this slide includes total parenteral nutrition, types, intravenous admixture, types
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2080, mangsir 29 Total Parenteral Nutrition Services Parbati Chaudhary M. Clinical Pharmacy, 2 nd semester PUSHS
IV Additive Program: Total Parenteral Nutrition: nutritional support given completely via the Systemic circulation, intravenously. may be short-term or long-term nutritional therapy 2
IV Additive Program: Total Parenteral Nutrition: Aim: to prevent and restore nutritional deficits. Neurodevelopment in babies Sufficient energy for various metabolic process Prevent catabolism Achieve positive nitrogen balance and protein sparing . Establish growth and maturation during critical postnatal period. 3
4 Indications Nothing by Mouth (NP0) for more than 7 days. Non-functional GIT or disorders requiring complete bowel rest such as ulceratitis, pancreatitis, short bowel syndrome secondary to surgery(Post-operative bowel anastomosis leak) Malnutrition or Severe diarrhea or vomiting Severely premature babies in PICU with immature GI system or congenital gastrointestinal malformation
WATER Water content in TPN solutions ranges from 70% to 85% of the total volume. Serves as the base for PN admixing. The water used : Sterile water for injection or bacteriostatic water for injection. 6
7 Macronutrients: Fig: Carbohydrate as glucose Fig: protein as amino acids Fig: fat as lipid emulsion
8 Carbohydrate as glucose Most commonly used: dextrose (hydrated form) provides 3.4 kcal/g carbohydrate. Provides 50–60% of total daily calories. Continuous dextrose infusion rates in adult patients : ≤4–7 mg/kg/min to avoid hyperglycemic episodes if the oxidation glucose rate is overtaken, liver abnormalities and ↑ CO2 production. Sudden discontinuation should be avoided to prevent Hypoglycemia. Fig: Dextrose
9 Protein as amino acids Provide energy (4 kal /g). As a source of nitrogen , amino acids: used in protein synthesis and in replacing protein stores that have been depleted secondary to disease. a mixture of essential and non-essential amino acids except arginine and glutamine. Prolonged TPN : Glutamine( protects guts epithelia lining) & choline( protects the liver from hepatic fat deposits). Minimum daily req : 1-1.5 gm/kg/day E.g.: Freamine , aminosyn Fig: amino acids
10 Lipid emulsion: Major component of PN as they prevent from essential fatty acids Deficiency and minimize the dependence on glucose as a major source of non-protein energy Available as 10% (1.1kcal/ml) or 20% (2 kcal/ml) solutions and provide energy as well as source of essential fatty acids. Rate of infusion : < 1 kcal/kg/h to avoid lipid overload. EFAD: Omega 3( alpha linoleic acid) omega 6( linoleic acid). Triglycerides: no contribution to TPN osmolality. E.g.: intralipid , smoflipid Fig: lipid emulsion
12 Micronutrients: Electrolytes Vitamins & Trace Elements
Electrolytes Electrolytes: Infused either as a component already contained I amino acid soln or as a separate additive. Starting doses of electrolytes: maintenance levels and evaluated daily during initial startup of PN therapy. Electrolytes recommendation per liter of parenteral nutrition: Na: 100 - 150 mEq Mg: 8 -24 mEq Ca: 10 - 20 mEq K: 50 to 100 mEq P: 15 to 30 mEq 13 Fig:Electrolytes
Micro-nutrients range 14 Usual adult range Infants/children Sodium 60 to 200 mEq /day 2 to 4 mEq/kg/day Potassium 60 to 200 mEq /day 2 to 4 mEq/kg/day Magnesium 8 to 40 mEq /day 0.25 to 0.5 mEq/kg/day Calcium 10 to 30 mEq /day 0.5 to 3 mEq/kg/day Phosphorus 10 to 40 mMol /day 0.5 to 2 mMol /kg/day Chloride As needed to maintain acid-base balance Same as adults Acetate As needed to maintain acid-base balance Same as adults
Vitamins & Trace Elements: Vitamins: An essential component of a patient's daily PN regimen because they are necessary for normal metabolism and cellular function. Trace Elements: Trace elements like zinc, copper, selenium, and chromium, and electrolytes. These are involved in nerve function, enzyme activation, and many other biological processes. 15 Fig: Vitamins
Daily trace elements requirements: 16 Adults Peds < 5 years Peds 5 - 12 years Copper 300 to 500 mcg 20 mcg/kg 200 to 500 mcg Manganese 60 to 100 mcg 2 to 10 mcg/kg 50 to 100 mcg Zinc 2.5 to 5 mg 0.1 mg/kg 2 to 5 mg Chromium 10 to 15 mcg 0.14 to 0.2 mcg/kg 5 to 15 mcg Selenium 60 mcg 2 to 3 mcg/kg 30 to 40 mcg Molybdenum As needed 0.25 mcg/kg As needed Iodine As needed 1 mcg/kg As needed Iron As needed As needed As needed
Central (Total) Parenteral Nutrition : Delivered through a central vein — usually, the superior vena cava located under collarbone where the tip of central catheter ends at the top of right atrium, where there is high blood flow. Types of PN:
Central (Total) Parenteral Nutrition : Advantage : High concn of nutrition with higher calories. No risk of phlebitis as TPN gets diluted quickly due to high blood flow. Useful for long term therapy:> than 3 weeks such as in prolonged bowel rest, chemotherapy Deliver total parenteral nutrition. Disadvantage : Chance of pneumothorax. Types of PN:
Peripheral Parenteral Nutrition : Delivered through a smaller, peripheral vein, perhaps in the neck or in one of the limbs. Used to provide partial parenteral nutrition temporarily, using the quicker and easier access of the peripheral vein. Types of PN:
Pheripheral Parenteral Nutrition : Advantage : Low possibility of pneumothorax. Useful for short term therapy. Deliver pheripheral parenteral nutrition. Disadvantage : High osmolality TPN soln can cause phlebitis due to low blood flow Only dilute TPN with Osm ( ideally <600mosm) can be give. Types of PN:
IV Additive Mixture: Sterile parenteral drugs products added to an IV fluid for medication purpose. consists of a drug product mixed with an appropriate diluent in a suitable dosing/ delivery device for the purpose of parenteral infusion to the patient. Preparation of parenteral sterile drug product that requires the measured additive of a medication to a 50 ml or larger bag or bottle of IV fluid ( eg , IV, IM, IT, SC, etc ). Does not include the drawing-up of medications into a syringe, adding medication to a buretrol , or the assembly and activation of an IV system that does not involve measuring the additive.
22 For e.g. If Cephalosporin in the syringe were added to 50 or 100 ml bag of IV fluid ( minibag ), then this would be preparing an IV admixture. The drawing up of medication (either powder or liquid form) into a syringe for direct administration to the patient or via Buretrol is reconstitution , neither compounding nor admixing. Admixture vs reconstitution
Diluents The most commonly used diluents for IV administration are 0.9 % sodium chloride injection, USP (normal saline), 5 % dextrose injection, USP (D5W), Ringer’s Injection, USP and Lactated Ringer’s Injection, USP IV Admixture consists of:
2.Components: During clinical administration, the IV admixture may come into contact with the following components: IV container : In many instances, the drug admixture may be prepared up to 24 h prior to dosing in the IV container. Infusion line : The admixture comes in contact with the infusion line during infusion, which may last between a few minutes to a few hours. IV catheter : The catheter usually has a much smaller contact area. However, a peripherally inserted catheter line which is considerably longer may have significant contact with the drug admixture PN Consists of:
Filters: Filters of 5 μm or smaller pore size (either in-line or add on) are commonly used during infusion to remove any adventitious particles from the admixture. Syringes: In cases where the infusion volume may be small the dose may be administered through a syringe pump (e.g., pediatric patients). PN Consists of:
Preparation of IV admixture: 1. Interpretation of the order: 2. Preparation of labels: 3.Assembly and Preparation: 4.Aseptic Technique: 5.Labelling and check: 26 Fig: Preparation of IV admixture
1.Interpretation of the order: Pharmacists addressographs the patient card with the patient’s full detail and checks for drug interactions, proper dose, compatibility through available reference resources, duplication of medication (includes medication ordered by the oral route), allergies, length of therapy, and other patient therapies. The intern/ technician who prepares the solution records the time of preparation and initials of patients card . 27 Fig: Interpretation of the order
All iv admixtures to be prepared by the pharmacy are labelled and checked against the patient profile card before releasing the iv assembly area. Label contains: 1.Patient name & Patient room no 2.Additive strength and amount 3.Primary iv solution 4.Expiration date and time 5.Prepared by 6.Preparation date and time 2.Preparation of labels: 28 Fig: Preparation of labels
3.Assembly and Preparation: The medication order and the IV profile card are attached to the completed label. These are assembled with the needed iv stock solution, additive and any transfer device (syringes, needles, etc ) on plastic tray. The prepared assembly tray is brought into laminar airflow hood and iv ad mixtures is prepared. Work flow must be from left to right in the hood. Only one admixture is prepared at a time. Additives must be protected from light,reconstituted , buffered and stabled. 29 Fig: Assembly and Preparation
