Equipment and Techniques in Intravenous Preparation

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Chapter 11
Created by Jennifer Majeske, Mineral Area College
Identify the role and function of equipment used
in intravenous preparation and administration,
including syringes, needles, intravenous sets,
catheters, infusion pumps, and filters.
Identify the components of an intravenous
administration set.
Describe common characteristics of intravenous
solutions, including pH value, osmolarity and
osmolality, tonicity, compatibility, and stability.
Created by Jennifer Majeske, Mineral Area College
Summarize the steps necessary for aseptic
technique in a hospital pharmacy.
Describe the correct procedure used in
preparing compounded sterile preparations
from vials and ampules for hazardous and
nonhazardous agents.
Discuss the preparation of total parenteral
nutrition.
Differentiate between expiration dating and
beyond-use dating.
Created by Jennifer Majeske, Mineral Area College
Understand the types of premade parenteral
products, including vial-and-bag systems and
frozen intravenous solutions, and their
handling requirements.
Calculate intravenous flow rate.
Discuss the importance of and techniques for
preparing, handling, and disposing of
hazardous agents.
Define the purpose and list examples of
quality assurance programs in the hospital.
Created by Jennifer Majeske, Mineral Area College
Hospitals carry out unique activities, such as the
preparation, handling, and disposing of
hazardous drugs.
A major responsibility of the pharmacy tech
involves compounded sterile products (CSPs).
Aseptic technique
 – the processes and physical
preparation methods used by sterile
compounding personnel to avoid introducing
pathogens, into parenteral products.
Compliance with sterile compounding and
aseptic technique standards established by USP.
Reflected in Chapter <797> standards.
Created by Jennifer Majeske, Mineral Area College
Syringes and Needles
: used for withdrawing
or injecting solutions during the preparation
of CSPs.
IV push (IVP)
 – bolus administration; rapid
injection of a medication.
Syringes
: made of glass or plastic; glass –
limited use, expensive; plastic – less
expensive, supplied in sterile packaging,
disposable.
Created by Jennifer Majeske, Mineral Area College
Main components:
Syringe tip
Barrel – contains calibration marks
Rubber-tipped piston plunger
Created by Jennifer Majeske, Mineral Area College
Technicians should choose the smallest
syringe that is able to hold the desired
volume; at least ¾ full.
Technicians should count the number of
marks between labeled measurement units,
to get the most accurate dose.
The volume of solution is  measured at the
point of contact between the rubber-tipped
piston plunger and the inside of the barrel.
Created by Jennifer Majeske, Mineral Area College
Needles are made of stainless steel or
aluminum.
Needle size is determined by length and
gauge.
Lengths range from 3/8 inch to 6 inches.
Gauge refers to the diameter of the opening;
the larger the gauge number the smaller the
opening (or size of the lumen).
31-gauge (smallest bore)
13-gauge (largest bore)
Created by Jennifer Majeske, Mineral Area College
Parts of a Needle
:
Needle tip
Bevel
Heel
Needle shaft
Needle lumen
Needle hub
Handling of the Needle-and-Syringe Unit
:
A syringe comes from the manufacturer in sterile
packaging.
Sterile compounding personnel must not touch the
sterile parts or critical sites of the syringe or needle.
Created by Jennifer Majeske, Mineral Area College
Critical site
 – the part of
the supply item that
includes any fluid-
pathway surface or
opening that is at risk
for contamination
by touch or
airflow interruption.
Created by Jennifer Majeske, Mineral Area College
IV administration set
 – a sterile, disposable
device used to deliver IV fluids and injectable
medications directly into a patient’s vein.
IV sets do not have expiration dates, but do
contain “Federal law restricts this device to
sale by or on the order of a physician.”
An IV infusion pump is nondisposable,
reusable equipment often referred to as
durable equipment
.
Created by Jennifer Majeske, Mineral Area College
Universal spike adaptor (
tubing spike 
or 
spike
)
Pierces the rubber stopper or port of the IV
Drip chamber
Allows healthcare personnel to view and count drops
of IV fluid
Roll clamp
Adjust flow rate
Flexible tubing
Delivers the fluid
Needle adaptor
Attaches a needle or catheter to the patient
Created by Jennifer Majeske, Mineral Area College
Universal Spike Adaptor
: 
spike
 – used to
pierce the IV’s tubing port; some IV sets have
an air vent.
Drip chamber
 – hollow drip chamber; allows
any air bubbles to rise to the top of the IV
fluid.
Drop set
 – number of drops it takes to make 1
mL; also know as the tubing’s 
drop factor
.
Macrodrip set
: 10, 15, 20 gtts/mL
Microdrip
 or
 minidrip set
: 60 gtts/mL
Created by Jennifer Majeske, Mineral Area College
Roll Clamp
 – a hard, plastic clip that contains a
smaller roller allowing control of the flow of
fluid.
Flexible tubing
IV tubing, molded from pliable
PVC and other plasticizers.
Needle adaptor
 – usually located at the distal
end of the IV set, close to the patient.
Additional Components of an IV set
:
Y-site injection port
 – allows medication to be added
to the IV solution
In-line filter
 – provides protection against particulates
Created by Jennifer Majeske, Mineral Area College
Length of IV sets vary, ranging from 6 to 120
inches.
What determines length of IV tubing?
Priming
 – the action of flushing out the small
particles in the tubing’s interior lumen before
medication administration.
The amount of fluid needed to prime the tubing
depends on the length of the set – 3 to 15 mL.
In-line filters has reduced the need for flushing
the line with IV fluid before administration.
Created by Jennifer Majeske, Mineral Area College
Nurses typically administer IV solutions to
patients by attaching the IV tubing to the
fluid container, establishing flow rate, and
managing overall regulation.
Catheter
 – tube, implanted in the patient and
affixed to the patient’s skin.
IV sets are changed every 24 – 96 hours to
minimize the risk of infection.
Created by Jennifer Majeske, Mineral Area College
Changes in the scope of pharmacy practice
make it necessary for pharmacy personnel to
have a complete understanding of IV sets and
their operations.
Pharmacist may:
Select IV sets
Serve on CPR or code teams
Provide in-service training
Use IV sets when transferring fluids
Prime IV sets
Created by Jennifer Majeske, Mineral Area College
Filter
 – a device used to remove contaminants
such as glass, fibers, and tiny bits of rubber that
may have inadvertently entered the CSP during
sterile compounding.
Depending on size, filtration should protect the
patient.
Filters do not remove virus particles or toxins.
Common filter sizes:
0.5 micron: random path membrane
0.45 micron: in-line filter
0.22 micron: removes bacteria to produce a sterile
solution
Created by Jennifer Majeske, Mineral Area College
Most IV preparations are comprised of
ingredients added to a sterile water medium
or base solution.
Certain chemical properties or characteristics
are needed of these preparations so damage
does not occur to the patients blood cells or
vessels or alters the chemical properties of
blood.
CSPs must possess chemical characteristics
similar to blood serum.
Created by Jennifer Majeske, Mineral Area College
Beyond-use date 
– the date and time after
which a CSP is no longer sterile, stable, or
effective.
pH Value
 
