Safety and quality of parenteral nutrition: Areas for improvement and future perspectives.

PURPOSE: This article is based on presentations and discussions held at the International Safety and Quality of Parenteral Nutrition (PN) Summit (held November 8-10, 2021, at Charleston, SC, and Bad Homburg, Germany) and aims to raise awareness concerning unresolved issues associated with the PN process and potential future directions, including a greater emphasis on patients' perspectives and the role of patient support. SUMMARY: Ensuring that every patient in need receives adequate PN support remains challenging. It is important to have a standardized approach to identify nutritional risk and requirements using validated nutritional screening and assessment tools. Gaps between optimal and actual clinical practices need to be identified and closed, and responsibilities in the nutrition support team clarified. Use of modern technology opens up opportunities to decrease workloads or liberate resources, allowing a more personalized care approach. Patient-centered care has gained in importance and is an emerging topic within clinical nutrition, in part because patients often have different priorities and concerns than healthcare professionals. Regular assessment of health-related quality of life, functional outcomes, and/or overall patient well-being should all be performed for PN patients. This will generate patient-centric data, which should be integrated into care plans. Finally, communication and patient education are prerequisites for patients' commitment to health and for fostering adherence to PN regimes. CONCLUSION: Moving closer to optimal nutritional care requires input from healthcare professionals and patients. Patient-centered care and greater emphasis on patient perspectives and priorities within clinical nutrition are essential to help further improve clinical nutrition.

Parenteral nutrition in clinical practice: International challenges and strategies.

PURPOSE: Parenteral nutrition (PN) is an established therapy when oral/enteral feeding is not sufficient or is contraindicated, but nevertheless PN remains a complex, high-alert medication that is susceptible to errors that may affect patient safety. Over time, considerable progress has been made to make PN practices safer. The purpose of this article is to address ongoing challenges to improve the PN use process from prescription to administration and monitoring, and to outline practical aspects fostering the safety, quality, and cost-effectiveness of PN, as discussed at the International Safety and Quality of PN Summit. SUMMARY: Opportunities to improve the PN use process in clinical practice include the promotion of inter-disciplinary communication, vigilant surveillance for complications, staff education to increase competency, and more consistent use of advanced technologies that allow automated safety checks throughout the PN process. Topics covered include considerations on PN formulations, including the value of intravenous lipid emulsions (ILEs), trends in compounding PN, the current and future role of market-authorized multi-chamber PN bags containing all 3 macronutrients (amino acids, glucose/dextrose, and ILE) in the United States and in Europe, and strategies to cope with the increasing global problem of PN product shortages. CONCLUSION: This review outlines potential strategies to use in clinical practice to overcome ongoing challenges throughout the PN use process, and ultimately promote PN patient safety.

Parenteral nutrition in the hospital setting/short-term parenteral nutrition.

PURPOSE: This article is based on presentations and discussions held at the International Safety and Quality of Parenteral Nutrition (PN) Summit concerning the acute care setting. Some European practices presented in this article do not conform with USP general chapter <797> requirements. Nevertheless, the purpose is to cover the challenges experienced in delivering high-quality PN within hospitals in the United States and Europe, in order to share best practices and experiences more widely. SUMMARY: Core issues regarding the PN process within an acute care setting are largely the same everywhere: There are ongoing pressures for greater efficiency, optimization, and also concurrent commitments to make PN safer for patients. Within Europe, in recent years, the use of market-authorized multi-chamber bags (MCBs) has increased greatly, mainly for safety, cost-effectiveness, and efficiency purposes. However, in the US, hospitals with low PN volumes may face particular challenges, as automated compounding equipment is often unaffordable in this setting and the variety of available MCBs is limited. This can result in the need to operate several PN systems in parallel, adding to the complexity of the PN use process. Ongoing PN quality and safety initiatives from US institutions with various PN volumes are presented. In the future, the availability of a greater selection of MCBs in the US may increase, leading to a reduction in dependence on compounded PN, as has been seen in many European countries. CONCLUSION: The examples presented may encourage improvements in the safety and quality of PN within the acute care setting worldwide.

Expert consensus statements and summary of proceedings from the International Safety and Quality of Parenteral Nutrition Summit.

