Background: Inaccurate penicillin allergy labels (PALs) affect antimicrobial stewardship, health outcomes, and costs. More than 95% of PALs can be de-labeled when tested, but this rarely happens.
Objective: We sought to determine whether education and an electronic health record (EHR) tool kit to identify low-risk PALs would facilitate inpatient penicillin allergy de-labeling by pharmacists.
Methods: Pragmatic Removal of Penicillin Allergy Electronic Health Record Labels was a stepped-wedge, nonblinded, randomized, controlled, pragmatic clinical trial including 12 inpatient medical units. From November 2020 to November 2021, units entered intervention at 1-month stepped intervals in random order. Medically stable, nonpregnant adults with an her-documented PAL who were hospitalized on intervention units for 24 hours were included. The intervention included pharmacist and nursing education, a patient list for systematic identification of PALs, presentation of a risk-assessment tool, and an oral amoxicillin challenge order set. The primary outcome was removal of PAL by hospital discharge. Secondary outcomes included safety and implementation measures, longer-term continued label removal, and antibiotic use.
Results: On 12 randomized units, 2,052 patients with a PAL presented during the 1-year trial. More intervention-exposed patients had EHR-documented penicillin allergy removal compared with controls (45 of 1,018 [4.4%] vs 31 of 1,034 [3%], respectively; adjusted odds ratio = 2.05; 95% CI, 1.08-3.91). More intervention-exposed patients received an EHR-documented penicillin allergy risk assessment than did controls (86 of 1,018 [8.4%] vs 27 of 1,034 [2.6%]; adjusted odds ratio = 6.42; 95% CI, 3.08-13.38). Moreover, 27 of 1,018 intervention patients (2.7%) received amoxicillin challenge compared with 21 of 1,034 control patients (2.0%). All amoxicillin challenges were tolerated.
Conclusion: Education and deployment of an inpatient EHR tool kit increased the rate of inpatient removal of inaccurate penicillin allergies before discharge.
Keywords: Allergy; De-labeling; Hospital; Implementation; Inpatient; Penicillin; Pharmacist; RCT; Trial.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.