– the degree of acidity or alkalinity of a
solution.
Less than 7.0 = acidic
Greater than 7.0 = basic (alkaline)
Blood plasma pH 7.4
IV solutions should have a pH that is neutral
(near 7.0) so they don’t adversely affect the pH
of the blood.
Created by Jennifer Majeske, Mineral Area College
Osmolarity
 – a measure of the number of
milliosmoles of solute per liter of solution (mOsm/L).
Blood plasma = 285 mOsm/L
Osmotic pressure
 – the pressure required to maintain
equilibrium, with no net movement of solution across
body membranes.
Osmolality
 – a measure of the number of
milliosmoles of solute per kilogram of solvent.
An IV preparation must be isoosmotic, meaning the
solution should have the same number of particles in
solution per unit volume and the same osmotic
pressure as blood.
Created by Jennifer Majeske, Mineral Area College
Hypotonic solution
 
– hypoosmolar solution;
fewer number of dissolved particles than blood
cells; water is drawn into cells, causing cells to
swell.
0.45% 
normal saline (NS)
Hypertonic solution
 – hyperosmolar solution;
greater number of dissolved particles than blood
cells; water is drawn out of cells, causing cells to
shrivel.
50% dextrose or 3% sodium chloride
Isotonic solution
 – similar number of dissolve
particles as blood.
0.9% NS
Created by Jennifer Majeske, Mineral Area College
Compatibility
 – the ability to combine two or
more base components or 
additives
 within a
solution, without resulting in changes to the
physical or chemical properties of the
additives.
Stability
: is affected by storage conditions;
some IV medications need to be refrigerated
or frozen after compounding; amber-colored
bags protect the drug from exposure to light.
Created by Jennifer Majeske, Mineral Area College
Multiple IV solutions are available.
Most common used IV infusions are dextrose
in water, normal saline, or dextrose in saline.
Table 11.1 pg. 444 Commonly Used IV
Products and Abbreviations
Technicians typically compound two types of
CSPs:
Large-volume parenterals
Primary source of hydration
Small-volume parenterals
“piggybacked”
Created by Jennifer Majeske, Mineral Area College
Large-volume parenteral (LVP)
 – is used to
replenish fluids and to provide drugs,
electrolytes, and nutrients such as vitamins,
minerals, and glucose.
LVPs commonly available:
250 mL, 500 mL, and 1000 mL
Potassium chloride is the most common
additive.
Lactated Ringer’s Solution
 – IV solution that
contains a specific mixture of electrolytes.
Created by Jennifer Majeske, Mineral Area College
Small-volume parenteral (SVP)
 – a CSP that is
dispensed in a minibag; over a short time period
10 minutes to an hour.
SVPs commonly available:
25 mL, 50 mL, 100 mL, 150 mL, or 250 mL
IV piggybacks (IVPBs)
 – majority of SVPs
prepared; small volume (50 to 100 mL) of a base
solution (D5W) and a medication.
Special SVP solutions include frozen IV
solutions, premade IVPBs, and vial-and-bag
systems.
Created by Jennifer Majeske, Mineral Area College
A CSP label should contain the following:
Patient’s name and id #
Room number
Medication name and dose
Base solution and amount
Infusion period
Flow rate
Beyond-use date
Signature or initials
Additional information
Created by Jennifer Majeske, Mineral Area College
Sterile preparations of IV medications by
pharmacy personnel include single- and
multi-dose vials, ampules, and other
containers that must be transferred to an LVP
or SVP.
CSPs must be prepared in an ISO Class 5
laminar airflow hood.
Table 11.2 pg. 447 Summary of Procedures to
Maintain Aseptic Technique During Sterile
Compounding
Created by Jennifer Majeske, Mineral Area College
Vials
 – a sealed, sterile, plastic or glass container
that has a hard plastic cap; sizes range from 1
mL to 250 mL.
Types of vials
:
Single-dose vials (SDV)
do not contain a preservative
one-time use
used within 1 hour or discarded
Multi-dose vials (MDV)
do contain a preservative
stable for 28 days
Created by Jennifer Majeske, Mineral Area College
First disinfect the rubber stopper with 70%
isopropyl alcohol.
Pierce the rubber top with a needle-and-
syringe unit.
Bevel up; penetrate at an angle; straightened
to 90 degrees.
Coring
 – the inadvertent introduction of a
small piece of rubber top into the solution.
A milking technique must be used to release
negative pressure within the vial.
Created by Jennifer Majeske, Mineral Area College
Some medications come freeze-dried
(lyophilized), and need to be reconstituted
with a 
diluent
 such as sterile water or NS
before being injected into the IV.
Vented needle
 – allows the diluent to be
injected into the vial while simultaneously
venting the positive pressure that has built up
within the vial.
Created by Jennifer Majeske, Mineral Area College
The technician should arrange the vial, filled
syringe, and the IV or IVPB base for a
pharmacists final check.
The pharmacist then verifies the technicians
work.
After verification the technician can proceed
with preparing the CSP; checking for leaks
and signs of incompatibility and labels the
CSP for delivery.
Created by Jennifer Majeske, Mineral Area College
Ampule
 – a small,
hermetically sealed
container that has a distinct,
elongated neck.
Contains no preservative
Some drugs are 
only
 available in an
ampule because of incompatibility with rubber
or PVC components of vials
 
