Ensuring the Safe Use of Parenteral Nutrition: Managing Shortages and Beyond

Ensuring the Safe Use of Parenteral Nutrition: Managing Shortages and Beyond

FAQs

How is insulin used in patients receiving parenteral nutrition?

Insulin is commonly administered to patients receiving parenteral nutrition (PN).  The optimal approach to insulin therapy during PN administration is a separate IV infusion of regular insulin.  The rate of infusion of regular insulin can be adjusted to maintain serum glucose concentrations within the target range.  If the IV regular insulin infusion must be discontinued, 80% of the IV regular insulin daily dose required for glycemic control can be added to the bag of PN solution.  The regular insulin dosing requirement in the PN admixture may require adjustment on a daily basis based on serum glucose concentrations.

When an IV insulin infusion is not feasible, insulin can be added to the PN admixture.  Only regular human insulin is compatible with PN admixtures.  Other types of insulin, including NPH, ultralente, lispro, aspart, detemir, glulisine, and glargine, are incompatible with PN admixtures.  Regular insulin 0.05-0.1 units per g of dextrose can be added to the PN formulation initially (i.e., 100 g dextrose x 0.1 units/g regular insulin = regular insulin 10 units).  The regular insulin concentration can be increased as needed to achieve the target serum glucose concentration.  Additional subcutaneous insulin therapy usually is required to achieve and maintain serum glucose concentrations in the target range.  If subcutaneous therapy is required, the amount of regular insulin in the PN admixture for the next day may be adjusted by adding one-half to two-thirds of the total supplemental (i.e., correction) subcutaneous insulin dose requirements given the previous day via sliding scale (correctional).

Reference

Newton L, Garvey WT. Nutritional and medical management of the diabetes mellitus in hospitalized patients. In: Mueller CM, ed. The A.S.P.E.N. Adult Nutrition Support Core Curriculum, 2nd ed.  American Society for Parenteral and Enteral Nutrition, 2012; 580-602.

Ayers P, Holcombe B, Plogsted S, Guenter P, eds. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. American Society for Parenteral and Enteral Nutrition, 2014.

What are the advantages of using a total nutrient admixture (TNA) instead of a 2-in-1 parenteral nutrition admixture?

A total nutrient admixture (TNA)—also referred to as a 3-in-1 admixture—contains the three macronutrients dextrose, amino acids, and IV fat emulsion (IVFE) along with electrolytes, minerals, vitamins, trace elements, and sterile water for injection in a single container.  Parenteral nutrition (PN) admixtures that contain dextrose and amino acids with electrolytes, minerals, vitamins, trace elements, and sterile water for injection are often referred to as 2-in-1 admixtures.  When 2-in-1 admixtures are used, IVFE is infused separately as a source of energy and essential fatty acids.

The differences between the two types of admixtures and potential advantages of using one type instead of the other have been debated.  The use of TNA is preferred in most healthcare organizations for adults requiring nutrition support.  However, patient safety, admixture compatibility, convenience, and cost should be carefully considered when choosing which type of admixture to use. 

Compared with 2-in-1 admixtures with separate infusion of IVFE, systems using the TNA offer improved safety with regard to microbial contamination and infectious complications because all components are aseptically prepared by the pharmacy, there is less manipulation of sterile infusion sets and catheters during administration (i.e., a lower potential for catheter contamination), and the rate of bacterial growth is slower if contamination occurs.  Additionally, the rate of IVFE clearance is faster when administration takes place over more than 12 hours than the separate piggyback infusion of IVFE that has a 12 hour hang-time limit. 

Most patients and healthcare providers find the TNA system more convenient than 2-in-1 admixtures.  Admixture preparation is more efficient, especially for pharmacies using automated compounders.   Less nursing time is required to administer one admixture than two (i.e., a 2-in-1 admixture of dextrose plus amino acids and a separate piggyback IVFE).  The TNA system is easier to administer, especially for patients receiving nutrition support at home.
The TNA system is more cost-effective due to reduced inventory and indirect cost savings from decreased administration time.

Consideration of admixture compatibility and stability is essential when deciding whether the TNA system will be used.  The stability of the IVFE in the TNA is influenced by a number of factors, including pH, fat globule size, light exposure, container size, and storage conditions.  A change in any of these factors may result in “cracking” of the emulsion (i.e., instability), precipitate formation, or both.  There is also a greater risk of medication and electrolyte incompatibility with TNAs than 2-in-1 admixtures.  The amount and concentration of electrolytes, especially trivalent and divalent cations, added to TNA formulations must be considered.  Calcium gluconate and sodium and potassium phosphate are less compatible and stable in TNAs than in 2-in-1 admixtures.  
All nutrition support admixtures must be filtered.  A disadvantage of the TNA system is that it requires filters with a larger pore size (1.2 microns) than 2-in-1 admixtures for which filters with a small pore size (0.2 microns) may be used.  Filters with a smaller pore size remove more particulate matter and some bacteria, which is advantageous.

