Geisinger Antibiotic Allergy Pilot Program: Assess and Address

Summary

This is a prospective non-inferiority study to evaluate penicillin allergy history in patients with reported penicillin allergy, who require penicillin or penicillin-derivative antibiotic during inpatient admission using a focused questionnaire. A simplified scoring system will be assigned to patient responses, and the total score will be utilized to identify low-risk patients that have a minimal risk of allergic reactions on exposure to penicillin or its derivative. Patients determined to have low risk based on this questionnaire will be offered a test dose (graded challenge) of amoxicillin in a supervised setting, and if they tolerate it, penicillin allergy label will be removed from patient's chart. We hypothesize that at least 95% of low-risk patients will successfully pass the graded amoxicillin challenge so the penicillin allergy label can be removed from their charts. A proportion as low as 0.85 would be a good clinical outcome and considered non-inferior to the expected proportion of 0.95.

Timeline

Start

2024-03-04

Primary completion

2026-01-20

Completion

2026-01-20

Publications

• Background Blumenthal KG, Phillips EJ. Positioning Drug Allergy Delabeling as a Critical Tool for Precision Medicine, Quality Improvement, and Public Health. J Allergy Clin Immunol Pract. 2020 Oct;8(9):2916-2919. doi: 10.1016/j.jaip.2020.07.046. Epub 2020 Aug 8. No abstract available.
• Background Louisias M, Wickner P. Drug allergy delabeling in the clinical setting: An all-hands-on-deck opportunity. Ann Allergy Asthma Immunol. 2020 Jun;124(6):542-543. doi: 10.1016/j.anai.2020.02.017. Epub 2020 Mar 6. No abstract available.
• Background Evaluation and Diagnosis of Penicillin Allergy for Healthcare Professionals | Community | Antibiotic Use | CDC. Published January 16, 2019. Accessed March 11, 2021. https://www.cdc.gov/antibiotic-use/community/for-hcp/Penicillin-Allergy.html
• Background Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010 Oct;105(4):259-273. doi: 10.1016/j.anai.2010.08.002.
• Background Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin "allergy" in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014 Mar;133(3):790-6. doi: 10.1016/j.jaci.2013.09.021. Epub 2013 Nov 1.
• Background Blumenthal KG, Lu N, Zhang Y, Li Y, Walensky RP, Choi HK. Risk of meticillin resistant Staphylococcus aureus and Clostridium difficile in patients with a documented penicillin allergy: population based matched cohort study. BMJ. 2018 Jun 27;361:k2400. doi: 10.1136/bmj.k2400.
• Background Parikh P, Patel NC, Trogen B, Feldman E, Meadows JA. The economic implications of penicillin allergy. Ann Allergy Asthma Immunol. 2020 Dec;125(6):626-627. doi: 10.1016/j.anai.2020.08.003. Epub 2020 Aug 6. No abstract available.
• Background Livirya S, Pithie A, Chua I, Hamilton N, Doogue M, Isenman H. Oral amoxicillin challenge for low-risk penicillin allergic patients. Intern Med J. 2022 Feb;52(2):295-300. doi: 10.1111/imj.14978. Epub 2022 Jan 12.
• Background Krishna MT, Misbah SA. Is direct oral amoxicillin challenge a viable approach for 'low-risk' patients labelled with penicillin allergy? J Antimicrob Chemother. 2019 Sep 1;74(9):2475-2479. doi: 10.1093/jac/dkz229.
• Background Trubiano JA, Vogrin S, Chua KYL, Bourke J, Yun J, Douglas A, Stone CA, Yu R, Groenendijk L, Holmes NE, Phillips EJ. Development and Validation of a Penicillin Allergy Clinical Decision Rule. JAMA Intern Med. 2020 May 1;180(5):745-752. doi: 10.1001/jamainternmed.2020.0403.
• Background Artino AR Jr, La Rochelle JS, Dezee KJ, Gehlbach H. Developing questionnaires for educational research: AMEE Guide No. 87. Med Teach. 2014 Jun;36(6):463-74. doi: 10.3109/0142159X.2014.889814. Epub 2014 Mar 24.
• Background Brown TM. Design and interpretation of non-inferiority studies: A clinician's perspective. J Nucl Cardiol. 2017 Dec;24(6):1994-1997. doi: 10.1007/s12350-017-1034-5. Epub 2017 Aug 10. No abstract available.
• Background Schumi J, Wittes JT. Through the looking glass: understanding non-inferiority. Trials. 2011 May 3;12:106. doi: 10.1186/1745-6215-12-106.
• Background Antibiotic Prescribing and Use. CDC. 2017 Oct; https://www.cdc.gov/antibiotic-use/clinicians/penicillin-allergy.html

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