Tpn guideline

Supported by

From the publisher of

Assessment Tools and Guidelines:

Parenteral NutritionTherapy

Copyright © 2009 M

cMahon Publishing Group unless otherw

ise noted.

All rights reserved. Reproduction in whole or in part w

ithout permission is prohibited.

Jay M. Mirtallo, MS, RPH, FASHP, BCNSPSpecialty Practice Pharmacist

Nutrition Support/SurgeryDepartment of Pharmacy

The Ohio State University Medical CenterColumbus, Ohio

Assessment Tools and Guidelines:

Parenteral NutritionTherapy

DISCLAIMER—This pocket guide is designed to be a summary of information. Although it is detailed, it is not an exhaustive pharmaceuticalreview; the entries in this publication present selected facts about each prod-uct. McMahon Publishing and Hospira assume no liability for the use of thisguide, and the accuracy of the information contained herein is not guaranteed.Readers are strongly urged to consult any relevant primary literature, the com-plete prescribing information available in the package insert of each drug, andappropriate clinical protocols. Copyright © 2008, McMahon Publishing,545 West 45th Street, New York, NY 10036. Printed in the USA. All rightsreserved, including the right of reproduction, in whole or in part, in any form.

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Table 1. Evaluation of Body Weight . . . . . . . . . . . . . . . . . . .7

Figure 1. Algorithm for the administrationof nutrition support. . . . . . . . . . . . . . . . . . . . . . .8-9

Figure 2. Health care organization nutrition consultation request form. . . . . . . . . . . .10

Table 2. Pharmaceutical and MetabolicEquations in PN Therapy . . . . . . . . . . . . . . . . . . . .12

Table 3. Metabolic Derangements in Which PN Should Be Used With Caution . . . . . . . .14

Table 4. Macronutrients:PN Dosing Guidelines . . . . . . . . . . . . . . . . . . .16-17

Figure 3. Consequences of protein calorie overfeeding. . . . . . . . . . . . . . . . . . . . . . . .18

Table 5. Micronutrients: PN Dosing Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . .20-21

Table 6. FDA Requirements for Labeling Aluminum Content of PN Products . . . . . . . . . . . .22

Table 7. ASPEN Safe Practice Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . .26-29

Figure 4. PN formulation standard order format—renal failure. . . . . . . . . . . . . . . . . .30

Figure 5. PN formulation standard label format—renal failure. . . . . . . . . . . . . . . . . .31

Table 8. ASPEN Recommendations on PN Standardization . . . . . . . . . . . . . . . . . . . . . . . .32

Table 9. Y-Site Injection Compatibilityof I.V. Medications With PN . . . . . . . . . . . . . . .34-38

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Nutrition Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Nutritional Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

PN Formulation Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Medication Compatibility With PN . . . . . . . . . . . . . . . . . . . . . .24

Glucose Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Guideline for Special Diseases . . . . . . . . . . . . . . . . . . . . . . . . .33

Withholding and Withdrawing PN . . . . . . . . . . . . . . . . . . . . . .39

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41-44

Other Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

Figures and Tables Table of Contents

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Introduction

Malnutrition is associated with more frequent treat-ment complications and longer stays in the intensive

care unit (ICU) and hospital, as well as increased costs ofmedical care. Patients at high risk for malnutrition shouldbe identified and evaluated for specialized nutrition sup-port (SNS).1

Determining the appropriate route of nutrition supportfor patients at risk for malnutrition is an important consid-eration when one is attempting to positively influencepatient outcomes. In patients with a functioning gastroin-testinal (GI) tract, enteral nutrition (EN) can improve out-comes.1 EN has been shown to improve nutritional statusand reduce length of stay in the ICU and is associated withfewer infectious complications than parenteral nutrition(PN).2 The major limitation of EN is the need to gain enter-al (postpyloric) access so that the nutrient infusion is tol-erated and serious complications, such as aspirationpneumonia,are avoided.1 Techniques are available to facil-itate access to the GI tract so that enteral tube feedingsmay be administered safely. For patients who have a non-functioning GI tract, PN is the available method of nutri-tional support.3 PN is essential for patients who areseverely malnourished and have GI tract problems that arenot expected to resolve within 7 days.1,4 When PN is con-sidered, it should be noted that this method is complexand has been associated with a unique set of complica-tions, some of which can be serious or even life-threaten-ing.3 In addition, few published reports can be found thatdemonstrate a consistently favorable effect of PN onpatient outcomes.4

This pocket guide discusses nutritional assessment,nutri-tional requirements, PN formulation design, medication

6 7

Table 1. Evaluation of Body Weight

continued on page 11

IBW, ideal body weight; UBW, usual body weight

Adapted from references 4 and 8.

current weight% of IBW =

IBW x 100

80% to 90% = mild malnutrition

70% to 79% = moderate malnutrition

0% to 69% = severe malnutrition

% of Ideal Body Weight

current weight% of UBW =

usual weight x 100

85% to 95% = mild malnutrition

75% to 84% = moderate malnutrition

0% to 74% = severe malnutrition

% of Usual Body Weight

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8 9

Figure 1. Algorithm for the administrationof nutrition support.

Obstruction, peritonitis,paralytic ileus,mesenteric ischemia,short-bowel syndrome,enterocutaneous fistula, malabsorption

EN tolerated? Continue EN

Continue PN

Nonfunctional Functional

Transition to EN

Aspiration, abdominaldistention, diarrhea,high gastric residuals

• Aggressive attempt to obtain enteral access

• Feedings may be more appropriatedistal to the pylorus for patients withhigh gastric residuals, critical illness, gastroparesis, or pancreatitis

Yes

Yes

No No

Inconclusive

Functional GI tract?

