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Chemical compound with a specifc structure |
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A drug after it has been administered |
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Animals
Plants
Synthetic chemicals
Genetically-engineered chemicals |
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Drugs do not create a response in the body but __________ the body's response |
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Drugs ________ multiple effects on the body rather than a single effect |
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Drug action occurs as a result of? |
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Definition
An interaction of the drug with a molecule or structure in the body |
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All drugs have 3 names. What are the 3 names? |
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Definition
Chemical
Generic/nonproprietary
Trade/brand/proprietary |
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Definition
Describes the drug using exact chemical structures |
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Term
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Definition
Derived from the chemical name.
First letter of name is NOT capitalized **These generic drug names are easy to categorize because they end the same as each other |
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Definition
Provided by drug manufacture
Usually easy to say
Protected by trademark of 17yrs.
1st letter IS capitalized |
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Term
Pure Food and Drug Act (1906) |
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Definition
1st major drug law
Provided accurate information about quality of drug products |
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Definition
Amended the Pure Food and Drug Act
Prohibited labeling drugs with false claims |
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Federal Food, Drug, and Cosmetic Act (1938) |
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Definition
Established the FDA
Required animal testing prior to FDA and goverment approval prior to marketing |
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Definition
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Term
Kefauver-Harris Amendment (1962) |
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Definition
Tightened controls on drug saftey
Authorized FDA to establish specific names for drugs |
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Term
Dietary Supplement Health and Education Act of 1994 |
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Definition
Regulate herbs and dietary supplements
FDA can pull drugs off market if at risk
Accuracy of labels not regulated
Effectivness and saftey of product do not need to be demonstrated prior to marketing |
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Term
Dietary supplement and Nonprescription drug consumer Protection Act (2007) |
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Definition
Contact info. required on labels
Keep records of adverse events for 6 years
Manufact. must evaluate products identity, purity, potency, and composition
Labels must accuratly describe contents |
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Prescription Drug User Fee Act (1992) |
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Definition
Yearly $$ fee which allowed FDA to higher more people and make the process faster |
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Term
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Definition
Small # of healthy volunteers that do not have the disease or ailment |
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Phase 2 of Clinical Trial |
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Definition
Small # of volunteers with the disease or ailment |
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Phase 3 of Clinical Trial |
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Definition
Large # of clients in research center. More risks are identified here |
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Phase 4 of Clinical Trials |
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Definition
Postmarketing surveillance of the drug |
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Term
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Definition
4 phases of the clinical evaluation process are shortened |
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Definition
Available to pts. with life-threatening diseases only |
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Term
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Definition
Used to treat rare or unusual diseases.
No one wants the cost of developing these medications |
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Term
Durham-Humphreys Amendments (1952) |
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Definition
Classified drugs as ones requiring prescriptions "Legend"
Not requiring prescription as OTC or non legend |
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Harrison Narcotic Law (1914) |
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Definition
Regulated habit-forming narcotics |
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Controlled substance act (1970) |
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Definition
Categorized according to abuse potential and medical usefulness
DEA is in charge of the saftey |
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Term
Overall goal of Pharmacotherapy |
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Definition
Safe and effective administration of medication |
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Term
Nursing Assessment in Drug Therapy includes... |
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Definition
Pt. interview and history
Physical Assessment
Examination of the medical record |
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Term
The ultimate nursing goal of the Planning and Implementation phase is for the nurse to: |
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Definition
Develop a plan of care to Maximize the therapeutic effects and Minimize the adverse effects of drug therapy |
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Term
The Six rights of med administration |
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Definition
1: right med 2: Right pt 3: right time 4: right dose 5: right route 6: right documentation |
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