legal & ethical issues Flashcards
formulary
list of drugs available from a pharmacy
Food, drug and cosmetic act 1938
monitor and regulate the manufacture and marketing of drugs
durham-humphrey amendment 1952
prescription vs. non prescription drugs
kefauver-harris amendment 1962
increase safety
controlled substances act 1970
decrease drug abuse
Stage 1
high abuse potential, no accepted medical use
stage 2
high abuse potential, accepted medical use
stage 3
less potential for abuse, medically accepted
stage 4
may cause dependence, medically accepted
stage 5
limited potential for dependence, medically accepted
FDA modernization act 1997
review of new drugs occurs more rapidly
Nurse practice act
what meds nurses can give, must give the way it was dosed
a
safe during pregnancy
b
safe during pregnancy
c
some risk to fetus
d
some risk to fetus
x
never give during pregnancy
what are the 5 rights of med administration?
right client right drug right dose right time right route
pre-clinical testing
lab and animal testing
phase 1
assess safety, dose range in healthy subjects
phase 2
safety and efficacy in subjects with disease
phase 3
saftey and efficacy in larger groups of subjects with disease
new drug application to fda
if approved drug goes to market
phase 4
purpose- long term use of drug
post- marketing, new indications
