NURS 316 Chapter Notes - Chapter All: Drug Interaction, Pharmacology, Fetus
27 Apr 2018
School
Department
Course
Professor
Nursing 316
pharmacology
the study of drugs and their interactions with living systems
drugs (medications)
chemicals introduced into the body to effect physiological processes
drug actions
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
1. effectiveness
2. safety
3. selectivity
effectiveness
drug that does something useful. all drugs must be effective prior to market release
safety
does not produce harmful effects
relative safety of a drug
increases by proper drug selection, dosage, and monitoring
selectivity
elicits only desired response and not undesired or adverse effects
3 principles of drug action
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
(1906) required listing of ingredients
federal food, drug, and cosmetic act
(1938) test drug toxicity, ability to recall drugs, only safe drugs receive FDA approval, gave
FDA power
Harris-Kefauver amendments
(1962) safety and efficacy had to be established before marketing. FDA power over drug
investigations
reason for discarded trial drug
1. lack of therapeutic activity
2. toxicity
3. teratogenic effects
4. not safe enough
teratogenic
developmental defects in the somatic tissues of a fetus
find more resources at oneclass.com
find more resources at oneclass.com
mutagenic
changes in genetic material
FDA pregnancy category
1. A: no risk
2. B: no risk
3. C: somewhat
4. D: risk
5. X: risk
controlled substances act
(1970) defined drug abuse and drugs that may be abused. control for distribution, storage, and
uses
DEA schedule of controlled substances
I (highest abuse) > V (lowest abuse)
orphan drugs
not financially viable, developed for diseases with low population.
generic drugs
not protected by patent. replicated by other companies after 7 years
over-the-counter (OTC)
available without a prescription
orphan drug act
(1983) facilitates developments of drugs for rare diseases. effects fewer than 200,000 people. ex.
Huntington's, Tourettes.
timeline of drug laws
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
(1951) makes certain drugs exempt from prescription; safe and effective and use for self-
medicating
requirements for OTC
1. acceptable margin of safety
2. wide therapeutic index
3. low abuse
4. no need for HCP
5. more pros than cons
6. safe and effective
black box (boxed) warning
1. strongest FDA warning
2. serious possible side effects
adverse drug reactions (ADR)
response to a medication that is unintended and undesired side effect @ normal drug dose. more
severe than side effects
ADR
find more resources at oneclass.com
find more resources at oneclass.com
very young and old are susceptible
>60 ADR=50%
drug interactions
altered or modified effect of a drug as a result of 2 or more drugs, nutrients, herbal
potentiated effects
intensification of effects
inhibitory effects
reduction of effects
unique response
combination of alcohol with disulfiram
PHARMACOKINETICS
involves the study of
1. absorption
2. distribution
3. metabolism
4. excretion
clinical consideration
1. onset of drug action
2. drug half-life
3. time peak of effect
4. duration of effects
5. metabolism of drug
6. site of excretion
onset of drug action
when drug starts to display its effects
drug half-life
time required for one-half of an administered drug to be lost through metabolism and
elimination.
peak effect
highest concentration of drug in the body
absorption
movement of drug from its site of administration to the bloodstream for distribution in the
tissues, passive diffusion or active transport
routes of administrations
1. inhalation
2. intramuscular (IM)
3. intravenous (IV)
4. mucous membranes (buccal, sublingual)
5. oral (PO)
6. rectal (PR)
7. subQ
8. topical
distribution
movement of a drug to the body's tissues, affected by tissue perfusion, protein binding, the BBB
rapid distribution
heart, brain, kidneys, liver
find more resources at oneclass.com
find more resources at oneclass.com
Document Summary
Harris-kefauver amendments (1962) safety and efficacy had to be established before marketing. Fda power over drug investigations reason for discarded trial drug: lack of therapeutic activity, toxicity, teratogenic effects, not safe enough teratogenic developmental defects in the somatic tissues of a fetus mutagenic changes in genetic material. Fda pregnancy category: a: no risk, b: no risk, c: somewhat, d: risk, x: risk controlled substances act (1970) defined drug abuse and drugs that may be abused. control for distribution, storage, and uses. >60 adr=50% drug interactions altered or modified effect of a drug as a result of 2 or more drugs, nutrients, herbal potentiated effects intensification of effects inhibitory effects reduction of effects unique response combination of alcohol with disulfiram. Life span considerations for pharmacology drug sensitivity in the very young results from organ system immaturity drug sensitivity in the elderly results from organ system dysfunction.
