Development and Validation of High-Performance Liquid Chromatography Method for the Quantification of Remdesivir in Intravenous Dosage Form.

Corona virus disease 2019 (COVID-19) has posed a mounting threat to public health with worldwide outbreak caused by a novel virus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Recently, remdesivir (RDV) has been approved by Food and Drug Administration (FDA) for treating COVID-19 patients ≥12 years old requiring hospitalization. To the best of our knowledge, a simple method to estimate RDV in the pharmaceutical formulations using high-performance liquid chromatography (HPLC) is still unexplored, highlighting the need for a precise analytical method for its quantification. The prime purpose of the current investigation was to develop and validate a well-grounded HPLC method for quantification of RDV in pharmaceutical formulations. The best chromatogram was obtained by means of an Inertsil ODS-3V column using a mobile phase of milli-Q water modified to pH 3.0 with o-phosphoric acid and acetonitrile (50:50, % v/v) at a flow rate of 1.2 mL/min and wavelength of detector set at 246 nm with retention time being achieved at 6.0 min. The method was validated following International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2 (R1) guidelines for various parameters such as specificity and selectivity, system suitability, linearity, precision, accuracy, limits of detection and quantification, and robustness. The method developed for the quantification of RDV was found to be linear in the concentration range of 25-2,500 ng/mL with limit of detection and limit of quantification of 1.95 and 6.49 ng/mL, respectively. Assay value of 102% ± 1% was achieved for marketed injectable dosage form when estimated by the validated method. Therefore, in this study a simple, rapid, sensitive, selective, accurate, precise, and robust analytical method was developed and validated for the quantification of RDV using HPLC. The established method was successfully employed for quantification of RDV in marketed pharmaceutical formulation.

Changes to Titration Standards Negatively Affect Nursing Practice.

Limits on nurse autonomy result in delayed care and professional burnout.

Standard Versus Long Peripheral Catheters for Multiday IV Therapy: A Randomized Controlled Trial.

OBJECTIVES: In children, intravenous therapy (IVT) is generally administered via peripheral intravenous catheters (PIVCs) (2-6 cm in length). There is evidence that PIVCs are unreliable after 2 days. Long peripheral catheters (LPCs) (6-15 cm in length) could improve the delivery of IVT. The aim of this trial was to determine if LPCs could decrease catheter failure and the number of catheters in children receiving multiday IVT. METHODS: This was an open-label randomized controlled trial conducted at Monash Children's Hospital in Melbourne, Australia. Participants were from the ages of 1 to 17 years, undergoing surgery and requiring >48 hours of postoperative IVT. Participants were randomly assigned to a 2.5-cm 22G PIVC or an 8-cm 22G LPC. RESULTS: Seventy-two children were randomly assigned, 36 received PIVCs, and 36 received LPCs. The median duration of IVT was 5.1 days and was similar between groups (P = .9). Catheter failure was higher for PIVCs than LPCs (66.7% vs 19.4%; relative risk [RR]: 3.4; P = .0001 or 187.9 vs 41.0 failures per 1000 catheter-days). Infiltration was the most common reason for PIVC failure (33.3% vs 2.8%; RR: 12.0; P = .001). LPCs exhibited superior life span (4.7 vs 3.5 days [median]; P = .01). Children with LPCs were twice as likely to complete therapy with a single catheter (80.6% vs 38.9%; RR: 2.1; P = .0006). CONCLUSIONS: LPCs reduce catheter failure and total catheters in children. They should be considered as the first-line device for peripheral access in any child receiving prolonged IVT.

Impact of surgical technique and analgesia on clinical outcomes after lung transplantation: A STROBE-compliant cohort study.

