Amoxicillin Challenge Research Articles

Single dose amoxicillin challenges are safe for the evaluation of pediatric penicillin allergy

Single dose amoxicillin challenges are safe for the evaluation of pediatric penicillin allergy

Rising to the Challenge: An ID Provider-Led Initiative to Address Penicillin Allergy Labels at a Large Veterans Affairs Medical Center.

Given the negative consequences associated with a penicillin allergy label, broader penicillin allergy delabeling initiatives are highly desirable but hindered by the shortage of allergists in the United States. To address this problem at our facility, the infectious diseases section introduced a quality improvement initiative to evaluate and remove allergy labels among inpatient veterans. Between 15 November 2022 and 15 December 2023, we identified inpatients with a penicillin allergy label. We subsequently interviewed eligible candidates to stratify penicillin allergy risk and attempt to remove the allergy label directly via chart review, following inpatient oral amoxicillin challenge or outpatient community care allergy referral. Delabeling outcomes, subsequent penicillin-class prescriptions, and relabeling were tracked after successful allergy label removal. We screened 272 veterans, of whom 154 were interviewed for this intervention. A total of 53 patients were delabeled: 26 directly, 23 following oral amoxicillin challenge, and 4 following outpatient allergy referrals. Of the patients who were delabeled, 25 received subsequent penicillin-class prescriptions. No adverse reactions occurred following inpatient oral amoxicillin challenges. Patients with a low-risk penicillin allergy history were more likely to undergo a challenge if admitted with an infectious diseases-related condition. Only 1 inappropriate relabeling event occurred during the study period, which was subsequently corrected. An infectious diseases provider-led initiative resulted in penicillin allergy label removal in more than one third of inpatients evaluated using direct removal or oral amoxicillin challenge. Efforts focused on patients who had been admitted for infections were particularly successful.

True Rate of Allergy among Pediatric Inpatients with Penicillin Allergy Labels (TRIAL).

Penicillin allergy is a common drug allergy diagnosis in pediatric patients; however, upon appropriate allergy testing, many of these patients are found not to have a true allergy. For patients with a reported allergy, alternative antibiotics are prescribed, which are less effective, more toxic, or more expensive. There is a lack of data evaluating allergies in hospitalized children and comparing allergy assessments conducted by pediatric allergists and pharmacists. To estimate the percentage of pediatric patients admitted with reported penicillin allergy who did not have a true penicillin allergy. This single-centre prospective cohort study included inpatients between 6 months and 17 years of age, with a documented penicillin allergy, who were admitted to the general pediatric and oncology units of a tertiary care children's hospital between November 2019 and March 2023. The allergy history, evaluation, and risk categorization were performed by pharmacists. The history was reviewed with the allergist, and the patient was then referred, underwent skin testing, or received oral amoxicillin challenge with monitoring for 1 hour. Thirty patients were included, of whom 29 (97%) had delabelling of their penicillin allergy. Four patients (13%) had delabelling on the basis of history alone, without risk assessment. Twenty-five (83%) of the patients were assessed as having low risk; 24 of these had delabelling following oral challenge, and 1 did not complete the oral challenge because of transfer to another hospital. One patient (3%) was assessed as having moderate risk, with delabelling on the basis of results of skin testing and oral challenge. The pharmacist's and allergist's risk assessments were in agreement in 29 (97%) of the 30 cases. Pediatric patients, including those with oncologic malignancies, are often mislabelled as having a penicillin allergy. Pharmacists are able to accurately determine true allergy risk and delabel penicillin allergies for pediatric patients in the hospital setting.