Lastly, the patient population must be considered when deciding which type of admixture to use.  The TNA system is commonly used in adults requiring nutrition support, and it may be considered for older infants and pediatric and adolescent patients, especially those going home on nutrition support.  However, the TNA system should not be used for neonatal patients due to the risk of instability and precipitation of complex admixtures. A 2-in-1 system with IVFE administered as a piggyback is preferred for neonates.

Reference

Slattery E, Rumore MM, Douglas JS, Seres DS. 3-in-1 vs 2-in-1 parenteral nutrition in adults: a review. Nutr Clin Pract. 2014; 29:631-5. http://www.ncbi.nlm.nih.gov/pubmed/24871494

Gervasio J. Total nutrient admixtures (3-in-1): pros vs cons for adults. Nutr Clin Pract. 2015  April 8. pii:10.1177/0884533615578458. [Epub ahead of print]

Blackmer AB, Partipilo ML. Three-in-one parenteral nutrition in neonates and pediatric patients: risks and benefits.  Nutr Clin Pract. 2015 April 9. pii 0884533615580596. [Epub ahead of print]

What guidance and recommendations are available for continuing PN and lipid infusions when patients are transferred from a patient care unit to the operating room or a procedural area?

The following statement is found in Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

Measures aimed at limiting manipulation of the catheter hub may reduce the risk of central line associated blood stream infections.  In acute care settings, policies that restrict tubing-catheter disconnections during routine patient care should be considered. Unscheduled interruptions in the PN infusion should be avoided because they may contribute to metabolic disturbances and suboptimal nutrient delivery.  PN administration should not be interrupted for medication administration. (1) PN should be discontinued prior to discharge or transport to another facility.

The risks of metabolic complications, particularly those related to glycemic control have raised questions regarding the safety of continuing PN during operative procedures.  However, no studies have adequately examined this issue.  One survey of pediatric anesthesiologists revealed a high degree of variability in the clinical management of blood glucose levels in patients receiving PN during anesthesia. (2)  As with other areas of PN administration, healthcare organizations should develop clear and consistent policies that address intraoperative PN infusion.  When the PN infusion is continued during surgery, the prescribed infusion rate should be maintained, with close monitoring of blood glucose levels and insulin administration as needed to maintain glycemic control. 

  1. Ayers J, Graves SA. Perioperative management of total parenteral nutrition, glucose containing solutions, and intraoperative glucose monitoring in paediatric patients: a survey of clinical practice.  Paediatr Anesth. 2001;11:41-44.
  2. Narual P, Hartigan D, Puntis JWL. The frequency and significance of errors related to parenteral nutrition in children.  Proc Nutr Soc. 2010;69(OCEy):E556.

 

What is the recommended dose of IV fat emulsion and glucose for an adult patient with advanced liver disease?

Adult patients with compensated, stable liver disease have normal protein and energy needs, although patients who are more critically ill have higher requirements.  Daily energy needs for adults with well-compensated liver disease are 25-35 kcal/kg. Malnourished patients may need 30-40 kcal/kg/day to promote anabolism.  Historically, protein restriction was recommended for patients with advanced liver disease to prevent hepatic encephalopathy.  However, recent studies have shown that high-protein diets are associated with a favorable prognosis in patients with cirrhosis because of improved nutritional status without exacerbating encephalopathy.  The current recommendation for daily protein intake in patients with advanced liver disease is 1-1.5 g/kg.  Patients with cirrhosis are at risk of hyperglycemia, so the daily glucose intake should not exceed 5-6 g/kg, and serum glucose concentrations should be monitored closely.  If hyperglycemia develops, the daily glucose intake should be reduced to 2-3 g/kg.  The recommended daily dose of IV soy oil-based fat emulsion should not exceed 1 g/kg.

Reference

Johnson TM, Overgard EB, Cohen AE, DiBaise JK.  Nutrition assessment and management in advanced liver disease. Nutr Clin Pract. 2013; 28:15-29.

What evidence-based recommendations are available for the frequency of laboratory monitoring for patients receiving PN?

The 2014 A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations provide the following guidelines concerning laboratory monitoring:

a. Patients who are new to PN should be monitored daily until stable (more frequently if clinically-significant metabolic abnormalities are found or patient is at risk for refeeding syndrome).

b. Patients in an unstable clinical condition (e.g., acutely ill, critically ill, recovering from critical illness, recent surgery) should be monitored daily until stable (more frequently if clinically significant abnormalities are observed).

c. Stable patients in the hospital with no required changes in formulation for 1 week should be monitored every 2 to 7 days.

d. Stable patients in a hospital, long-term care, or home setting with no changes in formulation for more than 1 week should be monitored every 1 to 4 weeks or longer in select clinically stable patients.

