Project description:ImportanceElectronic health records (EHRs) often include default alerts that can influence physician selection of antibiotics, which in turn may be associated with a suboptimal choice of agents and increased antibiotic resistance.ObjectiveTo examine whether removal of a default alert in the EHR to avoid cephalosporin use in patients with penicillin allergies is associated with changes in cephalosporin dispensing or administration in these patients.Design, setting, and participantsThis retrospective cohort study of a natural experiment included data on patients who had received antibiotic treatment in the hospital or outpatient setting in 2 regions of a large, integrated health system in California from January 1, 2017, to December 31, 2018. Of 4 398 792 patients, 4 206 480 met the eligibility criteria: enrollment in the health system during antibiotic use, availability of complete demographic data, and use of antibiotics outside of the washout period.Interventions or exposuresOral or parenteral antibiotics dispensed or administered after removal of an EHR alert to avoid cephalosporin use in patients with a recorded penicillin allergy.Main outcomes and measuresProbability that an antibiotic course was a cephalosporin. A multinomial logistic regression model was used to examine the change in rates of cephalosporin use before and after an EHR penicillin allergy alert was removed in 1 of the study regions. Temporal changes in use rates were controlled for by comparing changes in cephalosporin use among patients with or without a penicillin allergy at the site that removed the warning and among patients at a comparison site that retained the warning. Regression models were used to examine adverse events.ResultsOf the 4 206 480 patients who met all inclusion criteria, 2 465 849 (58.6%) were women; the mean (SD) age was 40.5 (23.2) years. A total of 10 652 014 antibiotic courses were administered or dispensed, divided approximately evenly between the period before and after removal of the warning. Before removal of an alert in the electronic health record system to avoid prescribing of cephalosporins to patients with a penicillin allergy at 1 of the 2 sites, 58 228 courses of cephalosporins (accounting for 17.9% of all antibiotic use at the site) were used among patients with a penicillin allergy; after removal of the alert, administration or dispensing of cephalosporins increased by 47% compared with cephalosporin administration or dispensing among patients without a penicillin allergy at the same site and patients at the comparison site that retained the warning (ratio of ratios of odds ratios [RROR], 1.47; 95% CI, 1.38-1.56) . No significant differences in anaphylaxis (9 total cases), new allergies (RROR, 1.02; 95% CI, 0.93-1.12), or treatment failures (RROR, 1.02; 95% CI, 0.99-1.05) were found at the course level. No significant differences were found in all-cause mortality (ratio of ratios of rate ratios [RRRR], 1.03; 95% CI, 0.94-1.13), hospital days (RRRR, 1.04; 95% CI, 0.99-1.10), and new infections (Clostridioides difficile: RRRR, 1.02; 95% CI, 0.84-1.22; methicillin-resistant Staphylococcus aureus: RRRR, 0.87; 95% CI, 0.75-1.00; and vancomycin-resistant Enterococcus: RRRR, 0.82; 95% CI, 0.55-1.22) at the patient level.Conclusions and relevanceIn this cohort study, removal of a warning in the electronic health record to avoid cephalosporin use in patients with penicillin allergies was associated with increased administration and dispensing of cephalosporin. This simple and rapidly implementable system-level intervention may be useful for improvement in antibiotic stewardship.
Project description:OBJECTIVE:To investigate documentation of antimicrobial allergy and to determine prescribing adherence to local antibiotic guidelines for inpatients with and without reported penicillin allergy treated for infection in a National Health Service (NHS) context. SETTING:Data were collected at two English hospital NHS trusts over two time-periods: June 2016 and February 2017. DESIGN:Cohort study. Trust 1 data were sourced from prospective point prevalence surveys. Trust 2 data were extracted retrospectively from an electronic report. PARTICIPANTS:Inpatients treated for urinary tract infection (UTI), community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP) and skin and soft tissue infection (SSTI). Data on allergy were collected, and antibiotic selection assessed for adherence to trust guidelines with differences between groups presented as adjusted ORs. RESULTS:A total of 1497 patients were included, with 2645 antibiotics orders. Patients were treated for CAP (n=495; 33.1%), UTI (407; 27.2%), HAP (330; 22%) and SSTI (265; 17.7%). There were 240 (16%) patients with penicillin allergy. Penicillin allergy was recorded as allergy (n=52; 21.7%), side effect (27; 11.3%) and no documentation (161; 67.1%). Overall, 2184 (82.6%) antibiotic orders were guideline-adherent. Adherence was greatest for those labelled penicillin allergy (453 of 517; 87.6%) versus no allergy (1731 of 2128; 81.3%) (OR 0.52 (95% CI 0.37 to 0.73) p<0.001). Guideline-adherence for CAP was higher if penicillin allergy (151 of 163; 92.6%) versus no allergy (582 of 810; 71.9%) (OR 0.20 (95% CI 0.10 to 0.37) p<0.001). There was no difference in adherence between those with and without penicillin allergy for UTI, HAP or SSTI treatment. CONCLUSIONS:A relatively high proportion of patients had a penicillin allergy and two thirds of these had no description of their allergy, which has important implications for patient safety. Patients with penicillin allergy treated for CAP, received more guideline adherent antibiotics than those without allergy. Future studies investigating the clinical impact of penicillin allergy should include data on adherence to antibiotic guidelines.
