Low-risk penicillin allergy delabeling through a direct oral challenge in immunocompromised and/or multiple drug allergy labeled patients in a critical care setting.
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ABSTRACT:
SUBMITTER: Koo G
PROVIDER: S-EPMC9188986 | biostudies-literature | 2022 Jun
REPOSITORIES: biostudies-literature
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Low-risk penicillin allergy delabeling through a direct oral challenge in immunocompromised and/or multiple drug allergy labeled patients in a critical care setting.
Koo Grace G Stollings Joanna L JL Lindsell Christopher C Dear Mary Lynn ML Kripalani Sunil S Nelson George E GE McCoy Allison B AB Rice Todd W TW Phillips Elizabeth J EJ Stone Cosby A CA
The journal of allergy and clinical immunology. In practice 20220205 6
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Project description:The penicillin allergy label has been consistently linked with deleterious effects that span the health care spectrum, including suboptimal clinical outcomes, the emergence of bacterial resistance, and increased health care expenditures. These risks have recently motivated professional organizations and public health institutes to advocate for the implementation of penicillin allergy delabeling initiatives; however, the burden of delabeling millions of patients is too expansive for any one discipline to bear alone. This review presents the unique perspectives and roles of various stakeholder groups involved in penicillin allergy diagnosis, assessment, and delabeling; we emphasize opportunities, barriers, and promising areas of innovation. We summarize penicillin allergy methods and tools that have proven successful in delabeling efforts. A multidisciplinary approach to delabeling patients with reported penicillin allergy, bolstered by evidence-based clinical practices, is recommended to reduce the risks that associate with the penicillin allergy label.
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Project description:BackgroundPenicillin (PCN) allergy labels are widely recognized to be highly inaccurate. Little is known about parental perceptions of the PCN allergy evaluation and removal process, especially in the hospital setting.MethodsFocus groups were held with parents of children and adolescents with a PCN allergy label discharged from a large academic children's hospital between January 1, 2019, and April 15, 2020. The open-ended, semistructured moderator guide included questions about PCN allergy testing and evaluation, accuracy of the PCN allergy diagnosis, amoxicillin oral challenges, delabeling process, and preferred setting for PCN allergy delabeling evaluation (outpatient clinic, hospital, etc). Study investigators coded the transcripts and identified underlying themes using inductive and deductive thematic analysis.ResultsA total of 21 parents and 2 adolescents participated across 4 focus groups. We developed a theoretical framework depicting key elements of parents' and adolescents' experiences with PCN allergies, consisting of 4 major interconnected themes: (1) family context; (2) the invitation to delabel; (3) decision context; and (4) the PCN delabeling outcome. PCN allergies remained a concern for families even if their children passed an oral challenge. Some parents preferred testing to be performed in the hospital and felt this was a safer location for the procedure.ConclusionsParents are amenable to hospital based PCN allergy evaluation and delabeling. Further studies should incorporate parental and patient preferences to implement safe and effective PCN allergy delabeling processes in the hospital setting.
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Project description:Penicillin allergy delabeling is an important component of antimicrobial stewardship and improves patient outcomes. We demonstrated the successful use of a nurse-initiated questionnaire to remove inappropriate penicillin allergy labels in inpatients. Nurses can play a key role in improving antibiotic allergy assessment and more broadly in interprofessional antimicrobial stewardship.
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Project description:BackgroundPenicillin allergy labels are often inaccurate in children and removing unnecessary labels results in improved outcomes and lower health care costs. Although the hospital setting is a frequent point of contact for children, strategies to evaluate penicillin allergies in the hospital are lacking.MethodsWe performed a prospective pilot study to determine the feasibility of a centralized, pharmacy-led approach to penicillin allergy evaluation. Children with a reported history of penicillin allergy admitted to our children's hospital were risk-stratified and those stratified as low-risk underwent a single-dose oral challenge by a central pharmacist, regardless of the need for antibiotics. After the completion of each patient's delabeling process, surveys were distributed to health care personnel involved in the patient's care to collect perceptions on the acceptability, appropriateness, and feasibility of this intervention. Measures were scored by using a 5-point Likert scale.ResultsOf the 23 patients who screened as low-risk, 20 underwent a penicillin allergy evaluation and an oral challenge. Of these, the penicillin allergy label was removed in 19 (95%) patients (Fig 1). The median age was 7 years (range 11 months-18 years). Participants rated the risk stratification and delabeling favorably overall, with high ratings on all 3 implementation measures: acceptability (mean 4.55, ± standard deviation [STD] 0.65), appropriateness (mean 4.58, STD ± 0.6), and feasibility (mean 4.51, STD ± 0.73). Measures of acceptability, appropriateness, and feasibility remained high when stratified by health care worker type and provider type.ConclusionsOur findings provide support for systemic implementation of penicillin allergy delabeling strategies in hospitalized children.
