Pharmacology in Rehabilitation

Question 1

for ever 5,000 compounds that enter preclinical trials, how many make it to clinical trials?

Answer 1

5

Question 2

how many drugs out of 5000 make it to market?

Answer 2

1

Question 3

if a drug has exceptional need or beneficial effecs, what happens?

Answer 3

apply to expedited review

Question 4

expedited review may save some time but w ( ) must often continue even after approval

Answer 4

drug testing

Question 5

about how how much time does expedited review save

Answer 5

18 months- 2 years

Question 6

drugs that are indicated for a relatively small population (less than 200,000 in USA)

Answer 6

orphan drugs

Question 7

why are drugs so expensive

Answer 7

takes drug company many years and money to get to market

Question 8

why are some drugs not approved in USA?

Answer 8

other countries may not make drug be effective in general population (needs to be safe)– leaves it to practintionor and patient to say if it works for them (FDA more strict)

Question 9

if a drug is only tested during clinical trials, some fatal side effects may not show up because?

Answer 9

takes larger population in order to find side effect

Question 10

perscription meds given by

Answer 10

physician, dentist, others

Question 11

are over the counter products safer?

Answer 11

not necesarily; don’t overdose

Question 12

prescription of a drug for a purpose that has not been approved by FDA?

Answer 12

off-label prescribing

Question 13

off label prescribing may contitute what percentage of all perscriptions?

Answer 13

40-60%

Question 14

if off-label prescribing legal?

Answer 14

yes; FDA can’t tell physicians how to practice medicine BUT physician needs a good reason to prescribe drugs (usually has further testing)

Question 15

routes of administration: oral, sublingual, buccal, rectal

Answer 15

enteral

Question 16

routes of administration: involves ailimentary canal

Answer 16

enteral

Question 17

routes of administration: injection, inhalation, topical (surface of skin), transdermal, eyedrops, ear drops

Answer 17

parenteral

Question 18

routes of administraion: treatment problem at site of the problem

Answer 18

parenteral

Question 19

enteral route tradeoff

Answer 19

fairly simple/easy but less pedictable absorption

Question 20

perenteral route tradeoff

Answer 20

more difficult/inconvenient but more predictable absorption

Question 21

the percent of the administered dose that appers in bloodstream

Answer 21

bioavailability

Question 22

if given IV, how much is bioavailable?

Answer 22

100%

Question 23

if a drug is administered orally, it has to pass through ( ) before goes to bloodstream

Answer 23

liver (first-pass)

Question 24

what effect can be extensive for some drugs?

Answer 24

first-pass

Question 25

absorption/distribution affected by...

Answer 25

administration route, chemical properties of drug, and various barriers and carriers

Question 26

primary storage sites

Answer 26

fat, muscle, bone, liver, kidneys, other organs/tissue

Question 27

is storage a good thing?

Answer 27

not usually bc local tissue damage and redistribution (leaks out at later time and goes somewhere else)

Question 28

drug activity is terminated by:

Answer 28

1) metabolism 2) excretion 3) combination

Question 29

active form is changed chemically to an inactive or less active "metabolit"

Answer 29

metabolism

Question 30

the active form of the drug is sent out of body

Answer 30

excretion

Question 31

drug metabolism aka

Answer 31

biotransformation

Question 32

primary site of drug metabolism

Answer 32

liver

Question 33

enzymes metabolize the drug via

Answer 33

oxidation (most common way), reduction, hydrolysis, conjugation

Question 34

some metabolites can continue to exert effects and side effects for prolonged periods

Answer 34

active metabolites

Question 35

primary site of excretion

Answer 35

kidneys

Question 36

minor sites of excretion:

Answer 36

sweat, saliva, breat milk

Question 37

amount of time required for 50% of active form of drug to be eliminated

Answer 37

half life

Question 38

nitroglycerins half life

Answer 38

1-4 min

Question 39

heparin half life

Answer 39

1-2 hr

Question 40

aspririn half life

Answer 40

2-3 hr

Question 41

valium half life

Answer 41

20-50 hr

Question 42

what also reaches peak when drug peaks?

Answer 42

side effects

Question 43

pharmacology broken down into

Answer 43

pharmacotherpaeutics and toxicology

Question 44

pharmacotherpeutics breaks down into

Answer 44

pharmacokinetics and pharmacodynamics

Question 45

what does the body do to drug

Answer 45

pharmacokinetics

Question 46

what does drug do to body

Answer 46

pharmacodyanamics

Question 47

each drug is identified by what 3 names?

Answer 47

chemical name, generic name, trade name

Question 48

drug is marketed by generic name when?

Answer 48

after patent has expired

Question 49

generic equivalents are actually the same as the brand name if:

Answer 49

"bioequivalent"

Question 50

bioequivalent if

Answer 50

1) same type and amount of active ingredienct 2) uses same administration route 3) same pharmacokinetic profile (absorption, distribution, elimination 4) found to have same therapeutic effects

Question 51

preclinical (animal) trials last

Answer 51

1-2 yrs

Question 52

clinical trials: phase 1

Answer 52

healthy volunteers,

Question 53

clinical trials: phase 2:

Answer 53

small patient sample, 2 yrs

Question 54

clinical trials: phase 3

Answer 54

larger sample, 3 yrs

Question 55

after approved for marketing, phase 4:

Answer 55

post-marketing surveillance