Exam 1 - Module 1 - Study Guide Flashcards
What are the 3 core ethical principals
1 - respect for persons
2 - beneficence - do no harm
3 - justice - making sure the patient understands what is going to happen
what are the 2 most important principles of informed consent
1 - right to be informed
2 - participation is voluntary - without coercion.
beneficence
the duty to protect research subjects from harm
what is phase 1 of the human clinical experimentation
Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
what is phase II of the human clinical experimentation
The drug or treatment is given to a larger group of people to see whether it is effective and to further evaluate its safety.
What is phase III of the human clinical experimentation
The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it with commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
What is Phase IV of the human clinical exprimentation
Studies are done after the drug or treatment has been marketed to gather information on the drug’s effects in various populations and to assess any side effects associated with long-term use.
chemical drug name
describes the’s drugs chemical structure
Brand (Trade) drug name
aka the proprietary name, chosen by the drug company and is usually a registered trademark.
generic drug name
official nonproprietary name for the drug - not owned by the drug company and is universally accepted
Pharmacodynamics
What the drug does to the body as the drug moves throughout the body. the study of the effects of the drugs on the body.
pharmacokinetics
process of drug movement throughout the body and what the body does to the drug. Movement of drug from circulation to body tissues
what are the 4 processes of pharmokinetics
1 - absorption - movement of the drug into the bloodstream after administration.
-Drug movement for the GI tract into the bloodstream’
- Disintegration - breakdown of oral drug form into small particles
- dissolution - combining small drug particles with liquid to form a solution
- this step includes transporting from one part of your body to the next
2 - distribution - movement of the drug from the circulation to body tissues
3 - metabolism (biotransformation) - process by which the body chemically changes drugs into a from that can be excreted. Liver is the primary site of metabolism
4 - excretion - elimination of drugs from the body - main route kidenys
which organ is primarily site for drug metabolism
liver
which organ is primarily responsible for excretion of drugs within the body
kidneys
What is the therapeutic index
the relationship between the therapeutic dose of the drug and the toxic dose of the drug.
what is ED50
dose of a drug that produces a therapeutic response in 50% of the population
what is TD50
dose of a drug that produces a toxic response in 50% of the population
therapeutic range
range of doses that produce a therapeutic response without causing significant adverse affects in patients
what are the 4 receptor families
1 - cell membrane embedded enzymes - the ligand binding domain for drug binding is on the cell surface. The drug activates the enzyme inside the cell and a response is initiated
2 - ligand-gated ion channels - channel crosses the cell membrane. when the channel opens, ions flow into and out of the cells - primarily effects sodium and calcium
3 - G protein-coupled receptor systems - 3 components 1-receptor 2-G protein that binds with GTP 3-the effector
4 - transcription factors - found in the cell nucleus on DNA, not on the surface. Activation of receptors through transcription factors regulates protein synthesis and is prolonged.
Notes - first 3 receptor groups - activation is rapid, last one response is prolonged
** see good chart in notes
What is a drug interaction
altered or modified action or effect of a drug as a result of interaction with one or multiple drugs
What are the pharmacokinetic interactions for drug absorption
when a person takes 2 drugs at the same time, the rate of absorption or one or both drugs can change. A drug can block, decrease, or increase the absorption of another drugs. Can do this in 3 ways
Factors affecting absorption
- food
- taking drugs with or without food
Example - laxatives increase the speed of gastric emptying - may increase gastric and intestinal motility and decrease drug absorption
what are the pharmacokinetic interactions for drug metabolism
A drug can increase the metabolism of another drug by stimulation liver enzymes. Drugs that promote induction of enzymes are called enzyme inducers
Examples - phenobarbital increase metabolism of most antipsychotics and drugs like warfarin.
Increased metabolism promotes drug elimination and decreases plasma concentration of the drug.
hepatic
relating to the liver
Drug enzyme inducer
Increases the metabolism of the drug so it moves through the system faster. Because it moves through the system faster the onset and termination of drug effect is slow and dosage may need to be increased
You would monitor serum levels to track this
Drug enzyme inhibitor
Decreases metabolism of the drug so it stay in the system longer. Because it stays in the system longer the onset of the drug effect usually occurs rapidly.
You would monitor serum levels to track this
what are the pharmacokinetic interactions for drug excretion
Most drugs are filtered through the glomeruli and excreted in the urine. Drugs can increase or decrease renal excretion and can have an effect on the excretion of other drugs.
Example - drugs that decrease cardiac output decrease blood flow to the kidneys, decrease blood flow to the kidneys results in decreased filtration rate, which can decrease or delay drug excretion
what is a pharmacodynamic interaction
interactions that result in additive, synergistic or antagonistic drug effects
additive drug effect
the sum of the effects of two drugs.
synergistic drug effect
the clinical effect of two drugs given together is substantially greater than that of either drug alone.
antagonistic drug effects
when drugs are administered together and one drug reduces or block the effect of the other.
pharmacogenetics
the study of variability in drug response due to heredity
Ultrarapid metabolizers
Increased efficiency in drug metabolism resulting in a possible decrease in effectiveness at established doses. Increased risk for adverse drug responses because of increased metabolite or active drug production.
What are dietary supplements required to have on the label
1 - name of supplement
2 - amount of the supplement
3 - nutrition labeling
4 - ingredient list
5 - name and place of the manufacturer, packer or distributor
what does active transport require
facilitated diffusion
pinocytosis
active transport where the drug is carried by particles that are pulling it in
First Pass Effect
from the GI tract to the liver - everything goes through the liver
Factors affecting bioavailability
drug form
route of administration
gastric mucosa and motility
administration with other food and drugs
changes in liver metabolism
Bioavailability
how much of the drug is in the body and available for use
what are some influencing factors of drug distribution
protein binding
free drugs
blood-brain barrier
some drugs may bind with protein making them not as available
drug metabolism
process of chemically changing drug into a form to be excreted
potency
how much of the drug do you need to take to get the desired effects
maximal efficacy
when the drug no longer gets a therapeutic response. You may develop a tolerance to the drug
drug onset
time it takes for the drug to reach minimum effective concentration
drug peak
highest concentration of the drug in the blood
drug duration
length of time drug exerts a therapeutic effect
what are the 3 reason drugs bind to receptors
to activate a receptor
to produce a response
to inactivate a receptor
Agonists
Activate receptors
produce desired response
Partial Agonists
elicit only moderate activity when binding to receptors
prevent receptor activation by other drugs
antagonists
prevent receptor activation
block response
what are the mechanisms of drug action
stimulation
depression
irritation
replacement
cytotoxic action
antimicrobial action
modification of immune status
drug toxicity
drug levels exceeds therapeutic range
drug tolerance
decreased responsiveness to drug over the course of the therapy. requires a higher dose to achieve the same therapeutic response
tachyphhaxis
acute, rapid decrease in response to a drug
if you are on herbal therapy how soon before surgery should you discontinue the herbal therapy
2 - 3 weeks
what does garlic used for
lower cholesterol and blood pressure
reduce heart disease
what are some side effects of garlic
heartburn
decrease blood clotting
what is ginger used for
nausea, motion sickenss, diarrhea
what are some side effects of ginger
gas, bloating
what is ginkgo biloba used for
asthma, bronchitis, improve memory, prevent alzheimer disease, treat sexual dysfunction
side effects of ginkgo biloba
headache, nausea, dizziness
