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chelleJ.Willihnganz,SamuelL.Gurevitz,BruceClaytonComplete
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,Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz:C l
o o o o o o o o o
ayton’sBasicPharmacology forNurses, 19thEdition o j
MULTIPLECHOICE
1. Whichname identifiesadruglisted bytheUSFood andoDruo
j j j
g Administration(FDA)?
j
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS:oC
Theofficialnameistheonameunderwhichadrug islistedbytheo FD j
A.oThebrandname, ortrademark,ois thenamegiventoadrugobyitsm
j j
anufacturer.oThe nonproprietary,oorgeneric,onameisproovidedbyt
j
heoUnited States AdoptedoNamesoCouncil.
j j
DIF: Cognitive Level:Knowledge
j REF:op.o9
OBJ:1NAT:NCLEXClientNeeds Category:Safe,oEffectiveCareoEnovironment
j j
TOP:oNursingoProcessoStep:oAssessment
CON:
PatientoEducation
2. Which sourcecontainsinformationspecifictonutritionalsupplements?
j
a. USPDictionaryofUSAN&Internationalo DrugNames
b. NaturalMedicinesComprehensiveDatabase
c. UnitedStatesPharmacopoeia/NationalFormulary(USPNF)
d. DrugInteractionFacts
ANS:oC
UnitedStatesPharmacopoeia/NationalFormularycontainsinformationspecificto nutritionalsuo pp j
lements.oUSPDictionaryofoUSAN&InternationaloDrugoNamesoisacompilation ofdrugnames,opro j
nunciationguide,oandpossiblefutureoFDAapproved drugs;oitdoesnotincludenutritionalsupploeme
j
nts.oNaturaloMedicinesComprehensiveoDatabaseocontains
evidence-
basedinformationonherbalmedicinesandherbalcombinationproducts;itdoesnotincludeinformoatio
n specific tonutritionalsupplements.oDrugoInteractionFactsocontainscomprehensiveinformaotion
j j
ondruginteraction facts;oit does notincludenutritional supplements.
j j j j
DIF:o o Cognitive Level:oKnowledge
j REF:op.o4
OBJ:3oNAT:oNCLEXClientoNeedsoCategory:oPhysiologicaloIntegrit
y
TOP:o Nursing ProcessStep:Assessment
j CON:oNutrition |PatientoEducation j
3. Which drugreferencecontainsdrugmonographsthatdescribealldrugsin atherapeutic class?
j j j
a. DrugFactsandComparisons
,TestBankoFor Clayton’s BasicPharmacologyfor Nurses19thEdition
j j j 3
b. DrugInteractionFacts
c. Handbook onInjectableoDrugs j
d. Martindale—TheCompleteDrugReference
ANS:oA
DrugFactsandoComparisonsocontainsdrug monographsthatdescribealldrugsin a therapo j j j
eutic class.Monographsareformatted astablesto allowcomparison ofsimilaroproducts,obro
j j j j
andnames,omanufacturers,ocostindices, andavailabledosageformsoOnlineversionis avaio j j
lable.
DIF: CognitiveLevel:Knowledge REF:o p.o4 Table1.2 j
OBJ:o 3 NAT:oNCLEXClientNeeds Category:Physiological Integrity j j
TOP:o Nursing ProcessStep:Assessment
j CON:oSafety|PatientoEducation |ClinicalJudgment j
4. Whichdrug reference contains monographsabout virtuallyeverysingle-
j j j j
entitydrug available intheoUnitedoStates anddescribestherapeuticusesofdrugs,oincludingapproovedandunap
j j j
proveduses?
a. Martindale:TheCompleteDrugReference
b. AHFSDrugInformation
c. DrugReference
d. DrugFacts and Comparisons j j
ANS:oB
AHFSDrugoInformationcontainsmonographsabout virtuallyeverysingle- j
entitydrugavailableinthe UnitedStatesanddescribes therapeuticusesofdrugs,oincludingapproveodandunap
j j
proveduses.
DIF: Cognitive Level:Knowledge REF:o p.o4 Table1.2
j j
OBJ:o 3 NAT:oNCLEXClientNeedsCategory:PhysiologicalIntegrity
TOP:o Nursing ProcessStep:Planning
j CON:oSafety|PatientoEducation |ClinicalJudgment j
5. Whichonlinedrug referencemakesavailabletohealthcareproviders andthepublicastandard,o o c
j j
omprehensive,oup-to-datelookup anddownloadableresourceabout medicines? j j
a. AmericanDrugIndex
b. AmericanHospitalFormulary
c. DailyMed
d. DrugReference
ANS:oC
DailyMedmakes availabletohealthcareprovidersandthepublica standard, comprehensive,oup-
j j j
oto-
datelookupanddownloadableresourceabout medicines.The AmericanDrugIndexisnotapproporia j j
te forpatientuse.oTheoAmericanoHospitaloFormularyoisnotappropriateforpatientuse.oTheodruogre
j
ferenceoisnotappropriateforpatientuse.
