[Neonates treated with individualized parenteral nutrition who are candidates to receive standardized parenteral nutrition]. / Neonatos en tratamiento con nutriciones parenterales individualizadas, candidatos a recibir nutriciones parenterales estandarizadas.

INTRODUCTION: Objetive: to quantify the number of neonates treated with individualized parenteral nutrition (IPN) who were candidates to receive standardized parenteral nutrition (SPN), and to calculate their treatment duration. Material and methods: this was a prospective, observational, descriptive cohort study. Inclusion criteria were: neonates with indication of parenteral nutrition (PN) and individualized prescription. Exclusion criteria included: patients who had not started diuresis, with specific nutritional needs, altered acid-base balance, and/or contraindication to receive SPN. Included variables were patient-related (gender, weight, weeks of gestation, and days of life) and treatment-related regarding IPN composition. Setting the volume of PN as the conversion criterion, theoretical contributions were calculated with the SPN. The criterion for a patient to be a candidate to receive SPN was that all the theoretical contributions calculated were within the reference requirements range. Results: a total of 33 neonates (9 women) received IPN with 94 prescriptions. The median weight of the patients included in the study was 2.14 (IQR, 0.9) kg, and they were born at 35 (IQR, 3) weeks of gestation. PN began between 0 and 4 days of life. In all, 71 % (22/31) of the patients in 54.1 % of their (46/85) prescriptions were candidates to receive SPN via central administration for 1 to 8 days, whereas no patient was candidate to receive SPN via peripheral administration. Conclusions: in our center, 71 % of neonates treated with central administration of IPN are candidates to receive SPN, thus promoting the normalization of nutritional support in this population.

INTRODUCCIÓN: Objetivo: cuantificar el número de pacientes neonatos en tratamiento con nutriciones parenterales individualizadas (NPI), candidatos a recibir nutriciones parenterales estandarizadas (NPE), así como el número de días. Material y métodos: estudio prospectivo observacional y descriptivo de cohortes. Los criterios de inclusión fueron: pacientes neonatos con indicación de nutrición parenteral (NP) y prescripción individualizada. Los criterios de exclusión fueron: pacientes que no hubieran iniciado la diuresis, con necesidades nutricionales específicas, con alteraciones del equilibrio ácido-base y/o con contraindicación de la NPE. Se emplearon variables relacionadas con el paciente (sexo, peso, semanas de gestación y días de vida) y relacionadas con el tratamiento (aportes de la NPI). Fijando como criterio de conversión el volumen de NP, se calcularon los aportes teóricos con la NPE. El criterio para que un paciente fuera candidato a recibirla fue que todos los aportes teóricos estuvieran dentro de los requerimientos de referencia. Resultados: se incluyeron 33 neonatos (9 mujeres) en tratamiento con NPI y con 94 prescripciones. La mediana de peso de los pacientes incluidos en el estudio fue de 2,14 (RIC: 0,9) kg, nacidos a las 35 (RIC: 3) semanas de gestación y en los que se inició NP entre los días 0 y 4. El 71 % (22/31) de los pacientes en el 54,1 % (46/85) de sus prescripciones fueron candidatos a recibir NPE administrada por vía central durante 1 a 8 días, mientras que ningún paciente fue candidato a recibirla por vía periférica. Conclusiones: en nuestro centro, el 71 % de los pacientes nenonatos en tratamiento con NPI administrada por vía central son candidatos a recibir NPE, lo que fomenta la normalización del soporte nutricional en esta población.

Quality and safety of parenteral nutrition for newborn and preterm infants as an on-ward preparation.

