Exam 1 Flashcards
Controlled Substance Act
1970
Designed to fix drug abuse by:
-Promoting drug education and research
-Strengthening the enforcement authority
-Establishment of treatment and rehab facilities
-Designation of categories of controlled substances according to abuse
Food and drug administration modernization act
1997
Regulated foods, drugs, devices, and biological products
HIPAA
Protects patient information
First federal pure foods and drugs act
1906
-Protected the public from adulterated or mislabeled drugs
-Required companies to label dangerous and possibly addicting drugs
-Established FDA
Shirley amendment
1912
-Prohibited false therapeutic claims
Teething syrup contained morphine
Durham humphrey amendment
1951
-you need a prescription for legend drugs
-needs to be refilled with physician authorization
-doctors can call pharmacy telling them to refill, but not all pharmacies allow this
-You don’t need a prescription for OTC
C-I, C-II, C-III, C-IV, C-V
C-I: high abuse potential, severe dependence, no accepted medical use; restricted to research
C-II: high abuse potential, severe dependence, requires specific type of rx, phone orders not accepted, refills require new rx
C-III: Moderate potential and dependence, written or phone rx allowed. May be refilled 5 times within 6 months from date of issuance
C-IV: Low abuse potential, limited dependence, same as C-III
C-V: Limited abuse potential, lowest dependence, OTC
Medications for pregnancy (categories A, B, C, D, X)
A: Well-controlled studies show no fetal risk
B: No well controlled studies on humans; animal studies show no fetal risk
C: No well control studies on humans; animal studies show adverse effect on fetus
D: Evidence of human risk to the fetus exists; benefits outweigh risks in certain studies
X: Controlled studies in animals or humans demonstrate fetal abnormalities; not worth it
Protein binding
When drugs are distributed in the plasma, many bind with plasma proteins
bound part of drug is inactive because it can’t interact with tissue receptors (think of a locked up student, can’t leave and study)
free drug does stuff
when free drug decreases, bound drug leaves to have balance
Bioavailability
How much drug gets used by the body
Study designs (Open label, single, double, triple blind)
Open label: everyone knows
Single blind: participants dont know
double blind: HCP and participants dont know
Triple blind: HCP and collects data and doesnt know, removing biases
DAW
Can’t substitute for generic drug
Dietary supplement health and education act
1994
All labels must contain:
-name of supplement
-amount
-nutrition labeling
-ingredient list
-name and place of manufacturer
1992 (related to CAMS)
what was developed to support studies of CAMS
office of alternative medicine
Can CAMS be patented?
no
When not to take CAMS?
If pregnant, taking rx meds, not for infants
ADME
absorption
distribution
metabolism
excretion
Absorption
Drugs dissolve better in acid
enteric coated drugs r better in alkaline small intestine (aspirin)
Passive transport
Diffusion (high to low), no energy required
You want to PASS your test so your LOW CONCENTRATION brain sleeps on a HIGH CONCENTRATION textbook (HIGH TO LOW) and it doesnt take energy
Active transport
Requires a carrier, like an enzyme or a protein to move the drug along the concentration gradient. Energy required to be ACTIVE
Lipid soluble drugs pass rapidly or slowly?
Rapidly through the GI membrane bc it’s made of lipid
Water soluble drugs
Need a carrier, enzyme or protein, to pass membrane
Between ionized and nonionized, what passes faster?
Nonionized. Even larger particles pass quicker if they are nonionized
Are IM drugs absorbed faster in deltoid or gluteals?
deltoid bc more blood vessels
IO, IM, IV, and SC, fast to slow?
IV and IO, IM, SC
First pass effect
Some drugs don’t go directly into circulation. Some pass intestinal lumen to get to the liver via the portal vein
Metabolism in the liver
Some drugs get turned inactive and excreted, some are metabolized into metabolite, an equal or stronger form of the drug
How much more should oral dose be compared to IV
3-5x more
What factors effect bioavailability (there are 5)
Drug form
route
GI mucosa and motility
presence of food and other drugs
changes in liver’s metabolism or inadequate hepatic blood flow
If the liver metabolizes a certain drug but the liver isn’t working, what happens to the drug?
More bioavailability
rapid vs slow absorption
Rapid: increases bioavailability, may be toxic
Slow: limits bioavailability, decrease in drug serum concentration
Protein binding
Some part of the drug binds with proteins and can’t interact with receptors, making them useless. Free drug helps. Once the body starts running out of free drug, bound drugs break free and become useful
how do low plasma protein levels affect protein binding?
low plasma protein levels=fewer proteins to bind with=more free drug=toxicity
BBB
Blood brain barrier
Protects the brain from foreign substances
Endothelial lining