The Feasibility and Applicability of Pediatric Inpatient Beta Lactam De-Labeling: From Bedside Challenge to Follow Up on Patient Chart Documentation

The Feasibility and Applicability of Pediatric Inpatient Beta Lactam De-Labeling: From Bedside Challenge to Follow Up on Patient Chart Documentation | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 9 January 2025 V1 Latest version Share on The Feasibility and Applicability of Pediatric Inpatient Beta Lactam De-Labeling: From Bedside Challenge to Follow Up on Patient Chart Documentation Authors : Michal Paret 0000-0002-7786-8751 [email protected] , Rinat Komargodski , Bella London , Hadas Paz , and Naama Epstein Rigbi 0000-0001-5321-1782 Authors Info & Affiliations https://doi.org/10.22541/au.173641463.38465697/v1 154 views 101 downloads Contents Abstract Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background. Beta-lactam allergy (BLA) labels are common in pediatric patients, but are often inaccurate, leading to unnecessary use of second line antibiotics. While direct oral challenge tests (OCTs) are effective for de-labeling, their incorporation in pediatric inpatient setting remains underexplored. This study aimed to assess the feasibility of implementing an inpatient pediatric BLA de-labeling program. Methods . A prospective study conducted in a pediatric ward involved inpatients undergoing a 2-step graded OCT. In-house pediatricians completed surveys to assess beliefs and barriers regarding inpatient OCT implementation. Follow-up included caregiver surveys and review of hospital and Health Maintenance Organization (HMO) electronic medical records (EMRs). Results. Of 192 eligible BLA-labeled patients, 32 (16.6%) were recruited, 93.8% carrying an amoxicillin allergy label and the vast majority without other drug allergy labels. All patients had a history of a mild reaction, 100% presented with a benign rash. 30/32 (93.4%) had a negative OCT. Pediatricians faced challenges such as workload pressures, staff shortages and overestimation of severe reaction risks, all serving as barriers for patient recruitment. At follow-up (median 37 months), 35.7% of caregivers reported de-labeling, while EMRs documented higher rates (HMO: 80%l; hospital: 70%). Despite successful OCTs, gaps in caregiver understanding and pediatrician support persisted. Conclusions . While direct OCTs are proved to be effective in de-labeling BLA, significant challenges persist in implementing inpatient de-labeling and ensuring their long-term success. These include low recruitment rates, pediatricians’ misconceptions and incomplete integration into EMRs. Addressing these barriers requires targeted education, improved communication and streamlined processes to improve de-labeling outcomes and support antibiotic stewardship. The Feasibility and Applicability of Pediatric Inpatient Beta Lactam De-Labeling: From Bedside Challenge to Follow Up on Patient Chart Documentation Michal Paret* 1,2 , MD, Rinat Komargodski* 3,4 , Bella London 1,2 , MD, Hadas Paz 1,2 , MD, Naama Epstein Rigbi 2,5 , MD. Pediatric Department, Shamir Medical Center, Israel 1 , Tel-Aviv University, The Faculty of Medical and Health Science, Israel 2 Pharmacy Services, Shamir Medical Center, Israel 3 , School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem 4 , The Institute of Allergy, Immunology and Pediatric Pulmonology, Shamir Medical Center, Israel 5 * These authors contributed equally to this work Running Title: Pediatric Inpatient Beta Lactam de-labeling Corresponding author: Michal Paret [email protected] Word Count: 3015 Tables: Four Figures: One Conflict of interest statement: The authors report no conflicts of interest related to this study. ABSTRACT Background. Beta-lactam allergy (BLA) labels are common in pediatric patients, but are often inaccurate, leading to unnecessary use of second line antibiotics. While direct oral challenge tests (OCTs) are effective for de-labeling, their incorporation in pediatric inpatient setting remains underexplored. This study aimed to assess the feasibility of implementing an inpatient pediatric BLA de-labeling program. Methods . A prospective study conducted in a pediatric ward involved inpatients undergoing a 2-step graded OCT. In-house pediatricians completed surveys to assess beliefs and barriers regarding inpatient OCT implementation. Follow-up included caregiver surveys and review of hospital and Health Maintenance Organization (HMO) electronic medical records (EMRs). Results. Of 192 eligible BLA-labeled patients, 32 (16.6%) were recruited, 93.8% carrying an amoxicillin allergy label and the vast majority without other drug allergy labels. All patients had a history of a mild reaction, 100% presented