There is paucity of data on the impact of surgical incision and analgesia on relevant outcomes.A retrospective STROBE-compliant cohort study was performed between July 2007 and August 2017 of patients undergoing lung transplantation. Gender, age, indication for lung transplantation, and the 3 types of surgical access (Thoracotomy (T), Sternotomy (S), and Clamshell (C)) were used, as well as 2 analgesic techniques: epidural and intravenous opioids. Outcome variables were: pain scores; postoperative hemorrhage in the first 24 hours, duration of mechanical ventilation, and length of stay at intensive care unit (ICU).Three hundred forty-one patients were identified. Thoracotomy was associated with higher pain scores than Sternotomy (OR 1.66, 95% CI: 1.01; 2.74, P: .045) and no differences were found between Clamshell and Sternotomy incision. The median blood loss was 800 mL [interquartile range (IQR): 500; 1238], thoracotomy patients had 500 mL [325; 818] (P < .001). Median durations of mechanical ventilation in Thoracotomy, Sternotomy, and Clamshell groups were 19 [11; 37] hours, 34 [IQR 16; 57.5] hours, and 27 [IQR 15; 50.5] hours respectively. Thoracotomy group were discharged earlier from ICU (P < .001).Thoracotomy access produces less postoperative hemorrhage, duration of mechanical ventilation, and lower length of stay in ICU, but higher pain scores and need for epidural analgesia.

Switching from intravenous to oral antibiotics in hospitalized patients with community-acquired pneumonia: A real-world analysis 2010-2018.

The Japanese Respiratory Society 2017 guidelines strongly recommend switching from intravenous (IV) to oral antibiotics in patients with community-acquired pneumonia (CAP), following improvement in clinical symptoms and laboratory findings. Here, we retrospectively investigated the real-world, nationwide treatment and switching patterns for hospitalized patients with CAP in Japan using administrative data from 372 Japanese Diagnosis Procedure Combination hospitals from April 2010 to December 2018. Hospitalizations for CAP (patient age ≥20 years) with an A-DROP classification for CAP severity and IV antibiotics initiated on the admission date were included. Overall, 210,314 hospitalizations (moderate CAP: 61.7%) in 183,607 patients were analyzed. The median (interquartile range [IQR]) age at admission was 79 (70-86) years. Penicillin (51.9%) and cephalosporin (38.9%) were the most common IV antibiotic classes used and the median (IQR) duration of IV use was 8 (6-11) days. Switching to oral antibiotics during a hospitalization occurred in 30.1% (n = 63,311) of patients after a median (IQR) of 7 (5-10) days of IV treatment. The most frequently used oral antibiotic classes after a switch were fluoroquinolone (45.9%) and penicillin (24.8%). The switch rate was higher among hospitalizations with milder CAP, in respiratory medicine ward and in larger hospitals. The overall switch rates did not change over the study period. The findings from this analysis suggest that early switch from IV to oral antibiotics was not widely implemented during the 8 years of the study period. Further observation will be needed to see the potential impact of the guidelines update in 2017 in Japan.

Physical stability of an all-in-one parenteral nutrition admixture for preterm infants upon mixing with micronutrients and drugs.

Objectives: The main objective was to investigate Y-site compatibility of intravenous drugs with one standard total parenteral nutrition (TPN) admixture for preterm infants. Since micro-precipitation was observed in the water phase after addition of trace elements, the concentration effect on micro-precipitation formation developed as a sub-goal. Methods: Seven drugs (ampicillin, ceftazidime, fluconazole, fosphenytoin, furosemide, metronidazole and paracetamol) were mixed in three mixing ratios with one preterm TPN admixture. Samples were investigated within 1 hour and again after 4 hours. Precipitation was studied in a lipid-free version called TPNaq by light obscuration, turbidimetry and visual examination. Emulsion stability data were assessed by light obscuration and laser diffraction. pH was measured to assess the theoretical risk of precipitation and emulsion destabilisation. The influence of different concentrations of trace elements on precipitation was investigated by visual examination, turbidimetry and light obscuration. Results: Ampicillin, ceftazidime, fosphenytoin and furosemide led to precipitation after mixing with TPNaq. In some samples of TPN and fluconazole, metronidazole and paracetamol, the emulsion droplet size was above the acceptance limit, although this might also be inherent to the TPN admixture. An unexpected formation of micro-precipitate correlating with increasing amounts of added trace elements might be caused by an interaction of cysteine and copper, and complicated the compatibility assessment with drugs. Conclusions: The micro-precipitate resulting from the addition of trace elements should be investigated further. This study did not provide sufficient evidence to recommend Y-site infusion of the tested drugs and the preterm admixture; however, it might offer some additional support to other compatibility data.

Sampling Site Has a Critical Impact on Physiologically Based Pharmacokinetic Modeling.

