pharmacology - ANS the study of drugs and their interactions with living systems
drugs (medications) - ANS chemicals introduced into the body to effect physiological processes
drug actions - ANS 1. replacing or acting as substitute for missing chemicals
2. increasing...
pharmacology - ANS the study of drugs and their interactions with living systems
drugs (medications) - ANS chemicals introduced into the body to effect physiological
processes
drug actions - ANS 1. replacing or acting as substitute for missing chemicals
2. increasing or stimulating cellular activities
3. depressing or slowing cellular activities
4. interfering with activities of foreign cells (antibiotics)
"ideal" drug - ANS 1. effectiveness
2. safety
3. selectivity
effectiveness - ANS drug that does something useful. all drugs must be effective prior to
market release
safety - ANS does not produce harmful effects
relative safety of a drug - ANS increases by proper drug selection, dosage, and monitoring
selectivity - ANS elicits only desired response and not undesired or adverse effects
3 principles of drug action - ANS 1. drugs modify existing functions within body
2. drug has a single action
3. effects are determined by drug interaction with body
pure food and drug act - ANS (1906) required listing of ingredients
federal food, drug, and cosmetic act - ANS (1938) test drug toxicity, ability to recall drugs,
only safe drugs receive FDA approval, gave FDA power
Harris-Kefauver amendments - ANS (1962) safety and efficacy had to be established
before marketing. FDA power over drug investigations
, reason for discarded trial drug - ANS 1. lack of therapeutic activity
2. toxicity
3. teratogenic effects
4. not safe enough
teratogenic - ANS developmental defects in the somatic tissues of a fetus
mutagenic - ANS changes in genetic material
FDA pregnancy category - ANS 1. A: no risk
2. B: no risk
3. C: somewhat
4. D: risk
5. X: risk
controlled substances act - ANS (1970) defined drug abuse and drugs that may be abused.
control for distribution, storage, and uses
DEA schedule of controlled substances - ANS I (highest abuse) > V (lowest abuse)
orphan drugs - ANS not financially viable, developed for diseases with low population.
generic drugs - ANS not protected by patent. replicated by other companies after 7 years
over-the-counter (OTC) - ANS available without a prescription
orphan drug act - ANS (1983) facilitates developments of drugs for rare diseases. effects
fewer than 200,000 people. ex. Huntington's, Tourettes.
timeline of drug laws - ANS 1906-pure food and drug act
1938-federal food, drug, and cosmetic act
1951-durham-humphrey amendment
1962-harris-kefauer
1970-controlled substances act
1983-oprhan drug act
durham-humphrey amendment to the 1938 pure food, drug, and cosmetic act - ANS (1951)
makes certain drugs exempt from prescription; safe and effective and use for self-medicating
requirements for OTC - ANS 1. acceptable margin of safety
2. wide therapeutic index
3. low abuse
4. no need for HCP
5. more pros than cons
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