DIF:o o CognitiveoLevel:oKnowledge REF:o p.o3o|p.o4
OBJ:3oNAT:oNCLEXClientoNeedsoCategory:oPhysiologicaloIntegrit
y
TOP:oNursingProcessStep:Implementation
CON:oSafety|Patient Education|ClinicalJudgment j
6. Which legislationauthorizestheFDAtodeterminethe safetyofa drugbeforeits marketing?
j j j j
a. FederalFood,Drug,and CosmeticAct(1938) j
b. Durham HumphreyAmendment(1952)
j
, TestBankoFor Clayton’s BasicPharmacologyfor Nurses19thEdition
j j j 4
c. ControlledSubstancesAct (1970) j
d. KefauverHarrisDrug Amendment(1962) j
ANS:oA
TheFederaloFood,oDrug,oandoCosmetic Actofo1938oauthorizedtheoFDAtodetermine thesafetyofaol j j
ldrugs before marketing.oLateramendmentsandacts helped tightenoFDAcontrolandensuredrug o s
j j j j j
afety.oTheoDurhamoHumphreyAmendmentdefinesthe kindsofdrugs thatcannotbeusedsafelywoith j j
outmedicalsupervisionandrestrictstheirsaleto prescriptionbyalicensedpractitioner.The Coo o ntrol j j
led SubstancesActaddresses onlycontrolled substancesand theircategorization.oTheoKefauvoerHa
j j j j
rris DrugAmendmentoensuresdrugefficacyand greaterdrugsafety.oDrug manufacturersareroequir
j j j
edto proveto theoFDAtheeffectivenessoftheirproducts beforemarketingthem.
j j j
DIF: CognitiveLevel:Knowledge
REF:op.o5Tablel.3oOBJ:o5
NAT:NCLEX Client NeedsCategory:PhysiologicalIntegrityoT j j
oOP:oNursingoProcessoStep:oAssessment
CON:oSafety|PatientoEducation|Evidence|HealthCare Law j
7. Whichclassificationdoesmeperidine(Demerol) fallunder? j
a. I
b. II
c. III
d. IV
ANS:oB
Meperidine (Demerol)oisaoScheduleoII drug;oit has ahighpotentialforabuseandmaylead tosevereop
j j j j j
sychologicalandphysicaldependence.ScheduleI drugshavehighpotential forabuseand norecoogniz j j j
ed medicaluse.oScheduleoIII drugs havesomeopotentialforabuse.oUsemayleadto lowtomodeoratep
j j j j
hysicaldependenceorhighpsychologicaldependence.oScheduleoIVodrugshavelowpotentialoforab
use.oUse mayleadtolimitedphysicalorpsychologicaldependence.
j
DIF:o o CognitiveoLevel:oKnowledge REF:op.o10
OBJ:2 NAT:oNCLEX Client NeedsCategory:oSafe,oEffectiveCare Eon
j j j j
vironment
TOP:o Nursing ProcessStep:Assessmento o o CON:oPatientoEducation|Addiction|Pain
j
8. WhichactionwouldtheFDAtaketoexpeditedrug developmentoandapprovalforan outbreak ofosmoa j j j
llpox?
a. Listsmallpoxas a health orphan disease. j j j j
b. Omitthepreclinicalresearchphase.
c. Extend the clinicalresearchphase.
j j
d. Fasttrack the investigationaldrug. j j
ANS:oD
Once theoInvestigationaloNewoDrug Applicationhasbeenapproved,othe drugcan receivehighestpor
j j j j
ioritywithintheagency,owhichiscalledfasttracking.oAsmallpoxoutbreakwouldbecomeapriorio ty
concernintheworld.oOrphandiseases arenotresearchedinaprioritymanner.oPreclinicalresearo ch iso j j
notomitted.oExtendinganyphase oftheresearchwould meanalongertimetodevelopavaccinoe.The j j
FDAmustensurethat allphasesofthepreclinicalandoclinical researchphasehavebeencomopleted in
j j j
a safemanner.
j
DIF: Cognitive Level:Knowledge j REF:o p.o7 OBJ:o5