PARENTERAL NUTRITION: CLEARING UP THE ISSUES

Transcription

1 Nutrition Dilemmas, PARENTERAL NUTRITION: CLEARING UP THE ISSUES

2 Frequent questions/issues that need to be settled Should all total parenteral solutions be infused within 24 hours? Can we allow beyond- use dating? Is there a need to incorporate micronutrients into every TPN bag? Would incorporating additives (micronutrients ) alter hangtime protocols? Is there still a need to reduce UV light exposure to all types of PN solutions once IV micronutrients are incorporated?

3 ISSUE #1 PN HANG TIME CAN BE EXTENDED FOR MORE THAN 24 HOURS

4 Beliefs and Practices Due to limited IV access, PN infusion may be interrupted. To consume the remaining solution, infusion time is extended beyond 24 hours. PN is costly. Therefore, extending its hangtime will be cost- effective without regard of total nutrient delivery. Delivery of nutrition intravenously increases risk of infection rates.

5 Where the dilemma lies Nutrition Dilemmas, IV Fat emulsions are capable of extracting DEHP (di(2- ethylhexyl)phthalate) from PVC (polyvinyl chloride) containers/administration sets. Neurotoxic, hepatotoxic, carcinogenic in animal models Recommend to use DEHP- free bags and tubings for: Chronic PN patients Pregnant patients Pediatric patients Parenteral Nutrition Administration and Monitoring, A.S.P.E.N. Parenteral Nutrition Handbook 2009, ed. Canada etal, p187,

6 Where the dilemma lies Parenteral nutrition has been associated with higher prevalence of pneumonia and catheter sepsis. Kudsk etal, Ann Surg 1992;215: Moore etal., J Trauma 1989;29:

7 Reference Hang PN beyond 24 hours? YES! Balegar KK, Azeem MI, Spence K, Badawi N. Extending total parenteral nutrition hang time in the neonatal intensive care unit: is it safe and cost effective? Journal of Paediatrics and Child Health 2013; 49(1): E57- E61 Driscoll DF, Bhargava HN, Li L, Zaim RH, Babayan VK, Bistrian BR. Physicochemical stability of total nutrient admixtures. Am J Health- Syst Pharm. 1995;52: Praire F and Llido LO. Parenteralnutrition delivery from 24 to 48 hours: assessment of mixture status and patient response. online Journal of Parenteraland Enteral Nutrition. submitted Dec 12, Posted July 29, racts4.php Findings Nutrition Dilemmas, Extending TPN hangtime from 24 to 48 h did not alter CLABSI rate and was associated with a reduced TPN- related cost and perceived nursing workload. The preparation and hang time of each PN solution that is not refrigerated should not exceed 30 hours due to stability concerns Three chamber parenteral nutrition (PN) bags can be delivered beyond 24 hours even reaching to 32 hours with minimum adverse events related to phlebitis and not to infection or more serious cause(s)

8 Hang PN beyond 24 hours? YES! Reference Boullata, J. et al. A.S.P.E.N. Clinical Guidelines: Parenteral Nutrition Ordering, Order Review, Compounding, Labeling, and Dispensing. JPEN 38: Findings As early as 1990, mixtures were stable for days at 4 0 to 5 0 refrigeration and for 2 days (48 hrs.) at room temperature

9 Hang PN beyond 24 hours? NO! Reference Mirtallo, J. et al. Safe Practices for Parenteral Nutrition. JPEN 28:6(Suppl) Cardinal Health: Let's get clinical: Best practices for determining appropriate hang time for IV fluids ( - insights/best- practices/ei- BestPractices- IVHangTime Findings 24 hours for TPN (with Lipids) Parenteral nutrition (with or without fat) hang time should not exceed 24 hours

10 Neutral Reference CDC MMWR Recommendations & Reports ( August 9, 2002 / 51(RR10);29) ( http: // preview/mmwrhtml/rr5110a3.htm Findings No recommendation for the hang time of intravenous fluids, including nonlipid- containing parenteral nutrition fluids

