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Effectiveness and Feasibility of Pharmacist-Driven Penicillin Allergy De-Labeling Pilot Program without Skin Testing or Oral Challenges.

ABSTRACT: Documented penicillin allergies have been associated with an increased risk of adverse outcomes. The goal of this project was to assess the effectiveness and feasibility of a pharmacist-led penicillin allergy "de-labeling" process that does not involve labor-intensive skin testing or direct oral challenges. Adult patients with penicillin allergies were identified and interviewed by an infectious diseases pharmacy resident during a 3-month pilot period. Using an evidence-based standardized checklist, the pharmacist determined if an allergy qualified for de-labeling. In total, 66 patients were interviewed during the pilot period. The average time spent was 5.2 min per patient interviewed. Twelve patients (18%) met the criteria for de-labeling and consented to the removal of the allergy. Four patients (6%) met the criteria but declined removal of the allergy. In brief, 58.3% of patients (7/12) who were de-labeled and 50% of patients (2/4) who declined de-labeling but had their allergy updated to reflect intolerance were subsequently prescribed beta-lactam antibiotics and all (9/9, 100%) were able to tolerate these agents. A pharmacist-led penicillin allergy de-labeling process utilizing a standardized checklist is an effective and feasible method for removing penicillin allergies in patients without a true allergy.

SUBMITTER: Song YC

PROVIDER: S-EPMC8293328 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportancePenicillin allergies are frequently mislabeled, which may contribute to use of less-preferred alternative antibiotics.ObjectiveTo evaluate a pharmacist-led allergy assessment program's association with antimicrobial use and clinical outcomes.Design, setting, and participantsA pharmacist-led allergy assessment program was launched in 2 phases (June 1, 2015, and November 2, 2016) at a single-center tertiary referral hospital. The longitudinal cross-sectional study included all study period adult admissions; hospitalwide outcomes were assessed by segmented regression. Individual outcomes were assessed within an embedded propensity score-matched case-control study of inpatients undergoing comprehensive allergy assessment following self-report of penicillin allergy. Analysis occurred from March 1, 2020, to February 29, 2020.ExposuresThe longitudinal study analyzed hospital-level outcomes over 3 periods: preintervention (15 months), phase 1 (structured allergy history alone, 16 months), and phase 2 (comprehensive assessment including penicillin skin testing, 52 months). The case-control study defined cases as individuals undergoing comprehensive allergy assessment.Main outcomes and measuresHospital-level outcomes included antibiotic days of therapy per 1000 patient-days and hospital-acquired Clostridioides difficile infection (CDI) incidence per 10 000 patient-days. Individual outcomes included antibiotic selection, overall survival, and CDI-free survival.ResultsLongitudinal analysis spanned 2014-2020 (median admissions, 46 416 per year; interquartile range [IQR], 46 001-50 091 per year). Hospitalwide, allergy histories were temporally associated with decreased use of nonpenicillin alternative antibiotics (rate ratio, 0.87; 95% CI, 0.79-0.97) and high-CDI-risk antibiotics (rate ratio, 0.91; 95% CI, 0.85-0.98). Penicillin skin testing was temporally associated with lower hospital-acquired CDI rates (rate ratio, 0.61; 95% CI, 0.43-0.86). The embedded case-control study included 272 cases and 819 controls. Median age was 63 years (interquartile range, 51-73 years), 553 (50.7%) patients were women, and 229 (21.0%) patients were Black. Allergy-assessed patients were less likely to receive high-CDI-risk antibiotics at discharge (odds ratio, 0.66; 95% CI, 0.44-0.98). Estimated reductions in mortality (hazard ratio, 0.77; 95% CI, 0.55-1.07) and hospital-acquired CDI risk (hazard ratio, 0.53; 95% CI, 0.18-1.55) were not statistically significant.Conclusions and relevancePharmacist-led allergy assessments may be associated with reduced high-CDI-risk antibiotic use at both hospitalwide and individual levels. Although individual reductions in mortality and CDI risk did not achieve significance, divergence of survival curves suggest longer-term benefits of allergy delabeling warrant future study.

Project description:BackgroundAllergy documentation is frequently inconsistent and incomplete. The impact of this variability on subsequent treatment is not well described.ObjectiveTo determine how allergy documentation affects subsequent antibiotic choice.DesignRetrospective, cohort study.Participants232,616 adult patients seen by 199 primary care providers (PCPs) between January 1, 2009 and January 1, 2014 at an academic medical system.Main measuresInter-physician variation in beta-lactam allergy documentation; antibiotic treatment following beta-lactam allergy documentation.Key results15.6% of patients had a reported beta-lactam allergy. Of those patients, 39.8% had a specific allergen identified and 22.7% had allergic reaction characteristics documented. Variation between PCPs was greater than would be expected by chance (all p<0.001) in the percentage of their patients with a documented beta-lactam allergy (7.9% to 24.8%), identification of a specific allergen (e.g. amoxicillin as opposed to "penicillins") (24.0% to 58.2%) and documentation of the reaction characteristics (5.4% to 51.9%). After beta-lactam allergy documentation, patients were less likely to receive penicillins (Relative Risk [RR] 0.16 [95% Confidence Interval: 0.15-0.17]) and cephalosporins (RR 0.28 [95% CI 0.27-0.30]) and more likely to receive fluoroquinolones (RR 1.5 [95% CI 1.5-1.6]), clindamycin (RR 3.8 [95% CI 3.6-4.0]) and vancomycin (RR 5.0 [95% CI 4.3-5.8]). Among patients with beta-lactam allergy, rechallenge was more likely when a specific allergen was identified (RR 1.6 [95% CI 1.5-1.8]) and when reaction characteristics were documented (RR 2.0 [95% CI 1.8-2.2]).ConclusionsProvider documentation of beta-lactam allergy is highly variable, and details of the allergy are infrequently documented. Classification of a patient as beta-lactam allergic and incomplete documentation regarding the details of the allergy lead to beta-lactam avoidance and use of other antimicrobial agents, behaviors that may adversely impact care quality and cost.

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Effectiveness and Feasibility of Pharmacist-Driven Penicillin Allergy De-Labeling Pilot Program without Skin Testing or Oral Challenges.

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