Parenteral nutrition insecurity: ASPEN survey to assess the extent and severity of parenteral nutrition access and reimbursement issues.

BACKGROUND: Parenteral nutrition (PN) shortages and lack of qualified professional staff to manage PN impact safe, efficacious care and costs of PN. This American Society for Parenteral and Enteral Nutrition (ASPEN)-sponsored survey assessed the frequency and extent to which PN access affects PN delivery to patients. METHODS: Healthcare professionals involved with PN were surveyed. Questions were developed to characterize the respondent population and determine the extent and severity of PN access issues to components, devices, and healthcare professionals, as well as their effects on discharge and transfer issues. Reimbursement issues included cost, adequacy of therapy, and healthcare professional reimbursement. Burdens were types and frequency of errors, adverse events, and nutrition problems resulting from PN access issues. Impact on professionals and organizations was determined. RESULTS: Respondents (N = 350) worked in hospitals (75%) and home infusion (25%). Per day, clinicians cared for <15 patients receiving PN. All age populations were represented. Respondents reported shortages of macronutrients (72%, 233 of 324) and micronutrients (91%, 297 of 324). Issues with access to healthcare workers were observed. PN access issues contribute to increased costs of PN, and knowledge regarding the current rate of PN reimbursement is limited. Respondents (75%, 197 of 261) observed an error due to PN access issues. Adverse events (57%, 149 of 259) were observed leading to temporary or permanent harm (24%, 61 of 259) as well as near death (4%, 9 of 259) and death (1%, 2 of 259). Providers reported time away from other job responsibilities and workplace stress. CONCLUSION: PN access issues result in "PN insecurity" that negatively impacts patients and healthcare providers and leads to adverse events including death in patients receiving PN.

Update on use of enteral and parenteral nutrition in hospitalized patients with a diagnosis of malnutrition in the United States.

BACKGROUND: Malnutrition continues to be associated with outcomes in hospitalized patients. METHODS: An updated review of national data in patients with a coded diagnosis of malnutrition (CDM) and the use of nutrition support (enteral nutrition [EN] and parenteral nutrition [PN]) was conducted using the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project and Medicare Claims data. RESULTS: Results demonstrated a growing trend in CDM accompanied by continued low utilization of PN and EN. CONCLUSION: Underutilization of nutrition support may be due to product shortages, reluctance of clinicians to use these therapies, undercoding of nutrition support, strict adherence to published guidelines, and other factors.

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.

Perceptions and barriers to the annual influenza vaccine compared with the coronavirus disease 2019 vaccine in an urban underserved population.

BACKGROUND: For a vaccine to be successful, communities must perceive it as important, safe, effective, and necessary. However, there are many barriers and hesitancies to vaccination. Underserved patient populations may face additional challenges related to access and cost. Because community pharmacists improve vaccine access and increase vaccination rates, it is beneficial for pharmacists to understand perceptions and barriers to vaccinations in their community to increase vaccine confidence. OBJECTIVES: This study aims to assess and compare barriers and perceptions of the annual influenza to the coronavirus disease 2019 (COVID-19) vaccine for underserved patients of a charitable pharmacy. METHODS: Patients who qualified to receive medications from an outpatient charitable pharmacy took an electronic survey when receiving medications. The survey incorporated questions developed by the World Health Organization's Strategic Advisory Group of Experts on Vaccine Hesitancy on a 5-point Likert scale. Questions about the influenza and COVID-19 vaccines mirrored one another. Demographic data such as age, race, sex, and education level were also collected. RESULTS: Of the 189 patients surveyed at the charitable pharmacy, 71.7% were 55 years old and older and 58.9% were female. Of note, 78% and 77% of participants agreed or strongly agreed that the influenza and COVID-19 vaccines, respectively, were important for the health of others in their community. Adverse effects and the cost of the COVID-19 vaccine were noted to be statistically significantly more of a concern with the COVID-19 vaccine than that of the influenza vaccine (P < 0.001). CONCLUSION: Ensuring equitable vaccine access, promoting the COVID-19 vaccine as free, and eliciting and addressing individual persons' concerns related to vaccine safety and adverse effects are all important ways pharmacists and other health care providers and community stakeholders can help promote vaccine confidence within the populations they serve.