11 Risk Level LOW Risk Level Classification and Beyond- Use Dating (BUD) Guidelines for Compounded Sterile Preparations Example/s Reconstitution of a single dose vial of lyophilized powder with a sterile diluent for transfer into another container (pediatric parenteral multivitamins) Room Temp (20-25 o C) BUD 48 hours 14 days Nutrition Dilemmas, Refrigeration (2-8 o C) MEDIUM HIGH Mixing of additives for transfer into a large- volume PN solution Preparation of non- sterile powder for intravenous infusion 30 hours 9 days 24 hours 3 days Parenteral Nutrition Formulations, A.S.P.E.N. Parenteral Nutrition Handbook 2009, Canada et al, p145

12 Routine Change of PN administration sets Intravenous Nurses Society & Centers for Disease Control Nutrition Dilemmas, All PN administration sets are to be changed using aseptic technique and universal precautions. Total Nutrient Admixture (TNA) administration sets are to be changed every 24 hours and immediately upon suspected contamination, or if product integrity has been compromised. 2- in- 1 administration sets are to be changed every 72 hours. Administration sets for a separate IVFE infusion are discarded after use, or at least every 12 hours if IVFE is infused continuously. Parenteral Nutrition Administration and Monitoring, A.S.P.E.N. Parenteral Nutrition Handbook 2009, ed. Canada etal, p187,

13 CLABSI while on TPN CLABSI incidence was reduced when CVC care bundle was practiced. Even in the era of falling CLABSI, PN still stands out as a risk factor for bloodstream infections, particularly fungemia. CLABSI reduction is best achieved using a team approach to reduce and improve PN use CLABSI: Central Line Associated Blood Stream Infections 50 0 PN no PN Gilbert K & Schechter L., Parenteral Nutrition- Associated CLABSI in the Era of Bundles, al- development/~/media/pdfs/prof- dev/2011/parenteralnutrition.ashx

14 ISSUES #2 & #3 INCORPORATION OF ADDITIVES SUCH AS MICRONUTRIENTS AFFECTS HANGTIME AND THE NEED FOR LIGHT PROTECTION

15 Beliefs and Practices Extend TPN up to 36 hours even with incorporations of vitamins and trace elements TPN bags with incorporations are not covered IVF bottles with vitamins are sometimes not covered Majority of incorporations are done by nurses at bedside or by pharmacists in their laminar flow facility

16 Recommendations PN solutions do not contain micronutrients and therefore must be incorporated to prevent micronutrient deficiencies. 1 IV micronutrients are light- sensitive and are stable up to only 24 hours. Incorporation of additives increase risk of contamination and error. ESPEN Recommendation Grade C, Clin Nutr 2009;28:

17 Where the dilemma lies Care must be taken to minimize interactions between nutrients and the infusion bags or giving sets. 1 Exposure to light (artificial or daylight) causes peroxidation in AIO PN solutions with micronutrient incorporations Substrates used in parenteral and enteral nutrition, Basics in Clinical Nutrition th ed., Subotka etal, p Grand etal., JPEN 2011;35:

18 What Is Oxidative Stress? Nutrition Dilemmas, Oxidative damage occurs when there is a dysequilibrium between ROS production and anti-oxidant systems in favor of ROS (pro-oxidants). This results in oxidative stress AOX ROS Oxidative stress Oxidative damage AOX, anti-oxidant;; ROS, reactive oxygen species. Sies H. Am J Med. 1991;;91(3C):31S-38S.

19 What Produces Oxidative Stress? Overproduction of ROS: Activated white blood cells Hypoxia or hyperoxia;; drugs;; ionizing radiation Conditions such as shock, trauma, sepsis, Lipid peroxidation Insufficiency or depletion of anti-oxidant systems AOX á ROS â AOX ROS Oxidative stress AOX, anti-oxidant;; ROS, reactive oxygen species. Accessed February 4, 2009.

