PHM 652: Exam 2 (Parenteral Products) Flashcards
Define Parenteral
administered by any way other than through the mouth; applied, for ex. , to the introduction of drugs or other agents into the body BY INJECTION
all parenteral products and ophthalmic dosage forms must be what
STERILE
define aseptic technique
ability of personnel to manipulate sterile preparations, sterile packaging components, and sterile administration devices in a way that excludes the introduction of viable microorganisms
ex. of parenteral routes
- IV
a. injection to venous (not arterial) system
I.perioheral
II. central - Intraarterial (uncommon)
- Intramuscular (IM)
- Intrathecal (IT)
a. injection into meninges of spinal cord) - Epidural
a. injection to tissues surrounding spinal cord, not spinal cord itself - Intradermal (ID)
a. injection within the skin - SubQ
a. injection beneath the skin
what does it mean to be sterile
freedom from all living organisms
an absolute. no such thing as almost sterile
medical devices used along with parenteral administration must be what
ex of these medical devices
STERILEEE
includes things like
needles syringes tubing bags etc
health status when compounding sterile products
need to be free from infectious disease
personal preparation
cover head and facial hair
remove cosmetics likely to flake
remove finger and wrist jewelry
how to wash hands
scrub hands and arms to elbows
pre wash
use 3-5ml for 30 seconds
wash hands even if gloves are to be worn
gloves
types:
composition
when should you change your gloves?
a.sterile vs non sterile
powdered vs non powdered
b.composition:
latex
vinyl
synthetic
c. depend on pharmacy but usually ~1 hr
better products for hand washing than plain soap in high risk situations
alcohols chlorhexidane gluconate iodophors hexaclorophene parachlorometaxylenol triclosan
gowns
composition
a. tyvek: non permeable substance
other coverings when preparing iv
shoe covers and sticky mats
masks: put on right b4 going in hood and changeeverytime leaving compounding area
note: surgical masks only protect product that you’re making, not you
what is the last step before entering iv room
WASH HANDS
Laminar air flow SYSTEM
types
how long should it be turned on for before using
Horizontal flow hoods (LAFS)(laminar air flow system): filtered air directed toward pharmacist/ tech located at back of hood
vertical flow hood (BSC)(Biological safety cabinets)
filtered air directed downward from a pen located at the top of hood. used for chemo. more preotection
at least 15 min. but UB SPPS policy is 30 min
HEPA
HIGH EFFICIENCY PARTICULATE AIR Filter
removes 99.9% of all particles 0.3 microns (um) or larger
disadvantage of laminar air flow
false sense of security
ISO classifications of particulate matter in room air
requires air quality in IV rooms iso class 5 or better (room mustn’t contain more than 3520 particles that are >/= 0.5 um in size)
(class 5: a.US class 100 b. Particle size I. ISO m3: 3520 FS 209E, ft3
besicaly the smaller the number, the better the air quality
pyrogens
metabolic products of living organisms, or dead microorganisms
lipopolysaccharides: soluble in water but insoluble in organic solvents
aseptic technique ideally prevents the intro to parenteral products
pharm effects of pyrogens
- vary
- in man, pyrogenic causes fever and chills
- after injection, rapid raise in body temp, chills and headache, malaise after 45-90 min latent period
- anaphylaxis
source of pyrogens in sterile compounding
- water (solvent)
- containers (packaging)
- chemicals (used for solution preparation)
how to eliminate pyrogens
- dry heat (for metal and glass ocntainers
- chemically : for solutions but can destroy durgs
- synthetic filter media:
- best approach . PREVENT THEM FROM OCCURING
unecessary factors that can cause microorganism intro to product in i room
talking
laughing
chewing gum
eat/drink
CSP (compounded sterile product) risk levels
definition:
assigned according to relative possibility that a compounded sterile product might be contaminated
LOW
MEDIUM
HIGH
what does this stand for
LAFS
also AKA
Laminar air flow system
aka horizontal flow hood
what does this stand for
BSC
biological safety cabinet (aka vertical flow hood)
what does this stand for
RBS
a. CAI
b. CACI
restricted barrier system
a. compounding aseptic isolator
b. compounding aseptic containment isolator
how to determine which iv bag to use
- determine conc. of drug in possible iv bag selection
2. compare to compatibility chart . must be below the max compatible concentration threshold stated on the chart
female IBW equation
45.5 +2.3(height over 5’ in inches)
male IBW eq.