with a benign rash. 30/32 (93.4%) had a negative OCT. Pediatricians faced challenges such as workload pressures, staff shortages and overestimation of severe reaction risks, all serving as barriers for patient recruitment. At follow-up \RL (median 37 months), 35.7% of caregivers reported de-labeling, while EMRs documented higher rates (HMO: 80%l; hospital: 70%). Despite successful OCTs, gaps in caregiver understanding and pediatrician support persisted. Conclusions . While direct OCTs are proved to be effective in de-labeling BLA, significant challenges persist in implementing inpatient de-labeling and ensuring their long-term success. These include low recruitment rates, pediatricians’ misconceptions and incomplete integration into EMRs. Addressing these barriers requires targeted education, improved communication and streamlined processes to improve de-labeling outcomes and support antibiotic stewardship. Keywords : Beta-lactam allergy, de-labeling, oral challenge tests, pediatric inpatients, pediatricians’ perceptions. Key Message Direct Beta Lactam oral challenge testing is safe and effective for de-labeling low risk children during hospitalization. However, this process faces several barriers impeding it’s success, starting with difficulties in recruiting patients due to staff work overload, patient and caregiver refusal due to anxiety, and finally, implementing the negative challenge results into the medical charts. These barriers deserve special attention and focus to provide a collaborative, comprehensive and effective de-labeling approach for inpatient settings. Background: The prevalence of self-reported penicillin allergy varies widely ranging from 1% to up to 40% across different treatment populations (1–4), while in the pediatric population it is reported to range between approximately 1-10% (5,6). As research increasingly shows, approximately 1% of the population has had a mild immediate allergic reaction, whereas a true anaphylactic reaction occurs only in a minority of 0.1% (2,4,7,8). A reported Beta-Lactam Allergy (BLA) is associated with increased use of alternative second-line antibiotics, which tend to be more expensive (1,9,10), less effective, associated with higher complication rates (1,9–13), increased toxicity (9), and an elevated risk of a resistant pathogen infection (14). These consequences have driven a trend for active de-labeling of BLA as early and as efficiently as possible (9,15,16). An oral challenge test (OCT) with the culprit drug is considered the gold standard for confirming the lack of an IgE-mediated allergy to a specific drug (7,17,18). There is emerging evidence regarding the safety of direct OCT without prior skin testing in select low-risk populations with penicillin allergy, given the low sensitivity and limited accuracy of skin testing (18,19). The majority of the studies that addressed direct OCT were performed in ambulatory settings (17–19). Research focusing on inpatient de-labeling is limited, primarily involving adults with most studies using prior penicillin skin testing (10,20–23). Data on de-labeling pediatric inpatients during acute hospitalization remain scarce (24,25). Interestingly, even after a negative OCT leading to the de-labeling of BLA, not all patients resume the use of penicillin when needed. The reasons for this avoidance are varied, including lack of personal confidence in the safety of penicillin use, insufficient understanding of the challenge results and the primary physician’s refusal to prescribe penicillin (26). To the best of our knowledge, long term follow-up of children de-labeled during hospitalization including verification of de-labeling in medical records and assessment of caregivers’ perspectives is limited. This study aimed to evaluate the applicability of implementing an inpatient pediatric de-labeling program. This was prospectively examined in two major key aspects. First, the feasibility of patient recruitment and performing the OCT within the pediatric ward. Second, the long-term success of de-labeling assimilation, examining whether the BLA label was effectively removed from the medical records as well as understanding parental perceptions regarding the safe use of beta-lactam (BL). Setting and Data Collection This was a single-center prospective interventional study conducted at the pediatric ward of a tertiary care medical center between June 2019 to October 2024. Pediatric inpatients over 1 year of age, with a documented BLA label were identified via electronic medical records. Patients with a reported BLA label were screened for enrollment. Exclusion criteria included history of an immediate anaphylactic reaction, history of a reaction in the past 