Reference

Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

What recommendations are available for laboratory monitoring of triglycerides and prealbumin in patients receiving nutrition support?

The A.S.P.E.N. Adult Nutrition Support Core Curriculum (2nd edition) recommends withholding IV fat emulsion if triglycerides exceed 400 mg/dL.

According to the 2012 consensus statement from the Academy of Nutrition and Dietetics and A.S.P.E.N. on characteristics recommended for the identification and documentation of adult malnutrition (undernutrition), indicators of inflammatory response traditionally used as indicators of malnutrition (e.g., serum albumin, prealbumin) should be interpreted with caution.

Reference

Mueller, Charles. A.S.P.E.N. Adult Nutrition Support Core Curriculum. 2nd ed. Silver Spring, MD: American Society of Parenteral and Enteral Nutrition, 2012.

White JV, Guenter P, Jensen G et al. Consensus Statement: Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition Characteristics Recommended for the Identification and Documentation of Adult Malnutrition (Undernutrition). JPEN J Parenter Enteral Nutr. 2012;36:275-283. 

Can an IV fluid warmer such as a hotline be used with parenteral nutrition in hypothermic patients or does this practice break down the formula and increase the risk for infection?

The stability of the PN formulation could be compromised during this process.

From FDA Alert, April 18, 1994:

“Parenteral nutrition admixtures should be administered within the following time frames: if stored at room temperature, the infusion should be started within 24 hours after mixing; if stored at refrigerated temperatures, the infusion should be started within 24 hours of warming. Because warming parenteral nutrition admixtures may contribute to the formation of precipitates, once administration begins, care should be taken to avoid excessive warming of the admixture.”

Reference

U.S. Food and Drug Administration. Hazards of Precipitation With Parenteral Nutrition.  Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm238205.htm (Accessed 4 June 2015).

Our pharmacists are often asked to make recommendations for correcting acidosis or potassium, phosphate, or other electrolyte or acid-base abnormalities.  What is the best source of guidance for inpatient pharmacists on making adjustments to PN therapy based on daily laboratory test results?

In general, it is inappropriate to manage short-term fluid, electrolyte, and acid-base imbalances using PN alone.  However, adjustments in the fluid, electrolyte, and acid-base content of PN solutions may avoid the risk and expense inherent in providing supplemental fluids and electrolytes.  The electrolyte composition of the PN solution may be varied based on the laboratory electrolyte results, changes in clinical status, organ function, and medications.  (Sacks GS, Mayhew S, Johnson D. Parenteral nutrition implementation and management. In: Merritt R, ed. The A.S.P.E.N. Nutrition Support Practice Manual, 2nd ed. Silver Spring, MD. 2005:108-117.)

The following resources should be helpful to pharmacists:

Btaiche IF, Khalidi N. Metabolic complications of parenteral nutrition in adults, Part 1. Am J Health Syst Pharm. 2004; 61:1938-49.

Btaiche IF, Khalidi N. Metabolic complications of parenteral nutrition in adults, Part 2. Am J Health Syst Pharm. 2004; 61:2050-7. Erratum in: Am J Health Syst Pharm. 2004; 61:2616.

Kraft MD, Btaiched IF, Sacks GS, Kudsk KA. Treatment of electrolyte disorders in adult patients in the intensive care unit. Am J Health Syst Pharm. 2005; 62:1663-82.

Rhoda KM, Porter MJ, Quintini C. Fluid and electrolyte management: putting a plan in motion. JPEN J Parenter Enteral Nutr. 2011; 35:675-85. http://pen.sagepub.com/content/35/6/675.full

Who may order parenteral nutrition?

Authority to order parenteral nutrition (PN) depends on many factors, including state regulations as well as institutional bylaws and policies.  Physicians, physician assistants, and nurse practitioners may order PN through their prescribing privileges, unless restricted from doing so by the institution in which they practice.  Authority to order PN can be delegated to pharmacists through consultative privileging in a specific practice setting.  In some states, registered dietitians (RDs) and registered nurses may have order writing privileges based on their professional board scope of practice standards.  In other states, order writing privileges may conflict with pharmacy and/or medical board rules or state licensing.

