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60 Cards in this Set
- Front
- Back
Legislation:
Drugs should be free from adulterants; required labeling of drug products |
Pure Food and Drug Act 1906
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Legislation:
Required that all drugs undergo testing; results of these tests were to be reviewed by the Food and Drug Administration (FDA); only drugs deemed safe by the FDA would be approved for marketing |
Food, Drug, and Cosmetic Act 1938
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Legislation:
Differentiated between (OTC) and prescription meds; identified meds that could and couldn't be refilled without a prescription |
Durham-Humphrey Amendment 1952
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Legislation:
Tightened controls on drug safety; Required proof of effectiveness before a drug could be marketed. This was the first law to demand that drugs actually be of some benefit; also required that all old drugs (1932-1962) be tested for effectiveness |
Kefauver-Harris Amendment 1962
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Legislation:
Set rules for the manufacture and distribution of drugs considered to have potential for abuse; Placed controlled substances into categories |
Comprehensive Drug Abuse Prevention and Control Act; Title II Controlled Substances Act 1970
- DEA responsible for regulation - nurses must keep all controlled substances locked with inventory and waste documentation |
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Drug Schedule:
Not approved for medical use; have a high abuse potential (Heroin, LSD. Marijuana) |
Schedule I
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Drug Schedule:
Used medically; have a high abuse potential; no refills(Opioid, Ridlin, Aderol) |
Schedule II
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Drug Schedule:
Drugs with less potential for abuse than in I and II, may lead to psychological or physical abuse (Tylenol 3, Darvoset) |
Schedule III
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Drug Schedule:
Some potential for abuse (sleeping pills, benzodiazapines) |
Schedule IV
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Drug Schedule:
Contain some controlled substance, require record keeping (Lamotil) |
Schedule V
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Legislation:
Increased client access to experimental drugs and medical devices; accelerated review of important new drugs; allows drug companies to disseminate information about off-label uses and costs of drugs (HIV, AIDS, Cancer) |
FDA Modernization Act 1997
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Which Clinical Testing Phase:
- healthy volunteers - safe doses - pharmacokinetics - toxicity |
Phase I
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Which Clinical Testing Phase:
- given to diseased subjects - responses compared with subjects in phase I |
Phase II
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Which Clinical Testing Phase:
- larger groups - studies with control groups - determine if benefits outweigh risks |
Phase III
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Which Clinical Testing Phase:
- FDA evaluates results - drug marketed with manufacturer monitoring - drug is more widely used and more adverse effects become evident during this phase |
Phase IV
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the portion of a drug that reaches the systemic circulation and is available to act on target body cells
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Bioavailability
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after a drug is absorbed via the GI tract, it is carried to the liver through the portal circulation and undergoes some degree of metabolism before reaching the systemic circulation
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First Pass Effect (only oral meds)
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Name 6 Mucous membranes:
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- sublingual
- buccal - nasal - conjunctival - vaginal - rectal |
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Name Four processs of Pharmacokinetics:
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- Absorption
- Distribution - Metabolism - Excretion |
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True or False:
The binding of drugs to protein(albumin) in the blood is reversible. |
True
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True or False:
Both free and protein-bound drug molecules can reach target cells. |
False, only free drug molecules
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The blood brain barrier only allows ______ soluble drugs to pass
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lipid
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What liver enzyme metabolizes lipid-soluble metabolites into water-soluble metabolites?
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cytochrome P450
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________ _________ accelerates drug metabolism because larger amounts of the enzymes (and more binding sites) allow larger amounts of a drug to be metabolized during a given time
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Enzyme induction
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________ _________ decreases drug metabolism and most often occurs with concurrent administration of two or more drugs that compete for the same metabolizing enzymes
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Enzyme inhibition
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Which lab value is most representative of kidney function?