Safe Penicillin Allergy Delabeling in Primary Care: A Systematic Review and Meta-Analysis

BackgroundTen % of the population is labeled as allergic to penicillin(s), when in fact 90% of these labels are inappropriate. Recent studies have shown that inpatient de-labelling by a direct drug challenge (dDC) is safe in low-risk patients. However, there is a need for outpatient and non-allergist de-labelling. ObjectiveTo assess the safety of de-labelling low-risk adults by means of dDC in primary care. MethodsWe searched MEDLINE, EMBASE and the Conchrane Library databases, from inception to March 15, 2022 (updated June 5, 2023) for studies performing dDC in adults in primary care or other outpatient settings. Two researchers independently screened studies for eligibility. The data extraction and critical appraisal was performed by one reviewer and we pooled the results in a meta-analysis. ResultsOut of 2,138 results, 12 studies (1070 participants) were eligible for inclusion. Three studies evaluated de-labelling in primary care and 9 studies in an outpatient hospital setting. There were no critical adverse events during dDC. No reaction occurred in 97.13% of the 1070 patients, who previously labeled as penicillin-allergic, and were safely de-labelled. Ten patients (<1%) developed an immediate reaction: three had self-limiting reactions, and seven needed antihistaminics, steroids, epinephrine and/or salbutamol. ConclusionNo serious allergic reactions are observed during direct amoxicillin challenge in adults in an outpatient setting. However, with the exception of one recent report, these studies are of low to moderate quality. Non-specialist de-labelling is promising but further research is required on correct risk stratification and safety assessment in large cohort studies evaluating dDC in primary care.

Beta-Lactam Allergy De-labeling in a Pediatric Hospital.

To assess the ability to de-label pediatric patients of their beta-lactam allergy by using a newly implemented institutional protocol and to identify potential barriers to the de-labeling process. All patients with reported allergies to prespecified beta-lactam antibiotics were eligible for a -beta-lactam allergy interview. Following the interview, patients were grouped into 4 risk categories-no risk, low risk, moderate risk, and high risk-and assessed for intervention eligibility. Potential interventions included de-labeling based on the interview alone or proceeding to an oral amoxicillin challenge with or without penicillin allergy skin testing. Of the 62 patients eligible for beta-lactam allergy interviews, 40% (n = 25) were de-labeled. Among de-labeled patients, 60% (n = 15) were de-labeled on the basis of the interview alone. Additionally, no failures were documented in patients who underwent an oral amoxicillin challenge or penicillin skin testing. Barriers to performing oral amoxicillin challenges or penicillin skin testing included concomitant systemic steroid or antihistamine use, refusal of intervention, and insufficient resources to perform penicillin skin testing. There was a high frequency of patients de-labeled of their beta-lactam allergies in this study. Increased education to patients, parents, and providers on the de-labeling process, as well as increased personnel available to coordinate and perform de-labeling interventions, may result in more beta-lactam allergy de-labeling.

Multisite primary care led amoxicillin challenge pathway to safely remove penicillin allergy label

Multisite primary care led amoxicillin challenge pathway to safely remove penicillin allergy label

Oral amoxicillin challenges for low-risk penicillin-allergic patients at a large Veterans Affairs facility: a retrospective feasibility analysis.

We retrospectively reviewed the records of 136 veterans with a penicillin allergy label during a quality improvement initiative. We identified 82 inpatients eligible for removal of penicillin allergy by oral amoxicillin challenge, including 40 out of 82 (48%) still eligible after accounting for other limiting factors.

