exam 2 lecture 1

Question 1

new england compounding center tragedy

Answer 1

infections + death due to insterile products
NECC case triggered changes in federal law
section 503A + 503B

Question 2

Reasons for concern

Answer 2

uncontrolled environments are still in use today
inadequate control leads to medication errors
- incorrect ingredients + strength of ingredients, contamination w/ pathogens and pyrogens

Question 3

importance to pharmacists

Answer 3

pharmacist is healthcare professional responsible for inspecting + approving or rejecting formulas, calculations, substances, containers, closures, and materials for compounded preparations

Question 4

repackaged avastatin

Answer 4

single-use is not meant for multiple uses

Question 5

flow of admixture orders

Answer 5

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

Question 6

USP chapters

Answer 6

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

Question 7

USP 797

Answer 7

the law of compounding sterile preparations

Question 8

parenteral products

Answer 8

in practice, means injectable product
taken into body or admin other by way other than digestive tract

Question 9

considerations about parenteral products

Answer 9

admin of therapeutic agent requires injury to body
admin bypasses body’s natural defense
admin makes body vulnerable

Question 10

requirements for parenteral

Answer 10

sterile
particle free
pyrogen free
objective: dosage from has right potency + proper label

Question 11

compounding chapters

Answer 11

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

Question 12

objective for 797

Answer 12

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

Question 13

sterile preparations

Answer 13

parenteral formulations must be free of microbial organisms
- steam (autoclave)
- filtration
- dry heat (oven)
- gas (ethylene oxide)
- irrigation (gamma rays)

Question 14

pyrogens

Answer 14

bacterial endotoxins
contaminants that produce fever and septic shock
remnants from microorganisms
sterilization does not eliminate them

Question 15

septicemia vs septic shock

Answer 15

septicemia - infection of the blood
septic shock - acute reaction to bacterial endotoxins

Question 16

particle free

Answer 16

particles trigger immune response
produce damage to lungs + kidneys
can kill people

Question 17

types of parenteral products

Answer 17

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

Question 18

definitions for parenterals

Answer 18

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

Question 19

size of preparation

Answer 19

LVP - large volume parenteral, single dose injections packaged in a container more than 100 mL
small volume parenteral, 100 mL or less

Question 20

vehicles

Answer 20

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)

Question 21

types of water

Answer 21

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

Question 22

SWFI secret

Answer 22

safe, sterile, particle free, pyrogen
but never inject plain water into bloodstream