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Advanced Pharm Exam 1 Nurp 422 > Week 1 > Flashcards

Flashcards in Week 1 Deck (20)
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1

Schedule I drugs have ___ abuse potential and an example is:

High
Heroin, LSD, Ecstacy

2

Regulatory body is:

Board of nursing

3

Schedule II meds have a ___ potential of abuse and examples include:

High
Narcotic: hydromorphone, methadone, oxycodone
Stimulant: amphetamine, Ritalin, adderall

4

Schedule II meds are allowed how many refills?

Zero

5

Schedule III meds have a ___ abuse potential and examples include:

Moderate
Narcotic: Tylenol with codeine, buprenorphine
Others: ketamine, Marinol, anabolic steroids

6

Schedule III meds may be filled up to:

5 refills in a 6 month period

7

Schedule IV drugs have a ___ potential for abuse and examples include:

Low
Lorazepam, Valium, tramadol

8

Schedule IV meds may be refilled:

Up to 5 times in a 6 month period

9

When is the Investigational new drug app filed to FDA?

After preclinical trials and before phase I clinical trials

10

Preclinical trial can take ___ and includes ___ testing.

Several years
Animal testing ( no human testing)

11

What phase of drug trials has a few number of healthy participants ( less than 100), establishes tolerance and identifies side effects?

Phase I

12

How long does phase 1 typically last?

Months

13

How long does phase 2 typically last?

Months to years

14

Goals of phase 2 include:

1. Establish proof of concept
2. Determine dosage and efficacy
3. Identify common side effects
4. Identify best regimen

15

What phase is the regulatory phase that achieves regulatory proof, furthers established safety and efficacy, and ascertains toxic effects?

Phase 3

16

How long does phase 3 last?

Years to decades

17

When is the new drug application filed?

After phase 3 and before phase 4

18

What phase is the ongoing, after market phase?

Phase 4- monitors safety of the new drug

19

Which phase has the highest failure rate?

Phase 2

20

Correct prescription:

Prescribers info
Pt identifiers: DOB, name, current address
Date written

Drug name and dose
Sig: instructions tell how and why
Dispense: how many tablets
Refill:

Np signature
License information
DEA if applicable