Nutrition assessmentDecision to initiate SNS

EN

PN only if EN contraindicated PN

Status of GI function

Status of GI function

EN trial Yes

EN, enteral nutrition; GI, gastrointestinal; PN, parenteral nutrition;SNS, specialized nutrition support

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compatibility with PN, and guidelines for special diseases,as well as an overview of evidence-based guidelines pub-lished by the American Society for Parenteral and EnteralNutrition (ASPEN).1,3 Also included in the review is a dis-cussion of FDA regulations concerning aluminumcontamination of PN,5 United States Pharmacopeia (USP)standards for sterile compounding,6 and recommenda-tions on the use of insulin in PN.7

Nutrition Assessment

The purpose of nutrition assessment is to identify thedegree to which the current or future nutritional status ofthe patient will influence his or her outcome. The currentnutritional status of the patient is determined by severalfactors, including the patient’s weight and how it compareswith ideal and usual weights (Table 1,page 7); the durationof weight loss if it has occurred; visceral protein status; lab-oratory values indicative of fluid, electrolyte, and potentialnutritional deficits; clinical condition; and whether thepatient may be nourished by oral, enteral, or parenteralmeans.1,4,8 During PN, both pharmaceutical and metaboliccalculations are used in the assessment of nutrition sup-port. Equations used to assess clinical, nutritional, andmetabolic status are provided in Table 2 (page 12).4,9-11

Figure 1 (pages 8-9) is a useful algorithm for determiningthe appropriate indications for PN. Clinicians should con-sider PN if a trial of enteral feedings has failed, if the enter-al route is contraindicated, or if the GI tract has severelydiminished function because of underlying disease ortreatment and GI function is not expected to return within7 days.1,4 Contraindications to PN include the following: afunctional GI tract; an inability to achieve appropriatevenous access;an unstable clinical condition;and terminal

10 11

Figure 2. Health care organization nutrition consultation request form.


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1312

Using Harris-Benedict Equationa:For males:

66 + 13.75 (wt in kg) + 5 (ht in cm) – 6.8 (age in years)For females:

655 + 9.6 (wt in kg) + 1.8 (ht in cm) – 4.7 (age in years)

1. Predicting Energy Needs

Table 2. Pharmaceutical and Metabolic EquationsIn PN Therapy

Catabolic index = 24-hour urine urea nitrogen [UUN] (g) – (0.5 dietary nitrogen intake + 3)Values 0-5 represent moderate stress and >5 represent severe stress.

2. Predicting the Degree of Metabolic Stress

I. Creatinine height index = 24 hr actual creatinine excreted in urine (mg)24 hr expected creatinine excreted in urine of

x 100

normal adult of same height

3. Predicting the Degree of Malnutrition

II. Body mass index (kg/m2) = weight (kg) / height (m2)

Nitrogen balance = (protein intake [g]/6.25) – (24-hour urine urea nitrogen [g] + 3-5 g)

4. Measuring the Success of Nutrition Support

a Stress factors should not be applied.PN, parenteral nutritionBased on references 4 and 9-11.

disease, critical illness, or metabolic derangement forwhich a favorable response to therapy is not feasible or therisk of complications is too high.4 In these conditions, themetabolic profile is such that exogenous nutrients arepoorly used and frequently cause complications thatrequire prolonged mechanical ventilation, intensive care,or hospitalization.4 Table 3 (page 14) lists some metabolicderangements that necessitate cautious use of PN until thepatient’s condition improves.4

Applying the algorithm using the aforementioned con-cepts in a nutrition consultation form (Figure 2,page 10) canhelp improve appropriate use of PN in an institution.Such aform also provides documentation for the need for SNS,and,along with the nutrition assessment, includes a recommen-dation for route and dose of nutrients to be provided.

Nutritional Requirements

Over the past several years, there has been a continualrefinement of PN, focusing on the delivery of the safest,most effective doses. Guidelines provide a framework fornutrient doses in a variety of disease states.1,3 In general,there has been a decline in recommended caloric doses,a liberalization of protein doses, especially for renal andliver failure, and more specific recommendations for fatdoses (Table 4,pages 16-17).1,3,4,12 Two specific purposes forfat—nonprotein calories and prevention of essential fattyacid deficiency—are listed. Obesity is becoming moreprevalent and needs to be considered in dosing of PN.Thebody mass index is used to classify patients with a valuegreater than 30 as obese and a value greater than 40 asseverely obese.1

Overfeeding of calories and protein can have serious con-sequences in patients receiving PN and has led to the


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14 15

specific recommendations provided in Table 4.1,3,4,12 Whenmaximum doses of macronutrients are exceeded, the con-sequences outlined in Figure 3 (page 18) are frequentlyreported.1,4,13,14

Micronutrients—electrolytes, trace elements, and vita-mins—are essential to the incorporation of macro-nutrients into the body cell mass. The content ofmicronutrients in the body tends to fluctuate on the basisof cellular needs and deficits created by periods of low orno intake or losses, and often occurs in patients with non-functional GI tracts.Daily monitoring of serum electrolytesand periodic (initial and every 2-3 weeks) assessment ofvitamin and trace element status is essential for a patientrequiring PN. Bariatric (gastric bypass) surgery for morbidobesity may result in protein calorie malnutrition as wellas deficiencies of thiamine, vitamin B12, folic acid, vitaminE, and calcium due to malabsorption and/or inadequateintake caused by complications of the surgery.15 In thesepatients, assessment for vitamin deficiencies should bemore frequent. Guidelines for dosing of micronutrients inPN are outlined in Table 5 (pages 20-21).3,4,16,17

The presence of aluminum as a contaminant in PN hascaused complications in patients at risk.18 Patients at risk arethose who receive large loads of aluminum on a per-kilo-gram-of-body-weight basis and/or who have compromisedrenal function.4 Aluminum toxicity has been observed inneonates receiving PN and adults with renal compromisereceiving PN for long periods (home PN therapy). Toxicityprimarily affects the bones and central nervous system(CNS).18 Aluminum interferes with bone formation and min-eralization, causing bone fractures or symptoms of bonepain.19 CNS toxicity has also been observed.18 A dementiasimilar to the dialysis dementia observed in patients with