1259. Successful Inpatient Penicillin Delabeling in Minimal and Low Risk Penicillin Allergic Patients

Abstract Background In the US, 10% of adults report a Penicillin (PCN) allergy but true IgE-mediated or serious reactions are rare. A PCN allergy label carries risk for harm including fewer first-line treatment options, increased antimicrobial resistance, toxicities, surgical site infections, and death. The objective of this study was to identify and safely remove penicillin allergy labels in eligible hospitalized patients. Methods Between June 2022 - February 2023, the Antimicrobial Stewardship team electronically identified hospitalized patients with documented PCN allergy admitted to adult internal medicine wards at Rush University Medical Center (RUMC), an academic hospital in Chicago, IL. Patients with possible minimal or low risk PCN allergy reactions via chart review were administered a standardized questionnaire, followed by triage into Minimal, Low, and Moderate Risk PCN allergy categories (Figure 1). Minimal Risk patients were delabeled by history alone, or per patient request, after amoxicillin challenge. Low risk patients were offered an amoxicillin challenge with a single 500mg oral dose. Moderate or high risk patients were excluded. Penicillin Allergy Risk Stratification Results Of 47 interviewed patients, 31 patients (20 minimal and 11 low risk) were appropriate for delabeling. 27 of 31 (87%) were successfully delabeled via history or amoxicillin challenge; 4 were not delabeled, due to patient discomfort or early discharge. 14 of the 31 (45%) were delabeled based on history alone; all had tolerated amoxicillin before. 13 amoxicillin challenges were administered, 9 of 11 patients in low risk, 4 of 20 in minimal risk group per patient request. 100% of amoxicillin challenges were well tolerated and patients successfully delabeled. Only 1 patient was relabeled at a subsequent hospitalization. Penicillin Delabeling Results Conclusion In this proof-of-concept intervention, patients with a minimal or low risk penicillin allergy were safely delabeled as inpatients by history or amoxicillin challenge. Expanding this to a larger scale on the inpatient and outpatient settings would enable more patients with PCN allergy to be delabeled, leading to use of standard of care antibiotics and improved outcomes. Disclosures All Authors: No reported disclosures

The role of major and minor determinants in penicillin allergy testing: Time to revisit an old friend?

Skin testing is an important step in evaluation of penicillin allergic reactions. It includes testing to the following: amoxicillin, benzyl penicillin, and products generated invivo after penicillin administration, the major determinant hapten penicilloyl-polylysine (PPL) and the minor determinant mixture (MDM). Although PPL and MDM are available as a commercial kit, their supply and cost remain problematic. We aimed to evaluate the performance and utility of PPL and MDM in penicillin allergy testing. A retrospective audit over a 5-year period was undertaken for those with penicillin testing in a tertiary immunology unit. In all, 214 patients were identified. Of those patients, 151 (70.6%) were female and the average age was 58 years. Unspecified penicillin was the most common index drug (n=127 [59.3%]), followed by amoxicillin (n=3 [24.8%]) and amoxicillin-clavulanic acid (n= 21 [9.7%]). The result of skin testing was positive in 23 patients (10.7%); skin prick testing was positive in 10 patients (4.7%), and intradermal testing (IDT) was positive in 13 patients (6.1%), the majority of whom had identified amoxicillin or amoxicillin-clavulanic acid as the index drug (n= 22 [95.7%]). The result of testing to PPL and/or MDM was positive with IDT only (n=5 [23.8%]). PPL and MDM positivity coexisted with a positive reaction to amoxicillin IDT in 2 patients, 1 of whom passed an amoxicillin challenge. Additionally, 2 positive tests to PPL were present with a negative result for MDM; of these 2 positive results, 1 was positive to amoxicillin IDT. In only 1 case were the results of testing for MDM and PPL both positive, with negative results to all native β-lactams tested; the patient tolerated an amoxicillin challenge. Overall, the negative predictive value for both skin prick testing and IDT was 89.5%. Benzyl penicillin and amoxicillin alone may be sufficient for invivo testing in suspected individuals with penicillin allergy.

Multisite Oral Amoxicillin Challenges During Pediatric Emergency Department Visits

Multisite Oral Amoxicillin Challenges During Pediatric Emergency Department Visits

83 Success of Amoxicillin Oral Challenges in Children at Low Risk of Allergy Requiring Antibiotic in the Emergency Department

