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60 Cards in this Set

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Legislation:

Drugs should be free from adulterants; required labeling of drug products
Pure Food and Drug Act 1906
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
Legislation:

Differentiated between (OTC) and prescription meds; identified meds that could and couldn't be refilled without a prescription
Durham-Humphrey Amendment 1952
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
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
Drug Schedule:

Not approved for medical use; have a high abuse potential (Heroin, LSD. Marijuana)
Schedule I
Drug Schedule:

Used medically; have a high abuse potential; no refills(Opioid, Ridlin, Aderol)
Schedule II
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
Drug Schedule:

Some potential for abuse (sleeping pills, benzodiazapines)
Schedule IV
Drug Schedule:

Contain some controlled substance, require record keeping (Lamotil)
Schedule V
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
Which Clinical Testing Phase:

- healthy volunteers
- safe doses
- pharmacokinetics
- toxicity
Phase I
Which Clinical Testing Phase:

- given to diseased subjects
- responses compared with subjects in phase I
Phase II
Which Clinical Testing Phase:

- larger groups
- studies with control groups
- determine if benefits outweigh risks
Phase III
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
the portion of a drug that reaches the systemic circulation and is available to act on target body cells
Bioavailability
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
First Pass Effect (only oral meds)
Name 6 Mucous membranes:
- sublingual
- buccal
- nasal
- conjunctival
- vaginal
- rectal
Name Four processs of Pharmacokinetics:
- Absorption
- Distribution
- Metabolism
- Excretion
True or False:

The binding of drugs to protein(albumin) in the blood is reversible.
True
True or False:

Both free and protein-bound drug molecules can reach target cells.
False, only free drug molecules
The blood brain barrier only allows ______ soluble drugs to pass
lipid
What liver enzyme metabolizes lipid-soluble metabolites into water-soluble metabolites?
cytochrome P450
________ _________ 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
Enzyme induction
________ _________ decreases drug metabolism and most often occurs with concurrent administration of two or more drugs that compete for the same metabolizing enzymes
Enzyme inhibition
Which lab value is most representative of kidney function?
Creatinine
Laboratory measure of the amount of a drug in the bloodstream at a particular time
Serum Drug Levels
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
MEC (minimum effective concentration)
time that drug levels are at or above MEC
Duration
time needed for the plasma concentration of a drug to be reduced to 50%
Half-Life
The point at which the amount of drug being administered and the amount eliminated balance off; full therapeutic effect usually seen.
Steady State
What is the equation for steady state?
steady state = half-life x 5
a drug that binds to and stimulates activity of one or more biochemical receptor types in the body
Agonist
a drug that binds to and inhibits the activity of one or more biochemical receptor types in the body
Antagonist (or inhibitors)
prolonged inhibition of cell function with an antagonist drug may increase the number of receptor sites on a cell
Up-regulation
prolonged stimulation of cell function with an agonist may decrease the number of receptor sites on a cell
Down-Regulation
Name 3 Drug types that do NOT act on receptor sites:
- Antacids
- Osmotic diuretics
- Anticancer drugs (antineoplastics)
True or False:

The presence of food in the stomach will speed absorption
False
Do Interference and Displacement belong in Increased or Decreased Drug Effects category?
Increased Drug Effects
Do Children (1 year to 12 years) metabolize drugs quicker or slower than adults?
Faster; children have a period of increased activity of drug-metabolizing enzymes so that some drugs are rapidly metabolized and eliminated
Developing tolerance to drugs in a related classification
(someone who drinks alcohol may need larger doses of sedative)
Cross-Tolerance
Adverse Drug Effect:

drugs that will harm the fetus if taken by a pregnant woman
Teratogenic Effect
Adverse Drug Effect:

an unexpected adverse reaction usually related to genetic predisposition
Idiosyncratic Effect
What are the two recently added Rights of Administration?
- Right documentation
- Right to refuse
What are seven essential pieces of information required for a medication order in a client's chart?
- Client's name
- drug name
- dose
- route
- frequency
- date/time
- signature
What are the eight routes of administration?
- oral
- GI
- Sub-Q
- IM
- IV
- MM
- Topical
- Inhalation
Many drugs prescribed to a client (elderly at risk)
Polypharmacy
Which 2 Oral tablets/capsules CANNOT be crushed and given via G-tube
- Enteric coated
- Extended release
Pregnancy Category:

Adequate studies in pregnancy; women demonstrate no risk to the fetus
Category A
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
Pregnancy Category:

Potential risk as a result of animal studies, no data from human studies; benefits outweigh potential risks
Category C (most drugs)
Pregnancy Category:

Evidence of human fetal risk, potential benefits to the mother may be acceptable despite potential risk to fetus (seizure meds)
Category D
Pregnancy Category:

Unacceptable for use in pregnant women (antineoplastics)
Category X
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
In the evaluation phase of the nursing process, what is one purpose of "pill counting"?
to check for compliance
Physiologic Changes:

What are three physiological changes that affect both Infants and Older Adults?
- slow peristalsis
- decreased renal blood flow
- fewer protein binding sites
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
Which wellknown fruit juice inhibits the cytochrome P450 isozyme specific to felodipine (a calcium channel blocker)?
grapefruit juice
Which 4 tests should be monitored for pt with hepatic impairment?
- ALT
- AST
- albumin
- INR/protime
What is the average time span for drug development and approval for market use?
12 years