Drug Regulation And Pharmacodynamics 1/26

Question 1

The American first legislation to address drug safety

Answer 1

Food drug and cosmetic act 1938
Antifreeze and sulfonamide tragedy
Required safety testing and then would be approved by the FDA

Question 2

The drug law that requires effectiveness before marketing

Rigorous testing requirements for the new drugs

Answer 2

Kefauver - Harris amendment 1962
Thalidomide tragedy in England
The tragedy due to non essential drugs

Question 3

Drug legislation talks about controlled substance abuse.

Answer 3

Controlled substances act 1970
Defines schedules 1, ll, lll ,lV, V based on potential for abuse
Enforced by FDA, schedule 1 has high abuse ,no medical benefit potential(narcotics) and the abuse potential become less as we progress from schedule ll to schedule v

Question 4

Increased availability of generic drugs

Answer 4

Hatch wax an act 1984

Question 5

Restrictions on labeling on supplements

Answer 5

Dietary supplemental health and education act

Supplements are not supposed to go thru FDA approval

Question 6

What was the first American law to regulate drugs

Answer 6

Federal pure food and drug act 1906

Weak law nothing about safety and effectiveness

Question 7

Key US drug legislation

Answer 7

1938 Food Drug Cosmetic Act - Basic Safety
1962 - Kefauver-Harris, required effectiveness, rigorous testing
1970 - Controlled substances act, Schedule 1-5, abuse. Narcotic means schedule 1, controlled with no medical use.
1984 - Hatch-Waxman - availability of generic drugs
1994 - Dietary supplement - restrictions on labelling supplements

Question 8

Clinical drug development phases

Answer 8

Preclinical - test on animals, toxicology(pharmacokinetics)
Phase 1 - Toxicology on healthy humans, 1 year(metabolism,kinetics, pharmacological effects)
Phase 2 - Effects and safety, 2 years(Therapeutic utility and usage)
Phase 3 - Safety and effectiveness, 3 years
Conditional approval of new drug application( NDA)
Phase 1V ; post marketing surveillance
Phase 4 - Post Marketing

Question 9

Drug names

Answer 9

Prescribing Information (PI)
What FDA approved, note could have off-brand uses
Black Box warnings - cause specific problems
Drug names: Chemical name, Generic Name( assigned by the US adopted names council), Brand Name(s)

Question 10

Pharmacodynamics

Answer 10

Pharmacokinetics - Action of body on drug - Absorb, distribute, metabolize, excrete
Pharmacodynamics - Action of the drug on the body, drug + receptor, Biological response