Abstract Background Up to 10% of children are labelled as penicillin allergic, requiring the use of suboptimal antibiotics as an alternative. In these children, a low-risk oral challenge with amoxicillin can be done to evaluate the accuracy of this allergy. An oral challenge pre-written order was implemented in our institution’s emergency department (ED). Objectives The aim of this study was to assess the success of the amoxicillin oral challenges in children labelled penicillin allergic in the ED. Design/Methods This is an ongoing prospective observational study conducted at a tertiary care paediatric hospital. Children considered at low risk of penicillin allergy (https://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Medicaments/Outil_aide-decision_allergies-EN_VF.pdf) and requiring amoxicillin according to the ED physician were prescribed an amoxicillin challenge according to a pre-written order set. In the absence of a reaction, patients were discharged with an amoxicillin prescription. Parents were contacted one month after the challenge to assess for late-onset reactions. Results Since June 2021, 70 children (24 female) underwent an amoxicillin challenge in the ED (Figure 1). The patients’ median age was 1 yo (6 months–12 yo). The most frequent discharge diagnoses in the ED were otitis media (65%) and pneumonia (24%). The challenge was successful in the ED for 69/70 (99%) patients. Sixty-two (89%) patients were successfully contacted for a follow-up phone call. Among them, 55/62 (89%) did not present any reaction. In total, 7/62 (11%) of the children had a reported reaction, one (1%) child had an immediate reaction to the challenge in the ED, while 6/62 (10%) had a rash appearing 1 to 61 days after the first dose of antibiotics. No severe reactions were reported by the parents after discharge from the ED. A correlation between the amoxicillin administration and the delayed reaction was considered less likely for 3/6 patients because of the later onset of symptoms (28-61 days). The three other patients were considered not to have a penicillin allergy after formal assessment at the allergy clinic. Conclusion Using a standardized pre-written order set for an amoxicillin challenge in the ED allowed 99% of participating children to be discharged safely with an amoxicillin prescription. Despite 10% presenting a rash after discharge, none were considered to have a late-onset reaction. This removed safely and rapidly the label of “penicillin allergy” from those paediatric ED patients, allowing optimal first-line antibiotics. It also eliminates the need for a consultation with an allergist in the majority of patients.

Short-Term Dietary Intervention with Whole Oats Protects from Antibiotic-Induced Dysbiosis.

Antibiotic-induced gut microbiome dysbiosis (AID) is known to be influenced by host dietary composition. However, how and when diet modulates gut dysbiosis remains poorly characterized. Thus, here, we utilize a multi-omics approach to characterize how a diet supplemented with oats, a rich source of microbiota-accessible carbohydrates, or dextrose impacts amoxicillin-induced changes to gut microbiome structure and transcriptional activity. We demonstrate that oat administration during amoxicillin challenge provides greater protection from AID than the always oats or recovery oats diet groups. In particular, the group in which oats were provided at the time of antibiotic exposure induced the greatest protection against AID while the other oat diets saw greater effects after amoxicillin challenge. The oat diets likewise reduced amoxicillin-driven elimination of Firmicutes compared to the dextrose diet. Functionally, gut communities fed dextrose were carbohydrate starved and favored respiratory metabolism and consequent metabolic stress management while oat-fed communities shifted their transcriptomic profile and emphasized antibiotic stress management. The metabolic trends were exemplified when assessing transcriptional activity of the following two common gut commensal bacteria: Akkermansia muciniphila and Bacteroides thetaiotaomicron. These findings demonstrate that while host diet is important in shaping how antibiotics effect the gut microbiome composition and function, diet timing may play an even greater role in dietary intervention-based therapeutics. IMPORTANCE We utilize a multi-omics approach to demonstrate that diets supplemented with oats, a rich source of microbiota-accessible carbohydrates, are able to confer protection against antibiotic-induced dysbiosis (AID). Our findings affirm that not only is host diet important in shaping antibiotics effects on gut microbiome composition and function but also that the timing of these diets may play an even greater role in managing AID. This work provides a nuanced perspective on dietary intervention against AID and may be informative on preventing AID during routine antibiotic treatment.