In 2014, the Center for Medicare and Medicaid Services ruled that RDs and other nutrition professionals may be privileged within their healthcare settings to order therapeutic diets, which by definition includes PN.  This ruling does not supersede individual state regulatory or institutional statutes, so further examination at the state and institutional level is required.  Regardless of which professional discipline is authorized to order PN, it is imperative that personnel with order writing privileges are competent to order PN.  Competence should be ensured through a systematic process, and competency assessments should be performed annually (see competency section).

Reference

Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Part II.  Section 3. Food and Dietetic Services (482.28).

Can commercially available premixed parenteral nutrition admixtures be used in place of customized PN admixtures?

Commercially available premixed parenteral nutrition (PN) admixtures are those in which two or three macronutrients are combined (after activation), with or without electrolytes, from separate chambers into a common chamber, all within one bag.  Potential benefits of using premixed PN include reduced cost, reduced labor, and the ability to provide greater amounts of specific nutrients during a drug shortage period. 

The 2014 A.S.P.E.N. Clinical Guidelines for Parenteral Nutrition Ordering, Order Review, Compounding, Labeling and Dispensing state that commercially available multi-chambered bags can be considered an available option along with customized PN formulations.  These products should be labeled with the percentage and amounts per liter or per bag rather than amount per day or amount per kilogram per day for pediatric patients and neonates as recommended in the 2014 A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations.  Appropriate staff education should be provided if these products are utilized to ensure safe delivery of PN.

Premixed PN products are best used for patients who are clinically stable and do not have unusual electrolyte requirements.  Standard amounts of electrolytes in premixed PN admixtures may not meet the needs of patients with unusual requirements.  The needs of patients who require specialized formulations (e.g., patients requiring substantial fluid restriction) may be better served with a custom PN admixture.  Clinical conditions in which premixed PN solutions may not be of benefit include severe malnourishment, critical illness, and conditions with significantly altered macronutrient and electrolyte requirements. For more details on premixed products, see the A.S.P.E.N. Statement on Parenteral Nutrition Standardization.

References

Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

Boullata J, Gilbert K, Sacks G et al. A.S.P.E.N. clinical guidelines for parenteral nutrition ordering, order review, compounding, labeling and dispensing. JPEN J Parenter Enteral Nutr. 2014; 38:334-77.

Kochevar M, Guenter P, Holcombe B et al. A.S.P.E.N. statement on parenteral nutrition standardization. JPEN J Parenter Enteral Nutr. 2007;31:441-8.

How should parenteral nutrition be ordered for a severely malnourished patient?

Patients who are severely malnourished are at risk for refeeding syndrome, a constellation of symptoms resulting from a shift to the fed state.  The most significant manifestations of refeeding syndrome are electrolyte alterations resulting from shifts and utilization in response to dextrose metabolism and insulin stimulation.  These alterations also may occur during protein or lipid metabolism due to gluconeogenesis.  The most common electrolyte alterations from refeeding syndrome are hypophosphatemia, hypokalemia, and hypomagnesemia.  Parenteral nutrition (PN) can be initiated in a severely malnourished patient if several steps are taken: 

  1. Assure that serum electrolyte concentrations are normalized prior to initiating PN, which may require the administration of individual electrolyte doses via the intravenous route.
  2. Order an initial PN formulation with reduced dextrose (and total energy) content to minimize the electrolyte shifts.  Some clinicians begin with dextrose 100-150 grams/day in adult patients or a maximum dextrose infusion rate of 2 mg/kg/minute (including all sources of dextrose).
  3. Include adequate amounts of phosphorus, potassium, and magnesium in the initial PN formulation; provide at least the minimum amounts per day as outlined in the ranges of normal daily electrolyte requirements. Daily monitoring of these important electrolytes is required with appropriate supplementation as serum concentrations dictate. 

More frequent monitoring, with admission to a monitored or intensive care unit, may be necessary in severe cases of malnourishment.  Advancing the PN dextrose content should not occur until serum electrolyte concentrations are stable.

References

Kraft MD, Btaiche IF, Sacks GS. Review of the refeeding syndrome. Nutr Clin Pract. 2005; 20:625-33. Abstract

Miller SJ. Death resulting from overzealous total parenteral nutrition: the refeeding syndrome revisited. Nutr Clin Pract. 2008; 23:166-71. Abstract

Rio A, Whelan K, Goff L et al. Occurrence of refeeding syndrome in adults started on artificial nutrition support: prospective cohort study. BMJ Open. 2013; 3:e002173. Available at: http://bmjopen.bmj.com/content/3/1/e002173.full.

Skipper A. Refeeding syndrome or refeeding hypophosphatemia. Nutr Clin Pract. 2012; 27:34-40. Abstract

Can parenteral nutrition be initiated at home?