Table 3. Metabolic Derangements in Which PN Should Be Used With Caution

Azotemia Blood urea nitrogen >100 mg/dL

Hyperchloremic Serum Cl metabolic acidosis >115 mEq/L

Hyperglycemia Serum glucose >300 mg/dL

Hypernatremia Serum sodium >150 mEq/L

Hyperosmolality Serum osmolality >350 mOsm/kg

Hypochloremic Serum Cl metabolic alkalosis <85 mEq/L

Hypokalemia Serum potassium <3 mEq/L

Hypophosphatemia Serum phosphorus <2 mg/dL

Metabolic Derangement Abnormality To Be Corrected


Based on reference 4.

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16 17

Normal Range Usual Doses Maximum Special Considerations

Calories 20-35 kcal/kg/d Obesity: Hypocaloric doses have been used. Measurement of energyexpenditure is advised.Critically ill: 25-30 kcal/kg/d.

Glucose 70%-85% ofnonprotein calories

7 g/kg/d;4-5 mg/kg/min

Improved outcomes have been observed in critically ill patients whenblood glucose has been maintained at <110 mg/dL.

Fat 15%-30% of nonproteincalories

<30% of nonprotein calories

2.5 g/kg/d Limited benefit to fat dose >30% nonprotein calories.When administered separately from PN, infusion should be completedwithin 12 hours.

Protein 0.8-2 g/kg/d 1-1.5 g/kg/d 2 g/kg/d Provided as high biologic value (ie, content high in essential AAs).Dose should be modified in conditions of renal and hepatic disease to thelowest dose needed to achieve positive nitrogen balance.Renal failure

Chronic RF, no dialysis: 0.6-0.8 g/kg/day.Chronic RF, hemodialysis, or peritoneal dialysis: 1.2-1.3 g/kg/day.RF, continuous hemofiltration: 1 g/kg/day.Acute RF: Balanced mixture of essential/nonessential AAs.Acute RF with severe MN or hypercatabolic state: 1.5-1.8g/kg/day.

Liver failureProtein restriction should be used for acute management of hepaticencephalopathy but not for chronic use.Specialized AA formulations indicated only in chronic encephalopathyunresponsive to pharmacotherapy.

Fat (lipids) Prevention ofessential fattyacid deficiency

1%-2% ofcaloric dose aslinoleic acid and0.5% of caloricdose as α-linolenic acid.

Contraindicated in patients with pancreatitis induced by hyperlipidemia.Withhold doses for triglyceride level >400 mg/dL.

Table 4. Macronutrients: PN Dosing Guidelines

AA, amino acid; MN, malnutrition; PN, parenteral nutrition; RF, renal failure

Based on references 1, 3, 4, and 12.

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end-stage renal disease who received dialysate contami-nated with aluminum has been reported.19

Since aluminum is ubiquitous, it is very difficult, if notimpossible, to remove it from products used in the prepara-tion of PN.19 As a result, the FDA proposed a set of regula-tions, which went into effect on July 26, 2004, requiringmanufacturers to label products used in the PN preparationprocess with their aluminum content (Table 6, page 22).5,20

The purpose is to stimulate the manufacturers of PN prod-ucts to prepare products with lower aluminum content andto inform clinicians of the aluminum content of PN prod-ucts.20 The FDA also sought to establish a maximum safelimit of aluminum loads at 5 mcg/kg body weight per day.5

Although aluminum is present in products other than PN(heparin, albumin), these products are not included in theregulation.20 For PN, salts of calcium and phosphorus havethe highest aluminum content.19

Compared with adults, neonates/pediatric patientsrequire higher doses, on a body weight basis, of calciumand phosphorus to ensure both growth and mainte-nance.18 Neonates also have less ability to renally excreteexcess aluminum loads.19 ASPEN released a statementadvising clinicians to identify patients at greatest risk ofdeveloping aluminum toxicity and attempt to minimizealuminum intake in these patients.18-20

PN Formulation Design

Formulations of PN are extremely complex productsintended for I.V. use. Careful consideration of nutrient doseand avoidance of unstable or incompatible ingredients arenecessary. Inconsistent compounding practices have led toserious harm in patients receiving PN.3 In an effort to provideconsistent, specific guidelines for PN, the National Advisory

18 19

Total caloriesLiver

• fatty infiltration

• ↑ aspartate aminotransferase

• ↑ alanine aminotransferase

• ↑ alkaline phosphatase

• hepatomegaly

• cholestasis

Figure 3. Consequences of protein calorie overfeeding.

DextroseHyperglycemia

• serum glucose >200 mg/dL

• hyperinsulinemia

• impaired phagocytosis andneutrophil chemotaxis

Pulmonary Function

• ↑ CO2 production and minuteventilation

• respiratory failure in patientswith limited reserve

• prolonged mechanical ventilation

Fat• ↑ serum triglycerides

• impaired pulmonary function

• altered immunologic function

• hepatobiliary disease

Protein• ↑ renal solute load

• azotemia

• impaired renal function

• acidosis

CO2, carbon dioxide

Based on references 1, 4, 13, and 14.continued on page 23

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20 21

Normal Daily Requirements Usual Daily Doses

Na, K 1-2 mEq/kg Individualize, variable.

Cl, acetate As needed for acid–base balance Equal amounts as sodium or potassium salt.

Phosphorus 20-40 mmol

Calcium 10-15 mEq Gluconate salt preferred for PN. Stability limited by concentration of calcium and phosphorus.

