PathoPharm exam 1 Flashcards
Investigational drug study phase 2
Small number volunteers with disease
Investigational drug study phase 1
Healthy volunteers
Investigational drug study phase 3
Large number volunteers with disease
Investigational drug study phase 4
Post marketing studies by drug company-voluntary
Pregnancy category A
No ill effects to fetus
Pregnancy category B
No risk to animal study
Pregnancy category C
Study in humans but not pregnant women. Shows harm in animals
Pregnancy category D
Risk to fetus. Risk of not taking meds is greater than taking it, can be used in life threatening
Pregnancy category X
Risk to fetus is definite. No benefit.
Tetratogenic effect
Results in structural effect in unborn fetus; crosses placental barrier
DEA Schedules and controlled substances: schedule 1 (CI)
High abuse potential (illegal, no prescription available)
DEA Schedules and controlled substances: schedule 2 (CII)
High abuse potential and severe dependence liability -30day supply with no refills- hand written only; ei: morphine, methadone, methamphetamine
DEA Schedules and controlled substances: schedule 3 (CIII)
Less abuse potential, low-moderate physical dependence, high psychological dependence -no more than 5 refills; ei: anabolic steroids, codeine, hydrocodone
DEA Schedules and controlled substances: schedule 4 (CIV)
Less physical abuse potential-accepted medical use-written or verbal prescription with max 5 refills; ie: diazepam/Valium, alprazolam/Xanax
DEA Schedules and controlled substances: schedule 5 (CV)
Limited abuse potential, small amount of narcotic used as antitussives or antidiarrheals- may not need prescription but must be recorded; ie: OTC cough meds with codeine or Tylenol 3