Parenteral nutrition compatibility and stability: Practical considerations.

Parenteral nutrition (PN) is a complex preparation that contains multiple component products with the associated risk for incompatibilities and diminished stabilities when combined together as an admixture. Significant patient harm can result from prescribing, preparing, and administering PN without confirming compatibility and stability. Incompatibility or instability is rarely obvious to the unaided eye, so safe PN admixture relies on incorporating physicochemical properties of the included components into compatibility and stability decisions. Practices include applying active ingredient concentration limits to reduce risk for incompatibilities and instabilities. The purpose of the current article is to distill the wide-ranging information on PN compatibility and stability into a feasible blueprint that individual healthcare organizations can then use to design and implement practical initiatives. Compatibility and stability considerations can be incorporated into the routine tasks of PN prescribing, order reviewing, preparing, and administering. The focus of this review is on identifying potential physicochemical interactions that can be addressed at each step in the PN use process. Organizations should incorporate compatibility and stability considerations into the routine procedures and practices of all clinicians involved with PN therapy. Those clinicians in healthcare organizations and caregivers in the home should then be in a position to safely provide the appropriate PN admixtures in terms of compatibility and stability.

Advances in Trace Element Supplementation for Parenteral Nutrition.

Parenteral nutrition (PN) provides support for patients lacking sufficient intestinal absorption of nutrients. Historically, the need for trace element (TE) supplementation was poorly appreciated, and multi-TE products were not initially subjected to rigorous oversight by the United States Food and Drug Administration (FDA). Subsequently, the American Society for Parenteral and Enteral Nutrition (ASPEN) issued dosage recommendations for PN, which are updated periodically. The FDA has implemented review and approval processes to ensure access to safer and more effective TE products. The development of a multi-TE product meeting ASPEN recommendations and FDA requirements is the result of a partnership between the FDA, industry, and clinicians with expertise in PN. This article examines the rationale for the development of TRALEMENT® (Trace Elements Injection 4*) and the FDA's rigorous requirements leading to its review and approval. This combination product contains copper, manganese, selenium, and zinc and is indicated for use in adults and pediatric patients weighing ≥10 kg. Comprehensive management of PN therapy requires consideration of many factors when prescribing, reviewing, preparing, and administering PN, as well as monitoring the nutritional status of patients receiving PN. Understanding patients' TE requirements and incorporating them into PN is an important part of contemporary PN therapy.

Safe care transitions for patients receiving parenteral nutrition.

Transitions of care require coordination between inpatient healthcare providers, care managers, outpatient/ambulatory providers, and the patient/caregiver and family members. Poor communication during transitions of care can affect health outcomes and economic costs for patients/caregivers, healthcare providers, and healthcare systems. The goal of this paper is to identify risk-prone processes in the transition of care for patients requiring parenteral nutrition (PN) between healthcare environments, including the hospital, home, skilled nursing facility, and long-term acute care hospital settings. To facilitate the evaluation of the transition, a sequential series of steps in the transition process were identified: initial notification, assessment in preparation for transfer, identifying the receiving organization, identifying accountable providers at each sending/receiving organization, communicating the nutrition care plan, implementing the plan and additional considerations regarding PN preparation and readmissions. Safety concerns with risk-prone processes are identified and recommended best practices are proposed for improving processes at each step of the transition. Pediatric considerations are included in the evaluation of the various steps in the transition of care. This paper was approved by the American Society for Parenteral and Enteral Nutrition (ASPEN) Board of Directors.

Association between protein intake and lean body mass in a group of Masters Athletes.

