The document provides an overview of sterile compounding and aseptic technique for pharmacy technicians. It discusses the historical roots of pharmacy and sterile compounding. It also outlines the key roles and responsibilities of pharmacy technicians in preparing sterile compounded preparations and defines important terms like aseptic technique. Maintaining aseptic technique is crucial for patient health and safety. The document reviews the training and certification requirements for pharmacy technicians set by organizations like USP and state boards of pharmacy.

2. Topics2
Chapter 1
Sterile Compounding as a
Pharmacy Technician
2012 Paradigm Publishing

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Learning Objectives
 Gain awareness of the historical roots of pharmacy and sterile
compounding.
 Define sterile compounding and aseptic technique.
 Describe the ways in which sterile compounding and aseptic technique
processes may affect patient health and safety.
 Define the objectives of USP Chapter <797>.
 Understand the training requirements for pharmacy technicians who
prepare sterile products, and describe the process validation tool used
for technique evaluation.
 Recognize various quality assurance and end-product testing procedures.
 Determine appropriate responses to medication safety questions.
 Demonstrate an awareness of the ethical issues in pharmacy.
2012 Paradigm Publishing

4. Topics4
Topics
 Learning Objectives
 Sterile Compounding
 Aseptic Technique
 Roles and Responsibilities of IV Technicians
 The Effect of Aseptic Technique on Patient Health and Safety
 USP
 Training and Testing Requirements
 Process Validation
 Quality Assurance
 Medication Safety
 Monitoring of Medication Errors
 Ethical Issues in Pharmacy Practice
 Chapter Summary
2012 Paradigm Publishing
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Sterile Compounding
 Sterile compounding involves the dilution, mixing,
and injection of various medication products using
aseptic technique
2012 Paradigm Publishing

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Aseptic Technique
 Aseptic technique is performed by sterile
compounding personnel or sterile products
personnel
 Vital to the compounding process to avoid the
introduction of pathogenic organisms or other
contaminants into a sterile environment or
preparation
2012 Paradigm Publishing

7. Topics77
Aseptic Technique…/2
 Failure to follow the protocol of aseptic technique
may lead to microbial contamination of the
medication
resulting in serious illness or, possibly, death of patient
recipients due to infection
 It is critical for patient health and safety that you, as
a pharmacy technician, become well-versed in
aseptic technique and the procedures for sterile
compounding
2012 Paradigm Publishing

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Roles and Responsibilities of
IV Technicians
 Pharmacy technicians play a major role in preparing
compounded sterile preparations (CSPs) in
pharmacies
 Specialized technicians are largely responsible for
preparing injectable medications for patients in
hospital and home healthcare settings
often referred to as sterile compounding technicians,
intravenous (IV) admixture technicians, or simply IV
technicians
2012 Paradigm Publishing

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Roles and Responsibilities of
IV Technicians…/2
 Injectable medications may be delivered to the
patient via parenteral routes of administration
refers to the method of medication administration by any
route other than through the alimentary canal including
the IV, intramuscular (IM), subcutaneous (Sub-Q), and
intrathecal (IT) routes
majority of medications prepared by sterile compounding
technicians are administered through an IV
2012 Paradigm Publishing

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Roles and Responsibilities of
IV Technicians…/3
 Parenteral solutions are sterile, injectable solutions
that are administered by one of the parenteral routes
of administration
 CSPs are comprised of small-volume or large-volume
parenteral solutions to which a medication or additive
has been added
2012 Paradigm Publishing

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Roles and Responsibilities of
IV Technicians…/4
Typical Volume for Various Routes of Administration*
Intradermal (ID) ≤ 0.1 mL
Sub-Q ≤ 1 mL
IM ≤ 3 mL
IT 1 mL–10 mL (larger volumes may be administered via syringe pump or
epidural cassette pump)
IV Push (IVP) 1 mL–60 mL (volumes ≥ 10 mL are usually administered via syringe
pump)
IVPB 25 mL–250 mL (infusion rate controlled via tubing’s roll clamp or IV pump)
IV > 250 mL (infusion rate controlled via IV pump)
*volumes may vary according to the age or size of the patient and the dosing guidelines
2012 Paradigm Publishing