It has been shown that arterial (central) and venous (peripheral) plasma drug concentrations can be very different. While pharmacokinetic studies typically measure drug concentrations from the peripheral vein such as the arm vein, physiologically based pharmacokinetic (PBPK) models generally output simulated concentrations from the central venous compartment that physiologically represents the right atrium, a merge of the superior and inferior vena cava. In this study, a physiologically based peripheral forearm sampling site model was developed and verified using nicotine, ketamine, lidocaine, and fentanyl as model drugs. This verified model allows output of simulated peripheral venous concentrations that can be meaningfully compared with observed pharmacokinetic data from the arm vein. The generalized effect of PBPK model sampling site on simulation output was investigated. Drugs and metabolites with large volumes of distribution showed considerable concentration discrepancy between the simulated central venous compartment and the peripheral arm vein after intravenous or oral administration, resulting in significant differences in values for C max and time taken to reach C max (t max ) In addition, the simulated central venous metabolite profile showed an unexpected profile that was not observed in the peripheral arm vein. Using fentanyl as a model compound, we show that using the wrong sampling site in PBPK models can lead to biased model evaluation and subsequent erroneous model parameter optimization. Such an error in model parameters along with the discrepant sampling site could dramatically mislead the pharmacokinetic prediction in unstudied clinical scenarios, affecting the assessment of drug safety and efficacy. Overall, this study shows that PBPK model publications should specify the model sampling sites and match them with those employed in clinical studies. SIGNIFICANCE STATEMENT: Our study shows that sampling from the central venous compartment (right atrium) during physiologically based pharmacokinetic model development gives rise to biased model evaluation and erroneous model parameterization when observed data are collected from the peripheral arm vein. This can lead to a clinically significant error in predictions of plasma concentration-time profiles in unstudied scenarios. To address this error, we developed and verified a novel peripheral sampling site model to simulate arm vein drug concentrations that can be applied to different drug dosing scenarios.

Complicações da terapia intravenosa para familiares de crianças hospitalizadas: validação de manual / Complicaciones de la terapia intravenosa para los familiares de los niños hospitalizados: validación del manual / Complications of intravenous therapy for relatives of hospitalized children: handbook validation

Objetivo validar o conteúdo e a aparência da tecnologia educacional "Complicações da Terapia Intravenosa em Crianças: Manual de Orientações para Familiares" na perspectiva de acompanhantes de crianças hospitalizadas. Método estudo metodológico, do tipo produção tecnológica. A validação foi realizada por 65 familiares de crianças hospitalizadas, mediante leitura e aplicação de questionário sobre todos os itens que faziam parte da tecnologia. Resultados a distribuição do índice de concordância de todas as variáveis alcançou mais de 90% segundo os acompanhantes das crianças hospitalizadas. Conclusão o manual demonstrou estar apto para utilização na prática clínica diária nos hospitais pediátricos, pois os familiares acompanhantes consideraram o conteúdo apropriado, clareza da linguagem utilizada e sua aparência, destacando a motivação durante a leitura das informações disponíveis.

Objetivo validar el contenido y el aspecto de la tecnología educacional "Complicaciones de la Terapia Intravenosa en Niños: Manual de Directrices para la Familia" en la perspectiva de los compañeros de los niños hospitalizados. Método un estudio metodológico, del tipo de la producción tecnológica. La validación fue realizada por 65 familiares de los niños hospitalizados a través de la lectura y la aplicación de un cuestionario sobre todos los elementos que eran parte de la tecnología. Resultados la distribución del índice de concordancia de todas las variables alcanzó más del 90% de acuerdo a los acompañantes de los niños hospitalizados. Conclusión el manual demostró ser adecuado para el uso en la práctica clínica diaria en los hospitales pediátricos, porque los cuidadores familiares consideran el contenido apropiado, la claridad del lenguaje utilizado y su apariencia, resaltando la motivación durante la lectura de la información disponible.

Objective to validate the content and layout of the educational technology "Complications of Intravenous Therapy in Children: Family's Guideline Handbook" in the perspective of companions of hospitalized children. Method methodological study, the technological production type. The validation was performed by 65 relatives of hospitalized children through reading and application of a questionnaire on all items that were part of the technology. Results the distribution of the concordance index of all variables reached more than 90% according to the companions of hospitalized children. Conclusion the handbook proved to be suitable for use in daily clinical practice in pediatric hospitals, because the family companions considered the content appropriate, clear language used and layout, highlighting the motivation during the reading of the information available.

