CHAPTER 8

CODE OF FEDERAL REGULATION (CFR)

A set of general or permanent rules
that are published in the Federal
Register by the federal govt.
CONTROLLED SUBSTANCES ACT (CSA)
Comprehensive drug Abuse Prevention
and Control Act of 1970
Federal govt.s drug policy governing
the manufacturing, importation,
possession, and distribution of certain
substances that have been classified
into five schedules based on their
potential abuse and accepted med use
DRUG ENFORCEMENT (DEA)
A law enforcement agency under the
DOJ
Responsible enforcement of drug policy
in US as required under CSA
FAILURE MODES
Any errors or defects in process,
design, or item, especially those that
affect the customer, and can be
potential or actual
EFFECTS ANALYSIS
Refers to studying the consequences of
those failures

POLICIES AND PROCEDURES

A set of written requirements dictated
by an organization that provide the
foundation for the written procedural
instructions in an organization
POWER OF ATTORNEY AUTHORIZATION
A legal document that allows another
person to act on your behalf
STOP ORDERS
An order that automatically
discontinues a medication based on
pre-established parameters
TAPER ORDER
An order that changes the dose of a
medication
The dose is either progressively
decreased or increased based on preestablished parameters
UNITED STATE PHARMACOPOEIA (USP)ISMP MEDICATION ERRORS REPORTING
PROGRAM (USP-MEDMARX)
A national program designed for the
voluntary reporting, categorizing, and
expert data analysis of medication
errors and adverse drug reactions.
CHAPTER 12

Interest, insurance, taxes, and storage

expenses

INVENTORY TURNS
Fraction of a year that an average item
remains in inventory
HIGHinventory turnover is a sign of
EFFICIENCY because inventory is
constantly at work and generating
revenue
LOW turnover= sign of INEFFICIENCY
JUST-IN-TIME INVENTORY MANAGEMENT
A philosophy of inventory management
where products are ordered and
delivered at just the right time
Minimizing wasted steps, labor and
cost
Neither over- nor under-stock products
ORDER BOOK
List of products that need to be ordered
from a supplier
PARETO ABC ANALYSIS
Based on the principle that states that
a relatively small number of drugs
account for a disproportionate amount
drug usage in health system.
Groups inventory products by
aggregate value and volume use in
three groupings:
Group A: small percentage of items
that make upon the greatest amount of
inventory cost
Group B & C: decreasingly less cost

INSTITUTE OF SAFE MEDICATION

PRACTICES (ISMP)
A non-profit organization with the
mission of enhancing patient safety
through education, collecting,
analyzing adverse drug events,
disseminating medication safety
information, collaborating with health
care orgs, and conducting research

ECONOMIC ORDER QUANTITY (EOQ)

A model of inventory control
Minimum Cost Quantity approach
Uses past history of inventory use,
costs, and demand to develop an
accounting model that predicts optimal
inventory order quantities that
minimizes order costs and inventory
holding costs

MEDICATION UTILIZATION EVALUATION

An examination of a specific
medication
Method usually incorporated into an
organizations performance
improvement program that examines
the utilization of a medication and its
effects on patient outcomes

GROUP PURCHASING ORGANIZATIONS

Purchasing groups consisting of health
system and hospitals who join together
to obtain greater buying power

PERPETUAL INVENTORY
Record of inventory that is constantly
updated when items are added or
subtracted from inventory

INVENTORY CARRYING COSTS

All costs associated with the
investment and storage

PRIME INVENDOR CONTRACT

Contract between a health-system
pharmacy and a wholesaler where the

PAR-LEVEL SYSTEMS
Individual inventory drug use falls with
a predictable range or par-level
Range is identified and minimum and
maximum order quantities are set.

pharmacy agrees to purchase most of

its pharmaceutical from a single
wholesale company in return for
advantageous pricing.. etc.
STOCK ROTATION
process of placing products nearest to
the time of expiration at the front of
the shelf or storage
CHAPTER 14
ANTE AREA (ANTEROOM)
An ISO class 8 or better air quality area
where personnel perform hand
hygiene, and garbing procedures,
staging of components, order entry,
CSP labeling & other high-particulate
generating activities
ASEPTIC TECHNIQUE
Methods used to manipulate
manufacturer- supplied sterile products
so that they remain sterile as CSP
BIOLOGICAL SAFETY CABINET (BSC)*
A primary engineering control
Ventilated cabinet
BUFFER AREA
Area where primary engineering
control (PEC) is physically located
Includes preparation and staging
components and supplies used when
compounding CSPs
CLEAN ROOM (OR BUFFER ROOM)
Room in which the concentration of
airborne particles is controlled to meet
a specified airborne particulate
cleanliness class.
COLD STORAGE CONDITIONS
(REFRIGERATOR)
2-8C (36-46F)
COMPONENTS
Individual ingredients, containers, and
closures, that are used to compound
sterile preps.

