Patho/Pharm Exam 1: Pharmacologic Principles, Pharmaceutics, Pharmacokinetics

drug

any chemical that affects the physiologic processes of a living organism

medications

drugs used to prevent, treat, or cure diseases

Drug name types

chemical, generic, trade

chemical name

chemical formula name for a drug

generic name

legal noncommercial name for a drug given after a drug is made (most often used)

trade name

The commercial name given to a drug by its manufacturer, proprietary name

FDA Drug approval process

pre-clinical investigational drug study, investigational new drug study, 4 clinical phases

preclinical investigational drug study

in vitro/animal testing before humans

investigational drug study

informed consent by humans

clinical phase 1

small # of healthy people, determine dosage and pharmacokinetics

clincal phase 2

small # of people w the disease, determine therapeutic dosage

clinical phase 3

large # of people, placebo included, determine adverse effects, FDA approval in this stage

clincal phase 4

post trial study to see long term therapetutic or adverse effects for long term use, min 2 years

black box warning

voluntary recall of a drug if drug has severe reactions, occurs in clinical phase 4, drug can still be prescribed

three classes of drug recall

class 1, class 2, class 3

class 1

most serious, adverse health effects or death

class 2

less severe, temporary or reversible health effects

class 3

least severe, unlikely of significant health problem

pharmocolgic principles

pharmaceutics, pharmocokinetics, pharmacodynamics

pharmaceutics

The science of preparing and dispensing drugs, including the form of dosage and how it affects the body

fastest type of oral preparations

oral disintegration

slowest type of oral preparations

enteric coated tablets, capsules

pharmacokinetics

what the body does to the drug from the time it enters to the time it exits the body completely

4 steps of pharmacokinetics

absorption, distribution, metabolism, excretion

Absorption

how do we take in the drug

bioavailability

the extent of the amount of drug that reaches circulation

first pass effect

decreases the bioavailability of the drug due to passing through the liver

high first pass effect

if the liver breaks down a large portion of the drug before it reaches circulation

IV drugs first pass effect

100%

bioequivalent

two drug products have identical bioavailabilty and concentration of an active ingrediant

Routes of absorption

enteral, parental, topical

Enteral Route

involves GI tract, anything going in the mouth or rectum

Parental Route

involves any kind of injection, fastest route

Topical Route

involves all things on the outside of body (skin, eyes, ears, nose, rectum, vagina, lungs)

Example of topical

inhalers, nasal spray, suppositories

Distribution

how the drug is transported by bloodstream to the body

order of distribution

major organs with extensive blood supply, circulation, liver/kidneys for metabolism

Albumins role in distribution

metabolites bound to plasma protein are not able to leave blood vessel and enter tissue

metabolism (biotransformation)

when the drug is converted to either lipid or water soluble

lipid soluble

absorbed by the body

water soluble

being excreted

Cytochrome P-450 enzymes

enzyme that targets lipophilic drugs that are difficult to elimate due to their slow metabolsim

hydrophilic drugs

fast metabolism

lipophilic drugs

slow metabolsim

diseases that decrease drug metabolism

cardiovascular disease, renal insufficiency

conditioons that decrease drug metabolism

starvation, jaundice

fast acetylator

increased drug metabolism

slow acetylator

decreased drug metabolism

P-450 inducer

increases drug metabolsim

P-450 inhibitor

decreases drug metabolsim

Excretions

all drugs must be removed ( liver, kidneys ,bowels

renal excretion

hydrophilic drugs eliminated by urine easily

biliary excretion

lipophilic drugs eliminated by stool and are more difficult to elimantie

what initiates excretion

liver, kidney finishes the job

half life importance

needed for correct dosage to prevent toxicity

half life

amount of time for half of the drug to be removed from body

steady state

the rate of elimination is equal to the rate of intake (most important for antibiotics)

how many half lives before a typical drug is eliminated

5 half lives

Drugs and time effect on the body steps

onset, peak, duration, toxicity

onset

time required for the drug to elicit the first therapeutic response

peak

time required to reach maximum therapeutic response

duration

length of time that a drug creates therapeutic response

toxicity

occurs when the peak blood level is too high

monitoring of drug effevts

know the window between the peak and trough to avoid toxicity which can damage the liver and kidneys

peak level

highest blood level of a drug

trough level

lowest blood level of a drug