Recommendations for protein intake are based on total body weight; however, these recommendations do not consider lean body mass (LBM). The purpose of the present study was to identify the average protein intake in g/kg LBM in a group of healthy Masters Athletes (≥26 years of age, exercising ≥2 d/week). Data were obtained from a cross-sectional study. Body weight (kg), height (cm) and LBM via dual-energy X-ray absorptiometry were measured. Dietary intake was measured using a 2005 Block Food Frequency Questionnaire. The average energy intake, the percent energy from protein and the average protein intake in g/kg LBM were calculated. Differences between protein intake and the US Recommended Dietary Allowance (US RDA) (0⋅8 g/kg body weight) were determined. Alpha levels were set a priori to P < 0⋅05. A total of 176 participants (94 women, 82 men; 39 ± 11 years of age; body mass index: 24⋅6 ± 3⋅4 kg/m2) were analysed. The average energy intake, the percent protein energy and the average protein intake were 7996⋅9 ± 110⋅9 kilojoules (kJ)/d (1,910⋅4 ± 26⋅5 kcal), 15⋅5 ± 2⋅6 % and 1⋅43 ± 0⋅53 g/kg LBM, respectively. No differences existed between women and men for protein intake/kg LBM. Both sexes had significantly higher protein intakes than the US RDA (P < 0⋅001). We identified the average protein intake (g/kg LBM) in healthy Masters Athletes that may contribute to evolving perspectives on the determination of protein needs. The present study helps establish the relationship between protein intake and LBM so that we may further increase our accuracy when developing future protein recommendations.

The Value of Nutrition Support Pharmacist Interventions.

The PHarmacist Avoidance or Reductions in Medical Costs in CRITically Ill Adults: PHARM-CRIT Study by Rech et al demonstrated the value of critical care pharmacists' interventions. The services provided by nutrition support pharmacists were briefly mentioned. This article aims to highlight the value of interventions provided by nutrition support pharmacists.

Parenteral nutrition compatibility and stability: A comprehensive review.

Several guidance documents support best practices across the stages of the parenteral nutrition (PN) use process to optimize patient safety. The critical step of PN order verification and review by the pharmacist requires a contextual assessment of the compatibility and stability implications of the ordered PN prescription. This article will provide working definitions, describe PN component characteristics, and present a wide-ranging representation of compatibility and stability concerns that need to be considered prior to preparing a PN admixture. This paper has been approved by the American Society for Parenteral and Enteral Nutrition (ASPEN) Board of Directors.

ASPEN lipid injectable emulsion safety recommendations part 2: Neonate and pediatric considerations.

Lipid injectable emulsions (ILEs) are complex pharmaceutical formulations intended as a source of energy and fatty acids for parenteral nutrition (PN) therapy. Part 1 of this series addressed issues associated with and safety recommendations pertaining to adult ILE use. Part 2 addresses ILE safety in neonatal and pediatric patients. Considerations for ILE use in the neonatal and pediatric populations differ from those of adults. For example, these patients often require higher doses compared with adult counterparts to support growth, development, and daily metabolic needs. ILE is also frequently administered as a separate infusion as opposed to in a total nutrient admixture owing to compatibility and stability issues and limitations to intravenous access in the neonatal and pediatric populations. ILE is the most frequent PN ingredient associated with PN errors occurring in the administration, prescribing, and transcribing processes. Concerns exist with use of in-line filters and repackaging of commercial products for infusion. ILE use in neonatal and pediatric patients has been associated with both minor and major adverse effects, which most often occur with doses exceeding manufacturer recommendations. Gaps in ILE best practices for neonatal and pediatric patients predispose to errors in the PN use system. This paper describes safe-use considerations for ILE products available in the United States in neonatal and pediatric patients, including indications, prescribing, order review, preparation, administration, and monitoring. This paper has been approved by the American Society for Parenteral and Enteral Nutrition (ASPEN) Board of Directors.

Enteral Medication for the Tube-Fed Patient: Making This Route Safe and Effective.

The administration of medication through an enteral access device requires important forethought. Meeting a patient's therapeutic needs requires achieving expected drug bioavailability without increasing the risk for toxicity, therapeutic failure, or feeding tube occlusion. Superimposing gut dysfunction, critical illness, or enteral nutrition-drug interaction further increases the need for a systematic approach to prescribing, evaluating, and preparing a drug for administration through an enteral access device. This review will explain the fundamental factors involved in drug bioavailability through the gut, address the influencing considerations for the enterally fed patient, and describe best practices for enteral drug preparation and administration.