Virtually supported penicillin allergy de-labelling during COVID-19

BackgroundPenicillin allergy is a commonly listed medication allergy despite rare overall incidence. Many patients erroneously have this label, which has personal, health, and societal costs. Penicillin allergy delabelling requires an oral challenge, which can be a rate limiting step in the de-labeling process; this is even more relevant with the reduction of in-person visits during the COVID-19 pandemic.ObjectiveTo identify the utility and broader applicability of using a virtually supported platform, initially adopted given COVID-19 restrictions, to expedite penicillin oral provocation challenge and penicillin de-labeling in patients at low to moderate risk of immediate hypersensitivity reaction and based on shared decision making.MethodsPatients in Vancouver catchment area were referred for penicillin allergy and virtually assessed by the consulting allergist between July 2020 and April 2021. Those deemed appropriate for oral challenge based on the allergist consultant were offered the option of a virtual oral provocation challenge to oral amoxicillin in a subsequent virtual visit. Patients who agreed and were consented underwent a virtually supervised oral amoxicillin challenge during the second virtual visit. Findings are summarized in this case series.ResultsTwenty-three patients, both adult and pediatric, ranging from no to significant co-morbidities were consented and underwent the virtual challenge. One hundred percent of patients were successful with no reaction after an hour post virtual oral provocation challenge with amoxicillin.ConclusionVirtual medicine is likely to remain in the allergist’s practice. Virtually supported penicillin allergy delabelling, based on shared decision making and risk stratification, presents another pathway for penicillin allergy delabelling.

Direct oral amoxicillin challenge for the outpatient evaluation of brazilian children and adolescents with low risk reactions

Antibiotic allergy labels contribute to longer hospitalizations, development of drug-resistant strains and are associated with increased costs and resource burdens for outpatient and hospital healthcare. Amoxicillin Direct Oral Challenge (DOC) may be safe and effective to delabeling low risk patients.

Beta lactam allergies in a large obstetric population: developing an allergy testing referral system

Beta lactam antibiotics are frequently indicated in obstetric care. We aim to describe beta lactam allergies in our obstetric population, improve identification and documentation of IgE-mediated allergies, and develop an expedited referral pathway for allergy relabeling. A retrospective chart review of beta lactam allergies in our patients who delivered within 2019-2020 was performed. A prospective referral system for allergy testing was then implemented from January-June 2022. Patients with previously documented allergies were flagged in the electronic medical record (EMR). Provider and patient education were provided to guide referrals. Allergy testing included skin testing and a graded amoxicillin challenge. Of the 7788 patients who delivered within 2019-2020, 365 (4.7%) reported beta lactam allergies. Penicillin (233, 63.8%) and amoxicillin (82, 22.5%) were the most common (Table 1). Of the patients with group B streptococcus colonization, 64/79 (81.0%) received an antibiotic other than penicillin. Forty-six patients received an antibiotic other than cefazolin (46/115, 40%) for cesarean perioperative prophylaxis. Chorioamnionitis was treated in 24 patients, and 21/24 (87.5%) received a regimen other than ampicillin/gentamicin. Since January 2022, 72 patients with reported beta lactam allergies were identified in one obstetric clinic (Figure 2). Of those, 54 (75%) were appropriately screened by their primary provider. Nine patients (9/54, 16.7%) were not referred due to recent anaphylaxis or lack of a IgE allergy. Nineteen patients (26.4%) have completed allergy testing thus far: 18/19 patients (94.7%) patients tolerated testing without allergic reaction and their beta lactam allergy was removed from the EMR. Beta lactam allergies are commonly reported by obstetric patients, which contributes to alternative antibiotic use. Patients can benefit from an expedited referral process for allergy testing to improve antibiotic stewardship in obstetrics. We have demonstrated the implementation of a successful multidisciplinary referral system for this testing.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

