Small-Volume Parenteral Preparations

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Chapter 9

Small-Volume Parenteral

Preparations

2012 Paradigm Publishing

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Learning Objectives

Recognize the origins of small-volume parenteral preparations—in particular, antibiotics.

Understand the USP Chapter <797> procedures that must be performed prior to sterile compounding procedures.

Identify the critical sites of various small-volume parenteral preparation supply items, and describe compounding situations in which certain supply items should be used.

Discover the USP Chapter <797> procedures that must be performed during small-volume parenteral preparation.

Demonstrate effective technique in the preparation of two small-volume compounded sterile preparations.


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Learning Objectives

Introduction

IVPBs

Compounding of IVPBs

Administration of IVPBs

Potential Complications of Parenteral Therapy

USP Chapter <797> Guidelines for SVPs

Understand the Resources and Supplies

Preview the Lab Procedure

Chapter Summary


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Introduction

Small-volume parenteral (SVP) preparations—known simply as SVPs—are sterile solutions that typically have a volume of 25 mL, 50 mL, 100 mL, 150 mL, or 250 mL

in general, these solutions are neutral, isotonic, and isosmotic


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IVPBs

The majority of SVPs prepared by sterile compounding personnel are IV piggybacks, or IVPBs

an IVPB is comprised of a small volume of a base solution and a medication

the standard IV base solution may be a sterile fluid such as dextrose 5% in water (D5W), normal saline (NS), half normal saline (½ NS), or sterile water


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IVPBs…/2

Unlike an LVP that is given for hydration or the continuous infusion of medication, an IVPB is used solely for the intermittent IV administration of medication according to a dosing schedule specified by a prescriber

this intermittent infusion is accomplished by piggybacking the SVP through the tubing containing a patient’s primary IV solution


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IVPBs…/3


A limited number of IVPBs are supplied as premixed, shelf-stable, or frozen products

other types are available in vial and bag systems

the majority of ordered IVPBs must be compounded by an IV technician

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Compounding of IVPBs

A prescriber typically indicates the medication name, dose, and dosing interval or schedule, without specifying the base solution or volume


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Compounding of IVPBs…/2

The pharmacist considers several factors when choosing the most appropriate IVPB base solution and volume, including:

the compatibility of the medication with the base solution

the length of time over which the IVPB is to be administered

the kidney function and hydration status of the patient recipient

the minimum or maximum concentration required for safe administration of the drug


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Antibiotic Preparations

Antibiotics are antimicrobial medicines used to treat a variety of infections caused by certain types of microorganisms, such as fungi, protozoa, or bacteria

not effective in the treatment of viruses

The terms antibiotic drugs and antibacterial drugs are sometimes used interchangeably


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Antibiotic Preparations…continued

Most bacterial microorganisms are said to be either gram-positive or gram-negative organisms

in essence, gram-positive bacteria have thicker cell walls than gram-negative bacteria

patients requiring IVPB antibiotic therapy often undergo blood testing (known as a culture and sensitivity test) to determine which pathogenic organism is causing the infection and—if the microorganism is a type of bacteria—whether the organism is gram-positive or gram-negative


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Administration of IVPBs

IVPBs are administered over a short period

Most IVPBs are administered by piggybacking them through a patient’s primary IV lineoccasionally, an IVPB medication is administered to a

patient who does not have a primary IV line

in this situation, the IVPB is administered through secondary IV tubing, directly into the patient’s vein, via a temporary injection port. This type of injection port—called a heparin lock, saline lock, or, simply, a lock—is attached to a flexible needle that is maintained in the patient’s vein


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Potential Complications of Parenteral Therapy

All patients receiving parenteral therapy should be monitored for the following complications:nosocomial infectionallergic reaction (including anaphylaxis)phlebitistissuingembolismextravasationcellulitisStevens-Johnson syndromenephrotoxicity


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Potential Complications of Parenteral Therapy…/2

For antibiotic SVPs, there is an increased likelihood for allergic reactions, including anaphylaxis; Stevens-Johnson syndrome; and nephrotoxicity


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Incompatibility Issues

In addition to these risks, IVPBs, due to their administration setup, have the potential for incompatibility issues

for example, if two incompatible medications are administered through the same IV tubing, a precipitatecould form, clogging the IV tubing and potentially causing injury to the patient


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Incompatibility Issues…continued

The primary IV tubing or the lock must be flushed after the IVPB medication has been administeredif the patient is receiving a primary IV solution, the flush is

performed by lowering the empty IVPB bag with secondary tubing attached to a height that allows gravity to force the primary IV solution to back up into the secondary tubing line

for patients without a primary IV solution, the lock is usually flushed with a small volume of either NS solution, or a heparinized saline solution


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Antibiotic-Resistant Bacteria