BACKGROUND: For newborn and preterm infants, standardised and individual parenteral nutrition (PN) is used. PN preparation is at risk for contamination and dosing errors. The quality of PN is crucial for infants and has a direct impact on their health status and safety. PURPOSE: The aim of this study is to evaluate the physicochemical and microbial quality of PN for newborn and preterm infants prepared on a neonatal ward. METHODS: Sampling of various individual PN prepared by nurses on a neonatal ward was performed. Formulations included maximal four electrolytes, variable dextrose and amino acid concentrations. Depending on the sample volume, up to three quality analyses were performed: (1) test for bacterial endotoxins by kinetic-chromogenic method, (2) sterility according to the European and US Pharmacopoeia, and (3) quantification of electrolytes by capillary electrophoresis and of dextrose by ultraviolet detection after enzymatic reaction of hexokinase. The concentrations obtained were evaluated based on the US and Swiss Pharmacopoeia specifications for compounded preparations and compared to the widened pharmacy specifications. RESULTS: The composition of 86% of the 110 analysed PN prepared by nurses on the neonatal ward corresponded to their medical prescription. 14% were out of the acceptable widened pharmacy ranges. We found no microbial contamination in the samples. All PN were free from endotoxins. CONCLUSION: Component concentrations of PN prepared on wards by nurses differed frequently and significantly from their medical prescription, and the deviation can be critical depending on the component and its mode of action. The sample size is too small to evaluate the microbial contamination.

Control de calidad de la elaboración de nutriciones parenterales: control gravimétrico y de productos utilizados / Quality control of parenteral nutrition compounding: gravimetric and component verification control

INTRODUCCIÓN: la elaboración de nutriciones parenterales (NP) es un proceso complejo y con alta probabilidad de aparición de errores. OBJETIVO: analizar los errores detectados en el control gravimétrico (CG) y de productos (CP) utilizados realizado en las NP elaboradas. MÉTODOS: se realizó un análisis prospectivo en el que durante tres años (enero de 2016 a diciembre de 2018) se pesaron las NP elaboradas. Se utilizó el programa informático MedicalOne Parenteral®, que calcula el peso teórico teniendo en cuenta la densidad y el volumen. Cada NP elaborada se pesaba para obtener el peso real. El error gravimétrico (%) (EG = (peso real - peso teórico) X 100 / peso teórico) se consideró correcto dentro del intervalo de ± 5 %. El CP consistía en la comprobación de los productos y los volúmenes utilizados con la hoja de elaboración. RESULTADOS: se realizó el control de 28.761 NP. Se pesaron 20.612 NP de adultos (NPA), siendo incorrectas 124 (0,6 %). De las 1203 NP de pacientes pediátricos no neonatos (NPP), 15 (1,25 %) fueron incorrectas, y de las 6946 de neonatos (NPN), 164 (2,96 %). Respecto al CP se detectaron 71 errores en las NPA (0,70 %), 6 (1,34 %) en las NPP y 5 (0,21 %) en las NPN. Los errores fueron: añadir más volumen de un componente [38 (46,34 %)], añadir menos volumen [17(20,73 %)] y producto erróneo [27 (32,93 %)]. CONCLUSIONES: el control de calidad realizado permitió detectar errores producidos durante la elaboración y evitó que llegaran al paciente. Se detectaron en el CG más NP incorrectas entre las NPN. Con el CP, el error mayoritario fue añadir más volumen de un componente

INTRODUCTION: parenteral nutrition (PN) compounding is a process with a high probability of errors. OBJECTIVE: to analyze PN compounding errors detected using a gravimetric control (GC) and a component verification control (CVC). METHODS: a prospective analysis was carried out during a three-year period (January 2016 to December 2018). The MedicalOne Parenteral® software program was used to calculate the theoretical weight of each PN based on density and volume. Each elaborated PN was weighed to obtain the real weight. Gravimetric error (%) ((real weight - theoretical weight) X 100 / theoretical weight) was considered correct if within the ± 5 % interval. The CVC consisted of checking that the correct ingredients and volumes were added according to the PN order. RESULTS: during the study period a total number of 28,761 PNs were checked out; 20,612 adult PNs (APN) were weighed and 124 were considered incorrect (0.60 %). Of the 1,203 non-neonatal pediatric PNs (NPPN), 15 (1.25 %) were incorrect, and of the 6,946 neonatal PNs (NPN), 164 (2.96 %) were incorrect. Regarding the CVC, 71 errors were detected in the APN (0.70 %), 6 (1.34 %) in the NPPN, and 5 (0.21 %) in the NPN group. The total number of errors included: adding more volume of one component [38 (46.34 %)], adding a wrong component [27 (32.93 %)], and absent volume of one component [17 (20.73 %)]. CONCLUSIONS: the quality control carried out allowed to detect errors during the preparation of PNs and prevented them from reaching the patient. More incorrect NPNs were detected through GC. The main error detected with CVC was adding more volume of a component

ESPEN guideline on home parenteral nutrition.