Magnesium 8-20 mEq

Provided by addition of multiple vitamin injection product.FDA mandated reformulation of vitamin products to increase thiamine, folic acid, pyridoxine, and ascorbic acid.Monitor warfarin carefully during transition to products with vitamin K.

Use manganese with caution in patients with an obstructed biliary tract.Accumulation may result in neurologic toxicity.Zinc requirements increase with high GI output.Selenium is indicated for long-term care and critically ill patients.Patients on long-term PN are prone to iron deficiency. Iron statusshould be assessed initially and every 3 months in these patients.

Thiamin (B1) 6 mg

Riboflavin (B2) 3.6 mg

Niacin (B3) 40 mg

Folic acid 600 mcg

Pantothenic acid 15 mg

Pyridoxine (B6) 6 mg

Cyanocobalamin (B12) 5 mcg

Biotin 60 mcg

Ascorbic acid 200 mg

Vitamin A 3,300 IU

Vitamin D 200 IU

Vitamin E 10 IU

Vitamin K 150 mcg

Chromium 10-15 mcg

Copper 0.3-0.5 mg

Manganese 60-100 mcg

Zinc 2.5-5.0 mg

Selenium 20-60 mcg

Iron Not routinely added

Table 5. Micronutrients: PN Dosing GuidelinesEl

ectr

olyt

esVi

tam

ins

Trac

e El

emen

ts

GI, gastrointestinal; PN, parenteral nutrition

Based on references 3, 4, 16, and 17.

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Group on Standards and Practice Guidelines for ParenteralNutrition published “Safe Practices for Parenteral Nutrition.”These guidelines provide recommendations for the PN labeland order, as well as PN compounding, compatibility, stabili-ty,and administration.3 They call for a standardized PN labelformat to promote correct interpretation of PN contentsacross all health care environments; describe the pharma-cist’s duty to review the PN formula to ensure it is completeand balanced, and will be stable and compatible uponadmixture; and include admixture processes and qualitycontrol requirements that foster safe and accurate com-pounding of PN formulas (Table 7,pages 26-29).3,6

In addition, pharmacists should refer to the revised USPGeneral Chapter <797> “Pharmaceutical Compounding—Sterile Preparations” (official as of June 1, 2008) for poli-cies and procedures on the handling of sterilepreparations.6 USP chapter <797> provides mandates forthe compounding of sterile products at 5 levels of riskbased on the probability of exposing patients to microbialor physical contaminants, as well as specific requirementsfor environmental quality and control and personnelcleansing and garbing.

Using the “Safe Practices” format for a patient with renalfailure receiving hemodialysis,caloric doses do not need tobe modified, but doses of protein, potassium, magnesium,phosphorus, and acetate require adjustment (see Figure 4for an example of a standard order form filled out for arenal failure patient; see Figure 5 for an example of a stan-dard PN label for renal failure dosing; pages 30-31). Thelabel format allows for evaluation of nutrient dose basedon body weight and literature recommendations.4

Recent interest in standard PN formulations is the resultof The Joint Commission National Patient Safety Goal 3b,

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Table 6. FDA Requirements For Labeling Aluminum Content Of PN Products

Large-volume parenterals • Concentrated dextrose, amino

acids, parenteral lipids, sterilewater for injection, saline, and electrolyte solutions

Small-volume parenterals andpharmacy bulk packages • Electrolyte salts of calcium,

phosphorus, potassium,magnesium, and sodium

• Multivitamins• Trace elements

Must contain ≤≤25 mcg/L of aluminum.

1. Must be labeled with the maximum level of aluminum in the product at expiration.

2. If reconstituted, must belabeled with the maximumlevel of aluminum at expirationin the reconstituted form.

3. Maximum amount of aluminum may be determined by any of the following methods:• Highest level measured in

batches over the last 3 years.• Highest level for the last

5 batches.• Maximum historical level.



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24 25

used solely for PN, but in patients with limited venousaccess this is not always possible. Medication ad-ministration with PN may be unavoidable. In these situa-tions, compatibility considerations are relevant.

The pharmacist’s objective is to ensure the safe,compat-ible,and efficacious provision of both pharmacologic ther-apy and nutrition support. In reviewing a patient’s regimenfor compatibility,it is important to consider whether the PNcontains fat emulsion. Studies have shown differences incompatibility based on the PN formulation used. Table 9(pages 34-38) was developed to provide consistent, reli-able, and up-to-date information on the compatibility ofdrugs administered via Y-site injection with PN.24-56 If nocompatibility data exist, the medication should not beadministered with PN.

There is a distinction between Y-site administration anddirect admixture of the drug with PN.Adequate assessmentof specific pharmacotherapeutic criteria16 for direct admix-ture of drugs (eg, ranitidine or famotidine) in PN isrequired.56 These criteria may be summarized as follows:• Stability and compatibility of the drug with the specif-

ic PN admixture over a 24-hour period must be deter-mined before the medication is added.

• The medication must have appropriate pharmacoki-netics and proven efficacy for continuous infusion.

• The medication dose must have remained constantthroughout the previous 24-hour period before admix-ture in PN.

• There must be a stable PN infusion rate for at least 24 hours before the medication is added.