The majority of patients who receive home parenteral nutrition (PN) have their PN initiated in the hospital setting during an admission related to their underlying illness.  However, PN may be initiated in the home setting in certain patients:

  • Patients without a chronic illness or in whom chronic illness is  well-controlled
  • Patients who are not at risk for refeeding syndrome or fluid overload (e.g., patients  with failed enteral nutrition)

Successful initiation of PN in the home setting involves use of an infusion provider who offers an interdisciplinary team management approach (e.g., physician, pharmacist, nurse, dietitian), slow progression when starting PN, and ongoing communication with the team, patient or caregiver, and physician.  Slow progression includes initiating a reduced dextrose amount to prevent complications, such as hyperglycemia and electrolyte imbalance.

References

Crocker KS, Riccardi C, Dileso M. Should total parenteral nutrition be initiated in the home or the hospital? Point-counterpoint: initiating total parenteral nutrition at home. Nutr Clin Pract. 1999; 14:124-29.

Durfee SM, Adams SC, Arthur E et al  A.S.P.E.N. Home and alternate site standards of practice. Nutr Clin Pract. 2014; 29:542-55.

Kovacevich DS, Frederick A, Kelly D et al. Standards for specialized nutrition support: home care patients. Nutr Clin Pract. 2007; 1:55-6.

Newton AF, DeLegge MH. Home initiation of parenteral nutrition. Nutr Clin Pract. 2007; 22:57-64.  Abstract

What are the contraindications to initiating parenteral nutrition?

The sole absolute contraindication to initiating parenteral nutrition (PN) is a fully functional gastrointestinal (GI) tract, unless enteral access is impossible.  Providing PN when the GI tract can be used unnecessarily increases the risk for metabolic and infectious complications.  Other contraindications to use of PN include lack of appropriate vascular access, a terminal diagnosis, or any other situation where the risks of PN outweigh the benefits.  Delaying the start of PN is often recommended if a patient is experiencing substantial metabolic and hemodynamic instability.

Reference

Newton AF, DeLegge MH. Home initiation of parenteral nutrition. Nutr Clin Pract. 2007; 22:57-64.  Abstract

What is the role of the electronic health record and PN?

The 2014 A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations state that PN should be ordered using a standardized electronic process, such as a computerized prescriber order entry (CPOE) system.  Clinical decision support should be available with alerts for safe prescribing of macronutrients and micronutrients. The CPOE system should be fully integrated with an automated compounding device and electronic health record.

When CPOE is not available, PN should be prescribed using a standardized editable order template to avoid handwritten orders.

Reference

Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

How is the competency of all involved in the PN process assessed?

The 2014 A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations state that a comprehensive education and competency assessment shall be developed for healthcare professionals involved in the care of PN patients.  Competency should be assessed annually. Organizations shall have written policies addressing credentials, training, and competency certification. 

A.S.P.E.N. has developed a model for competencies, Standardized Competencies for Parenteral Nutrition Prescribing The American Society for Parenteral and Enteral Nutrition Model, that should be met for institutions to privilege a provider to prescribe PN. The A.S.P.E.N. recommendations state that pharmacists involved in order review and verification should have specialty residency training and/or be board certified.  In the absence of board certification, the organization should provide opportunities for formal staff training.  Pharmacists and pharmacy technicians involved in the preparation of PN should undergo annual competency assessment in the following areas:

  • Calculations
  • Compounding base admixtures
  • Preparing dilutions and aliquots
  • Aseptic technique
  • Technology for preparation
  • Anticipating incompatibilities

The administration section of the A.S.P.E.N. Consensus Recommendations lists the following components for competency:

  • Role responsibilities
  • Required equipment
  • Verification procedures
  • Administration
  • Infection control measures
  • Monitoring
  • Complications and trouble shooting
  • Termination of therapy
  • Patient education
  • Documentation

The use of checklists is an effective means for performing and documenting competency for all personnel involved in the PN process.

Reference

Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

Guenter P, Boullata JI, Ayers P, et al. Standardized competencies for parenteral nutrition prescribing: The American Society for Parenteral and Enteral Nutrition model. Nutr Clin Pract. 2015 June 15. pii:10.1177/0884533615591167. [Epub ahead of print].

How can news of PN product shortages and resolved shortages be communicated effectively?

Methods used to communicate news and changes in policies and the drug formulary may also be effective for conveying information regarding product shortages, including resolved shortages.  These methods might involve newsletters, departmental websites, FDA or organizational “apps”, and message boards.

Attaching auxiliary labeling to the PN admixture could be used as a means for communicating with providers and patients about PN shortages. The 2014 A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations provide specific guidance regarding communication of PN product shortages.