20 PUFA Content of Parenteral Lipid Emulsions 80 Proportion of PUFAs ( %) 1, Soybean Structured triglyceride MCT/LCT Soy/MCT/ olive/fish MCT/soy/ fish CLINOLEIC 1. Driscoll DF. Nutr Clin Pract. 2006;;21(4): Antébi H, et al. JPEN J Parenter Enteral Nutr. 2004;;28(3):

21 Lipid peroxidation with additives Cytotoxic lipid peroxidation (LPO) can be measured using malondialdehyde (MDA) concentrations. MDA concentrations in PN solutions were significantly higher at 24 hours than at 0 hours when they contained multivitamins, trace elements or iron. It is higher when all 3 micronutrients were incorporated or when solutions were exposed to light. Grand et al., JPEN 2011;35(4):

22 German Guidelines: German Association for Nutritional Medicine Parenteral vitamins and trace element supplies should be provided to patients receiving total PN (C). Vitamins and trace elements should be generally substituted in PN, unless there are contraindications. The supplementation of vitamins and trace elements is obligatory after a PN duration of >1 week. A standard dosage of vitamins and trace elements is generally recommended because individual requirements cannot be easily determined. Preferably, all vitamins and trace elements supplied with a normal diet should also be substituted with PN as available(c). The quantities of daily parenteralvitamin and trace element supplies are based on current dietary reference intakes for oral feeding (A). Biesalski et al.: Water, electrolytes, vitamins and trace elements. German Medical Science 2009, Vol. 7, ISSN

23 German Guidelines: Nutrition Dilemmas, Practical handling of AIO admixtures Trace elements and/or combination preparations of water- soluble/fat- soluble vitamins can be added to PN admixtures for PN compatibility and stability has been documented (B). Micronutrients must be injected to admixtures under strict asepsis, optimally using a laminar flow. Admixing should be restricted on hospital wards for hygienic purposes (A). If this is not possible, this must be carried out according to pharmaceutical guideline, immediately before administration, and by specifically trained staff. Mühlebach et al.: Practical handling of AIO admixtures. German Medical Science 2009, Vol. 7, ISSN

24 Light protection guidelines Loss of activity can be minimized by dissolving the vitamins in a lipid solution or by using a light protection covering. 1 Light protection must be provided when micronutrients in aqueous solutions are applied as a (piggy bag) infusion. Light protection with overwraps must have a documented and proven effectiveness. 2 Protecting the PN bag and presence of fat emulsions minimizes the effect (of UV light) Smith JL, et al. J Parenter Enteral Nutr. 1988;12(5): Mühlebach et al. German Medical Science 2009, Vol. 7, ISSN Substrates used in parenteral and enteral nutrition, Basics in Clinical Nutrition 4 th ed. Sobotka et al, p279

25 /pictures/ wholesaler.com/userimg/670/695s w1/photophobic- iv- set- 832.jpg

26 Garb Nutrition Dilemmas, ü Coveralls with head cover ü Gloves ü Face mask ü Booties

27 Work Environment Cleanroom and Barrier Isolators ISO class 5 (class 100) laminar air flow workbench located in ISO class 8(class 100,000 or better) cleanroom with ante area. <797> Pharmaceutical Compounding Sterile Preparation. USP 30/NF 25

28 What can we say? PN, whether premixed commercially or individually compounded, is complex. It requires training, knowledge and skill in its preparation, storage and delivery. This is best done in a team approach.

29 Continous Staff Development of the Nutrition Team PERSONNEL EDUCATION, TRAINING AND EVALUATION

30 What can we say? PN preparation, hangtime and delivery must consider a number of factors. Some of which are the following: Manner of preparation Material of bags and administration sets Micronutrient incorporations and other admixtures Temperature Presence or absence of IVFE Light protection requirements

31 What can we say? Nutrition Dilemmas, In light of PN complexity and the potential dangers that can arise with PN use, we recommend the following: Judicious use of parenteral nutrition Strict asepsis in the preparation and delivery of PN Hangtime of 24 hours may be extended to 48 hours Micronutrient incorporation in PN when all macronutrients are included Discontinuing the use of light protection during micronutrient incorporation for as long as lipids (IVFE) are in the PN Close monitoring, not only of clinical parameters, but also of standard PN formulation techniques to prevent errors in PN delivery

