scholarly journals 1093. Bypassing Penicillin Skin Testing in favor of Direct Oral Challenge: A Pharmacy-driven Inpatient Program

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S637-S638
Author(s):  
YoungYoon Ham ◽  
Shyam Joshi ◽  
Kendall J Tucker ◽  
Diana Yu ◽  
James Lewis ◽  
...  

Abstract Background Patient interview, penicillin skin testing (PST) and/or an oral challenge can be used to evaluate penicillin allergies. Programs favor PST prior to oral challenge, but there is interest in bypassing PST and directly oral challenging for logistical and financial reasons. Data on the safety and efficacy of a direct challenge in the inpatient setting when the index reaction is moderate to severe (e.g. swelling of throat, angioedema, anaphylaxis) is lacking. Methods Adult patients (≥18 years) admitted with a penicillin allergy were evaluated for eligibility between September 2019 and June 2021. Pregnant patients were excluded, while critically ill patients and those on anti-histamine medications were evaluated if clinical need was high. Institutional protocols allowing for patients to be challenged without PST if reaction was more than 10 years ago were used. Data collected included the number of patients challenged and delabeled, number of patients who had moderate to severe index reactions, number of patients who were relabeled without cause, and number of patients who declined further testing. Results Two hundred twenty-five patients were evaluated; 11 patients declined testing. Two hundred four patients were delabeled (95%) among those fully evaluated. One hundred twelve patients were delabeled by interview and chart review alone (52%), 99 by oral challenge (46%), and 2 by PST and oral challenge (1%). Twenty-nine patients with moderate to severe reactions were challenged and 27 were delabeled. Ten patients could not be delabeled due to mild or delayed reactions to challenge or subsequent treatment, including 2 patients with severe index reactions who had mild challenge reactions and required no rescue medications. No patients required epinephrine during challenge. Five patients were relabeled and then delabeled again as no new reaction had occurred. Conclusion Penicillin allergies can be removed with a pharmacy-driven algorithm that prioritizes direct challenges when appropriate even when the index reaction was moderate to severe. Risks of a reaction are low, and reactions tend to be mild. Given well-documented benefits of delabeling patients for the patient and the institution, more hospitals should consider starting such services. Disclosures All Authors: No reported disclosures

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S95-S96
Author(s):  
YoungYoon Ham ◽  
Shyam Joshi ◽  
Ellie Sukerman ◽  
Kendall J Tucker ◽  
Diana Yu ◽  
...  

Abstract Background Penicillin allergies are reported by approximately 10% of the US population; however, studies reveal that >90% of those patients can tolerate penicillins. Penicillin allergies are associated with negative health outcomes, both clinical and financial, due to reduced efficacy and increased adverse effects of alternative antibiotics. Patient interview, penicillin skin testing (PST) and/or an oral graded challenge can be used to evaluate penicillin allergies. Different facilities use various algorithms for testing. The objective of this project was to determine whether a pharmacist-driven penicillin allergy evaluation and testing protocol which largely bypasses PST could safely de-label patients. Methods Adult patients (≥18 years) admitted with a penicillin allergy were evaluated for eligibility between September 2019 and June 2020. Pregnant patients, critically-ill patients, and patients receiving test-invalidating medication were excluded. Patients were evaluated and tested using institutional protocols, which allowed for the majority of patients to be challenged without PST. Allergies were removed with standardized documentation, and patients were given a pamphlet and counseled to discourage relabeling. Data collected included but were not limited to, the number of patients challenged and de-labeled, number of patients who were relabeled, and number of patients whose change in allergy status resulted in change of therapy. Results Forty-eight patients were interviewed and evaluated. One patient was evaluated by PST and oral graded challenge while 27 patients underwent an oral graded challenge only. Twenty patients were de-labeled as a result of patient interview. One patient failed oral challenge with minor itching that did not require any treatment, while 27 patients passed. Forty-seven allergies were removed or modified. Two patients who were de-labeled were relabeled with no record of a new reaction. Of de-labeled patients, 50% received a penicillin following removal of the allergy. Conclusion Penicillin allergies can be evaluated and removed using a pharmacy-driven algorithm that prioritizes direct challenges when appropriate. Risks of a reaction are low, and removal leads to change in treatment in a significant portion of patients. Disclosures All Authors: No reported disclosures


2020 ◽  
Author(s):  
Abhishek Goyal ◽  
Saurabh Saigal ◽  
Ankur Joshi ◽  
Dodda Brahmam ◽  
Yogesh Niwariya ◽  
...  

