exam 2 lecture 1 Flashcards
new england compounding center tragedy
infections + death due to insterile products
NECC case triggered changes in federal law
section 503A + 503B
Reasons for concern
uncontrolled environments are still in use today
inadequate control leads to medication errors
- incorrect ingredients + strength of ingredients, contamination w/ pathogens and pyrogens
importance to pharmacists
pharmacist is healthcare professional responsible for inspecting + approving or rejecting formulas, calculations, substances, containers, closures, and materials for compounded preparations
repackaged avastatin
single-use is not meant for multiple uses
flow of admixture orders
physician prescribes –> admixture sent to pharmacy –> pharmacist reviews –> incompatibility checks + profile reviewed –> label generated –> components assembled –> admixture prepared –> expiration time stamped –> pharmacist checks –> admixture delivered –> nurse obtains admixture –> nurse verifies admixture –> admixture administered
- beyond use date is last after opening
USP chapters
chapters greater than 1000 - recommendations
chapters less than 1000 - must follow
USP 797 - pharmaceutical compounding and sterile preparation
USP 800 - hazardous drugs - handling in healthcare
USP 797
the law of compounding sterile preparations
parenteral products
in practice, means injectable product
taken into body or admin other by way other than digestive tract
considerations about parenteral products
admin of therapeutic agent requires injury to body
admin bypasses body’s natural defense
admin makes body vulnerable
requirements for parenteral
sterile
particle free
pyrogen free
objective: dosage from has right potency + proper label
compounding chapters
USP 795 + 800: non-sterile hazardous
USP 795: non-sterile and non-hazardous
USP 797: sterile and non hazardous
USP 797 + 800: sterile and hazardous
objective for 797
prevent patient risk of harm
1. microbial contamination
2. excessive bacterial exotoxins
3. variability in intended strength of correct ingredients
4. unintended chemical + physical contaminants
5. ingredients of inappropriate quality
sterile preparations
parenteral formulations must be free of microbial organisms
- steam (autoclave)
- filtration
- dry heat (oven)
- gas (ethylene oxide)
- irrigation (gamma rays)
pyrogens
bacterial endotoxins
contaminants that produce fever and septic shock
remnants from microorganisms
sterilization does not eliminate them
septicemia vs septic shock
septicemia - infection of the blood
septic shock - acute reaction to bacterial endotoxins
particle free
particles trigger immune response
produce damage to lungs + kidneys
can kill people
types of parenteral products
solutions ready for injection
dry, soluble preparations ready for solvent combo
suspensions ready for inj
dry, insoluble preparations ready for vehicle combo
emulsion
liquid concentrates
definitions for parenterals
injection - liquid preparations that are drug substances or solutions
for injection - dry or solid preparations that require suitable vehicles for injection
injectable emulsion - liquid preparations of drug substances dissolved in emulsion
injectable suspension - liquid preparations of solids suspended in liquid
for injectable suspension - dry solids that require suitable vehicles for injection
size of preparation
LVP - large volume parenteral, single dose injections packaged in a container more than 100 mL
small volume parenteral, 100 mL or less
vehicles
solvents or mediums for administration of therapeutic agents
needs to meet USP guidelines for pyrogen test
water is most common vehicle in parenteral products (water is preferred)
types of water
water for injection (WFI) - pyrogen free, non sterile, single use container
sterile water for injection USP (SWFI) - pyrogen free, sterile, packed in sealed containers, not larger than 1000 mL (use this)
bacteriostatic water for injection USP (BWFI) - pyrogen free, sterile + antimicrobial agent added
SWFI secret
safe, sterile, particle free, pyrogen
but never inject plain water into bloodstream
