IV things (exam 2) Flashcards
What is the definition of parenteral?
adj: 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
para enteron: beside from the intestine
parenteral products must be sterile!!
Definition of aseptic technique
-the ability of personnel to manipulate sterile preparations, sterile packaging components, & sterile administration devices in a way that excludes the introduction of viable microorganisms
Intravenous injections
- peripheral: injection to the arm or leg
* central: use of a central venous catheter)
Intra-arterial (IA)
- uncommon for the administration of medication –> to the high pressure side of the circulatory system
- testing (1st pass kinetics, arterial pressure)
Intramuscular (IM)
-injection to within muscle tissues
Intrathecal (IT)
-injection to the meninges of the spinal cord
Epidural
-injection to the tissues surrounding the spinal cord, not the spinal cord itself
intradermal (ID)
injection within the skin
Subcutaneous (Sc, SQ)
injection beneath the skin
Definition of Sterility
- freedom from all living organisms, an absolute term & no such thing as almost sterile*
- all parenteral & ophthalmic dosage forms must be sterile!
Health status in terms of sterility
- sterile prep personnel should be free from infectious diseases
- -> if you have a “cold” and are coughing and/or sneezing stay out of the sterile prep room!
(chills, fever)
Personal Prep for sterile room
- cover both head and facial hair
- remove cosmetics likely to flake
-remove finger and wrist jewelry
Hand-washing rules
- scrub hands & arms to elbows
- plain soap and water not enough for high risk situations (alcohol, chlorhexidine gluconate, iodophors, hexachliphene, parachlorometaxylenol & triclosan)
- use 3-5ml for 30 secs
- wash hands even if gloves are to be worn (leakage rate can be more than 50%) also wash hands after gloves removed
Gloves
- selection based on type of compounding, material durability, reliability, comfort & protection from bacteria or hazardous drug penetration
- for IV room- use SURGICAL gloves
-change ~1 hour
Glove composition**
- latex
- vinyl
-synthetic
Gowns
- should be made of a low-particulate material that protects against bacterial passage and drug permeability
- Tyvek: standard for non-permeable garments
other coverings (shoes & masks)
- shoe covers & sticky mats (change frequently)
- masks: don just prior to working in hood, change each time leaving compounding area, surgical masks offer no protection against inhaling of powdered or aerosolized hazardous drugs
LAFS horizontal flow hood
- filtered air is directed toward the pharmacist/tech from a plenum (and HEPA filter) located at the back of the hood
- most common for general purpose parenteral
BSC Vertical flow hood
- filtered air is directed downward from a plenum (and HEPA filter) located at the top of the hood
- used for chemo therapy
-provides more protection for the pharmacist/tech than does the horizontal hood
Laminar Air Flow
- HEPA Filter removes 99.97% of all particles 0.3 microns or larger
- operate for at least 15 min prior to use –> most institutions require 30 mins
What is the greatest disadvantage of a laminar air flow vibe?
a false sense of security
ISO classifications of particulate matter in room air
(0.5 um and >) theres a whole chart but basically the smaller the number- the higher the air quality
What are pyrogens?
- metabolic products of living organisms, or the dead microorganisms themselves
- chemically: lipopolysassharides, soluble in water but insoluble in organic solvents
-aseptic technique (ideally) prevents the introduction of pyrogens to parenteral products
pharmacologic effects of pyrogens
- vary with the microbial source of the pyrogen & pt receiving the injection
- in man, pyrogenic reaction is fever & chills
- following injection, latent period 45-90 mins, then rapid rise in body temp, chills, headache & malaise
- anaphylaxis
Sources of pyrogens
- water used as the solvent
- containers used in preparation, packaging, storage or administration
-chemicals used in the preparation of the solution
Elimination of pyrogens
- dry heat: for metal and glass containers
- chemically: for solutions (disadvantage: can destroy drugs)
-synthetic filter media: 0.22 micron filter
Best approach: prevent them from occurring
unnecessary factors for when preparing sterile products
talking, laughing, chewing gum, eat/drink
CSP risk levels
-assigned according to relative possibility that a compounded sterile product might become contaminated
*LAFS
laminar airflow system
*BSC
biologic safety cabinet
RABS (CAI & CACI)
-restricted access barrier system
CAI: compounding aseptic isolator
CACI: compounding aseptic containment isolator
Clean rooms: an environment where contamination is limited/controlled to prevent:
particles, organisms & pyrogens
Clean rooms: environmental control:
temperature, humidity & relative barometric pressure
Clean room design (list all the things in there and they supplies they are made from)
- layout: equipment & traffic flow