PURPOSE: The International Safety and Quality of Parenteral Nutrition (PN) Summit consisted of presentations, discussions, and formulation of consensus statements. The purpose here is to briefly summarize the summit and to present the consensus statements. SUMMARY: There was a high degree of consensus, with all statements approved by all authors/summit experts. These consensus statements should be regarded not as formal guidelines but rather as best-practice guidance intended to complement national and international nutrition society evidence-based guidelines and position statements. This article also summarizes key discussion topics from the summit, encompassing up-to-date knowledge and practical guidance concerning PN safety and quality in various countries and clinical settings, focusing on adult patients. Clear geographical differences exist between practices in Europe and the United States, and different approaches to improve the safety, quality, and cost-effectiveness of PN vary, particularly with regard to the delivery systems used. Discussion between experts allowed for an exchange of practical experience in optimizing PN use processes, opportunities for standardization, use of electronic systems, potential improvements in PN formulations, better management during PN component shortages, and practical guidance to address patients' needs, particularly during long-term/home PN. CONCLUSION: The consensus statements are the collective opinion of the panel members and form best-practice guidance. The authors intend that this guidance may help to improve the safety and quality of PN in a variety of settings by bridging the gap between published guideline recommendations and common practical issues.

Safety in parenteral nutrition compounding.

Parenteral nutrition (PN) compounding is a complex process that requires knowledge and training to ensure the safety and efficacy of this form of nutrition support therapy. Unfortunately, errors and lack of adherence to safe PN compounding recommendations and sterile compounding requirements have resulted in patient injury and death. These lapses in the safe provision of PN have been the result of various factors, including a lack of understanding of PN compatibility, stability, and sterility requirements, as well as drug product shortages and order entry errors. This review will describe the current challenges with the education and training regarding PN compounding, compatibility and stability of PN admixtures, simultaneous administration of nonnutrient medications with PN admixtures, and specific challenges with special populations such as neonates, pediatrics, and those receiving home care.

Electronic Health Record and Parenteral Nutrition Functionality: A Gap Analysis.

Parenteral nutrition (PN) is a complex, high-alert medication that contains up to 40 different ingredients. Surveys have shown that current electronic health record (EHR) systems may lack functionality for safe and optimal delivery of PN. A gap analysis was performed by a multihospital system to identify opportunities to enhance the current PN process using the EHR utilized by the organization.

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.

Recommendations for photoprotection of parenteral nutrition for premature infants: An ASPEN position paper.

Although crucial in improving health outcomes in the preterm infants, parenteral nutrition (PN) is not without risk, especially if handled improperly. A growing body of evidence suggests that components of PN admixtures, including lipid injectable emulsions (ILEs), are susceptible to degradation, including oxidation when exposed to light (ie, photo-oxidation), resulting in the production of reactive oxygen species. Infants, especially those born preterm, are considered more susceptible to consequences of oxidative stress than children and adults. Oxidative stress is associated with bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intestinal failure-associated liver disease. The American Society for Parenteral and Enteral Nutrition (ASPEN) assembled a working group to provide recommendations on clinical practice surrounding photoprotection of PN.This Position Paper reviews the scientific literature on the formation of quantifiable peroxides and other degradation products when PN admixtures and ILEs are exposed to light and reports adverse clinical outcomes in premature infants exposed to PN. Recommendations for photoprotection of PN admixtures and ILEs are provided, as well as the challenges in achieving complete photoprotection with the equipment, supplies, and materials currently available in the US. ASPEN and the authors understand that the full implementation of complete photoprotection may not currently be feasible given current product availability; recommendations provided in this paper serve to represent the goal to which to strive as well as to highlight the importance of product availability to achieve these practices. This paper has been approved by the ASPEN Board of Directors.

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.

ASPEN Consensus Recommendations for Refeeding Syndrome.

INTRODUCTION: In the spring of 2017, the American Society for Parenteral and Enteral Nutrition (ASPEN) Parenteral Nutrition Safety Committee and the Clinical Practice Committee convened an interprofessional task force to develop consensus recommendations for identifying patients with or at risk for refeeding syndrome (RS) and for avoiding and managing the condition. This report provides narrative review and consensus recommendations in hospitalized adult and pediatric populations. METHODS: Because of the variation in definitions and methods reported in the literature, a consensus process was developed. Subgroups of authors investigated specific issues through literature review. Summaries were presented to the entire group for discussion via email and teleconferences. Each section was then compiled into a master document, several revisions of which were reviewed by the committee. FINDINGS/RECOMMENDATIONS: This group proposes a new clinical definition, and criteria for stratifying risk with treatment and screening strategies. The authors propose that RS diagnostic criteria be stratified as follows: a decrease in any 1, 2, or 3 of serum phosphorus, potassium, and/or magnesium levels by 10%-20% (mild), 20%-30% (moderate), or >30% and/or organ dysfunction resulting from a decrease in any of these and/or due to thiamin deficiency (severe), occurring within 5 days of reintroduction of calories. CONCLUSIONS: These consensus recommendations are intended to provide guidance regarding recognizing risk and identifying, stratifying, avoiding and managing RS. This consensus definition is additionally intended to be used as a basis for further research into the incidence, consequences, pathophysiology, avoidance, and treatment of RS.

