Final!! #1 Flashcards
The perfect drug?
T: treat the pt condition
R: rapid
M: mouth
A: No ADRs
I:inexpensive
I:infrequently take
N:No med interaction
E:elminated from the body quickly
Medication errors
Wrong drug 22%
Overdosage 17%
Wrong route 8%
Pure food and drug act of 1906
Protect public from mis labelled drugs
Drug company lists 1 of 11 dangerous things
Sherly amendment (1912)
no fraudulent claims
Food, drug and cosmetic act (1938)
Must test for harmful objects and drugs labels complete
Durham humphrey amendment (1952)
how drugs can be ordered and dispensed
Kefauver-Harris amendment (1962)
Safety and efficacy, permitted generic versions
FDA drug approval
Preclinical: 6.5 years
Phase I: 1.5 years - small set of volunteers
Phase II: 2 years - patients with disease, tests for effectiveness and side effects
Phase III: 3.5 years - tests for safe dosage
FDA review - 1.5 years
Drug price competition and patent term restoration act of 1984
5 years of market exclusivity before making generics
Generic approve criteria
pharmaceutical equivalence
Same active?
May have different?
ingredients, dosage form, strength, route
shape, scoring, and excipients
Generic approve criteria
bioequivalence
AUC?:
Cmax?
Tmax?
Must line within 80 to 125%
(-20%, +20%)
AUC: area under curve, level of drug in blood over 24 hrs
C: max concentration
T:how much time it takes to make
Schedule I drugs
high abuse potential
no accepted medical use
severe dependence
Heroin, marijuana, LSD, ecstasy
Schedule II drugs
accepted medical use
prescription pad ONLY, no refills
Opioids, cocaine, barbiturates
Schedule III drugs
low physical dependence
high psychological dependence
6 months of refills
Norco, nalbuphine, steroids, ketamine
Schedule IV drugs
limited dependence
6 months of refills
Phenobarbital, diazepam
Schedule V drugs
may or not require a prescription
codeine
Pharmaceutics
science of drug administration
Dosage forms
Pharmacokinetics
what the body does to the drug
absorption
distribution
metabolisum
elimination
Pharmacodynamics
what the drug does to the body
Antagonism
prevents a response to an agonist
can be irreversible or reversible
Enteral administration
Small intestine
high surface area,
rich blood supply,
basic pH (BEST PLACE)
Parenteral administration
Advantages
used for drugs that are poorly absorbed immediate onset
long lasting
specific location
predictable, titratable
Parenteral administration
Disadvantages
pain, irreversible
phlebitis, no self admin
infection
Parenteral location
Intravenous, intramuscular, subcutaneous, epidural
intrathecal
intra-articular
intra-arterial
intra-articular, where?
Joint
Intrathecal, where?
subarachnoid space
spinal cord