Ch. 2 Drug approval process

Question 1

U.S. FDA

Answer 1

Approves new drugs. 23 approvals/year.

Question 2

Critical Path Initiative

Answer 2

Strategy to drive innovation in the process of medical development, evaluation and manufacturing of medical products

Question 3

Current 3 volume source for drug standards published annually

Answer 3

United States Pharmacopeia National Formulary (USP-NF)

Question 4

Schedule I controlled substances

Answer 4

Not approved for medical use

Question 5

Schedule II-V controlled substances

Answer 5

Accepted Medical Use

Question 6

Nations sole legal drug enforcement agency

Answer 6

DEA (in the Dept. of Justice)

Question 7

Negligence; giving the wrong drug or drug dose that results in the patients death

Answer 7

Misfeasance

Question 8

Omission; omitting a drug dose that results in the patients death

Answer 8

Nonfeasance

Question 9

Giving the correct drug but by the wrong route that results in the patients death

Answer 9

Malfeasance

Question 10

Described by drugs chemical structure

Answer 10

Chemical name

Question 11

Official, nonproprietary name for the drug

Answer 11

Generic name

Question 12

Proprietary name chosen by the drug company

Answer 12

Brand(trade) name

Question 13

Published by the American Society of Health System Pharmicists, providing accurate and complete drug information on nearly all prescription drugs marketed in the U.S.

Answer 13

American Hospital Formulary Service Drug Information (AHFS)

Question 14

3 volume set available in most hospitals and pharmacies providing drug information for health care providers IA/IB

Answer 14

United States Pharmacopeia-Drug Information (USP-DI)

Question 15

USP-DI vol II

Answer 15

Offers drug info for patients