Parts of an Ampule
:
head, neck, shoulder,
and body.
Break ring
 – a scored area on the neck that
marks the site where a technician will break the
glass to access the ampule’s contents.
Created by Jennifer Majeske, Mineral Area College
Opening an Ampule
: safe opening of an ampule
can be done with a piece of gauze, sterile 70%
IPA swab or a 
ampule breaker
 a small plastic cap,
placed over the head of an ampule.
Hold the ampule upright, clear the medication from
the head and neck.
Clean the neck of the ampule.
Hold the ampule in the non-dominant hand, grasping
the head of the ampule with the dominant hand.
Exert firm but gentle pressure on the break ring to
snap the ampule’s neck.
Created by Jennifer Majeske, Mineral Area College
Withdrawing Medication from an Ampule
:
hold the ampule upright; bevel down in the
corner near the opening.
When the ampule is nearly empty, tilt the
ampule slightly to allow easier access to the
remainder of the medication.
A filter needle should be used when drawing
medication out of an ampule to avoid glass
fragments.
Created by Jennifer Majeske, Mineral Area College
Preparing a CSP with an Ampule’s Contents
:
similar to the process of preparation for a vial
so that it can be checked by the pharmacist.
The pharmacist verifies the technicians work.
After verification the technician may proceed
with the making of the CSP.
Lastly, the technician will need to check for
leaks and signs of incompatibility and label
the CSP for delivery.
Created by Jennifer Majeske, Mineral Area College
Total parenteral nutrition (TPN)
 – IV solutions
that provide long-term nutritional support for a
specific patient population.
Why might a patient need a TPN?
TPN Components
: approximately 15
components including:
Sterile water for hydration
Dextrose for calories and energy
Amino acids for protein synthesis
Fatty acids for chemical processes and energy
Additives: electrolytes, vitamins, and minerals
Medication for treatment of a disease or disorder
Created by Jennifer Majeske, Mineral Area College
Preparing a TPN
: 1,000 to 2,000 mL to
provide nutritional support for 12 – 24 hours.
Automated compounding device (ACD)
for the preparation of large volumes of TPN
solutions.
IV fat emulsion is known as a 3-in-1 TPN
solution.
Administering TPN
: 
central venous catheter
(CVC)
central line
, into the subclavian vein –
is required form the administration of a TPN.
Created by Jennifer Majeske, Mineral Area College
Created by Jennifer Majeske, Mineral Area College
Premade parenteral products benefits the
hospital pharmacy, the nursing staff and the
patients.
These commercially available products come as:
Vial-and-bag systems
Frozen sterile IV solutions
The expiration date varies compared with
standard beyond-use dating.
The expiration date is based on scientific studies
and can be found on the product, and can be
found on the vial or in the product package
insert.
Created by Jennifer Majeske, Mineral Area College
Vial-and-bag system
 – provides both a single
vial of powdered medication with an adaptor
and a specified IV solution that acts as the
diluent.
Types of Vial-and-Bag Systems
: ADD-
Vantage (Hospira), MINI-BAG Plus (Baxter
Healthcare); not considered CSPs.
Stability and expiration date varies with the
type and concentration of the drug, diluent,
storage conditions, and activation.
Created by Jennifer Majeske, Mineral Area College
Some of the benefits of vial-and-bag systems
include less wastage, improved safety,
efficiency, and cost-effectiveness.
Safety
: admixing errors are minimized; risk of
contamination is also minimized.
Efficiency
: doses are premeasured for rapid
reconstitution and easy assembly.
Cost-effectiveness
: no admixing is necessary
and no additional supply costs.
Created by Jennifer Majeske, Mineral Area College
Each vial-and-bag system differs somewhat,
but the concept is similar.
The vial of drug – that is not reconstituted – is
coupled (with or without an adaptor) with an
appropriate volume of IV solution.
Assembly
: the technician is responsible for
assembly; performed in the hood to maintain
sterility.
Activation
: nursing staff is responsible for
activation.
Created by Jennifer Majeske, Mineral Area College
Commercially available products and are not
considered CSPs.
Most are antibiotics and are manufactured as SVPs in
a premixed frozen state.
Handling of Frozen IV Solutions
: kept in the freezer
until an order is received; the product is then thawed
at room temp. or in the refrigerator.
Expiration date varies with the drug and storage
conditions.
Ancef – expiration date of 48 hours at room temp., 30 days
in the refrigerator
Zosyn – expiration date of 24 hours at room temp., 14
days in the refrigerator
Created by Jennifer Majeske, Mineral Area College
Certain calculation skills are necessary by a
pharmacy technician who prepares CSPs.
Most dosage calculations are done by the
pharmacy technician.
IV flow rate is used to calculate days supply
for IVs and IVPBs.
Calculation and verification differs for
chemotherapy agents, neonatal IV
medications and certain TPN preparations.
Created by Jennifer Majeske, Mineral Area College
Daily IV run
 or 
batch
 – preparation of all CSPs needed
for all patients during a specific period.
Calculations address the following questions:
What is the infusion rate in mL/hour?
Divide total volume by the number of hours: TV/H = x
How long will this bag last?
Divide the total volume by the infusion rate: TV/IR = x
What time will the next bag be needed?
Add the number of hours calculated, (x) calculated in the
previous step to the current standard time
How many bags will be needed for the patient in a 24-
hour period?
Divide 24 by the number of hours calculated in the
previous step (x).
Examples 1-4
Created by Jennifer Majeske, Mineral Area College
Electrolyte solution
 – IV fluid containing
dissolved mineral salts.
What is the most common electrolyte additive?
Electrolyte solutions are measure in
milliequivalents (mEq).
Pharmacy technicians must use pharmacy math
formulas to determine the amount of additive
that must be drawn up to provide a prescribed
dosage.
Example 5
Created by Jennifer Majeske, Mineral Area College
Hazardous agents require special handling
and preparation by pharmacy personnel.
Cytotoxic drug
 – any drug that destroys
cancer cells.
Antineoplastic drug
 – reduces or prevents
the growth of cancer cells.
Before 1980, there were few safety standards
for handling of hazardous drugs.
There exists persistent contamination in both
preparation and patient care areas.
Created by Jennifer Majeske, Mineral Area College
1.
Trauma or injury
: accidentally prick oneself with a
needle or cut from a broken container
2.
Inhalation of the hazardous substance
: releasing a
fine mist of medication and inadvertently inhaling
the substance
3.
Ingestion
: ingest minute powder when crushing an
oral tablet or cleaning a tray
4.
Direct skin contact
: accidental spill
Asparaginase can cause skin irritation
Doxorubicin can cause tissue death and sloughing
Nitrogen mustards can cause irritation of the eyes, mucous
membranes, and skin
Steptozocin is a potential carcinogen if it comes into
contact with skin
Created by Jennifer Majeske, Mineral Area College
Healthcare workers with exposure to hazardous
agents can suffer acute, chronic and long-term
health consequences.
Risks should be understood by a woman of
reproductive age who routinely works with
hazardous agents.
Incorrect aseptic technique may result in
contamination and potential infection.
Closed-system transfer devices (CSTDs) are
increasingly being used to prepare and
administer hazardous drugs.
Created by Jennifer Majeske, Mineral Area College
USP Chapter <797> indicates the donning of
protective clothing when working with
hazardous agents.
The gown should be a disposable, lint-free,
impervious, and closed-front.
Hair cover and shoe covers; eye protection,
face mask, chemotherapy gloves worn over
sterile disposable gloves 
(double gloving
)
.
Created by Jennifer Majeske, Mineral Area College
Gloves need to be worn when preparing
hazardous agents, as well as when receiving,
stocking, inventorying, and disposing.
Storage areas should be labeled: “Caution:
Hazardous Agents.”
Refrigerated hazardous agents should be
stored separately from other drugs.
Access to hazardous materials should be
limited to trained personnel.
Created by Jennifer Majeske, Mineral Area College
Strict aseptic techniques should be used in
the preparation of CSPs that contain
hazardous agents.
Biological Safety Cabinet (BSC)
 – a
specialized hood that is used to prepare
chemotherapy drugs and other hazardous
compounds.
Compounding Aseptic Containment
Isolator
 – a vertical airflow hood that is used
in the preparation of hazardous drugs.
Created by Jennifer Majeske, Mineral Area College
Specialized Supplies
:
Closed-System Transfer Devices
 