12 months, history of a severe delayed drug reaction (e.g. serum-sickness, acute generalized exanthematous pustulosis, drug-induced hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis), unstable medical condition and inability of parent/caregiver to sign informed consent. Medical history regarding the initial reaction to BL agent leading to allergy labeling was collected from caregivers according to their recollection. Eligible patients underwent a full allergy assessment using a standardized questionnaire supervised by study investigators. Informed consent was obtained by their caregivers prior to participation. The study was approved by the Institutional Ethical Review Board at Shamir Medical Center, Israel, . No funding was obtained to support this study. Oral Challenge Test Eligible patients were challenged with a 2-step oral graded challenge to amoxicillin. OCTs were undertaken during admission and were supervised by the primary team. The challenge was performed in 2 steps: a first dose comprised of 10% of the full dose followed by 30 minutes of observation and subsequent administration of a full therapeutic dose (50 mg per kg up to 500 mg). Patients were observed for 2 hours after the full therapeutic dose. Vital signs were recorded prior to each dose and at the end of observation of each step. Any positive reaction was treated immediately by the attending physician and the OCT was stopped at once. When in doubt of reaction, an allergist specialist was consulted. A negative OCT was recorded in the patient’s discharge letter along with a recommendation to remove the allergy label from the Health Maintenance Organization (HMO) electronic record, and for the safe future use of BL antibiotics if required. All caregivers were provided with a written document explaining the OCT performed and the implications of a negative result. The document also included explanations for the treating pediatrician, along with recommendations for allergy de-labeling from the HMO records. Follow up All patients were instructed to contact the principal investigator if any delayed reactions occurred. \RL Long term follow-up included phone surveys to caregivers during which they completed a questionnaire addressing whether the medical chart had been de-labeled and whether a BL agent had been administered since de-labeling. Additionally, electronic medical records (EMRs) within the HMO were reviewed by contacting the local primary care physician. Hospital EMRs were also examined to verify de-labeling in hospital system. Pediatric Ward Physicians’ Perspectives on BLA De-labeling During Hospital Admissions: In-House Survey A comprehensive survey was conducted among in-house pediatricians, both residents and attending physicians. The survey aimed to evaluate beliefs, concerns and perceptions regarding the de-labeling of BLA labels. Topics addressed included their understanding of BLA-labels risks, benefits of de-labeling, concerns regarding potential adverse reactions and logistical barriers such as work volume overload. Statistical Analysis Data are presented as numbers and percentages for nominal parameters and as median and interquartile range (IQR) for continuous variables. All statistical analysis was done with Excel (Microsoft Office 2019). Results Patient Demographics and Clinical Background Among 19,530 pediatric ward admissions from 2019 to 2024, 192 patients (1%) had a documented beta-lactam allergy label. Out of these patients 32 were recruited (16.7%), while 160 were either excluded based on exclusion criteria, not recruited due to patient/caregiver refusal, or missed due to lack of awareness among pediatricians. The median age was 5.7 years (IQR \RL 3.1-13.8), females comprised 37.5% of the group (n=12). A background of atopy was present in 40.6% of the patients. Only one patient (3.1%) had an additional drug allergy label, specifically to dipyrone. \RL Most patients (30/32, 93.8%) were labeled allergic to amoxicillin, with a single patient each labeled allergic to amoxicillin/clavulanic acid and cephalexin (3.1% each). Age at the time of allergy labeling was under one year in 25% of patients, between one and five years in 65.6%, between 5.1 and 12 years in 6.3%, and over 12 years in 3.1% ( Table 1 ). Regarding the initial reaction to BL leading to an allergy label, the interval between drug exposure and initial reaction varied. The majority (56.3%) reacted within 1-24 hours, 25% within 24 hours to 7 days, 15.6% after more than 7 days, and one patient (3.1%) reacted within one hour following drug exposure. A rash was recalled in all cases (100%), with 37.5% presenting urticaria, 34.4% maculopapular rash, and 28.1% other types of rashes. The duration of