967. Safety Outcomes of a Hospital-wide β-Lactam Graded Challenge Allergy Protocol

Abstract Background Up to 15% of hospitalized patients report a penicillin allergy, but most can tolerate a β-lactam (BL). Use of second-line non-BL antibiotics poses untoward health consequences. Assessing for true penicillin allergies includes penicillin skin testing (PST) and a direct amoxicillin challenge, each with their own limitations in hospitalized patients. For inpatients, a graded challenge (GC) with the desired BL offers a streamlined approach for many who could benefit from a first-line BL agent. In 2019, a hospital-wide BL Allergy Assessment and Clinical Pathway was implemented, including a BL GC protocol for low-risk patients. This study aimed to assess the safety of the GC procedure in hospitalized patients. Methods A retrospective, observational cohort study of adult inpatients who completed a GC procedure between Sept 2019 – Sept 2021 was conducted. Primary objective: determine the incidence of a significant hypersensitivity reaction from a BL GC. Secondary objectives: 1) determine the incidence of a non-hypersensitivity reaction and 2) identify antimicrobial stewardship interventions in those tolerant to a BL GC (e.g. antibiotic switch to a BL with completion of treatment course and de-labeling of penicillin allergy). Results Fifty-one patients completed a GC procedure. Most (78%) had a reported allergy to penicillin vs. other BL antibiotics. Reported allergic reactions stratified by risk for a serious hypersensitivity episode were: low/reaction &amp;gt; 10 yrs ago – 33%; moderate-high/reaction &amp;gt; 10 yrs ago – 47%, and moderate-high/reaction &amp;lt; 5 yrs ago – 19.6%. A PST prior to a GC was performed in 75% of patients. Common GC agents included amoxicillin-clavulanate (16%), amoxicillin (12%) and ceftriaxone (12%). One patient experienced a hypersensitivity reaction managed with diphenhydramine and another patient had a non-hypersensitivity reaction. Both cases were non-life-threatening. Of the 49 patients who tolerated a GC, 76% were switched to a BL with completion of treatment course, and 84% of documented penicillin allergies were de-labeled or clarified in the electronic medical record. Conclusion The GC procedure in our hospitalized patients was generally well tolerated including those with an allergy history concerning for a moderate-high risk hypersensitivity reaction. Disclosures Nathaniel J. Rhodes, PharmD, MSc, American Academy of Colleges of Pharmacy: Grant/Research Support|Paratek: Grant/Research Support|Third Pole Therapeutics: Advisor/Consultant Marc H. Scheetz, PharmD, MSc, Abbvie: Advisor/Consultant|Allecra: Grant/Research Support|Merck: Advisor/Consultant|Nevakar: Advisor/Consultant|Nevakar: Grant/Research Support|Premier Healthcare Solutions: Honoraria|Spero: Advisor/Consultant|SuperTrans Medical: Advisor/Consultant|SuperTrans Medical: Grant/Research Support|Takeda: Advisor/Consultant|Third Pole Therapeutics: Advisor/Consultant.

559. Inpatient Allergy Delabeling of Pediatric Patients with Low-Risk Penicillin Allergy Status through Direct Graded Oral Amoxicillin Challenge

Abstract Background Only 1% of patients with penicillin allergy are truly allergic but it remains the most common drug allergy reported. Studies show that direct oral challenge is a safe method to delabel low-risk patients using institutional screening stratification tools. There is no verified universal screening tool to perform this function, underscoring the need to address this clinical gap. This study aims to assess the efficacy of our institutional screening questionnaire at correctly stratifying penicillin allergy risk status and determine whether direct graded oral amoxicillin challenge can be safely used to delabel patients with low-risk penicillin allergy status. Figure 1Flow chart showing patient categorization based on penicillin allergy risk status and subsequent disposition following screening. Methods This was a pilot prospective study to verify penicillin allergy status among patients 3-18 years old in our institution from September 2021-March 2022. Patients were stratified using institutional screening questionnaire to no-risk, low-risk and high-risk penicillin allergy status. Low-risk patients underwent direct graded oral amoxicillin challenge using an institutional algorithm and delabeled based on their response to the testing. No-risk patients were delabeled without challenge testing. High-risk patients were referred to allergy. Results Ninety-two patients were identified with penicillin allergy. Forty (43.5%) of the 92 patients were screened using our institutional screening questionnaire. Of the 40 screened patients, 6 (15%) were identified as no-risk, 28 (70%) were identified as low-risk, and 6 (15%) were identified as high-risk. Twenty-four (86%) of the 28 low-risk patients were eligible for direct amoxicillin oral challenge. Seventeen (71%) of the 24 consented to the challenge testing but only 12 (70%) underwent direct amoxicillin oral challenge. Eleven (92%) of the 12 who underwent oral challenge were successfully delabeled. Five (83%) of the 6 no-risk patients were successfully delabeled. Three (50%) of 6 high-risk patients were referred to allergy. Overall, 16 (40%) of the 40 patients who were screened were successfully delabeled. Conclusion Our institutional risk stratification screening tool is effective at identifying penicillin allergy risk status and direct graded oral amoxicillin challenge is a safe initiative to delabel patients with low-risk penicillin allergy status. Disclosures All Authors: No reported disclosures.

