Investigators found it essential to implement process enhancements with the goal of optimizing the efficiency of drug procurement, distribution, and delivery after a patient has been identified as a suitable candidate for a direct oral challenge (DOC), according to new research.¹

These new findings also indicated that a delabeling program for penicillin utilizing a DOC could be helpful in pediatric emergency departments (PEDs). This research was conducted to assess distinctions among younger patients as far as allergy risk and DOC results.

The new research was viewed as important, given that the conducting of a DOC to remove a label of penicillin allergy in lower-risk populations can lead to more favorable health outcomes among children.² The new research was led by David Vyles, DO, MS, from the Children’s Corporate Center Department of Pediatrics at 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 a cohort study which involved the inclusion of children in the age range of 2 - 16 years, all of whom had been reported by their guardians to have an allergy to penicillin. These younger subjects were met with at 1 of 3 urban Midwest teaching PEDs known to be included in the Pediatric Emergency Care Applied Research Network, and they were met with between March 2019 and November 2020.

The research team’s data analysis was carried out in the period between November and December of 2020. The team were given approval from the institutional review boards of the participating hospitals.

The parents or guardians of the subjects were given questionnaires to fill out that inquired about their childrens’ allergy symptoms, and these answers were later used by the investigators to classify the subjects into the categories of ‘low’ or ‘high’ risk based upon the information about their symptoms.

The eligibility of the children for their challenge was assessed through the use of established criteria, and the families of these subjects gave written consent to the investigators for DOC. The investigators approached clinicians to get their approval for the use of amoxicillin in the research.

Data management was carried out through the use of REDCap, and the team utilized descriptive statistics to summarize their subjects’ demographic data, information drawn from the allergy questionnaire, and the results of the childrens’ challenges.

Among the 3 locations used in the study, the investigators approached 1,189 parents, and 31% of the resulting questionnaires were shown to be completed successfully. The team found that the average age of their subjects was shown to be 9.03 years, with a standard deviation of 4.40 years, and 51.6% of them were reported as male.

After applying specific exclusion criteria and receiving approval from healthcare professionals, a total of 117 participants completed the team’s DOC assessment. Notably, the investigators found there were major differences they saw among the 3 research sites, denoted as A, B, and C.

These 3 sites were designated in terms of having low-risk (57%, 69%, and 46%, respectively; P < 0.001), family interest in the subjects’ DOC (87%, 75%, and 58%, respectively; P < 0.02), and clinician willingness to go along with the DOC (85%, 94%, and 56%, respectively; P < 0.001). The clinicians were found to have decided not to use the DOC 19 times, with the primary reason being listed as time constraints.

“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.”

References

1. ^{Vyles D, Hoganson G, McAneney C, et al. Multisite Oral Amoxicillin Challenges During Pediatric Emergency Department Visits. JAMA Pediatr. Published online October 02, 2023. 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.}