This guideline will inform physicians, nurses, dieticians, pharmacists, caregivers and other home parenteral nutrition (HPN) providers, as well as healthcare administrators and policy makers, about appropriate and safe HPN provision. This guideline will also inform patients requiring HPN. The guideline is based on previous published guidelines and provides an update of current evidence and expert opinion; it consists of 71 recommendations that address the indications for HPN, central venous access device (CVAD) and infusion pump, infusion line and CVAD site care, nutritional admixtures, program monitoring and management. Meta-analyses, systematic reviews and single clinical trials based on clinical questions were searched according to the PICO format. The evidence was evaluated and used to develop clinical recommendations implementing Scottish Intercollegiate Guidelines Network methodology. The guideline was commissioned and financially supported by ESPEN and members of the guideline group were selected by ESPEN.

Investigation of tryptophan-related yellowing in parenteral amino acid solution: Development of a stability-indicating method and assessment of degradation products in pharmaceutical formulations.

Parenteral amino acid solutions containing tryptophan tend to develop a yellow colouration upon storage. Hence, the aim of the present study was to find out whether tryptophan degradation products are the reason for the yellowing. The degree of discolouration and tryptophan degradation was examined by visual examination and UV/Vis measurements with respect to oxygen presence, pH value, and duration of steam sterilization. LC-UV analyses of autoclaved tryptophan solutions indicated eight degradation products, namely R,R/R,S 2-amino-3-(oxoindolin-3-yl)propanoic acid, R,R/R,S 2-amino-3-hydroxy-2-oxoindolin-3-yl)propanoic acids, cis/trans 3a-hydroxy-1,2,3,3a,8,8a-hexahydropyrrolo[2,3-b]indole-2-carboxylic acid, N´-formylkynurenine, and kynurenine. The proposed degradation products were confirmed by spiking of synthesized degradation products and LC-UV/MS analyses. The LC-UV analysis method was optimized and validated according to the ICH guideline Q2 (R1). Tryptophan stability in commercially available parenteral amino acid formulations was evaluated over a storing period of 12 months in two common types of primary packaging after autoclave procedure.

[Quality control of mixtures for pediatric parenteral nutrition: Validation of sodium and potassium assay method]. / Contrôle qualité des mélanges pour nutrition parentérale pédiatriques : validation de la méthode de dosage du sodium et du potassium.

OBJECTIVES: Control of electrolyte concentration in mixtures for parenteral nutrition (MPN) for newborns is crucial before the release of the final product. We aimed to assess the validation of the electrolytes assay in MPN. METHODS: Electrolytes assay was performed with Ilyte Analyzer®. Validation of method was realized in accordance with ICH (International Conference on Harmonization) guideline Q2(R1) and the commission report of the French society of pharmaceutical science and technology. Linearity test solutions were prepared in triplicate using five levels of concentrations for sodium and potassium (60-140% of theoretical concentrations). Accuracy of the method was deducted from the same results of linearity. The intermediate precision was ensured by dosing the main electrolyte in six MPN, during three successive days. RESULTS: Linearity was assessed with correlation coefficients greater than 0.996 for both electrolytes. A non-significant result of comparison test of the intercept with zero (Student test) was obtained. A highly significant result of the test of existence of slopes (Fisher test) proved a linear regression for the 2 electrolytes (P<0.1%). Inter-day precision values were 2.68% and 2.65% respectively for sodium and potassium. CONCLUSION: The validation of sodium and potassium assay method was successfully performed with Ilyte Analyzer® allowing routine quality control in MPN.

