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1. d. i te d. ib t e ro h no s p e i Parenteral is Assessment Tools and Guidelines: n Nutrition rw sio he is Therapy ot rm ss pe le ut un ho From the publisher of up wit Supported by ro G art ng n p hi i is r bl e o Pu ol h on w ah in cM n M tio c 09 du 2 0 ro © ep t R gh d. ri e py erv Co es r ts gh ri ll A
A ll ri gh Co ts py re ri gh se rv t © ed 20 .R 09 ep M Assessment Tools and Guidelines: ro cM on du Parenteral ah in ct i on w Pu ol Nutrition bl e o is h hi Therapy ng n p r G art i ro up wit un ho le ut Jay M. Mirtallo, MS, RPH, FASHP, BCNSP ss DISCLAIMER—This pocket guide is designed to be a summary of Specialty Practice Pharmacist ot rm information. Although it is detailed, it is not an exhaustive pharmaceutical Nutrition Support/Surgery he review; the entries in this publication present selected facts about each prod- Department of Pharmacy pe rw sio uct. McMahon Publishing and Hospira assume no liability for the use of this The Ohio State University Medical Center guide, and the accuracy of the information contained herein is not guaranteed. Columbus, Ohio is is e Readers are strongly urged to consult any relevant primary literature, the com- no s p plete prescribing information available in the package insert of each drug, and n t e ro h appropriate clinical protocols. Copyright © 2008, McMahon Publishing, i d. 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form. ib i te d.
Figures and Tables Table of Contents A Table 1. ll Evaluation of Body Weight . . . . . . . . . . . . . . . . . . .7 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 ri gh Co Figure 1. Algorithm for the administration Nutrition Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 ts py of nutrition support. . . . . . . . . . . . . . . . . . . . . . .8-9 Nutritional Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 re ri Figure 2. Health care organization gh se nutrition consultation request form. . . . . . . . . . . .10 PN Formulation Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 rv t © ed Table 2. Pharmaceutical and Metabolic Medication Compatibility With PN . . . . . . . . . . . . . . . . . . . . . .24 20 .R Equations in PN Therapy . . . . . . . . . . . . . . . . . . . .12 09 Glucose Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33 Table 3. Metabolic Derangements in ep M ro Which PN Should Be Used With Caution . . . . . . . .14 Guideline for Special Diseases . . . . . . . . . . . . . . . . . . . . . . . . .33 cM on Table 4. Macronutrients: du Withholding and Withdrawing PN . . . . . . . . . . . . . . . . . . . . . .39 ah in ct PN Dosing Guidelines . . . . . . . . . . . . . . . . . . .16-17 i on w Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 Figure 3. Consequences of protein Pu ol calorie overfeeding. . . . . . . . . . . . . . . . . . . . . . . .18 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41-44 bl e o is h Table 5. Micronutrients: PN Dosing Other Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45 hi Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . .20-21 ng n p Table 6. FDA Requirements for Labeling r G art i ro Aluminum Content of PN Products . . . . . . . . . . . .22 up wit Table 7. ASPEN Safe Practice un ho Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . .26-29 le ut Figure 4. PN formulation standard ss order format—renal failure. . . . . . . . . . . . . . . . . .30 ot rm Figure 5. PN formulation standard he label format—renal failure. . . . . . . . . . . . . . . . . .31 pe rw sio is Table 8. ASPEN Recommendations on is e PN Standardization . . . . . . . . . . . . . . . . . . . . . . . .32 no s p Table 9. Y-Site Injection Compatibility n t e ro h i d. of I.V. Medications With PN . . . . . . . . . . . . . . .34-38 ib i te d.
