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| Prescription or "Legend" drugs |
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Definition
| Prescription requires and med must have the statement "Federal law prohibits dispensing without a prescription" |
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Definition
| May be dispensed without a prescription |
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Definition
| New drug with FDA approval given for research; available for use only with patients in study groups |
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Definition
| Reflects chemical structure of the substance |
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Term
| Brand name/ trade name/ proprietary name |
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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 |
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Term
| Generic name or nonproprietary name |
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Definition
| Name assigned once drug is already marketed, independent of manufacturer, Often reflects pharmacological or chemical characteristics. A drug can have only one. |
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Term
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Definition
| tablet: including enteric coated, sustained release; capsule, caplets, troche, suppository |
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Definition
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Definition
| oil- based, stays longer on skin |
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Definition
| syrup, elixir, tincture, suspension, emulsion |
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Term
| Drug routes/ forms: enteral |
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Definition
absorbed via oral or gastrointestinal mucosa
oral, sublingual, rectal |
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Term
| Drug routes/ forms: parenteral |
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Definition
injection, absorbed through tissue such as needle
subcutaneous (SQ or SC), intramuscular (IM), intravenous (IV), intradermal (ID) |
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Term
| Drug routes/ forms: topical |
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Definition
absorbed via surface
skin, transdermal (patches), inhalation, eye ears nose drops, rectal |
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Term
| Department of Health and Human Services |
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Definition
| overall responsible for anything related to health and illness |
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Term
| Drug Enforcement Agency (DEA) |
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Definition
| branch of dept of justice responsible for all laws relative to sale and distribution of medications, particularly controlled substances |
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Term
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Definition
| responsible for control of advertising |
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Term
| Food and Drug Administeration (FDA) |
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Definition
| responsible for overseeing developmental and approval of new drugs, determining whether OTC or prescription |
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Term
| Laws: Pure Food and Drug Act |
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Definition
| First law to restrict manufacture and distribution of drugs by requiring government pre-approval of a drug. Didn't require proof of safety |
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Term
| Laws: Harrison Narcotic Act |
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Definition
| established narcotic as a legal term; regulated manufacture, sale, and distribution of narcotics |
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Term
| Laws: Food, drug, cosmetic act |
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Definition
| requires proper testing for proof of safety and FDA approval before a drug could be marketed |
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Term
| Laws: Durham Humphrey Amendment |
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Definition
| recognizes OTC drugs by defining what drugs require prescription; limited refills |
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Term
| Law: Kefauver Harris Amendment |
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Definition
| requires proof of both safety and efficacy before marketing; mandated animals trials before testing drugs in humans; initiated new drug research |
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Term
| Law: Comprehensive Drug Abuse Prevention Control Act (Controlled Substances Act) |
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Definition
| categorizes drugs according to abuse potential; regulates distribution |
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Term
| Law: Poison Prevention Act |
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Definition
| requires "childproof" packaging on all controlled substances and most prescription drugs |
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Term
| Law: Food and Drug Administration Modernization Act |
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Definition
| fast-track approval for drugs for serious illnesses; drug testing on children; allowed sharing of into on "off label" uses |
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Term
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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 |
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Term
| Categories of Controlled Drugs: Schedule I |
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Definition
| high abuse potential; no accepted medical use and not prescribed. (Heroin, cocaine, hallucinogens) |
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Term
| Categories of Controlled Drugs: Schedule II |
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Definition
| high abuse potential but accepted medical use; most narcotics, amphetamines, strong sedatives; must be written on script |
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Term
| Categories of Controlled Drugs: Schedule III and IV |
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Definition
| varying degree of abuse potential; prescription valid for 6 months or 5 refills. |
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Term
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Definition
| anabolic steroids (body building), narcotic combination products |
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Term
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Definition
| tranquilizers, sleeping pills |
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Term
| Categories of Controlled Drugs: Schedule V |
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Definition
| small amount of narcotic, may include OTC drugs, varies state to state |
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Term
| Florida's "Negative Formulary" Law |
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Definition
| requires pharmacist to offer generic form of drug unless physician specifies no substitutions |
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Term
| New Drug Approval Process |
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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 |
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Term
| Phases of human testing/ clinical trials |
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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 |
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Definition
| actual physiological effect that occurs- therapeutic or adverse |
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Definition
| drug attaches completely and elicits appropriate response (perfect fit) |
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Definition
| drug attaches but does not elicit a response |
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Definition
| drug attaches and gets some response not as much as agonist, may have some antagonist effect |
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Term
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Definition
| time which there is sufficient drug-receptor interaction to initiate a response |
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Definition
| time between onset of action and return to minimum effective concentration |
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Term
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Definition
| range between minimum effective level and maximum |
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Definition
| index of HOW MUCH (amount) administered to achieve desired response |
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Term
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Definition
| effectiveness; maximal response a drug can produce |
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Term
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Definition
| factors affect all phases in general in an individual; human variability; affected by age because organ function varies |
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Term
| Pharmacokinetics require drugs to cross in 3 ways: |
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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 |
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Term
| Pharmacokinetics: absorption |
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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 |
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Term
| Routes of administration for absorption |
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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 |
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Term
| Pharmacokinetics: Distribution |
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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
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Term
| Pharmacokinetics: Metabolism |
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Definition
enzymatic alteration of drug; occurs in liver
drug starts as active--> inactive
inactive--> active
active--> another active
poor liver= poor metabolism
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Definition
| greater metabolism, less effect of drug |
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Definition
| less metabolism, more effect of drug |
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Term
| Pharmacokinetics: excretion |
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Definition
removing drug from body; occurs in kidneys, but can also occur by inhaling, bug bites, bile, breast milk
clearance: speed drug leaves body
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Term
| Factors affecting renal excretion of drugs |
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Definition
| renal blood flow and glomerular filtration, pH of urine, lipid solubility, evaluate renal funtion by assessing BUN and creatinine |
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Term
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Definition
| time it takes to reduce drug concentration by 50% etc. |
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Definition
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Term
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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) |
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Term
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Definition
| blood draw 1/2 hour before net scheduled dose, lowest drug level, monitors whether drug level remains therapeutic |
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Term
| Pharmacodynamic Reactions |
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Definition
| one drug affects pharmacological effect of another |
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Term
| Pharmacodynamic Reactions: additive |
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Definition
| 2/more drugs with same effect are combined in a cumulative effect (1+1=2) |
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Term
| Pharmacodynamic Reactions: synergistic |
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Definition
| 2/more drugs with different effect are combined with resultant outcome being greater than effect of either drug alone (1+1=5) |
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Term
| Pharmacodynamic Reactions: potentiation |
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Definition
| 2/more drugs with different effect combined with resultant outcome of one of drugs being enhanced (1A+1B=2A) |
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Term
| Pharmacodynamic Reactions: antagonistic |
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Definition
| combined effect less than effect of single agent; one drug diminishes another; (1+1=<1) |
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Term
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Definition
| most commonly uncomfortable, but tolerable symptoms; may be life-threatening; predictable; usually not dose related |
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Term
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Definition
| life threatening; dose related; reduce dose= reduce effect |
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Term
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Definition
| unpredictable, unexpected reaction due to genetic differences |
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Term
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Definition
| developed as a result of treatment, such as renal failure from nephrotoxic drug |
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Term
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Definition
| most commonly hepatotoxicity and nephrotoxicity |
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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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