567. The Quality &amp; Management of Penicillin Allergy Labels in a Pediatric Birth Cohort

Abstract Background Penicillin allergy labels (PALs) influence antibiotic prescribing, yet little is known about the quality and management of PALs placed in the pediatric outpatient setting. Methods We performed a retrospective chart review of 500 randomly selected children with PALs from a ten-year birth cohort (n=18,015) from Texas Children’s Pediatrics and Children’s Hospital of Philadelphia Primary Care Networks. PALs were classified as “not allergy” (family history, isolated diarrhea), “low risk” (maculopapular rash &amp;gt;24 hours into antibiotic course, no hives or pruritis), “moderate or high risk” (hives or pruritis, maculopapular rash &amp;lt; 24 hours into antibiotic course, anaphylaxis, swelling, or respiratory symptoms), “severe cutaneous reaction” (erythema multiforme, serum sickness), or “unable to classify” (information not available or unspecified rash characteristics or timing) based on 1) information in the allergy tab and 2) encounter notes. We used kappa-statistic measure-of-agreement to determine allergy classification agreement between the allergy tab and notes. Results The median age of PAL placement was 1.4 years (IQR 0.9, 2.2). Most (n=303, 63%) PALs were placed by physicians. Half of PALs were categorized as “unable to classify; physicians were just as likely to place ambiguous PALs as other providers (48 vs 53%, p=0.31). Most (80%) children were evaluated at a primary care office within 1 week of their reaction. There was fair agreement between the allergy tab and encounter note documentation (Table 1). Of 54 (11%) children evaluated by an allergist, 25/25 passed an oral amoxicillin challenge. Only 69 (14%) children were de-labeled during the study period, more by an allergist (48%) than in the community (9.6%, p&amp;lt; 0.001). Table 1.Risk stratification by penicillin allergy label and notes. Conclusion PAL classification was ambiguous in half of labeled children; there was fair risk classification agreement between the allergy tab and notes. Children with PALs were rarely referred to allergists or de-labeled in the community. Future quality improvement efforts should seek to improve PAL documentation and access to allergy services. Disclosures Debra Palazzi, MD, MEd, AAP: Board Member|AHRQ: Grant/Research Support|AMA: Board Member|Elsevier: Honoraria.

Single-step Direct Drug Provocation Testing is Safe for Delabelling Selected Non−low-risk Penicillin Allergy Labels