Introduction Table 1. Evaluation of Body Weight A alnutrition is associated with more frequent treat- M ll ment complications and longer stays in the intensive ri % of Ideal Body Weight current weight gh Co care unit (ICU) and hospital, as well as increased costs of % of IBW = x 100 IBW ts py medical care. Patients at high risk for malnutrition should re ri be identified and evaluated for specialized nutrition sup- 80% to 90% = mild malnutrition gh se port (SNS).1 70% to 79% = moderate malnutrition rv t 0% to 69% = severe malnutrition © Determining the appropriate route of nutrition support ed 20 for patients at risk for malnutrition is an important consid- .R % of Usual Body Weight 09 eration when one is attempting to positively influence ep current weight M patient outcomes. In patients with a functioning gastroin- ro % of UBW = x 100 cM on usual weight du testinal (GI) tract, enteral nutrition (EN) can improve out- ah in ct comes.1 EN has been shown to improve nutritional status 85% to 95% = mild malnutrition i on w and reduce length of stay in the ICU and is associated with 75% to 84% = moderate malnutrition fewer infectious complications than parenteral nutrition Pu ol 0% to 74% = severe malnutrition (PN).2 The major limitation of EN is the need to gain enter- bl e o is h al (postpyloric) access so that the nutrient infusion is tol- IBW, ideal body weight; UBW, usual body weight hi erated and serious complications, such as aspiration Adapted from references 4 and 8. ng n p pneumonia,are avoided.1 Techniques are available to facil- r G art i ro itate access to the GI tract so that enteral tube feedings up wit may be administered safely. For patients who have a non- functioning GI tract, PN is the available method of nutri- un ho tional support.3 PN is essential for patients who are le ut ss severely malnourished and have GI tract problems that are ot rm not expected to resolve within 7 days.1,4 When PN is con- he sidered, it should be noted that this method is complex pe rw sio and has been associated with a unique set of complica- is tions, some of which can be serious or even life-threaten- is e no s p ing.3 In addition, few published reports can be found that n t e ro h demonstrate a consistently favorable effect of PN on i d. patient outcomes.4 This pocket guide discusses nutritional assessment,nutri- tional requirements, PN formulation design, medication ib i continued on page 11 te d. 6 7
Nutrition assessment A Decision to initiate SNS ll ri • Aggressive attempt to obtain gh Co enteral access ts py • Feedings may be more appropriate re ri gh distal to the pylorus for patients with se Functional GI tract? Yes EN rv t high gastric residuals, critical © ed illness, gastroparesis, or pancreatitis 20 .R 09 ep M ro Inconclusive cM on du ah in ct EN trial Yes EN tolerated? Yes Continue EN i on w Pu ol Aspiration, abdominal bl e o No No is distention, diarrhea, h hi Obstruction, peritonitis, high gastric residuals ng n p paralytic ileus, mesenteric ischemia, r PN only if EN G art short-bowel syndrome, PN i ro contraindicated enterocutaneous up wit fistula, malabsorption un ho le ut Status of Status of ss GI function GI function ot rm he Nonfunctional pe Functional rw sio is is e no s p Continue PN Transition to EN n t e ro h i d. Figure 1. Algorithm for the administration of nutrition support. ib EN, enteral nutrition; GI, gastrointestinal; PN, parenteral nutrition; i SNS, specialized nutrition support te d. 8 9