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.

Malnutrition diagnoses and associated outcomes in hospitalized patients: United States, 2018.

In the US, malnutrition is prevalent among hospitalized patients and is associated with higher morbidity, mortality, and healthcare costs when compared with those without malnutrition. Over time, national data have indicated the rate of coded malnutrition diagnoses among hospital discharges rising over time, and more current data on demographic and clinical characteristics of these patients are needed. Data on malnutrition discharges from the 2018 Healthcare Cost and Utilization Project (HCUP)-the most recent nationally representative data-were examined and compared with earlier HCUP findings. Based on International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, 8.9% of all US non-maternal, non-neonatal hospital discharges in 2018 had a coded diagnosis of malnutrition (CDM). From this 2018 data, those with a CDM were older, had longer lengths of stay, and incurred higher costs, as compared with those without a CDM. Higher readmission rates and higher inpatient mortality were also observed in this group. These findings provide more recent demographic and clinical evidence for standardized malnutrition diagnostic and interventional programs to treat and/or prevent this condition.

Identifying Nutrition Risk in a Charitable Pharmacy Population.

While prior research has shown that food insecurity and malnutrition worsen health outcomes and increase health care costs, nutrition risk is rarely assessed in the community setting. Tools exist to screen for food insecurity and malnutrition individually, but none screen for both. This study aimed to implement a dual-purpose screening tool to identify nutrition risk in a community setting, to characterize nutrition risk in a charitable pharmacy population, and to identify patients who screen positive for nutrition risk and connect them to community nutrition resources. Of the 221 patients screened during their initial and annual qualification interview at the Charitable Pharmacy of Central Ohio, 140 (63%) screened positive for nutrition risk. There were 84 (38%) patients positive for food insecurity, 14 (6%) positive for malnutrition risk, and 42 (19%) positive for both. Patients at nutrition risk were referred to nutrition resources, including food pantries, home-delivered meals, and SNAP.

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.

Value of Nutrition Support Therapy: Impact on Clinical and Economic Outcomes in the United States.

OBJECTIVE: Healthcare leaders seek guidance on prudent investment in programs that improve patient outcomes and reduce costs, which includes the value of nutrition therapy. The purpose of this project was to conduct an evidence review and evaluate claims analyses to understand the financial and quality impact of nutrition support therapy on high-priority therapeutic conditions. METHODS: Task 1 included a review of existing literature from 2013 to 2018 to identify evidence that demonstrated the clinical and economic impact of nutrition intervention on patient outcomes across 13 therapeutic areas (TAs). In Task 2, analytic claims modeling was performed using the Medicare Parts A and B claims 5% sample dataset. Beneficiaries diagnosed in 5 selected TAs (sepsis, gastrointestinal [GI] cancer, hospital-acquired infections, surgical complications, and pancreatitis) were identified in the studies from Task 1, and their care costs were modeled based on nutrition intervention. RESULTS: Beginning with 1099 identified articles, 43 articles met the criteria, with a final 8 articles used for the Medicare claims modeling. As examples of the modeling demonstrated, the use of advanced enteral nutrition formula could save at least $52 million annually in a sepsis population. The total projected annual cost savings from the 5 TAs was $580 million. CONCLUSION: Overall, optimization of nutrition support therapy for specific patient populations is estimated to reduce Medicare spending by millions of dollars per year across key TAs. These findings demonstrate the evidence-based value proposition of timely nutrition support to improve clinical outcomes and yield substantial cost savings.

Efficiency analysis of a barcode-enabled and integrated medication-tracking system.

