Exam 1 Flashcards
Describe the 4 phases required by the FDA
Phase I : evaluation of drug metabolism, healthy volunteers, effects on humans (S&S)
Phase II : SMALL group, determine therapeutic effects, tested in SICK pts, safety & effectiveness (non refillable)
Phase III : LARGE group, dose ranges, side effects & effectiveness, pt safety, hundreds-thousands of ppl
Phase IV : REFINE the dosage range, new side effects may be discovered, GENERAL population, conditional approval from FDA
What are the drug names
Chemical: scientific name, describes the molecular structure of a drug
Generic: “OFFICIAL” name of a drug, non-proprietary
Trade: named by pharm company that made the drug, propietary
Define the 5 drug schedules from the Controlled Substance Act
Schedule I : all non-research use is forbidden, HIGHEST risk for abuse….heroin, LSD, weed
Schedule II : no phone scripts, NO refills, high risk for abuse….cocaine, oxy, fentanyl
Schedule III : script must be rewritten after 6 months, moderate risk for abuse…..tylenol w/ codeine, testosterone, ketamine
Schedule IV : differs in penalties for illegal possession, low potential for abuse….xanax, valium, tramadol
Schedule V : limited dependence, OTC…..cough syrup w/ codeine, lyrica
What are the sources of drug info available for HCP
Official : National Formulary, US Pharmacopeia
Non-Official : USP Dispensing Info
Other : PDR - pharm info, Internet- FDA
What are the rights of drug admin
Right drug
Right pt
Right dose
Right route
Right time
Right documentation
Describe the methods of drug admin
Enteral : oral (PO)
Parenteral : IM, IV, Subcut, Intradermal
Topical : sublingual, dermal, vaginal, rectal, inhalation (drink water 10-15 mins before med admin
Describe drug-food interactions
- alters rate of absorption
- inhibits drug metabolism
- increases toxicity of a drug
Describe drug-drug interactions
- INcrease therapeutic effect
- INcrease ADRs
- DEcrease effectiveness
- DEcrease side effects
- toxic to same organ
- DEcrease renal perfusion
Describe absorption in parenteral
- can move larger amt of med throughout the body
- circulates before reaches liver
- goes right into circulatory system
What influences distribution
- First Pass effect
- blood flow to tissue
- ability of drug to exit vascular system (strong binding=slow release….weak binding=quick release
Where does drug metabolism occur
liver
Describe drug metabolism
- biotransformation
- converts fat soluble drugs into water soluble metabolites
- can be affected by CYP450 system
Describe drug excretion
- removal of drugs from the body
- released from kidney via urine
-released from GI tract via stool - released from lungs via exhaled air (releases bile)
What is the drug half life
time needed for the amt of drug in the bpdy to decrease by 50%
Drug dosing is determined by what
half life