COMPOUNDED STERILE PREPARATION

(CSP)
A dose or doses of medication that are
prescribed for a patient that must be
prepared for administration and is
sterile
COMPOUNDING ASEPTIC CONTAINMENT
ISOLATOR (CACI)*
A primary engineering control that is
designed to provide worker protection
from exposure to undesirable levels of
airborne drug throughout the
compounding and material transfer
processes and to provide an aseptic
environment for compounding sterile
preparations.
COMPOUNDING ASEPTIC ISOLATOR (CAI) *
A primary engineering control that is a
form of isolator specifically designed
for compounding pharmaceutical
ingredients and preparations.
Designed to maintain an aseptic
compounding envt. w/in the isolator
throughout the compounding and
material transfer
CRITICAL SITE
Location that includes any component
or fluid pathway surfaces or openings
exposed and at risk of direct contact
with air, moisture, or touch
contamination.
with the size of openings and
exposure time
DIRECT COMPOUNDING AREA (DCA)
Critical area w/in the ISO Class 5
primary engineering control where
critical sites are exposed to
unidirectional HEPA-filtered air, also
known as first air
FIRST AIR
The air exiting the HEPA filter in
unidirectional air stream that is
essentially particulate free
GARB

Clothing worn by the personnel during

the compounding of sterile
preparations to minimize particulates
being shed from body and clothing into
the buffer room and PEC

HAZARDOUS DRUGS
If studies in animals or humans
indicate that exposure to them has
potential for causing cancer,
developmental, or reproductive toxicity
or harm to organs.
LAMINAR AIR FLOW WORK BENCH
(LAFW)*
Primary engineering control that is a
controlled envt. created by HEPA filter
to retain airborne particles and
microorganisms.
Decreases chance of microbial
contamination during the compounding
of sterile prep.
MEDIA- FILL TEST
Test used to qualify aseptic technique
of compounding personnel or
processes and to ensure that processes
used are able to produce sterile
product without microbial
contamination.
PRIMARY ENGINEERING CONTROL (PEC)
Device or room that provides an ISO
class 5 envt. for the exposures of
critical sites when compounding CSPs
LAFW, BSC, CAI, CACI ****
PYROGENS (BACTERIAL ENDOTOXINS)
Metabolic products of living
microorganisms or dead
microorganisms that cause a pyretic(
temp.) response upon injection.
RISK LEVELS

LOW RISK
Involves only transfer, measuring, and
mixing manipulations using n.m.t. 3
commercially manufactured packages
of sterile products and n.m.t. 2 entries
into any one sterile container/ device to
prepare CSP

MEDIUM RISK
Multiple individual or small doses of
sterile products are combined or
pooled to prepare as CSP, administered
to multiple patients or to one patient
on multiple occasions
Complex aseptic manipulations other
than single-volume transfer
Unusually long duration
HIGH RISK
Contains nonsterile ingredients,
including manufactured products not
intended for sterile routes of
administration,

SECONDARY ENGINEERING CONTROLS

Ante area and buffer area
STANDARD OPERATING PROCEDURES
(SOP)
Set of instructions or steps someone
follows to complete a job safely, w/ no
adverse impact on the envt. and in a
way that optimizes operational and
production requirements
USP CHAPTER <797>: PHARMACEUTICAL
COMPOUNDING-STERILE PREPARATIONS
Pharmacy-related general chapter that
is among below 1000 so as tobe
enforceable by FDA, The Joint
commission, and some State Boards
pharmacy
CHAPTER 15
AMPUL
A single-use container composed
entirely of glass
CANNULA
Tube like needle or catheter used to
nfuse parenteral fluids and medications
into the vascular system or other body
spaces
ELECTROLYTE
Dissolved ions that include Na, K , Cl,
Ca, PO4, and others
EPIDURAL

