Low-risk penicillin allergy delabeling: a scoping review of direct oral challenge practice, implementation, and multi-disciplinary approaches.

INTRODUCTION: Penicillin allergy is common, and there is increased clinician interest in direct oral challenge (DOC) as a testing strategy for low-risk penicillin allergy. To aid wider implementation of DOC, consensus definitions of low-risk penicillin allergy phenotypes, and standardized approaches to assessment, DOC procedures, and evaluation, are required. AREAS COVERED: This review systematically reviews studies that have utilized penicillin DOC in healthcare settings to identify heterogeneity in implementation approaches and synthesize low-risk definitions, procedures, and evaluation. EXPERT OPINION: Opportunity exists to standardize penicillin DOC procedures in patients with a low-risk penicillin allergy to optimize antimicrobial prescribing and reduce the burden of penicillin allergy. Standardizing the definitions of 'low-risk' and 'positive challenge,' and improving the evaluation of patient safety, alongside the development of a unified approach to the structure of undertaking an oral challenge, is likely to increase uptake and confidence among non-allergist clinicians.

Assessment of inter-rater reliability of screening tools to identify patients at risk of medication-related problems across the emergency department continuum of care.

BACKGROUND: Following a national multicentre study, two emergency department (ED) screening tools were developed to determine risk of medication-related problems; one for use at ED presentation and another at ED discharge to the community. This study aimed to determine the inter-rater reliability amongst ED health professionals when applying these screening tools to a series of case scenarios. METHODS: A prospective, cross-sectional study was undertaken in the ED of a major metropolitan hospital. Twelve case scenarios were developed following ED observation of a range of patients, which were incorporated into a questionnaire and distributed to 50 health professionals. Inter-rater reliabilities of each explanatory variable of the screening tools and overall assessment were calculated using Fleiss' multi-rater kappa. RESULTS: The questionnaire was completed by 15 doctors, 19 nurses and 16 pharmacists. Fleiss' kappa showed an overall inter-rater reliability for the ED presentation tool of 0.83 (95% CI 0.83-0.84), indicating near perfect agreement. Fleiss' kappa for the ED discharge tool was 0.83 (95% CI 0.83-0.85), which also showed near perfect agreement. CONCLUSIONS: The screening tools produced favourable inter-rater reliability amongst ED health professionals. These results have important implications for ensuring consistency of ED decision-making in screening patients at risk of developing medication-related problems.

Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy: The PALACE Randomized Clinical Trial.

Importance: Fewer 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. Objective: To 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 Participants: This 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. Interventions: Patients 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 Measure: The 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). Results: A 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 Relevance: In 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 Registration: ClinicalTrials.gov Identifier: NCT04454229.

The Who, What, When, and Where of Inpatient Direct Oral Penicillin Challenge-Implications for Health Services Implementation.

Inpatient direct oral challenge programs are increasingly deployed as part of antimicrobial stewardship initiatives to reduce the burden and impacts of penicillin allergy labels on antibiotic prescribing. Using data from a prospective, multicenter cohort inpatient penicillin allergy program, we identify the key targets for delabeling to aid health service implementation.

Improving the safety of anticoagulation initiation in patients discharged from the emergency department.

OBJECTIVE: To improve the safety of anticoagulation initiation by increasing the proportion of patients reviewed by a pharmacist. METHODS: An electronic intervention was developed to ensure all patients prescribed anticoagulation on discharge were reviewed by an ED pharmacist. Safe anticoagulation initiation was compared for patients seen and not seen. RESULTS: The intervention increased the number of patients seen by an ED pharmacist. Pre-intervention (n = 238) 84.5% of patients were reviewed by a pharmacist. Post-intervention (n = 253) 99.6% of patients were reviewed by a pharmacist. Of the 38 patients not reviewed by a pharmacist, 20 (52.6%) had safe anticoagulation initiation and in a sample of 40 patients reviewed by a pharmacist, all 40 (100%) had safe anticoagulation initiation (52.6% vs 100%, P < 0.001). CONCLUSION: The real-time electronic intervention improved the number of patients reviewed by a pharmacist. ED pharmacist reviewed patients were more likely to have safe anticoagulation initiation.

Development of Screening Tools to Predict Medication-Related Problems Across the Continuum of Emergency Department Care: A Prospective, Multicenter Study.