  1. Healthcare organizations (including vendors and home infusion providers) shall have a process to communicate PN component shortages and outages to prescribers and staff who participate in providing PN therapy.
  2. Healthcare organizations shall develop and approve written PN component substitution protocols to be used in the event of a PN component shortage or outage.
  3. Healthcare organizations shall develop and approve written protocols for PN component substitution and/or conservation strategies to be used in the event of a PN component shortage or outage.
  4. Healthcare organizations have a process to communicate PN component substitution protocols and PN component conservation strategies to prescribers and staff who participate in providing PN therapy.
  5. Healthcare organizations have a process to implement PN component substitution protocols and/or PN component conservation strategies to prescribers and staff who participate in providing PN therapy.

Reference

Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

What are strategies for management of delivery of PN in the absence of a formal team?

The optimal nutrition support team should include a physician, pharmacist, dietitian, and nurse with appropriate training and experience.  In the absence of a formal team, an organizational committee should be established to develop and implement policies, procedures, and protocols related to nutrition support.  The committee should meet on a regular basis to establish collegial relationships, review and revise documents related to nutrition support, and remain abreast of guidelines and standards related to nutrition support.

What is the standard format or template for prescribing parenteral nutrition for adult and pediatric patients?

Parenteral nutrition (PN) is a complex medication therapy with many potential safety concerns.  Many errors that occur with PN therapy are related to the prescribing process.  There is a lack of uniformity in the PN ordering process from institution to institution.  The benefits of standardized order writing processes in reducing prescribing errors have been demonstrated.   A systematic approach to prescribing PN improves the quality and minimizes the risk of error, including incompatible quantities of electrolytes, dextrose, amino acids, and IV fat emulsions as well as the omission of nutrients.  Furthermore, a standardized format reduces the need for healthcare professionals, caregivers, and PN consumers to interpret orders and improves documentation for each bag of PN administered.

Components of a PN order form are described in the American Society for Parenteral and Enteral Nutrition’s (A.S.P.E.N.) Safe Practices for Parenteral Nutrition.

The A.S.P.E.N. Parenteral Nutrition Safety Task Force reinforced the benefit of a standardized PN order format or template and further recommended standardizing the entire PN process.  Standardized electronic PN orders (e.g., computerized prescriber order entry [CPOE]) should be used.  Handwritten orders should be avoided due to the potential for error.  When a CPOE system is not available, PN should be prescribed using an editable electronic document to avoid the need for handwritten orders.

PN order templates should be clear and easily understood by all healthcare professionals involved in the care of patients receiving PN therapy.  The list of components and the sequence of the components that shall be included in the PN order are listed in the 2014 A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations (Table 1).  The sequence of the PN components in the order should match that on the PN label. 

All PN ingredients shall be ordered in amounts per day (e.g. adult patients) or amounts per kilogram per day (e.g. pediatric and neonatal patients) rather than amounts per liter, percent concentration, or volume.  Electrolytes shall be ordered as the complete salt rather than the individual ion.

Standardized templates for an adult PN order and a pediatric/neonatal PN order can be found in 2014 A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations Figure 1 and Figure 2, respectively.

References

Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

Mirtallo J, Canada T, Johnson D et al. Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr. 2004; 28:S39-S70.

What are the essential components of a parenteral nutrition label?

The pharmacy-generated label for a parenteral nutrition (PN) admixture is a critical tool used to compare the PN ingredients and administration information against the PN order.  Standardized pharmacy labels shall provide information in a clear, uniform, and organized manner as well as facilitate the PN order verification process for pharmacists.  The label also serves as a final check for those administering PN, including nurses, patients, and caregivers.  The ingredients should be listed on the label in the same sequence with the same units of measure as in the PN order.  This avoids the need for calculations and reduces the risk of misinterpretation of the label.

A complete list of the elements of a PN label and example labels can be found in the Parenteral Nutrition Order Review and Verification Process section of the A.S.P.E.N. Parenteral Nutrition Safety Recommendations. Labels for home PN formulations should be consistent with USP General Chapter <17> Prescription Container Labeling.

Reference

Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

What is the standard format for a parenteral nutrition label?

Standardized pharmacy labels shall provide information in a clear, uniform, and organized manner as well as facilitate the parenteral nutrition (PN) order verification process for pharmacists.  The label also serves as a final check for those administering PN, including nurses, patients, and caregivers.  The label must be formatted in the same manner as the PN order for ease of verification. The 2004 A.S.P.E.N. Parenteral Nutrition Safe Practices and the 2014 A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations provide sample standardized PN labels for adult PN admixtures, pediatric/neonatal PN admixtures, adult IV fat emulsions, a pediatric/neonatal IV fat emulsion, and a home PN admixture.

References

Ayers P, Adams S, Boullata J et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014; 38:296-333.