Is the subcutaneous route an alternative for administering ertapenem to older patients? PHACINERTA study.

BACKGROUND: Antibiotic administration by subcutaneous (SC) injection is common practice in French geriatric wards as an alternative to the intravenous (IV) route, but few pharmacokinetic/pharmacodynamic data are available. Ertapenem is useful for the treatment of infections with ESBL-producing enterobacteria. OBJECTIVES: To report and compare ertapenem pharmacokinetic data between IV and SC routes in older persons. METHODS: Patients >65 years of age receiving ertapenem (1 g once daily) for at least 48 h (IV or SC, steady-state) were prospectively enrolled. Total ertapenem concentrations [residual (C0), IV peak (C0.5) and SC peak (C2.5)] were determined by UV HPLC. Individual-predicted AUC0-24 values were calculated and population pharmacokinetic analyses were performed. Using the final model, a Monte Carlo simulation involving 10 000 patients evaluated the influence of SC or IV administration on the PTA. Tolerance to ertapenem and recovery were also monitored. ClinicalTrials.gov identifier: NCT02505386. RESULTS: Ten (mean ± SD age=87±7 years) and 16 (age=88±5 years) patients were included in the IV and SC groups, respectively. The mean C0 and C2.5 values were not significantly different between the IV and SC groups (C0=12±5.9 versus 12±7.4 mg/L, P=0.97; C2.5=97±42 versus 67±41 mg/L, P=0.99). The mean C0.5 was higher in the IV group compared with the SC group (C0.5=184±90 versus 51±66 mg/L, P=0.001). The mean individual AUCs (1126.92±334.99 mg·h/L for IV versus 1005.3±266.0 mg·h/L for SC, P=0.38) and PTAs were not significantly different between groups. No severe antibiotic-related adverse effects were noted. CONCLUSIONS: SC administration of ertapenem is an alternative to IV administration in older patients.

Improving the safety of high-concentration potassium chloride injection.

Objectives: Serious adverse effects, including arrhythmia and cardiac arrest, result from rapid intravenous high concentration of potassium chloride (KCl). We aimed to eliminate prescription of undiluted KCl and encourage dilution of KCl to 400 mEq/L and 40 mEq/L in the intensive care units (ICUs) and general and outpatient departments, respectively. Methods: Before the first intervention, we collected data regarding high-concentration KCl and interviewed representatives of physicians prescribing high-concentration KCl. Based on the guidelines in other countries on safely used concentrations of KCl (400 mEq/L), we negotiated with physicians to dilute KCl below 400 mEq/L. In the first intervention, we made rules based on surveys above. In the second intervention, we revised the rules based on opinions from physicians and pharmacists and investigated the change in the number of prescriptions of KCl concentration in each department. Continuing efforts with the safety manager ensured compliance of the rules by physicians and nurses in all departments. Results: After the first and second interventions, prescriptions for undiluted KCl in ICUs and general wards were eliminated (median=0). Prescriptions for <400 mEq/L KCl increased to 110 (median) after the first intervention and to 137 (median) after the second. In the general ward, 7 months after the first intervention, prescriptions for <400 mEq/L KCl had not increased. Compliance with our rules was high, and more than 72% of physicians and nurses were aware of the rules. Conclusions: The rules for administration of high-dose KCl successfully eliminated prescription of undiluted KCl, which was maintained using two plan-do-study-act cycles. Our intervention process could be useful in countries where prediluted formulations are unavailable or where prescriptions are not matched and undiluted ampules are used.

Cost-effectiveness of infusion pumps to reduce errors in a Pediatric ICU.