the rash was between one and seven days in 62.5%, was under one day in 18.8% of patients, and unknown in 18.8%. Angioedema and respiratory symptoms were each reported in one patient (3.1%), while no gastrointestinal or severe cutaneous adverse reactions were noted. Nearly 50% of the patients did not require anti-allergic treatment for the initial reaction (n=15), while antihistamines were administered to 40.6% (n=13) and systemic steroids to one patient (3.1%). Symptoms resolution occurred within 1-24 hours in 28.1% of cases, over 24 hours in 34.4%, and was unknown in 37.5%. After the allergy label was assigned, 12 patients subsequently received treatment with another BL: 6.3% were given amoxicillin and amoxicillin/clavulanic acid each, and 12.6% received either cephalexin or cefuroxime \RL ( Table 1 ). Despite the safe use of BLs, their BLA label remained documented in electronic records. De-labeling by Oral Challenge Test During Hospitalization The diagnosis admission was diverse and included respiratory indications (28.1%, n=9), gastrointestinal (18.8%, n=6), neurological (9.4%, n=3\RL(, urinary (3.1%, n=1), and other reasons (40.6%, n=13) ( Table 2 ). Additionally, 62.5% of patients (n=20) were admitted due to an infectious disease. A BL agent was indicated during hospitalization in 40.6% of the cases (n=13). The interval between admission and the BL challenge was a median of 2 days (IQR 2-3 days). Among the 15 patients with known timing of the initial allergic reaction, the median interval from the first reaction to the challenge was 2 years (IQR 1-4.8 years). Most patients safely tolerated the OCT without any allergic signs or symptoms, with 30/32 (93.4%) yielding negative results. Among the 2 patients (6.3%) who exhibited a positive reaction, one was classified with an immediate reaction occurring within 90 minutes of drug exposure, presenting as non-specific skin erythema. The other patient developed a mild maculopapular rash several hours after the OCT, which resolved within several days. Neither case required anti-allergic treatment. No cases of urticaria or angioedema were observed. Long-Term Follow-Up of Patients with Negative Beta-Lactam Challenge Tests Among the 30 patients with negative BL challenge tests, the median follow-up period was 37 months (IQR 9–55 months) ( Table 3 ). Two patients could not be reached by phone. Of the 28 patients contacted via phone survey, caregivers self-reported that only 10 children (35.7%) had been de-labeled, 9 (32.1%) retained their BLA label, and 9 (32.1%) were unaware of their child’s BLA label status. Among the 9 patients who were not de-labeled, the reasons included caregiver refusal (22.2%), pediatrician refusal (11.1%), documentation errors (22.2%), and unknown reasons (44.4%). Nine patients (32.1%) were re-exposed to the culprit BL, with no adverse reactions reported (100%). However, 17 patients (60.7%) did not use BLs after the negative challenge. Reasons for avoiding BL included lack of clinical indication (82.4%), parental/caregiver preference (11.8%), and pediatrician preference (5.9%). Upon review of the HMO charts through contact with primary care physicians s (n=30), 24 patients (80%) had their BLA de-labeled, 5 patients (16.7%) retained the label, and the status was unknown for 1 patient (3.3%). In comparison, the hospital EMR documented de-labeling of only 21/30 patients (70%) who had a negative BL challenge test. Pediatric Ward Physicians’ Perspectives on BLA De-labeling During Hospital Admission In the survey of 32 pediatric physicians working in the pediatric ward, 59.4% had over 5 years of medical experience, 25% had 1–5 years, and 15.6% had less than 1 year of experience. Half of the responders had performed a BLA de-labeling using an OCT prior to participating in the survey. The main barrier for conducting an OCT was the significant time it required, cited by 28.1% of responders as challenging during patient care in a busy pediatric ward. Concerns about the possibility of a severe allergic reaction were noted by 18.8%. Additionally, two responders felt the pediatric ward was not an appropriate setting for conducting an OCT (6.2%). Notably, nearly half (49.6%) of the participants expressed no concerns about conducting a direct challenge test during hospitalization ( Figure 1 ). In the survey, 78% agreed that second-line antibiotics alternatives are often less effective and may increase clinical complications. However, 72% of participants believed a child with a non-severe BLA label was at high risk of a severe reaction following a direct challenge test, and 65.2% preferred using a non-BL alternative for such cases ( Table 4 ). Discussion In this study, we evaluated the