Diagnosis and treatment of simple acid-base disorders.

The ability to diagnose and treat acid-base disorders is an important component in the practice of the nutrition support clinician. A complete understanding of the basic principles of metabolic and respiratory disorders allows the practitioner to formulate educated decisions regarding fluids, parenteral nutrition salts, and the management of electrolytes. This review will discuss the diagnosis and treatment of common metabolic and respiratory disorders encountered in nutrition support practice.

Parenteral Nutrition Safety: The Story Continues.

Parenteral nutrition (PN) is an important therapeutic modality used for a variety of indications in adults, children, and infants. PN is a complex, high-alert medication that requires appropriate education and ongoing competency assessment to ensure a safe process. PN is not recognized by many organizations as a medication, which leads to underreporting of errors. This article will provide important insight and recommendations to promote a safe PN process.

Lipid Injectable Emulsions: Infusion Confusion.

The commentary addresses discussion regarding the duration of infusion for lipid injectable emulsions (ILEs; previously known as intravenous fat emulsion) when administered separately from amino acids and dextrose (2:1) admixtures. The article by Mundi et al describes the administration time of ILEs administered separately as up to 24 hours, while previous American Society for Parenteral and Enteral Nutrition documents have outlined the infusion time not to exceed 12 hours.

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.

Residents as preceptors and educators: What we can learn from a national survey to improve our residency programs.

INTRODUCTION: Developing pharmacy residents into effective preceptors is essential to meet the demands of pharmacy education. A survey was created to assess the availability of resident precepting educational opportunities, identify common barriers associated with developing preceptors' skills, and discover strategies to optimize programming. METHODS: An online survey focused on the development of residents as preceptors was e-mailed to all residency program directors (RPD) for American Society of Health-System Pharmacists accredited residencies in the United States. Information was collected on program demographics, level of support and precepting activities offered and resident employment outcomes. RESULTS: Five hundred thirty-eight responses were received. The majority were postgraduate year one RPDs and had less than six residents. Sixty-one percent of programs were affiliated with a college of pharmacy. Seventy-eight percent devoted 10hours or less per month in developing residents as preceptors with 33% providing less than five hours. Seventy-one percent of the residency programs did not offer a formal precepting rotation. However, 59% of respondents indicated that their residency graduates frequently accepted positions, which required teaching/precepting. The most common barriers to developing residents as preceptors included: lack of time for residents to precept within the residency structure (41%), availability of preceptors to mentor residents throughout experience (33%) and lack of preceptors' availability to mentor residents' precepting abilities over time (30%). DISCUSSION AND CONCLUSIONS: RPDs should prioritize training of residents as preceptors. Requiring residents to serve as primary preceptors in rotations dedicated to teaching is important to prepare for future job responsibilities.

A call to action for optimizing the electronic health record in the parenteral nutrition workflow.

Parenteral nutrition (PN) is a complex therapeutic modality provided to neonates, children, and adults for various indications. Surveys have shown that current electronic health record (EHR) systems are in need of functionality enhancement for safe and optimal delivery of PN. This is a consensus statement from the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists outlining some of the key challenges to prescribing, order review/verification, compounding, and administration of PN using EHRs today and is a call to action for clinicians and vendors to optimize their EHRs regarding the PN build and workflow.

A Call to Action for Optimizing the Electronic Health Record in the Parenteral Nutrition Workflow.

Parenteral nutrition (PN) is a complex therapeutic modality provided to neonates, children, and adults for various indications. Surveys have shown that current electronic health record (EHR) systems are in need of functionality enhancement for safe and optimal delivery of PN. This is a consensus statement from the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists outlining some of the key challenges to prescribing, order review/verification, compounding, and administration of PN using EHRs today and is a call to action for clinicians and vendors to optimize their EHRs regarding the PN build and workflow.