OBJECTIVE: To analyze cost-effectiveness and to calculate incremental cost-effectiveness ratio of the use of infusion pumps with drug library to reduce errors in intravenous drug administration in pediatric and neonatal patients in Intensive Care Units. METHODS: Mathematical modeling for economic analysis of the decision tree type. The base case was composed of reference and alternative settings. The target population was neonates and pediatric patients hospitalized in Pediatric and Neonatal Intensive Care Units, comprising a cohort of 15,034 patients. The cost estimate was based on the bottom-up and top-down approaches. RESULTS: The decision tree, after RollBack, showed that the infusion pump with drug library may be the best strategy to avoid errors in intravenous drugs administration. CONCLUSION: The analysis revealed that the conventional pump, although it has the lowest cost, also has lower effectiveness.

Cost-effectiveness of infusion pumps to reduce errors in a Pediatric ICU / El costo-efectividad de bombas de infusión para la reducción de errores en una UTI Pediátrica / Custo-efetividade de bombas de infusão para a redução de erros em uma UTI Pediátrica

ABSTRACT Objective: To analyze cost-effectiveness and to calculate incremental cost-effectiveness ratio of the use of infusion pumps with drug library to reduce errors in intravenous drug administration in pediatric and neonatal patients in Intensive Care Units. Methods: Mathematical modeling for economic analysis of the decision tree type. The base case was composed of reference and alternative settings. The target population was neonates and pediatric patients hospitalized in Pediatric and Neonatal Intensive Care Units, comprising a cohort of 15,034 patients. The cost estimate was based on the bottom-up and top-down approaches. Results: The decision tree, after RollBack, showed that the infusion pump with drug library may be the best strategy to avoid errors in intravenous drugs administration. Conclusion: The analysis revealed that the conventional pump, although it has the lowest cost, also has lower effectiveness.

RESUMEN Objetivo: Analizar el costo-efectividad y calcular la razón de costo-efectividad incremental del uso de bombas de infusión con una biblioteca de fármacos para reducir errores en la administración de medicamentos por vía intravenosa, en pacientes pediátricos y neonatales en unidades de terapia intensiva. Método: Modelaje matemático para el análisis económico, del tipo árbol de decisión. El caso base se compone de escenarios de referencia y alternativo. La población objetivo fueron pacientes neonatos y pediátricos internados en unidades de terapia intensiva pediátrica y neonatal, componiendo una cohorte de 15.034 pacientes. La estimación de costos se basó en los enfoques bottom-up y top-down. Resultados: El árbol de decisión, después de Roll Back, mostró que la bomba de infusión con biblioteca de fármacos puede ser la mejor estrategia para evitar errores en la administración de medicamentos intravenosos. Conclusión: El análisis reveló que la bomba convencional, aunque tiene el menor costo, tiene también menor efectividad.

RESUMO Objetivo: Analisar o custo-efetividade e calcular a razão de custo-efetividade incremental do uso de bombas de infusão com biblioteca de fármacos para reduzir erros na administração de medicamento pela via intravenosa, em pacientes pediátricos e neonatais em Unidades de Terapia Intensiva. Método: Modelagem matemática para análise econômica, do tipo árvore de decisão. O caso-base foi composto pelos cenários de referência e alternativo. A população alvo foram pacientes neonatos e pediátricos internados em Unidades de Terapia Intensiva pediátrica e neonatal, compondo uma coorte de 15.034 pacientes. A estimativa de custos foi baseada nas abordagens bottom-up e top-down. Resultados: A árvore de decisão, após RollBack, mostrou que a bomba de infusão com biblioteca de fármacos pode ser a melhor estratégia para evitar erros na administração de medicamentos intravenosos. Conclusão: A análise revelou que a bomba convencional, embora tenha o menor custo, tem também menor efetividade.

Intravenous cancer chemotherapy administration errors: An observational study at referral hospital in Jordan.

This study aimed to describe types, frequencies and stages of errors which occurred during administration of commonly used intravenous (IV) cancer chemotherapy medications inclusive of "aseptic technique." A disguised direct observational cross-sectional prospective study was performed. A checklist consisting of appropriate process of administration of injectable chemotherapy agents along with the "aseptic technique" was developed and used. The study was conducted at the haematology and oncology wards at King Hussein Medical Centre/Jordanian Royal Medical Services (KHMC/JRMS). In all, 10 nurses who administrated IV chemotherapy in both inpatient and outpatient settings were observed. Overall, administration processes of 654 cases, consisting of 15,042 error opportunities, were observed of which 4112 (27.3%) errors were detected. A total of 19.9% (2217/11,118) and 48.3% (1895/3924) of the errors were in the administration process and "aseptic techniques," respectively. Nurses who had finished a cancer chemotherapy medication preparation and administration training course committed significantly (p > 0.05) more medication administration errors compared to those who had not completed such course. This study highlighted a significant incidence of medication errors during administration of injectable chemotherapy agents. Educational programmes are required for safe administration of IV chemotherapy agents in some settings in Jordan.