• PN must include appropriate labeling to avoid pharma-cotherapeutic problems associated with abrupt discontinuation.57

which recommends standardizing and limiting the num-ber of drug concentrations used by an organization.21 Inits original Frequently Asked Questions (FAQ), The JointCommission suggested that this rule should apply to PN,which is included in its definition of medications(drugs).22 In addition, it was noted that standardized PNsolutions are available from manufacturers, and havebeen shown to be practical for most patients and topotentially improve outcomes.22 This interpretation ofGoal 3b has caused a great deal of concern and confu-sion among clinicians responsible for PN in their respec-tive organizations. Subsequently, a revised JointCommission FAQ,updated in January 2007 in conjunctionwith ASPEN, noted that Goal 3b may not apply to PNbecause of its multicomponent nature. The emphasis ofthe revision was on a standardized approach to PN as rec-ommended by the ASPEN Safe Practice Guidelines.22 Thisprompted ASPEN to create a Statement on ParenteralNutrition Standardization,23 which was approved by theBoard of Directors in June 2007.This evidence-based anal-ysis of the literature resulted in the recommendations pro-vided in Table 8 (page 32).This statement recommends astandardized PN process, recognizes the need for clini-cians with PN expertise to be involved with the process,and addresses the patient with complex needs in whom acustomized PN formulation may be necessary.23

Medication Compatibility With PN

Patients receiving PN usually need medications to beadministered intravenously.Multiple-lumen central venouscatheters have alleviated some problems associated withcoadministration of medications with PN.3 It is recom-mended that the catheter or port for PN administration be


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26 27

Table 7. ASPEN Safe Practice Guidelines

Section Practice Guidelines

Labeling PN formulations

1. Labels for PN admixtures should be standardized:• the amount per day is required;• quantity per liter may also be used;• dosing weight is required on the label.

2. Auxiliary labels may be used, especially when ordersare written in a different format from the label.

3. Patient transfer between health care environmentssuch as hospital to home requires pharmacist-to-pharmacist communication of the PN prescription.

4. The PN label should be compared with the order,and the beyond-use date should be checked beforeadministration.

Ordering PN 1. Standardized order forms should be used.2. PN formula is assessed to determine that the con-

tents are appropriate for patient condition (adult orpediatric), or if the patient's disease state warrants adose outside the standard range.

3. Nutrients are indicated as total daily dose.4. Percentage concentration should not be used on the

order form.5. Avoid potentially dangerous abbreviations.6. All components of the PN order are rewritten when

PN is reordered.

Standard nutrient requirements

1. The pharmacist should assess the PN contents toensure that the dose of all nutrients is appropriate to the patient’s needs.

2. IVFE should be provided to adult and pediatricpatients to avoid essential fatty acid deficiency when fat is not included in the base formula.

3. All PN patients should receive a parenteral vitaminpreparation daily.

4. PN products should be chosen with the lowest aluminum content when possible.

5. Parenteral iron should not be used routinely in PN therapy.


Compound-ing of PNformulations

Screening1. Review of PN contents is required to ensure that a

balanced and complete formulation is provided.2. Each PN component is assessed for adequacy of

dose and potential for a compatibility or stabilityproblem.

3. Any dose outside the accepted range and notexplained by a specific patient condition should be clarified prior to compounding PN.

PN compounding1. The additive sequence is optimized and validated

as a safe, efficacious method.2. A review of the compounding method is recommend-

ed if PN is compounded manually or if there has beena change in commercial source of PN products.

3. Manufacturers of automated methods of PN com-pounding should provide the additive sequence thatensures the safety of the compounding device basedon the nutrient products used at the institution.

4. Each PN formulation compounded must be inspectedfor signs of particulate contamination and/or phaseseparation of TNA.

Quality assurance1. Gravimetric analysis of PN formulations can be

applied, focusing on the most dangerous additives tol-erating the least margin of error (eg, potassium salts).

2. Chemical analysis can be incorporated into the PNcompounding operations of the pharmacy.

3. Refractometric analysis is an alternative but is limited to formulations that do not contain fat.

4. Daily in-process or end-product testing of PN formulations is recommended.

5. Compounding accuracy of PN prepared by automat-ed compounding devices should be verified by end-product testing.

6. Aseptic extemporaneous preparation of PN formula-tions should adhere to the USP General Chapter<797> Pharmaceutical Compounding—Sterile Preparations.6

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28 29

Table 7. ASPEN Safe Practice Guidelines (continued)


Stability and compatibility of PN formulations

1. All PN processes are confirmed to ensure that allcomponents are stable and compatible.

2. The pharmacist ensures that the co-infusion of medications with PN admixtures is safe, stable,and compatible.

3. If no information exists about a medication’s compatibility with PN, it should be administered separate from PN.

4. Compatibility information should be evaluatedaccording to the concentration of medication andwhether the PN formulation is a 2-in-1 or TNA.

5. Insulin use in PN should be consistent throughoutthe health system.

6. Decisions are made based on the most recent evidencefrom the literature or direct from the manufacturer.

7. Use of 2-in-1 formulas with separate administrationof IVFE is recommended for neonatal/infant patients.

PN admin-istration

Venous catheters1. Central PN should be administered via CVC with

distal tip in SVC adjacent to right atrium.2. Avoid use of femoral catheters for PN administration.3. Proper CVC placement should be confirmed prior to

initiating PN and any time signs/symptoms of malposition are present.

4. Care for CVC according to published standards.Equipment1. A 0.2-micron filter should be used for 2-in-1

formulations and a 1.2-micron filter for TNAs.2. Alternatively, a 1.2-micron filter may be used for all

PN formulations to remove larger particles. The FDArequires a 1.2-micron filter for TNA and a 0.2-micron filter for 2-in-1 formulations.

3. A filter that clogs during administration may bereplaced but never removed entirely.

4. Use containers and sets free of DEHP if IVFE is used.5. Change administration sets for IVFE given separately

from PN after use, or at least every 24 hours if administered as a continuous infusion.

6. Change TNA administration sets every 24 hours.7. Change 2-in-1 administration sets every 72 hours.8. PN infusion pumps should have adequate “free flow”

protection.9. Medical devices should be selected that protect the user

from needlesticks and exposure to blood-bornepathogens.

Administration1. The label should be used to verify the patient’s identity

prior to administration.2. The PN should be inspected prior to setup and not used

if its integrity appears to be compromised (precipitate, color change, or cracked emulsion).

