Nutrition Support in the Home Care Patient Natalie

Nutrition Support in the Home Care Patient Natalie S. Tu, RD, CNSC © 2016 Option Care. All rights reserved. Confidential and proprietary information. 1

Objectives 1. Identify three roles of the home care dietitian 2. Describe two basic criteria needed for Home Enteral Nutrition (HEN) Medicare coverage 3. Describe two basic criteria needed for Home Parenteral Nutrition (HPN) Medicare coverage 4. Identify three considerations when planning a HEN regimen 5. Identify three common complications in the HPN patient © 2016 Option Care. All rights reserved. Confidential and proprietary information. 2

Home Care Dietitian Role Intake Coordination • Review all HPN and HEN referrals for completeness, safety & stability • Coordinate discharge plans • Support reimbursement issues and concerns üObtaining Medicare qualification criteria üAssist providing clinical data for commercial insurance authorization © 2016 Option Care. All rights reserved. Confidential and proprietary information. 3

Home Care Dietitian Role Clinical • Perform nutrition assessments as ordered by prescriber üIn-home visits for new and long-term HPN patients üOngoing care for HPN and HEN patients üProviding patient education prn • Ongoing coordination of clinical care with all team members: MD, RN/home agency, pharmacist • Resource for patients as issues arise © 2016 Option Care. All rights reserved. Confidential and proprietary information. 4

Home Care Dietitian Role Sales & Nutrition Program Management • Joint sales calls with Account Managers: Case Managers/Discharge Planners, MD offices, fairs/seminars • Strategic market planning • Ongoing nutrition support education for staff, external audiences • Quality Improvement activities; Outcomes collection and reporting, CNW © 2016 Option Care. All rights reserved. Confidential and proprietary information. 5

Medicare Enteral Nutrition Coverage

Medicare HEN Coverage Must meet two basic criteria 1. Permanence: Length of Need => 90 days 2. Non-function or disease of the structures that normally permit food to reach the small bowel • • Dysphagia- Neurological, Functional Obstructions, Fistulas Malabsorption Gastroparesis or Dumping Syndrome

Medicare EN Coverage Main Covered Diagnoses Documentation Needed Dysphagia • H&P or Progress Note documenting dysphagia • Copy of swallow study (if not available, need statement why it was not completed) • LON => 90 days Obstruction or Fistula • H&P or Progress Note documenting diagnosis • Test results and/or report confirming diagnosis • LON => 90 days Malabsorption • H&P or Progress Note documenting malabsorption • Test results and/or report confirming diagnosis • LON => 90 days Functional or Structural Issues • H&P or Progress Note documenting condition • Test results and/or report confirming diagnosis • LON => 90 days

Medicare EN Coverage Specialty Formula Documentation Needed Diabetic Formula • • Renal Formula • ESRD stage 5 diagnosis, on HD • Elevated creatinine level • Documentation-standard trial, why cannot be used Peptide or AA Formula • Diagnosis of condition of GI tract which affects digestion/absorption • Documentation-standard trial, why cannot be used Pulmonary Formula • Pulmonary diagnosis (COPD) • Documentation-standard trial, why cannot be used Hepatic Formula • Hepatic failure diagnosis • Elevated liver enzymes/ammonia • Documentation-standard trial, why cannot be used Diagnosis of diabetes Serum blood glucose levels (need at least 3) Medication list Documentation-standard TF trial, or why standard cannot be used

Conditions with No Medicare EN Coverage • • Psychological Disorders End stage disease with anorexia or nausea Failure to thrive Dementia Dehydration Poor appetite Alzheimer’s/memory issues – forgetting to eat Aphasia

What if the Patient Can Eat? Enteral nutrition is warranted if the patient cannot “maintain weight and strength commensurate with overall health status” with oral intake Acceptable: • “for pleasure only” • Sips • Bites • Small amounts • Calorie counts with intake <50% of estimated needs

Additional Documentation is Required Pump-assisted feeding • Failure to tolerate gravity/bolus feedings due to: • • Reflux Aspiration Severe diarrhea Dumping syndrome • Administration rate < 100 cc/hour • Blood glucose fluctuations • Circulatory overload Patient receiving > 2000 kcal or <750 kcal/day More than three NG tubes, or one G/JT every three months

Medicare Home Parenteral Nutrition Coverage

Medicare TPN Coverage “Parenteral nutrition is covered for a patient with permanent severe pathology of the alimentary (GI) tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient’s general condition. ” • The patient must have: A condition involving the small intestine and/or its exocrine glands which significantly impairs the absorption of nutrients OR A disease of the stomach or intestine which is a motility disorder and impairs the ability of nutrients to be transported through the GI system • There must be objective evidence supporting the diagnosis • Meet definition of permanence >=90 days

