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, Chapter1:DrugDefinitions, Standards,andInformationSources Test Bank
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MULTIPLECHOICE j
1. What is the name under whichadrugis 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 j
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, name
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is provided by the U.S. Adopted Names Council.
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DIF: Cognitive Level: KnowledgeREF: p. 1 OBJ: 2TOP: Nursing
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Process Step: Assessment
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MSC: NCLEXClient Needs Category: Safe,EffectiveCareEnvironment
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2. Whichsourcecontains information specificto nutritional supplements?
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a. USPDictionary of USAN &International Drug Names j j j j j j j
b. NaturalMedicines ComprehensiveDatabase j j j
c. UnitedStates Pharmacopoeia/National Formulary(USPNF) j j j j j
d. DrugInteraction Facts j j
ANS: C j
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: KnowledgeREF: p. 2 OBJ: 4TOP: Nursing
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Process Step: Assessment
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MSC: NCLEXClient NeedsCategory: Physiological Integrity
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3. What is the most comprehensive reference available to research adruginteraction?
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a. DrugFacts and Comparisons j j j
b. DrugInteraction Facts j j
c. Handbookon Injectable Drugs j j j
d. Martindale—TheCompleteDrugReference j j j
ANS: B j
First published in 1983, Drug Interaction Facts is the most comprehensive book available ondrug
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interactions. In addition to monographs listing various aspects of drug interactions, this
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information is reviewed and updated byan 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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, NursingProcess Step: Assessment j j j
MSC: NCLEXClient NeedsCategory: 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 j
b. Brand andGenericName section j j j j
c. ProductCategorysection j j
d. ProductInformationsection j j
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DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 4TOP:
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NursingProcess Step: Planning j j j
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, uptodatelook upand downloadable resourceaboutmedicines?
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a. American Drug Index j j
b. American Hospital Formulary j j
c. DailyMed
d. Physicians’DeskReference(PDR) j j j
ANS: C j
DailyMed makes available to health care providers and the public a standard, comprehensive, up to
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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: KnowledgeREF: 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 determinethe safetyof adrugbeforeits marketing?
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a. Federal Food, Drug, and CosmeticAct (1938) j j j j j j
b. Durham HumphreyAmendment (1952) j j j
c. ControlledSubstances Act (1970) j j j
d. KefauverHarris Drug Amendment(1962) j j j j
ANS: A j
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of all
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drugs before marketing. Later amendments and acts helped tighten FDA control and ensure drug
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safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used safely
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without medical supervision and restricts their sale to prescription by a licensedpractitioner.The
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Controlled Substances Actaddresses onlycontrolledsubstances and their categorization. The
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Kefauver Harris Drug Amendment ensures drug efficacy and greater drug safety. Drug
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manufacturers are required to prove to the FDA the effectiveness of their products before marketing
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them.
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DIF: Cognitive Level: KnowledgeREF: p. 4 OBJ: 8TOP: Nursing
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Process Step: Assessment
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MSC: NCLEXClient NeedsCategory: Physiological Integrity
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7. Meperidine(Demerol) is anarcotic with ahigh potential forphysical andpsychological j j j j j j j j j j j j
, dependency. Under which classification does this drug fall? j j j j j j j
a. I
b. II
c. III
d. IV
ANS: B j
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 havehigh 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: NCLEXClient Needs Category: Safe,EffectiveCareEnvironment
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8. What would the FDA do to expedite drugdevelopment and approval foran outbreak of
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smallpox, for which there is no known treatment?
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a. List smallpox asahealth orphan disease.
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b. Omitthepreclinical research phase. j j j j
c. Extendtheclinical research phase. j j j j
d. Fasttrack theinvestigationaldrug. j j j j
ANS: D j
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 alongertimeto develop a
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vaccine.The FDA must ensurethat all phases of thepreclinical and clinical research phase have
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been completed in a safe manner.
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DIF: Cognitive Level: KnowledgeREF: p. 7 OBJ: 8TOP: Nursing
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Process Step: Assessment
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MSC: NCLEXClient Needs Category: Safe,EffectiveCareEnvironment
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9. Whichstatement is true about overthe counter (OTC) drugs?
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a. Theyare not listed in the USP NF. j j j j j j j
b. Aprescription from a health careprovideris needed.
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c. Theyare sold without aprescription. j j j j j
d. They are known onlyby their brand names. j j j j j j j
ANS: C j
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 require
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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 NeedsCategory: Physiological Integrity
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10. Whichis the most authoritative referenceformedications that areinjected?
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