A Risk- and Science-Based Approach to the Acceptance Sampling Plan Inspection of Protein Parenteral Products.

The requirement for visual inspection of pharmaceuticals has been a compendial expectation for over a century, with some advancement of visible particle control strategies in recent years. Current philosophies include a 100% inspection and an Acceptance Sampling Plan inspection. The particles found during these inspections are normally categorized simply by particle size (visible vs. subvisible), particle source (intrinsic vs. extrinsic) and particle type (inherent vs. extraneous). We believe that a more risk- and science-based approach is attainable, which is grounded in forensic data, toxicological/medical opinions and prior knowledge. We have provided an outline for how to determine patient safety impact of visible particles found in parenteral products and potential actions that could be taken within the quality system regarding lot disposition. We believe this approach focuses efforts on patient safety risks, enhances the use of prior knowledge and improves consistency in how particle observations are handled.

Assessing the appropriateness of parenteral nutrition use in hospitalized patients. A comparison on parenteral nutrition bag prescription in different wards and nutritional outcomes.

PURPOSE: Our aim is to assess parenteral nutrition (PN) bag prescription in hospitalized patients and evaluate clinical outcomes linked to PN therapy. METHODS: We performed an observational longitudinal retrospective study on PN prescription in a General Public Hospital in Turin, Italy, on ninety-five patients receiving PN prescribed by the Nutrition Support Team (NST). We described patients' demography and assessed nutritional outcomes, as well as PN bag prescription in different wards. Medians were calculated for several clinical parameters before and after PN therapy. A z-test for proportions has been performed to better understand the impact of various conditions on clinical outcomes and to compare differences between administered nutrients and required amounts. RESULTS: The NST resulted responsible for only 18% of bags prescribed in the geriatrics ward and for 48% in the surgery wards. PN was not able to fulfill nutritional requirements resulting in a median lack of 3.1 calories and 0.23 g of proteins per kilogram of reference body weight per day. Despite this, PN therapy was able to improve total blood proteins and calcium blood levels in our cohort. The NST changed the prescription in 55.8% of the pre-existing PN regimens. CONCLUSIONS: More strict adherence to guidelines is needed in order to maximize effectiveness of PN and observe a positive impact on clinical parameters.

Physicochemical stable standard all-in-one parenteral nutrition admixtures for infants and children in accordance with the ESPGHAN/ESPEN guidelines.

OBJECTIVE: Because there are almost no standard all-in-one parenteral nutrition admixtures available for infants and children, the aim was to develop standard two-compartment parenteral nutrition bags for different weight categories based on the ESPGHAN/ESPEN (European Society of Paediatric Gastroenterology, Hepatology and Nutrition/European Society for Clinical Nutrition and Metabolism) guidelines. The 1 g/kg/d lipid version for the 3 to 10 kg weight category (PED1) was assessed for short- and long-term physicochemical stability with the ability to add additional electrolytes (PED1+E). METHODS: The lipid compartment A and the all-in-one admixture of A + B + vitamins + trace elements were assessed physically by visual inspection, Sudan red test, pH measurement, and lipid droplet size distribution. Chemical stability for compartment A was evaluated by quantitative analyses of non-esterified fatty acids and peroxide content. The glucose-amino acid-electrolyte compartment B was evaluated physically by visual inspection, measuring particle contamination and pH. Chemical stability was assessed by discoloration, quantitative analyses of glucose, and the amino acids L-cysteine, L-tyrosine, and L-tryptophan. RESULTS: No phase separation or coalescence occurred, and the mean droplet size diameter did not exceed 0.5 µm. Peroxide content and non-esterified fatty acids concentration of compartment A remained well below the limit of acceptation. No precipitation was detected for compartment B; only a slight yellow discoloration was noted at 80 d. Concentrations of glucose, L-tyrosine, and L-tryptophan remained stable; only L-cysteine decreased significantly from its initial concentration. CONCLUSION: The two-compartment PED1 and PED1+E admixtures are stable up to 80 d 2° to 8°C + 24 h room temperature (RT) with an additional 7 d 2° to 8°C + 48 h RT after mixing and addition of vitamins and trace elements.

