Chapter 1 Flashcards
define pharmacology
study of effects of chemicals on the body
define drugs
chemicals introduced to the body to bring about change
define pharmatherapeutics
uses drugs to treat, diagnose, prevent disease
define adverse effects
“side effects” - undesirable, unpleasant, dangerous
nurse’s responsibilities (6) regarding drug therapy
Administering safely
Assessment of effects of drug - requires knowledge of drug
Interventions to make regimen more tolerable
Teaching patients about drugs
Monitoring overall plan of care
Preventing errors
2 sources of drugs
natural
synthetic
3 sources of natural drugs + examples
Plants: digitalis from foxglove; morphine & codeine from poppy seeds; herbal OTC products
Animals: drugs that replace human chemicals - formerly insulin; hormone replacement
Compounds: fluoride, iron, aluminum, gold salts
define drug evaluation & its purpose
determines safety & efficacy of drug
how long does drug evaluation usually take?
5-6 years
stages of drug evaluation
preclinical trials
phase I
phase II
phase III
FDA approval
phase IV
what are the populations studied in each stage of drug eval?
preclinical: animals
I: healthy volunteers
II: diseased volunteers
III: widespread
IV: widespread use
which phase of drug eval starts to see unexpected effects of drug?
phase III
what 3 names are drugs given?
trade, generic, chemical
what are categories of drugs based on use during pregnancy?
Categories A, B, C, D, X
describe category A
Studies demonstrate safety
describe category B
Animal studies demonstrate no risk, but no adequate studies in pregnant women OR
Animal studies show adverse effect, but adequate studies in pregnant women do not demonstrate risk
describe category C
Animal studies show effect on fetus, but no adequate studies in pregnant women OR
Benefits of drug during pregnancy may outweight risk OR
No adequate reproduction studies in animals or humans
describe category D
Evidence of risk to human fetus, but benefits of drug during pregnancy may outweigh risk
describe category x
Demonstrated abnormalities or adverse reactions - risk clearly outweighs possible benefits
__________ gave FDA control of drugs following drug ______ causing birth defects
1962 - Kefauver-Harris Act
thalidomide
act that regulates drugs known to have abuse potential
1970 - Controlled Substance Act
nursing interventions when handling controlled substances (5)
Account for all drugs
Keep a special record
Countersign all wasted medications
Ensure documentation and drugs on hand match
Only authorized persons have access to locked system
what are the DEA schedules of controlled substances?
Schedule 1-5 (C-I through C-V)
high abuse potential - no approved medical use
schedule 1