Parenteral Nutrition Prescribing and Order Review Safety Study: The Need for Pharmacist Intervention.

INTRODUCTION: Errors have been reported in the literature to occur at each step of the parenteral nutrition (PN) use process, necessitating standardized processes, clinician competence, and open communication for those involved. This study was performed at Central Admixture Pharmacy Services (CAPS®) in collaboration with the American Society for Parenteral and Enteral Nutrition (ASPEN) with the purpose to study the need for and success of PN pharmacist interventions. METHODS: A survey was developed and sent to all CAPS customers for study enrollment and to identify their demographic and practice characteristics. For those enrolled, CAPS pharmacists reviewed every PN order in a 1-month period using an error/intervention tool to capture data on prescription elements requiring intervention, along with acceptance of that intervention. RESULTS: Two hundred thirty-two unique CAPS customers (23% response rate) participated in the study, representing 37,634 unique PN prescriptions. Two hundred forty-eight PN prescriptions (0.66%) from 59 customers required ≥1 intervention. The top 3 intervention types were electrolyte dose clarification, calcium/phosphorus incompatibility, and amino acid dose clarification. A greater number and percentage of interventions were required for neonatal prescriptions, as compared with adult and pediatric prescriptions. No significant difference was found in many of the other customer characteristics. CONCLUSION: This study supports the need for institutions to develop systems to comply with published PN safety recommendations, including knowledgeable and skilled pharmacists to complete the order review and verification steps for this high-alert medication.

ASPEN Lipid Injectable Emulsion Safety Recommendations, Part 1: Background and Adult Considerations.

Lipid injectable emulsions (ILEs) are complex pharmaceutical formulations used as a source of energy and essential fatty acids in parenteral nutrition. Issues associated with ILE use are distinctly different from oral fat and arise from emulsion stability, dose, and infusion tolerance. Since 1975, soybean oil has been the consistent source oil used in ILE formulations in the US. Partly because of safety concerns with the soybean-based ILE and frequent and long-standing problems with product inventory shortages, new ILE products have become available. Gaps in ILE best practices create a risk for ILE safety errors in prescribing, compounding, and administration of these products. This paper provides information on appropriate indications, dosing, and methods to avoid potential errors with ILE products in the US. This paper (Part 1) will focus on ILE background, information, and recommendations for adult patients, whereas Part 2 of this series will focus on neonatal and pediatric patient-specific information.

Summary of Proceedings and Expert Consensus Statements From the International Summit "Lipids in Parenteral Nutrition".

BACKGROUND: The 2018 Lipids in Parenteral Nutrition summit involved a panel of experts in clinical nutrition, lipid metabolism, and pharmacology, to assess the current state of knowledge and develop expert consensus statements regarding the use of intravenous lipid emulsions in various patient populations and clinical settings. The main purpose of the consensus statements is to assist healthcare professionals by providing practical guidance on common clinical questions related to the provision of lipid emulsions as part of parenteral nutrition (PN). METHODS: The summit was designed to allow interactive discussion and consensus development. The resulting consensus statements represent the collective opinion of the members of the expert panel, which was informed and supported by scientific evidence and clinical experience. RESULTS: The current article summarizes the key discussion topics from the summit and provides a set of consensus statements designed to complement existing evidence-based guidelines. Lipid emulsions are a major component of PN, serving as a condensed source of energy and essential fatty acids. In addition, lipids modulate a variety of biologic functions, including inflammatory and immune responses, coagulation, and cell signaling. A growing body of evidence suggests that lipid emulsions containing ω-3 fatty acids from fish oil confer important clinical benefits via suppression of inflammatory mediators and activation of pathways involved in the resolution of inflammation. CONCLUSIONS: This article provides a set of expert consensus statements to complement formal PN guideline recommendations.

Use of Intravenous Lipid Emulsions With Parenteral Nutrition: Practical Handling Aspects.