4.Aseptic Technique: All the iv admixtures are prepared in laminar air flow hood using aseptic technique. All the operation are carried out in such a way to minimize possibility of contamination of the admixture. Routinely, the laminar flow counter is swabbed with 70% isopropyl alcohol, starting from the back and working forward. 30 Fig: Aseptic Technique
5.Labelling and check: The prepared label is stamped with the appropriate expiration date and fixed to the iv bottle over the manufacturer’s label so that the one line identification of the labels remain visible. Dosage, ingredients, auxiliary labels, compatibility, route, rate, absence of particulate matter, discoloration and container integrity are verified. Usually, each IV dose is numbered in consecutive order. After delivery to the CCU, the solution is once again checked by the person who will be administering the drug. IV admixtures should be refrigerated until shortly prior to use. If it is not used within 24 hours, it should be returned to pharmacy to be redistributed or destroyed 31 Fig: Labelling and check
32 Advantages : Lengthen expiration date: Provides nutritive fluids (glucose, electrolytes) Quick onset High quality patient care Proper reconstitution of drugs Disadvantages: High risk of incompatibility and bacterial contamination. Need of skilled and trained pharmacist. Time consuming Require of aspetic area, special equipment such as refrigerator for storage Iv admixtures
33 TPN admixture Chemotherapeutics Nuclear pharmacy Other types of iv admixtures:
34 Different methods of PN admixture Preparation S.n . PN admixture Mixing method Product of mixing Additive which should be added in order to obtain complete PN admixture 1. Basic Preparation: 1.Amino acid soln 2.Glucose soln 3.Water and/or electrolyte soln 5.Fat emulsion in separate bottles or containers Filling separate bag Bag 125-400 ml Micronutrients added to the bottles before or to the bag after mixing via injection port. 2. Two chamber bag: containing amino acids & glucose solutions in two separate chambers without or with fixed amount of electrolytes. breaking of peelable seals Bag 1000–2000 ml Fat emulsion transferred by transfer set after mixing Vitamins and trace elements added after mixing by injection. When necessary, electrolytes and additional fluids may be added before adding fat emulsion.
35 Different methods of PN admixture Preparation S.n . PN admixture Mixing method Product of mixing Additive which should be added in order to obtain complete PN admixture 3. Three chamber bag – containing amino acids solution, glucose solution and fat emulsion in 3 separate chambers with fixed amount of electrolytes breaking of peelable seals Bag 1000–2500 ml Vitamins and trace elements added after mixing via injection port. Electrolytes and additional fluids may be added when necessary after mixing 4. Industrial mix – containing mixture of amino acids, glucose, fat emulsion and fixed amount of electrolytes in one ready to use bag, stored under refrigeration Already mixed Already mixed Already mixed Vitamins and trace elements added just before use via injection port
Environmental condition & precaution of Iv additives Preparation 36 ENVIRONMENTAL CONDITIONS : 1.Maintenance of good aseptic technique in the personnel who prepare and administer sterile products. 2.Maintenance of a sterile compounding area , complete with sterilized equipment and supplies 3.Maintenance of the skills needed to properly use a laminar airflow workbench (LAFW) or laminar airflow hood.
Precautions: 1.Hand Washing/ Foam and Gel 37 2. Designated Area 3. Inspection 4. Additive Ports and Vial 5. Touch Contamination 6. Quality assurance 7 . Preparation Technique
BASIC TPN PREPARATION VIDEO 38
Commercially available TPN Nutriflex Lipid Peri 1250ml Kabiven Perikabiven Numeta Olimel N9E Oliclinomel N7-1000E Oliclinomel N4-550E 39
40 REFERENCES: https://www.lllnutrition.com/mod_lll/TOPIC9/old_version/m93.pdf Basics in clinical nutrition: Parenteral nutrition admixtures, how to prepare parenteral nutrition (PN) admixtures M.I. Barnett a , Marek Pertkiewicz b , Allan G. Cosslett c , Stefan Mu¨hlebach Accepted 27 January 2009 https://www.academia.edu/43266672/Intravenous_admixture_Academic_year_4_th https://www.researchgate.net/publication/299683870_Intravenous_Admixture_Compatibility_for_Sterile_Products_Challenges_and_Regulatory_Guidance https://sarmoko.blog.unsoed.ac.id/files/2011/05/IV-Admixture-Policy.pdf http://file.cop.ufl.edu/ce/consultwb/2013workbook/chapter%2017.pdf . https://basicmedicalkey.com/aseptic-technique-sterile-compounding-and-iv-admixture-programs/ https://opentextbc.ca/clinicalskills/chapter/8-8/ https://ameripharmaspecialty.com/what-is-in-a-tpn-solution/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9659055/ https://my.clevelandclinic.org/health/treatments/22802-parenteral-nutrition https://www.tlectures.com/ivadmixtures.pdf