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COLLEGE OF PHARMACY. STERILE PRODUCTS PHT 434. large volume PARENTERAL Iv fluids, electrolyte replenishment therapy, total parenteral nutrition IV admixtures &incompatibilities. Dr. Mohammad Javed Ansari, PhD. Contact info: mj.ansari@psau.edu.sa. objectives of the lecture.
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COLLEGE OF PHARMACY STERILE PRODUCTS PHT 434 large volume PARENTERAL Iv fluids, electrolyte replenishment therapy, total parenteral nutrition IV admixtures &incompatibilities Dr. Mohammad Javed Ansari, PhD. Contact info: mj.ansari@psau.edu.sa
objectives of the lecture • At the end of this lecture, you will be aware of: • What are large volume parenteral dosage forms (LVP)? • What are various types of LVP and rationale of uses? • What are body fluids and electrolytes? • What are various types of IV FLUIDS and electrolytes? • What are various types of IV FLUIDS and electrolytes replacement therapies? • What is total parenteral nutrition (TPN)? • Rationale, indications, functions, compositions of TPN. • What are energy requirement and dose calculations? • Routes of TPN administration and complications? • IV admixtures, rationale, advantages, disadvantages. • Incompatibilities in IV admixtures, its preventions and interventions.
Large volume Parenterals (lvp) • A single-dose IV fluids packaged in bags or bottles containing more than 100 mL. (upto 1-2 liters). • Infused continuously / intermittently over 24 hours. • No anti-microbial agents added in LVP. • Isotonic, Sterile, Pyrogen-Free, free of particulate matter. • Types of LVP • IV FLUIDS: • VEHICLES IN IV ADMIXTURE: WFI, DEXTROSE, NACL. • ELECTROLYTES: RINGER SOLUTION • TOTAL PARENTERAL NUTRITION: Carbohydrate (Glucose), Protiens (Amino acids), Lipids/Fats(fatty acids) and vitamins • DYLYSATE: NOT FOR IV but Peritoneal dialysis of hypertonic solution using surgical catheter to remove harmful substances by osmosis. • IRRIGATION SOLUTION: NOT FOR IV but topical application to clean moisten or irrigate the organ or tissues.
lvp-iv fluids-rationale of uses • 60-70% of human body weight is comprised of fluid (Water containing electrolytes, nonelectrolytes (glucose), minerals, vitamins, blood cells etc). • The body is able to replace, at best, only about one-third of what it loses during exercise (fluids, calories & electrolytes). • However, severe body fluid deficit / loss due to dehydration, vomiting, diarrhea, trauma, burn etc results in improper functioning of nervous, cardiac, muscular, respiratory and digestive systems (death in severe loss of body fluids) • Glucose / Fats / protein provide energy required to the cells. • Electrolytes and minerals are necessary for fluid balance, acid-base balance, muscle contractions and transmission of nerve impulses. • Administration of IV fluids containing these essential substances are very important to recover the lost body fluid (water, energy, electrolytes etc) to save the life of the patients.
Conditions when tpn is required or necessary • When normal oral feeding is not possible. • Gastric & esophageal carcinoma, paralytic ileus, generalized peritonitis, GI obstruction, intractable vomiting. • When food intake is undesirable (bowel rest). • Post GIT surgery, chronic inflammatory diseases, intractable diarrhea. • When patients able to ingest food, but refuse. • Post operative patients, adolescents with anorexia nervosa, some psychiatric patients with prolonged depression. • When food is incompletely absorbed. • Major burns, multiple injuries, radiation therapy, ulcerative colitis, chemotherapy treatment, short bowel syndrome. • SYMPTOMS • Has a low serum albumin <3.5g/dL. • Has a recent loss of 10% or greater of his weight. • Has a history of recent poor intake for > 7 days.
Rationale / functions of tpn • Parenteral Nutrition allows the body to be provided with all basic nutrients substrates and energy required for maintaining or restoring all vital body functions and for building up body mass. ( by preventing the breakdown of endogenous protein for energy needs ) • Good nutrition is necessary for optimal resistance to infection and trauma • Good nutrition is necessary for optimal efficacy of medical and surgical treatment.
Composition of tpn • There are six types of nutrients which are required to sustain life: • 1-Water: Sufficient to avoid dehydration (35 mL/kg/d)& 300 - 700 mL/d/degree in fever ((13% increase in water need for each degree above 37ْC) • 2-Carbohydrate: Dextrose should constitute 50-60% of total calories provided,1g= 3.4 Kcal. Generally 150 g of dextrose is given at a rate of (2mg/kg/min). • 3-Protein: 0.5g/kg/day, increase up to 1.5 - 1.8 g/kg/day (1 g of protein provides 4 kcal), 1 g of nitrogen is equivalent to 6.3 g protein.
Composition of tpn • 4-Fat: 0.5 g/kg/day increase gradually upto 1.5 g/kg/day, 1 g = 10 Kcal. Fat is formed mainly of essential fatty acids (linoleic acid) stabilized by egg yolk phospholipids to a main particle size of 0.13 micron, glycerol is added to render emulsion isotonic (300 mosm/1). • 5-Minerals: Na, K, Mg, Ca, PO4 and trace elements like (Cu, Fe, Zn, Mn, Se and Cr etc.) • 6-Vitamins: B complex, Ascorbic acid, ADEK. 10 cc/day (MVI).