3. The PN infusion should be completed within 24 hours ofits initiation.

4. The PN patient should be monitored for PN efficacy,complications, change in clinical condition, and to document clinical outcomes.

5. Policies and procedures should be in place to deal withPN compounded by an outside facility.


CVC, central venous catheter; DEHP, diethylhexyl phthalate; IVFE, intravenous fat emulsion; PN, parenteral nutrition; SVC, superior vena cava; TNA, total nutrient admixture;USP, United States PharmacopeiaAdapted from references 3 and 6. American Society for Parenteral and Enteral Nutrition(ASPEN) does not endorse this material in any form other than its entirety.

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Figure 4. PN formulation standard orderformat—renal failure.

Figure 5. PN formulation standard labelformat—renal failure.a

Ingredient Amount per Day

Amount per Liter

Dextrose (g) 302 210

Amino acids (g) 72 50

Fat emulsion (20%, g) 58 40

Base Formula

Multiple vitamins 10 mL —

Multiple trace elements 3 mL —

Vitamins, Trace Elements, and Medications

Sodium acetate (mEq) 58 40

Potassium chloride (mEq) 14 10

Potassium phosphate (mmol of P)

14 10

Calcium gluconate (mEq of Ca)

10 5.6

Magnesium sulfate (mEq of Mg)

4 2.8

Electrolytes

a This formula is infused at 60 mL/h and provides 1,886 calories or 30 kcal/kgbody weight (dosing weight of 63 kg), 72 g amino acids or 1.1 g/kg bodyweight, 0.9 mEq/kg of sodium, 0.5 mEq/kg of potassium, a 25% decrease inphosphorus dose, and a 50% decrease in magnesium dose. Further dosing modifications are necessary based on serum electrolytes and the effectivenessof hemodialysis in removing protein and electrolytes and maintaining normalacid–base status.

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In general, only H2 antagonists and insulin have beenadmixed in 3-in-1 admixtures. These drugs may also beadmixed with 2-in-1 solutions. Other drugs that have beenshown to be stable and efficacious in 2-in-1 solutions areheparin,aminophylline,hydromorphone,hydrochloric acid(maximum concentration, 100 mEq/L), and iron dextran(Table 9,pages 34-38).24-56

Glucose Control

Serum glucose control at a value of less than 110 mg/dLhas been shown to improve clinical outcome (ie, shorterICU stay,less ventilator use,and lower mortality) in some sur-gical critically ill patients.12 This has led to a keen interest intight glucose control during PN.7 A reasonable target levelfor blood glucose is between 100 and 150 mg/dL.3 Glucoseshould be monitored every 4 to 6 hours when insulin isadded to PN.If the patient’s glucose level is above goal,sup-plemental insulin should be administered every 4 to 6 hoursaccording to the previous day’s sliding scale insulin use.Thefrequency of glucose monitoring can only decrease onceglycemic control has been achieved. If glucose values con-sistently exceed 150 mg/dL over a 24-hour period, regularinsulin should be increased by 0.05 units each day in the PNformulation. It is recommended not to exceed approxi-mately 0.2 units of insulin per gram of dextrose.4

Guidelines for Special Diseases

Some important concepts related to specific diseaseshave been included in the recent guidelines published byASPEN.1 Although there are several formulas for determin-ing energy requirements measurement of energy expendi-ture is specifically recommended for patients withneurologic impairment and critical illness,and overfeeding

Table 8. ASPEN Recommendations on PN Standardization

PN, parenteral nutrition


1. A standardized process for PN management is advocated. This mayinclude use of standardized PN formulations (including standard-ized commercial PN products) but also includes aspects of ordering,labeling, screening, and administration of PN.

2. The evidence on patient safety does not support the general use ofstandardized PN formulations across health care organizations.

3. The evidence suggests advantages in efficiency, economy, and clinical appropriateness with the use of standardized PN formula-tions compared to individualized PN formulations in select patientpopulations.

4. When an organization implements standardized PN formulations(including standardized commercial PN products), a mechanismshould be established to provide, compound, or make available,customized PN formulations for individuals who have complexrequirements secondary to disease or underlying illness, or whenotherwise warranted by routine monitoring of electrolytes, organfunction, growth, and development.

5. A standardized process must include clinicians with expertise in thearea of nutrition support.

6. PN compounding practices should adhere to recommendations pro-mulgated by national professional organizations.


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Table 9. Y-Site Injection Compatibility Of I.V. Medications With PNa

Acetazolamide I —

Acyclovir I I

Amikacin sulfate C C/I

Aminophylline C/I C

Amphotericin B I I

Ampicillin sodium C/I C

Ampicillin sodium-sulbactam sodium C C

Atracurium besylate C —

Aztreonam C C

Bumetanide C C

Buprenorphine HCl C C

Butorphanol tartrate C C

Calcium gluconate C C

Carboplatin C C

Cefazolin sodium C/I C

Cefepime C —

Cefoperazone sodium C C

Cefotaxime sodium C C

Cefotetan disodium C C

Cefoxitin sodium C C

Ceftazidime sodium C C

Ceftizoxime sodium C C

Ceftriaxone sodium C C

Cefuroxime sodium C C

Chloramphenicol sodium succinate C —

Chlorpromazine HCl C C

Cimetidine C C

Ciprofloxacin lactate I C

Cisplatin I C

Medication Admixture Type2-in-1 3-in-1

Clindamycin phosphate C C

Cyclophosphamide C C

Cyclosporine C/I C/I

Cytarabine I C

Dexamethasone sodium phosphate C C

Digoxin C C

Diphenhydramine HCl C C

Dobutamine HCl C C

Dopamine HCl C C/I

Doxorubicin HCl I I

Doxycycline hyclate C I

Droperidol C I

Enalaprilat C C

Epinephrine HCI C —

Epoetin alfa C —

Erythromycin lactobionate C C

Famotidine C C

Fentanyl citrate C C

Fluconazole C C

5-Fluorouracil C/I C/I

Foscarnet C —

Furosemide C/I C

Gallium nitrate C C

Ganciclovir sodium I/C I

Gentamicin sulfate C C

Granisetron HCl C C

Heparin sodium C I

Hydrochloric acid Cb —

Hydrocortisone sodium phosphate C C

C, compatibility has been demonstrated. When Y-site compatibility was not available,medications compatible in-solution for 24 hours were assumed to be Y-site compatible;I, incompatibility has been demonstrated; —, compatibility data not available;

