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