Space superior to the dura mater of the

brain and spinal cord and inferior to the
ligamentum flavum
Outside the subarachnoid space whre
the cerebrospinal fluid flows

EXTRAVASATION
The inadvertent administration of
VESICANT medication or solution into
the tissue surrounding an artery or vein
An adverse drug event
INCOMPATIBILITY
Incapable of being mixed or used
simultaneously w/out undergoing
chemical or physical changes or
producing undesirable effects ( loss of
potency of act. ing. , formation of ppt
or toxic ing., color changes)
INFILTRATION
Inadvertent administration of NONVESICANT medication or solns into the
tissue surrounding an artery or vein
Adverse drug event, unless intended
INTRATHECAL
Space w/in the spinal canal
PARENTERAL (OR INJECTABLE)
Dosage form intended for injection
through one or more layers of skin or
other external boundary tissue, rather
than thru the alimentary (enteral) canal
SHARPS
Objects in the healthcare setting that
can be reasonably anticipated to
penetrate the skin and to result in an
exposure incident
Needle, scalpels, lancets, broken glass,
broken capillary tubes
STANDARD PRECAUTIONS
Guidelines designed to protect workers
w/ occupational exposure to blood
borne pathogens
All blood and body fluids= potentially
infectious
TOTAL PARENTERAL NUTRITION (TPN OR
HYPERALIMENTATION)

Intravenous provision of total

nutritional needs for a patient who is
unable to take appropriate amount of
foods enterally.
Carbs, proteins, electrolytes, vit, trace
elements

VEHICLE
Water for injection is the liq. in w/c
active ing. are dissolved
VIAL
-

Plastic or glass container w/ a rubber

closure secured to its top by a metal
ring

CHAPTER 16
ATTITUDE THEORY
A theory stating that the beliefs leaders
hold about people greatly influences
both the managers behavior and the
followers responses.
Divides leaders into 2 categories:
Theory X leaders and Theory Y leaders
BEHAVIORAL THEORIES
A group of leadership theories that
argue that the greatest predictors of
leadership effectiveness are the
behaviors and abilities that people
learn over time
All revolve around the degree to w/c
leaders are task-oriented or followeroriented
BIG L LEADERS
Label used to describe individuals in
formal positions of authority
EMOTIONAL INTELLIGENCE
A group of soft skills critical for
productive interactions w/ others
Comprised of self-awareness, selfregulation, motivation, empathy, and
social skills
FOLLOWER-ORIENTED LEADERS
They express greater concern for the
follower than the task at hand
Demonstrate SUPPORTIVE behavior

LAISSEZ-FAIRE LEADERSHIP
Describes a hands-off approach to
leadership.
LEADERSHIP
Process through w/c an individual
attempts to intentionally influence
another individual or group in order to
accomplish a goal
LEADER
Individuals who influence by setting
direction for others, communicating a
common vision, and motivating and
inspiring followers
Considered different but closely related
to the term manager
LITTLE L LEADERS
Label that describes people with
influence who DO NOT possess a
formal position of authority
MANAGER
People who influence by providing
order and consistency through
activities of planning, budgeting,

organizing, staffing, controlling, and

problem solving
POWER
Ability to influence
Types:

Formal

Reward

Punishment

Expert

Charismatic

Informational

SITUATIONAL THEORIES
Group of theories that attempt to
understand, explain, and predict the
role of context in effective leadership
The greatest predictor of leadership
effectiveness and success is the
SITUATION FACED by leaders and how
leaders REACT to those situations
STRUCTURES
The degree to w/c a leader frames
responsibilities and goals for achieving
tasks.

Consists of setting goals, providing

training, defining expectations, setting
limits on behavior, and establishing
rules and procedures to be followed

SUPPORTIVE BEHAVIOR
Degree to w/c a leader indicates
respect and concern for the followers.
Treats them as human beings, watches
out for their welfare, and express
appreciation for their contributions.
TASK-ORIENTED LEADERS
They focus on accomplishing the job w/
much less concern about the followers
who accomplish the job
Concentrate on providing the
necessary structure followers need to
complete their work
TRAIT THEORIES
Describes a group of theories that
argue that the greatest predictors of
leadership effectiveness and success
are the TRAITS and DISPOSITIONS w/
which people are endowed at birth or
develop early in life.