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S627-S627
Author(s):  
Jae Hyun Shin ◽  
R Ann Hays ◽  
Cirle Warren

Abstract Background There are limited options for Clostridioides difficile infection (CDI) refractory to conventional antibiotic therapy (metronidazole, vancomycin, or fidaxomicin). Fecal microbiota transplant (FMT) is considered a safe and effective treatment for recurrent CDI but has not been widely utilized for refractory CDI due to concerns about safety. Even when included in studies, refractory CDI has not been analyzed separately from recurrent CDI. We reviewed cases of FMT performed in the inpatient setting for CDI to evaluate its safety and efficacy for refractory CDI. Methods Patients who received FMT inpatient at University of Virginia Health System for recurrent or refractory CDI after Infectious Diseases and Gastroenterology consultation signed informed consent acknowledging that FMT was considered investigational use in CDI not responding to standard of care as per 2014 FDA guidance. Charts were reviewed as part of quality improvement efforts to evaluate safety and efficacy of FMT in inpatient setting. Results Starting in July 2014, 13 patients received FMT for CDI as inpatients. Six received FMT for recurrent CDI, with four having complete resolution, one had recurrent CDI, and one had persistent C. difficile-negative diarrhea, for cure rate of 83%, comparable to published studies. Seven patients received FMT for refractory CDI, with three resulting in complete resolution. One responded to FMT but refused further care, one died from multiorgan failure after initial response to FMT that was possibly related to CDI, strongyloides, and/or CMV. Two patients had ongoing diarrhea suggestive of post-infectious irritable bowel syndrome, one was C. difficile-negative and one was not tested. The cure rate was 57%, lower than that of the recurrent CDI, but without any clear evidence of microbiologic failure. Outcome of patients undergoing FMT for CDI in the inpatient setting at University of Virginia Health System Conclusion Cure rate for FMT for refractory CDI was lower than recurrent CDI, but review of the cases of treatment failures did not reveal any microbiologic evidence of failure. FMT should be considered an alternative option when treating refractory CDI. Disclosures All Authors: No reported disclosures


2021 ◽  
pp. 1-5
Author(s):  
David E Saudek ◽  
Deborah Walbergh ◽  
Peter Bartz ◽  
Sara Shreve ◽  
Amy Schaal ◽  
...  

Abstract Background: Intranasal dexmedetomidine is an attractive option for procedural sedation in pediatrics due to ease of administration and its relatively short half-life. This study sought to compare the safety and efficacy of intranasal dexmedetomidine to a historical cohort of pediatric patients sedated using chloral hydrate in a pediatric echo lab. Methods: Chart review was performed to compare patients sedated between September, 2017 and October, 2019 using chloral hydrate and intranasal dexmedetomidine. Vital signs, time to sedation, duration of sedation, need for second dose of medication, rate of failed sedation, and impact on vital signs were compared between groups. Subgroup analysis was performed for those with complex and cyanotic heart disease. Results: Chloral hydrate was used in 356 patients and intranasal dexmedetomidine in 376. Patient age, complexity of heart disease, and duration of sedation were similar. Rates of failed sedation were very low and similar. Average heart rate and minimum heart rate were lower for those receiving intranasal dexmedetomidine than chloral hydrate. Impact on vital signs was similar for those with complex and cyanotic heart disease. No adverse events occurred in either group. Conclusions: Sedation with intranasal dexmedetomidine is comparable to chloral hydrate in regards to safety and efficacy for children requiring echocardiography. Consistent with the mechanism of action, patients receiving intranasal dexmedetomidine have a lower heart rate without morbidity.


