Implementation of Penicillin Allergy De-Labeling Protocol at Freestanding Children’s Hospital within a Statewide Health System
Authors: Kussin Michelle L , Lex Amanda , Schneider Jack G , Manaloor John , Pritchard Haley , Vitalpur Girish 
Published: January 2025

Corresponding Author: Michelle L. Kussin, PharmD, BCOP, Riley Hospital for Children at Indiana University Health, Indiana University School of Medicine Ryan White Center for Pediatric Infectious Diseases & Global Health, 705 Riley Hospital Drive l Office 5862A l Indianapolis, IN 46202, 317.944.6674 (office) l 317.948.0860 (fax ID clinic) 317.948.5840 (fax pharm admin), mkussin@iuhealth.org

Alternate Corresponding Author: Girish Vitalpur, MD, FAAP, FAAAAI, No conflict, Indiana University School of Medicine Division of Pediatric Pulmonology, Allergy-Immunology, and Sleep Medicine, Riley Hospital for Children at Indiana University Health, 705 Riley Hospital Drive, ROC 4270 Indianapolis, IN 46202, TEL: 317-944-7493 or 317-948-7208 FAX: 317-944-5791, gvitalpu@iu.edu

No conflicts of interest.

Background

De-labeling of penicillin allergies aims to restore use of first-line antibiotic treatment options and reduce risk of adverse health outcomes, antimicrobial resistance, surgical site infections, duration of hospitalizations and increased overall health care costs that are associated with a penicillin allergy label.1-7 At Riley Hospital for Children and the statewide Indiana University Health (IUH) health system an inpatient beta-lactam allergy de-labeling protocol was implemented in 2020 to address inappropriate penicillin allergy labeling and offer penicillin skin testing, amoxicillin oral challenge, and/or cephalexin oral challenge based on clinical assessment.

Methods

This study is a retrospective chart review of electronic medical records (EMRs) at IUH hospitals from August 2020 to July 2023 for patients admitted to Riley Hospital for Children. The study aimed to evaluate impact of the IUH de-label algorithm, specifically, the oral antibiotic challenge and/or penicillin skin testing component for eligible candidates. A patient list was generated electronically, selecting for those with oral antibiotic challenge and/or penicillin skin testing orders in the inpatient EMR. Data collection variables included length of hospital stay, infection type, alternative antibiotic use, penicillin use after de-labeling, and results of skin tests and oral challenges.

Results

In total, 26 pediatric patients (100%) were de-labeled using the penicillin allergy de-labeling protocol. One patient was ordered for oral antibiotic challenge which was subsequently discontinued upon de-label by history alone, while all remaining patients underwent either oral challenge alone (19, 73%) skin testing plus oral challenge (5, 19%), or graded IV antibiotic challenge guided by allergy consult (1, 4%). All patients were admitted during the assessment and all but one patient completed the de-label process during their stay. One patient completed skin test in hematology-oncology infusion clinic, which was novel for our hospital, to accommodate patient schedule. The majority of allergy labels were to penicillin, amoxicillin, and/or amoxicillin/clavulanic acid (24, 92%), and the remaining involved cephalosporins. Of those de-labeled, the most common infections being treated at the time included skin and soft tissue infections (24%), bone and joint infections (20%), and community-acquired pneumonia (12%), however, need for antibiotics was not required by our protocol to be eligible for de-label. No patients required the use of a hypersensitivity kit due to an adverse reaction during the de-label process. Following de-label, 92% of patients were de-escalated to a narrower spectrum antibiotic and 40% were converted to a penicillin or a penicillin derivative for their current infection or received one of these antibiotics subsequently between time of de-label until time of chart review. On average, patients used 15 days of a narrower-spectrum antibiotic, thus sparing 350 days of broader-than-needed antibiotics, in total. Two patients were re-labeled with the beta-lactam allergy between the time of their original de-label and chart review, and re-labeled was documented once by a nurse and once by a medical assistant.

Conclusion

The beta-lactam allergy de-labeling protocol implemented at IUH was safe and effective at de-labeling pediatric patients at Riley Hospital for Children and resulted in the use of narrower-spectrum antibiotic courses. Additional effort is needed to prevent re-labeling of beta-lactam allergies.

References

1. Is it Really a Penicillin Allergy? Centers for Disease Control and Prevention. Accessed July 13, 2023.

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3. Macy E. Penicillin allergy: optimizing diagnostic protocols, public health implications, and future research needs. Curr Opin Allergy Clin Immunol. 2015;15(4):308-313. doi:10.1097/ACI.0000000000000173

4. Trubiano JA, Chen C, Cheng AC, et al. Antimicrobial allergy ‘labels’ drive inappropriate antimicrobial prescribing: lessons for stewardship. J Antimicrob Chemother. 2016;71(6):1715-1722. doi:10.1093/jac/dkw008

5. Trubiano JA, Thursky KA, Stewardson AJ, et al. Impact of an Integrated Antibiotic Allergy Testing Program on Antimicrobial Stewardship: A Multicenter Evaluation. Clin Infect Dis. 2017;65(1):166-174. doi:10.1093/cid/cix244

6. Blumenthal KG, Ryan EE, Li Y, Lee H, Kuhlen JL, Shenoy ES. The impact of a reported penicillin allergy on surgical site infection risk. Clinical Infectious Diseases. 2018;66(3):329-36. dio:10.1093/cid/cix794.

7. Copaescu AM, Vogrin S, James F, et al. Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy: The PALACE Randomized Clinical Trial. JAMA Intern Med. 2023 Sep 1;183(9):944-952.