Criteria A - Massive Small Bowel Resection Recent massive small bowel (sb) resection leaving 5 feet (152 cm) or less of sb beyond the ligament of Treitz Need: • Operative report or other test indicating amount of bowel remaining and resection 3 months prior to PN initiation • H & P/progress notes/Discharge Summary with diagnosis • Documentation of LON >= 90 days • 20 -35 kcal/kg/day

Criteria B - Short Bowel Syndrome Short bowel syndrome where enteral intake >2. 5 -3 L/day, gastrointestinal fluid and electrolyte losses exceed 50% of enteral intake, and urine output is less than 1 liter per day Need: • Operative/Diagnostic Reports • H & P/progress notes/Discharge Summary with diagnosis • Detailed record of Intake/Outputs • Documentation of LON >= 90 days • 20 -35 kcal/kg/day

Criteria C – Bowel Rest Bowel rest required for at least three months for pancreatitis, severe exacerbation of regional enteritis, or fistula where distal TF is not possible Need: Diagnostic tests: Xrays, CT scans, US, Fistulograms Evidence of pancreatitis with lipase/amylase levels Fistula location and outputs H & P/progress notes/Discharge Summary with diagnosis and documented need for NPO • Documentation of LON=>90 days • 20 -35 kcal/kg/day • • © 2016 Option Care. All rights reserved. Confidential and proprietary information. 17

Criteria D – Bowel Obstruction Complete mechanical small bowel obstruction where surgery is not an option Need: • Diagnostic test or operative report confirming obstruction • H & P/progress notes/Discharge Summary with diagnosis, that patient is not surgical candidate & feeding distal to obstruction is not possible • Documentation of LON=>90 days • 20 -35 kcal/kg/day © 2016 Option Care. All rights reserved. Confidential and proprietary information. 18

Criteria E – Severe Malabsorption Significant malnutrition with very severe fat malabsorption as evidenced by a standard 72 -hour fecal fat test Need: • 72 hr. fecal fat study with >50 gms fat enteral intake, and fecal fat exceeding 50% of enteral intake • 10% weight loss over three months, Nutrition Assessment • Serum albumin <3. 4 gm/d. L • H & P/progress notes/Discharge Summary with diagnosis and LON=>90 days • 20 -35 kcal/kg/day © 2016 Option Care. All rights reserved. Confidential and proprietary information. 19

Criteria F – Severe Motility Disturbance Significant malnutrition with severe motility disturbance of the small intestine and/or stomach which is unresponsive to prokinetic medication Need: • • • Small bowel motility study/Scintigraphic or Radiographic report H & P/progress notes/Discharge Summary with diagnosis 10% weight loss over three months, Nutrition Assessment Serum albumin <3. 4 gm/d. L Documentation of LON=>90 days 20 -35 kcal/kg/day © 2016 Option Care. All rights reserved. Confidential and proprietary information. 20

Criteria G/H – Other Qualifying Conditions & Failed Tube Trial Significant malnutrition with clinical condition unresponsive to altering the manner of delivery of nutrients: Unable to maintain weight despite modifying enteral diet’s nutrient composition & utilizing pharmacologic means to treat the etiology of the malabsorption Need: • • • H & P/progress notes/Discharge Summary with qualifying diagnosis Diagnostic tests/Operative report/Nutrition Assessment Medication records 10% weight loss over three months, Serum albumin <3. 4 gm/d. L Documentation of LON=>90 days 20 -35 kcal/kg/day © 2016 Option Care. All rights reserved. Confidential and proprietary information. 21

Criteria G/H – Other Qualifying Conditions & Failed Tube Trial Need: • Documentation of Failed TF Trial, or why trial not medically feasible • Documentation reflecting diet or TF adjustments to enhance tolerance © 2016 Option Care. All rights reserved. Confidential and proprietary information. 22

Criteria G/H – Other Qualifying Conditions & Failed Tube Trial AND…. Need one of the following Qualifying Conditions: • Moderate fat malabsorption • Small bowel motility disturbance unresponsive to prokinetic medications • > 5 feet sb remaining beyond the ligament of Treitz • Short bowel syndrome with GI losses <50% • Mild or moderate exacerbation of regional enteritis • Partial sb obstruction where surgery is not an option © 2016 Option Care. All rights reserved. Confidential and proprietary information. 23

Conditions with No Medicare HPN Coverage • • Swallowing disorders Temporary defects in gastric emptying Psychiatric disorders impairing food intake Metabolic disorders inducing anorexia, such as cancer Physical disorders impairing food intake, such as dyspnea Renal failure and/or dialysis (IDPN) Side effects of medication © 2016 Option Care. All rights reserved. Confidential and proprietary information. 24

When Additional Documentation is Required • • • Caloric intake <20 or >35 kcals/kg/day Protein intake <0. 8 or >1. 5 gms/kg/day Dextrose concentration <10% Lipids>150 units/month (1 unit=10 gms) – 1, 500 gms/month HPN infusion <7 days/week Need for special nutrients © 2016 Option Care. All rights reserved. Confidential and proprietary information. 25

