAMA Pediatr. 2023;177(12):1348–1350. doi:10.1001/jamapediatrics.2023.3659.
  2. Vyles D, Chiu A, Routes J, et al. Oral amoxicillin challenges in low-risk children during a pediatric emergency department visit. J Allergy Clin Immunol Pract. 2020;8(3):1126-1128.e1. doi:10.1016/j.jaip.2019.09.022.
  3. Vyles D, Chiu A, Simpson P, Nimmer M, Adams J, Brousseau DC. Parent-reported penicillin allergy symptoms in the pediatric emergency department. Acad Pediatr. 2017;17(3):251-255. doi:10.1016/j.acap.2016.11.004.
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