C/I, conflicting compatibility has been demonstrated and strength of evidence supportscompatibility; I/C, conflicting compatibility has been demonstrated and strength of evi-dence supports incompatibility


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Table 9. Y-Site Injection Compatibility Of I.V. Medications With PN (continued)a

Hydromorphone HCl C I/C

Ifosfamide C C

Imipenem-cilastatin sodium C C

Immune globulin — —

Indomethacin sodium trihydrate I —

Insulin, regular C C

Iron dextran C/I I/C

Isoproterenol HCl C C

Kanamycin sulfate C C

Leucovorin calcium C C

Levorphanol tartrate C I

Lidocaine HCl C C

Linezolid C —

Lorazepam C I

Magnesium sulfate C C

Mannitol C C

Meperidine HCl C C

Meropenem — C

Mesna C C

Methotrexate I C

Methyldopate HCl C C/I

Methylprednisolone sodium succinate C C

Metoclopramide HCl I/C C

Metronidazole C C

Miconazole C C

Midazolam HCl I/C I

Milrinone lactate C —

Mitoxantrone HCl I C

Morphine sulfate C C/Ic

Nafcillin sodium C C

Nalbuphine HCl C I

Nitroglycerin C C

Norepinephrine bitartrate C C

Octreotide acetate C C

Ondansetron HCl C I

Oxacillin sodium C C

Paclitaxel C C

Penicillin G potassium C C

Penicillin G sodium C —

Pentobarbital sodium C I

Phenobarbital sodium C I

Phenytoin sodium I —

Piperacillin sodium-tazobactam sodium C C

Potassium chloride C C

Potassium phosphate I I

Prochlorperazine edisylate C C

Promethazine HCl C/I C

Propofol C —

Ranitidine HCl C C

Sargramostim C —

Sodium bicarbonate I/C C

Sodium nitroprusside C C

Sodium phosphate I I

Tacrolimus C C

Ticarcillin disodium C C

Ticarcillin disodium–clavulanate potassium C C

Tobramycin sulfate C C

Trimethoprim-sulfamethoxazole C C

C, compatibility has been demonstrated. When Y-site compatibility was not available,medications compatible in-solution for 24 hours were assumed to be Y-site compatible;I, incompatibility has been demonstrated; —, compatibility data not available;

C/I, conflicting compatibility has been demonstrated and strength of evidence supportscompatibility; I/C, conflicting compatibility has been demonstrated and strength of evi-dence supports incompatibility



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Table 9. Y-Site Injection Compatibility Of I.V. Medications With PN (continued)a

Vancomycin HCl C C

Vecuronium bromide C —

Vitamin K1 (phytonadione) C —

Zidovudine C C

a During simulated studies of compatibility, a 1:1 volume ratio of drug mixture withPN is used. For example, 1 mL of drug solution is combined with 1 mL of test PNadmixture for a period consistent with that usually observed in practice during Y-siteadministration of the drug with PN.

b Hydrochloric acid: Not to exceed a concentration of 100 mEq/L. Maintain pH of finalsolution >3.0.

c Morphine sulfate incompatible at concentration of 15 mg/mL, compatible at concentration of 1 mg/mL.

—, compatibility data not available.C, compatibility has been demonstrated. When Y-site compatibility was not available,

medications compatible in solution for 24 hours were assumed to be Y-site compati-ble.

C/I, conflicting compatibility has been demonstrated and strength of the evidence sup-ports compatibility.

I, Incompatibility has been demonstrated.I/C, conflicting compatibility has been demonstrated and strength of evidence supports

incompatibility.HCI,hydrochloridePN, parenteral nutrition; all forms of I.V. nutrition, including 3-in-1 and 2-in-1 admixtures

or I.V. fat emulsions. Also known as parenteral nutrient solution.Y-site injection, drug administration via piggyback, I.V. push, or other I.V. methods at

the Y-site injection port or other access port (ie, stopcock) between the PN solutionand the central venous catheter.

2-in-1, traditional parenteral nutrient admixtures containing dextrose and amino acidsand having a yellow appearance similar to that of I.V. solutions containing multi-vitamins. Also known as dextrose–amino acid solution.

3-in-1, combination of dextrose, amino acids, and fat in 1 final container, resulting inan I.V. fluid having a milky white appearance. Also referred to as a total nutrientadmixture.

Based on references 24-56.

is cautioned against in patients with pulmonary disease.The guidelines also address permissive underfeeding inobesity cases and emphasize the use of EN in patients withpancreatitis and GI fistulas, conditions for which PN hasbeen considered the therapy of choice.1 This summary isnot all-inclusive, but it highlights some concepts that havesurfaced and may stimulate consideration of a change inpractice. More specific information can be found in theguideline document and its supporting literature.

Recently, the benefit of PN in bone marrow transplantrecipients has come into question. Issues related to glu-cose homeostasis, infection rates,and other complicationshave been raised.58 Particular attention should be paid tothe indication, nutrient dose, and system for managing thebone marrow recipient on PN.

