Intro to Parenteral Products Flashcards
Pharmacist role in health care
THE health care prof responsible for inspecting and approving, or rejecting all formulas, calculations, substances, containers, closures and in-process materials pertaining to compounded sterile preparations
3 levels of safety for patient
Physician
Nurse
Pharmacist
Steps 6-7 on flow of admixture orders
Components assembled
Admixture prepared
USP chapters with numbers >1000
Recommendations
USP chapters with numbers <1000
Enforceable (MUST FOLLOW)
Critical USP to parenteral product:
USP <797> -Pharm compounding -sterile prep
<USP> 800 - hazardous drugs - handling in healthcare settings, (official July 1, 2020)
</USP>
USP <797>
Law of compounding sterile mixtures
Anything that has to do with parenteral products: <797>
Parenteral meaning
Not by mouth (administered by injection)
Considerations about Parenteral Products
Admin of the therapeutic agent requires an injury to body
Admin bypasses the body’s natural defense
Admin makes the body vulnerable
Must meet some stringent requirements
Requirements of parenterals
Sterile
Particle free
Pyrogen free
(right potency, properly labeled)
Risk of harm to patient USP
Microbial contamination
Excessive bacterial endotoxins
Variability in the intended strength of correct ingredients
Unintended chemical and physical contaminants
Ingredients of inappropriate quality
(20% USP - meets MINIMUM requirements)
Sterilization
Steam (autoclave)
Filtration (bacteria retentive membrane)
Dry heat (oven)
Gas (ethylene oxide)
Irradiation (gamma rays)
Pyrogens definition
Bacterial endotoxins; contaminants that “produce fever.” they can also produce septic shock (pyro = fire; fever)
Where pyrogens come from
Remnants from microorganisms
Does sterilization eliminate pyrogens?
NO - kills them, but does not eliminate; leftover bodies
Septicemia vs Septic shock
Septicemia - infection of the blood (death in relation to the infection)
Septic shock - acute reaction to bacterial endotoxins (death due to reaction of body to pieces of bacteria in endotoxins)
Particle free importance
Foreign particles can trigger immune response
Can produce damage to the lungs
Can produce damage to kidneys
can and have killed people
Types of parenteral products
Solutions ready for injection
Dry, soluble preparations ready to be combined w/a solvent before use
Suspensions ready for injection
Dry, insoluble preps ready to be combined w/a vehicle before use
Emulsions
Liquid concentrates ready for dilution prior to admin
Injection vs FOR injection
Injection- Liquid preps that are drug substances or solutions thereof
FOR injection - dry solids or liquid preparations that, upon the addition of suitable vehicles, yield solutions conforming in all respects to the requirements for injections (i.e. something has to be done to it before injected)
Parenteral products variation as seen through Purduemycin
Purduemycin injection
- Drug in solution, may or may not be aqueous
for injection - sterile liquid or solid that needs to be reconstituted with a vehicle
-Injectable suspension
-Injectable emulsion
LVP
Large volume parenteral - single dose injections packaged in a container containing more than 100mL
Small volume parenterals
100mL or less
LVP importance
If something goes wrong in a large quantity - big problem
LVP is typically used in hospitals
Components of parenteral products: Vehicles
Solvents or mediums for the admin of therapeutic agents
Whatever the vehicle, it MUST meet USP standards for the pyrogen
“water” is the most common vehicle used in parenteral products
Water is the preferred vehicle
Water for injection USP (WFI)
Pyrogen free, non sterile, single use sealed container
Sterile water for injection USP (SWFI)
Pyrogen free, sterile, packed in sealed containers not larger than 1000mL
Bacteriostatic Water for Injection USP (BWFI)
Pyrogen free, sterile with antimicrobial agent added
SWFI is
Pharmacologically/biologically safe
Sterile
Particle free
Pyrogen free
Remember with SWFI
NEVER inject plain water (SWFI) directly into blood stream - cells will swell like balloons