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Roles and Responsibilities of
IV Technicians…/5
 Small-volume CSPs are those ranging from less than
1 mL to as much as 250 mL
some are administered by intravenous piggyback (IVPB)
 Often, a drug is diluted in powder form with a
solvent such as sterile water or normal saline (NS)
diluted drug is drawn into syringe and injected into sterile
IVPB base solution such as dextrose 5% in water (D5W) or
0.9% sodium chloride (NS)
nurse then injects the final prepared solution
2012 Paradigm Publishing

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Roles and Responsibilities of
IV Technicians…/6
 Large-volume CSPs are
500 mL or greater and
are infused parenterally
by the IV route of
administration
2012 Paradigm Publishing

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Roles and Responsibilities of
IV Technicians…/7
 Prior to the 1980s, most CSPs were prepared at the
patient’s bedside by a doctor or nurse
 Since then, most CSPs have been prepared in the
pharmacy
 The use of the laminar airflow workbench (LAFW)
has also become commonplace
 In 2008, revisions to USP Chapter <797> led to
sweeping changes in sterile compounding practices
and set forth requirements for training and testing
2012 Paradigm Publishing

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The Effect of Aseptic Technique on
Patient Health and Safety
 Correct sterile compounding and aseptic technique
are essential to patient health and safety
 To ensure that these aseptic practices are strictly
followed, sterile compounding technicians must
undergo frequent and comprehensive evaluations
 These safeguards not only prevent medication errors
but hold technicians to the highest quality-control
standards
2012 Paradigm Publishing

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The Effect of Aseptic Technique on
Patient Health and Safety…/2
 United States Pharmacopeia (USP) oversees quality
control of pharmacy practices by establishing public
standards for the preparation and dispensing of
prescription and over-the-counter medications
 Guidelines set forth by the USP are used by
government agencies
determine whether or not healthcare institutions receive
government reimbursement for their products
2012 Paradigm Publishing

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Your Turn
2012 Paradigm Publishing
1) The majority of medications prepared by sterile compounding
technicians are administered through this route.
a. Sub-Q
b. IT
c. IV
d. IM
2) In 2008, revisions to this USP Chapter led to sweeping changes in
sterile compounding practices.
a. <979>
b. <797>
c. <676>
d. <767>
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USP
 USP Pharmacists’
Pharmacopeia is an
official publication whose
guidelines are a mainstay
for both pharmacists and
pharmacy technicians
offers valuable information
on nearly every aspect of
pharmacy practice
2012 Paradigm Publishing

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USP…/2
 The most relevant part to sterile compounding and
aseptic technique is the chapter titled
“Chapter <797> Pharmaceutical Compounding –
Sterile Preparations”
includes importance of beyond-use dating (BUD)
also identifies four specific risk levels for CSPs: low-risk
level, medium-risk level, high-risk level, and immediate
use
designates the types of preparations that may be
compounded and the special training and testing required
for sterile compounding personnel
2012 Paradigm Publishing

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USP…/3
 USP produced a supplemental
guidebook for sterile
compounding personnel titled
USP <797> Guidebook to
Pharmaceutical Compounding
– Sterile Preparations
commonly referred to as the
USP <797> Guidebook
2012 Paradigm Publishing

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Training and Testing Requirements
 Most states now require that pharmacy technicians
pass a national certification exam
Pharmacy Technician Certification Exam (PTCE) is offered
by the Pharmacy Technician Certification Board (PTCB) and
accepted by all of the U.S. Boards of Pharmacy
Exam for the Certification of Pharmacy Technicians
(ExCPT) is offered by the Institute for the Certification of
Pharmacy Technicians (ICPT), is currently accepted by only
a portion of the State Boards of Pharmacy
2012 Paradigm Publishing

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Training and Testing
Requirements…/2
 Some agencies develop guidelines for training
Accreditation Council on Pharmacy Education (ACPE)
American Society of Health-Systems Pharmacists (ASHP)
American Pharmacists Association (APhA)
Board of Pharmacy for each individual state
 Many refer to USP Chapter <797> as a guideline for
developing policies
 Another tool widely used is the ASHP’s Model
Curriculum for Pharmacy Technician Training
2012 Paradigm Publishing