Reducing Readmissions Post-tonsillectomy: A Quality Improvement Study on Intravenous Hydration.

INTRODUCTION: Dehydration is a potentially preventable complication post-tonsillectomy and can result in an Emergency Department visit and/or readmission. Our objectives were to identify risk factors for dehydration readmissions and develop interventions to prevent them. METHODS: We used retrospective chart reviews to determine if increased intravenous (IV) hydration post-tonsillectomy prevented hospital readmissions for dehydration. All children aged 1-18 years who underwent tonsillectomy between July 1, 2007 and September 30, 2015 were included in this quality improvement study. Using the Pediatric Health Information System database, patients who experienced a readmission for dehydration within 72 hours of surgery were identified and validated with internal data. We analyzed the pre-implementation and post-implementation readmission rates after standardization of increased IV fluids (1.5 times maintenance). An interrupted time series analysis was used to estimate the effects of our hydration initiative. RESULTS: Of 11,157 patients who underwent tonsillectomy during the study period, 96 (0.9%) met the criteria for readmissions for dehydration. The pre-implementation readmission rate was 1% compared to 0.2% post-implementation, a reduction of 82%. CONCLUSIONS: The hydration initiative was associated with a significant decrease in hospital readmissions. This safe, low-cost, easy-to-implement approach to preventing dehydration post-tonsillectomy could be explored at other institutions.

Fewer adverse effects associated with a modified two-bag intravenous acetylcysteine protocol compared to traditional three-bag regimen in paracetamol overdose.

Context: The intravenous (IV) N-acetylcysteine (NAC) regimen used worldwide in paracetamol overdose is complex with three separate weight-based doses and is associated with a high incidence of adverse events including non-allergic anaphylactoid reactions (NAARs). In 2012, Denmark adopted the two-bag IV NAC regimen which combined the first two infusions of the three-bag regimen and kept the third infusion unchanged. We compared the safety and efficacy of the two-bag IV NAC regimen with the traditional Danish three-bag regimen. Methods: A medical chart review was conducted in three Danish medical centers from January 2012 through December 2014. Safety and efficacy data were compared for patients who received the traditional infusion protocol in Denmark or the 20-h two-bag IV regimen. Results: Four hundred and ninety-three cases received the two-bag regimen and 274 received the three-bag regimen. The overall incidence of NAARs was 9% with all being mild to moderate in intensity. Fewer subjects in the two-bag group (4%) developed NAARs compared to 17% in the three-bag group (p < .001). Overall, 31 patients (4%) developed hepatotoxicity. There was no apparent difference in hepatotoxicity rates between the groups and no deaths or liver transplants. Patients receiving the two-bag regimen had fewer interruptions or delays (5%) compared to the three-bag regimen cohort (12%). Overall, there were very few medication errors reported (1%). Conclusions: The incidence of NAARs was lower in patients receiving acetylcysteine in a two-bag regimen compared to the traditional Danish three-bag regimen without an apparent reduction in efficacy.

Use of Short Peripheral Intravenous Catheters: Characteristics, Management, and Outcomes Worldwide.

