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Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz:
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Clayton’sBasicPharmacology forNurses,19thEdition
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MULTIPLECHOICE b
1. Whichnameidentifies adruglisted bythe US Food and Drug
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Administration (FDA)?
b b
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C b
The official name is the name under which a drug is listed by the
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FDA. The brand name, or trademark, is the name given to a drug
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by its manufacturer. The nonproprietary, or generic, name is
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provided by the United States Adopted Names Council.
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DIF: CognitiveLevel:Knowledge REF: p. 9 b b b b
OBJ: 1NAT: NCLEX Client NeedsCategory: Safe,EffectiveCare b b b b b b b b
Environment TOP: Nursing Process Step: Assessment
b CON: b b b b b
Patient Education
b b
2. Whichsourcecontainsinformationspecifictonutritionalsupplements?
b b b b b b b
a. USPDictionary ofUSAN &International DrugNames b b b b b b b
b. NaturalMedicinesComprehensiveDatabase b b b
c. UnitedStatesPharmacopoeia/NationalFormulary(USPNF) b b b b b
d. DrugInteractionFacts b b
ANS: C b
UnitedStatesPharmacopoeia/NationalFormularycontainsinformationspecifictonutritional
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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
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evidence-basedinformationonherbalmedicines andherbalcombinationproducts;itdoesnot b b b b b b b b b b b
include information specific to nutritional supplements. Drug Interaction Facts contains
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comprehensive information on drug interaction facts; it does not include nutritional supplements.
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DIF: Cognitive Level: Knowledge REF: p. 4 OBJ:3 b b b b b
NAT: NCLEX Client Needs Category: Physiological Integrity
b b b b b b b
TOP: NursingProcessStep:Assessment
b CON: Nutrition|Patient Education b b b b b b b
3. Whichdrugreference contains drugmonographs that describeall drugsina therapeutic class?
b b b b b b b b b b b b b
a. DrugFactsandComparisons b b b
TestBankForClayton’sBasicPharmacology forNurses19th Edition
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,TestBank For Clayton’s Basic PharmacologyforNurses19thEdition
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b. DrugInteractionFacts b b
c. Handbookon Injectable Drugs b b b
d. Martindale—TheCompleteDrugReference b b b
ANS: A b
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
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therapeuticclass.Monographsareformattedastablestoallowcomparison ofsimilar
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products, brand names, manufacturers, cost indices, and available dosage forms Online
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version is available.
b b b
DIF: Cognitive Level: Knowledge REF: p. 4Table 1.2 b b b b b b
OBJ: 3 b NAT: NCLEXClientNeedsCategory:PhysiologicalIntegrity
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TOP: NursingProcessStep:Assessment
b CON: Safety|PatientEducation|ClinicalJudgment b b b b b b b b b b
4. Whichdrugreference containsmonographs about virtuallyeverysingle-entitydrugavailable in the
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United States and describes therapeutic uses of drugs, including approved and unapproved uses?
b b b b b b b b b b b b b
a. Martindale:TheComplete DrugReference b b b b
b. AHFSDrugInformation b b
c. DrugReference b
d. DrugFactsandComparisons b b b
ANS: B b
AHFS Drug Information contains monographs about virtually every single-entity drug availablein
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theUnitedStatesanddescribestherapeuticusesofdrugs,includingapproved and unapproved uses.
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DIF: Cognitive Level: Knowledge REF: p. 4Table 1.2 b b b b b b
OBJ: 3 b NAT: NCLEXClientNeedsCategory:PhysiologicalIntegrity
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TOP: NursingProcessStep: Planning
b CON: Safety|PatientEducation|ClinicalJudgment b b b b b b b b b b
5. Which online drug reference makes available to healthcare providers and the public a standard,
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comprehensive, up-to-datelookupanddownloadableresourceaboutmedicines?
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a. AmericanDrugIndex b b
b. AmericanHospitalFormulary b b
c. DailyMed
d. DrugReference b
ANS: C b
DailyMedmakes available tohealthcareproviders and thepublic astandard,comprehensive, up-
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to-datelookupanddownloadableresourceaboutmedicines.TheAmericanDrugIndexis not
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appropriate for patient use. The American Hospital Formulary is not appropriate for patient use.
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The drug reference is not appropriate for patient use.
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DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 b b b b b b b OBJ:3 b
NAT: NCLEX Client Needs Category: Physiological Integrity
b b b b b b b
TOP: NursingProcessStep:Implementation
b b b b
CON: Safety|PatientEducation|ClinicalJudgment
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6. Whichlegislation authorizestheFDAto determinethesafetyofadrugbeforeitsmarketing?