applicability and feasibility of performing an active de-labeling protocol in pediatric admitted patients, throughout all the stages of this process: patient recruitment, bed side OCT, caregiver education upon discharge and incorporation of the de-labeling into the HMO EMRs. Our main finding was that although direct OCTs are safe and have an extremely high success rate, all stages of the de-labeling process were met with challenges and barriers that impede and interfere with achieving the main goal of providing better healthcare. Among 19,530 admissions over a five-year period, 1% had a documented BLA label, aligning with the reported prevalence of 1-10% in the general pediatric population(5), although on the lower end of this range. Since data regarding pediatric BLA is sparse, this might reflect the more accurate prevalence of BL hypersensitivity labeling (6). In accordance to reported literature (6), the direct BL challenge yielded promising results for allergy de-labeling, with 93.4% (30/32) of patients showing no adverse reactions, suggesting that most children with BLA label are likely to be mislabeled (6,19,27). These results further highlight the potential for active de-labeling in the pediatric population and support the use of direct challenge testing to refine allergy histories and improve antibiotic stewardship. However, in this current study, we were able to recruit only a minority of patients, precisely 32 of 192 (16.6%), highlighting the significant barriers associated with the de-labeling process. In accordance with our findings, and despite a vast body of literature depicting the success and good safety of direct OCT in both pediatric and adult outpatients, (26,27), there are, to our knowledge, only few studies examining the active de-labeling of pediatric inpatients (25,28,29). These studies showed a good safety profile for direct OCTs, but the recruitment rate varied from 7.7% (29) to 15.7% (28). These studies suggest that while active de-labeling of inpatients is promising, it is underutilized, with only a small proportion of eligible patients receiving this intervention. One of the obstacles in recruiting patients originated from factors such as parental anxiety leading to refusal, most likely attributed to the acute hospital setting. During hospitalization, the primary focus is on the child’s acute medical condition, leading to reduced engagement in what might be perceived as a “secondary” outcome. In a study offering a direct OCT for low risk children in the Emergency Department (ED) (30), 59% of parents felt uncomfortable with this procedure performed in the ED, with 72% attributing this concern to fear of an allergic reaction. This contrasts to the ambulatory setting, where caregivers are often highly engaged, having taken the initiative to schedule and attend the appointment for de-labeling, which ensures their focused attention on the test and its results. Indeed, in a different study assessing parent perspective on OCT in an allergy center (31), 63% felt comfortable undergoing this process. These findings are emphasized by a vast number of outpatient direct de-labeling studies (10,18,26,32–34) versus very few inpatient studies, both in pediatric (25,29) as well as adult (22,35,36) populations. An additional significant challenge arose from the in-house pediatricians, revealing barriers such as time constraints, fear of severe reactions, and the belief that the pediatric ward is unsuitable for performing a direct drug allergy test. Additionally, although most responders recognized the clinical disadvantages of second-line antibiotics, 72% believed children with non-severe BL allergy labels remain at high risk for severe reactions during challenges, reflecting a potential overestimation of risk. These barriers have been shown in other studies (31) and were addressed through the implementation of staff education and assessment tools. Importantly, despite the high rate of negative challenge tests, several barriers in implementing long-term de-labeling were evident. At follow-up, only 35.7% of patients were reported as de-labeled from the caregiver perspective, and nearly one-third retained their allergy label due to reasons such as parental or pediatrician refusal, documentation errors, and lack of understanding the challenge results. Interestingly, EMR reflected a higher rate of de-labeling (HMO: 80%, hospital: 70%), indicating discrepancies between caregiver reports and clinical documentation. However, even the documentation in medical records did not fully capture the higher actual success rate of de-labeling achieved during admission. The long-term follow-up outcomes after a negative challenge test have been previously reported