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Pharm Unit 1 Introductory Concepts
N/A
75
Nursing
Undergraduate 1
01/15/2013

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Cards

Term
Prescription or "Legend" drugs
Definition
Prescription requires and med must have the statement "Federal law prohibits dispensing without a prescription"
Term
Non-prescription or OTC
Definition
May be dispensed without a prescription
Term
Investigational drug
Definition
New drug with FDA approval given for research; available for use only with patients in study groups
Term
Chemical name
Definition
Reflects chemical structure of the substance
Term
Brand name/ trade name/ proprietary name
Definition
name registered with the US patent office and approved by FDA to be used only by company registering the patent. A drug may have many
Term
Generic name or nonproprietary name
Definition
Name assigned once drug is already marketed, independent of manufacturer, Often reflects pharmacological or chemical characteristics. A drug can have only one.
Term
Drug forms: solids
Definition
tablet: including enteric coated, sustained release; capsule, caplets, troche, suppository
Term
Troche
Definition
dissolves in mouth
Term
suppository
Definition
rectal, vaginal
Term
Drug forms: semi solids
Definition
ointment, cream
Term
ointment
Definition
oil- based, stays longer on skin
Term
cream
Definition
water-soluble
Term
Drug forms: Liquids
Definition
syrup, elixir, tincture, suspension, emulsion
Term
Drug routes/ forms: enteral
Definition

absorbed via oral or gastrointestinal mucosa

oral, sublingual, rectal

Term
Drug routes/ forms: parenteral
Definition

injection, absorbed through tissue such as needle

subcutaneous (SQ or SC), intramuscular (IM), intravenous (IV), intradermal (ID)

Term
Drug routes/ forms: topical
Definition

absorbed via surface

skin, transdermal (patches), inhalation, eye ears nose drops, rectal

Term
Department of Health and Human Services
Definition
overall responsible for anything related to health and illness
Term
Drug Enforcement Agency (DEA)
Definition
branch of dept of justice responsible for all laws relative to sale and distribution of medications, particularly controlled substances
Term
Federal Trade Commission
Definition
responsible for control of advertising
Term
Food and Drug Administeration (FDA)
Definition
responsible for overseeing developmental and approval of new drugs, determining whether OTC or prescription
Term
Laws: Pure Food and Drug Act
Definition
First law to restrict manufacture and distribution of drugs by requiring government pre-approval of a drug. Didn't require proof of safety
Term
Laws: Harrison Narcotic Act
Definition
established narcotic as a legal term; regulated manufacture, sale, and distribution of narcotics
Term
Laws: Food, drug, cosmetic act
Definition
requires proper testing for proof of safety and FDA approval before a drug could be marketed
Term
Laws: Durham Humphrey Amendment
Definition
recognizes OTC drugs by defining what drugs require prescription; limited refills
Term
Law: Kefauver Harris Amendment
Definition
requires proof of both safety and efficacy before marketing; mandated animals trials before testing drugs in humans; initiated new drug research
Term
Law: Comprehensive Drug Abuse Prevention Control Act (Controlled Substances Act)
Definition
categorizes drugs according to abuse potential; regulates distribution
Term
Law: Poison Prevention Act
Definition
requires "childproof" packaging on all controlled substances and most prescription drugs
Term
Law: Food and Drug Administration Modernization Act
Definition
fast-track approval for drugs for serious illnesses; drug testing on children; allowed sharing of into on "off label" uses
Term
Black Box Warning
Definition
warning on med from FDA because of reported problems; it is not illegal for MD to prescribe against it but does increase liability risk
Term
Categories of Controlled Drugs: Schedule I
Definition
high abuse potential; no accepted medical use and not prescribed. (Heroin, cocaine, hallucinogens)
Term
Categories of Controlled Drugs: Schedule II
Definition
high abuse potential but accepted medical use; most narcotics, amphetamines, strong sedatives; must be written on script
Term
Categories of Controlled Drugs: Schedule III and IV
Definition
varying degree of abuse potential; prescription valid for 6 months or 5 refills.
Term
Schedule III
Definition
anabolic steroids (body building), narcotic combination products
Term
Schedule IV
Definition
tranquilizers, sleeping pills
Term
Categories of Controlled Drugs: Schedule V
Definition
small amount of narcotic, may include OTC drugs, varies state to state
Term
Florida's "Negative Formulary" Law
Definition
requires pharmacist to offer generic form of drug unless physician specifies no substitutions
Term
New Drug Approval Process
Definition

1. Lab tests and animal tests to prove safety and efficacy

2. Application to FDA to proceed trials in humans

3. Testing in humans (3 phases)

4. Each phase requires FDA approval before going to the next

Term
Phases of human testing/ clinical trials
Definition

Phase 1: healthy subjects, small groups, designed to prove safety in humans, determine safe dosage, route of administration

