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13 Cards in this Set

  • Front
  • Back

Food, Drug & Cosmetic Act

Required safety (toxicity) testing

Kefauver-Harris Amendments

Effectiveness required (in addtion to safety)
Rigorous testing requirements for new drugs

Controlled Substances Act

Defines Schedules I, II, III, IV and V based on potential for abuse


Enforced by DEA

Hatch-Waxman Act

Increased availability of generic drugs

Dietary Supplement Health & Education Act

Restrictions on labeling of supplements


Note: supplements not required to go through FDA drug review/approval process

Why is pharmacology important for nurses?

Time


High quality care


Patient education/questions


Monitoring


Questioning & clarification


Communication w/ other health care prof

3 stages of new drug development

1. Pre-clinical (in vitro, animal)


2. Clinical (human)


3. Marketing

3 ways to name drugs

1. chemical name


2. generic name


3. brand name (trade)

Pharmacodynamics

The actions of a drug ON the body


Drug + receptor interactions


Biological responses (therapeutic & adverse)


Pharmacokinetics

The actions of the body ON a drug

Ligand

Molecule that binds to receptor

Receptor

Macromolecule, to which a drug (LIGAND) binds to produce an effect

Drugs ______ or ______ naturally occurring ligands.

mimic, block