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Training and Testing
Requirements…/3
 It is considered best practice that all personnel
complete an ACPE-accredited training program in
sterile product preparation and aseptic technique
 Sterile compounding technicians should either be
experienced and knowledgeable pharmacy
technicians who have good backgrounds in math and
science, or students who have graduated from well-
designed pharmacy technician schools or training
programs
2012 Paradigm Publishing

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Training and Testing
Requirements…/4
 Students should receive a minimum of forty hours of
hands-on training
 Employees should receive a minimum of forty hours
of practical on-the-job training and must pass
intensive process validation evaluations and quality
assurance testing
 USP Chapter <797> requires annual recertification
2012 Paradigm Publishing

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Process Validation
 During process validation, instructors observe,
critique, and grade students’ technique on
specialized process validation checklists
sterile garbing and gloving
horizontal laminar airflow hood cleaning
vial preparation
ampule preparation
large-volume parenteral preparation
2012 Paradigm Publishing

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Process Validation…/2
 Once you become a sterile
compounding technician,
the process validation
checklists continue to
serve you as a valuable
tool—a study aid to help
you prepare for your
initial and annual
competency tests
2012 Paradigm Publishing

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Quality Assurance
 Sterile compounding personnel must also undergo
various quality assurance procedures
negative-growth fingertip test
properly clean and disinfect a hood
aseptic technique testing kit
end-product testing
 All personnel who prepare sterile products should
successfully complete process validation and an
aseptic technique testing kit at least once a year
2012 Paradigm Publishing

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Quality Assurance…/2
 The media-fill kit is one of
the most commonly used
aseptic technique testing
kits
 If the person being tested
has a break in technique,
the aseptic technique
testing kit will indicate
that error in technique
2012 Paradigm Publishing

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Medication Safety
 Any breach of established guidelines could lead to a
medication error
 Verify the five patient “rights” of correct drug
administration: right patient, right drug, right dose,
right route, and right time
 Medication errors typically involve incorrect drugs
(“right drug” errors) or errors in pharmacy
calculations (“right dose” errors)
2012 Paradigm Publishing

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Monitoring of Medication Errors
 Several organizations track medication errors
The Institute for Safe Medication Practice (ISMP) is a
nonprofit organization that educates the healthcare
community and consumers about safe medication practices
MedWatch, a voluntary program of the Food and Drug
Administration (FDA), supports healthcare workers in the
reporting of medication errors and adverse drug effects
(ADEs)
The Joint Commission has several programs designed to
decrease medication errors and improve patient safety
2012 Paradigm Publishing

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Monitoring of Medication Errors…/2
 Every pharmacy has its own policies and procedures
in place to reduce medication errors and encourage
error reporting
examine the system that allowed the error to occur, rather
than placing blame on the individual responsible for the
error
 Once processes have been put in place to reduce the
chance of error, individuals are then held responsible
for adhering to those improved processes
2012 Paradigm Publishing

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Ethical Issues in Pharmacy Practice
 Each state’s Board of Pharmacy provides legal
guidelines and oversight for pharmacy-practice
most states have regulations defining mandatory error
reporting procedures
 The American Association of Pharmacy Technicians
(AAPT) has published the Code of Ethics for
Pharmacy Technicians
serves as a standard for technicians faced with ethical and
legal decisions
2012 Paradigm Publishing

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Ethical Issues in Pharmacy
Practice…/2
 Many pharmacy technician training programs
develop a code of ethics for pharmacy technicians
frequently part of a training program’s student handbook
and is sometimes recited by students during the program’s
graduation ceremony
outlines and defines the ethical responsibilities of the
pharmacy technician, often including guidelines that
promote patient health and safety and encourage honest
and dependable actions by the pharmacy technician
2012 Paradigm Publishing

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Your Turn
2012 Paradigm Publishing
3) How many patient “rights” of correct drug administration are there?
a. 5
b. 6
c. 7
d. 8
4) This association has published the Code of Ethics for Pharmacy
Technicians.
a. APTT
b. APPT
c. APAT
d. AAPT
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