Risk of Self-Reported Penicillin Allergy Despite Removal of Penicillin Allergy Label: Secondary Analysis of the PALACE Randomized Clinical Trial.
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SUBMITTER: Copaescu AM
PROVIDER: S-EPMC11327879 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
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Risk of Self-Reported Penicillin Allergy Despite Removal of Penicillin Allergy Label: Secondary Analysis of the PALACE Randomized Clinical Trial.
Copaescu Ana Maria AM Vogrin Sara S Douglas Abby A Turner Nicholas A NA Phillips Elizabeth J EJ Holmes Natasha E NE Trubiano Jason A JA
JAMA network open 20240801 8
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Project description:ObjectivesIn high-income countries, up to 25% of inpatients have a self-reported penicillin allergy (PA). After testing, 95% of these self-reported PAs are incorrect. These incorrectly labelled PAs increase the use of broad-spectrum antibiotics, and drive bacterial resistance. The epidemiology of PA in low- and middle-income countries is unknown. We aimed to describe the epidemiology and delabelling outcomes of self-reported PA in South African (SA) inpatients.MethodsWe conducted point prevalence surveys between April 2019 and June 2021 at seven hospitals in Cape Town, South Africa. A team trained in the PEN-FAST allergy decision tool conducted in-person interviews, and reviewed patient notes to identify and risk stratify inpatients with a self-reported PA. These patients were referred to the Groote Schuur Hospital (GSH) allergy clinic for delabelling.ResultsA total of 1486 hospital inpatients were surveyed and 3.2% (n = 48) carried a PA label. Importantly, 64.6% (n = 31) were classified by PEN-FAST as low risk for true penicillin hypersensitivity. Overall, 25% of the self-reported PAs received a β-lactam antibiotic in hospital and were directly delabelled. Delabelling attrition was very high, with 6.3% (3/48) of the self-reported PAs attending the GSH allergy clinic, and only one patient proceeding to a negative oral penicillin challenge.ConclusionsInpatient self-reported PA was lower in South Africa hospitals compared with other upper-middle-income countries, and the majority of patients carried a low-risk PA label. Linkage for delabelling with the allergy clinic was very poor, and thus strategies to improve access and delivery of delabelling remains an urgent public health issue.
| S-EPMC9942546 | biostudies-literature
Project description: Not available
| S-EPMC7554064 | biostudies-literature
Project description:ImportanceFewer than 5% of patients labeled with a penicillin allergy are truly allergic. The standard of care to remove the penicillin allergy label in adults is specialized testing involving prick and intradermal skin testing followed by an oral challenge with penicillin. Skin testing is resource intensive, limits practice to specialist-trained physicians, and restricts the global population who could undergo penicillin allergy delabeling.ObjectiveTo determine whether a direct oral penicillin challenge is noninferior to the standard of care of penicillin skin testing followed by an oral challenge in patients with a low-risk penicillin allergy.Design, setting, and participantsThis parallel, 2-arm, noninferiority, open-label, multicenter, international randomized clinical trial occurred in 6 specialized centers, 3 in North America (US and Canada) and 3 in Australia, from June 18, 2021, to December 2, 2022. Eligible adults had a PEN-FAST score lower than 3. PEN-FAST is a prospectively derived and internationally validated clinical decision rule that enables point-of-care risk assessment for adults reporting penicillin allergies.InterventionsPatients were randomly assigned to either direct oral challenge with penicillin (intervention arm) or a standard-of-care arm of penicillin skin testing followed by oral challenge with penicillin (control arm).Main outcome and measureThe primary outcome was a physician-verified positive immune-mediated oral penicillin challenge within 1 hour postintervention in the intention-to-treat population. Noninferiority was achieved if a 1-sided 95% CI of the risk difference (RD) did not exceed 5 percentage points (pp).ResultsA total of 382 adults were randomized, with 377 patients (median [IQR] age, 51 [35-65] years; 247 [65.5%] female) included in the analysis: 187 in the intervention group and 190 in the control group. Most patients had a PEN-FAST score of 0 or 1. The primary outcome occurred in 1 patient (0.5%) in the intervention group and 1 patient (0.5%) in the control group, with an RD of 0.0084 pp (90% CI, -1.22 to 1.24 pp). The 1-sided 95% CI was below the noninferiority margin of 5 pp. In the 5 days following the oral penicillin challenge, 9 immune-mediated adverse events were recorded in the intervention group and 10 in the control group (RD, -0.45 pp; 95% CI, -4.87 to 3.96 pp). No serious adverse events occurred.Conclusions and relevanceIn this randomized clinical trial, direct oral penicillin challenge in patients with a low-risk penicillin allergy was noninferior compared with standard-of-care skin testing followed by oral challenge. In patients with a low-risk history, direct oral penicillin challenge is a safe procedure to facilitate the removal of a penicillin allergy label.Trial registrationClinicalTrials.gov Identifier: NCT04454229.
