This document provides an overview of pediatric compounding sterile preparations. It discusses how pediatric medicine considers the specific healthcare needs of children. Pediatric compounding involves preparing small volume sterile solutions and considering factors like pediatric dosing, formulations, administration routes, potential complications, and USP guidelines. The document outlines supplies and procedures for compounding a pediatric special dilution, including anteroom and clean room preparation steps.
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Learning Objectives
Recognize the origins of pediatric medicine and pharmacy.
Identify the special situations and actions that must be
considered when preparing medicine for pediatric use.
Identify the USP Chapter <797> procedures that must be
performed when compounding pediatric preparations.
Demonstrate correct technique in preparing a pediatric special
dilution.
2012 Paradigm Publishing
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Topics
Learning Objectives
Introduction
Pediatric CSPs
Pediatric Dosing
Pediatric Formulations
Administration of Pediatric CSPs
Potential Complications of Pediatric CSPs
USP Chapter <797> Guidelines for Pediatric
CSPs
Understand the Resources and Supplies
Preview the Lab Procedure
Chapter Summary
2012 Paradigm Publishing
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Introduction
Pediatric medicine, as well
as pediatric pharmacy,
acknowledges the specific
healthcare needs of
children by providing
specialized sterile
preparations that are safe
and effective for this
patient population
2012 Paradigm Publishing
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Pediatric CSPs
Pediatric CSPs are sterile solutions that typically
have a volume of 500 mL or less
the most commonly prepared pediatric CSPs include IV
push antibiotics, LVP solutions for hydration, and total
parenteral nutrition solutions
the physical and chemical properties of parenteral
pediatric medications vary somewhat, but most of these
medications are generally isotonic, isoosmotic, and pH
neutral
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Pediatric Dosing
During child growth and development, the
biochemical and physiological processes that control
drug disposition undergo important changes
this is especially true for the first three years of a child’s life
at this young age, drugs may be absorbed or eliminated
more slowly or more rapidly than in adults
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Pediatric Dosing…/2
Many factors must be considered
when determining pediatric
dosing for a patient, including:
pediatric anatomy and physiology
body weight or body surface area
(BSA)
age
diagnosis
drug disposition
organ functioning
2012 Paradigm Publishing
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Pediatric Formulations
Pediatric dosing has long been based on adult-
strength formulations of medications
This method of dosing continues to be used today,
with prescribers using body weight or BSA to help
them determine appropriate dosages for parenteral
medications
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Pediatric Formulations…/3
Many manufacturers have reformulated certain
adult-strength medications into diluted
concentrations, or pediatric-strength formulations,
making pediatric dose preparation easier and more
accurate
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Pediatric Formulations…/4
Regardless of whether the pediatric medication is
based on an adult-strength formulation or a
pediatric-strength formulation, all drugs for pediatric
use are required to undergo studies prior to approval
by the Food and Drug Administration
this federal law—included in a 2007 amendment to the
Federal Food, Drug, and Cosmetic Act— was established to
improve the safety and efficacy of pediatric medications
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Administration of Pediatric CSPs
Pediatric CSPs are primarily given as continuous IV
infusions or as intermittent doses using the IV push
route of administration
Continuous IV Infusion
Many pediatric patients receive a continuous IV
infusion during their hospitalization
are generally comprised of an IV base solution to which an
additive, such as potassium chloride, is injected during
sterile compounding procedures
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Administration of Pediatric CSPs…/2
Continuous IV Infusion…continued
Administration of a Continuous IV Infusion
a peripheral access point is established
for some pediatric patients, it may be more practical for
the nursing staff to establish a central line or gain IV access
through a femoral line or umbilical line
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Administration of Pediatric CSPs…/3
Continuous IV
Infusion…continued
Administration of a Continuous
IV Infusion…continued
once an access point has been
established, nursing personnel
use an IV pump programmed to
deliver the medication at a flow
rate designated by the prescriber
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Administration of Pediatric CSPs…/4
Intermittent CSP
Administration
Parenteral medications
requiring intermittent
dosing are commonly
administered by the IV
push route
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Administration of Pediatric CSPs…/5
Intermittent CSP Administration…continued
Compounded Syringes
compounded syringes are syringes of medication that are
compounded in the pharmacy and then sent to a nursing
unit for patient administration
are typically sent without an attached needle
using a syringe cap rather than a capped needle is a
precautionary measure taken to avoid a needle stick from
the accidental dislodgment of the needle cap during
transport
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Administration of Pediatric CSPs…/6
Intermittent CSP
Administration…continued
Compounded
Syringes…continued
once the syringe cap is
attached, an IVA syringe
seal is then placed over
the cap to ensure that the
contents of the syringe
remain sterile
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Administration of Pediatric CSPs…/7
Intermittent CSP Administration…continued
Empty Evacuated Containers
often, a pediatric IV push medication is compounded into
patient-specific vials or empty plastic bags known as
empty evacuated containers (EECs)
useful for neonatal patients whose size dictates further
dilution of a pediatric-strength drug with preservative-free
(PF) sterile water or NS
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Administration of Pediatric CSPs…/8
Intermittent CSP Administration…continued
Empty Evacuated Containers…continued
EECs have several advantages for nursing and pharmacy
personnel:
• EECs can still be used if the patient dosage changes
• EECs are transported as vials, not as syringes
• preparing batches of EECs is easier and more
convenient
one disadvantage of EECs is that they are more costly than
the syringe dosage form
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Administration of Pediatric CSPs…/9
Intermittent CSP
Administration…continued
Administration of Pediatric
Push Medications
should be administered
either by a syringe pump or
by the use of a buretrol
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Administration of Pediatric CSPs…/10
Intermittent CSP Administration…continued
Administration of Pediatric Push
Medications…continued
a buretrol is a special type of tubing that contains a large,
tube-shaped cylinder
the IV push medication is injected into the cylinder, where
it mixes with a specific volume of fluid from the patient’s
primary IV solution
the diluted medication is then administered through the
tubing via a pump programmed to slowly inject the
medication over a preset period
2012 Paradigm Publishing
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Your Turn
2012 Paradigm Publishing
1) Often, a pediatric IV push medication is compounded into patient-
specific vials or empty plastic bags known as this.
