legal & ethical issues

Question 1

formulary

Answer 1

list of drugs available from a pharmacy

Question 2

Food, drug and cosmetic act 1938

Answer 2

monitor and regulate the manufacture and marketing of drugs

Question 3

durham-humphrey amendment 1952

Answer 3

prescription vs. non prescription drugs

Question 4

kefauver-harris amendment 1962

Answer 4

increase safety

Question 5

controlled substances act 1970

Answer 5

decrease drug abuse

Question 6

Stage 1

Answer 6

high abuse potential, no accepted medical use

Question 7

stage 2

Answer 7

high abuse potential, accepted medical use

Question 8

stage 3

Answer 8

less potential for abuse, medically accepted

Question 9

stage 4

Answer 9

may cause dependence, medically accepted

Question 10

stage 5

Answer 10

limited potential for dependence, medically accepted

Question 11

FDA modernization act 1997

Answer 11

review of new drugs occurs more rapidly

Question 12

Nurse practice act

Answer 12

what meds nurses can give, must give the way it was dosed

Question 13

a

Answer 13

safe during pregnancy

Question 14

b

Answer 14

safe during pregnancy

Question 15

c

Answer 15

some risk to fetus

Question 16

d

Answer 16

some risk to fetus

Question 17

x

Answer 17

never give during pregnancy

Question 18

what are the 5 rights of med administration?

Answer 18

right client
right drug
right dose
right time
right route

Question 19

pre-clinical testing

Answer 19

lab and animal testing

Question 20

phase 1

Answer 20

assess safety, dose range in healthy subjects

Question 21

phase 2

Answer 21

safety and efficacy in subjects with disease

Question 22

phase 3

Answer 22

saftey and efficacy in larger groups of subjects with disease

Question 23

new drug application to fda

Answer 23

if approved drug goes to market

Question 24

phase 4

Answer 24

purpose- long term use of drug

post- marketing, new indications

Question 25

who regulates advertisement of otc drugs?

Answer 25

the ftc

Question 26

who regulates advertisement of prescription drugs?

Answer 26

the fda