large-volume parenteral preparations

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Chapter 8

Large-Volume

Parenteral Preparations

2012 Paradigm Publishing

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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.


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Learning Objectives

Introduction

Physiology of Fluid Balance

Properties of Parenteral Products

Potential Complications of Parenteral Therapy

LVP Preparations

USP Chapter <797> Guidelines for LVPs

Understand the Resources and Supplies

Preview the Lab Procedure

Chapter Summary


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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


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Physiology of Fluid Balance

Water is a critical element of the human body, composing approximately 70% of the body’s weight

primarily found within the cells of the body, or intracellular spaces, but it also can be found in the spaces between the cells, or interstitial spaces, and in the spaces outside the cells, or extracellular spaces

also a component of blood vessels, where it is found in the intravascular spaces


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Physiology of Fluid Balance…/2

Maintaining the proper level of fluid and electrolytes within the body, called homeostasis, is essential for human life

fluid enters the body through the normal processes of drinking and eating and exits the body through the processes of perspiration, respiration, urination, and bowel evacuation


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When certain conditions affect normal fluid intake and output patients may be at risk for dehydration

occurs when the amount of water entering the body is less than the amount of water leaving the body

extreme loss of fluid may lead to kidney failure, cardiac arrest, or death

the quickest method of rehydration is through the injection of parenteral solutions into the blood supply

The vast majority of CSPs prepared by IV technicians are large-volume parenteral products


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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


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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


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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


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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 solventosmolality refers to the number of ions or molecules in a

solution


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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


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Tonicity

Tonicity refers to the way that cells or tissues respond to surrounding fluid


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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


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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 cavathese larger veins have significantly more blood flowing

through them and can more easily accommodate the hypertonic solution


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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


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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 additivesa 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


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Your Turn


1) A solution with a pH of 7.0 is considered to be this.

a. acidic

b. alkaline

c. neutral

d. low

2) This type of solution contains a greater number of dissolved particles than human blood plasma.

a. hypertonic

b. hypotonic

c. isotonic

d. isoosmotic

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Potential Complications of Parenteral Therapy

Preparation Hazards

In fact, parenteral medications are considered to be more dangerous than enteral products for several reasons:

parenteral products are administered directly into a patient’s blood supply, organs, or tissues

parenteral solutions injected into the bloodstream have little or no chance of reversal if a medication error is made

parenteral administration introduces 100% of the drug into the bloodstream


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Potential Complications of Parenteral Therapy…/2

Administration Hazards

All patients receiving parenteral fluids should be monitored for nosocomial infection, extravasation, tissuing, phlebitis, cellulitis, embolism, allergic reaction (including anaphylaxis), Stevens-Johnson syndrome, and nephrotoxicity

to manage these complications, healthcare practitioners use various techniques, including the use of access points, to administer LVPs


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Administration Hazards…continued

The most common access point is through a peripheral vein, into which a nurse inserts a needle, a catheter, or cannula, which is attached to IV tubing

this type of IV line is known as a peripheral IV line is most often used for a patient who requires short-term treatment

Patients who require long-term treatment may need a PICC line


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Administration Hazards…continued

Other IV access points include the subclavian vein, superior vena cava, or femoral vein

these access points are reached through the use of various access devices such as the central line, Hickman line, Broviac line, and various implantable ports


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Adherence to USP Chapter <797> Guidelines

In light of these potential complications, IV technicians must adhere to strict aseptic technique when preparing parenteral medications, and healthcare personnel must be vigilant during their administration to patients


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LVP Preparations

Large-volume parenteral (LVP) preparations—or, simply, LVPs—are sterile solutions of 250 mL or greater that are administered parenterally


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LVP Preparations…/2

The most common LVPs are IV solutions compounded from a standard solution or base solution such as 0.9% sodium chloride (also known as NS), dextrose 5% in water (D5W), dextrose 5% in normal saline (D5NS), and LR solution

The most common volumes for LVPs are 250 mL, 500 mL, and 1000 mL

These IV solutions can be administered as either a continuous infusion or a drip


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Continuous Infusion

A continuous infusion—also called a maintenance infusion, replacement infusion, or hydration infusion—typically consists of a base solution with additives


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Continuous Infusion…continued

A continuous infusion is used to:

prevent or correct dehydration and restore electrolyte balance in a patient whose condition impedes adequate fluid consumption

replace fluids in a patient who has experienced significant blood loss from trauma or a surgical procedure

provide easy vein access for blood draws and medication administration in a patient during a hospital stay


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Drip

A second type of LVP solution is referred to as a drip

unlike continuous infusions, drip solutions are used to continuously deliver an IV medication to treat a specific medical condition

A physician may order an IV drip to be “titrated to effect”

in this instance, a medication such as nitroglycerin is administered at such a rate as to relieve the patient’s chest pain


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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 CSPs


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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


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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 positivepressure to the closed system

this technique prevents aspiration2012 Paradigm Publishing

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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


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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)


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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


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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


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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


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Preview the Lab Procedure…/2

Clean Room Preparatory Procedures

cleansing hands with sterile, foamed 70% IPA

donning sterile gloves

cleaning the hood


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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


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Your Turn


3) This is used to continuously deliver an IV medication to treat a specific medical condition.

a. milking technique

b. continuous infusion

c. drip solution

d. aspiration

4) This is an undesired event that occurs when a needle is inserted incorrectly into a vial’s rubber top.

a. tissuing

b. shadowing

c. coring

d. milking

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large-volume parenteral preparations

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