Mirtallo J, Canada T, Johnson D et al. Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr. 2004; 28:S39-S70.

Which trace elements should be provided daily to adults receiving parenteral nutrition?

Trace elements are minerals present in humans at very low concentrations.  The recommendations for parenteral trace elements for adults were first published in 1979 by the American Medical Association Nutrition Advisory Group and included daily requirements ranges for four trace elements:  zinc, copper, manganese, and chromium.  Since the original publication, various groups have revised the recommendations for these trace elements and added a daily dose range for selenium.  The 2004 A.S.P.E.N. Safe Practices for Parenteral Nutrition included recommendations for daily parenteral trace element requirements for adult patients receiving parenteral nutrition.  Although several scientific groups, including the American Medical Association Nutritional Advisory Group (AMA NAG) and A.S.P.E.N., have recommended revising the daily requirement ranges for parenteral trace elements, the FDA has not updated its guidelines for daily parenteral trace element intake.

In 2009, A.S.P.E.N. held a research workshop on parenteral trace elements.  During this workshop, an international group of experts reviewed the current recommendations for parenteral trace elements and agreed that changes should be made regarding daily requirements.  Any changes would affect commercially-available multiple trace element products.  A group was appointed to assess the scientific evidence for the clinical use of trace elements and provide recommendations for changing the multiple trace element products.  Recommended changes include significantly reducing the daily requirements for copper and manganese due to reports of toxicity from these trace minerals when administered in doses provided in current products.

Trace Element

A.S.P.E.N. Recommended Daily Adult Requirement

Zinc (Zn)

2.5-5 mg

Copper (Cu)

0.3-0.5 mg

Manganese (Mn)

0.06-0.1 mg

Chromium (Cr)

10-15 mcg

Selenium (Se)

20-60 mcg

References:

Buchman AL, Howard LJ, Guenter P et al. Micronutrients in parenteral nutrition: too little or too much? The past, present, and recommendations for the future. Gastroenterology. 2009; 137(5 Suppl):S1-S6.

Vanek VW, Borum P, Buchman A, et al. A.S.P.E.N. position paper recommendations for changes in commercially available parenteral multivitamin and multi-trace element products. NutrClinPract. 2012;27:440-491.  

Mirtallo J, Canada T, Johnson D et al. A.S.P.E.N. Board of Directors and Task Force for the Revision of Safe Practices for Parenteral Nutrition. Safe practices for parenteral nutrition [published correction appears in JPEN J Parenter Enteral Nutr. 2006;30:177.] JPEN J Parenter Enteral Nutr. 2004; 28:S39-S70..

Clark SF. Vitamins and trace elements. In: Mueller CM, ed. The A.S.P.E.N. Adult Nutrition Support Core Curriculum, 2nd ed. American Society for Parenteral and Enteral Nutrition. Silver Spring, MD; 2012.

Which trace elements should be provided daily to pediatric and neonatal patients?

Trace elements are minerals present in humans at very low concentrations.  The recommendations for parenteral trace elements for adults were first published in 1979 by the American Medical Association Nutrition Advisory Group and included daily requirement ranges for four trace elements:  zinc, copper, manganese, and chromium.  Since the original publication, various groups have revised the recommendations for these trace elements and added a daily dose range for selenium.  The 2004 A.S.P.E.N. Safe Practices for Parenteral Nutrition included recommendations for daily parenteral trace element requirements for pediatric and neonatal patients receiving parenteral nutrition.  Although groups revised the daily dose ranges for parenteral trace elements, the FDA has not updated its guidelines for daily parenteral trace element intake.

In 2009, A.S.P.E.N. held a research workshop on parenteral trace elements.  During this workshop, an international group of experts reviewed the current recommendations for parenteral trace elements and agreed that changes should be made regarding daily requirements.  Any changes would affect commercially available multiple trace element products.  A group was appointed to assess the scientific evidence for the clinical use of trace elements and provide recommendations for changing the multiple trace element products.  The group recommended that the daily parenteral dose of chromium be reduced substantially because the dose provided in current U.S. products has resulted in elevated serum concentrations and chromium nephrotoxicity.  The recommendations from this group regarding multiple trace element products are as follows:

  • In addition to multiple trace element products that contain chromium, a multiple trace element product without added chromium should be made available;
  • Decrease manganese to 1 mcg/kg/day in neonates; and
  • Add selenium 2 mcg/kg/day in all pediatric/neonatal preparations.

References:

Buchman AL, Howard LJ, Guenter P, et al. Micronutrients in parenteral nutrition: too little or too much? The past, present, and recommendations for the future. Gastroenterology. 2009; 137(5 Suppl):S1-S6.