Withholding and Withdrawing PN

The decision to use PN can be difficult when a patient isunresponsive to therapy or in the terminal stages of disease.As a means of nourishment,PN is potentially life-sustaining,and as a component of other therapies, it can improve orresolve the patient’s condition. The potential risks versusbenefits of PN should be considered. Also, it is often diffi-cult to determine whether the therapy will improve qualityof life or increase suffering. The decision to withhold orwithdraw PN should be discussed with the medical staffand the patient or a designee. The discussion shouldinclude the elucidation of the patient’s preferences, goals,and values (including religious beliefs), as well as adetailed list of the possible benefits and burdens of thera-py. If the benefit versus risk is not easy to predict, considera time-related trial period to evaluate effectiveness, bene-fits,and burdens.This process requires an understanding of

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for the use of parenteral and enteral nutrition in adult and pediatric patients.JPEN J Parenter Enteral Nutr. 2002;26(1 suppl):1SA-138SA.

2. Marik PE, Zaloga GP. Meta-analysis of parenteral nutrition versus enteral nutri-tion in patients with acute pancreatitis. BMJ; 2004.doi:1136/bmj.38118.593900.55

3. Mirtallo J,Canada T,Johnson D,et al, for the Task Force for the Revision of SafePractices for Parenteral Nutrition.Safe practices for parenteral nutrition. JPEN JParenter Enteral Nutr. 2004;28(6 suppl):S39-S70.

4. Gottschlich MM,DeLegge MH,Mattox T,Mueller C,Worthington P,eds.TheA.S.P.E.N.Nutrition Support Core Curriculum: a Case-Based Approach—the AdultPatient.Silver Spring,MD:American Society for Parenteral and Enteral Nutrition;2007.

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Conclusion

PN can be effective in treating malnutrition. Its proper-ties, however, confer a unique set of complications thatmay adversely affect patient outcome. Optimal use of PNrequires careful consideration of the patient’s clinical con-dition and nutritional state,and the physical and chemicalcharacteristics of the admixture. In addi tion, the use ofguidelines for determining the proper indication, mode ofdelivery, and mode of administration of PN facilitates theprovision of the most appropriate nutritional therapy.

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24. Veltri M, Lee CK. Compatibility of neonatal parenteral nutrient solutions withselected intravenous drugs. Am J Health Syst Pharm. 1996;53(21):2611-2613.

25. Akkerman SR, Zhang H, Mullins RE,Yaughn K. Stability of milrinone lactate inthe presence of 29 critical care drugs and 4 i.v. solutions. Am J Health SystPharm. 1999;56(1):63-68.

26. Maxipime® [package insert]. Princeton, NJ: Bristol-Myers Squibb Company;2007.

27. Schuetz DH, King JC. Compatibility and stability of electrolytes, vitamins andantibiotics in combination with 8% amino acids solution. Am J Hosp Pharm.1978;35(1):33-44.

28. Trissel LA, Gilbert DL, Martinez JF, Baker MB,Walter WV, Mirtallo JM. Compatibili-ty of parenteral nutrient solutions with selected drugs during simulated Y-siteadministration. Am J Health Syst Pharm. 1997;54(11):1295-1300.

29. Gilbar PJ, Groves CF.Visual compatibility of total parenteral nutrition solution(Synthamin 17 premix) with selected drugs during simulated Y-site injection.Aust J Hosp Pharm. 1994;24:167-170.

30. Trissel LA, Gilbert DL, Martinez JF, Baker MB,Walter WV, Mirtallo JM. Compatibili-ty of medications with 3-in-1 parenteral nutrition admixtures. JPEN J ParenterEnteral Nutr. 1999;23(2):67-74.

31. Baptista RJ, Lawrence RW. Compatibility of total nutrient admixtures and sec-ondary antibiotic infusions. Am J Hosp Pharm. 1985;42(2):362-363.

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39. Trissel LA, Bready BB, Kwan JW, Santiago.The visual compatibility of sar-gramostim with selected chemotherapeutic drugs, anti-infectives, and otherdrugs during simulated Y-site injection. Am J Hosp Pharm. 1992;49(2):402-406.

40. Veltri MR, Conner KG. Physical compatibility of milrinone lactate with intra-venous drugs commonly used in the intensive care unit. Am J Health SystPharm. 2002;59(5):452-454.

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51. Nieves-Cordero AL, Luci HM, Souney PF. Compatibility of narcotic analgesicsolutions with various antibiotics during simulated Y-site injection. Am J HospPharm. 1985;42(5):1108-1109.

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59. O’Sullivan J, Maillet J. Ethics. In: Merritt R, DeLegge MH, Holcombe B, et al, eds.ASPEN Nutrition Support Practice Manual. 2nd ed. Silver Spring, MD: AmericanSociety for Parenteral and Enteral Nutrition; 2005:378-382.

Other ResourcesAmerican Society for Parenteral and Enteral Nutrition,8630 Fenton St,Suite 412,Silver Spring,MD 20910-3805.Phone: (301) 587-6315. E-mail: [email protected] access:www.nutritioncare.org.

Merritt R,DeLegge MH,Holcombe B,et al, eds.ASPEN Nutrition Support PracticeManual. 2nd ed.Silver Spring,MD:American Society for Parenteral and Enteral Nutrition; 2005.

Rombeau JL, Rolandelli RH, eds. Clinical Nutrition/Parenteral Nutrition. 3rd ed.Philadelphia, PA:WB Saunders Co; 2001.

Shikora SA,Martindale RG,Schwaitzberg SD,eds.Nutritional Considerations in theIntensive Care Unit: Science,Rationale and Practice. American Society for Parenteraland Enteral Nutrition.Dubuque, IA: Kendall-Hunt Publishing Co; 2002.

Trissel LA,ed. Handbook on Injectable Drugs. 14th ed.Bethesda,MD:American Soci-ety of Health-System Pharmacists; 2006.

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Tpn guideline

Education

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