To describe the outcome of an oral amoxicillin challenge in patients labeled allergic to penicillin.One hundred forty nine patients from 1 to 98 years of age labeled allergic to penicillin were included in the study.Patients were categorized as low risk (side effects, family history of penicillin allergy, remote [>5 years] history of penicillin allergy without IgE-mediated features, or unknown reaction not requiring hospitalization, n = 64) or nonlow risk (anaphylaxis, urticaria within 2 hours of penicillin administration, or angioedema with or without urticaria, n = 85). The low risk patients underwent challenge with a single dose of oral amoxicillin (125 mg for patients 1 to 11 months of age, 250 mg for 1 to 11 years, and 500 mg for all patients more than 12 years) followed by 2 hours of observation to evaluate for Gell and Coombs type 1/IgE-mediated/immediate-type hypersensitivity reactions. The nonlow risk patients underwent penicillin skin testing and if negative, oral amoxicillin challenge. Excluded patients were those with history of: (1) Gell and Coombs type 2 reactions, for example, hemolytic anemia or thrombocytopenia; (2) type 3 reactions, for example, serum sickness or vasculitis; or (3) severe type 4 or severe cutaneous adverse reactions, for example, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis or drug reaction with eosinophilia and systemic symptoms.All (64 of 64, 100%) of the low risk patients tolerated the amoxicillin challenge without reaction during the observation period, although 3 developed a maculopapular rash subsequently. All (85 of 85, 100%) of the nonlow risk patients had negative penicillin skin testing, and 84 of 85 (99%) tolerated the amoxicillin challenge without reaction during the observation period, whereas 1 patient developed pruritus and rash that resolved with antihistamine treatment, and 2 subsequently developed a maculopapular rash.The authors conclude that a single step oral amoxicillin challenge is safe.Six percent of children are reported to be allergic to penicillin, although only about 5% of that 6% (0.3%) have positive penicillin skin tests. The remainder either never had IgE-mediated allergy or the allergy was lost over time. Being mislabeled as allergic to penicillin is not benign, but rather leads to suboptimal treatment, more side effects (eg, Clostridium difficile), higher costs, and more antibiotic resistance. Thus, there is currently a strong push to “delabel” the vast majority of children who are labeled as allergic to penicillin but are not. Children are typically referred to allergists to undergo oral amoxicillin challenges under observation with or without prior penicillin skin testing, depending on the history. However, this paper suggests that, given the safety of these challenges, consideration can be given to performing them in pediatricians’ offices. If a careful history excludes patients with histories of “nonlow risk” immediate allergic reactions and those with serious nonimmediate reactions, the remainder with low risk histories can undergo a single dose oral amoxicillin challenge, which the vast majority will tolerate and can be successfully “delabeled.”URL: www.pediatrics.org/cgi/doi/10.1542/peds.10.1016/j.anai. 2021.04.008

PENICILLIN ALLERGY DELABELLING IN A PEDIATRIC PRIMARY CARE SETTING

<h3>Introduction</h3> Penicillin allergy labels are common in childhood; however, over 95% of patients with a penicillin allergy label can safely tolerate penicillin. Previous studies have demonstrated the safety and efficacy of direct amoxicillin challenges in children with a penicillin allergy label. Novel strategies are needed to increase access to penicillin allergy testing beyond specialist centers. We report the initial results of a prospective pilot study of pediatric primary care-driven direct amoxicillin challenges in delabeling penicillin allergy. <h3>Methods</h3> Children (2-18 years old) with a penicillin allergy label presenting for a routine visit at an outpatient general pediatrics clinic were recruited. Patients with an index history consistent with a severe cutaneous adverse reaction to penicillins were excluded. A two-step direct amoxicillin challenge (total dose 250mg) was offered with a 60 minute observation during which patients completed their routine pediatrician visit. Delayed symptoms were assessed via phone call 7-10 days post challenge. The primary outcome was the number of patients for which direct amoxicillin challenge was completed. <h3>Results</h3> Of 87 patients screened, 58 were eligible, 39 were interested in participating, and 12 completed amoxicillin challenges so far. Fear of worsened reaction was the most reported reason for not proceeding with challenge. All 12 children who underwent graded amoxicillin challenge passed without any immediate reactions. At the 7-10 day follow-up, only one patient had a delayed rash which had resolved with oral antihistamines. <h3>Conclusion</h3> These preliminary results demonstrate that graded oral amoxicillin challenges can be performed in the pediatric primary care setting during routine visits.