Physicochemical Stability and Sterility of Standard Parenteral Nutrition Solutions and Simulated Y-Site Admixtures for Neonates.

BACKGROUND: Parenteral nutrition (PN) is frequently needed in neonatal intensive care. The use of standard PN has emerged as an easy-to-prescribe approach that allows one to have on-site, ready-to-use PN. The aim of this study was to test the physicochemical stability and sterility of 2 specific PN solutions as well as simulate Y-site compatibility with lipid injectable emulsions (ILE). METHODS: Our study considered 2 standard ILE-free PN solutions according to neonatal weight. These solutions were prepared in duplicate and stored at 4°C. The following physicochemical parameters were tested: visual alterations, turbidity, pH, osmolarity, and calcium concentration. Sterility was assessed by means of agar blood culture and glucose concentration determination. In addition, we assessed the stability of simulated Y-site admixtures. For each standard ILE-free PN solution, 2 3-in-1 PN admixtures were designed, considering extreme values of fluid requirements (50 and 150 ml/kg/d) and a fat supply of 2 g/kg/24 h. The physicochemical parameters tested were phase separation and fat mean droplet size distribution. RESULTS: No alterations were detected by visual inspection. Calcium concentrations, turbidity, pH, and osmolarity values remained stable in all the determinations. All agar blood cultures were negative and glucose concentration was constant over time. Physical stability of simulated Y-site admixtures was considered acceptable as mean droplet size distribution remained below 500 nm in all the emulsions. CONCLUSION: The 2 tested standard ILE-free PN solutions for neonates are physicochemically stable and sterile for 31 days under refrigeration (4°C). These solutions are also stable in case of Y-site administration with ILE at the conditions tested.

Calcium Chloride and Calcium Gluconate in Neonatal Parenteral Nutrition Solutions without Cysteine: Compatibility Studies Using Laser Light Obscuration Methodology.

There are no compatibility studies for neonatal parenteral nutrition solutions without cysteine containing calcium chloride or calcium gluconate using light obscuration as recommended by the United States Pharmacopeia (USP). The purpose of this study was to do compatibility testing for solutions containing calcium chloride and calcium gluconate without cysteine. Solutions of TrophAmine and Premasol (2.5% amino acids), containing calcium chloride or calcium gluconate were compounded without cysteine. Solutions were analyzed for particle counts using light obscuration. Maximum concentrations tested were 15 mmol/L of calcium and 12.5 mmol/L of phosphate. If the average particle count of three replicates exceeded USP guidelines, the solution was determined to be incompatible. This study found that 12.5 and 10 mmol/L of calcium and phosphate, respectively, are compatible in neonatal parenteral nutrition solutions compounded with 2.5% amino acids of either TrophAmine or Premasol. There did not appear to be significant differences in compatibility for solutions containing TrophAmine or Premasol when solutions were compounded with either CaCl2 or CaGlu-Pl. This study presents data in order to evaluate options for adding calcium and phosphate to neonatal parenteral nutrition solutions during shortages of calcium and cysteine.

Characterization of surface properties of glass vials used as primary packaging material for parenterals.

