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, Chapter1:DrugDefinitions, Standards,andInformation Sources Test Bank
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MULTIPLECHOICE ,
1. What is the name under which a drug is listed bythe U.S. Food and Drug Administration
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(FDA)?
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a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C ,
The official name is the name under which a drug is listed by the FDA. The brand name, or
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trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic,
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name is provided by the U.S. Adopted Names Council.
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DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: 2TOP: Nursing
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Process Step: Assessment
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MSC: NCLEX Client Needs Category: Safe, Effective CareEnvironment
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2. Whichsource contains information specific to nutritional supplements?
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a. USP Dictionary of USAN &International Drug Names , , , , , , ,
b. Natural Medicines Comprehensive Database , , ,
c. United States Pharmacopoeia/National Formulary (USP NF) , , , , ,
d. Drug Interaction Facts , ,
ANS: C ,
United States Pharmacopoeia/National Formulary contains information specific to nutritional
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supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
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names, pronunciation guide, and possible future FDA approved drugs; it does not include
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nutritional supplements. Natural Medicines Comprehensive Database contains evidence based
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information on herbal medicines and herbal combination products; it does not include information
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specific to nutritional supplements. Drug Interaction Facts contains comprehensive information
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on drug interaction facts; it does not include nutritional supplements.
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DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: 4TOP: Nursing
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Process Step: Assessment
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MSC: NCLEXClient Needs Category: Physiological Integrity
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3. What is the most comprehensive reference available to research a drug interaction?
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a. Drug Facts and Comparisons , , ,
b. Drug Interaction Facts , ,
c. Handbook on Injectable Drugs , , ,
d. Martindale—TheComplete Drug Reference , , ,
ANS: B ,
First published in 1983, Drug Interaction Facts is the most comprehensive book available
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ondrug interactions. In addition to monographs listing various aspects of drug interactions, this
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information is reviewed and updated by an internationally renowned group of physicians
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andpharmacists with clinical and scientific expertise.
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DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 3TOP:
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, Nursing Process Step: Assessment , , ,
MSC: NCLEXClient Needs Category: Physiological Integrity
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4. The physician has written an order for a drug with which the nurse is unfamiliar. Which section of
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the Physicians’ Desk Reference (PDR) is most helpful to get information about this drug?
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a. Manufacturer’ssection ,
b. Brand and Generic Name section , , , ,
c. Product Categorysection , ,
d. ProductInformationsection , ,
ANS: B
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DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 4TOP:
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Nursing Process Step: Planning , , ,
MSC: NCLEXClient NeedsCategory: Physiological Integrity
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5. Which online drug reference makes available to health care providers and the public a
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standard, comprehensive, uptodate look up and downloadable resource about medicines?
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a. American Drug Index , ,
b. American Hospital Formulary , ,
c. DailyMed
d. Physicians’ DeskReference (PDR) , , ,
ANS: C ,
DailyMed makes available to health care providers and the public a standard, comprehensive, up
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to date look up and downloadable resource about medicines. The American Drug Index is not
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appropriate for patient use. The American Hospital Formulary is not appropriate for patient use.
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The PDR is not appropriate for patient use.
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DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 5TOP: Nursing
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Process Step: Implementation
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MSC: NCLEXClient NeedsCategory: Physiological Integrity
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6. Whichlegislation authorizes the FDA to determine the safety of a drug before its marketing?
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a. Federal Food, Drug, and Cosmetic Act (1938) , , , , , ,
b. Durham Humphrey Amendment (1952) , , ,
c. Controlled Substances Act (1970) , , ,
d. Kefauver Harris Drug Amendment (1962) , , , ,
ANS: A ,
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of
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all drugs before marketing. Later amendments and acts helped tighten FDA control and ensure
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drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used
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safely without medical supervision and restricts their sale to prescription by a licensed
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practitioner. The Controlled Substances Act addresses onlycontrolled substances and their
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categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater drug
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safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products
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before marketing them.
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DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 8TOP: Nursing
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Process Step: Assessment
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MSC: NCLEXClient Needs Category: Physiological Integrity
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7. Meperidine(Demerol) is a narcotic with a high potential for physical and psychological
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, dependency. Under which classification does this drug fall? , , , , , , ,
a. I
b. II
c. III
d. IV
ANS: B ,
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to severe
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psychological and physical dependence. Schedule Idrugs have high potential forabuse and no
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recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to low to
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moderate physical dependence or high psychological dependence. Schedule IV drugs have low
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potential for abuse. Use may lead to limited physical or psychological dependence.
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DIF: Cognitive Level: Comprehension REF: p. 4 |p. 5 OBJ: 7TOP:
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Nursing Process Step: Assessment
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MSC: NCLEX Client Needs Category: Safe, Effective CareEnvironment
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8. What would the FDA do to expedite drug development and approval for an outbreak of
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smallpox, for which there is no known treatment?
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a. List smallpox as a health orphan disease.
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b. Omit the preclinical research phase. , , , ,
c. Extend the clinical research phase. , , , ,
d. Fast track the investigational drug.
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ANS: D ,
Once the Investigational New Drug Application has been approved, the drug can receive highest
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priority within the agency, which is called fast tracking. A smallpox outbreak would become a
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priority concern in the world. Orphan diseases are not researched in a priority manner. Preclinical
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research is not omitted. Extending any phase of the research would mean a longer time to develop a
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vaccine. The FDA must ensure that all phases of the preclinical and clinical research phase have
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been completed in a safe manner.
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DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 8TOP: Nursing
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Process Step: Assessment
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MSC: NCLEX Client Needs Category: Safe, Effective CareEnvironment
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9. Whichstatement is true about over the counter (OTC) drugs?
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a. They are not listed in the USP NF. , , , , , , ,
b. A prescription from a health care provider is needed.
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c. Theyare sold without a prescription. , , , , ,
d. They are known only by their brand names. , , , , , , ,
ANS: C ,
OTC medications do not require a prescription. A variety of names, both generic and trade, can be
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used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription drugs
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require an order by a health professional who is licensed to prescribe, such as a physician, nurse
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practitioner, physician assistant, or dentist.
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DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: 2TOP: Nursing
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Process Step: Planning
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MSC: NCLEXClient Needs Category: Physiological Integrity
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10. Whichis the most authoritative reference for medications that are injected?
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