| S-EPMC10352926 | biostudies-literature
Project description:Hypersensitivity reactions to drugs are often unpredictable and can be life threatening, underscoring a need for understanding their underlying mechanisms and risk factors. The extent to which germline genetic variation influences the risk of commonly reported drug allergies such as penicillin allergy remains largely unknown. We extracted data from the electronic health records of more than 600,000 participants from the UK, Estonian, and Vanderbilt University Medical Center's BioVU biobanks to study the role of genetic variation in the occurrence of self-reported penicillin hypersensitivity reactions. We used imputed SNP to HLA typing data from these cohorts to further fine map the human leukocyte antigen (HLA) association and replicated our results in 23andMe's research cohort involving a total of 1.12 million individuals. Genome-wide meta-analysis of penicillin allergy revealed two loci, including one located in the HLA region on chromosome 6. This signal was further fine-mapped to the HLA-B∗55:01 allele (OR 1.41 95% CI 1.33-1.49, p value 2.04 × 10-31) and confirmed by independent replication in 23andMe's research cohort (OR 1.30 95% CI 1.25-1.34, p value 1.00 × 10-47). The lead SNP was also associated with lower lymphocyte counts and in silico follow-up suggests a potential effect on T-lymphocytes at HLA-B∗55:01. We also observed a significant hit in PTPN22 and the GWAS results correlated with the genetics of rheumatoid arthritis and psoriasis. We present robust evidence for the role of an allele of the major histocompatibility complex (MHC) I gene HLA-B in the occurrence of penicillin allergy.
| S-EPMC7536643 | biostudies-literature
Project description:IntroductionUp to 20% of the US population carries a penicillin allergy label; however, over 95% of those patients can safely tolerate penicillin. This discrepancy has important personal and public health consequences. There is no published curriculum for medical trainees that covers penicillin allergy history taking, risk assessment, and antibiotic prescribing.MethodsWe created a 60-minute, interactive curriculum that targeted medical students during their internal medicine rotation. We employed learning strategies including didactics, case-based learning, and role-playing. We compared self-efficacy and knowledge before and after the intervention using paired t tests.ResultsA total of 28 medical students participated, with 25 completing both the pre- and postworkshop surveys. There was a statistically significant improvement in student-rated preparedness to prescribe antibiotics to patients with a penicillin allergy label (p < .001) and determine whether a patient has a history of an allergic reaction that was severe or life-threatening (p < .001). There was additionally a statistically significant increase in students' perception that penicillin allergy labels carry important health consequences (p = .005), as well as increase in their total knowledge scores (p = .006).DiscussionThe workshop employs adult learning techniques to improve self-efficacy and knowledge regarding penicillin allergy in medical students. Further work is needed to refine the curriculum, seek external validity, and determine the impact of this workshop on clinical outcomes.
