THE AUTHOR OF THIS WHAT S NEW IN NUTRITION? OBJECTIVES & OUTLINE EVIDENCE-BASED MEDICINE: PARENTERAL NUTRITION (PN)

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1 WHAT S NEW IN NUTRITION? Alisha Mutch, Pharm.D., BCPS THE AUTHOR OF THIS PRESENTATION HAS NOTHING TO DISCLOSE. OBJECTIVES & OUTLINE MALNUTRITION OBJECTIVES Indicate when parenteral nutrition (PN) is warranted Identify changes in PN management related to drug shortages OUTLINE Review malnutrition in critical care Review evidence for PN indication and timing Discuss drug shortages impacting PN Involuntary weight loss or gain 10% within 6 months 5% within 1 month OR Body weight over or under 20% of IBW AND Inadequate nutrition intake Ziegler TR. NEJM. 2009;361: MALNUTRITION Risk Factors Decreased food intake at onset illness NPO for diagnostic procedures Abnormal nutrient loss Skeletal muscle wasting Increased energy expenditure Consequences of Malnutrition Increased morbidity/ mortality Delayed wound healing Increased length of stay (LOS) Increased risk of rehospitalization Higher costs EVIDENCE-BASED MEDICINE: PARENTERAL NUTRITION (PN) VERSUS ENTERAL NUTRITION (EN) Ziegler TR. NEJM. 2009;361:

2 ENTERAL NUTRITION PARENTERAL NUTRITION Benefits of EN Disadvantages of EN Study Reduced cost Better maintenance of gut integrity Reduced infection rates Decreased hospital LOS Aspiration Pneumonia High gastric residuals Diarrhea Bacterial colonization of the stomach Ischemic bowel Purpose Inclusion Exclusion Outcomes measured Examine TPN complications and mortality rates in critically ill patients RCT comparing TPN to standard of care Critically ill or surgical patients Comparisons of PN with EN Pediatrics Mortality, complications, LOS Overall number 26 RCT with 2211 patients Martindale RG, et al. Crit Care Med. 2009;37(5): Ziegler TR. NEJM. 2009;361: Heyland DK, MacDonald S, Keefe L, Drover JW. JAMA, 1998;280(23): PARENTERAL NUTRITION No difference in mortality RR 1.03, 95% CI A priori subgroup analysis Higher mortality in critical care patients No treatment effect on surgical patients Trend towards lower complication rates RR 0.84, 95% CI A priori subgroup analysis Critical care patients: trend toward higher complication rates Surgery patient: lower complication rates Malnourished patient had lower complication rates ENTERAL VERSUS PARENTERAL NUTRITION EN is associated with fewer infectious complications (IC) and should be the chosen route for nutritional support. Significant reduction in IC with EN compared to PN OR 0.64, 95% CI , p = No significant difference in mortality OR 1.08, 95% CI , p = 0.70 Heyland DK, MacDonald S, Keefe L, Drover JW. JAMA, 1998;280(23): Gramligh L, et al. Nutrition 2004;20: PARENTERAL NUTRITION PARENTERAL NUTRITION Purpose Inclusion Exclusion Outcomes measured Overall population Study Details EN versus PN outcomes using component approach RCT with outcome measurements Critical care patients Compare primary feeding interventions English language Studies through 2003 Excessive loss to follow-up Immune-enhance nutrition A meaningful outcome 9 trials with 559 patients Mortality benefit with PN OR = 0.51, 95% CI , p = 0.04 Dependant upon time of initiation Infectious complications increased OR = 1.66, 95% CI , p = Simpson F, Doig GF. Intensive Care Med 2005;31: Simpson F, Doig GF. Intensive Care Med 2005;31:

