Week 1

Question 1

What is Schedule 1

Answer 1

Highest level of abuse. No medical use. Ex: Heroin, Marijuana, LSD

Question 2

What is Schedule 2

Answer 2

Requires DEA #, High potential for abuse both physiological and psychological dependence. No refills. Ex: narcotics and stimulants

Question 3

What is Schedule 3

Answer 3

Abuse may lead to moderate or low physical dependence or high psychological dependence. Ex: narcotics such as buprenorphine, Tylenol with codeine, anabolic steroids

Question 4

What is Schedule 4

Answer 4

Lower potential for abuse compared to schedule 3. Ex: Lorazepam, Valium, Tramadol

Question 5

What is Schedule 5

Answer 5

Low potential for abuse compared to Schedule 4. Limited quantities of certain narcotics. Ex: codeine (Robitussin AC)

Question 6

Generic Name

Answer 6

written in lower case

Question 7

Trade Name

Answer 7

patent lasts for 20 yrs, name of medication is capitalized.

Question 8

Preclinical Stage

Answer 8

Files new drug clinical trial application with the FDA.

Question 9

Which stage involves animal testing

Answer 9

Preclinical

Question 10

Stage 1

Answer 10

Determines safety and safe dose ranges, identifies side effects / tolerance

Question 11

How many people are tested during Phase 1

Answer 11

20-100 people of healthy participants

Question 12

Phase 2

Answer 12

Identifies common, short term side effects. Controlled studies on human subjects with target disease or disorder. Lasts for several months or years

Question 13

What type and how many people are tested during Phase 2

Answer 13

Those with the disease and disorder

100-200 people

Question 14

Which phase has the highest drug failures

Answer 14

Phase 2

Question 15

Phase 3

Answer 15

Submits new drug application (NDA) to FDA, has thousands of participants (hospital and outpt setting)

Question 16

What type of research method is used during phase 3

Answer 16

Double Blind

Question 17

Phase 4

Answer 17

Monitors safety of new drug in the market

Serious / Unexplained events must be reported within 15 days to the FDA

Question 18

What type of research method is used in Phase 4?

Answer 18

Observational Studies

Question 19

What is included when writing a prescription?

Answer 19

• If schedule 2 (watermark and DEA number)
• Pt name and DOB
• Drug name, Strength, Route and Dose
• Signature and provider information
• Instructions
• # of refills

Question 20

What is an adverse effect?

Answer 20

Noxious, unintended and undesired effect of a drug. Ex: Angioedema s/p ace inhibitor

Question 21

What is a side effect?

Answer 21

Unintended effect occurring at a normal dose

Ex: Nausea s/p narcotic adminstration