ASPEN survey of parenteral nutrition access issues: How the system fails the patient.

BACKGROUND: Product shortages and a lack of qualified providers to manage care may impact the safety and efficacy of parenteral nutrition (PN). This survey assessed the frequency and extent to which limitations to PN-related access affects patients. METHODS: Outpatient/patients receiving home PN were surveyed. Questions were developed to characterize the population and determine the extent and severity of PN access issues with components, devices, healthcare professionals, and transfers of care. Reimbursement issues surveyed included insurance coverage, contribution of healthcare costs to annual income, and the extent to which adjunctive therapy was reimbursed. Burdens surveyed included impact on disease symptoms and medical outcomes as well as the types and frequency of medical or system errors experienced, adverse events, or resultant nutrition problems. RESULTS: Respondents (N = 170) were well educated, rented or owned their own home, and were either employed or retired. All age populations were represented. Patients made frequent contact with care providers. Most were able to manage PN costs but feared losing insurance or changes to insurance. Patients used additional prescribed therapies that are poorly covered by insurance. Patients reported symptoms or exacerbation of disease, development or worsening of malnutrition, and episodes of nutrient deficiency. Patients noted errors occur, especially during periods of transitions of care, when they also often encounter clinicians with little understanding of PN. These are high-acuity patients who have difficulty finding providers for their care. CONCLUSION: This patient survey provides evidence that access issues can result in the "failure of the PN system" to assure care is consistently safe and effective.

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.

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.

Ethical Aspects of Artificially Administered Nutrition and Hydration: An ASPEN Position Paper.

The American Society for Parenteral and Enteral Nutrition (ASPEN) Position Paper focus is on applying the 4 ethical principles for clinician's decision-making in the use of artificially administered nutrition and hydration (AANH) for adult and pediatric patients. These basic principles are (1) autonomy, respect the patient's healthcare preferences; (2) beneficence, provide healthcare in the best interest of the patient; (3) nonmaleficence, do no harm; and (4) justice, provide all individuals a fair and appropriate distribution of healthcare resources. Preventing and resolving ethical dilemmas is addressed, with an emphasis on a collaborative, interdisciplinary approach. Optimizing early communication and promoting advance care planning, involving completion of an advance directive, including designation of a surrogate decision-maker, are encouraged. Clinicians achieve respect for autonomy when they incorporate the patient, family, community, country, geographical, and presumed cultural values and religious belief considerations into ethical decision-making for adults and children with a shared decision-making process. These discussions should be guided by the 4 ethical principles. Hospital committees and teams, limited-time trials, clinician obligation with conflicts, and forgoing of AANH are addressed. Specific patient conditions are addressed because of the concern for potential ethical issues: coma, decreased consciousness, and dementia; advanced dementia; cancer; eating disorders; and end-stage disease/terminal illness. Incorporated in the Position Paper are ethical decisions during a pandemic and a legal summary involving ethical issues. International authors presented the similarities and differences within their own country or region and compared them with the US perspective.

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.

Implementation of a prioritized scoring tool to improve time to pharmacist intervention.

PURPOSE: The implementation of a prioritized scoring tool to improve time to pharmacist intervention is described. SUMMARY: At the Ohio State University Wexner Medical Center, pharmacists are accepted providers of therapeutic drug monitoring of vancomycin and aminoglycosides. At the onset of this initiative and despite the implementation of an integrated electronic medical record (EMR), management of pharmacokinetically monitored medications was conducted using a paper monitoring form. The potential for transcription errors during this process provided an opportunity for improvement. For these reasons, the department of pharmacy focused its initial efforts for a patient scoring system on the pharmacokinetics scoring module. Adjustment of associated medications based on pharmacokinetic values was a core function of pharmacists of the institution and was expected to be conducted without fail. Vancomycin was used as the index surrogate pharmacokinetically monitored medication within the module for testing and validation because of the clear expectations and standardized resources available to pharmacists to complete the task. The pharmacokinetics scoring module was designed specifically for the function of dosing management, searching throughout the EMR and concisely displaying the information a pharmacist needs to make a clinical decision. Importantly, integration of the scoring module reduced the time to intervention from hours to minutes. The median time to intervention was reduced to within a clinical working shift (8 hours) with the scoring module versus 24 hours or longer with the paper monitoring system. CONCLUSION: The implementation of an internally developed pharmacokinetics scoring module built into the EMR substantially reduced the time to clinical intervention for pharmacokinetic monitoring of vancomycin drug levels.

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.

National survey of comprehensive pharmacy services provided in cancer clinical trials.

PURPOSE: Pharmacy services provided in clinical trials at National Cancer Institute (NCI)-designated centers were assessed. METHODS: This was a cross-sectional survey of 61 NCI-designated cancer centers. Directors of pharmacy were contacted and data were collected electronically via Qualtrics over 2 months. Trial participants were asked to estimate the frequency that their sites performed 26 services and the perceived importance of these services. Services were examined with respect to the difference between their reported performance and their reported importance. Eight of the 26 services showed a difference of at least 40% between the proportion of respondents performing the activities "often" or "almost always" and the proportion considering them "important" or "very important." Demographic information was collected, as well as perceived barriers. RESULTS: Survey response rate was 59% (36 out of 61). The majority of services for clinical trials (19 out of 26) were viewed as important for pharmacists to perform; however, less than half (10 out of 26) were performed more than 50% of the time. Eight services had a gap of more than 40% when comparing the importance versus extent of implementation. Some of the largest gaps were reported in investigator-initiated trials development, medication reconciliation, therapeutic drug monitoring, and oral chemotherapy adherence assessment. Future studies can assist with cost justification by demonstrating the regulatory, safety, and financial benefits of pharmacist involvement in cancer trials. CONCLUSION: A survey of pharmacy directors at cancer centers revealed gaps between what respondents considered important pharmacist services in the provision of cancer clinical trials and the actual performance of those services in their institution.

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.

Implementation of a "second victim" program in a pediatric hospital.

PURPOSE: A formal support program for pharmacy employees involved in adverse drug events, patient-related injuries, and other traumatic work experiences is described. SUMMARY: Healthcare workers are sometimes referred to as the "second victims" of patient care mishaps due to the anxiety, loss of confidence, and career uncertainty they may experience. After a survey indicating that about 30% of its staff had been involved in a second-victim event, the Nationwide Children's Hospital (NCH) pharmacy department implemented a peer-based support initiative (the YOU Matter program) based on an established three-tiered intervention model. All staff members are trained to identify second victims. The core of the program is a team of trained peer supporters who serve as first responders; if additional support is required, referrals to behavioral health, social work, and employee assistance personnel are made as appropriate. Staff members involved in troubling work-related events can seek support via a Web-based portal for event reporting and discussion. Since the launch of the NCH second victim program, the team of trained peer supporters has been expanded from 13 to over 120. In a postimplementation survey, 85% of the NCH pharmacy department staff indicated that the YOU Matter program has been beneficial. CONCLUSION: The majority of the NCH pharmacy staff reported that the department benefited from implementation of the second victim program. A survey conducted five months after implementation of the program revealed that 3 respondents had personally used the program and 11 had referred a coworker to a peer supporter.

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.