Background: Medication-related problems (MRPs) occur across the continuum of emergency department (ED) care: they may contribute to ED presentation, occur in the ED/short-stay unit (SSU), at hospital admission, or shortly after discharge to the community. This project aimed to determine predictors for MRPs across the continuum of ED care and incorporate these into screening tools (one for use at ED presentation and one at ED/SSU discharge), to identify patients at greatest risk, who could be targeted by ED pharmacists. Methods: A prospective, observational, multicenter study was undertaken in nine EDs, between July 2016 and August 2017. Blocks of ten consecutive adult patients presenting at pre-specified times were identified. Within 1 week of ED discharge, a pharmacist interviewed patients and undertook a medical record review to determine a medication history, patient understanding of treatment, risk factors for MRPs and to manage the MRPs. Logistic regression was undertaken to determine predictor variables. Multivariable regression beta coefficients were used to develop a scoring system for the two screening tools. Results: Of 1,238 patients meeting all inclusion criteria, 904 were recruited. Characteristics predicting MRPs related to ED presentation were: patient self-administers regular medications (OR = 7.95, 95%CI = 3.79-16.65), carer assists with medication administration (OR = 15.46, 95%CI = 6.52-36.67), or health-professional administers (OR = 5.01, 95%CI = 1.77-14.19); medication-related ED presentation (OR = 9.95, 95%CI = 4.92-20.10); age ≥80 years (OR = 3.63, 95%CI = 1.96-6.71), or age 65-79 years (OR = 2.01, 95%CI = 1.17-3.46); potential medication adherence issue (OR = 2.27, 95%CI = 1.38-3.73); medical specialist seen in past 6-months (OR = 2.02, 95%CI = 1.42-2.85); pharmaceutical benefit/pension/concession cardholder (OR = 1.89, 95%CI = 1.28-2.78); inpatient in previous 4-weeks (OR = 1.60, 95%CI = 1.02-2.52); being male (OR = 1.48, 95%CI = 1.05-2.10); and difficulties reading labels (OR = 0.63, 95%CI = 0.40-0.99). Characteristics predicting MRPs related to ED discharge were: potential medication adherence issue (OR = 6.80, 95%CI = 3.97-11.64); stay in ED > 8 h (OR = 3.23, 95%CI = 1.47-7.78); difficulties reading labels (OR = 2.33, 95%CI = 1.30-4.16); and medication regimen changed in ED (OR = 3.91, 95%CI = 2.43-6.30). For ED presentation, the model had a C-statistic of 0.84 (95% CI 0.81-0.86) (sensitivity = 80%, specificity = 70%). For ED discharge, the model had a C-statistic of 0.78 (95% CI 0.73-0.83) (sensitivity = 82%, specificity = 57%). Conclusion: Predictors of MRPs are readily available at the bedside and may be used to screen for patients at greatest risk upon ED presentation and upon ED/SSU discharge to the community. These screening tools now require external validation and implementation studies to evaluate the impact of using such tools on patient care outcomes.

Comprehensive identification of medication-related problems occurring prior to, during and after emergency department presentation: An Australian multicentre, prospective, observational study.

OBJECTIVE: Patients present to EDs with various medication-related problems (MRPs). MRPs are also associated with ED care, occurring during ED presentation or shortly afterwards. The aim of the present study is to describe the prevalence and nature of MRPs that occur prior to, during or shortly after leaving ED. METHODS: We undertook a prospective, observational study in nine Australian EDs. Blocks of 10 consecutive adult patients who were not seen by a pharmacist in ED and who presented at pre-specified times were identified. Within 1 week of ED discharge, a pharmacist interviewed patients and undertook a medical record review to determine their medication history, patients' understanding of treatment, potential MRP risk factors and manage any identified MRPs. RESULTS: A total of 904 patients were recruited: 14.8% aged ≥80 years, 18.9% taking more than eight regular medications; 581 MRPs were identified; 287 (49.4%, 95% confidence interval [CI] 45.3-53.5%) of moderate-high significance. Most highly significant MRPs involved high-risk medications, particularly strong opioids, insulin and anti-coagulants. The most common types of MRPs were prescribing errors (46.8%), patient adherence/knowledge issues (31.2%) and adverse drug reactions (7.4%). Of all patients, 381 (42.1%, 95% CI 38.9-45.5%) had at least one MRP; 31.4% (95% CI 28.4-34.6%) had MRPs that could be identified or managed by screening at ED presentation and 12.4% (95% CI 10.4-14.8%) had MRPs that could be identified or managed by screening at ED discharge. CONCLUSIONS: Patients experienced a range of MRPs throughout the ED continuum of care. From these data, screening tools will be developed so that ED clinicians may identify patients at greatest risk of MRPs.

Pharmacist-assisted electronic prescribing at the time of admission to an inpatient orthopaedic unit and its impact on medication errors: a pre- and postintervention study.