Project description:About 10% of U.K. patients believe that they are allergic to penicillin and have a "penicillin allergy label" in their primary care health record. However, around 90% of these patients may be mislabelled. Removing incorrect penicillin allergy labels can help to reduce unnecessary broad-spectrum antibiotic use. A rapid review was undertaken of papers exploring patient and/or clinician views and experiences of penicillin allergy testing (PAT) services and the influences on antibiotic prescribing behaviour in the context of penicillin allergy. We reviewed English-language publications published up to November 2017. Limited evidence on patients' experiences of PAT highlighted advantages to testing as well as a number of concerns. Clinicians reported uncertainty about referral criteria for PAT. Following PAT and a negative result, a number of clinicians and patients remained reluctant to prescribe and consume penicillins. This appeared to reflect a lack of confidence in the test result and fear of subsequent reactions to penicillins. The findings suggest lack of awareness and knowledge of PAT services by both clinicians and patients. In order to ensure correct penicillin allergy diagnosis, clinicians and patients need to be supported to use PAT services and equipped with the skills to use penicillins appropriately following a negative allergy test result.
Project description:BackgroundSuspected penicillin allergy (Pen-A) is often not verified by diagnostic testing. In third line penicillin allergy labels were associated with prescription of broad spectrum antibiotics, hospital stay duration and readmission.ObjectiveAssess the impact of Pen-A labels on antibiotic and health care use in primary care.MethodsA retrospective cohort study was conducted in primary care in the Utrecht area, the Netherlands. All patients registered with a penicillin allergy on 31 December 2013 were selected from the General Practitioner Network database. Each patient with a Pen-A label was matched for age, gender, follow-up period with three patients without Pen-A label. Risk (OR) of receiving a reserve and second choice antibiotic, number and type of antibiotics prescribed during follow-up and number of GP contacts were compared between the two cohorts.ResultsOf 196,440 patients, 1254 patients (0.6%) with a Pen-A label were identified and matched with 3756 patients without Pen-A label. Pen-A labels resulted in higher risk of receiving ≥1 antibiotic prescription per year (OR 2.56, 95% CI 2.05-3.20), ≥1 s choice antibiotic prescription per year (OR 2.21 95% CI 1.11-4.40), and ≥4 GP contacts per year (OR 1.71 95% CI 1.46-2.00). The chance of receiving tetracyclins (OR 2.24, 95% CI 1.29-3.89), macrolides/lincosamides/streptogamins (OR 8.69, 95% CI 4.26-17.73) and quinolones (OR 2.59, 95% CI 1.22-5.48) was higher in Pen-A patients.ConclusionsIn primary health care Pen-A labels are associated with increased antibiotic use, including second choice antibiotics, and more health care use.