as challenging, even in ambulatory settings (34). A study performed by Lachover-Ruth et al, examining long-term de-labeling results in patients with BLA found that over 50% of patients continued to carry a penicillin allergy label despite an uneventful OCT (26). Additionally, nearly 40% of the cohort refused to use penicillin due to various reasons including lack of personal confidence in safety of penicillin, misunderstanding the results and refusal of family physicians to prescribe penicillin. The low implementation of the negative OCT into the EMRs highlights the need for improved communication, education and coordination between patients, primary physicians and the inpatient medical system. Addressing these gaps is crucial for future medical encounters, as parent-reported BLA reactions may lead to the automatic reintroduction of the allergy label into the EMR, preserving unnecessary restrictions and suboptimal antibiotic use. These barriers put together raise the question whether direct OCTs performed during hospitalization are a feasible form of de-labeling. Globally, there have been different initiatives focused on improving antibiotics stewardship (31,36). First and foremost, effort has been put into staff education, both of primary and secondary care set-ups, and in the implementation of de-labeling programs after screening for low-risk patients (35–37). However, these are still to be proved feasible and therefore complementary approaches are needed as well. In Southern California, for example, cephalosporine warnings were removed from EMRs in patients with penicillin allergy labels, increasing the administration of cephalosporines without showing negative outcomes such as anaphylaxis(38). This simple and rapidly implementable system-level intervention may be useful for improvement in antibiotic stewardship. The main limitation of this study is the small sample size, attributed to caregiver refusal and challenges in patient recruitment, as discussed above. Moreover, data regarding patients who were not de-labeled was not collected, and therefore information is missing regarding prior reactions and the clinical background of all patients documented with a BLA label. Additionally, the reasons for patient refusal as well as the reasons for not performing an OCT, were not documented, . Documentation of these could have helped assemble a better outlook on barriers and challenges. In conclusion, this study demonstrates that though direct BL challenge testing is a safe and effective method for de-labeling inpatient children, it withholds several barriers, from patient recruitment, engaging primary in house pediatricians and ultimately implementing the de-labeling in EMRs. Future studies should focus on strategies to enhance better implementation of a collaborative de-labeling approach in the hospital setting, led by the allergy team but actively carried out by primary care teams. Additionally, more focus should be dedicated to promoting broader education of the public and primary caregivers to further encourage proactive de-labeling of out-patients. Acknowledgments We would like to thank the whole staff of the pediatric ward at The Shamir Medical Center, including residents, senior pediatricians and nurses, for taking part in patient recruitment, directing oral challenge tests and answering the study questionnaire. We would also like to thank our patients for actively participating in this study. References: 1. Lucas M, Arnold A, Sommerfield A, Trevenen M, Braconnier L, Schilling A et al. Antibiotic Allergy Labels in Children Are Associated with Adverse Clinical Outcomes. J Allergy Clin Immunol Pr 2019; 7 :975–982.2. Graham F, Tsabouri S, Caubet JC. Hypersensitivity reactions to beta-lactams in children. Curr Opin Allergy Clin Immunol 2018; 18 :284–290.3. Castells M, Khan D, Phillips EJ. Penicillin Allergy. NEJM 2019; 6 :2338–2351.4. 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Patient demographic and clinical background Demographics and clinical background Age (years) 5.7 (3.1-13.8) Gender (Female) 12 (37.5%) Atopic Background 13 (40.6%) Other drug allergy label 1 (3.1%) Culprit BLA label Allergy label Amoxicillin 30 (93.8%) Amoxicillin/Clavulanic Acid 1 (3.1%) Cephalexin 1 (3.1%) Age when allergy label given 12 years 1 (3.1%) Interval from drug exposure to reaction <1 hour 1 (3.1%) 1 hour-24 hours 18 (56.3%) 24 hours - 7 days 8 (25%) More than 7 days 5 (15.6%) Initial reaction Rash 32 (100%) Urticaria 12 (37.5%) Maculopapular 11 (34.4%) Other rash 9 (28.1%) Duration rash < 1 day 6 (18.8%) 1-7 days 20 (62.5%) Not known 6 (18.8%) Angioedema 1 (3.1%) Respiratory symptoms 1 (3.1%) Gastrointestinal symptoms 0 Severe cutaneous adverse