compatibility with PN, and guidelines for special diseases, A as well as an overview of evidence-based guidelines pub- ll lished by the American Society for Parenteral and Enteral ri gh Co Nutrition (ASPEN).1,3 Also included in the review is a dis- ts py cussion of FDA regulations concerning aluminum re ri contamination of PN,5 United States Pharmacopeia (USP) gh se standards for sterile compounding,6 and recommenda- rv t © tions on the use of insulin in PN.7 ed 20 .R Nutrition Assessment 09 ep M The purpose of nutrition assessment is to identify the ro cM on du degree to which the current or future nutritional status of ah in ct the patient will influence his or her outcome. The current i on w nutritional status of the patient is determined by several factors, including the patient’s weight and how it compares Pu ol bl e o with ideal and usual weights (Table 1,page 7); the duration is h of weight loss if it has occurred; visceral protein status; lab- hi oratory values indicative of fluid, electrolyte, and potential ng n p nutritional deficits; clinical condition; and whether the r G art i ro patient may be nourished by oral, enteral, or parenteral up wit means.1,4,8 During PN, both pharmaceutical and metabolic calculations are used in the assessment of nutrition sup- un ho port. Equations used to assess clinical, nutritional, and le ut ss metabolic status are provided in Table 2 (page 12).4,9-11 Figure 2. Health care organization ot rm nutrition consultation request form. Figure 1 (pages 8-9) is a useful algorithm for determining he the appropriate indications for PN. Clinicians should con- pe rw sio sider PN if a trial of enteral feedings has failed, if the enter- is al route is contraindicated, or if the GI tract has severely is e no s p diminished function because of underlying disease or n t e ro h treatment and GI function is not expected to return within i d. 7 days.1,4 Contraindications to PN include the following: a functional GI tract; an inability to achieve appropriate venous access; an unstable clinical condition; and terminal ib i continued on page 13 te d. 10 11
Table 2. Pharmaceutical and Metabolic Equations disease, critical illness, or metabolic derangement for In PN Therapy A which a favorable response to therapy is not feasible or the ll 1. Predicting Energy Needs risk of complications is too high.4 In these conditions, the ri gh Co Using Harris-Benedict Equationa: metabolic profile is such that exogenous nutrients are ts py For males: poorly used and frequently cause complications that re 66 + 13.75 (wt in kg) + 5 (ht in cm) – 6.8 (age in years) ri require prolonged mechanical ventilation, intensive care, gh se For females: or hospitalization.4 Table 3 (page 14) lists some metabolic rv t 655 + 9.6 (wt in kg) + 1.8 (ht in cm) – 4.7 (age in years) © derangements that necessitate cautious use of PN until the ed 2. Predicting the Degree of Metabolic Stress 20 patient’s condition improves.4 Catabolic index = .R 09 Applying the algorithm using the aforementioned con- ep 24-hour urine urea nitrogen [UUN] (g) – (0.5 dietary nitrogen intake + 3) M cepts in a nutrition consultation form (Figure 2,page 10) can ro Values 0-5 represent moderate stress and >5 represent severe stress. cM on du help improve appropriate use of PN in an institution. Such a 3. Predicting the Degree of Malnutrition ah in ct form also provides documentation for the need for SNS,and, i I. Creatinine height index = on w along with the nutrition assessment, includes a recommen- 24 hr actual creatinine excreted in urine (mg) x 100 dation for route and dose of nutrients to be provided. Pu ol 24 hr expected creatinine excreted in urine of bl e o normal adult of same height Nutritional Requirements is II. Body mass index (kg/m2) = weight (kg) / height (m2) h hi Over the past several years, there has been a continual ng n p 4. Measuring the Success of Nutrition Support refinement of PN, focusing on the delivery of the safest, r G art Nitrogen balance = (protein intake [g]/6.25) – (24-hour urine urea i ro nitrogen [g] + 3-5 g) most effective doses. Guidelines provide a framework for up wit a Stress factors should not be applied. nutrient doses in a variety of disease states.1,3 In general, PN, parenteral nutrition there has been a decline in recommended caloric doses, un ho Based on references 4 and 9-11. a liberalization of protein doses, especially for renal and le ut ss liver failure, and more specific recommendations for fat ot rm doses (Table 4,pages 16-17).1,3,4,12 Two specific purposes for he fat—nonprotein calories and prevention of essential fatty pe rw sio acid deficiency—are listed. Obesity is becoming more is prevalent and needs to be considered in dosing of PN.The is e no s p body mass index is used to classify patients with a value n t e ro h greater than 30 as obese and a value greater than 40 as i d. severely obese.1 Overfeeding of calories and protein can have serious con- sequences in patients receiving PN and has led to the ib i continued on page 15 te d. 12 13
