Background: Penicillin allergies are commonly reported, yet many patients who carry this labelhave never had a true allergic reaction. A significant proportion of individuals with a reported childhoodpenicillin (PCN) allergy have been misdiagnosed, often due to viral illnesses that were incorrectlyattributed to the drug. This mislabeling leads to suboptimal antibiotic use, including unnecessaryavoidance of penicillin and other beta-lactam antibiotics.
Purpose: The purpose of this quality improvement (QI)initiative is to implement a safe, systematic protocol to de-label patients with a low-risk penicillin allergyin a primary care setting by conducting oral amoxicillin challenges. The goal is to safely assess whetherpatients can tolerate amoxicillin, thereby optimizing future antibiotic prescribing and reducing theoveruse of broad-spectrum antibiotics.
Description: The protocol applies to patients with a documented history of a benign rash withoutmucosal involvement or systemic symptoms that occurred more than five years ago. We conduct a thorough patient screening to ensure eligibility based on specified criteria. Patients with histories of severe allergic reactions such as anaphylaxis or severe cutaneous adversereactions (SCAR) are excluded. Protocol to be conducted in the outpatient setting in the Morrell InternalMedicine Clinic. Patients with a remote history (≥5 years) of benign rash without systemic ormucosal involvement attributed to penicillin will be enrolled for de-labeling after providing informedconsent. On the day of testing, baseline vitals will be documented. An oral amoxicillin challenge will beperformed using a two-step protocol: an initial dose of 125 mg followed by a 30-minute observation with vitals reassessment, then a 500 mg dose with an additional 60-minuteobservation with vitals assessment, if no reaction occurs. Patients will be monitored on-site for immediatehypersensitivity reactions and instructed to self-monitor for delayed reactions over 48 hours. Those whotolerate the challenge will receive documentation de-labeling their penicillin allergy, with updates made totheir electronic health records. Outcomes and patient characteristics will be recorded in a dedicatedregistry for analysis.
Conclusions: Penicillin allergy labels, especially those based on childhood reactions, are ofteninaccurate and lead to unnecessary antibiotic restrictions. By offering a controlled and evidence-basedapproach, this initiative seeks to safely identify patients who no longer need the penicillin allergy label,improving antibiotic stewardship. The implementation of the oral amoxicillin challenge in our clinic willprovide a valuable opportunity to improve the accuracy of penicillin allergy documentation and optimizeantibiotic use. By conducting this QI initiative, we aim to enhance patient care and reduce theunnecessary use of broad-spectrum antibiotics, contributing to better health outcomes and improvedantibiotic stewardship. Currently, we are in the process of training clinic staff on the implementation ofthis protocol and identifying eligible patients. As we move forward, we will document the number ofpatients successfully de-labeled and evaluate the overall impact of the protocol.