The appropriate selection of adequate primary packaging, such as the glass vial, rubber stopper, and crimp cap for parenteral products is of high importance to ensure product stability, microbiological quality (integrity) during storage as well as patient safety. A number of issues can arise when inadequate vial material is chosen, and sole compliance to hydrolytic class I is sometimes not sufficient when choosing a glass vial. Using an appropriate pre-treatment, such as surface modification or coating of the inner vial surface after the vial forming process the glass container quality is often improved and interactions of the formulation with the surface of glass may be minimized. This study aimed to characterize the inner surface of different type I glass vials (Exp33, Exp51, Siliconized, TopLyo™ and Type I plus®) at the nanoscale level. All vials were investigated topographically by colorimetric staining and Scanning Electron Microscopy (SEM). Glass composition of the surface was studied by Time-of-Flight - Secondary Ion Mass Spectrometry (ToF-SIMS) and X-ray Photoelectron Spectroscopy (XPS), and hydrophobicity/hydrophilicity of the inner surface was assessed by dye tests and surface energy measurements. All containers were studied unprocessed, as received from the vendor, i.e. in unwashed and non-depyrogenized condition. Clear differences were found between the different vial types studied. Especially glass vials without further surface modifications, like Exp33 and Exp51 vials, showed significant (I) vial-to-vial variations within one vial lot as well as (II) variations along the vertical axis of a single vial when studying topography and chemical composition. In addition, differences and heterogeneity in surface energy were found within a given tranche (circumferential direction) of Exp51 as well as Type I plus® vials. Most consistent quality was achieved with TopLyo™ vials. The present comprehensive characterization of surface properties of the different vial types may serve as basis to further guide the selection of adequate primary packaging based on the desired quality target product profile and to support studies of glass surface interactions with formulations. The proposed analytical method panel can be used for characterization of future glass vials either before delivery to the manufacturer or drug product manufacturing.

Drug Shortages: Effect on Parenteral Nutrition Therapy.

Drug shortages continue to be a threat to the health and welfare of numerous patients in the United States. For patients who depend on parenteral nutrition (PN) for survival, these shortages pose an even greater threat. Almost 75% of active drug shortages are sterile injectables, which includes PN components. Providing PN therapy is particularly challenging for clinicians because this is a complex medication and may contain 40 or more individual ingredients, of which multiple components may simultaneously be in limited supply. The availability of PN components must be considered during every step of the PN use process from ordering the PN prescription to administering this therapy to a patient. Alterations to a standardized process can lead to medication errors that can adversely affect patient outcomes and consume healthcare resources.

Water Soluble Vitamins Enhance the Growth of Microorganisms in Peripheral Parenteral Nutrition Solutions.

Peripheral parenteral nutrition (PPN) solutions contain amino acids, glucose, and electrolytes, with or without some water soluble vitamins. Peripheral venous catheters are one of the causes of catheter related blood stream infection (CRBSI), which requires infection control. In Japan, PPN solutions have rarely been prepared under aseptic conditions. However, in recent years, the necessity of adding vitamins to infusions has been reported. Therefore, we investigated the effects of water soluble vitamins on growth of microorganisms in PPN solutions. AMINOFLUID® (AF), BFLUID® (BF), PARESAFE® (PS) and PAREPLUS® (PP) PPN solutions were used. Water soluble vitamins contained in PP were also used. Causative microorganisms of CRBSI were used. Staphylococcus epidermidis decreased after 24 hours or 48 hours in all solutions. On the other hand, Escherichia coli, Serratia marcescens, Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans increased, especially in PP. When each water soluble vitamin was added to BF and PS, growth of S. aureus was greater in solutions that contained nicotinamide than in solutions that contained other vitamins. As for C. albicans, they grew in all test solutions. C. albicans grew especially well in solutions that contained biotin. When commercial amino acids and glucose solutions with electrolytes are administered, in particular those containing multivitamins or water soluble vitamins, efforts to control infection must be taken to prevent proliferation of microorganisms.

ASPEN-FELANPE Clinical Guidelines.