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a. FederalFood,Drug,and CosmeticAct(1938) b b b b b b
b. DurhamHumphreyAmendment (1952) b b b
TestBankForClayton’sBasicPharmacology forNurses19th Edition
b b b b b b b b b b
,TestBank For Clayton’s Basic PharmacologyforNurses19thEdition
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c. ControlledSubstancesAct(1970) b b b
d. KefauverHarrisDrugAmendment(1962) b b b b
ANS: A b
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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ControlledSubstancesActaddressesonlycontrolledsubstancesand theircategorization. The
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Kefauver Harris DrugAmendment ensures drugefficacyand 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.
b
DIF: Cognitive Level: Knowledge REF: p. 5Tablel.3 b b b b b b
OBJ: 5 b NAT:NCLEXClientNeedsCategory:PhysiologicalIntegrity b b b b b b
TOP: Nursing Process Step: Assessment
b b b b b
CON: Safety|Patient Education|Evidence |HealthCareLaw
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7. Whichclassificationdoesmeperidine(Demerol)fall under?
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a. I
b. II
c. III
d. IV
ANS: B b
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and maylead to severe
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psychological and physicaldependence.Schedule Idrugshavehigh potentialforabuse 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: Knowledge REF: p. 10 OBJ:2 b b b b b
NAT: NCLEXClient NeedsCategory: Safe,EffectiveCareEnvironment
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TOP: NursingProcessStep:Assessment
b CON: PatientEducation|Addiction|Pain b b b b b b b b b
8. WhichactionwouldtheFDAtaketoexpeditedrugdevelopment andapproval foranoutbreak of
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smallpox?
b
a. Listsmallpox asahealth orphandisease.
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b. Omitthepreclinical researchphase. b b b b
c. Extendtheclinicalresearchphase. b b b b
d. Fasttracktheinvestigationaldrug. b b b b
ANS: D b
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 anyphase of the research would mean alongertimetodevelop a
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vaccine.TheFDAmust ensurethatall phasesof thepreclinical and clinical research phase have been
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completed in a safe manner.
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DIF: Cognitive Level: Knowledge b b REF: p. 7 b b b OBJ: 5 b
TestBankForClayton’sBasicPharmacology forNurses19th Edition
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, TestBank For Clayton’s Basic PharmacologyforNurses19thEdition
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NAT:NCLEXClient NeedsCategory:Safe,EffectiveCareEnvironment
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TOP: Nursing Process Step: Assessment
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CON: HealthCareLaw|HealthCarePolicy|Infection|CareCoordination
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9. Whichstatement istrueabout over-the-counter(OTC) drugs?
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a. Theyarenot listed in theUSPNF. b b b b b b b
b. Aprescription fromahealthcareprovideris needed.
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c. Theyaresoldwithout aprescription. b b b b b
d. Theyare known onlybytheir brand names. b b b b b b b
ANS: C b
OTC medications do not require a prescription. A variety of names, both generic and trade, canbe
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used forindividualdrugssoldOTC.OTC drugs arelistedintheUSP NF.Prescription drugs require an
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order by a health professional who is licensed to prescribe, such as a physician, nurse practitioner,
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physician assistant, or dentist.
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DIF: Cognitive Level: Comprehension REF: p. 2 OBJ:2 b b b b b
NAT: NCLEX Client Needs Category: Physiological Integrity
b b b b b b b
TOP: NursingProcessStep: Planning
b CON: PatientEducation b b b b b
10. Whichisthemost authoritativereference formedicationsthatareinjected?
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a. Martindale:TheComplete b b
b. Handbookon Injectable Drugs b b b
c. DailyMed
d. HandbookofNonprescriptionDrugs b b b
ANS: B b
The Handbook on Injectable Drugs is the most comprehensive reference available on the topicof
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compatibilityofinjectabledrugs. Itisacollection ofmonographs formorethan300 injectable drugs
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that are listed alphabetically by generic name.
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DIF: Cognitive Level: Knowledge REF: p. 4 OBJ:3 b b b b b
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcessStep:Assessment
b CON: ClinicalJudgment |Safety b b b b b b b
11. Whichstatementistrueabout Lomotil? b b b b b
a. Abusepotential forthisdrugis low. b b b b b b
b. Psychologicaldependencyislikely. b b b
c. Thereis ahigh potential forabuse. b b b b b b
d. Thisdrugisnot acontrolled substance. b b b b b b
ANS: A b
Lomotil, a Schedule V drug, has an abuse potential of limited physical or psychological dependence
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liabilitycompared withdrugsinSchedule IV.Because abusepotentialislow with aSchedule Vdrug, a
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prescription maynot be required. Psychological dependencyis not likely with a Schedule V drug.
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Schedule V drugs are classified as controlled substances.
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DIF: Cognitive Level: Knowledge REF: p. 5 Box 1.1 OBJ:2 b b b b b b b
NAT: NCLEX Client Needs Category: Physiological Integrity
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TOP: NursingProcessStep:Assessment
b CON: ClinicalJudgment |Safety|PatientEducation b b b b b b b b b b