p p p p p p p p p p
y Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton Complet
p p p p p p p p p
e
,Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz
p p p p p p p p
: Clayton’s Basic Pharmacology for Nurses, 19th Edition
p p p p p p p
MULTIPLEpCHOICE
1. WhichpnamepidentifiespapdrugplistedpbypthepUSpFoodpandp
DrugpAdministrationp(FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS:p C
Thepofficialpnamepispthep namepunderpwhichpapdrugpisplistedpby
pthepFDA.pThepbrandpname,porptrademark,pispthepnamepgivenpt
opapdrugpbypitspmanufacturer.pThepnonproprietary,porpgeneric,p
namepispprovidedpbypthepUnitedpStatespAdoptedpNamespCoun
cil.
DIF: CognitivepLevel:pKnowledge REF:p p.p9
OBJ:p1NAT:pNCLEXpClientpNeedspCategory:pSafe,pEffectivepCarep
EnvironmentpTOP:p NursingpProcesspStep:pAssessment
CON:p
PatientpEducation
2. Whichpsourcepcontainspinformationpspecificptopnutritionalpsupplements?
a. USPpDictionarypofpUSANp &pInternationalpDrugpNames
b. NaturalpMedicinespComprehensivepDatabase
c. UnitedpStatespPharmacopoeia/NationalpFormularyp(USPpNF)
d. DrugpInteractionpFacts
ANS:p C
UnitedpStatespPharmacopoeia/NationalpFormularypcontainspinformationpspecificptopnutritionalps
upplements.pUSPpDictionarypofpUSANp&pInternationalpDrugpNamespispapcompilationpofpdrugpna
mes,ppronunciationpguide,pandppossiblepfuturepFDApapprovedpdrugs;pitpdoespnotpincludepnutritio
nalpsupplements.pNaturalpMedicinespComprehensivepDatabasepcontains
evidence-
basedpinformationponpherbalpmedicinespandpherbalpcombinationpproducts;pitpdoespnotpincludepinf
ormationpspecificptopnutritionalpsupplements.pDrugpInteractionpFactspcontainspcomprehensivepi
nformationponpdrugpinteractionpfacts;pitpdoespnotpincludepnutritionalpsupplements.
DIF: CognitivepLevel:pKnowledge REF:p p.p4
OBJ:p3pNAT:p NCLEXpClientpNeedspCategory:pPhysiologicalpIntegr
ity
TOP:p NursingpProcesspStep:pAssessment CON:p Nutritionp|pPatientpEducation
3. Whichpdrugpreferencepcontainspdrugpmonographspthatpdescribepallpdrugspinpaptherapeuticpclass?
a. DrugpFactspandpComparisons
,TestpBankpForpClayton’spBasicpPharmacologypforpNursesp19thpEdition 3
b. DrugpInteractionpFacts
c. HandbookponpInjectablepDrugs
d. Martindale—ThepCompletepDrugpReference
ANS:p A
DrugpFactspandpComparisonspcontainspdrugpmonographspthatpdescribepallpdrugspinpapth
erapeuticpclass.pMonographsparepformattedpasptablesptopallowpcomparisonpofpsimilarpprod
ucts,pbrandpnames,pmanufacturers,pcostpindices,pandpavailablepdosagepformspOnlinepver
sionpispavailable.
DIF: CognitivepLevel:pKnowledge REF:p p.p4pTablep1.2
OBJ:ppp 3 NAT:p NCLEXpClientpNeedspCategory:pPhysiologicalpIntegrity
TOP:p NursingpProcesspStep:pAssessment CON:p Safetyp|pPatientpEducationp|pClinicalpJudgment
4. Whichpdrugpreferencepcontainsp monographspaboutp virtuallypeverypsingle-
entitypdrugpavailablepinpthepUnitedpStatespandpdescribesptherapeuticpusespofpdrugs,pincludingpap
provedpandpunapprovedpuses?
a. Martindale:pThepCompletepDrugpReference
b. AHFSpDrugpInformation
c. DrugpReference
d. DrugpFactspandpComparisons
ANS:p B
AHFSpDrugpInformationpcontainspmonographspaboutpvirtuallypeverypsingle-
entitypdrugpavailablepinpthepUnitedpStatespandpdescribesptherapeuticpusespofpdrugs,pincludingpappr
ovedpandpunapprovedpuses.
DIF: CognitivepLevel:pKnowledge REF:p p.p4pTablep1.2
OBJ:ppp 3 NAT:p NCLEXpClientpNeedspCategory:pPhysiologicalpIntegrity
TOP:p NursingpProcesspStep:pPlanning CON:p Safetyp|pPatientpEducationp|pClinicalpJudgment
5. Whichponlinepdrugpreferencepmakespavailableptophealthcarepproviderspandptheppublicpapstand
ard,pcomprehensive,pup-to-dateplookpuppandpdownloadablepresourcepaboutpmedicines?
a. AmericanpDrugpIndex
b. AmericanpHospitalpFormulary
c. DailyMed
d. DrugpReference
ANS:p C
DailyMedpmakespavailableptophealthcarepproviderspandptheppublicpapstandard,pcomprehensive,pu
p-to-
dateplookpuppandpdownloadablepresourcepaboutpmedicines.pThepAmericanpDrugpIndexpispnotpapp
ropriatepforppatientpuse.pThepAmericanpHospitalpFormularypispnotpappropriatepforppatientpuse.p
Thepdrugpreferencepispnotpappropriatepforppatientp use.