ROUTES OF TPN: Central TPN: • (usual osmolarity = 2000 mosmol/L) • Advantages • Can provide full nutritional support • (No limits in concentration of dextrose and amino acids) • No risk of thrombophlebitis • No risk of edema • No pain • Disadvantages • Requires surgery • More risk of sepsis than peripheral TPN • High risk of mechanical complications
Peripheral TPN: • (maximum osmolarity in neonates = 1100/L, • Pediatrics = 1000/L, Adults = 900/L) • Advantages • Does not require surgery • Less risk of sepsis than central TPN • No risk of mechanical complications • Disadvantages • High risk of thrombophlebitis • Painful, and chance of edema • Does not require full nutrition support. Needs more fluids to provide more nutrition. (maximum dextrose = 7.5% and AA = 2.5%)
Abnormalities of serum electrolytes and minerals Gallbladder complications Cholelithiasis and cholecystitis Volume overload (suggested by > 1 kg/day weight gain)
Intravenous Admixture • The combination of two or more parenteral products in one container for administration as a single entity is called IV admixture. • The preparation of pharmaceutical products that require the measured additive of a medication to a 50 ml or larger bag or bottle of IV fluid. • It 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. • Compounding: The preparation of a pharmaceutical mixture of two or more drugs. • Reconstitution: The drawing up of medication (either powder or liquid form) into a syringe for direct administration to the patient or via Buretrol. • Reconstitution is neither compounding nor admixing.
Intravenous Admixture IV admixture is of prime importance compared to other dispensing activities, because of the critical problems, which can result from improper compounding. To ensure sterility by applying aseptic technique, stability, accurate pharmaceutical calculations, and avoid incompatibility, establishing of a centralized pharmacy IV admixture service is essential.
Advantages of IV Admixture Systems • Reduction in number of injections. • Convenience and time saving. • Treatment of several conditions simultaneously. • To provide drug in dosing flexibility. • Increases the safety of parenteral medications. • Compounding of commercially unavailable products. • DISADVANTAGES • Expiration dating is usually shorter than for other systems • Unused doses that are wasted are greater than other systems. • Occurrence of incompatibilities leading to mild to serious / dangerous consequences.
Considerations in IV Admixture Systems • Sterility: The pharmacy must maintain clean area out of the direct flow of traffic with vertical or horizontal laminar air-flow hood to prepare I.V. admixture. • Facility: Detailed information regarding the preparation, labeling, storage and expiration dating of parenteral products should be available in the pharmacy. • Stability :Drug stability information must be readily accessible to the pharmacist in order to determine optimum conditions for drug storage prior to and after preparation. • Total pharmaceutical care: In order to affect patent monitoring program for medications, it is necessary to centralize the preparation of all medications so that appropriate review can be accomplished.
Considerations in IV Admixture Systems • Dose calculation: Extremely important in parenteral therapy dosages, especially in nutrition and chemotherapy admixtures. • Compatibility: The pharmacist can control both the I.V. solutions that are used and the medications that can be combined in the solutions. • Process: Guidelines for preparing parenteral products should be outlined in the pharmacy. Firsts upon receiving the medication order, the pharmacist will determine if dosage, diluent, volume of diluent and rate of administration are correct. • Quality: Proper policies for inspecting solutions prior to and after preparation are an integral part of pharmacy-based programs as compatibility, sterility, and labeling of admixtures • Label should be re-checked against the original order.
Considerations in IV Admixture: Labeling • It is suggested that the following information be placed on all I.V admixtures immediately following preparation: • Patient name, identification number, and room number. • Bottle sequence number. • Name and amount of drug added. • Name and volume of admixture solution. • Approximate final total volume of the admixture. • Prescribed flow rate. • Date and time of scheduled administration. • Date and time of preparation. • Expiration date. • Initials of the person who prepares and/or checks the I.V admixture. • Ancillary labeling: supplemental instructions and precautions.
Considerations in IV Admixture: Incompatibilities • Incompatibility: Incompatibility is an undesirable reaction that occurs between the drug and the solution, container or another drug. • Incompatibility in IV admixture means undesirable reaction that occurs when one drug is mixed with other leading the mixture unsuitable for administration to the patient. • In contrast to the drug interaction, an incompatibility reaction occurs inside a fluid container or infusion line and is usually visible. • A drug interaction describes the alteration of a drug effect due to the influence of another substance (i.e. drug, chemical substance, nutrition-foods and braverages). • Drug interaction occurs inside the body leading to synergism, antagonism or totally new effect hence cannot be seen at once.
Types of IV Admixture Incompatibilities • Physical incompatibility: When two or more products produce visible change in the resulting solution upon mixing like change in the appearance of the solution like change in color, formation of precipitates etc. • Chemical incompatibilities: Chemical reactions like hydrolysis, oxidation, reduction, decomposition or complexation may occur between mixed products. May or may not produce visible change (turbidity, ppt, colour), however results in the deterioration or inactivation of an active ingredient. • Therapeutic incompatibilities: Occur when two or more drugs administered result in undesirable effect. • Less or no effect: antagonistic pharmacologic action. • More effect or Toxic effect=synergistic pharmacologic action.
Consequences of IV Admixture Incompatibilities • Tissue irritation due to major pH changes. • Particulate emboli from crystallization and separation. • The precipitated product may irritate the veins or cause occlusion of vessels. • Toxic decomposition of products • Therapeutic failure. • Adverse effects of drug incompatibilities extend periods of patients’ hospitalization and the total costs for hospitals. • Pharmacist must deal with problems of physical, chemical and therapeutic incompatibilities, and to design suitable alternatives when these problems arise.
How to minimize IV Admixture Incompatibilities • Use drug incompatibility chart or programme • consistently check alternative modes of administration or use multi-lumen catheters.
