Introduction + FDA Flashcards
scientific definition of drug
external molecules interact with internal molecules that lead to biochemical changes
federal definition of drug
“articles” (instead of molecules) used for treatment / prevention of disease and are intended to affect body or animals
CDER
evaluation and research of drugs
responsibilities of CDER
testing for drug safety and efficacy
quality control for drug manufacturing
oversight of drug marketing and advertising
post-approval surveillance of drugs on the market
dietary supplements are regulated as ____ by _____
food products
CFSAN
what does dietary supplements being regulated as food mean?
-less stringent manufacturing guidelines
-no pre-approval safety testing
-no need for efficacy testing
like drugs, dietary supplements can
have therapeutic benefits
be toxic
produce unwanted interactions
1906 pure food and drug act
standards for drug strength and purity
1938: food, drug, and cosmetic act
prompted by elixir sulfanilamide tragedy (diethylene glycol - kidney failure)
mandated safety testing
1962: amendment of food, drug, and cosmetic act
stronger safety standards and efficacy testing
prompted by thalidomide disaster (birth defects)
2007: FDA amendements act
prompted by COX-2 inhibitor heart problems
more FDA control over approved drugs
blockbster drugs
account for most drug revenue (fuels rest of company costs)
first in class medications
does things that no other drug does (innovative but expensive)
me too medications
modified versions, cheaper to make, creates competition so it lowers drug costs
orphan drugs
pharm agent developed to treat medical conditions, which because they are so rare, wouldn’t be profitable to produce without government assistance
double blind design (phase III clinical trials)
no one knows the treatment condition, removes bias
placebo control
comparison permits examination of natural course of disease without drug
placebo effect
patients respond to placebo 10-20% of time
MedWatch
post marketing surveillance of drug safety
can lead to meds being withdrawn from market
changes in use parameters
recalls or altered labeling
black box warning
FDA required label that prescription drugs carry significant risk of serious / life threatening effect
off label use
FDA approves for specific condition - anything other than normal usage is considered off label
providers can prescribe drugs outside marketed indications
no pharmaceutical company marketing allowed
category A (pregnancy)
pregnant women show no increased risk in fetal abnormalities
category X (teratogen)
pregnant women demonstrated evidence of fetal abnormalities
teratogen
substances that harm a developing fetus / embryo
chemical drug name
chemical structure
code drug name
short name by pharm company for use during drug eval
generic drug name
refers to drug or class of drugs (can be same as other company)
brand / trade drug name
name by manufacturer (all different)
generic drugs must be
-pharmaceutically equivalent to brand name
-bioequivalent
-therapeutically equivalent
-manufactured under same FDA standards
generic drugs must not
-look the same as brand
-can have different flavors, inactive ingredients, formulations
prescription drugs need a prescription because
need authorization for purchase (habit forming, toxic, not easily diagnosed)
prescription important points
drug name (brand / generic), strength, quantity, instructions
ad lib
at pleasure
b.i.d.
twice a day
b.d.s.
twice a day
h.s.
at bedtime
non rep
do not repeat (refill)
npo
not by oral administration
po
by mouth
prn
as needed
qXh
every X hours
qd
every day
qid
four times a day
im
intramuscular
iv
intravenous
sc, subc, SQ
subcutaneous
common errors in prescription
wrong drug dispensed
wrong dose
vague description of use parameters
OTC drugs
no prescription needed
same FDA regulations as prescription
often lower doses than prescription formulas (ibuprofen)
controlled drugs
those that have abuse potential, regulated by DEA, need license to purchase
schedule I
high abuse potential, not legal
schedule II
high abuse potential, prescription needed
Schedule III and IV
intermediate and lower abuse potential
schedule V
low abuse potential, dispensed by provider without prescription
state challenges to FDA
some states recognize medical use but feds don’t