PEDIATRICS ◽  
2002 ◽  
Vol 109 (Supplement_E1) ◽  
pp. 357-361
Author(s):  
Robert C. Strunk

A physician faces many challenges in making a definitive diagnosis of asthma in young children. Although there are clinical and historical features consistent with asthma, identical features are present in many other diseases. Furthermore, there is no specific test for asthma. Other diseases must always be ruled out before a definitive diagnosis of asthma is made. Determining whether cough or wheeze is the primary symptom is important because asthma is primarily a wheezing disease. Sweat chloride testing, chest radiography, and allergy skin testing should be performed in children with persistent wheezing to rule out other causes and help support a diagnosis of asthma. Allergy skin testing provides particularly useful information for making a diagnosis of asthma in the preschool-aged child. A chart review of patients presenting consecutively to the Division of Allergy and Pulmonary Medicine provides insight and information on an approach to make an asthma diagnosis for this population.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3658-3658
Author(s):  
Mohammed Abdullah Alsheef ◽  
Mukhtar Alomar ◽  
Abdul Rehman Z. Zaidi ◽  
Ghaydaa Juma Kullab ◽  
Mohammed AlHazzaa ◽  
...  

Background: Cerebral venous thrombosis (CVT) is an uncommon cause of stroke that mainly affects young adults and children. Initial treatment with heparin followed by wafarin is the mainstay of treatment. Only insufficient experience is available for direct oral anticoagulants (DOACs). Aims: The study aims to demonstrate the efficacy and safety of DOACs such as (Rivaroxaban and Dabigatran) in patients with objectively confirmed CVT. Methods: Data of 46 cases of CVT collected using a standardized case report form. Inclusion criteria were patients diagnosed with CVT, confirmed by CT or MRI imaging. Results: The total number of patients was 46 (9 males and 37 females). The mean age of the patients was 35.2± 5 years. The most common clinical manifestations among our patients were headache followed by seizure. 52% of cases were unprovoked, while 48% were provoked by pregnancy and oral contraceptive pills. Superior sagittal sinus (55%) and transverse sinus (44.9%) were the most common sites. Involvement of more than three venous sinuses was 34.8%. Thrombophilic abnormality was detected in 21.7% of patients. Initiation of anticoagulation (AC) was mostly low molecular weight heparin (LMWH) (80%), followed by unfractionated heparin (UFH) (17.7%) and fondaparinex (2%). Maintenance AC with Rivaroxaban after heparin (LMWH/UFH) was in 63% of our patients, the rest were switched from Warfarin to Rivaroxaban (34.8%), and one was treated by Dabigatran (2%). CVT recurrence was observed in one patient. Major bleeding (according to ISTH criteria) was not reported in our case series. Conclusions: DOACs demonstrated good safety and efficacy profile and can potentially replace warfarin in CVT patients. Disclosures No relevant conflicts of interest to declare.


PEDIATRICS ◽  
1959 ◽  
Vol 24 (6) ◽  
pp. 1009-1015
Author(s):  
Richard L. London ◽  
Jerome Glaser

A study of 400 allergic patients of all ages, who were skin tested with eggwhite, is reported. The authors agree with those who believe that a positive reaction in infants who have in no known way been exposed to eggwhite after birth is in all probability due to intrauterine sensitization. There is a possibility, however, that some reactions to eggwhite may be due to a primary histamine or serotonin releasing substance present in the eggwhite which has no relationship to antigen-antibody reaction. The circumstances under which this takes place are not known. In all age groups the family history was positive in about 65% of cases. It was surprising to find, in view of previous opinions, that in the youngest age group (infants up to 2 years of age), the skin test was positive in less than half the patients (42%) in the presence of clinical sensitivity. It was also unexpected to find that the number of patients clinically sensitive to eggwhite but giving negative skin tests increased as age advanced. This justifies the common practice of eliminating egg as a trial measure in the diet of the first age group, regardless of the results of skin testing, and suggests that this should be done in any age group where food is considered a possible etiologic factor. In the youngest age group somewhat more than one-third (34%) of the patients reacted positively to eggwhite but were not clinically sensitive. This finding was completely unexpected as it had been thought that in this age group a positive skin test to eggwhite was practically pathognomonic of clinical sensitivity. In this study more positive reactions in children to eggwhite were obtained (70.5%) than in a somewhat comparable series where the incidence was much less (20%). We attribute this to the fact that in our series both scratch and intradermal tests were made while in the other series only scratch tests were done. This reflects the greater sensitivity of the intradermal test. Only about half the patients of all ages who react to eggwhite are also clinically sensitive. Attention is drawn to a theory which explains why a positive cutaneous test to a food, as eggwhite, may be clinically significant in atopic dermatitis even though the test (wheal reaction) does not reproduce the type of dermatitis being studied. There was no definite evidence, because the number of cases studied is far too small, to indicate that the severity of asthma which may ultimately develop in infants not asthmatic at the time of skin testing is proportional to the strength of the initial reaction to eggwhite.