Table 3. Metabolic Derangements in Which specific recommendations provided in Table 4.1,3,4,12 When A PN Should Be Used With Caution maximum doses of macronutrients are exceeded, the con- ll sequences outlined in Figure 3 (page 18) are frequently ri Metabolic Derangement Abnormality To Be Corrected gh Co reported.1,4,13,14 ts py Azotemia Blood urea nitrogen Micronutrients—electrolytes, trace elements, and vita- re ri >100 mg/dL mins—are essential to the incorporation of macro- gh Hyperchloremic se Serum Cl nutrients into the body cell mass. The content of rv t metabolic acidosis >115 mEq/L © micronutrients in the body tends to fluctuate on the basis ed 20 Hyperglycemia Serum glucose of cellular needs and deficits created by periods of low or .R >300 mg/dL 09 no intake or losses, and often occurs in patients with non- Hypernatremia ep Serum sodium M functional GI tracts. Daily monitoring of serum electrolytes ro >150 mEq/L cM on du and periodic (initial and every 2-3 weeks) assessment of Hyperosmolality Serum osmolality ah in ct >350 mOsm/kg vitamin and trace element status is essential for a patient i on w requiring PN. Bariatric (gastric bypass) surgery for morbid Hypochloremic Serum Cl obesity may result in protein calorie malnutrition as well Pu ol metabolic alkalosis <85 mEq/L bl e o Hypokalemia Serum potassium as deficiencies of thiamine, vitamin B12, folic acid, vitamin is h <3 mEq/L E, and calcium due to malabsorption and/or inadequate hi intake caused by complications of the surgery.15 In these ng n p Hypophosphatemia Serum phosphorus <2 mg/dL patients, assessment for vitamin deficiencies should be r G art i ro Based on reference 4. more frequent. Guidelines for dosing of micronutrients in up wit PN are outlined in Table 5 (pages 20-21).3,4,16,17 The presence of aluminum as a contaminant in PN has un ho caused complications in patients at risk.18 Patients at risk are le ut ss those who receive large loads of aluminum on a per-kilo- ot rm gram-of-body-weight basis and/or who have compromised he renal function.4 Aluminum toxicity has been observed in pe rw sio neonates receiving PN and adults with renal compromise is receiving PN for long periods (home PN therapy). Toxicity is e no s p primarily affects the bones and central nervous system n t e ro h (CNS).18 Aluminum interferes with bone formation and min- i d. eralization, causing bone fractures or symptoms of bone pain.19 CNS toxicity has also been observed.18 A dementia similar to the dialysis dementia observed in patients with ib i continued on page 19 te d. 14 15
Table 4. Macronutrients: PN Dosing Guidelines Normal Range Usual Doses Maximum Special Considerations A ll Calories 20-35 kcal/kg/d Obesity: Hypocaloric doses have been used. Measurement of energy ri expenditure is advised. gh Co Critically ill: 25-30 kcal/kg/d. ts py Glucose 70%-85% of 7 g/kg/d; Improved outcomes have been observed in critically ill patients when re ri nonprotein 4-5 mg/kg/min blood glucose has been maintained at <110 mg/dL. gh caloriesse rv t © Fat 15%-30% ed <30% of 2.5 g/kg/d Limited benefit to fat dose >30% nonprotein calories. 