Intro the Pharm (Exam 1)

Question 1

Pharmacology

Answer 1

study of biological effects of chemicals (natural or synthesized)

Question 2

Drugs

Answer 2

chemicals introduced into the body to cause some type of effect

Question 3

pharmacotherapeutics (clinical pharmacology)

Answer 3

branch of pharm; uses drugs to treat, prevent, and diagnose disease
2 concerns: drug effect on body, body’s response to drug

Question 4

Chemical Name

Answer 4

describes a drug’s chemical composition and structure

Question 5

Generic Name

Answer 5

name given by the United States adopted name Council

Question 6

Trade Name “brand name”

Answer 6

name given by the drug’s owner or manufacturer; usually carries a registered trademark

Question 7

Natural Sources of Drugs

Answer 7

Plants-synthetic version of the active chemical found in a plant
animal products-replace human chems loss due to disease or genetic problems
inorganic compounds- salts of various elements can have therapeutic effects in the human body

Question 8

Clinical Trials

Answer 8

rigorous scientific testing performed to evaluate therapeutic value and toxic effects of potential drugs
tightly controlled by the FDA

Question 9

Preclinical Trials

Answer 9

chemicals tested on laboratory animals
determines drug-dose range
examines adverse effects
results considered inconclusive

Question 10

phase I studies

Answer 10

chemicals tested on human volunteers

Question 11

phase II studies

Answer 11

drug tried on informed patients with the target disease

Question 12

phase III studies

Answer 12

drugs must pass approval of FDA to enter clinical market

Question 13

Phase IV studies

Answer 13

continual evaluation of the drug

Question 14

Pure food and drug act

Answer 14

1906 control labeling

Question 15

food and drug cosmetic act

Answer 15

1938 procedure for introducing of new drugs; power of enforcement; drug recalls

Question 16

kefauver-harris act

Answer 16

1965 FDAregulator power-efficacy/safety must be established-result of misuse of thalidomide-helped turn the corner

Question 17

controlled substance act

Answer 17

1970 defined drug abuse and classification for potential of abuse, restrict drugs with abuse potential, drugs placed into 1 of 5 schedules

Question 18

orphan drug act

Answer 18

1983 provided incentives for development of drugs to treat rare diseases

Question 19

tetratogen

Answer 19

substance that has potential to cause defect in an unborn child during pregnancy

Question 20

teratogen drug classificaition

Answer 20

A: studied in women; no evidence of risk
B: studied in animals; risk unknown for human
C: studied in animals; reveal adverse effects
D: studies: confirmation of fetal risk
X: studies: reveal fetal abnormalities

Question 21

Drug enforcement administration (DEA)

Answer 21

enforces control
each prescriber has a DEA number-DEA monitors patterns
hospitals and pharmacies must maintain complete records of scheduled drugs

Question 22

Schedule I (C-I)

Answer 22

high abuse potential and no accepted medical use (heroin, marijuana, LSD)

Question 23

Schedule II (C-II)

Answer 23

high abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates)

Question 24

Schedule III (C-III)

Answer 24

less abuse potential than schedule II drugs and moderate dependence liability (nonbarburate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)

Question 25

Schedule IV (C-IV)

Answer 25

less abuse potential than schedule III and limited dependence liability (some sedatives, anti-anxiety agents, and nonnarcotic analgesics)