PURPOSE: Operational efficiency improvements for pharmacy workflow processes were evaluated using a barcode-enabled and integrated medication-tracking system for medications dispensed from the pharmacy to the emergency department (ED). METHODS: The preimplementation study period (Period 1) was defined as November 17-December 16, 2015; system implementation and training, were defined as December 17, 2015-January 18, 2016; and postimplementation (Period 2) was defined as January 19-February 17, 2016. Periods 1 and 2 were compared to (1) quantify the number and type of phone calls received related to medication inquiries, (2) evaluate the percentage of redispensed doses per total dispensed doses, and (3) assess the rate of medication administration record (MAR) messages received per total dispensed doses. RESULTS: A reduction in the total number of phone calls by 77% was observed (from 125 to 29 calls). A 0.7% difference was detected for re-dispensed doses as well as MAR messages (0.009% difference in rate) between the 2 study periods. This difference was observed despite an increase in the total amount of dispensed doses that occurred for both redispensed doses (936) and MAR messages (920) during Period 2. CONCLUSION: A barcode-enabled and integrated medication-tracking system was successfully implemented into the medication distribution process in the ED. The process change increased operational pharmacy efficiencies by decreasing medication status phone calls, redispensed doses, and MAR messages.

Evaluation of Parenteral Nutrition Errors in an Era of Drug Shortages.

BACKGROUND: Ingredient shortages have forced many organizations to change practices or use unfamiliar ingredients, which creates potential for error. Parenteral nutrition (PN) has been significantly affected, as every ingredient in PN has been impacted in recent years. MATERIALS AND METHODS: Ingredient errors involving PN that were reported to the national anonymous MedMARx database between May 2009 and April 2011 were reviewed. Errors were categorized by ingredient, node, and severity. Categorization was validated by experts in medication safety and PN. A timeline of PN ingredient shortages was developed and compared with the PN errors to determine if events correlated with an ingredient shortage. This information was used to determine the prevalence and change in harmful PN errors during periods of shortage, elucidating whether a statistically significant difference exists in errors during shortage as compared with a control period (ie, no shortage). RESULTS: There were 1311 errors identified. Nineteen errors were associated with harm. Fat emulsions and electrolytes were the PN ingredients most frequently associated with error. Insulin was the ingredient most often associated with patient harm. On individual error review, PN shortages were described in 13 errors, most of which were associated with intravenous fat emulsions; none were associated with harm. There was no correlation of drug shortages with the frequency of PN errors. CONCLUSION: Despite the significant impact that shortages have had on the PN use system, no adverse impact on patient safety could be identified from these reported PN errors.

Perspectives on parenteral micronutrient shortages.

Micronutrients are essential components of parenteral nutrition (PN). Problems related to deficiency and toxicity occur during routine practice, which could be related to the content of commercial sources, inadequate prescribed doses, and the high frequency of at-risk patients receiving PN. Shortages of commercial products result in increased risk of deficiency. Even though there are recommendations to conserve supplies for those at highest risk, practices that provide no micronutrients or doses less than desired are not safe. This article reviews the evidence describing patients at risk for micronutrient deficiency, the rationale for micronutrient product reformulation, and characteristics of deficiency observed during shortages of micronutrient products.

Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013.

The development of intravenous fat emulsion (IVFE) is the culmination of physiological, biochemical, nutritional, and medical scientific advancements. IVFEs have the ability to deliver critical nutritional substrates to the patient. Recent literature purports that they may also play roles in modulation of immune functionality and pulmonary physiology, but data supporting these potential benefits are limited. While soybean-based IVFEs have comprised the dominant fat in U.S. markets, a number of other novel IVFEs may prove to optimize the care of children and adults in both hospitalized and home settings. The October 2013 U.S. Food and Drug Administration (FDA)/American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Public Workshop brought together scientists, researchers, and clinical experts to present updated clinical perspectives of IVFEs, including historical development, current state of usage throughout the world, and considerations for the regulatory approval of new IVFEs in the United States.

Challenges and opportunities for nutrition education and training in the health care professions: intraprofessional and interprofessional call to action.