| S-EPMC11427523 | biostudies-literature
Project description:ObjectivesMore than 90% of patients who report a penicillin allergy have the allergy disproved when tested. Unnecessary use of alternative (non-beta-lactam) antibiotics can result in more treatment failures and adverse reactions. We described the prevalence and impact of a reported penicillin allergy in high-cost, high-need (HCHN) patients.Study designRetrospective cohort.MethodsWe identified HCHN patients in a care management program of an urban academic medical center (January 1, 2014, to December 31, 2016). We used multivariable logistic regression models to determine the association between a reported penicillin allergy and antibiotic use. We used multivariable Poisson regression models to determine the association between a reported penicillin allergy, with or without multiple drug intolerance syndrome (MDIS; ≥3 reported drug allergies), and healthcare resource utilization (HRU).ResultsOf 1870 HCHN patients, 383 (20%) reported penicillin allergy, 835 (45%) had MDIS, and 290 (16%) had both. HCHN patients reporting penicillin allergy had an increased odds of beta-lactam alternative antibiotic use (adjusted odds ratio, 3.84; 95% CI, 2.17-6.80). HRU was significantly higher for patients reporting a penicillin allergy alone (adjusted relative risk [aRR], 1.13; 95% CI, 1.03-1.25) and with concurrent MDIS (aRR, 1.20; 95% CI, 1.08-1.34).ConclusionsHCHN patients had a high burden of reported drug allergy. A reported penicillin allergy conferred a 4-fold increased odds of beta-lactam alternative antibiotic use. Reporting penicillin allergy, with and without MDIS, was associated with significantly more HRU. HCHN care management programs should consider systematic drug allergy evaluations to optimize antibiotic use in these fragile patients.
| S-EPMC7153533 | biostudies-literature
Project description:IntroductionPenicillin allergies are highly prevalent in the healthcare setting and associated with the prescription of second-line inferior antibiotics. More than 85% of all penicillin allergy labels can be removed by skin testing and 96%-99% of low-risk penicillin allergy labels can be removed by direct oral challenge. An internally and externally validated clinical assessment tool for penicillin allergy, PEN-FAST, can identify a low-risk penicillin allergy without the need for skin testing; a score of less than 3 has a negative predictive value of 96.3% (95% CI, 94.1 to 97.8) for the presence of a penicillin allergy. It is hypothesised that PEN-FAST is a safe and effective tool for assessing penicillin allergy in an outpatient clinic setting.Methods and analysisThis is an international, multicentre randomised control trial using the PEN-FAST tool to risk-stratify penicillin allergy labels in adult outpatients. The study's primary objective is to evaluate the non-inferiority of using PEN-FAST score-guided management with direct oral challenge compared with standard care (defined as prick and intradermal skin testing followed by oral penicillin challenge). Participants will be randomised 1:1 to the intervention arm (direct oral penicillin challenge) or standard of care arm (skin testing followed by oral penicillin challenge, if skin testing is negative). The sample size of 380 randomised patients (190 per treatment arm) is required to demonstrate non-inferiority.Ethics and disseminationThe study will be performed according to the guidelines of the Helsinki Declaration and is approved by the Austin Health Human Research Ethics Committee (HREC/62425/Austin-2020) in Melbourne Australia, Vanderbilt University Institutional Review Board (IRB #202174) in Tennessee, USA, Duke University Institutional Review Board (IRB #Pro00108461) in North Carolina, USA and McGill University Health Centre Research Ethics Board in Canada (PALACE/2022-7605). The results of this study will be published and presented in various scientific forums.Trial registration numberNCT04454229.
| S-EPMC9364402 | biostudies-literature
Project description:IntroductionBeing allergic to penicillin can lead to the overuse of broad-spectrum antibiotics, contributing to the growing problem of multidrug resistance. Knowing the exact allergy history is essential as some circumstances may allow reinitiating penicillin. This study focused on assessing the prevalence and characteristics of self-reported penicillin allergy in the Saudi Arabian population.MethodsWe conducted a nationwide cross-sectional study via an electronic self-administered questionnaire directed toward the Saudi Arabian general adult population. Variables about respondent demographics as well as type and characteristics of the allergy were collected.ResultsOne hundred ninety-three out of 2022 participants who completed the survey (9.5%) reported allergy to penicillin, with the most reported reaction being anaphylaxis in 89 participants (46.1%), non-anaphylaxis reported by 69 participants (35.8%). Twenty-two participants (11.4%) were identified as not having a true allergy due to reporting a tolerability issue or a non-penicillin-type agent. About 38% reported that the allergy occurred more than ten years ago.ConclusionThis is the first study to report the prevalence and characteristics of self-reported penicillin allergy in Saudi Arabia. The data from this study provides valuable information to consider starting in-hospital penicillin de-labeling programs and providing evidence for healthcare providers to consider re-challenging certain qualified patients.