BACKGROUND: Prescribing and administration errors related to pre-admission medications are common amongst orthopaedic inpatients. Postprescribing medication reconciliation by clinical pharmacists after hospital admission prevents some but not all errors from reaching the patient. Involving pharmacists at the prescribing stage may more effectively prevent errors. The aim of the study was to evaluate the effect of pharmacist-assisted electronic prescribing at the time of hospital admission on medication errors in orthopaedic inpatients. METHODS: A pre- and postintervention study was conducted in the orthopaedic unit of a major metropolitan Australian hospital. During the 10-week intervention phase, a project pharmacist used electronic prescribing to assist with prescribing admission medications and postoperative venous thromboembolism (VTE) prophylaxis, in consultation with orthopaedic medical officers. The primary endpoint was the number of medication errors per patient within 72 h of admission. Secondary endpoints included the number and consequence of adverse events (AEs) associated with admission medication errors and the time delay in administering VTE prophylaxis after elective surgery (number of hours after recommended postoperative dose-time). RESULTS: A total of 198 and 210 patients, pre- and postintervention, were evaluated, respectively. The median number of admission medication errors per patient declined from six pre-intervention to one postintervention (p < 0.01). A total of 17 AEs were related to admission medication errors during the pre-intervention period compared with 1 postintervention. There were 54 and 63 elective surgery patients pre- and postintervention, respectively. The median delay in administering VTE prophylaxis for these patients declined from 9 h pre-intervention to 2 h postintervention (p < 0.01). CONCLUSIONS: Pharmacist-assisted electronic prescribing reduced the number of admission medication errors and associated AEs.

The Prevalence and Nature of Medication Errors and Adverse Events Related to Preadmission Medications When Patients Are Admitted to an Orthopedic Inpatient Unit: An Observational Study.

BACKGROUND: Medication errors commonly occur when patients move from the community into hospital. Whereas medication reconciliation by pharmacists can detect errors, delays in undertaking this can increase the risk that patients receive incorrect admission medication regimens. Orthopedic patients are an at-risk group because they are often elderly and use multiple medications. OBJECTIVE: To evaluate the prevalence and nature of medication errors when patients are admitted to an orthopedic unit where pharmacists routinely undertake postprescribing medication reconciliation. METHODS: A 10-week retrospective observational study was conducted at a major metropolitan hospital in Australia. Medication records of orthopedic inpatients were evaluated to determine the number of prescribing and administration errors associated with patients' preadmission medications and the number of related adverse events that occurred within 72 hours of admission. RESULTS: Preadmission, 198 patients were taking at least 1 regular medication, of whom 176 (88.9%) experienced at least 1 medication error. The median number of errors per patient was 6 (interquartile range 3-10). Unintended omission of a preadmission medication was the most common prescribing error (87.4%). There were 17 adverse events involving 24 medications in 16 (8.1%) patients that were potentially related to medication errors; 6 events were deemed moderate consequence (moderate injury or harm, increased length of stay, or cancelled/delayed treatment), and the remainder were minor. Conclusion and Relevance: Medication errors were common when orthopedic patients were admitted to hospital, despite postprescribing pharmacist medication reconciliation. Some of these errors led to patient harm. Interventions that ensure that medications are prescribed correctly at admission are required.

Slick scripts: impact on patient flow targets of pharmacists preparing discharge prescriptions in a hospital with an electronic prescribing system.

RATIONALE, AIMS AND OBJECTIVES: Inpatient bed access decreases when ward discharge is delayed. This contributes to prolonged emergency department (ED) length of stay (LOS) which has been associated with increased hospital LOS and mortality. Delays in preparation of discharge medication prescriptions by ward doctors may contribute to delayed ward discharge. This project aimed to evaluate the effect on patient flow of having a pharmacist collaborate with ward doctors to prepare discharge prescriptions at a hospital with an electronic prescribing system. METHOD: Eight-week pre- and post-intervention study on two surgical wards at a major metropolitan Australian hospital. During the intervention, a project pharmacist (PP) electronically prepared discharge prescriptions, in consultation with ward doctors, which were reviewed by the regular ward pharmacist before being dispensed. Outcome measures, based on hospital performance indicators, included: Percentage of patients transferred to wards from ED within four and six hours of presentation; Median time (minutes) past 9 am that patients were discharged from the wards; Percentage of patients discharged from wards by 9 am; Staff satisfaction. RESULTS: Pre- and post-intervention, there were 259 and 246 patients transferred from ED to the study wards, respectively. The percentage of patients transferred within four and six hours of presentation did not change. There were 320 and 341 patients discharged, pre- and post-intervention, respectively, who required a discharge prescription. The PP prepared 273 (80%) prescriptions during the post-intervention period. Patients were discharged 57 minutes earlier with the intervention (median 211 vs. 154 minutes past 9 am, P = 0.01). The percentage of patients discharged before 9 am increased from 6% to 12% (P = 0.01). All 26 health-professional respondents (79% response rate) were satisfied with the service and recommended its continuation. CONCLUSIONS: Pharmacist collaboration with doctors to prepare discharge prescriptions did not impact upon ED access targets, but resulted in patients being discharged earlier.