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Project description:BackgroundApproximately 10% of people have an unverified penicillin allergy, with multiple personal and public health consequences.ObjectivesTo assess the efficacy and safety of direct oral challenge, without prior skin testing, in this population.MethodsMEDLINE, EMBASE, CINAHL, the Cochrane Library and Google Scholar were searched from inception to 28 June 2020 (updated November 2020) to find published and unpublished studies that reported direct oral challenge for the purpose of removal of penicillin allergy labels. Population weighted mean was used to calculate the proportion of patients who developed an immediate or delayed reaction to direct oral challenge across the studies.ResultsThirteen studies were included in the review, with a sample size of 1202 (range 7-328). Studies included inpatient and outpatient cohorts assessed as low risk for true allergy. In pooled analysis of all 13 studies there were 41/1202 (3.41%) mild immediate or delayed reactions to direct oral challenge. The population-weighted mean incidence of immediate or delayed reaction to an oral challenge across studies was also 3.41% (95% CI: 2.38%-4.43%). There were no reports of serious adverse reactions, 96.5% of patients could be de-labelled and many were subsequently successfully treated with penicillin.ConclusionsDirect oral challenge is safe and effective for de-labelling patients assessed as low risk for true allergy. Non-specialist clinicians competent in using an assessment algorithm can offer evaluation of penicillin allergy labels using direct oral challenge in appropriate patients. These measures will facilitate optimal infection treatment for patients, support antimicrobial stewardship, and minimize antimicrobial resistance.
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Project description:In a cross-sectional study of 20 Massachusetts long-term care (LTC) facilities, 19% (n = 449) of residents received antibiotics, with approximately one-third having a documented penicillin allergy. This documented allergy decreased the likelihood of prescribing beta-lactam antibiotics for infections. Improved penicillin allergy assessments and delabeling could optimize antibiotic prescribing in LTC settings.
| S-EPMC11488468 | biostudies-literature
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.
| S-EPMC8120333 | biostudies-literature
Project description:Efforts to delabel penicillin allergic patients are important as the majority of suspected penicillin allergy can be ruled out by relevant allergy testing. The aim is to change the antibiotic pattern in delabeled patients to minimize use of unnecessary broad-spectrum antibiotics, reducing the risk of antimicrobial resistance and making treatment more cost effective. However, published information on subsequent antibiotic use is scarce. To evaluate the effect of delabeling on subsequent antibiotic use in primary care, a cohort of 2911 patients tested for penicillin allergy was compared to a matched control group of 14,522 individuals from the background population. In total 86.4% of the tested patients were delabeled. For delabeled patients, penicillin use increased from 0.07 prescriptions per patient year before allergy investigation, to 0.53 prescriptions per patient year post investigation (p < 0.001). The use of fluoroquinolones and macrolides was reduced and reached a level comparable to the background population. This study shows that penicillin allergy delabeling has significant positive impact on subsequent antibiotic use in primary care, and that penicillin use increases to levels similar to the background population. Penicillin allergy delabeling should be prioritized as an important and efficient element in antimicrobial stewardship initiatives.
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Project description:ObjectiveThe huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of 'point-of-care' tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling.MethodsThis prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC.ResultsN = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors.InterpretationDPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings.
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Project description:Secondary prevention with penicillin aims to prevent further episodes of acute rheumatic fever and subsequent development of rheumatic heart disease (RHD). Penicillin allergy, self-reported by 10% of the population, can affect secondary prevention programs. We aimed to assess the role for (i) routine penicillin allergy testing and the (ii) safety of penicillin allergy delabeling approaches in this context. We searched MEDLINE, Embase, CENTRAL, ClinicalTrials.gov, WHO ICTRP, ISRCTN, and CPCI-S to identify the relevant reports. We found 2419 records, but no studies addressed our initial question. Following advice from the WHO-Guideline committee and experts, we identified 6 manuscripts on allergy testing focusing on other populations showing that the prevalence of allergy confirmed by testing was low and the incidence of life-threatening reactions to BPG was very low (< 1-3/1000 individuals treated). A subsequent search addressed penicillin allergy delabeling. This found 516 records, and 5 studies addressing the safety of direct oral drug challenge vs. skin testing followed by drug administration in patients with suspected penicillin allergy. Immediate allergic reactions of minor severity were observed for a minority of patients and occurred less frequently in the direct drug challenge group: 2.3% vs. 11.5%; RR = 0.25, 95%CI 0.15-0.45, P < 0.00001, I2 = 0%. No anaphylaxis or deaths were observed. Severe allergic reactions to penicillin are extremely rare and can be recognized and dealt by trained healthcare workers. Confirmation of penicillin allergy diagnosis or delabeling using direct oral drug challenge or penicillin skin testing seems to be safe and is associated with a low rate of adverse reactions.
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