Pharmacology Chapter 3 - Drug Regulation, Development, Names, and Information

Question 1

Federal Pure Food and Drug Act

Answer 1

Passed in 1906 - drugs should be free of adulterants/impurities. First American drug law.

Question 2

Food, Drug and Cosmetic Act

Answer 2

Passed in 1938. First drug law that talks about safety.

Question 3

Kefauver-Harris Amendments

Answer 3

Passed in 1962 - requires proof of EFFECTIVENESS.

Question 4

Controlled Substances Act

Answer 4

Passed 1970. 5 categories - Schedule 1-5 (roman numerals.) 1 is bad - like LSD, heroine, etc. Others are accepted for use, and goes from 2-5 in terms of most potential for abuse.

Question 5

Fast-Track

Answer 5

1992 - a drug can be approved for marketing prior to completion of phase three - mainly for HIV and Cancer drugs.

Question 6

FDA Modernization Act

Answer 6

1997 - fast track system for aids and cancer drugs now includes other serious, life threatening illnesses. Also, if a manufacturer plans to stop production of a drug, they might inform patients 6 months in advance. Child can be be required to be tested upon.

Question 7

New Drug Development - estimate of time and cost.

Answer 7

Roughly 6-12 years, 800 million dollars.

Question 8

Pre-Clinical Testing

Answer 8

Animal testing. Looks for toxicity of drug, pharmacokinetic properties, etc. May last 1-5 years and can be tested on humans, too. If this is okayed, then Drug receives “Investigational New Drug” award.

Question 9

Clinical Testing

Answer 9

4 phases. May take 2-10 years. Phases 1-3 are done before drug is marketed, and phase 4 is after.

Question 10

Phase 1

Answer 10

Conducted in normal volunteers. This evaluates drug metabolism and effects on humans.

Question 11

Phase 2 & 3

Answer 11

Tested in patients to determine therapeutic effects, dosage ranges, and patient safety. Total numbers of subjects is about 500-5000. Lasts about 3-6 months. After phase 3, application for conditional approval is made.

Question 12

Phase 4

Answer 12

Usage for general population, new side effects may be discovered, and such. Children, women, and geriatric patients are not studied much.

Question 13

Drug names - 3 types.

Answer 13

Chemical Name, Generic Name, Trade Name

Question 14

Drug Name Example - Tylenol

Answer 14

Chemical Name - N-acetyl-para-aminophenol
Generic Name - Acetaminophen
Trade Name - Tylenol

Question 15

Chemical names -

Answer 15

chemical make up of compound. Usually too complex for people to remember.

Question 16

generic Name -

Answer 16

assigned by the United States Adopted Names Council.

Question 17

Trade Name

Answer 17

Name by which the drug is marketed. Acetaminophen has 31 trade names.

Question 18

Over The Counter Drugs

Answer 18

OTC - account for more than 60% of all doses administered.