Project description:ObjectivePenicillin (PCN) allergy labels affect antimicrobial selection for surgical prophylaxis. We aimed to increase the percentage of cefazolin usage in patients with PCN allergy labels undergoing orthopedic surgery from 50% to 80%.DesignQuality improvement initiative.SettingChildren's Mercy Kansas City (CMKC), a freestanding children's hospital.PatientsChildren scheduled for an orthopedic surgery (excluding spinal surgery) at CMKC who had a PCN allergy label and received a perioperative antibiotic.MethodsNo standardized process existed to identify and clarify PCN-allergic-labeled patients preoperatively. We developed a process for patient identification combined with a pharmacist phone interview for PCN allergy clarification. In plan-do-study-act (PDSA) part 1, we implemented a computer-generated patient list. In PDSA part 2, we combined automated identification with a phone interview. In PDSA part 3, we enhanced the patient list, making it timely and concise. In PDSA part 4, we included a PCN allergy clarification electronic survey to caregivers via the electronic medical record.ResultsCefazolin use in PCN-allergic surgical patients increased from 50% to 74% following interventions. Patients who had their PCN allergy label clarified were 4 times more likely to receive cefazolin compared to those whose allergy labels were not clarified (OR, 4.21; 95% CI, 1.68-11.61; P = 0.003). Moreover, 90% of patients received cefazolin when their PCN allergy was clarified and cefazolin was recommended. When a PCN allergy label was not clarified, only 59% of patients received cefazolin.ConclusionsAppropriate clarification and documentation of PCN allergy labels increases the use of cefazolin for surgical prophylaxis.
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.
Project description:Objectives To develop a behavioural intervention package to support clinicians and patients to amend incorrect penicillin allergy records in general practice. The intervention aimed to: (1) support clinicians to refer patients for penicillin allergy testing (PAT), (2) support patients to attend for PAT and (3) support clinicians and patients to prescribe or consume penicillin, when indicated, following a negative PAT result. Methods Theory-based, evidence-based and person-based approaches were used in the intervention development. We used evidence from a rapid review, two qualitative studies, and expert consultations with the clinical research team to identify the intervention ‘guiding principles’ and develop an intervention plan. Barriers and facilitators to the target behaviours were mapped to behaviour change theory in order to describe the proposed mechanisms of change. In the final stage, think-aloud interviews were conducted to optimise intervention materials. Results The collated evidence showed that the key barriers to referral of patients by clinicians were limited experience of referral and limited knowledge of referral criteria and PAT. Barriers for patients attending PAT were lack of knowledge of the benefits of testing and lack of motivation to get tested. The key barriers to the prescription and consumption of first-line penicillin following a negative test result were patient and clinician beliefs about the accuracy of PAT and whether taking penicillin was safe. Intervention materials were designed and developed to address these barriers. Conclusions We present a novel behavioural intervention package designed to address the multiple barriers to uptake of PAT in general practice by clinicians and patients. The intervention development details how behaviour change techniques have been incorporated to hypothesise how the intervention is likely to work to help amend incorrect penicillin allergy records. The intervention will go on to be tested in a feasibility trial and randomised controlled trial in England.
Project description:BackgroundThe diagnosis of allergic reactions to penicillins (AR-PEN) is very complex as there is a loss of sensitization over time, which leads to negative skin tests (STs) and specific IgE in serum, and even to tolerance to the drug involved. However, STs may become positive after subsequent exposure to the culprit drug (resensitization), with the risk of inducing potentially severe reactions. The exact rate of resensitization to penicillins is unknown, ranging from 0% to 27.9% in published studies.ObjectivesTo analyze the rate of resensitization in patients with suggestive AR-PEN by repeating STs (retest) after an initial evaluation (IE).Material and methodsPatients with suspected AR-PEN were prospectively evaluated between 2017 and 2020. They underwent STs, and a randomized group also underwent a drug provocation test (DPT) with the culprit. Only patients with negative STs and/or DPT were included. All included cases were retested by STs at 2-8 weeks.ResultsA total of 545 patients were included: 296 reporting immediate reactions (IRs) and 249 non-immediate reactions (NIRs). Eighty (14.7%) cases had positive results in retest (RT+): 63 (21.3%) IRs and 17 (6.8%) NIRs (p < 0.0001). The rate of RT+ was higher in anaphylaxis compared with all other reactions (45.8% vs 9.1%, p < 0.0001). The risk of RT+ was higher from the fifth week after IE (OR: 4.64, CI: 2.1-11.6; p < 0.001) and increased with the patient's age (OR: 1.02; CI: 1.01-1.04; p = 0.009).ConclusionsDue to the high rate of resensitization, retest should be included in the diagnostic algorithm of IRs to penicillins after an initial negative study, especially in anaphylaxis, to avoid potentially severe reactions after subsequent prescriptions of these drugs.
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.