32 Areas of pharmaceutical care within the nutrition team Transfer of pharmaceutical knowledge on products and equipment used for PN. Potential interactions or incompatibilities between components and other administered admixtures/medicines, and their prevention. Providing instructions regarding the stability of PN regimes and their correct handling (storage, light protection, administration, etc.). Checking the patient- specific prescriptions of admixtures, their preparation and concomitant drugs. Nutrition Dilemmas, Advisory function regarding the selection, composition and administration of PN as well as further additions in hospital patient and patients discharged on home PN. Advising on drug- related problems or observations: admixing, stability, incompatibility, bioavailability, documentation/clarification of adverse reactions to drugs. Providing an insight into measures to increase drug safety (evidence- based medicine/pharmacy). Support in integration and standardisation of treatment regimens, including suggestions for therapeutic strategies. German Medical Science 2009, Vol. 7, ISSN

33 Drugs compatible with PN TOTAL NUTRIENT ADMIXTURES (Lipid-containing formulations) Amikacin Aminophylline Ampicillin Ampicillin/Sulbacta m Aztreonam Calcium gluconate Cefotetan Cefoxitin Ceftazidime Cefuroxime Cimetidine Clindamycin Dexamethasone Digoxin Diphenhydramine Dobutamine Dopamine Enalaprilat Famotidine Fentanyl Fluconazole Gentamicin Hydrocortisone Imipenem Insulin, regular Leucovorin Lorazepam Magnesium sulfate Meperidine Meropenem Metronidazole Morphine Nafcillin Nitroglycerin Nitroprusside Norepinephrine Octreotide Piperacillin Piperacillin/ Tazobactam Potassium chloride Ranitidine Tacrolimus Ticarcillin/Clavulan ate Tobramycin Co-trimoxazole Vancomycin Zidovudine

34 Drugs compatible with PN PN WITHOUT LIPIDS (only dextrose-amino acid solutions) Amikacin Aminophylline Ampicillin Ampicillin/Sulbac tam Aztreonam Calcium gluconate Cefotetan Cefoxitin Ceftazidime Cefuroxime Cimetidine Clindamycin Dexamethasone Digoxin Diphenhydramin e Dobutamine Dopamine Enalaprilat Erythromycin Famotidine Fentanyl Fluconazole Gentamicin Heparin Haloperidol Hydrocortisone Imipenem Insulin, regular Leucovorin Lorazepam Magnesium sulfate Meperidine Metronidazole Morphine Nafcillin Nitroprusside Norepinephrine Octreotide Ondansetron Pentobarbital Piperacillin Piperacillin/ Tazobactam Propofol Ranitidine Tacrolimus Ticarcillin/Clavula nate Tobramycin Co-trimoxazole Vancomycin Zidovudine

35 Drugs incompatible with PN PN WITHOUT LIPIDS (only dextrose-amino acid solutions) Acyclovir Amphotericin B Cefazotin Ciprofloxacin Cisplatin Cyclosporin Cytarabine Doxorubicin Fluorouracil Furosemide Ganciclovir Immune globulin Methotrexate Metoclopramide Midazolam Minocycline Mitoxanthone Phenytoin Potassium phosphate Promethazine Sodium bicarbonate Sodium phosphate TOTAL NUTRIENT ADMIXTURES (Lipid-containing formulations) Acyclovir Albumin Amphotericin B Cyclosporin Dopamine Doxorubicin Doxycycline Droperidol Erythromicin Fluorouracil Ganciclovir Haloperidol Heparin Hydromorphone Levorphanol Lorazepam Midazolam Minocycline Morphine Nalbuphine Ondansetron Pentobarbital Phenobarbital Phenytoin Potassium phosphate Sodium phosphate

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37 THANK YOU