3 LIMITATIONS WHAT ARE WE TO DO? Limited quantity Heterogeneity Controversial Low quality studies Small populations GUIDELINES GUIDELINES American Society for Parenteral and Enteral Nutrition (ASPEN) ASPEN ESPEN CANADIAN European Society for Clinical Nutrition and Metabolism (ESPEN) Canadian Clinical Practice Guidelines EN not feasible or inadequate Major surgical procedure planned and EN not feasible Full oral diet not expected Intolerant or insufficient EN EN preferred Unable to specify Singer P, et al. Clinical Nutrition. 2009;28: Heyland DK, et al. JPEN and Available online: Singer P, et al. Clinical Nutrition. 2009;28: Heyland DK, et al. JPEN and Available online: ASPEN INDICATIONS Enteral nutrition (EN) preferred Indications for parenteral nutrition (PN) Diffuse peritonitis Intestinal obstruction Paralytic ileus Gastrointestinal ischemia Intractable vomiting/diarrhea Tube feeding intolerance Timing and duration of PN TIMING OF PN ASPEN Board. JPEN. 2002;26(1):1SA-150SA. 3

4 GUIDELINES GUIDELINE PN INDICATION PN TIMING ASPEN EN not feasible or inadequate Major surgical procedure planned and EN not feasible Adequate nutrition: wait 7 days before initiation Malnourished patients: immediately ESPEN Not expected on full oral diet Insufficient EN Intolerant to EN Within 3 days Canadian EN preferred Individual case by case basis Provider preference Singer P, et al. Clinical Nutrition. 2009;28: Heyland DK, et al. JPEN and Available online: TIMING OF PN epanic Trial N= 4640 Purpose: Timing of PN initiation after EN failure Intervention: EN + early versus late PN Outcome: Mortality, complications Results: No difference in mortality; increased rate IC in early PN group The Early PN Trial N = 1372 Purpose: Review PN outcomes when initiated within 24 hours Intervention: PN within 24 hours versus SOC Outcome: 60-day mortality Results: No difference in mortality Caesar MP, et al. NEJM 2011;365(6): Doig et al. JAMA 2013;309(20): ENTERAL OR PARENTERAL? Functional GI Tract Yes EN No PN WHENTOHOLDTUBEFEEDS Continue if tolerated Fail or inadequate EN Transition to EN when possible ASPEN Board. JPEN. 2002;26(1):1SA-150SA. MONITORING EN Evidence of bowel motility is not required to initiate EN Monitor for tolerance of EN Complaints of pain or distention Passage of flatus/stool Abdominal radiographs Gastric residuals Hypoactive bowel sounds Increasing nasogastric tube output Increasing metabolic acidosis Martindale RG, et al. Crit Care Med 2009;37(5):1-30. ENTERAL NUTRITION Avoid inappropriate cessation of EN Hold TF > 500 ml gastric residuals TF residuals ml Reduce risk of aspiration Raise head of bed degrees Hold TF for gastric residuals < 500 ml only if symptomatic Does not correlate to increased mortality Does not increase incidence of pneumonia TF < 500 ml do not increase risk of: Regurgitation Aspiration Pneumonia Martindale RG, et al. Crit Care Med 2009;37(5):

5 DRUG SHORTAGES 2010: 178 shortages (132 injectables) 2011: 215 shortages (183 injectables) 2013: 324 shortages (228 injectables) DRUG SHORTAGES WITH PN ASPEN. Drug Shortage Updates. Available online: Accessed PN PRODUCT SHORTAGES IMPACT ON RESOURCES Amino acid Ascorbic acid Calcium chloride Calcium gluconate Copper Cyanocobalamin Fat emulsions L-cysteine Multivitamins Potassium acetate Potassium phosphate Selenium Sodium acetate Sodium chloride Sodium phosphate Trace elements Vitamin A Zinc Increased stress on purchasing staff Additional labor and time to find product Precious clinical hours lost to time-consuming activities required to manage shortages Use of secondary or gray markets Purchasing unfamiliar PN products Increase in drug expenditures Holcombe, B. JPEN J Parenter Enteral Nutr. 2012;36,:44S-47S IMPACT ON PATIENT SAFETY Increasing volume of medications Use of less desirable, unfamiliar alternatives Absence or delay in treatment Preventable adverse events by use of alternative drugs Lack of advanced warning Poor patient outcomes ASPEN S ROLE IN DRUG SHORTAGES Ask FDA to provide safe Recommend that the FDA approve importation from global markets Support legislation to prevent and resolve drug shortages Facilitate communication between leaders and A.S.P.E.N. members Distinguish between local supply issues and a true national shortage Develop recommendations on management of product shortages Work with ISMP regarding safety issues Encouraging A.S.P.E.N. members to report shortages Survey clinicians on the impact Holcombe, B 2012;36,:44S-47S ASPEN. Drug Shortage Updates. Available online: Accessed ASPEN. Drug Shortage Updates. Available online: Accessed

