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62 Cards in this Set
- Front
- Back
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pharmacology |
study of nature, chemistry, effects, and uses of drugs |
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clinical pharmacology |
study of drugs in humans |
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metrology |
science of measurements; measuring and calculation drugs accurately |
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pharmacotherapeautics |
branch of pharmacology that involves using drugs to treat, prevent or diagnose diseases or prevent pregnancy |
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effective drug |
elicits the response for which it is given |
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safe drog |
a drug that doesn't produce harmful effect - DOES NOT EXIST |
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selective drug |
a drug that elicits only the response for which it is given - DOES NOT EFFECT |
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properties of pharmacology |
reversible, predictable, easy to administer, freedom from interaction with other drugs, cheap, chemically stable, simple name that cannot be confused |
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what % of adults incorrectly interpret dosage instructions for medications |
52% |
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how many accidental overdose and allergic reactions account for thousands of ER visits/yr |
700,000/yr |
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what are the most common problematic prescription drugs |
insulin, coumadin, and amoxicillin |
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how many preventable med error happen a year |
1.5 million |
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parmacopeia |
total of all authorized drugs available in a country, containing description, recipes, strengths, standards of purity, and dosage forms for the drugs |
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who adopted the USP and NF as official standards for drugs in 1906 |
pure food and drug act |
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what does the american hospital formulary contain |
extensive information of drugs classes; published annually |
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when is the FDA drug bulletin issued |
quarterly news letter that is free to the public |
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what does the USP dispensing information contain |
catergories, precautions, side effects, actions, dosage and labeling information; useful for nurses |
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who provides package inserts/labels? |
the manufacter |
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what does the physicians desk reference contain |
contains information provided by manufacturer; used in clinical settings |
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natural drugs derive from |
plants (morphine, digitalis), animals (thyroid drugs), inorganic compounds iron (gold, aluminum) |
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synthetic drugs derive from |
plants, genetically engineered chemicals |
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ways to group drugs |
body system effect (ex. GI drugs), chemical characteristics (ex. nervous system), therapeutic use (ex. osteoperosis), prototypes |
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drug names consist of the |
chemical, generic (nonproprietary), and trade name (brand, proprietary)
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how many drugs end up on the market |
5 out of 100,000 |
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how many drugs are tested on humans that make it to the market |
1 of every 5,000 |
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how many years does it usually take to get a drug on the market |
12 years |
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how much is it to get a drug approved |
$350 million |
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how many steps does it take to test a drug |
preclinical (animal testing - average of 3-5 years) and clinical (four phases) |
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what is the purpose of animal testing |
effect on living tissue and evaulate adverse reaction like toxicity (LD 50) and TI (LD 50/ED 50) |
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first phase of clinical testing |
healthy volunteers; small numbers; to determine metabolism, potential adverse SE - if toxicity anticipated, volunteers with the disease; usually young males |
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second phase of clinical testing |
volunteer with disease/condition to evaluate safety, toxicity, effectiveness and SE; small number - refining of therapeutic dose range |
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third phase of clinical testing |
large number of patients at research centers to find any infrequent or rare side effect - establishes effectiveness, safety, dose range, benefit-to-risk ratio; uses a control group - compare to existing therapy - placebo controlled - NDA to FDA; marketing begins after NDA appoval |
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fourth phase of clinical testing |
post marketing surveillance to gather more information - at least 2 years - voluntary reporting with medwatch |
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how does expedited drug approval work |
still undergo the four phases of clinical evaluation - after phase 1 and 2, process is expedited. can apply to use drugs in phase 2 or 3 if pt meets criteria. EX. AIDS drugs |
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orphan drugs |
tax benefits to develop drug affecting 200,000 or less |
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what can compassionate use of drugs do |
they are available w/o FDA approval - life-threatening disease and can get drug approval w/o enrolling in full clinical trial |
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who are limited from testing procedures |
women and children |
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side effect |
all drugs have effects other than those for which it is given |
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idiosyncratic |
genetically determined abnormal response to ordinary dose of a drug |
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nephrotoxicity |
toxicity to the kidneys |
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neurotoxicity |
toxicity to the nervous system |
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ototoxicity |
toxicity to the auditory system |
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hepatotoxicity |
toxicity to the blood |
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teratogenic |
agent that can cause birth defects |
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carcinogenic |
agent that can cause cancers |
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mutagenic |
agent that cause alterations to the DNA (not given in pregnancy) |
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ways to prevent adverse drug effects |
verify allergies; administer at recommended rate, dose etc, monitor lab, take appropriate measurements (BP, pulse, LOC etc) |
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drug-drug interactions |
two drugs interact and produce an effect; addictive - two or more like drugs; synergistic - two or more "unlike drugs" result in a greater effect; potentiated effect - effect of only one of the drugs is increased |
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drug-food interaction |
fats/protein may absorb slowly; grapefruit - need to ingest separately, blocks enzymes that break down drugs leading to toxic levels (calcium, antidepressants, statins, channel blockers) |
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off label drug |
use of a drag in ways or purposes other than what was approved by the FDA; different indication, different population, altered dose |
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legislation of the pure food and drug act of 1906 |
establishes USP and NF as offical reference; ingredients must be listed on label |
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legislation of sherley amendment of 1912 |
prohibited fradulent therapeutic claims |
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legislation of harrison narcotic act of 1914 |
classified certain drugs as narcotics |
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legislation of food drug and cosmetic act of 1938 |
result of 100 deaths from ingestion of diethylene glycol solution of sulanilamide; required labeling "warning may be habit forming" and other labeling on drug containers; established the FDA with power to enforce |
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durham-humphrey amendment of 1938 act in 1952 |
differentiated drugs that could be sold without perscription from "legend drugs"; "caution, federal law prohibits dispensing without a perscription" |
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kefauver-harris amendment of 1938 act in 1962 |
resulted from thalidomide tragedy; protects public by ensuring that adequate preclinical testing is performed; must prove that drug is "safe and effective"; informed consent; black box warnings; "off label" |
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comprehensive drug abuse and prevention act of 1970s "contolled substances act" |
response to misuse and abuse of the 60s; ranges from CI-CV |
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CI |
only approved with protocols; abuse very high; dependence severe; ex. heroin - only one not used for medical purposes |
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CII |
written script only, no refill; abuse high; dependence severe; ex cocaine |
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CIII & CIV |
script expires in 6 mos (5 refills in 6 mos); III is moderate abuse, IV is low abuse; III is moderate dependency, IV is limited dependency; ex. codiene, barbituate |
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CV |
written script or OTC - varies by state; very low abuse; very lmited dependency; cough and diarhhea rx |
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drug abuse |
use of any drug in a manner that deviates from approved medical or social pattern |