IV technicians should be aware of a growing health concern in the use of antibiotic therapy—the development of antibiotic-resistant bacteria

known as superbugs

the evolution of superbugs has been influenced by two factors: the widespread use of antimicrobial disinfectants and the overuse of antibiotics


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Antibiotic-Resistant Bacteria …continued

Antimicrobial Overuse

an antimicrobial is a substance or chemical compound capable of killing or inhibiting the growth of microorganisms

antimicrobial agents may be found in many hand soaps, cleansers, and surface disinfectants, as well as some medicines

the rise in the use of these products has helped to strengthen various microbes


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Antibiotic-Resistant Bacteria …continued

Antibiotic Overuse

often, prescribers yield to a patient’s demand for an antibiotic for an illness that may be viral, not bacterial

another source of antibiotic overuse comes from the use of antibiotics in the meat and dairy industries, whose policies allow for the administration of prophylactic antibiotic treatment to promote animal growth and to prevent and treat illness in livestock


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Superbugs as a Global Health Threat

Due to the widespread use of antimicrobials and antibiotics, superbugs such as methicillin-resistant Staphylococcus aureus (MRSA), carbapenem-resistant Klebsiella pneumoniae (CRKP), and New Delhi metallo-beta-lactamase (NDM-1) are on the rise and considered by many scientists to pose a serious threat to global health


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Superbugs as a Global Health Threat…continued

The World Health Organization (WHO) used World Health Day (April 7, 2011) to issue an urgent plea: The message on this World Health Day is loud and clear. The world is

on the brink of losing these miracle cures. The emergence and spread of drug-resistant pathogens has accelerated. More and more essential medicines are failing. The therapeutic arsenal is shrinking. The speed with which these drugs are being lost far outpaces the development of replacement drugs. In fact, the R&D pipeline for new antimicrobials has practically run dry. The implications are equally clear. In the absence of urgent corrective and protective actions, the world is heading towards a post-antibiotic era, in which many common infections will no longer have a cure and, once again, kill unabated.


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Your Turn


1) This is a substance or chemical compound capable of killing or inhibiting the growth of microorganisms.

a. microbe

b. antibiotic

c. antimicrobial

d. saline

2) These are considered by many scientists to pose a serious threat to global health.

a. colds

b. bacterial infections

c. superbugs

d. viruses

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USP Chapter <797> Guidelines for SVPs

During the preparatory and compounding procedures of SVPs, an 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

in accordance with these guidelines, sterile compounding personnel must pay strict attention to aseptic technique protocols both in the anteroom and clean room


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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


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Understand the Resources and Supplies…/2

Procedure-Specific Supplies

IVPB Supplies – Vials

most IVPB compounding procedures require an IV technician to reconstitute a powdered antibiotic within a vial

to do so, the technician draws up diluent from a separate vial and injects that fluid into the vial containing the powdered antibiotic

there are several methods that may be used to complete this procedure, including the use of the milking technique, a vented needle, or a repeater pump


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IVPB Supplies – Vials…continued

because positive pressure was created within the vial when the diluent was injected, the milking technique can be used to withdraw the dissolved powder from the vial without injecting air

this method of reconstituting a powder within a vial is best used when preparing a single CSP in which the entire contents of a vial are injected into the IVPB to provide the desired dose


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IVPB Supplies – Vented Needles

in addition to regular needles, some IVPB sterile compounding situations require the use of a vented needle


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IVPB Supplies – Vented Needles…continued

a vented needle has a razor tip and is surrounded by a tiny aluminum needle sheath

this unique design allows the injection of the diluent into the vial while simultaneously venting air from the vial

this type of needle is used solely to reconstitute a powdered medication within a vial


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IVPB Supplies – IVPB Base Solutions

an IVPB base solution bag is very similar in design and function to that of an LVP bag

the IVPB base solution bag is only available with a tail injection port

when using an IVPB bag, the needle should be inserted directly into the injection port without regard to the position of the needle bevel, and without creating any bend to the needle, as is done when inserting a needle into a vial


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Critical Sites of Essential Supplies and IVPB Supplies

Before beginning preparatory procedures in the anteroom or clean room, the IV technician must recall the critical sites of the supplies

After identifying the critical sites of all supply items, care must be taken not to taint the critical site of any supply item 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

Once the hood has been cleaned, you must transfer the clean supplies from the transport vehicle or clean countertop to certain areas of the hood


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SVP Compounding Procedure, Scenario One: Reconstitution Using the Milking Technique


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SVP Compounding Procedure, Scenario Two: Reconstitution Using a Vented Needle


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Your Turn


3) This technique can be used to withdraw the dissolved powder from a vial without injecting air.

a. shadowing

b. reconstitution

c. milking

d. filtering

4) This type of needle has a razor tip and is surrounded by a tiny aluminum needle sheath.

a. regular

b. filter

c. vented

d. beveled

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Health & Medicine

Small-Volume Parenteral Preparations