- walls: epoxy coated
- flooring: seamless, vinyl
- ceiling system: gasketed, t-grid
- filtreation/Air flow: HEPA, positive pressure
- lighting: sealed, gasketed
- easy clean surfaces
Clean room classifications: class 100,000
- particle count not to exceed a total of 100,000 particles per cubic foot of a size 0.5 micron and larger
- and/or 700 particles per cubic foot of a size 5 microns and larger
Clean room classifications: class 100
- particle count not to exceed a total of 100 particles per cubic foot of a size 0.5 micron and larger
- and/or 0.7 particles per cubic foot of a size 5 micron and larger
end product testing: product observation
- container leaks & integrity
- particulates in solution
-solution color, volume and odor
end product testing: retrospective check:
- calculations
- ingredients
- quantities
- containers
end product testing: analytical testing
- evaluates the contents of prepared sterile products
- weight verification (specific gravity), refractometry verification, spectrometry, pH testing, microbial testing
Process Validation
- systematically demonstrates that a process will reproducibly meet its claim
- involves manipulation of microbial growth media according to the aseptic process being validated
-should schedule process under worst conditions
How to validate aseptic processes
- a growth medium: is introduced with a sample of the process being evaluated (product/process sample)
- the medium will support organisms introduced to the process by the operator
- the sample must be a product of the same aseptic process being validated
- should be conducted: at random intervals & without the operator’s knowledge*
more stability: 3 things in green
- the extent to which a Rx preparation remains within specified limits in terms of: chemical composition, physical composition & microbiologic activity/contamination
- at the time of use a medication must be: at the stated potency & safe for administration to the pt
Product stability:
is subject to specific storage conditions & is the primary basis for an expiration date/time
Lyophilization
- drugs in solution tend to be less stable than those in dry or suspended form
- a process of rapid freezing & drying under high vacuum (sublimation), the product is a dry powder
Sterilization
- 0.22 micron filter
- autoclave
antioxidants
- metasulfite & sulfite ions
- sodium salts, potassium salts (metabisulfite, bisulfite & sulfite)
Inert and semi-inert gasses
nitrogen, carbon dioxide & helium
Particulate matter
-may be present in parenteral products: undesirable, unintentional, potentially harmful to the pt, mobile, undissolved substances
Sources of particulate matter
- IV solution and/or additives: manufacturing process
- packaging components: paper, cardboard
- IV tubing/sets and administration devices
- preparation processes: laminar flow hood, patient bedside
IV fluid incompatibility*
- occurs when a drug is combined with an IV fluid or another drug, to produce by physiochemical means, a product unsuitable for administration to the patient *
ex: phenytoin in D5W (a physical & chemical incompatibility)
Therapeutic classification of incompatibilities
-2 or more drugs administered concurrently, result in undesirable antagonistic or synergistic pharmacologic action - drug/drug interaction
Physical classification of incompatibilities
the combination of ONE or more drugs in solution resulting in compositional change & appearance (change in color, formation of turbidity, precipitation & evolution of a gas)
Chemical classification of incompatibilites
-degradation of drug substances as a result of being in solution & as a result of being in contact with other drugs
The greatest single factors (3) causing incompatibility between IV fluids and their contents:
variations in pH, solubility & stability
minimizing incompatibilities
- use freshly prepared solutions whenever possible
- encourage use of as few additions as possible
- study to demonstrate proficiency in IV therapy
- educate MDs/Rns
- be skillfull with reference materials (Trissel’s, Clinical Pharmacology)
Parenteral administration advantages
- fast
- some drugs not effective orally
- uncomplicated admin. where the pt is: uncooperative, nauseous, unconscious NPO
- patient compliance: gives MD control of drug, pt must return for therapy, cant trust some pts to take medications
- correction of fluid/electrolyte imbalance
- TPN administration: when pt is NPO
Parenteral administration disadvantages
- special training required (special procedure, aseptic)
- invasive
- pain
- difficult to reverse
- more expensive
- incompatibilities
IV compatibility idk other green things to know
- -in general, use smallest possible bag
- refrigerate vs room temp
- light sensitivity
- pay attention to manufacture’s codes when provided*
sterility & integrity requirements for sterile IV admixtures
freedom from living organisms, freedom from dead organisms & pyrogens
H2O insoluble
dead organisms, parts of dead organisms & metabolic products of organisms