9.7 Pharmacology 2

Question 1

What is the FDA responsible for?

Answer 1

• monitoring use of existing drugs

- developing/approving new drugs

Question 2

testing phases

Answer 2

• preclinical testing

- human testing

Question 3

What is involved with preclinical testing?

Answer 3

• laboratory tests to determine drug effects and safety

- animal studies

Question 4

How many phases of human testing?

Answer 4

4

Question 5

Human testing: What is involved in phase I?

Answer 5

• determining effects and safe dosage

- fewer than 100 healthy subjects

Question 6

Human testing: What is involved in phase II?

Answer 6

• assess drug’s effectiveness

- 200-300 with disorder

Question 7

Human testing: What is involved in phase III?

Answer 7

• assess safety and effectiveness in larger sample

- 1000-3000 with disorder

Question 8

Human testing: What is involved in phase IV?

Answer 8

post-marketing surveillance to continue monitoring safety and effectiveness after approval for public use

Question 9

How long does the drug approval process take?

Answer 9

7-9 years

Question 10

When would the drug approval process be expedited?

Answer 10

drugs that show promise in treating difficult diseases such as cancer or AIDS

Question 11

orphan drugs

Answer 11

• rare diseases, fewer than 200,000 people in the US
• expensive
• FDA may provide extra funding

Question 12

off-label prescribing

Answer 12

using a drug to treat a condition for which not originally intended

Question 13

Why might practitioners prescribe the drug for other conditions?

Answer 13

• their judgment

- evidence from additional research

Question 14

What is neurontin (antiseizure drug) used for offlabel?

Answer 14

pain

Question 15

caveat for off-label prescribing

Answer 15

Carries some risk if the drug is used for something not originally intended

Question 16

OTC

Answer 16

• can be purchased directly by the consumer

- judged to be safe if used without oversight of a medical practitioner

Question 17

OTC and expense

Answer 17

• Usually less expensive

- the consumer may have to pay out of pocket and actually have higher cost

Question 18

Physicians must have a ___ license to prescribe scheduled substances

Answer 18

DEA

Question 19

Schedule I

Answer 19

• highest potential for abuse
• not normally used for medical treatment
• usu. only in research or psychological purposes

Question 20

Schedule II

Answer 20

• approved for specific medical use

- high potential for abuse and addiction

Question 21

Schedule II drugs are commonly prescribed by

Answer 21

• hospice docs

- anesthesiologists

Question 22

Schedule III

Answer 22

• mild-moderate physical dependence

- strong psychologic dependence

Question 23

Schedule IV

Answer 23

lower potential for abuse

Question 24

Schedule V

Answer 24

lowest relative abuse potential

Question 25

What is the schedule? morphine

Answer 25

Schedule II

Question 26

What is the schedule? opioids

Answer 26

Schedule III

Question 27

What is the schedule? low dose opiods in cough medicine

Answer 27

Schedule V

Question 28

What is the schedule? - heroin - LSD - hallucinogens

Answer 28

Schedule I

Question 29

What is the schedule? anabolic steroids

Answer 29

Schedule III

Question 30

What is the schedule? antidiarrheal preparations

Answer 30

Schedule V

Question 31

What is the schedule? - stimulants - depressants

Answer 31

Schedule IV

Question 32

What is the schedule? amphetamines

Answer 32

Schedule III

Question 33

Which categories of drugs are not FDA approved?

Answer 33

herbal supplements

Question 34

Characteristics of prescriptions drugs

Answer 34

- greater potential for adverse effects - monitoring needed for interactions - restricted period of time for use