BACKGROUND: The management of patients with enterocutaneous fistula (ECF) requires an interdisciplinary approach and poses a significant challenge to physicians, wound/stoma care specialists, dietitians, pharmacists, and other nutrition clinicians. Guidelines for optimizing nutrition status in these patients are often vague, based on limited and dated clinical studies, and typically rely on individual institutional or clinician experience. Specific nutrient requirements, appropriate route of feeding, role of immune-enhancing formulas, and use of somatostatin analogues in the management of patients with ECF are not well defined. The purpose of this clinical guideline is to develop recommendations for the nutrition care of adult patients with ECF. METHODS: A systematic review of the best available evidence to answer a series of questions regarding clinical management of adults with ECF was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group. An anonymous consensus process was used to develop the clinical guideline recommendations prior to peer review and approval by the ASPEN Board of Directors and by FELANPE. QUESTIONS: In adult patients with enterocutaneous fistula: (1) What factors best describe nutrition status? (2) What is the preferred route of nutrition therapy (oral diet, enteral nutrition, or parenteral nutrition)? (3) What protein and energy intake provide best clinical outcomes? (4) Is fistuloclysis associated with better outcomes than standard care? (5) Are immune-enhancing formulas associated with better outcomes than standard formulas? (6) Does the use of somatostatin or somatostatin analogue provide better outcomes than standard medical therapy? (7) When is home parenteral nutrition support indicated?

ASPEN Safe Practices for Enteral Nutrition Therapy [Formula: see text].

Enteral nutrition (EN) is a valuable clinical intervention for patients of all ages in a variety of care settings. Along with its many outcome benefits come the potential for adverse effects. These safety issues are the result of clinical complications and of process-related errors. The latter can occur at any step from patient assessment, prescribing, and order review, to product selection, labeling, and administration. To maximize the benefits of EN while minimizing adverse events requires that a systematic approach of care be in place. This includes open communication, standardization, and incorporation of best practices into the EN process. This document provides recommendations based on the available evidence and expert consensus for safe practices, across each step of the process, for all those involved in caring for patients receiving EN.

Aluminum Content of Neonatal Parenteral Nutrition Solutions.

INTRODUCTION: Calcium chloride (CaCl2) has been the only calcium additive available in the United States that has a low aluminum (Al) content. Calcium gluconate in glass vials (CaGluc-Gl) has a high Al content while calcium gluconate in plastic vials (CaGluc-Pl) has a low Al content. The purpose of this study was to measure Al concentrations in neonatal parenteral nutrition (PN) solutions prepared using various calcium additives. METHODS: Samples of solutions compounded with CaCl2 or CaGluc-Gl and sodium phosphate (NaPhos) as well as CaGluc-Pl and sodium glycerophosphate (NaGP) with and without cysteine were analyzed for Al content. Samples of the cysteine and calcium gluconate additives were also sent for analysis. RESULTS: Solutions containing CaCl2 and CaGlu-Pl had mean Al concentrations of 1.2-2.3 mcg/dL, while those with CaGlu-Gl had mean concentrations of 14.6-15.1 mcg/dL. Solutions made with NaGP were low in Al content. The measured Al content of 2 lots of the cysteine additive were 168 ± 23 mcg/L and 126 ± 5 mcg/L. The Al concentration equalled 2730 ± 20 mcg/L for the CaGlu-Gl additive and 310 ± 80 mcg/L for the CaGlu-Pl additive. CONCLUSION: The study indicates that solutions containing CaCl2 or CaGluc-Pl and NaPhos or NaGP are low in Al content. Using these options for calcium and phosphate additives can limit aluminum intake from neonatal PN to levels within the Food and Drug Administration guideline of ≤5 mcg/kg/d.

Requerimientos en nutrición parenteral pediátrica / Requirements for pediatric parenteral nutrition

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Standardized Competencies for Parenteral Nutrition Order Review and Parenteral Nutrition Preparation, Including Compounding: The ASPEN Model.

Parenteral nutrition (PN) is a high-alert medication with a complex drug use process. Key steps in the process include the review of each PN prescription followed by the preparation of the formulation. The preparation step includes compounding the PN or activating a standardized commercially available PN product. The verification and review, as well as preparation of this complex therapy, require competency that may be determined by using a standardized process for pharmacists and for pharmacy technicians involved with PN. An American Society for Parenteral and Enteral Nutrition (ASPEN) standardized model for PN order review and PN preparation competencies is proposed based on a competency framework, the ASPEN-published interdisciplinary core competencies, safe practice recommendations, and clinical guidelines, and is intended for institutions and agencies to use with their staff.