Chp. 1-6 Week 1 PPT Flashcards
Study of biological effects of chemicals?
pharmacology
chemicals that are introduced into the body to cause some sort of change
drugs
Branch of pharmacology that uses drugs to treat, prevent, and diagnose disease?
Pharmocotherapeutics
5 nursing responsibilities (PA MIA)
P: Providing patient teaching about drugs/ drug regimens
A: Administer drugs
M: Monitor patient care plan to prevent medication errors.
I: Intervening to make drug regimen more tolerable
A: Assessing drug effects
4 natural sources and 1 unnatural source drugs can come from:
-plants, food, animals, salts of inorganic compounds
- synthetic sources
What does the icon “P” use to designate specific drugs as?
Prototype: either original drug within the class or the one that has emerged to be most effective
Which government body evaluate drugs for approval of use (development and sale)
U.S. Food and Drug Administration (agency of the U.S. Department of Health and Human Services)
How many phases are there regarding drug development from start to finish?
5
This phase of drug development involves testing of potential drugs either in vitro (outside of a living organism) or in vivo (inside or on a living organism) to determine therapeutic or adverse effects (NO human subjects).
Preclinical Trail
Testing done outside of a living organism is:
in vitro
testing done inside or onside a living organism is called:
in vivo
Which phase of drug development involves a pilot study of a potential drug using a small number of selected, usually healthy, human volunteers?
Phase 1
Which phase of drug development involves a clinical study of proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat?
Phase II
Which phase of drug development involves use of the proposed drug on a larger sample of the population of patients who have the disease the drug is thought to treat?
Phase III
Which phase of drug development involves continuous evaluation of a drug after it has been released for marketing?
Phase IV
After which phase are drugs evaluated by the FDA for FDA committee approval for marketing?
Phase III
An approved drug is given this type of name by the pharmaceutical company that developed it:
Brand name (trade nameI)
The name of a drug that is the original designation that the drug was given when the drug company applied for the approval process:
Generic name
The names that reflect the chemical structure of a drug:
chemical names
What is listed on the FDA label of a drug?
-approved uses
-risks
-benefits
-absorption
-distribution
-metabolism
-excretion from the body
All based on the clinical trials
—- —- refers to uses of a drug that are not part of the stated therapeutic indication for which the drug was approved by the FDA
“off-label”
How does a drug develop an “off-label” use?
Once available for use, it may be found to be effective in a situation not FDA approved
The use of drugs and their risk for pregnancy use, having been in use since 1979 is called what?
Previous Pregnancy-Risk Categories
This category for pregnancy-risk is a no-risk in human studies, included pregnant women, and has not shown to be of risk to the fetus during the first trimester.
Category A
