Intro Lecture (Hx)

Question 1

Curare

Answer 1

muscle relaxant

Question 2

ether

Answer 2

surgical anesthetic

Question 3

_________ is a local anesthetic similar to morphine

Answer 3

cocaine

Question 4

____ offsets the effects of curare

Answer 4

nicotine

Question 5

_____ kills bacterial cells without harming human cells

Answer 5

penicillin

Question 6

____ aka diphenylhydantonin allowed epileptics to live normal lives

Answer 6

dilantin

Question 7

Pure food and drug act was initiated in the year _____ and it’s purpose was___

Answer 7

1906; regulate products manufactured domestically… make sure their claims of purity, strength, and quality were correct.

Question 8

Shirley amendment was instituted in ____, and did ___

Answer 8

prohibited false claims of therapeutic effects (they must do what they claim to do)

Question 9

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 _____

Answer 9

1938, sulfanilamide, antifreeze; FDA

Question 10

In ______(yr) the FDA was formed to enforce the ______act

Answer 10

food, drug, and cosmetic act - evaluate clinical trials, safety, quality.

Question 11

The food, drug, and cosmetic act required that products be _______ but not _______

Answer 11

safe for human use, but not effective

Question 12

In _____(yr), ______ was used as a sedative and lead to limb related birth defects

Answer 12

1960; thalidomide

Question 13

The use of Thalidomide lead to the passage of the _______ amendment in _______ that required ______

Answer 13

Kefauver-harrison amendment is 1962, required drugs be safe AND effective

Question 14

OTC/non-prescription VS. Hazardous/Prescription

Answer 14

OTC: deemed safe enough for ppl to self-treat; Prescript: drugs only useful after professional diagnosis or too dnagerous for self medication

Question 15

The ______act in ________ lead to the DEA administering drugs and the classification of different “schedules/classes” of drugs

Answer 15

comprehensive drug abuse prevention and control act in 1970

Question 16

CI drugs differ from CII-V in that they are said to have __

Answer 16

no accepted medical use

Question 17

CI drugs have a _____potential for abuse and include drugs such as _______ & _________

Answer 17

High (the highest potential); heroin and LSD

Question 18

CI &CII are said to cause _______ psychological/physiologic dependence

Answer 18

Severe

Question 19

CV and CIV have a ____ potential for abuse and cause _______ psychological/physiologic dependence

Answer 19

low (CV is the lowest), cause limited dependence

Question 20

Name the schedule of the following drugs: Morphine & Oxycodone, codeine, diphenyloxylate, diazepam

Answer 20

CII, CIII, CV, CIV

Question 21

In ____ the FDA passed the _____ act to incentivize companies to make drugs that stood to provide less profit (ie pediatric, AIDS, Alzheimers drugs)

Answer 21

1997 FDA modernization act

Question 22

Preformation Vs formulation Vs preclinical studies

Answer 22

Preform: define phys and chem properties; formulation: develop product/dosage; preclinical: cell culture and animal studies for effectiveness and safety

Question 23

What is the population, size, length, and purpose of phase 1 trials

Answer 23

<100 HEALTHY volunteers, over several months to eval SAFETY (not efficacy)

Question 24

What is the population, size, length, and purpose of phase 2 trials

Answer 24

up to several hundo ppl w/condition, several mo - 2 yrs, eval mainly efficacy

Question 25

What is the population, size, length, and purpose of phase 3 trials

Answer 25

several 100 to thousands, 1-4yrs, dosage and efficacy (therapeutic window),

Question 26

What is the phase 4 of clinical studies

Answer 26

drug can now be prescribed, is under surveillance for adverse effects

Question 27

1 out of every 80-100 drugs are ____ every year

Answer 27

recalled (in phase 4)

Question 28

what are black box warnings?

Answer 28

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

Question 29

Name the black box warnings for: 1)all antidepressants, 2)celebrex(celecoxib) 3)Depo-proverva

Answer 29

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

Question 30

Trade names may indicate ____ or be ______

Answer 30

disease or condition the drug is used to treat (pepcid=peptic ulcers, restoril-sleep aid) or be simplified versions of the generic name