Author(s):  
Ruben Berrocal Timmons

Objective: Treatment of joint pain with an injection of the amniotic membrane has not been adequately studied. This study retrospectively reviewed Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analgesic usage data from patients treated with the injection of cryopreserved amniotic membrane (CAM) in their knees to determine the impact of treatment on patients’ pain, quality of life, and analgesic usage. Methods: Chart review was conducted on 40 patients. Institutional Review Board (IRB) approval was obtained prior to initiation of the project. The membrane was utilized as per the FDA guidance of 21CFR1271. Retrospective data, including demographics, medical history, pain score, quality of life score, analgesic usage and adverse events, were collected from their medical records for each consenting patient through 6 months after CAM injection. Results: A total of 40 patients were considered in the final analysis. Mean VAS for pain level improved from 7.0 to 2.6 (p<0.001). WOMAC daily activity function score improved from a mean score of 52 to 28 (p<0.001). Opioid and non-steroidal anti-inflammatory drug (NSAID) usage decreased from 97% to 25% (p<0.001). No adverse events were reported. Conclusion: Mean values for VAS and WOMAC scores significantly improved at all time points and the number of patients who used analgesics decreased as compared to baseline. CAM injection into painful knee joints decreases pain, improves physical function, and decreases the use of analgesics in the absence of adverse events.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19513-e19513
Author(s):  
John E. Godwin ◽  
Bassam Ibrahim Mattar ◽  
Michael B. Maris ◽  
Carlos R. Bachier ◽  
Don A. Stevens ◽  
...  

e19513 Background: Concerns about adverse events (AEs) related to CAR T cell therapy have resulted in administration of this therapy largely in an inpatient setting. OUTREACH (NCT03744676) evaluates safety and efficacy of liso-cel in patients (pts) with R/R large B-cell lymphoma (LBCL) across inpatient and outpatient settings at nonuniversity medical centers (NMCs). Methods: NMCs, including centers naïve to CAR T cell therapy, enrolled adults with R/R LBCL in this open-label, multicenter study. Eligible pts had R/R PET-positive disease after ≥2 lines of prior systemic therapy, ECOG PS ≤1, and adequate organ function. Prior autologous HSCT was allowed. Pts received sequential infusions of equal target doses of CD8+ and CD4+ cells at a total target dose of 100 × 106 CAR+ T cells. Primary endpoint was incidence of grade (G) ≥3 cytokine release syndrome (CRS) graded per 2014 Lee criteria, neurological events (NEs), prolonged cytopenias (Day 29 G ≥3 lab values), and infections. Secondary endpoints were safety and overall response rate (ORR). Outpatient AE monitoring/management was managed by a multidisciplinary CAR T cell therapy team following standard operating procedures (SOPs). Results: At data cutoff, 46 pts (inpatients n = 16, outpatients n = 30) were treated with liso-cel. Inpatients and outpatients had similar demographics and baseline disease characteristics; median age was 63 y (range, 34–83), 63% had diffuse LBCL not otherwise specified, and 91% were refractory to last therapy. Safety data were similar across inpatients and outpatients (Table). Early (study Day ≤4) and overall hospitalization in outpatients was reported in 27% and 63%, respectively; median time to hospitalization was 5 (2–61) days and median length of stay was 6 (1–28) days. For efficacy-evaluable pts (n = 44), ORR was 75% for inpatients and 79% for outpatients; CR rates were 50% and 61%, respectively. Conclusions: Liso-cel was successfully administered to pts with R/R LBCL in the outpatient setting and pts were monitored for CAR T cell therapy–related toxicities by multidisciplinary teams using SOPs. The incidences of severe CRS and NEs and use of tocilizumab and/or corticosteroids were similar in inpatients and outpatients, and consistent with the pivotal study observations (Abramson, The Lancet 2020). Updated data with longer follow-up will be presented. Clinical trial information: NCT03744676. [Table: see text]


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