Phase 2: patients with disease drug is to treat; results compared to the healthy; prove effectiveness, monitor side effects, refine therapeutic range

Phase 3: larger group of patients with disease the drug is to treat; determine benefit vs risk

Term
pharmacodynamics
Definition
actual physiological effect that occurs- therapeutic or adverse
Term
agonist
Definition
drug attaches completely and elicits appropriate response (perfect fit)
Term
antagonist
Definition
drug attaches but does not elicit a response
Term
partial agonist
Definition
drug attaches and gets some response not as much as agonist, may have some antagonist effect
Term
Onset of action
Definition
time which there is sufficient drug-receptor interaction to initiate a response
Term
duration of action
Definition
time between onset of action and return to minimum effective concentration
Term
therapeutic index
Definition
range between minimum effective level and maximum
Term
potency
Definition
index of HOW MUCH (amount) administered to achieve desired response
Term
efficacy
Definition
effectiveness; maximal response a drug can produce
Term
Pharmacokinetics
Definition
factors affect all phases in general in an individual; human variability; affected by age because organ function varies
Term
Pharmacokinetics  require drugs to cross in 3 ways:
Definition
passage through channels/ pores (only small ions), transport systems, direct penetration of cell membrane (most common) requires drug to be lipid soluble for easy passing
Term
Pharmacokinetics: absorption
Definition

drug must first be released from dosage form to be absorbed (tablet dissolved, unbinding from chemical combination)

after release, transfer of drug into circulation

influenced by route of administration, surface area, blood flow

Term
Routes of administration for absorption
Definition

IV: no absorption- drug immediately in circulation

IM: capillary wall has large pores that permit substances to enter easily so no significant barrier to absorption if good blood flow to area

Oral: 2 barriers to cross: GI epithelial lining and capillary wall; oral meds absorbed in small intestine; primary factor: gastric emptying time and time in small intestine

GI: parenteral (except IV) and topical absorption depend on blood flow

Term
Pharmacokinetics: Distribution
Definition

moving drug throughout body

major factor: blood flow

protein binding: only free or unbound drug can move across cell membranes; less protein levels= slower drug may distribute

OATP(organic anion transporting polypeptide): transport system for meds; compete with eachother so given separate

 

Term
Pharmacokinetics: Metabolism
Definition

enzymatic alteration of drug; occurs in liver

drug starts as active--> inactive

inactive--> active

active--> another active

poor liver= poor metabolism

 

Term
Enhancement of drugs
Definition
greater metabolism, less effect of drug
Term
inhibition of drugs
Definition
less metabolism, more effect of drug
Term
Pharmacokinetics: excretion
Definition

removing drug from body; occurs in kidneys, but can also occur by inhaling, bug bites, bile, breast milk

clearance: speed drug leaves body

 

Term
Factors affecting renal excretion of drugs
Definition
renal blood flow and glomerular filtration, pH of urine, lipid solubility, evaluate renal funtion by assessing BUN and creatinine
Term
Drug half life
Definition
time it takes to reduce drug concentration by 50% etc.
Term
Steady state
Definition
4-5 half lives
Term
Peak
Definition
blood draw 1/2 hour after completion og a dose that was administered, time of infusion; reflects highest drug level and monitors possible toxicity (max concentration of drug)
Term
Trough
Definition
blood draw 1/2 hour before net scheduled dose, lowest drug level, monitors whether drug level remains therapeutic
Term
Pharmacodynamic Reactions
Definition
one drug affects pharmacological effect of another
Term
Pharmacodynamic Reactions: additive
Definition
2/more drugs with same effect are combined in a cumulative effect (1+1=2)
Term
Pharmacodynamic Reactions: synergistic
Definition
2/more drugs with different effect are combined with resultant outcome being greater than effect of either drug alone (1+1=5)
Term
Pharmacodynamic Reactions: potentiation
Definition
2/more drugs with different effect combined with resultant outcome of one of drugs being enhanced (1A+1B=2A)
Term
Pharmacodynamic Reactions: antagonistic
Definition
combined effect less than effect of single agent; one drug diminishes another; (1+1=<1)
Term
Side effect
Definition
most commonly uncomfortable, but tolerable symptoms; may be life-threatening; predictable; usually not dose related
Term
toxic effect
Definition
life threatening; dose related; reduce dose= reduce effect
Term
Idiosyncratic reaction
Definition
unpredictable, unexpected reaction due to genetic differences
Term
Iatrogenic disease
Definition
developed as a result of treatment, such as renal failure from nephrotoxic drug
Term
organ toxicity
Definition
most commonly hepatotoxicity and nephrotoxicity
Term
teratogenic
Definition
causes fetal effects
Term
carcinogenic
Definition
causes cancer
Term
allergic reaction
Definition
antibody- antigen reaction in sensitive individual. most common is hives, but can be life threatening anaphylactic reaction with difficulty breathing.
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