9.7 Pharmacology 2 Flashcards Preview

8501 Clin Med > 9.7 Pharmacology 2 > Flashcards

Flashcards in 9.7 Pharmacology 2 Deck (34)
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1

What is the FDA responsible for?

- monitoring use of existing drugs
- developing/approving new drugs

2

testing phases

- preclinical testing
- human testing

3

What is involved with preclinical testing?

- laboratory tests to determine drug effects and safety
- animal studies

4

How many phases of human testing?

4

5

Human testing: What is involved in phase I?

- determining effects and safe dosage
- fewer than 100 healthy subjects

6

Human testing: What is involved in phase II?

- assess drug’s effectiveness
- 200-300 with disorder

7

Human testing: What is involved in phase III?

- assess safety and effectiveness in larger sample
- 1000-3000 with disorder

8

Human testing: What is involved in phase IV?

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

9

How long does the drug approval process take?

7-9 years

10

When would the drug approval process be expedited?

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

11

orphan drugs

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

12

off-label prescribing

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

13

Why might practitioners prescribe the drug for other conditions?

- their judgment
- evidence from additional research

14

What is neurontin (antiseizure drug) used for offlabel?

pain

15

caveat for off-label prescribing

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

16

OTC

- can be purchased directly by the consumer
- judged to be safe if used without oversight of a medical practitioner

17

OTC and expense

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

18

Physicians must have a ___ license to prescribe scheduled substances

DEA

19

Schedule I

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

20

Schedule II

- approved for specific medical use
- high potential for abuse and addiction

21

Schedule II drugs are commonly prescribed by

- hospice docs
- anesthesiologists

22

Schedule III

- mild-moderate physical dependence
- strong psychologic dependence

23

Schedule IV

lower potential for abuse

24

Schedule V

lowest relative abuse potential

25

What is the schedule?

morphine

Schedule II

26

What is the schedule?

opioids

Schedule III

27

What is the schedule?

low dose opiods in cough medicine

Schedule V

28

What is the schedule?

- heroin
- LSD
- hallucinogens

Schedule I

29

What is the schedule?

anabolic steroids

Schedule III

30

What is the schedule?

antidiarrheal preparations

Schedule V

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