Understanding and applying nutrition knowledge and skills to all aspects of health care are extremely important, and all health care professions need basic training to effectively assess dietary intake and provide appropriate guidance, counseling, and treatment to their patients. With obesity rates at an all-time high and the increasing prevalence of diabetes projected to cost the Federal government billions of dollars, the need for interprofessional nutrition education is paramount. Physicians, physician assistants, nurses, nurse practitioners, pharmacists, dentists, dental hygienists, occupational therapists, physical therapists, speech and language pathologists, and others can positively affect patient care by synchronizing and reinforcing the importance of nutrition across all specialty areas. Although nutrition is a critical component of acute and chronic disease management, as well as health and wellness across the health care professions, each profession must reevaluate its individual nutrition-related professional competencies before the establishment of meaningful interprofessional collaborative nutrition competencies. This article discusses gaps in nutrition education and training within individual health professions (ie, nursing, pharmacy, dentistry, and dietetics) and offers suggestions for educators, clinicians, researchers, and key stakeholders on how to build further capacity within the individual professions for basic and applied nutrition education. This "gaps methodology" can be applied to all health professions, including physician assistants, physical therapists, speech and language pathologists, and occupational therapists.

Improvement of medication event interventions through use of an electronic database.

PURPOSE: Patient safety enhancements achieved through the use of an electronic Web-based system for responding to adverse drug events (ADEs) are described. SUMMARY: A two-phase initiative was carried out at an academic pediatric hospital to improve processes related to "medication event huddles" (interdisciplinary meetings focused on ADE interventions). Phase 1 of the initiative entailed a review of huddles and interventions over a 16-month baseline period during which multiple databases were used to manage the huddle process and staff interventions were assigned via manually generated e-mail reminders. Phase 1 data collection included ADE details (e.g., medications and staff involved, location and date of event) and the types and frequencies of interventions. Based on the phase 1 analysis, an electronic database was created to eliminate the use of multiple systems for huddle scheduling and documentation and to automatically generate e-mail reminders on assigned interventions. In phase 2 of the initiative, the impact of the database during a 5-month period was evaluated; the primary outcome was the percentage of interventions documented as completed after database implementation. During the postimplementation period, 44.7% of assigned interventions were completed, compared with a completion rate of 21% during the preimplementation period, and interventions documented as incomplete decreased from 77% to 43.7% (p < 0.0001). Process changes, education, and medication order improvements were the most frequently documented categories of interventions. CONCLUSION: Implementation of a user-friendly electronic database improved intervention completion and documentation after medication event huddles.

A parenteral nutrition use survey with gap analysis.

BACKGROUND: Parenteral nutrition (PN) is a high-alert medication for which safe practice guidelines are available. Recent adverse events associated with PN have been widely reported. A survey of current practices was indicated as new guidelines are being considered. METHODS: A web-based survey consisting of 70 items was made available for the month of August 2011. Respondents provided answers to questions that addressed all aspects of the PN use process. RESULTS: There were a total of 895 respondents to the survey, including dietitians, nurses, pharmacists, and physicians. They predominantly represented hospital settings (89%), with 44% from academic institutions. Most organizations use a once-daily PN admixture with 21% outsourcing preparation. Electronic PN order entry is available in one-third of organizations, and the use of standardized order sets prevails. Unfortunately, electronic interfaces between computer systems remain infrequent, meaning that at least one transcription step is required by most in the PN use process. There are a wide variety of methods for ordering PN components, many of which are inconsistent with safe practices. Most organizations dedicate a pharmacist to review the PN orders, many of which require clarifications. Documentation at each step of the PN use process with oversight to identify deviations from best practice recommendations is infrequent. A significant proportion (44%) does not track PN-related medication errors. CONCLUSIONS: The survey data are a valuable snapshot of current practices with PN. Poor compliance with some of the safe practice guidelines continues. This will help guide new safety initiatives for the PN use process.

Parenteral nutrition: can outcomes be improved?

This article explores parenteral nutrition (PN) not only as a therapy but also as a system of care, highlighting the potential "evidence gaps" in guidelines for PN use. The importance of interdisciplinary nutrition care, error reporting, and data-driven practice changes on improving PN therapy is emphasized. Finally, the American Society for Parenteral and Enteral Nutrition's current and future role in advancing the science, practice, and safety of PN is reviewed.

Parenteral nutrition product shortages: the A.S.P.E.N. strategy.

Product (drug) shortages have had a significant impact on the healthcare system, particularly on patients and clinicians. This has been especially true with patients requiring parenteral nutrition (PN). The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) has dealt with PN product shortages in the past on behalf of its members and their patients. However, the shortage severity and duration have made dealing with the PN product shortages in 2010-2012 extremely challenging.