A number of topics important to the handling of intravenous lipid emulsions (ILEs) were discussed at the international summit. ILE handling includes the preparation and the administration steps in the typical use of parenteral nutrition (PN). The discussion and consensus statements addressed several issues, including standardization of the PN process, use of commercially available multi-chamber PN or compounded PN bags, the supervision by a pharmacist with expertise, limiting ILE repackaging, and infusion duration.

Hemofilter Obstruction with Intravenous Lipid Administration.

A critically ill patient requiring continuous venovenous hemofiltration therapy received parenteral nutrition through the same commonly used intravascular device. The inclusion of injectable lipid emulsion had an adverse effect on hemofilter function. This was successfully managed first by using lipid-free parenteral nutrition and then by administering the total nutrient admixture via a separate central venous access device.

Sedentary behavior time as a predictor of hemoglobin A1c among adults, 40 to 59 years of age, living in the United States: National Health and Nutrition Examination Survey 2003 to 2004 and 2013 to 2014.

BACKGROUND: Sedentary behavior activities have been associated with an increased risk of type 2 diabetes. Aim: Our aim was to determine whether sedentary behavior time (SBT) is predictive of hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol). METHODS: We used cross-sectional data, adults 40 to 59 years of age, from the National Health and Nutrition Examination Survey (NHANES) for 2003 to 2004 and 2013 to 2014. Responses to questions on the Physical Activity Questionnaire regarding time watching television/videos, and time spent sitting in front of a computer per day were compiled into tertiles. Binary logistic regression analysis was used to determine whether SBT was a predictor of a HbA1c ≥ 6.5% adjusting for age, sex, race and ethnicity, and body mass index. RESULTS: In a univariate model, adults reporting ≥ 8 hours of SBT in NHANES 2003-2004 had 2.02 increased odds of a HbA1c ≥ 6.5% (OR = 2.02, 95% CI: 1.31, 3.13, p < 0.0001) compared to adults reporting ≤ 3 hours. After adjusting the regression model for age, sex, race and ethnicity, and body mass index, adults reporting ≥ 8 hours of SBT in NHANES 2003 to 2004 had 1.72 increased odds of HbA1c ≥ 6.5% (OR = 2.02, 95% CI: 1.10, 2.68, p < 0.0001) compared to adults reporting ≤ 3 hours of SBT. Reported SBT was not a predictor of HbA1c ≥ 6.5% for NHANES 2013 to 2014. CONCLUSION: Reported SBT was a predictor of HbA1c ≥ 6.5% among adults, 40 to 59 years of age, in NHANES 2003 to 2004, but was not a predictor in 2013 to 2014.

Drug-Nutrition Interactions and the Brain: It's Not All in Your Head.

PURPOSE OF REVIEW: The interactions between nutrition and medication can be numerous with potential impact on health outcomes. Several subtypes of drug-nutrition interactions exist. Each of these interaction subtypes may influence patients receiving medication for neurologic disorders. After defining drug-nutrition interactions, this review will describe the various types using a handful of widely used central nervous system agents as examples. RECENT FINDINGS: Medication may be the object of interactions perpetrated by a specific meal, a food component, a nutrient, or nutrition status thereby altering drug disposition and clinical effect. On the other hand, drugs can influence nutrition status generally or the status of specific nutrients by any number of mechanisms. Individuals using medication for neurologic disorders are at risk for drug-nutrition interactions of all types.

Serum 25OHD concentration as a predictor of haemoglobin A1c among adults living in the USA: NHANES 2003 to 2010.