Clark SF. Vitamins and trace elements. In: Mueller CM, ed. The A.S.P.E.N. Adult Nutrition Support Core Curriculum, 2nd ed. American Society for Parenteral and Enteral Nutrition. Silver Spring, MD; 2012.

Fessler TA. Trace elements in parenteral nutrition: a practical guide for dosage and monitoring in adult patients. Nutr Clin Pract. 2013; 28:722-9. Abstract

Finch CW. Review of trace mineral requirements for preterm infants: what are the current recommendations for clinical practice? Nutr Clin Pract. 2015; 30:44-58. Abstract

Mirtallo J, Canada T, Johnson D et al. A.S.P.E.N. Board of Directors and Task Force for the Revision of Safe Practices for Parenteral Nutrition. Safe practices for parenteral nutrition [published correction appears in JPEN J Parenter Enteral Nutr. 2006;30:177.] 2004; 28:S39-S70.

Vanek VW, Borum P, Buchman A et al. A.S.P.E.N. position paper recommendations for changes in commercially available parenteral multivitamin and multi-trace element products. Nutr Clin Pract. 2012; 27:440-91.   

Wong T. Parenteral trace elements in children: clinical aspects and dosage recommendations. Curr Opin Clin Nutr Metab Care. 2012;15:649-56. Abstract

How should pharmacists and other healthcare professionals monitor trace element status of patients receiving parenteral nutrition?

Trace element dosing and monitoring in patients receiving parenteral nutrition (PN) varies with the underlying condition and length of therapy.  Dosing adjustments for trace elements provided in PN are usually guided by serum concentrations.  However, clinical conditions that affect the elimination of trace elements affect serum concentrations.  For example, patients with high output fistulas, chronic diarrhea, or short bowel syndrome may require higher than the recommended daily maintenance doses provided in multiple trace element products.  Conversely, patients with diseases associated with decreased bile flow, such as cholestasis, may require lower daily doses of manganese and copper to avoid accumulation and toxicity. 

Pharmacists and other healthcare professionals caring for patients receiving PN should be knowledgeable about disease states and clinical conditions that may alter the clearance of specific trace elements and anticipate abnormal serum concentrations.  Patients receiving long-term PN, such as those on home PN therapy, should have serum concentrations of trace elements assessed every 6 months.  Patients also should undergo physical examinations to detect signs of deficiency or toxicity from trace elements. Clinicians should be aware of the clinical signs and symptoms of trace element deficiencies and toxicities because serum concentrations do not always reflect deficiency or toxicity. 

Patients receiving PN during prolonged shortages of commercial multiple component and individual trace element products are at an increased risk of developing deficiencies.  Patients may receive inadequate dosing for an extended period resulting in deficiency despite the use of conservation and rationing strategies.   Pharmacists and healthcare professionals should have a heightened awareness of the risk of deficiency during product shortages.

Btaiche IF, Carver PL, Welch KB. Dosing and monitoring of trace elements in long-term home parenteral nutrition patients. JPEN J Parenter Enteral Nutr. 2011; 35:736-47.  

Clark SF. Vitamins and trace elements. In: Mueller CM, ed. The A.S.P.E.N. Adult Nutrition Support Core Curriculum, 2nd ed. American Society for Parenteral and Enteral Nutrition. Silver Spring, MD; 2012.

Fessler TA. Trace elements in parenteral nutrition: a practical guide for dosage and monitoring in adult patients. Nutr Clin Pract. 2013; 28:722-29. Abstract

Mirtallo J. Perspectives on parenteral micronutrient shortages. Nutr Clin Pract. 2015; 30:86-91. Abstract 

Vanek VW, Borum P, Buchman A et al. A.S.P.E.N. position paper recommendations for changes in commercially available parenteral multivitamin and multi-trace element products. Nutr Clin Pract. 2012;27:440-491.  

Winkler M, Hagan E, Albina J. Home nutrition support. In: Mueller CM, ed. The A.S.P.E.N. Adult Nutrition Support Core Curriculum, 2nd ed. American Society for Parenteral and Enteral Nutrition. Silver Spring, MD; 2012.

How do I know when a parenteral nutrition product shortage is resolved?

A shortage of a parenteral nutrition (PN) component is considered resolved when

  • The product is available through the normal supply chain;
  • The product can be obtained without allocations, direct orders, or drop shipments;
  • The quantity of the product that can be procured is sufficient to prescribe and administer full daily doses; and
  • The FDA considers shortage resolved.

References: 

ASHP Drug shortages: resolved drugs

Holcombe B. Challenges and strategies for optimizing patient care during shortages. Presented at 49th ASHP Midyear Clinical Meeting and Exposition. Anaheim, CA; 2014 Dec.

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