Inpatient Penicillin Allergy Delabeling by Direct Oral Challenge at a Free-standing Children’s Hospital in Connecticut

Abstract Corresponding Author: Laura Kvenvold, MD No Conflicts, Pediatric Infectious Diseases and Immunology, Connecticut Children’s Medical Center, Hartford, Connecticut, USA, Department of Infectious Diseases, University of Connecticut School of Medicine, Farmington, Connecticut, USA, Tele: 978-328-6646, Address: CCMC Infectious Diseases, 85 Seymour St, Suite 816, Hartford, CT, 06106, Email: [email protected], [email protected] Dr. Girotto has received unrestricted grant funds from Pfizer and is a consultant for Lexi Comp Background In the United States, approximately 10% of people report a penicillin allergy; however, when formally tested, 1% had an acute reaction and far fewer had an anaphylactic reaction. Our hospital has achieved >90% of penicillin allergy documentation in admitted patients and review of 6 months of baseline data indicates that approximately 9% of patients in this cohort were labeled as having a penicillin allergy. Penicillin allergy labels are not benign and have numerous negative impacts including increased side effects from alternative antibiotics, risk for treatment failure, postoperative infections, cost to healthcare facilities, and risk for the development of resistant organisms. Practice parameter updates for allergy management from the Joint Task Force on Practice Parameters in association with the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology in 2022 emphasized proactive penicillin allergy delabeling, and, in pediatric patients, using direct oral drug challenge to delabel low risk patients without the need for skin testing. There is insufficient access to allergy specialists in the United States, so it is important that non-allergy trained providers take a role in delabeling efforts. We describe our strategy to create a standardized pathway for penicillin drug allergy delabeling that will be managed by non-allergy specialists. Methods This program does not qualify as human subjects research as determined by the IRB at Connecticut Children’s. After review of the updated 2022 allergy guidelines, meetings were held with our Clinical Pathway/Quality Improvement team that then expanded to include recommendations from Infectious Diseases and Allergy/Immunology divisions. This resulted in clinical consensus to 1) identify patients with penicillin allergy that are low risk for delabeling and 2) provide a clear protocol for direct oral penicillin challenge in the inpatient setting prior to discharge. Stake-holder buy-in was sought from nursing, pediatric residents, pharmacy, and Pediatric Hospitalist Medicine (PHM) to ensure alignment across end-users. Results Consensus recommendations were compiled in a visual algorithm. In summary, patients will be included if they have listed penicillin allergy and have been admitted to PHM with an infectious disease for which penicillin is the first line therapy. Exclusion criteria include prior anaphylaxis, angioedema, hypotension, or severe cutaneous reaction after receiving penicillin; critical illness; prior organ-specific drug injury from penicillins; recent receipt of steroids or antihistamines; current requirement for supplemental oxygen; and inability to receive enteral medications. If patient/family agree to the delabeling, the patient will receive a 45 mg/kg oral dose of amoxicillin (or amoxicillin-clavulanate if appropriate for the infectious condition) before discharge and they will be monitored for 1 hour for any immediate adverse reactions. If no reaction occurs, the allergy will be removed from the electronic medical record with documentation of the drug challenge in the EMR. Conclusion Our strategy to delabel penicillin allergy in hospital patients before discharge is evidence-based, low risk, supported by providers and pragmatic.