Case Study #1 67 yo Female with PMH colon cancer, s/p chemo, pancreatic insufficiency (on Creon), depression, now diagnosed with tongue cancer presenting with anorexia & odynophagia Ht: 62 in/157. 5 cm; Wt: 97 lbs. /44. 1 kg Usual BW: 120 lbs. /54. 5 kg last weighed 2 ½ months ago 81% UBW = 19% wt loss Albumin drawn last week=2. 9 gm/d. L Would this patient qualify for HPN under Medicare? What type of nutrition support is most appropriate for her? © 2016 Option Care. All rights reserved. Confidential and proprietary information. 26

Case Study #2 68 yo Male with PMH adenocarcinoma s/p jejunal resection, c/w ECF with drain, >1 L output/day. Surgeon wants NPO and HPN for 2 -4 months to heal fistula; pt too malnourished to undergo another surgery Ht: 72 in/183 cm; Wt: 173 lbs. /78. 6 kg; 30 lb. wt loss since prior to diagnosis 4 months ago. Last Albumin=2. 0 gm/d. L Would this patient qualify for HPN under Medicare? © 2016 Option Care. All rights reserved. Confidential and proprietary information. 27

Home Enteral Nutrition

Clinical Indications for HEN • Mechanical GI tract dysfunction • Motility disorders • Malabsorptive syndromes (IBD, SBS, Pancreatitis) • Malignancies of the head & neck, digestive system • Neurologic conditions (CHI, CVA, ALS) • Hyperemesis gravidarum • Failure to Thrive • Inborn Errors of Metabolism © 2016 Option Care. All rights reserved. Confidential and proprietary information. 29

Candidates for Home Nutrition Support • • • Safe home environment Patient and/or caregiver physically able Clinically and medical stable Appropriate feeding access Reimbursement available © 2016 Option Care. All rights reserved. Confidential and proprietary information. 30

Reimbursement for HEN & HPN 1. 2. 3. 4. • • Medicare Medicaid – varies by state and policy Self-Pay Private or Commercial Coverage of formula, supplies varies by employer contract May need a pre-authorization Required documents may vary Many use Medicare qualification criteria © 2016 Option Care. All rights reserved. Confidential and proprietary information. 31

Developing the HEN & HPN Plan -Team Approach is best practice • Involves MD, RN, Pharmacist, Case Manager, Social Worker, Patient and Caregiver -Explain risks & benefits -Assess patient and caregiver’s ability to perform home nutrition support therapyrelated tasks © 2016 Option Care. All rights reserved. Confidential and proprietary information. 32

Routes of Administration Determined by: • Expected length of therapy, long term if >6 weeks • Risk of pulmonary aspiration • Anatomical issues ie obstructions, fistulas • Feeding tolerance history • Diagnosis © 2016 Option Care. All rights reserved. Confidential and proprietary information. 33

Routes of Administration Gastric Feedings: nasogastric (NG), gastrostomy tube (surgically-placed GT or endoscopically placed=PEG) • Bolus/syringe, gravity or pump • GT buttons – low profile/skin level, extension set Jejunal Feedings: nasojejunal (not often seen in home care), Jejunostomy tube (surgically placed JT or endoscopically placed PEG/J), G/JT buttons • Pump or gravity only © 2016 Option Care. All rights reserved. Confidential and proprietary information. 34

Methods of Administration Bolus/Syringe: inexpensive, no electricity, not tied to pump, easiest instruction, portable, inexact delivery, fastest (<1/2 hr. ), increased risk for vomiting/aspiration Gravity Bag: inexpensive, no electricity, use bedside pole or hook, easy instruction, portable, inexact delivery, given over mins. (15 -45 mins. ) Pump: expensive, electricity needed, tied to pump (backpack), most education required, reduced labor (set up and go), exact delivery, reduced risk of gi intolerance & aspiration. Continuous, cyclic, intermittent © 2016 Option Care. All rights reserved. Confidential and proprietary information. 35

Formula Selection Polymeric: available in 1. 0, 1. 2, 1. 5, 2. 0 kcal/cc, Higher Fiber, High Protein, Prebiotics (support beneficial bacteria, enhances fluid/electrolyte absorption) Blenderized: Compleat, Liquid Hope/Nourish, Real Food Blends, Kate Farms Issues: • Increased cost • Insurance coverage • Pump issues – viscosity, Infinity only? , Dilution needed? • Decreased hang time 4 hrs vs. 8 hrs. open system © 2016 Option Care. All rights reserved. Confidential and proprietary information. 36

Formula Selection Diabetic/Glucose Intolerance – higher fat/lower carb/with fiber • • First minimize overfeeding with polymeric/standard Maximize medications Consider diabetic formula if above fails Glucerna, Diabetisource AC Malabsorption – hydrolyzed proteins to peptides, AA • No routine use in malabsorption, diarrhea intolerance • First examine medications, clinical state, infusion rate/method © 2016 Option Care. All rights reserved. Confidential and proprietary information. 37

