Penicillin De-Labeling in the Pediatric Primary Care Setting

Reported adverse drug reactions to penicillins are common; however, more than 90% of patients with a penicillin allergy label can safely tolerate penicillins (1, 2). numerous adverse outcomes are associated with an unverified penicillin allergy, and elective evaluation for penicillin allergy has been recommended (1, 3, 4). There is a vast disparity between the number of patients with a penicillin allergy label and practicing allergists in the united States, with over 30 million penicillin-allergic labeled patients and less than 5000 practicing allergists (5, 6). With such a significant prevalence of labeled penicillin allergy, no single medical discipline can handle this burden alone; a coordinated effort across both primary care and subspecialists will be required to address this. as the majority of penicillin allergy labels occur in young childhood, pediatricians are uniquely situated to have a significant impact in reducing the long-term consequences of a penicillin allergy label through delabeling strategies (1, 5). Direct oral challenge in low-risk patients has been recommended as a delabeling strategy for this population, and is standard of care in the evaluation of penicillin allergy in low risk patients by allergists (7-9). Cumulative studies have now evaluated the safety and efficacy of direct amoxicillin challenge in children with a penicillin-allergy label in over 1400 subjects (8-16); the majority of studies have taken place in the outpatient allergist setting. across studies, positive challenge rates ranging from 0-13%. The largest study was a single center prospective study which defined low-risk allergy patients as an absence of severe cutaneous adverse reactions (SCaRs); they reported on 818 patients and found a 6% positive challenge rate (8). across the above studies, all reactions were mild and only required treatment with oral antihistamines, no epinephrine use was documented in any of these studies. While there is significant evidence for the safety and efficacy of direct penicillin challenge in the evaluation of penicillin allergy, this has not yet been widely implemented in the primary care setting. There have been two pilot studies exploring direct amoxicillin challenge in the pediatric primary care setting. The first was a retrospective study of 42 children in australia who included children greater than 18 months old. They performed direct amoxicillin challenges after 3 months had elapsed from the index reaction. There was a 3% positive challenge rate and all reactions resolved with only oral diphenhydramine. The second was a prospective study that included 102 children in ireland and there no positive challenges to amoxicillin challenge. This approach has not been studied in the united States. a recent survey of uS-based pediatricians identified perceived barriers to implementing penicillin allergy evaluations into their routine care (17). Significant gaps in knowledge exist regarding the feasibility of this approach involving risk stratification evaluation of reported penicillin adverse reactions and direct amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting. The goal of this project is to explore the feasibility of implementing a penicillin allergy delabeling protocol for low-risk pediatric patients in the primary care setting. Specifically, we seek to demonstrate risk-stratification of reported adverse reactions to penicillins and completion of direct amoxicillin challenge in low-risk subjects can be performed in the outpatient pediatric primary care setting. (See form a for references)