Intro Lecture (Hx) Flashcards
Curare
muscle relaxant
ether
surgical anesthetic
_________ is a local anesthetic similar to morphine
cocaine
____ offsets the effects of curare
nicotine
_____ kills bacterial cells without harming human cells
penicillin
____ aka diphenylhydantonin allowed epileptics to live normal lives
dilantin
Pure food and drug act was initiated in the year _____ and it’s purpose was___
1906; regulate products manufactured domestically… make sure their claims of purity, strength, and quality were correct.
Shirley amendment was instituted in ____, and did ___
prohibited false claims of therapeutic effects (they must do what they claim to do)
In ____(yr) a new wonder drug called ____ was dissolved in diethylene glycol (commonly known as ____) and killed at least 100 ppl … This resulted in the formation of the _____
1938, sulfanilamide, antifreeze; FDA
In ______(yr) the FDA was formed to enforce the ______act
food, drug, and cosmetic act - evaluate clinical trials, safety, quality.
The food, drug, and cosmetic act required that products be _______ but not _______
safe for human use, but not effective
In _____(yr), ______ was used as a sedative and lead to limb related birth defects
1960; thalidomide
The use of Thalidomide lead to the passage of the _______ amendment in _______ that required ______
Kefauver-harrison amendment is 1962, required drugs be safe AND effective
OTC/non-prescription VS. Hazardous/Prescription
OTC: deemed safe enough for ppl to self-treat; Prescript: drugs only useful after professional diagnosis or too dnagerous for self medication
The ______act in ________ lead to the DEA administering drugs and the classification of different “schedules/classes” of drugs
comprehensive drug abuse prevention and control act in 1970
CI drugs differ from CII-V in that they are said to have __
no accepted medical use
CI drugs have a _____potential for abuse and include drugs such as _______ & _________
High (the highest potential); heroin and LSD
CI &CII are said to cause _______ psychological/physiologic dependence
Severe
CV and CIV have a ____ potential for abuse and cause _______ psychological/physiologic dependence
low (CV is the lowest), cause limited dependence
Name the schedule of the following drugs: Morphine & Oxycodone, codeine, diphenyloxylate, diazepam
CII, CIII, CV, CIV
In ____ the FDA passed the _____ act to incentivize companies to make drugs that stood to provide less profit (ie pediatric, AIDS, Alzheimers drugs)
1997 FDA modernization act
Preformation Vs formulation Vs preclinical studies
Preform: define phys and chem properties; formulation: develop product/dosage; preclinical: cell culture and animal studies for effectiveness and safety
What is the population, size, length, and purpose of phase 1 trials
<100 HEALTHY volunteers, over several months to eval SAFETY (not efficacy)
What is the population, size, length, and purpose of phase 2 trials
up to several hundo ppl w/condition, several mo - 2 yrs, eval mainly efficacy
What is the population, size, length, and purpose of phase 3 trials
several 100 to thousands, 1-4yrs, dosage and efficacy (therapeutic window),
What is the phase 4 of clinical studies
drug can now be prescribed, is under surveillance for adverse effects
1 out of every 80-100 drugs are ____ every year
recalled (in phase 4)
what are black box warnings?
warn pts of serious side effects, this is the strongest warning the fda req’s (b4 pulling it off the market) – sig risks seen in clinical trials or life threatening adverse events
Name the black box warnings for: 1)all antidepressants, 2)celebrex(celecoxib) 3)Depo-proverva
1) all antidep increase risk of suicide for adolescents 2)inc risk of thrombic events 3) inc risk of bone loss with long term use
Trade names may indicate ____ or be ______
disease or condition the drug is used to treat (pepcid=peptic ulcers, restoril-sleep aid) or be simplified versions of the generic name