Formula Selection Immune Modulating – omega 3’s/arginine/nucleotides (Impact), omega 3’s/arginine/glutamine (Pivot) • surgical, trauma, critical care; head & neck cancer • Impact rarely used in home care; Pivot occasionally Pulmonary Failure– 55% kcals fat (PUFA, MCT) • COPD, respiratory failure/vent, cystic fibrosis • Rarely used in home care • Nutren Pulmonary, Pulmocare © 2016 Option Care. All rights reserved. Confidential and proprietary information. 38

Formula Selection Hepatic Failure – high BCAA: aromatic aa • No evidence to support its use • Nutrihep • Never used in home care Renal Failure – fluid restricted, protein/electrolytes/vits/minerals optimized • Designed for dialysis, acute or chronic RF • Nepro, Novasource Renal • Seen in home care most often in dialysis patients © 2016 Option Care. All rights reserved. Confidential and proprietary information. 39

Developing the HEN Plan © 2016 Option Care. All rights reserved. Confidential and proprietary information. 40

Developing the HEN Plan • Establish feeding access • Define short & long-term goals • Identify best formula • Keep TF regimen simple • Round to nearest ½ can if possible • Minimize modulars/powders • Include realistic water flushes/total additional water needs • Begin planning ASAP for discharge • Check into insurance coverage • Identify who will write HEN orders © 2016 Option Care. All rights reserved. Confidential and proprietary information. 41

HEN Administration Method • Consider pt’s lifestyle & activities/schedules • Choose lowest tech method of administration • Trial gravity drip or bolus syringe for gastric feeds • Trial cycling for jejunostomy feedings • Ambulatory pump/backpack if unable to cycle, active lifestyle © 2016 Option Care. All rights reserved. Confidential and proprietary information. 42

Creating HEN Order • Components: Formula, MOA, Access Route, water • Flushes: amount before/after feeds, can give every 1 -8 hrs. Provide total additional water goal (po/tube) • Give progression if needed • No residual checks used in home care, only s/s gi tolerance • If at risk for Refeeding Syndrome, get lab draw orders arranged © 2016 Option Care. All rights reserved. Confidential and proprietary information. 43

Refeeding Syndrome: Seen in EN & PN Aggressive PN (especially dextrose) § stimulates insulin release § intracellular shift of electrolytes and minerals § potential for severe hypophosphatemia, hypomagnesemia and hypokalemia Physical symptoms: § fatigue, lethargy, muscle weakness, edema, cardiac arrhythmia, respiratory and cardiac failure, aspiration and death © 2016 Option Care. All rights reserved. Confidential and proprietary information. 44

Identifying Refeeding Syndrome Risk www. nice. org. uk/guidance/cg 32/evidence/fullguideline-194889853; accessed 3/25/16. © 2016 Option Care. All rights reserved. Confidential and proprietary information. 45

Preventing Refeeding Syndrome Correct electrolytes prior to any dextrose administration Take several days to increase to goal, while closely monitoring labs (K, Mg, Phos), I/O’s and weight “Safe Start” • ~25 -50% estimated needs on Day 1 • Dextrose 100 -150 g/day or <2 mg/kg/min • Protein: < 1. 5 gm/kg/day • Additional Thiamine (100 mg) • Advance PN formula only if electrolytes and clinical status stable, over 3 -5 days • Fluids: ~1000 ml/day © 2016 Option Care. All rights reserved. Confidential and proprietary information. 46

HEN Monitoring • Weight • Hydration • Tolerance: nausea, vomiting, diarrhea, constipation, cramping, reflux, abd distention • Osmolality, caloric density, MOA, tube placement, absorptive capacity • Labs as indicated (Refeeding Syndrome, fingerstick Glucose) • Access device function & site care • Achievement of goals – short and long-term • Readiness to transition to oral © 2016 Option Care. All rights reserved. Confidential and proprietary information. 47

HEN Complications üMechanical: tube position, clogging, accidental removal ü ü Causes - Inadequate/improper flush, med/nutrient interaction Intervention – use only warm tap water, give meds separately & flush afterward, declog with pancreatic enzymes üOverfeeding/Underfeeding/Non-compliance üFormula Contamination: clean can top, change bag every 24 hrs, wash syringes, hang time (4 hrs. reconstituted or diluted; 8 -12 hrs. ready to use) © 2016 Option Care. All rights reserved. Confidential and proprietary information. 48

HEN Complications üMetabolic üDehydration – thirst, skin turgor, UOP changes, BMP üHyperglycemia – monitor Glucose üRefeeding Syndrome – BMP, Mg, Phos, & monitor hydration üGastrointestinal üNausea/emesis – meds, illness, too rapid MOA, caloric density, reflux/GERD, constipation üDiarrhea – meds/antibiotics, illness, too rapid MOA, caloric density üConstipation – check water intake, med changes, add/remove fiber üAspiration – keep HOB>30 -45 degrees üVitamin/Mineral Deficiencies © 2016 Option Care. All rights reserved. Confidential and proprietary information. 49