BACKGROUND: Peripheral intravenous catheter (PIVC) use in health care is common worldwide. Failure of PIVCs is also common, resulting in premature removal and replacement. OBJECTIVE: To investigate the characteristics, management practices, and outcomes of PIVCs internationally. SETTING/PATIENTS: Cross-sectional study. Hospitalized patients from rural, regional, and metropolitan areas internationally. MEASUREMENTS: Hospital, device, and inserter characteristics were collected along with assessment of the catheter insertion site. PIVC use in different geographic regions was compared. RESULTS: We reviewed 40,620 PIVCs in 51 countries. PIVCs were used primarily for intravenous medication (n = 28,571, 70%) and predominantly inserted in general wards (n = 22,167, 55%). Two-thirds of all devices were placed in non-recommended sites such as the hand, wrist, or antecubital veins. Nurses inserted most PIVCs (n = 28,575, 71%); although there was wide regional variation (26% to 97%). The prevalence of iIn this study, we found that many PIVCs were placed in areas of flexion, were symptomatic or idle, had suboptimal dressings, or lacked adequate documentation. This suggests inconsistency between recommended management guidelines for PIVCs and current practice.dle PIVCs was 14% (n = 5,796). Overall, 10% (n = 4,204) of PIVCs were painful to the patient or otherwise symptomatic of phlebitis; a further 10% (n = 3,879) had signs of PIVC malfunction; and 21% of PIVC dressings were suboptimal (n = 8,507). Over one-third of PIVCs (n = 14,787, 36%) had no documented daily site assessment and half (n = 19,768, 49%) had no documented date and time of insertion. CONCLUSIONS: In this study, we found that many PIVCs were placed in areas of flexion, were symptomatic or idle, had suboptimal dressings, or lacked adequate documentation. This suggests inconsistency between recommended management guidelines for PIVCs and current practice.

Modelling interactions between procedures and resilience skills.

Although work in complex socio-technical systems needs support from several "resources for action", the interactions between these are not usually managed systematically. This study introduces a six-step framework for analyzing the interactions between two key resources for action, namely the use of standardized operating procedures and resilience skills (RSs). The main steps for applying the framework involve: (i) a content analysis of the procedure, which allows for the identification of underspecified rules and situations that could be emphasized in scenario-based training focused on developing RSs; and (ii) the identification of factors that set the stage for the emergence of RSs, which could be accounted for by procedures and the broader work system design. An application of the framework is presented in the preparation and administration of intravenous medications in an emergency department. Data collection involved 98 h of observations, 14 interviews, and document analysis. Based on this field study, a model of the interactions between procedures and RSs is proposed as well as the lessons learned from applying the framework are discussed.

The role of intravenous access during oral food challenges in food protein-induced enterocolitis syndrome.

BACKGROUND: Food protein-induced enterocolitis syndrome (FPIES) is a non-immunoglobulin E mediated food hypersensitivity syndrome characterized by profuse vomiting and diarrhea, which leads to lethargy, dehydration, and hypotension. Given the potential severity of reactions, resolution of FPIES is confirmed via oral food challenge (OFC) during which intravenous (IV) access is recommended to facilitate IV fluids (IVF) and steroid therapy. Risk factors for IV treatment are not well characterized. OBJECTIVES: The objectives of this study were to analyze predictors for IV treatment during OFC in patients with FPIES. METHODS: A retrospective chart review was conducted of patients with The International Classification of Diseases, Ninth Revision codes 558.3 and 558.9, and with OFC who were seen in an allergy and immunology clinic from January 2000 to October 2015. OFC reaction severity was scored (1, mild; 2, moderate; 3, severe), and demographics, IV treatment frequency, and OFC outcomes were evaluated. The Fisher exact test and Wilcoxon rank sum test statistical analyses were performed. RESULTS: Of 184 patients, 28 met inclusion criteria, with 39 OFCs performed. The median age of onset of FPIES was 6 months. The median age at OFC was 2.6 years. This was 2.2 years (range, 0.3-8.5 years) from symptom onset. Of 39 OFCs, IV treatment, including IVF and/or steroids, was required in only 7.7%. Thirty-eight OFCs (97.4%) were of equal or lesser severity than historical reactions. The median severity of presenting reaction (3[IV+]:1[IV-]; p = 0.05) was greater in those who required IV treatment. OFCs with IV treatment were in younger patients (15 months [IV+]:32 months [IV-]; p = 0.039) who underwent OFCs earlier relative to the time of diagnosis (8 months [IV+]:28 months [IV-]); p = 0.018). CONCLUSION: Although FPIES can potentially elicit severe symptomatology, the patients most commonly experienced only vomiting and diarrhea, which often resolved with minimal treatment. Reactions generally did not worsen over time. Fewer than 10% of the patients challenged required IV treatment, all were young and with severe FPIES. It is reasonable to consider age and length of time from historical reactions when evaluating the necessity of IV placement in patients undergoing FPIES OFC.