DIF: CognitivepLevel:pKnowledge REF:p p.p3p|pp.p4
OBJ:p3pNAT:p NCLEXpClientpNeedspCategory:pPhysiologicalpIntegr
ity
TOP:p NursingpProcesspStep:pImplementation
CON:p Safetyp|pPatientpEducationp|pClinicalpJudgment
6. WhichplegislationpauthorizespthepFDAptopdeterminepthepsafetypofpapdrugpbeforepitspmarketing?
a. FederalpFood,pDrug,pandpCosmeticpActp(1938)
b. DurhampHumphreypAmendmentp(1952)
, TestpBankpForpClayton’spBasicpPharmacologypforpNursesp19thpEdition 4
c. ControlledpSubstancespActp(1970)
d. KefauverpHarrispDrugpAmendmentp(1962)
ANS:p A
ThepFederalpFood,pDrug,pandpCosmeticpActpofp1938pauthorizedpthepFDAptopdeterminepthepsafet
ypofpallpdrugspbeforepmarketing.pLaterpamendmentspandpactsphelpedptightenpFDApcontrolpandpen
surepdrugpsafety.pThepDurhampHumphreypAmendmentpdefinespthepkindspofpdrugspthatpcannotpb
epusedpsafelypwithoutpmedicalpsupervisionpandprestrictsptheirpsaleptopprescriptionpbypaplicensedpp
ractitioner.pThepControlledpSubstancespActpaddressesponlypcontrolledpsubstancespandptheirpcateg
orization.pThepKefauverpHarrispDrugpAmendmentpensurespdrugpefficacypandpgreaterpdrugpsafety.
pDrugpmanufacturerspareprequiredptopproveptopthepFDApthepeffectivenesspofptheirpproductspbefor
epmarketingpthem.
DIF: CognitivepLevel:pKnowledge REF:pp.p 5pTablepl.3
OBJ:p 5
NAT:pNCLEXpClientpNeedspCategory:pPhysiologicalpIntegrityp
TOP:p NursingpProcesspStep:pAssessment
CON:p Safetyp|pPatientpEducationp|pEvidencep|pHealthpCarepLaw
7. Whichpclassificationpdoespmeperidinep(Demerol)pfallpunder?
a. I
b. II
c. III
d. IV
ANS:p B
Meperidinep(Demerol)pispapSchedulepIIpdrug;pitphaspaphighppotentialpforpabusepandpmaypleadptopse
vereppsychologicalpandpphysicalpdependence.pSchedulepIpdrugsphavephighppotentialpforpabusepand
pnoprecognizedpmedicalpuse.pSchedulepIIIpdrugsphavepsomeppotentialpforpabuse.pUsepmaypleadpto
plowptopmoderatepphysicalpdependenceporphighppsychologicalpdependence.pSchedulepIVpdrugsph
aveplowppotentialpforpabuse.pUsepmaypleadptoplimitedpphysicalporppsychologicalpdependence.
DIF: CognitivepLevel:pKnowledge REF:p p.p10
OBJ:p2pNAT:p NCLEXpClientpNeedspCategory:pSafe,pEffectivepCarep
Environment
TOP:p NursingpProcesspStep:pAssessment CON:p PatientpEducationp|pAddictionp|pPain
8. WhichpactionpwouldpthepFDAptakeptopexpeditepdrugpdevelopmentp andpapprovalpforpanpoutbreakpo
fpsmallpox?
a. Listpsmallpoxpaspaphealthporphanpdisease.
b. Omitptheppreclinicalpresearchpphase.
c. Extendpthepclinicalpresearchpphase.
d. Fastptrackpthepinvestigationalpdrug.
ANS:p D
OncepthepInvestigationalpNewpDrugpApplicationphaspbeenpapproved,pthepdrugpcanpreceivephighe
stpprioritypwithinpthepagency,pwhichpispcalledpfastptracking.pApsmallpoxpoutbreakpwouldpbecome
papprioritypconcernpinpthepworld.pOrphanpdiseasesparepnotpresearchedpinpapprioritypmanner.pPrecli
nicalpresearchpispnotpomitted.pExtendingpanypphasepofpthepresearchpwouldpmeanpaplongerptimeptop
developpapvaccine.pThepFDApmustpensurepthatpallpphasespofptheppreclinicalpandpclinicalpresearchpp
hasephavepbeenpcompletedpinpapsafepmanner.
DIF: CognitivepLevel:pKnowledge REF:pppp.p7 OBJ:p 5