– a double
internal needle transfer with duel membranes to
provide a tight seal connection.
Chemotherapy Compounding Mat
 – a thin mat
whose side is made of absorbent material to
soak up potential fluid spills within the BSC.
Chemotherapy Dispensing Pin
 – chemo pin –
small plastic device that has a spike at one end
and an adaptor at the other end.
Created by Jennifer Majeske, Mineral Area College
Hazardous CSPs may need to be prepared from
a vial.
If a CSTD is not available, a vented
chemotherapy dispensing pin may be used to
safely withdraw fluid from a hazardous drug vial.
Negative pressure techniques: no introduction
of air into the vial or by introducing a volume of
air that is 
less than the solution volume
 to be
withdrawn.
Never inject into a hazardous drug vial more
than 75% of the volume that you plan to
withdraw.
Created by Jennifer Majeske, Mineral Area College
The process of withdrawing a hazardous drug
from an ampule is the same as with a non
hazardous drug.
A 5 micron filter needle should be place on
the syringe to withdraw the solution from the
ampule.
A standard needle is then used to inject the
fluid into an IV or IVPB.
Created by Jennifer Majeske, Mineral Area College
Hazardous oral drugs can be handled in
community, home healthcare, long-term care
and hospital pharmacies.
Counting and pouring of these medications
should be done carefully, and counting trays
should be immediately cleaned after use.
Crushing of hazardous drugs should be done
by placing the medication in a small, sealable
plastic bag and crushing with a spoon or
pestle.
Created by Jennifer Majeske, Mineral Area College
Occasionally prepared in a nuclear pharmacy
by a specially trained and certified nuclear
technician.
Handling, preparation, and disposal of
radioactive agents are beyond the scope of
this class and text.
http://www.ehow.com/facts_6822371_nuclea
r-pharmacy-technician-certification.html
Created by Jennifer Majeske, Mineral Area College
Priming and IV Administration Set
:
Wipe with sterile 70% IPA
Transported in a sealed plastic bag
Priming should be done in the BSC or CACI
Labeling Hazardous Agents
:
Patient’s name and room number, solution name and
volume, drug name(s) and dosage, CSP
administration information and storage requirements
Administering Hazardous Agents
:
A nurse must wear a mask, gloves and a special gown
Created by Jennifer Majeske, Mineral Area College
Pharmacy personnel, in the event of a
hazardous agent spill, must be aware of
proper cleanup procedures and disposal.
Spill kits
Why when cleaning up a spill should you work
from the outside in?
Spill, cleanup and personnel exposure must
be documented.
Created by Jennifer Majeske, Mineral Area College
Material Safety Data Sheet (MSDS) or Safety
Data Sheet (SDS) outlines specific
recommendations on how to handle exposure to
a hazardous substance.
Skin exposure – flush affected area immediately;
cleanse area with soap and water.
Eye contact – flush the eyes with large amounts
of water.
Remove contaminated garments; wash hands;
go to the emergency room.
Created by Jennifer Majeske, Mineral Area College
Inspection of CSP
: accuracy; technique;
packaging; labeling; physical appearance.
When combining one than more drug there is
the likelihood of physical incompatibility.
Combining an acidic and alkaline salt may
result in a solid precipitate.
Reference for physical drug incompatibility is
Trissel’s Stability of Compounding
Formulations
.
Created by Jennifer Majeske, Mineral Area College
Delivery of a CSP must be done without
damage to the package.
Proper storage conditions must be met.
IV administration times must be documented
by the nurse in the medication administration
record (MAR).
Proper labeling and storage of CSPs is
necessary if to be administered at a later
time.
Created by Jennifer Majeske, Mineral Area College
What if a CSP is returned? When can a CSP be
re-dispensed?
CSP storage conditions must be met by the
nursing unit, what happens if they are not?
What about the return of vial-and-bag
systems?
Created by Jennifer Majeske, Mineral Area College
Quality assurance (QA) program
 – detect
and correct errors; identify problems and try
to correct them so they do not recur.
What can occur if there is a breakdown in
accuracy?
The QA program is to be outline in the
hospital pharmacies P&P manual.
Following appropriate aseptic technique
minimizes microbial contamination.
Created by Jennifer Majeske, Mineral Area College
Personal training and proper handling of
CSPs and hazardous agents documentation is
required by USP Chapter <797> and Joint
Commission standards.
What areas of training must be covered for
hazardous agents?
Training must be documented and repeated
each year.
Created by Jennifer Majeske, Mineral Area College
Created by Jennifer Majeske, Mineral Area College
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Explore the role and function of equipment like syringes, needles, IV sets, catheters, etc., in IV preparation. Learn about IV solution characteristics, aseptic technique in pharmacy, handling hazardous drugs, and quality assurance programs in hospitals. Discover the importance of aseptic technique in sterile compounding and compliance with USP standards.