a. CCEs
b. CEEs
c. ECCs
d. EECs
2) This is a special type of tubing that contains a large, tube-shaped
cylinder.
a. buretrol
b. special dilution
c. nasogastric
d. secondary
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Potential Complications of Pediatric
CSPs
All patients receiving parenteral therapy should be
monitored for the following complications:
nosocomial infection
allergic reaction (including anaphylaxis)
phlebitis
tissuing
embolism
extravasation
cellulitis
Stevens-Johnson syndrome
nephrotoxicity
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Potential Complications of Pediatric
CSPs…/2
Preparation Risks
During the compounding of pediatric preparations,
pediatric CSP ingredients must be considered
benzyl alcohol may cause damage to multiple organ
systems, potentially triggering a life-threatening condition
called benzyl alcohol gasping syndrome
for this reason, only preservative- free (PF) ingredients
should be used in pediatric CSPs
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Potential Complications of Pediatric
CSPs…/3
Preparation Risks…continued
The compounding of pediatric CSPs requires
additional oversight to ensure the accuracy of
pharmacy calculations
because of the small size and delicate nature of pediatric
patients, even minor errors in dosage calculation of a
pediatric CSP could be fatal
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Potential Complications of Pediatric
CSPs…/4
Administration Risks
Because children,
especially neonates, are so
small, the total volume of
parenteral fluid being
administered to this patient
population must be
significantly smaller than
the fluid volumes given to
adult patients
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Potential Complications of Pediatric
CSPs…/5
Administration Risks…continued
If too much fluid were to be administered to a
neonate too quickly (generally referred to as
accidental rapid administration), hypervolemia,
cardiac arrest, or death may result
the cause of such an error is most commonly a nursing or
IV pump error
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Potential Complications of Pediatric
CSPs…/6
Administration
Risks…continued
Many hospitals avoid
accidental fluid overload by
enacting policies that prohibit
the use of 1000-mL IV bags
with pediatric patients
in addition, facilities limit the
size of an IV bag to 250 or
500 mL for neonates
2012 Paradigm Publishing
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USP Chapter <797> Guidelines
for Pediatric CSPs
IV technicians must adhere to strict dosage
verification and aseptic protocols when preparing
pediatric CSPs
any breach in these protocols may result in medication
errors, sepsis, or, possibly, death for patient recipients
as an IV technician, you bear primary responsibility for the
preparation and integrity of the CSPs
2012 Paradigm Publishing
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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
The type, number, and
amount of procedure-specific
supply items are determined
by the IV technician prior to
performing the procedure,
based on information
provided on the CSP label and
the medication additive label
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Understand the Resources and
Supplies…/3
Procedure-Specific Supplies…continued
Pediatric Special Dilution Supplies
the process of compounding certain pediatric CSPs
involves the manipulation of regular needles and, in
particular, medication, diluent, and EEC vials
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Understand the Resources and
Supplies…/4
Procedure-Specific Supplies…continued
Pediatric Special Dilution Supplies…continued
PF Gentamicin Vial - check the vial’s medication label for
the word Pediatric (or Pedi) and for the words
preservative-free or the abbreviation PF
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Understand the Resources and
Supplies…/5
Procedure-Specific Supplies…continued
Pediatric Special Dilution Supplies…continued
PF Diluent Vial—the type of diluent most often used when
preparing pediatric CSPs is normal saline (NS)
EECs—are used to prepare custom-made CSPs
• pediatric special dilutions provide accurate parenteral
medication dosing
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Understand the Resources and
Supplies…/6
Critical Sites of Essential Supplies and Pediatric CSP
Supplies
Before beginning preparatory procedures in the
anteroom or clean room, the IV technician must
recall the critical sites of the supplies
identifying the critical site of each supply item helps you
determine the proper procedure for handling the supply
item once you have entered the clean room and begin
working in the hood
2012 Paradigm Publishing
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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
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…/2
Pediatric Special Dilution Compounding Procedure
bring the PF gentamicin vial into the direct compounding
area (DCA)
you are now ready to begin the compounding procedure
in preparation for the verification check, position the filled
and capped diluent syringe next to the diluent vial on the
hood’s work surface
after the verification check, reposition the EEC vial
upon completion of the pediatric special dilution
compounding procedure, dispose of used vials and supply
items in the appropriate waste container
2012 Paradigm Publishing
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Your Turn
2012 Paradigm Publishing
3) Many hospitals avoid accidental fluid overload by prohibiting the use of
these IV bags with pediatric patients.
a. 50-mL
b. 500-mL
c. 1000-mL
d. 100-mL
4) This is the type of diluent most often used when preparing pediatric
CSPs.
a. sterile water
b. dextrose
c. lactated Ringer’s
d. normal saline
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