| S-EPMC10023521 | biostudies-literature
Project description:Background:A reported penicillin allergy may compromise receipt of recommended antibiotic prophylaxis intended to prevent surgical site infections (SSIs). Most patients with a reported penicillin allergy are not allergic. We determined the impact of a reported penicillin allergy on the development of SSIs. Methods:In this retrospective cohort study of Massachusetts General Hospital hip arthroplasty, knee arthroplasty, hysterectomy, colon surgery, and coronary artery bypass grafting patients from 2010 to 2014, we compared patients with and without a reported penicillin allergy. The primary outcome was an SSI, as defined by the Centers for Disease Control and Prevention's National Healthcare Safety Network. The secondary outcome was perioperative antibiotic use. Results:Of 8385 patients who underwent 9004 procedures, 922 (11%) reported a penicillin allergy, and 241 (2.7%) had an SSI. In multivariable logistic regression, patients reporting a penicillin allergy had increased odds (adjusted odds ratio, 1.51; 95% confidence interval, 1.02-2.22) of SSI. Penicillin allergy reporters were administered less cefazolin (12% vs 92%; P < .001) and more clindamycin (49% vs 3%; P < .001), vancomycin (35% vs 3%; P < .001), and gentamicin (24% vs 3%; P < .001) compared with those without a reported penicillin allergy. The increased SSI risk was entirely mediated by the patients' receipt of an alternative perioperative antibiotic; between 112 and 124 patients with reported penicillin allergy would need allergy evaluation to prevent 1 SSI. Conclusions:Patients with a reported penicillin allergy had a 50% increased odds of SSI, attributable to the receipt of second-line perioperative antibiotics. Clarification of penicillin allergies as part of routine preoperative care may decrease SSI risk.
| S-EPMC5850334 | biostudies-literature
Project description:BackgroundMethicillin-sensitive Staphylococcus aureus (MSSA) bacteremia is a morbid infection. First-line MSSA therapies (nafcillin, oxacillin, cefazolin) are generally avoided in the 10% of patients reporting penicillin (PCN) allergy, but most of these patients are not truly allergic. We used a decision tree with sensitivity analyses to determine the optimal evaluation and treatment for patients with MSSA bacteremia and reported PCN allergy.MethodsOur model simulates 3 strategies: (1) no allergy evaluation, give vancomycin (Vanc); (2) allergy history-guided treatment: if history excludes anaphylactic features, give cefazolin (Hx-Cefaz); and (3) complete allergy evaluation with history-appropriate PCN skin testing: if skin test negative, give cefazolin (ST-Cefaz). Model outcomes included 12-week MSSA cure, recurrence, and death; allergic reactions including major, minor, and potentially iatrogenic; and adverse drug reactions.ResultsVanc results in the fewest patients achieving MSSA cure and the highest rate of recurrence (67.3%/14.8% vs 83.4%/9.3% for Hx-Cefaz and 84.5%/8.9% for ST-Cefaz) as well as the greatest frequency of allergic reactions (3.0% vs 2.4% for Hx-Cefaz and 1.7% for ST-Cefaz) and highest rates of adverse drug reactions (5.2% vs 4.6% for Hx-Cefaz and 4.7% for ST-Cefaz). Even in a "best case for Vanc" scenario, Vanc yields the poorest outcomes. ST-Cefaz is preferred to Hx-Cefaz although sensitive to input variations.ConclusionsPatients with MSSA bacteremia and a reported PCN allergy should have the allergy addressed for optimal treatment. Full allergy evaluation with skin testing seems to be preferred, although more data are needed.
| S-EPMC4542891 | biostudies-literature