20 .R of nonprotein nonprotein When administered separately from PN, infusion should be completed 09 calories calories ep within 12 hours. M Protein 0.8-2 g/kg/d ro 1-1.5 g/kg/d 2 g/kg/d Provided as high biologic value (ie, content high in essential AAs). cM on du Dose should be modified in conditions of renal and hepatic disease to the ah in ct lowest dose needed to achieve positive nitrogen balance. i on w Renal failure Pu ol Chronic RF, no dialysis: 0.6-0.8 g/kg/day. bl e o Chronic RF, hemodialysis, or peritoneal dialysis: 1.2-1.3 g/kg/day. is h RF, continuous hemofiltration: 1 g/kg/day. hi Acute RF: Balanced mixture of essential/nonessential AAs. ng n p Acute RF with severe MN or hypercatabolic state: 1.5-1.8 r G art g/kg/day. i ro Liver failure up wit Protein restriction should be used for acute management of hepatic un ho encephalopathy but not for chronic use. Specialized AA formulations indicated only in chronic encephalopathy le ut ss unresponsive to pharmacotherapy. ot rm Fat (lipids) Prevention of 1%-2% of Contraindicated in patients with pancreatitis induced by hyperlipidemia. he pe essential fatty caloric dose as Withhold doses for triglyceride level >400 mg/dL. rw sio acid deficiency linoleic acid and is 0.5% of caloric is e dose as α- no s p linolenic acid. n t e ro h i d. AA, amino acid; MN, malnutrition; PN, parenteral nutrition; RF, renal failure Based on references 1, 3, 4, and 12. ib i te d. 16 17
Protein end-stage renal disease who received dialysate contami- A • ↑ renal solute load nated with aluminum has been reported.19 • azotemia ll Since aluminum is ubiquitous, it is very difficult, if not ri gh Co • impaired renal function impossible, to remove it from products used in the prepara- ts py • acidosis tion of PN.19 As a result, the FDA proposed a set of regula- re ri Total tions, which went into effect on July 26, 2004, requiring gh se calories manufacturers to label products used in the PN preparation rv t © Liver process with their aluminum content (Table 6, page 22).5,20 Fat ed 20 The purpose is to stimulate the manufacturers of PN prod- .R • fatty infiltration • ↑ serum triglycerides 09 • ↑ aspartate ucts to prepare products with lower aluminum content and • impaired pulmonary function ep aminotransferase M to inform clinicians of the aluminum content of PN prod- ro cM on • altered immunologic function • ↑ alanine du ucts.20 The FDA also sought to establish a maximum safe • hepatobiliary disease aminotransferase ah in ct limit of aluminum loads at 5 mcg/kg body weight per day.5 i • ↑ alkaline on w Although aluminum is present in products other than PN phosphatase (heparin, albumin), these products are not included in the Pu ol • hepatomegaly regulation.20 For PN, salts of calcium and phosphorus have bl e o • cholestasis is h the highest aluminum content.19 hi Dextrose Compared with adults, neonates/pediatric patients ng n p Hyperglycemia require higher doses, on a body weight basis, of calcium r G art i ro • serum glucose >200 mg/dL and phosphorus to ensure both growth and mainte- up wit • hyperinsulinemia nance.18 Neonates also have less ability to renally excrete • impaired phagocytosis and excess aluminum loads.19 ASPEN released a statement un ho neutrophil chemotaxis advising clinicians to identify patients at greatest risk of le ut ss Pulmonary Function developing aluminum toxicity and attempt to minimize • ↑ CO2 production and minute ot rm aluminum intake in these patients.18-20 ventilation he pe • respiratory failure in patients rw sio PN Formulation Design with limited reserve is Formulations of PN are extremely complex products is e • prolonged mechanical no s p ventilation intended for I.V. use. Careful consideration of nutrient dose n t e ro h and avoidance of unstable or incompatible ingredients are i Figure 3. Consequences d. necessary. Inconsistent compounding practices have led to of protein calorie overfeeding. serious harm in patients receiving PN.3 In an effort to provide CO2, carbon dioxide consistent, specific guidelines for PN, the National Advisory Based on references 1, 4, 13, and 14. ib i continued on page 23 te d. 18 19