Patient/Caregiver Education • Goal: Enable independence, provide safe/effective home therapy • Start teaching inpatient, continue on discharge • Teach with supplies & equipment needed at home • Provide written reference material • Have patient demonstrate competency © 2016 Option Care. All rights reserved. Confidential and proprietary information. 50

HEN Teaching Checklist • Explains rationale for HEN, therapy goals • States tube type • States site & tube care • Describes clean technique • States feeding schedule • Demonstrates administration of water and feeding © 2016 Option Care. All rights reserved. Confidential and proprietary information. 51

HEN Teaching Checklist • States/demonstrates medication administration • States technique for self monitoring and identify potential complications: üWeight, measure I/O if needed, temperature, Glucose levels • States proper formula storage • States whom to contact with questions or in emergency © 2016 Option Care. All rights reserved. Confidential and proprietary information. 52

HEN Case Study 66 yr old Female s/p CVA with Dysphagia, s/p aspiration pneumonia, pleasure feeds only. PMH: DM, osteoarthritis, hyperlipidemia. Had PEG placed yesterday, RD consulted for HEN regimen, daughter caregiver. Meds: Metformin, Motrin, Simvastatin, Doxycycline Ht: 65 in. /165. 1 cm. Wt: 145 lbs. /65. 9 kg. Usual BW: 148 lbs. Est Needs: 1650 kcals (25 kcals/kg); 66 -79 gms pro (1 -1. 2 gms/kg); 1650 cc water (1 cc/kg) TF Regimen Goal: 6 c/day Jevity 1. 2 @ 2 c. tid via bolus/syringe via GT with 60 cc water flush before, 120 cc after each feed, 60 cc flush after meds. Provides: 1710 kcals, 79 gms pro, 1685 cc water © 2016 Option Care. All rights reserved. Confidential and proprietary information. 53

HEN Case Study TF Progression: Start with 3 c/day given 1 c. tid via bolus/syringe, increase day 2 to 1 ½ c. tid, Day 3 increase to Goal 2 c. tid with flushes as per goal. Pt tolerating TF without nausea, vomiting, stools becoming more frequent/liquid 1 -3 x/day. Daughter & pt given feeding demonstration at hospital. Gluc ranging 130 -160 mg/d. L Discharged to home: Pt received delivery and RN visit with teaching completed. One week later home care staff receives call that pt having frequent diarrhea and asks for TF formula change. Home care RD consulted, learns that antibiotic therapy just completed. Confirms pt is receiving adequate water flushes, suggests yogurt orally. Daughter/RD makes MD aware of diarrhea, MD orders stool culture for C Diff, which comes back negative. MD orders Lomotil. Two weeks later f/u reveals pt back to 1 -2 liquidy BMs/day while on Jevity 1. 2. © 2016 Option Care. All rights reserved. Confidential and proprietary information. 54

Home Parenteral Nutrition

HPN Indications § GI tract not functioning § GI tract cannot be accessed § Whose nutritional needs cannot be met with enteral alone • When need for PN is > 2 weeks and hospitalization no longer required • Covered by insurance • In 2002 - estimated 39, 000 people in US on HPN • Average Treatment Length – 108 days © 2016 Option Care. All rights reserved. Confidential and proprietary information. 56

HPN Indications Dysfunctional GI tract § § § § SBO Paralytic ileus High Output Fistula (>200 ml) Malabsorption Syndromes üShort Bowel Syndrome üRadiation Enteritis üCrohn’s colitis requiring bowel rest Mesenteric ischemia Intractable vomiting Intractable/high volume diarrhea Uncontrolled anastomotic leak © 2016 Option Care. All rights reserved. Confidential and proprietary information. 57

HPN Contraindications • Need is <7 -14 days without evidence of severe malnutrition • Functioning GI tract • Comfort measures only • Terminal illness/End stage of life • Insufficient PO intake © 2016 Option Care. All rights reserved. Confidential and proprietary information. 58

Venous Access Devices © 2016 Option Care. All rights reserved. Confidential and proprietary information. 59

PN Components © 2016 Option Care. All rights reserved. Confidential and proprietary information. 60

PN Components: AA • Crystalline amino acids • Structural component for cells/tissues • 4 kcal/gm • 15 -20% of total calories • Estimated needs: 0. 8 -2. 5 gm/kg • Essential/ Nonessential AA © 2016 Option Care. All rights reserved. Confidential and proprietary information. 61

PN Components: Lipids • Concentrated, isotonic source of energy • Aids in glycemic control • Linoleic and linolenic acids cannot be synthesized in body (essential FA) • Prevention of EFAD; providing 4 -8% total kcal as fat © 2016 Option Care. All rights reserved. Confidential and proprietary information. 62