  • IV preparation
  • sterile compounding
  • aseptic technique
  • pharmacy equipment
  • hospital activities

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  1. Chapter 11 Created by Jennifer Majeske, Mineral Area College

  2. Identify the role and function of equipment used in intravenous preparation and administration, including syringes, needles, intravenous sets, catheters, infusion pumps, and filters. Identify the components of an intravenous administration set. Describe common characteristics of intravenous solutions, including pH value, osmolarity and osmolality, tonicity, compatibility, and stability. Created by Jennifer Majeske, Mineral Area College

  3. Summarize the steps necessary for aseptic technique in a hospital pharmacy. Describe the correct procedure used in preparing compounded sterile preparations from vials and ampules for hazardous and nonhazardous agents. Discuss the preparation of total parenteral nutrition. Differentiate between expiration dating and beyond-use dating. Created by Jennifer Majeske, Mineral Area College

  4. Understand the types of premade parenteral products, including vial-and-bag systems and frozen intravenous solutions, and their handling requirements. Calculate intravenous flow rate. Discuss the importance of and techniques for preparing, handling, and disposing of hazardous agents. Define the purpose and list examples of quality assurance programs in the hospital. Created by Jennifer Majeske, Mineral Area College

  5. Hospitals carry out unique activities, such as the preparation, handling, and disposing of hazardous drugs. A major responsibility of the pharmacy tech involves compounded sterile products (CSPs). Aseptic technique the processes and physical preparation methods used by sterile compounding personnel to avoid introducing pathogens, into parenteral products. Compliance with sterile compounding and aseptic technique standards established by USP. Reflected in Chapter <797> standards. Created by Jennifer Majeske, Mineral Area College