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Creatinine
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Laboratory measure of the amount of a drug in the bloodstream at a particular time
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Serum Drug Levels
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the minimal level of drug that must be present in the body before any action is exerted on the body cells; drug levels must be at or above this mark to be therapeutic
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MEC (minimum effective concentration)
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time that drug levels are at or above MEC
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Duration
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time needed for the plasma concentration of a drug to be reduced to 50%
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Half-Life
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The point at which the amount of drug being administered and the amount eliminated balance off; full therapeutic effect usually seen.
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Steady State
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What is the equation for steady state?
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steady state = half-life x 5
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a drug that binds to and stimulates activity of one or more biochemical receptor types in the body
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Agonist
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a drug that binds to and inhibits the activity of one or more biochemical receptor types in the body
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Antagonist (or inhibitors)
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prolonged inhibition of cell function with an antagonist drug may increase the number of receptor sites on a cell
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Up-regulation
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prolonged stimulation of cell function with an agonist may decrease the number of receptor sites on a cell
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Down-Regulation
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Name 3 Drug types that do NOT act on receptor sites:
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- Antacids
- Osmotic diuretics - Anticancer drugs (antineoplastics) |
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True or False:
The presence of food in the stomach will speed absorption |
False
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Do Interference and Displacement belong in Increased or Decreased Drug Effects category?
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Increased Drug Effects
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Do Children (1 year to 12 years) metabolize drugs quicker or slower than adults?
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Faster; children have a period of increased activity of drug-metabolizing enzymes so that some drugs are rapidly metabolized and eliminated
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Developing tolerance to drugs in a related classification
(someone who drinks alcohol may need larger doses of sedative) |
Cross-Tolerance
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Adverse Drug Effect:
drugs that will harm the fetus if taken by a pregnant woman |
Teratogenic Effect
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Adverse Drug Effect:
an unexpected adverse reaction usually related to genetic predisposition |
Idiosyncratic Effect
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What are the two recently added Rights of Administration?
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- Right documentation
- Right to refuse |
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What are seven essential pieces of information required for a medication order in a client's chart?
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- Client's name
- drug name - dose - route - frequency - date/time - signature |
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What are the eight routes of administration?
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- oral
- GI - Sub-Q - IM - IV - MM - Topical - Inhalation |
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Many drugs prescribed to a client (elderly at risk)
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Polypharmacy
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Which 2 Oral tablets/capsules CANNOT be crushed and given via G-tube
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- Enteric coated
- Extended release |
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Pregnancy Category:
Adequate studies in pregnancy; women demonstrate no risk to the fetus |
Category A
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Pregnancy Category:
Animal studies indicate no risk to the fetus; no studies in pregnant women OR animal studies show adverse effects, but studies in pregnant women have not demonstrated a risk |
Category B
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Pregnancy Category:
Potential risk as a result of animal studies, no data from human studies; benefits outweigh potential risks |
Category C (most drugs)
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Pregnancy Category:
Evidence of human fetal risk, potential benefits to the mother may be acceptable despite potential risk to fetus (seizure meds) |
Category D
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Pregnancy Category:
Unacceptable for use in pregnant women (antineoplastics) |
Category X
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Legislation:
"a vitamin, mineral, herb or other botanical used to supplement the diet Cannot claim to diagnose, prevent, relieve, or cure specific human diseases unless approved by the FDA |
Dietary Supplement Health and Education Act (DSHEA) 1994
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In the evaluation phase of the nursing process, what is one purpose of "pill counting"?
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to check for compliance
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Physiologic Changes:
What are three physiological changes that affect both Infants and Older Adults? |
- slow peristalsis
- decreased renal blood flow - fewer protein binding sites |
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Prior to the clinical testing phases (which last 5-10 years) is the preclinical testing in which what subject is tested for the following?
- toxicities - pharmacokinetic properties - potential usefulness |
Animals
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Which wellknown fruit juice inhibits the cytochrome P450 isozyme specific to felodipine (a calcium channel blocker)?
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grapefruit juice
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Which 4 tests should be monitored for pt with hepatic impairment?
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- ALT
- AST - albumin - INR/protime |
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What is the average time span for drug development and approval for market use?
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12 years
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