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Identify federal legislation that control drug use and abuse.
Pure Food and Drug Act of 1906: set standards for drug labeling (everything had to be true); declare on label any identified dangerous or addicting substances (did not state if effective or safe); set standards for purity, potency, bioavailability, efficacy, and safety
Food, Drug, and Cosmetic Act of 1938: replaced the 1906 act; added the requirement of safety testing of drugs before marketing
Durham-Humphery Admendment 1952: distinguishes drugs that need or don't need a new prescription with refills
Kefauver-Harris Drug Amendment 1962: provisions for evaluation for testing method; tightened controlls on drug safety; establishement of effectiveness of new drugs
Controlled Substance Act 1970: 1) promotion of education and information on preventino and treatment of drug dependency, 2) strenthening of enforcement authority, 3) establish treatment facilities, 4) schedules for controlled substances
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Differentiate among Schedule I, II, III, IV, and V medications.
Schedule I: high abuse potential; no accepted medical use
Schedule II: high abuse potential with medical use; written prescription only; no refills
Schedule III: medically accepted; may cause dependence; low physical, high psychological; written/oral prescription; 5 refills
Schedule IV: mild physical/psychological dependence; 5 refills
Schedule V: limited potential for dependence; written prescription or OTC
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Describe the nursing responsibilites associated with the administrating of each schedule.
1) Account for all controlled drugs
2) Keep a special controlled-substance record for required information
3) Countersign all discarded or wasted medication
4) Ensure that documentation and drugs on hand match
5) Keep all controlled drugs in a locked storage area
6) Be certain that only authorized persons have access to the keys
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Discuss how new drugs are tested for safety.
Phase I: small groups (20-100); 4-6 week trial; purpose: determine optimal dosage range and pharmacokinetics
Phase II: clients with disease, sevearl 100's; purpose: effective for diesase?, monitor SE
Phase III: large numbers (1000's), medical research centers; purpose: identify infrequent, rare adverse effects-double blind study; new drug application
Stage IV: post marketing survey; ongoing review; other uses; refine dose; drug interactions
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Define orphan drugs.
no company would "adopt"; not profitable to develop; market too small or patent protection expired
Orphan Drug Act of 1983: research grants, protocol development by FDA, 7 year exclusive marketing rights (shortens approval process, because no one would want to develop the drug)
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Discuss the role of the nurse in drug testing.
asking relevant questions about informed consent and risk to benefit ratio; awareness of initial indicators of change in the client; prediction of increased risk for adverse drug reactions; recruitment and assessment of study subjects; thorough understanding of protocol; validity and reliability of measurement instruments; ongoing teamwork; communication with health care providers
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Define informed consent.
must be fully informed about all treatments to enable clients to make decisions about their health care; not coerced, alert; nurses teach about the medications
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Identify ways to maintain confidentiality in drug administration.
respect privileged information; need to know; don't talk in public; don't discuss medications in front of others; always ID the client first
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Purpose of medications.
1) Diagnosis of disease
2) Treatment of disease
3) Cure disease
4) Relief of symptoms
5) Prevention of disease
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Drug Names.
Chemical Name: drug's chemical compostition and molecular structure
Generic Name: common name used by any manufacturer
Official Name: chosen by FDA, often same as generic name
Trade Name: brand name; regestered name given by manufacturer
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Units of measurment in metic system.
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Metic to Household measurements.
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Identify various routes for administering medications.
IM, IV, Subcut, Oral
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