  6. Syringes and Needles: used for withdrawing or injecting solutions during the preparation of CSPs. IV push (IVP) bolus administration; rapid injection of a medication. Syringes: made of glass or plastic; glass limited use, expensive; plastic less expensive, supplied in sterile packaging, disposable. Created by Jennifer Majeske, Mineral Area College

  7. Main components: Syringe tip Barrel contains calibration marks Rubber-tipped piston plunger Created by Jennifer Majeske, Mineral Area College

  8. Technicians should choose the smallest syringe that is able to hold the desired volume; at least full. Technicians should count the number of marks between labeled measurement units, to get the most accurate dose. The volume of solution is measured at the point of contact between the rubber-tipped piston plunger and the inside of the barrel. Created by Jennifer Majeske, Mineral Area College

  9. Needles are made of stainless steel or aluminum. Needle size is determined by length and gauge. Lengths range from 3/8 inch to 6 inches. Gauge refers to the diameter of the opening; the larger the gauge number the smaller the opening (or size of the lumen). 31-gauge (smallest bore) 13-gauge (largest bore) Created by Jennifer Majeske, Mineral Area College

  10. Parts of a Needle: Needle tip Bevel Heel Needle shaft Needle lumen Needle hub Handling of the Needle-and-Syringe Unit: A syringe comes from the manufacturer in sterile packaging. Sterile compounding personnel must not touch the sterile parts or critical sites of the syringe or needle. Created by Jennifer Majeske, Mineral Area College

  11. Critical site the part of the supply item that includes any fluid- pathway surface or opening that is at risk for contamination by touch or airflow interruption. Created by Jennifer Majeske, Mineral Area College

  12. IV administration set a sterile, disposable device used to deliver IV fluids and injectable medications directly into a patient s vein. IV sets do not have expiration dates, but do contain Federal law restricts this device to sale by or on the order of a physician. An IV infusion pump is nondisposable, reusable equipment often referred to as durable equipment. Created by Jennifer Majeske, Mineral Area College

  13. Universal spike adaptor (tubing spike or spike) Pierces the rubber stopper or port of the IV Drip chamber Allows healthcare personnel to view and count drops of IV fluid Roll clamp Adjust flow rate Flexible tubing Delivers the fluid Needle adaptor Attaches a needle or catheter to the patient Created by Jennifer Majeske, Mineral Area College

  14. Universal Spike Adaptor: spike used to pierce the IV s tubing port; some IV sets have an air vent. Drip chamber hollow drip chamber; allows any air bubbles to rise to the top of the IV fluid. Drop set number of drops it takes to make 1 mL; also know as the tubing s drop factor. Macrodrip set: 10, 15, 20 gtts/mL Microdrip or minidrip set: 60 gtts/mL Created by Jennifer Majeske, Mineral Area College

  15. Roll Clamp a hard, plastic clip that contains a smaller roller allowing control of the flow of fluid. Flexible tubing IV tubing, molded from pliable PVC and other plasticizers. Needle adaptor usually located at the distal end of the IV set, close to the patient. Additional Components of an IV set: Y-site injection port allows medication to be added to the IV solution In-line filter provides protection against particulates Created by Jennifer Majeske, Mineral Area College

  16. Length of IV sets vary, ranging from 6 to 120 inches. What determines length of IV tubing? Priming the action of flushing out the small particles in the tubing s interior lumen before medication administration. The amount of fluid needed to prime the tubing depends on the length of the set 3 to 15 mL. In-line filters has reduced the need for flushing the line with IV fluid before administration. Created by Jennifer Majeske, Mineral Area College

  17. Nurses typically administer IV solutions to patients by attaching the IV tubing to the fluid container, establishing flow rate, and managing overall regulation. Catheter tube, implanted in the patient and affixed to the patient s skin. IV sets are changed every 24 96 hours to minimize the risk of infection. Created by Jennifer Majeske, Mineral Area College

  18. Changes in the scope of pharmacy practice make it necessary for pharmacy personnel to have a complete understanding of IV sets and their operations. Pharmacist may: Select IV sets Serve on CPR or code teams Provide in-service training Use IV sets when transferring fluids Prime IV sets Created by Jennifer Majeske, Mineral Area College

  19. Filter a device used to remove contaminants such as glass, fibers, and tiny bits of rubber that may have inadvertently entered the CSP during sterile compounding. Depending on size, filtration should protect the patient. Filters do not remove virus particles or toxins. Common filter sizes: 0.5 micron: random path membrane 0.45 micron: in-line filter 0.22 micron: removes bacteria to produce a sterile solution Created by Jennifer Majeske, Mineral Area College

  20. Most IV preparations are comprised of ingredients added to a sterile water medium or base solution. Certain chemical properties or characteristics are needed of these preparations so damage does not occur to the patients blood cells or vessels or alters the chemical properties of blood. CSPs must possess chemical characteristics similar to blood serum. Created by Jennifer Majeske, Mineral Area College

  21. Beyond-use date the date and time after which a CSP is no longer sterile, stable, or effective. pH Value the degree of acidity or alkalinity of a solution. Less than 7.0 = acidic Greater than 7.0 = basic (alkaline) Blood plasma pH 7.4 IV solutions should have a pH that is neutral (near 7.0) so they don t adversely affect the pH of the blood. Created by Jennifer Majeske, Mineral Area College