reaction 0 Treatment \RL administered for initial reaction No treatment 15 (46.9%) Antihistamines 13 (40.6%) systemic steroids 1 (3.1%) Time to symptom resolution < 1 hour 0 1 hour-24 hours 9 (28.1%) More than 24 hours 11 (34.4%) Not known 12 (37.5%) Use of other BLA since allergy label BLA treatment (n=12) Amoxicillin ¶ 2 (6.3%) Amoxicillin/Clavulanic Acid 2 (6.3%) Cephalexin 4 (12.6%) Cefuroxime 4 (12.6%) Categorical variables presented as numbers and percentage; Continuous Variables presented as median and interquartile ranges. BLA= beta lactam antibiotics. ¶ Two patients with Amoxicillin allergy label received Amoxicillin Table 2. De-labeling by oral challenge test during hospitalization Clinical Admission Background Diagnosis admission Respiratory 9 (28.1) Gastrointestinal 6 (18.8) Urinary tract 1 (3.1) Neurological 3 (9.4) Other 13 (40.6) Admission due to Infectious disease 20 (62.5) BLA indicated during hospitalization 13 (40.6) Direct BLA Challenge Interval between admission to challenge (days) 2 (2-3) Interval from initial reaction to challenge (years) (n=15) 2 (1-4.8) Challenge result Negative 30 (93.4) Positive 2 (6.3) Positive Reaction Challenge (n=2) Type of reaction challenge (n=2) Immediate ¶ 1 (50) Delayed 1 (50) Symptoms reaction (n=2) Maculopapular rash 1 (50) Urticaria 0 Angioedema 0 Other rash 1 (50) Treatment reaction (n=2) No treatment 2 (100) Antihistamines 0 Systemic steroids 0 Duration of rash Less than 1 day 2 (100) More than 1 day 0 Categorical variables presented as numbers and percentage; Continuous Variables presented as median and interquartile ranges. BLA= beta lactam allergy ¶ In this patient presented as mild skin erythema Table 3. Long Term follow-up for patients with a negative oral challenge test \RL outcome (n=30) Interval challenge to follow up (months) 37 (9-55) De-labeling Status: Parent /Caregiver perspective (n=28) ¶ Status of BL Allergy label according to parent/caregiver (n=28) BLA de- labeled 10 (35.7) BLA NOT de-labeled 9 (32.1) Status unknown 9 (32.1) Reason for NOT de-labeling (n=9) Parent/Caregiver refusal 2 (22.2) Pediatrician refusal 1 (11.1) Documentation Error 2 (22.2) Unknown 4 (44.4) Culprit BL used after challenged-labeling (n=28) ¶ Yes 9 (32.1) No 17 (60.7) Unknown 2 (7.1) Reaction to BL upon re-introduction (n=9) Yes 0 No 9 (100) Reason for avoiding BL (n=17) Not indicated 14 (82.4) Parent/caregiver preference 2 (11.8) Pediatrician preference 1 (5.9) De-labeling Status: HMO EMR (n=30) Status of BL Allergy label according to HMO EMR BLA de- labeled 24 (80) BLA NOT de-labeled 5 (16.7) Status unknown 1(3.3) De-labeling Status: Hospital EMR (n=30) Status of BL Allergy label according to Hospital EMR (n=30) BLA de- labeled 21 (70) BLA NOT de-labeled 9 (30) Categorical variables presented as numbers and percentage; Continuous Variables presented as median and interquartile ranges BL= beta lactam; HMO= health maintenance organization; EMR= electronic medical records ¶ Two patients were lost to follow-up Table 4. Pediatrician Survey: Perspectives and Beliefs on Beta-Lactam Allergy De-Labeling (n-=32) ”Patients with a BLA label (non-anaphylaxis) have an elevated risk of developing an immediate hypersensitivity reaction during oral challenge testing” 23 (71.9%) 8 (25%) 1 (3.1%) ”Patients with BLA label face increased risk of complications due to use of second-line antibiotics” 7 (21.9%) 14 (43.8%) 11 (34.4%) ”Administration of a non-beta-lactam agent to patients with BLA label (non-anaphylactic) - is preferred to minimize the risk of hypersensitivity reactions” 20 (65.2%) 9 (28.1%) 3 (9.4%) BLA: Beta Lactam Allergy Figure Legend Figure 1. Barriers and concerns of ward pediatricians regarding oral challenge tests (OCTs). 32 ward pediatricians answered the survey aimed to understand their perceptions regarding the conduction of OCTs during hospital admission. Information & Authors Information Version history V1 Version 1 09 January 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Authors Affiliations Michal Paret 0000-0002-7786-8751 [email protected] Tel Aviv University Faculty of Medicine View all articles by this author Rinat Komargodski Shamir Medical Center Assaf Harofeh View all articles by this author Bella London Tel Aviv University Faculty of Medicine View all articles by this author Hadas Paz Tel Aviv University Faculty of Medicine View all articles by this author Naama Epstein Rigbi 0000-0001-5321-1782 Tel Aviv University Faculty of Medicine View all articles by this author Metrics & Citations Metrics Article Usage 154 views 101 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Michal Paret, Rinat Komargodski, Bella London, et al. 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