PN Components: Lipids • LCT: soybean/safflower oil • IVFE 10%: 11 kcal/gm, 1. 1 kcal/ml • IVFE 20% (2 kcal/ml), 30% (3 kcal/ml): 10 kcal/gm • SMOF 20%: Soybean/MCT/Olive oil/Fish oil • 12 hour hang time CDC recommendation (2 -in-1) • 24 hour hang time (3 -in-1) • Should not exceed 0. 11 g/kg/hr • Max: 30% total kcal or no more than 1 gm/kg (critical care), <2. 5 gm/kg/day other • Egg allergy-lecithin content* • Fish allergy-SMOF* *test dose: 1 ml/minute x 30 mins © 2016 Option Care. All rights reserved. Confidential and proprietary information. 63

PN Components: Lipids Why not use Soybean-based oils? §Omega 6 Fatty Acids=pro-inflammatory §Phytosterols impair bile drainage §Direct effect of lipids on hepatocytes Why use Fish-based oil emulsions? §Omega 3 Fatty Acids=reductions in phytosterols and pro-inflammatory mediators © 2016 Option Care. All rights reserved. Confidential and proprietary information. 64

PN Components: Lipids © 2016 Option Care. All rights reserved. Confidential and proprietary information. 65

PN Components: Alternative Lipids FDA approved in the US: Clinolipid-not yet available § Olive Oil (Immunoneutral) + Soy Oil (Baxter) Omegaven Fish Oil (Only available in the U. S. for compassionate use and research for patients with PNALD) § Requires special FDA and institutional approval © 2016 Option Care. All rights reserved. Confidential and proprietary information. 66

PN Components: Dextrose • Primary energy source • Protein sparing/reduces N 2 excretion • Minimum for neurological function = 130 g/d • 3. 4 kcal/gm • Dextrose based PN with little or no fat implicated in steatosis • Excess CHO - deposit in liver-steatosis • Maximum glucose infusion for hospital patient= <5 mg/kg/min • Stable hospitalized or home may tolerate >5 mg/kg/min © 2016 Option Care. All rights reserved. Confidential and proprietary information. 67

PN Components: Fluids • Needs constantly changing • ~1 to 1. 5 L to support urine output • ~500 -1000 ml for insensible losses • Replace emesis, ostomy, drain output • Fever • Consider status of CHF, ARF/CRF • Consider other sources: IVF, oral, tube feeding • 30 -40 ml/kg © 2016 Option Care. All rights reserved. Confidential and proprietary information. 68

Daily Adult Electrolyte Requirements © 2016 Option Care. All rights reserved. Confidential and proprietary information. 69

PN Component: Vitamins Available commercial products 12 or 13 • Vitamin K or without Current available MVIs • MVI 12 (Hospira) • Infuvite adult (Baxter) • Cernevit-12 (Baxter) Thiamine 100 mg/day should be added • During PN MVI shortages • Refeeding Syndrome • ETOH abuse has been established © 2016 Option Care. All rights reserved. Confidential and proprietary information. 70

PN Component: Vitamins © 2016 Option Care. All rights reserved. Confidential and proprietary information. 71

PN Component: Trace Elements © 2016 Option Care. All rights reserved. Confidential and proprietary information. 72

PN Component: Trace Elements Excreted via Urine • Chromium • Selenium • Zinc (also via skin & intestine) • Copper (20%) Excreted via biliary tract • Copper (80%) • Manganese ü Consider holding/decreasing Copper and Manganese when Bilirubin elevated after checking levels, then monitor levels © 2016 Option Care. All rights reserved. Confidential and proprietary information. 73

PN Component: Trace Elements All Contaminants: • Zinc, copper, manganese, chromium, selenium and aluminum Manganese • At risk population – long-term PN patients • May lead to manganese deposition in the basal ganglia and neurological symptoms Aluminum • At risk population – long-term PN patients and neonate/pediatric patients on PN > 10 days • Safe limit is 5 mcg/kg/day • Products of most concern are calcium and phosphate salts © 2016 Option Care. All rights reserved. Confidential and proprietary information. 74

PN Compatible Medications Insulin –Regular human insulin only Octreotide § 300 mcg/d H 2 Blockers § Famotidine 40 mg/d § Cimetidine 1200 mg/d § Ranitidine 150 mg/d Heparin § 1 unit/ml Corticosteroids © 2016 Option Care. All rights reserved. Confidential and proprietary information. 75

TNA Stability Component Acceptable Range Lipid 20 -60 g/L Dextrose 40 -250 g/L Amino Acid 20 -60 g/L Divalent cations (Ca m. Eq+Mg m. Eq) < 20 m. Eq/L Ca m. Eq/L* m. Eq phosphates/L © 2016 Option Care. All rights reserved. Confidential and proprietary information. <200 76