  22. Osmolarity a measure of the number of milliosmoles of solute per liter of solution (mOsm/L). Blood plasma = 285 mOsm/L Osmotic pressure the pressure required to maintain equilibrium, with no net movement of solution across body membranes. Osmolality a measure of the number of milliosmoles of solute per kilogram of solvent. An IV preparation must be isoosmotic, meaning the solution should have the same number of particles in solution per unit volume and the same osmotic pressure as blood. Created by Jennifer Majeske, Mineral Area College

  23. Hypotonic solution hypoosmolar solution; fewer number of dissolved particles than blood cells; water is drawn into cells, causing cells to swell. 0.45% normal saline (NS) Hypertonic solution hyperosmolar solution; greater number of dissolved particles than blood cells; water is drawn out of cells, causing cells to shrivel. 50% dextrose or 3% sodium chloride Isotonic solution similar number of dissolve particles as blood. 0.9% NS Created by Jennifer Majeske, Mineral Area College

  24. Compatibility the ability to combine two or more base components or additives within a solution, without resulting in changes to the physical or chemical properties of the additives. Stability: is affected by storage conditions; some IV medications need to be refrigerated or frozen after compounding; amber-colored bags protect the drug from exposure to light. Created by Jennifer Majeske, Mineral Area College

  25. Multiple IV solutions are available. Most common used IV infusions are dextrose in water, normal saline, or dextrose in saline. Table 11.1 pg. 444 Commonly Used IV Products and Abbreviations Technicians typically compound two types of CSPs: Large-volume parenterals Primary source of hydration Small-volume parenterals piggybacked Created by Jennifer Majeske, Mineral Area College

  26. Large-volume parenteral (LVP) is used to replenish fluids and to provide drugs, electrolytes, and nutrients such as vitamins, minerals, and glucose. LVPs commonly available: 250 mL, 500 mL, and 1000 mL Potassium chloride is the most common additive. Lactated Ringer s Solution IV solution that contains a specific mixture of electrolytes. Created by Jennifer Majeske, Mineral Area College

  27. Small-volume parenteral (SVP) a CSP that is dispensed in a minibag; over a short time period 10 minutes to an hour. SVPs commonly available: 25 mL, 50 mL, 100 mL, 150 mL, or 250 mL IV piggybacks (IVPBs) majority of SVPs prepared; small volume (50 to 100 mL) of a base solution (D5W) and a medication. Special SVP solutions include frozen IV solutions, premade IVPBs, and vial-and-bag systems. Created by Jennifer Majeske, Mineral Area College

  28. A CSP label should contain the following: Patient s name and id # Room number Medication name and dose Base solution and amount Infusion period Flow rate Beyond-use date Signature or initials Additional information Created by Jennifer Majeske, Mineral Area College

  29. Sterile preparations of IV medications by pharmacy personnel include single- and multi-dose vials, ampules, and other containers that must be transferred to an LVP or SVP. CSPs must be prepared in an ISO Class 5 laminar airflow hood. Table 11.2 pg. 447 Summary of Procedures to Maintain Aseptic Technique During Sterile Compounding Created by Jennifer Majeske, Mineral Area College

  30. Vials a sealed, sterile, plastic or glass container that has a hard plastic cap; sizes range from 1 mL to 250 mL. Types of vials: Single-dose vials (SDV) do not contain a preservative one-time use used within 1 hour or discarded Multi-dose vials (MDV) do contain a preservative stable for 28 days Created by Jennifer Majeske, Mineral Area College

  31. First disinfect the rubber stopper with 70% isopropyl alcohol. Pierce the rubber top with a needle-and- syringe unit. Bevel up; penetrate at an angle; straightened to 90 degrees. Coring the inadvertent introduction of a small piece of rubber top into the solution. A milking technique must be used to release negative pressure within the vial. Created by Jennifer Majeske, Mineral Area College

  32. Some medications come freeze-dried (lyophilized), and need to be reconstituted with a diluent such as sterile water or NS before being injected into the IV. Vented needle allows the diluent to be injected into the vial while simultaneously venting the positive pressure that has built up within the vial. Created by Jennifer Majeske, Mineral Area College

  33. The technician should arrange the vial, filled syringe, and the IV or IVPB base for a pharmacists final check. The pharmacist then verifies the technicians work. After verification the technician can proceed with preparing the CSP; checking for leaks and signs of incompatibility and labels the CSP for delivery. Created by Jennifer Majeske, Mineral Area College

  34. Ampule a small, hermetically sealed container that has a distinct, elongated neck. Contains no preservative Some drugs are only available in an ampule because of incompatibility with rubber or PVC components of vials Parts of an Ampule: head, neck, shoulder, and body. Break ring a scored area on the neck that marks the site where a technician will break the glass to access the ampule s contents. Created by Jennifer Majeske, Mineral Area College

  35. Opening an Ampule: safe opening of an ampule can be done with a piece of gauze, sterile 70% IPA swab or a ampule breaker a small plastic cap, placed over the head of an ampule. Hold the ampule upright, clear the medication from the head and neck. Clean the neck of the ampule. Hold the ampule in the non-dominant hand, grasping the head of the ampule with the dominant hand. Exert firm but gentle pressure on the break ring to snap the ampule s neck. Created by Jennifer Majeske, Mineral Area College

  36. Withdrawing Medication from an Ampule: hold the ampule upright; bevel down in the corner near the opening. When the ampule is nearly empty, tilt the ampule slightly to allow easier access to the remainder of the medication. A filter needle should be used when drawing medication out of an ampule to avoid glass fragments. Created by Jennifer Majeske, Mineral Area College

