orientation to pharmacology

Question 1

pharmacodynamics

Answer 1

the drug’s effects on the body

Question 2

pharmacology

Answer 2

study of drugs and their interactions with living systems

Question 3

pharmacokinetics

Answer 3

study of what the body does to the drug

Question 4

pharmacotherapeutics

Answer 4

study of the medical use of drugs

Question 5

what should the nurse prioritize when administering a drug

Answer 5

intensity of the response

Question 6

three most important characteristics a drug has

Answer 6

• safety
• selectivity
• effectiveness (THE MOST MOST IMPORTANT)

Question 7

objective of drug therapy

Answer 7

to provide maximum benefit with minimal harm

Question 8

characteristics that determine the patient’s response to a drug

Answer 8

age, weight, sex, genetics

Question 9

prototype drug

Answer 9

a great representation of all drugs in that classification; usually the first drug in its class

Question 10

orphan drug

Answer 10

abandoned drug; way too much money to make OR not worth to keep funding due to rarity of disease

Question 11

off-label prescribing

Answer 11

drug found to work better for a different reason, but need to go back to Phase I for testing that reason, → taking off label for another reason

Question 12

legend drugs

Answer 12

drug that you need prescription for

Question 13

complementary and alternative medicine (CAM)

Answer 13

treatment practice that are not widely accepted to practiced by mainstream clinicians in a given culture (herbal supplements)

Question 14

black box warning

Answer 14

highlights the most serious warning

Question 15

chemical name

Answer 15

describes chemical makeup of the drug, assigned to every drug

Question 16

generic name

Answer 16

based on chemical makeup with a prefix and suffix, DO NOT CAPITALIZE

Question 17

trade name

Answer 17

manufacturer name given by a company that sells it, CAPITALIZE THIS

Question 18

what are big differences between generic vs trade name drugs

Answer 18

1. cost
2. bioavailability
3. pharmacist may need approval from health care provider before substituting generic

Question 19

bioavailability

Answer 19

rate + extent to which the active ingredients are absorbed and made available at the site of action

(there can be enough of a difference with bioavailability in generic and trade)

Question 20

chemical composition

Answer 20

describes chemical base of the drug

Question 21

physiologic effect

Answer 21

which body system the drug is affecting

Question 22

therapeutic use

Answer 22

pt response after treatment

Question 23

what are the phases of clinical development

Answer 23

1. preclinical testing
2. clinical trials
   - phase 1
   - phase 2
   - phase 3
   - FDA reporting
   - phase 4

Question 24

preclinical testing

Answer 24

• testing done on anything alive except humans (usually rats)

Question 25

phase 1 clinical trial

Answer 25

• healthy humans (college students)
• chemical name
• purpose: find pharmacokinetics, biologic effects, metabolism of the drug

Question 26

phase 2 clinical trials

Answer 26

• will this drug actually treat _____
• what is the possible dose range
• chemical name
• purpose: find adverse effects and dosage range associated with the drug

Question 27

phase 3 clinical trial

Answer 27

• bigger sample size
• more side effects
• chemical name
• purpose: find risks associated with the drug, SAFETY and EFFECTIVENESS?

Question 28

t/f: clinical trials are always double blind studies

Answer 28

true

Question 29

fda reporting of clinical trial

Answer 29

• where drug gets generic name

Question 30

phase 4 of clinical trial

Answer 30

• cont. forever (can be taken off the market anytime)
• purpose: find efficiency of the drug with respect to other drugs in the market belonging to the same therapeutic category

Question 31

pure food and drug act of 1906

Answer 31

• first law to regulate drugs
• power to gov to take over sanitary conditions

Question 32

sherley amendment of 1912

Answer 32

businesses cannot claim results from drugs until they can prove it

Question 33

federal food, drug, and cosmetic act of 1938

Answer 33

first legislation to address drug safety

Question 34

harris-kefauver amendment

Answer 34

• tighter control of drugs in the US
• drug efficacy had to be PROVEN and SAFE before US market

Question 35

harrison narcotic act

Answer 35

• regulated + taxed prod/import/distribution of opiates and coca products

Question 36

controlled substances act of the 1970s

Answer 36

• “schedule” categories for all narcotic drugs to regulate use

Question 37

prescription drug user fee act of 1992

Answer 37

• if big pharm pays gov money, drugs can be released faster and skip clinical trials
• usually used in emergency

Question 38

food and drug administration modernization act of 1997

Answer 38

• companies need to give 6 month notice before they stop the marketing of a drug

Question 39

fda amendments act of 2007

Answer 39

• fda has more control over drugs

Question 40

schedule I drug
–> examples?

Answer 40

drugs with no medical use, not being testing bc NO medical reason to

ex: cocaine, meth, heroin, marijuanna

Question 41

schedule ii

Answer 41

• drugs with medical reasons BUT with the most restriction due to addictiveness and toxicity, abuse potential
• typically no refills

Question 42

schedule iii drug

Answer 42

• used for medical reasons
• less restrictions and less addictive
• refills available

Question 43

schedule iv drug

Answer 43

• used for medical reasons
• OTC but just ask pharmacist