Glucose Control Issues Hyperglycemia § Start with 0. 05 -0. 1 units insulin/gm of dextrose in PN or 0. 150. 2 units insulin/gm of dextrose § Add ½ or 2/3 of total amount of sliding scale insulin needed over previous 24 hours to next day’s PN § Check BS on PN, not during taper up or down § Glycemic Goal: 140 -180 mg/d. L Hypoglycemia § Can occur from abrupt d/c of PN or excessive insulin § Avoid by running D 10 or 25 -50 ml D 50 -inpatient § Avoid by tapering rate down by 1 or 2 hours § Check BS 30 -45 mins after PN disconnected, monitor for s/s © 2016 Option Care. All rights reserved. Confidential and proprietary information. 77

HPN Monitoring Lab Draws • CMP, Mg, Phos, Trigs, CBC after 1 st bag infused if home start, after changes to assess tolerance/needs • Usually done weekly until stable, then transition to every 2 weeks or monthly Nutrition Assessments • Before home starts, after lab draws to assess tolerance/needs • Involve patient, caregiver, RN, Pharmacist, MD • Assessments should include weight changes, hydration status, gi symptoms, all intakes/outputs, med changes, labs, compliance • Micronutrient draws: Vitamin D, Zinc, Manganese, as per physical assessment, intake history findings. Long-term draw every 6 -12 months or prn © 2016 Option Care. All rights reserved. Confidential and proprietary information. 78

Essential Fatty Acid Deficiency EFAD § Determined by triene: tetraene ratio § Check annually or if deficiency suspected § Can occur 1 -3 weeks of lipid-free PN § 1 -2% daily energy from linoleic acid and 0. 3% from linolenic acid § 500 ml 10% IVFE or 250 ml 20% IVFE twice/week or 500 ml 20% IVFE once/week § Topical EFA application © 2016 Option Care. All rights reserved. Confidential and proprietary information. 79

© 2016 Option Care. All rights reserved. Confidential and proprietary information. 80

Hypertriglyceridemia • Goal =<400 mg/d. L; < 500 mg/d. L for liver-failure patients (non-fasting) • Hold lipids when labs exceed these levels • Can occur with overfeeding of dextrose • IVFE should be <30% total kcal or < 1 gm/kg/day (may prevent PNALD) • May impair immune response, alter pulmonary hemodynamics or increase risk for pancreatitis © 2016 Option Care. All rights reserved. Confidential and proprietary information. 81

Preventing Refeeding Syndrome Correct electrolytes prior to any dextrose administration Take several days to increase to goal, while closely monitoring labs (K, Mg, Phos), I/O’s and weight “Safe Start” • ~25 -50% estimated needs on Day 1 • Dextrose 100 -150 g/day or <2 mg/kg/min • Protein: < 1. 5 gm/kg/day • Additional Thiamine (100 mg) • Advance PN formula only if electrolytes and clinical status stable, over 3 -5 days • Fluids: ~1000 ml/day © 2016 Option Care. All rights reserved. Confidential and proprietary information. 82

Hepatobiliary Complications PN-associated Cholestasis § Impaired bile secretion or frank biliary obstruction (pediatrics) § Elevated Alk Phos, GGT, Direct Bili >2 mg/d. L with or without Jaundice; ~ 3 weeks on PN Gallbladder Stasis § Results in sludge or gallstones § Lack of EN stimulation and decreased CCK release § Impaired bile flow and GB contractility Steatosis (hepatic fat accumulation) § Predominant in adults § Elevated AST after~ 2 weeks of PN § May be due to overfeeding § Avoid “fat free” PN © 2016 Option Care. All rights reserved. Confidential and proprietary information. 83

Hepatobiliary Complications Strategies to manage PN-associated complications § Avoid overfeeding § Decrease dextrose to < 7 gm/kg/day § Decrease IVFE to <1 gm/kg/day, give only 3 -5 days/week § Cycle PN (8 -12 hrs) may reduce serum LFTs and bilirubin § Reduce by 2 hrs/day (BS abnormalities, fluid issues) or 4 hrs/day § Encourage PO and/or TF, even if small amounts or slow rate § Hold/decrease Manganese and Copper when Direct Bili >2 mg/d. L after checking levels, then monitor levels © 2016 Option Care. All rights reserved. Confidential and proprietary information. 84

Metabolic Bone Disease-Causes Limited Ca in TNA due to incompatibility with phosphorus Higher urinary Ca losses with: § Higher Ca in PN § Inadequate phosphorus in PN § Higher protein in PN – limit to 1 gm/kg/day if stable Chronic metabolic acidosis associated with hypercalciuria and MBD Vitamin D § Deficiency and toxicity result in bone disease § Excess Vitamin D suppresses PTH and promotes bone resorption © 2016 Option Care. All rights reserved. Confidential and proprietary information. 85

Metabolic Bone Disease-Causes Aluminum Toxicity Magnesium Deficiency § Results in hypophosphatemia due to increased phosphorus excretion § Due to diuretics Copper Deficiency © 2016 Option Care. All rights reserved. Confidential and proprietary information. 86