BACKGROUND: Vitamin D status influences glucose metabolism. Serum 25-hydroxyvitamin D (25OHD) concentrations have been inversely associated with type 2 diabetes risk. The optimal serum 25OHD level needed for adequate glycaemic control is unknown. OBJECTIVE: To determine the relationship among serum 25OHD concentrations and degree of glucose regulation using percentage of haemoglobin A1c (HbA1c%). METHODS: Data for adults ≥ 20 years from the National Health and Nutrition Examination Survey (NHANES) (2003-2010) were included. A binary logistic regression was used for serum 25OHD (nmol/L) as a continuous variable to determine the OR and 95% CI for HbA1c >6.5%, adjusting for sex, race and body mass index (BMI). Measures of serum 25OHD were grouped into quartiles and entered into a binary logistic regression model to determine the OR and 95% CI for HbA1c >6.5% in an adjusted model. RESULTS: Across all NHANES cycles, lower serum 25OHD was associated with greater odds of HbA1c ≥ 6.5% when adjusting for sex, race, age and BMI (NHANES 2003-2004 (N=4402): OR 0.985, 95% CI 0.979 to 0.990; NHANES 2005-2006 (N=4409): OR 0.976, 95% CI 0.969 to 0.982; NHANES 2007-2008 (N=4525): OR 0.989, 95% CI 0.984 to 0.993; and NHANES 2009-2010 (N=5660): OR 0.988, 95% CI 0.984 to 0.991). In an adjusted model, the lowest quartile of serum 25OHD (0-41 nmol/L, N=4879) was associated with greater odds of HbA1c ≥ 6.5% compared with the highest quartile (73-260 nmol/L, N=4472), OR 2.37, 95% CI 2.03 to 2.77. The odds of HbA1c ≥ 6.5% were also greater for adults with serum 25OHD considered to be sufficient compared with the highest quartile, OR 1.68, 95% CI 1.56 to 1.61). CONCLUSION: Lower serum 25OHD concentrations are associated with poor glycaemic control (HbA1c ≥ 6.5%). Sufficient serum 25OHD levels were also associated with poorer blood glucose control. Further research is needed to investigate an optimal serum concentration or threshold to support adequate blood glucose control.

Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study.

BACKGROUND: Patients with intestinal failure associated with short bowel syndrome (SBS-IF) require parenteral support (PS) to maintain fluid balance or nutrition. Teduglutide (TED) reduced PS requirements in patients with SBS-IF in the randomized, placebo (PBO)-controlled STEPS study (NCT00798967) and its 2-year, open-label extension, STEPS-2 (NCT00930644). METHODS: STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day). Baseline was the start of TED treatment, in either STEPS or STEPS-2. At the end of STEPS-3, patients treated with TED in both STEPS and STEPS-2 (TED-TED) received TED for ≤42 months, and patients treated with TED only in STEPS-2 (no TED treatment [NT]/PBO-TED) received TED for ≤36 months. RESULTS: Fourteen patients enrolled (TED-TED, n = 5; NT/PBO-TED, n = 9) and 13 completed STEPS-3. At the last dosing visit, mean (SD) PS was reduced from baseline by 9.8 (14.4 [50%]) and 3.9 (2.8 [48%]) L/week in TED-TED and NT/PBO-TED, respectively. Mean (SD) PS infusions decreased by 3.0 (4.6) and 2.1 (2.2) days per week from baseline in TED-TED and NT/PBO-TED, respectively. Two patients achieved PS independence; 2 additional patients who achieved independence in STEPS-2 maintained enteral autonomy throughout STEPS-3. All patients reported ≥1 treatment-emergent adverse event (TEAE); 3 patients had TEAEs that were reported as treatment related. No patient had a treatment-related treatment-emergent serious AE. CONCLUSIONS: Long-term TED treatment yielded a safety profile consistent with previous studies, sustained efficacy, and a further decline in PS requirements.

Standardized Competencies for Parenteral Nutrition Administration: The ASPEN Model.

Parenteral nutrition (PN) is a highly complex medication and its provision can be prone to a variety of errors. Safe administration of this therapy requires that the competency of clinicians, particularly nurses, be demonstrated using a standardized process. In this document, a standardized model for PN administration competency is proposed based on a competency framework, the ASPEN-published interdisciplinary core competencies, discipline-specific standards of practice, safe practice recommendations, and clinical guidelines. ASPEN recognizes that all healthcare institutions may not currently meet the aspirational goals of this document. This framework will guide institutions and agencies in developing tools and procedures and maintaining competency of staff members around safe PN administration. The ASPEN Board of Directors has approved this document.