Ch 1 - Issues for the Practitioner in Drug Therapy

Question 1

Phase of clinical trial involving lab and animal studies

Answer 1

Preclinical phase

Question 2

Phase of clinical trial that examines safety, using 20-80 healthy participants

Answer 2

Phase I

Question 3

Phase of clinical trial focused on measuring safety, side effects and effectiveness. Involves 100-300 participants with the disorder.

Answer 3

Phase II

Question 4

Phase of clinical trial measuring effectiveness and side effects. Involves 1,000-3,000 participants with disorder. FDA application at the end of this phase.

Answer 4

Phase III

Question 5

Phase of clinical trial examining long-term side effects after the drug is on the market. Measures efficacy and cost effectiveness compared to other drugs on the market.

Answer 5

Phase IV

Question 6

High potential for abuse. No routine therapeutic use.

Answer 6

Schedule 1

Question 7

Valid medical use. High potential for abuse.

Answer 7

Schedule 2

Question 8

Moderate potential for abuse. Prescriptions cannot be refilled.

Answer 8

Schedule 3

Question 9

Low potential for abuse. Limited physiologic dependency.

Answer 9

Schedule 4

Question 10

Least potential for abuse. Moderate amount of opioids.

Answer 10

Schedule 5

Question 11

Identifies healthcare providers by a unique number in transactions, medical records and prescriptions

Answer 11

National Provider Identifier (NPI)

Question 12

Prescribing date
Patient name, address, DOB
Drug name
Dose, dosage regimen, route of administration
Allowable substitutions
Prescriber’s signature and license number

Answer 12

Standard Components of Prescriptions