  37. Preparing a CSP with an Ampules Contents: similar to the process of preparation for a vial so that it can be checked by the pharmacist. The pharmacist verifies the technicians work. After verification the technician may proceed with the making of the CSP. Lastly, the technician will need to check for leaks and signs of incompatibility and label the CSP for delivery. Created by Jennifer Majeske, Mineral Area College

  38. Total parenteral nutrition (TPN) IV solutions that provide long-term nutritional support for a specific patient population. Why might a patient need a TPN? TPN Components: approximately 15 components including: Sterile water for hydration Dextrose for calories and energy Amino acids for protein synthesis Fatty acids for chemical processes and energy Additives: electrolytes, vitamins, and minerals Medication for treatment of a disease or disorder Created by Jennifer Majeske, Mineral Area College

  39. Preparing a TPN: 1,000 to 2,000 mL to provide nutritional support for 12 24 hours. Automated compounding device (ACD) for the preparation of large volumes of TPN solutions. IV fat emulsion is known as a 3-in-1 TPN solution. Administering TPN: central venous catheter (CVC) central line, into the subclavian vein is required form the administration of a TPN. Created by Jennifer Majeske, Mineral Area College

  40. Created by Jennifer Majeske, Mineral Area College

  41. Premade parenteral products benefits the hospital pharmacy, the nursing staff and the patients. These commercially available products come as: Vial-and-bag systems Frozen sterile IV solutions The expiration date varies compared with standard beyond-use dating. The expiration date is based on scientific studies and can be found on the product, and can be found on the vial or in the product package insert. Created by Jennifer Majeske, Mineral Area College

  42. Vial-and-bag system provides both a single vial of powdered medication with an adaptor and a specified IV solution that acts as the diluent. Types of Vial-and-Bag Systems: ADD- Vantage (Hospira), MINI-BAG Plus (Baxter Healthcare); not considered CSPs. Stability and expiration date varies with the type and concentration of the drug, diluent, storage conditions, and activation. Created by Jennifer Majeske, Mineral Area College

  43. Some of the benefits of vial-and-bag systems include less wastage, improved safety, efficiency, and cost-effectiveness. Safety: admixing errors are minimized; risk of contamination is also minimized. Efficiency: doses are premeasured for rapid reconstitution and easy assembly. Cost-effectiveness: no admixing is necessary and no additional supply costs. Created by Jennifer Majeske, Mineral Area College

  44. Each vial-and-bag system differs somewhat, but the concept is similar. The vial of drug that is not reconstituted is coupled (with or without an adaptor) with an appropriate volume of IV solution. Assembly: the technician is responsible for assembly; performed in the hood to maintain sterility. Activation: nursing staff is responsible for activation. Created by Jennifer Majeske, Mineral Area College

  45. Commercially available products and are not considered CSPs. Most are antibiotics and are manufactured as SVPs in a premixed frozen state. Handling of Frozen IV Solutions: kept in the freezer until an order is received; the product is then thawed at room temp. or in the refrigerator. Expiration date varies with the drug and storage conditions. Ancef expiration date of 48 hours at room temp., 30 days in the refrigerator Zosyn expiration date of 24 hours at room temp., 14 days in the refrigerator Created by Jennifer Majeske, Mineral Area College

  46. Certain calculation skills are necessary by a pharmacy technician who prepares CSPs. Most dosage calculations are done by the pharmacy technician. IV flow rate is used to calculate days supply for IVs and IVPBs. Calculation and verification differs for chemotherapy agents, neonatal IV medications and certain TPN preparations. Created by Jennifer Majeske, Mineral Area College

  47. Daily IV run or batch preparation of all CSPs needed for all patients during a specific period. Calculations address the following questions: What is the infusion rate in mL/hour? Divide total volume by the number of hours: TV/H = x How long will this bag last? Divide the total volume by the infusion rate: TV/IR = x What time will the next bag be needed? Add the number of hours calculated, (x) calculated in the previous step to the current standard time How many bags will be needed for the patient in a 24- hour period? Divide 24 by the number of hours calculated in the previous step (x). Examples 1-4 Created by Jennifer Majeske, Mineral Area College

  48. Electrolyte solution IV fluid containing dissolved mineral salts. What is the most common electrolyte additive? Electrolyte solutions are measure in milliequivalents (mEq). Pharmacy technicians must use pharmacy math formulas to determine the amount of additive that must be drawn up to provide a prescribed dosage. Example 5 Created by Jennifer Majeske, Mineral Area College

  49. Hazardous agents require special handling and preparation by pharmacy personnel. Cytotoxic drug any drug that destroys cancer cells. Antineoplastic drug reduces or prevents the growth of cancer cells. Before 1980, there were few safety standards for handling of hazardous drugs. There exists persistent contamination in both preparation and patient care areas. Created by Jennifer Majeske, Mineral Area College

  50. Trauma or injury: accidentally prick oneself with a needle or cut from a broken container 2. Inhalation of the hazardous substance: releasing a fine mist of medication and inadvertently inhaling the substance 3. Ingestion: ingest minute powder when crushing an oral tablet or cleaning a tray 4. Direct skin contact: accidental spill Asparaginase can cause skin irritation Doxorubicin can cause tissue death and sloughing Nitrogen mustards can cause irritation of the eyes, mucous membranes, and skin Steptozocin is a potential carcinogen if it comes into contact with skin Created by Jennifer Majeske, Mineral Area College 1.

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