50.0+2.3 (height over 5’ in inches)
10% rule with iv bags
if adding fluid greater than 10% to an iv bag, must remove that equiv. amount from iv bag first
refrigerated temp
2-4 degrees C
room temp
20C-25C
clean rooms. what are they
env. where contamination is controlled/limited form stuff such as
particles
organisms
pyrogens
environment control of clean rooms
temp
humidity
relative barometric pressure
conventional IV rooms ar always maintained at what kind of pressure
positive pressure
end product testing
container leaks and integrity
particulates in solution
solution color, volume, and odor
pursuant to individual products
analytical testing
weight verification refractometry ph testing microbial testing etc.
process validation
what is it
when should it be conducted
more general
basic process n institution commands products to ensure sterility
involves manipulation of microbial growth media according to aseptic process being validated
SHOULD BE CONDUCTED AT RANDOM INTERVALS AND NOT AT THE OPERATORS KNOWLEDGE, if possible
stability
extent product remains within specified limits in terms of
chemical composition
physical composition
microbiologic activity
stability
at the time of use, a medication must be
at the stated potency
and safe for admin. to the pt.
product stability
subject to..
primary basis for..
subject to specific storage conditions
primary basis for an expiration date/ time
maintenance of stability
lyophilization
what is it?
what does it entail?
process of rapid freezing sublimation product becomes dry power is more stable than in solution.
maintenance of stability
what are some methods of sterilization
0.22 micron filter
autoclave (applying heat to kill of microorganisms)
maintenance of stability
antioxidants
ex:
metasulfate and sulfate ions used as preservatives. a.sodium salts b. K+ salts: I. metabisulfits (for low pH) II. bisulfites (intermediate pH) sulfite (high pH ranges)
maintenance of stability
removal of O2 and insert of what inert and semi inert gassses
nitrogen
Carbon dioxide (CO2)
helium
b/c o2 is highly reactive
particulate matter
what are they
what are some sources
dust spores
sources: iv solution, packaging, iv tubing, preparation process (laminar now hood or pt bids)
iv fluid compatibility
occurs when a drug is combined with an IV fluid , or another drug to produce by physiochemical mens, a product unsuitable for administration to the pt.
ex: phenytoin in D5W
therapeutic incompatibles
basically DDI
have very little to do with route of admin
physical incompatibility
combo of one or more drugs in solution resulting in compositional change and appearance.
chemical incompaitbility
degredation of drug substances as a result of being in solution or coming in contact w. other drugs
greatest single factor causing incompatibility btw iv fluids and their contents
variations in pH
solubility: physical
stability: chemical
how to minimize incompatibilities
use freshly prepared solutions whenever possible
encourage use of few additions as possible
study to demonstrate proficiency in iv therapy
educate mds, RNs
be skillful with reference materials (ex. trissells, clinical pharmacology)
pros of parenteral admin:
fast
some drugs not effective orally
uncomplicated admin where pt is uncooperative, npo, NAUSEOUS , unconcious,
pt compliance (md control when and how they get it)
correction of fluid/ electrolyte imbalance
tPN ADMINSTRATION
cons of parenteral admin
special traning
invasive
painful
difficult to reverse
more expensive
incompatibilities
things to consider when determinining iv bag compatiility
use smallest bag
refrigerate vs room temp (look at test conditions)
light sensitivity
pay attention to manufacturers codes when provided
sterility and integrity requirements for sterile iv admixtures
free from…
free from..
1.living organisms
2.dead organisms
3.pyrogens
a. h2o insolubule
I. dead organisms
II. parts of dead organisms
metabolic products of organisms
b.h20 soluble I. lipopolysacharides II.metabolic products of organisms 4. freedom from particulates 5. physical, chemical, microbiologic stability