6 IV FAT EMULSION Adults 100 gm fat weekly Monitor for essential fatty acid deficiency Remainder of non-protein calories (NPC) provided by dextrose Daily fats Pediatric/neonatal patients Glucose intolerance Severely malnourished Pregnant patients Risk for refeeding syndrome AMINO ACIDS SHORTAGE Use specialty amino acids (AA) only for indicated population Review entire portfolio of AA for availability of different concentration Review brands carefully NOT always substitutable Reserve high concentration AA for fluidrestricted patients ASPEN. Drug Shortages. Available online: www. Nutritioncare.org. Accessed ASPEN. Drug Shortages. Available online: www. Nutritioncare.org. Accessed MULTIVITAMIN SHORTAGE Use of pediatric multivitamin (MVI) not recommended for adults Substitute 12-vitamin and 13-vitamin products When supplies are exhausted: Reduce daily dose by 50% OR Give MVI infusion dose three times a week OR Administer individual parenteral vitamin entities daily Thiamine 6 mg Ascorbic acid200 mg Pyridoxine6 mg Folic acid 0.6 mg Vitamin K mg/day or 5-10 mg/wk Cyanocobalamin once per month ASPEN. Drug Shortages. Available online: www. Nutritioncare.org. Accessed TRACE ELEMENTS SHORTAGE Conserve supply for vulnerable population Do not substitute pediatric/adult formulations Decrease or eliminate daily amount added to PN Consider supply outreach to others in your area Monitor for deficiencies Signs/symptoms Serum trace element concentrations ASPEN. Drug Shortages. Available online: www. Nutritioncare.org. Accessed ELECTROLYTE SHORTAGES Consider prioritization Minimize use in IV fluids Reconsider use of automatic IV electrolyte replacement Use oral replacement Review entire portfolio of products available Consider premix PN with standard electrolytes Observe for increase in deficiencies MANAGING PN SHORTAGES Operational Assessment & Therapeutic Assessment Validate details of shortage, estimate time to Identify primary patient population and possible impact, determine supply of alternatives alternative products Shortage Impact Analysis Estimate impact on patient care, therapeutic differences, prescribing, distribution, Establish final plan administration, and financials Communicate & Implement ASPEN. Drug Shortages. Available online: www. Nutritioncare.org. Accessed Pick effective date, educate, create temporary guidelines and procedures IT changes, inventory changes, new procedures ASHP Expert Panel. Am J Health-Syst Pharm. 2009;66:

7 ORGANIZATIONS ROLE IN SHORTAGES Consider drug-shortage committee Development and revision of policies to ration or restrict PN resources Ensure appropriate PN indications Prioritization of patient populations Avoid stockpiling Research alterative products Resource allocation within buying group EXAMPLES Pharmacist consult service Retrospective chart review 2009 Order set initiated Compliance ASPEN Guidelines Dietary approval required Clinical pharmacists write TPNs 2008: 50% compliance 2010: 60% compliance 2013: 75% compliance ASHP Expert Panel. Am J Health-Syst Pharm. 2009;66: EXAMPLE EXAMPLES Total PN Patients per Year Number of Patients Fat days 50 gm twice a week Mondays-Thursdays Nutrition gives bi-weekly or daily recommendation Thrice-weekly MVI/trace elements Pro-active approach to P&T committee Resource allocation Share potassium formulations with infusion service Incorporated into drug shortage committee Different products Calcium chloride for calcium gluconate THINK-PAIR-SHARE 7

8 WHAT S NEW IN NUTRITION? Alisha Mutch, Pharm.D., BCPS 8