Large-Volume Parenteral Preparations in Hospitals PRINCE SATTAM BIN ABDUL AZIZ UNIVERSITY COLLEGE OF PHARMACY Sterile Dosage Form (PHT 434) Large-Volume Parenteral Preparations in Hospitals PRESENTED BY : Dr shahid Jamil

Large-Volume Parenteral Preparations

Learning Objectives Gain an awareness of the historical roots of large-volume parenteral preparations. Understand the physiology of fluid balance and the chemical properties of parenteral products. Identify the risks associated with parenteral administration. Describe the components and critical sites of various large-volume parenteral preparation supply items. Identify the USP Chapter <797> procedures that must be performed prior to compounding large-volume parenteral preparations. Demonstrate correct aseptic technique in preparing large-volume parenteral products.

Topics Learning Objectives Introduction Properties of Parenteral Products LVP Preparations USP Chapter <797> Guidelines for LVPs Understand the Resources and Supplies Preview the Lab Procedure Chapter Summary In Slide Show view, click the desired topic to the left to link directly to the related slide. To return to this slide at any point in the presentation, click the Topics button below.

Introduction In hospital pharmacy settings, IV technicians are largely responsible for preparing parenteral solutions for patient administration medications administered by any route other than through the alimentary canal maintain or correct the fluid status of patients whose conditions disrupt their bodies’ innate fluid balance

Properties of Parenteral Products Because parenteral products are administered directly into a patient’s blood supply, these solutions must have certain chemical properties or characteristics that render them safe for patient administration some characteristics include pH value, osmolarity, osmolality, and tonicity, as well as the compatibility of CSP additives

Properties of Parenteral Products…/2 pH Value The degree of alkalinity or acidity of a solution is referred to as its pH value and is measured on a scale from 0 to 14 any solution with a pH of less than 7.0 is considered to be acidic any solution with a pH greater than 7.0 is considered to be alkaline a solution with a pH of 7.0 is considered to be neutral

Properties of Parenteral Products…/3 pH Value…continued Human blood plasma has a pH of 7.4, which is slightly alkaline the pH of blood plasma must be maintained for optimal health Some facilities inject a buffer solution, such as sterile sodium bicarbonate, into the CSP to neutralize the pH and prevent patient discomfort

Properties of Parenteral Products…/4 Osmolarity and Osmolality Osmolarity is a measure of the number of milliosmoles of solute per liter of solution (mOsm/L) osmolarity refers to the osmotic pressure applied by a solution across a cell wall osmotic pressure is the pressure required to maintain equilibrium within the cells Osmolality is a measure of the number of milliosmoles of solute per kilogram of solvent osmolality refers to the number of ions or molecules in a solution

Properties of Parenteral Products…/5 Osmolarity and Osmolality…continued Osmolarity and osmolality affect the flow of fluid into and out of cells within the body To maintain optimal health, the cells should be maintained in a state of equilibrium CSPs must be neither hyperosmotic nor hypoosmotic this state of equilibrium is called isoosmotic, meaning that the solution has relatively the same number of dissolved particles and the same osmotic pressure as human blood plasma

Properties of Parenteral Products…/6 Tonicity Tonicity refers to the way that cells or tissues respond to surrounding fluid

Properties of Parenteral Products…/7 Tonicity…continued A hypertonic solution contains a greater number of dissolved particles than human blood plasma A hypotonic solution contains fewer dissolved particles than human blood plasma An isotonic solution contains a number of dissolved particles equivalent to human blood plasma

Properties of Parenteral Products…/8 Tonicity…continued Some conditions require treatment with a parenteral solution that is either hypertonic or hypotonic Total parenteral nutrition (TPN) and other hypertonic solutions are generally administered into larger veins such as the subclavian vein or the superior vena cava these larger veins have significantly more blood flowing through them and can more easily accommodate the hypertonic solution

Properties of Parenteral Products…/9 Tonicity…continued Unlike hypertonic solutions, hypotonic solutions, are rarely administered to patients occasionally, critical care patients who are experiencing diuresis are treated with these solutions to replace the high volume of fluid output without significantly increasing plasma sodium concentration (PNa) these patients must be monitored closely to ensure that they do not develop a potentially life-threatening electrolyte imbalance such as hyponatremia

Properties of Parenteral Products…/10 Compatibility Compatibility may be defined as the ability to combine two or more base components or additives within a solution, without creating a resultant change in the physical or chemical properties of any of the solution components or additives a CSP comprised of one or more incompatible components may result in a change to the physical or chemical characteristics this undesirable change is called an incompatibility and may be dangerous to the patient recipient

Pharmaceutical compounding sterile preparation USP Chapter <797> Guidelines for LVPs During the preparatory and compounding procedures of LVPs, the IV technician must adhere to the overarching principles set forth in USP Chapter <797> these guidelines are reinforced in each facility’s P&P manual as well As an IV technician, you bear primary responsibility for the preparation and integrity of the (compounded sterile preparation) CSPs

Understand the Resources and Supplies Essential Supplies Most sterile compounding procedures require the same essential supply items to be available for use in both the anteroom and the clean room For the anteroom, these include a standard calculator, aseptic garb, presaturated aseptic cleaning wipes, a waste container, and various other compounding supplies

Understand the Resources and Supplies…/2 Procedure-Specific Supplies LVP Supplies – Vials a vial is a sealed, sterile container that has a rubber top through which an IV technician draws fluid contains a medication either in a powdered form, which must be dissolved with a liquid diluent, or in a liquid form because a vial is a closed-system container, an IV technician uses a milking technique to easily and safely release the negative pressure within a vial to perform this technique, the IV technician adds positive pressure to the closed system this technique prevents aspiration

Understand the Resources and Supplies…/3 Procedure-Specific Supplies LVP Supplies – Vials …continued coring is an undesired event that occurs when a needle is inserted incorrectly into the rubber stopper atop a solution vial, causing a small bit of the stopper to tear off and contaminate the solution inside the vial

Understand the Resources and Supplies…/4 Procedure-Specific Supplies LVP Supplies – IV Base Solutions an IV base solution is commonly provided by the manufacturer in an IV bag made of flexible plastic or polyvinyl chloride (PVC)

Understand the Resources and Supplies…/5 Procedure-Specific Supplies LVP Supplies – IV Base Solutions…continued the button or nipple injection port can be found at the bottom of the IV bag’s face the tail injection port, the most common type of IV injection port, is located at the very bottom of the IV bag

Understand the Resources and Supplies…/6 Critical Sites of Essential Supplies and LVP Supplies Before beginning, the IV technician must recall the critical sites of the supplies care must be taken not to taint the critical site of any of the supply items through touch contamination, shadowing, or incorrect placement of the item within the hood

Preview the Lab Procedure Anteroom Preparatory Procedures verifying the CSP label against the medication order performing correct pharmacy calculations to determine type, size, and number of supply items needed gathering and cleaning of supplies performing aseptic garbing and hand washing donning a sterile gown

Preview the Lab Procedure…/2 Clean Room Preparatory Procedures cleansing hands with sterile, foamed 70% IPA donning sterile gloves cleaning the hood

Preview the Lab Procedure…/3 LVP Compounding Procedure with the small supply items arranged in the outer six-inch zone and the large supply items placed in the DCA, you are ready to begin the LVP compounding procedure