HPN Case Study • GU is a 58 yo F with Crohn’s Disease referred by MD to start PN at home • 30 lbs. weight loss d/t diarrhea 4 -5 x/day x 3 months • Ht: 5’ 2” Wt: 36. 4 kg (80 lbs. ) IBW: 49. 6 kg Usual Wt: 49. 6 kg (110 lbs. ) • Initial Labs: K=2. 7* (sent to ER for K-rider, redraw 3. 7); Mg=1. 2*, Phos=2. 1* • PN initiated with higher electrolyte levels on 2/15, labs drawn 2/18: K=2. 3*, Mg=1. 0*, Phos=2. 7, sent to ER 2/19 for K & Mg riders, redraw K=3. 6, Mg=1. 7 (low). Weight increased to 93 lbs. (up 13 lbs. ) *=critically low lab value © 2016 Option Care. All rights reserved. Confidential and proprietary information. 87

HPN Case Study • PN dispensed on 2/20 with higher amounts of K and Mg • Blood draw 2/23 K=4. 1, then on 2/28 K=5. 8, Phos=3. 0, Mg=1. 9. Weight up to 98 lbs. (total gain 18 lbs. ) with fluid retention • Weight on 3/1=87 lbs. (down 11 lbs. ) © 2016 Option Care. All rights reserved. Confidential and proprietary information. 88

HPN Case Study Did this patient exhibit Refeeding Syndrome? What went wrong? How could she have avoided another ER visit? © 2016 Option Care. All rights reserved. Confidential and proprietary information. 89

HPN Case Study - Answers • Yes, she exhibited Refeeding Syndrome • Oral meds included Lasix, K-dur, Pepcid and Lomotil • Never give dextrose unless you have documented normal levels of K, Mg and Phos • Always redraw electrolytes after supplementation, with the goal of normalizing them prior to giving dextrose • Ideally, draw labs on Day 2, after first full bag of PN infused © 2016 Option Care. All rights reserved. Confidential and proprietary information. 90

Conclusions • Knowledge of therapy complexity • Providing HEN and HPN requires a multidisciplinary approach • Communication is key • Patient safety depends on clinicians knowledge base • Dietitian is an indispensible team asset © 2016 Option Care. All rights reserved. Confidential and proprietary information. 91

References 1. 2. 3. 4. 5. 6. 7. 8. Brantley SL, Mills, ME. Overview of enteral nutrition. IN: Mueller CM, ed. , The ASPEN Adult Nutrition Support Core Curriculum, 2 nd ed. , Silver Spring MD ASPEN 2013: 170 -184 Medicare Parenteral Nutrition Determination. Centers for Medicare and Medicaid Services website. https: //www. cms. gov/medicare-coverage-database/indexes/lcd-alphabeticalindex. aspx? Doc. Type=Active&bc=Ag. IAAAAAA%3 d%3 d&. Accessed August 15, 2016 Cresci G, et al. Enteral Formulations. Bankhead RR, Fang JC. Enteral Access Devices. IN: Mueller CM, ed. , The ASPEN Adult Nutrition Support Core Curriculum, 2 nd ed. , Silver Spring MD APEN 2013 Malone AM, et al. Complications of Enteral Nutrition. IN: Mueller CM, ed. , The ASPEN Adult Nutrition Support Core Curriculum, 2 nd ed. , Silver Spring MD ASPEN 2013 Bankhead R, et al. Enteral Nutrition Practice Recommendations. JPEN. 2009; 33: 122 -167 www. nice. org. uk/guidance/cg 32/evidence/full-guideline-194889853; accessed 3/25/16 Winkler M, Hagan E, Albina J. Home Nutrition Support. IN: Mueller CM, ed. , The ASPEN Adult Nutrition Support Core Curriculum, 2 nd ed. , Silver Spring MD ASPEN 2013: 639 -655 Krzywda E, et al. Parenteral Access Devices. IN: Gottschlich MM, ed. , The ASPEN Nutrition Support Core Curriculum. American Society for Parenteral and Enteral Nutrition 2007 © 2016 Option Care. All rights reserved. Confidential and proprietary information. 92

References 9. Kumpf VJ, et al. Complications of Parenteral Nutrition. IN: Gottschlich MM, ed. , The ASPEN Nutrition Support Core Curriculum. American Society for Parenteral and Enteral Nutrition 2007 10. Mirtallo J, et al; Task Force for the Revision of Safe Practices for Parenteral Nutrition. Safe practices for parenteral nutrition. J Parenter Enteral Nutr. 2004; 28(suppl): 39 SA-70 SA. Erratum 2006; 30: 177 11. Driscoll D. Lipid Injectable Emulsions. 2006 NCP 21: 381 -386 © 2016 Option Care. All rights reserved. Confidential and proprietary information. 93