Table 5. Micronutrients: PN Dosing Guidelines A Normal Daily Requirements Usual Daily Doses Na, K ll 1-2 mEq/kg Individualize, variable. ri gh Co Cl, acetate As needed for acid–base balance Equal amounts as sodium or potassium salt. ts py Electrolytes Phosphorus 20-40 mmol re ri gh Calcium se 10-15 mEq Gluconate salt preferred for PN. Stability limited by concentration rv t of calcium and phosphorus. © ed 20 Magnesium 8-20 mEq .R 09 ep M ro Thiamin (B1) 6 mg Provided by addition of multiple vitamin injection product. cM on du Riboflavin (B2) 3.6 mg FDA mandated reformulation of vitamin products to increase thiamine, folic acid, pyridoxine, and ascorbic acid. ah in Niacin (B3) 40 mg ct i Monitor warfarin carefully during transition to on w Folic acid 600 mcg products with vitamin K. Pu ol Pantothenic acid 15 mg bl e o Vitamins Pyridoxine (B6) 6 mg is h hi Cyanocobalamin (B12) 5 mcg ng n p Biotin 60 mcg r G art Ascorbic acid 200 mg i ro up wit Vitamin A 3,300 IU Vitamin D 200 IU un ho Vitamin E 10 IU le ut ss Vitamin K 150 mcg ot rm Chromium 10-15 mcg Use manganese with caution in patients with an obstructed he Trace Elements biliary tract. pe Copper 0.3-0.5 mg rw sio Accumulation may result in neurologic toxicity. is Manganese 60-100 mcg Zinc requirements increase with high GI output. is e Zinc 2.5-5.0 mg Selenium is indicated for long-term care and critically ill patients. no s p Patients on long-term PN are prone to iron deficiency. Iron status n t e ro h Selenium 20-60 mcg should be assessed initially and every 3 months in these patients. i d. Iron Not routinely added GI, gastrointestinal; PN, parenteral nutrition ib Based on references 3, 4, 16, and 17. i te d. 20 21
Table 6. FDA Requirements Group on Standards and Practice Guidelines for Parenteral For Labeling Aluminum Content A Nutrition published “Safe Practices for Parenteral Nutrition.” ll Of PN Products These guidelines provide recommendations for the PN label ri gh Co and order, as well as PN compounding, compatibility, stabili- Large-volume parenterals Must contain ≤ 25 mcg/L ts py • Concentrated dextrose, amino of aluminum. ty, and administration.3 They call for a standardized PN label re ri acids, parenteral lipids, sterile format to promote correct interpretation of PN contents gh se water for injection, saline, and across all health care environments; describe the pharma- rv t electrolyte solutions © cist’s duty to review the PN formula to ensure it is complete ed 20 and balanced, and will be stable and compatible upon .R 09 Small-volume parenterals and 1. Must be labeled with admixture; and include admixture processes and quality pharmacy bulk packages ep the maximum level of M control requirements that foster safe and accurate com- ro • Electrolyte salts of calcium, aluminum in the product cM on du phosphorus, potassium, at expiration. pounding of PN formulas (Table 7, pages 26-29).3,6 ah in ct magnesium, and sodium 2. If reconstituted, must be In addition, pharmacists should refer to the revised USP i labeled with the maximum on w • Multivitamins General Chapter <797> “Pharmaceutical Compounding— level of aluminum at expiration • Trace elements Sterile Preparations” (official as of June 1, 2008) for poli- Pu ol in the reconstituted form. bl e o 3. Maximum amount of cies and procedures on the handling of sterile is h aluminum may be preparations.6 USP chapter <797> provides mandates for hi determined by any of the compounding of sterile products at 5 levels of risk ng n p the following methods: based on the probability of exposing patients to microbial r • Highest level measured in G art i ro batches over the last 3 years. or physical contaminants, as well as specific requirements up wit • Highest level for the last for environmental quality and control and personnel 5 batches. cleansing and garbing. un ho • Maximum historical level. Using the “Safe Practices” format for a patient with renal le ut ss failure receiving hemodialysis,caloric doses do not need to ot rm Based on reference 5. be modified, but doses of protein, potassium, magnesium, he phosphorus, and acetate require adjustment (see Figure 4 pe rw sio for an example of a standard order form filled out for a is renal failure patient; see Figure 5 for an example of a stan- is e no s p dard PN label for renal failure dosing; pages 30-31). The n t e ro h label format allows for evaluation of nutrient dose based i d. on body weight and literature recommendations.4 Recent interest in standard PN formulations is the result of The Joint Commission National Patient Safety Goal 3b, ib i continued on page 24 te d. 22 23