v v v v v v v v v
MULTIPLEvCHOICE
1. WhatvisvthevnamevundervwhichvavdrugvisvlistedvbyvthevU.S.vFoodvandvDrugvAdministrationv(
FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS:v C
ThevofficialvnamevisvthevnamevundervwhichvavdrugvisvlistedvbyvthevFDA.vThevbrandvname,vorvtr
ademark,visvthevnamevgivenvtovavdrugvbyvitsvmanufacturer.vThevnonproprietary,vorvgeneric,vna
mevisvprovidedvbyvthevU.S.vAdoptedvNamesvCouncil.
DIF:vCognitivevLevel:vKnowledgevREF:vp.v1vOBJ:v2TOP:v NursingvPr
ocessvStep:vAssessment
MSC:v NCLEXvClientvNeedsvCategory:vSafe,vEffectivevCarevEnvironment
2. Whichvsourcevcontainsvinformationvspecificvtovnutritionalvsupplements?
a. USPvDictionaryvofvUSANv&vInternationalvDrugvNames
b. NaturalvMedicinesvComprehensivevDatabase
c. UnitedvStatesvPharmacopoeia/NationalvFormularyv(USPvNF)
d. DrugvInteractionvFacts
ANS:v C
UnitedvStatesvPharmacopoeia/NationalvFormularyvcontainsvinformationvspecificvtovnutritionalvs
upplements.vUSPvDictionaryvofvUSANv&vInternationalvDrugvNamesvisvavcompilationvofvdrugvna
mes,vpronunciationvguide,vandvpossiblevfuturevFDAvapprovedvdrugs;vitvdoesvnotvincludevnutritio
nalvsupplements.vNaturalvMedicinesvComprehensivevDatabasevcontainsvevidencevbasedvinforma
tionvonvherbalvmedicinesvandvherbalvcombinationvproducts;vitvdoesvnotvincludevinformationvspec
ificvtovnutritionalvsupplements.vDrugvInteractionvFactsvcontainsvcomprehensivevinformationvonv
drugvinteractionvfacts;vitvdoesvnotvincludevnutritionalvsupplements.
DIF:vCognitivevLevel:vKnowledgevREF:vp.v2vOBJ:v4TOP:v NursingvPr
ocessvStep:vAssessment
MSC:v NCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrity
3. Whatvisvthevmostvcomprehensivevreferencevavailablevtovresearchvavdrugvinteraction?
a. DrugvFactsvandvComparisons
b. DrugvInteractionvFacts
c. HandbookvonvInjectablevDrugs
d. Martindale—ThevCompletevDrugvReference
ANS:v B
Firstvpublishedvinv1983,vDrugvInteractionvFactsvisvthevmostvcomprehensivevbookvavailablevond
rugvinteractions.vInvadditionvtovmonographsvlistingvvariousvaspectsvofvdrugvinteractions,vthisvinf
ormationvisvreviewedvandvupdatedvbyvanvinternationallyvrenownedvgroupvofvphysiciansvandphar
macistsvwithvclinicalvandvscientificvexpertise.
DIF:vCognitivevLevel:vComprehensionvREF:vp.v3vOBJ:v3TOP:
, NursingvProcessvStep:vAssessment
MSC:v NCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrity
4. Thevphysicianvhasvwrittenvanvordervforvavdrugvwithvwhichvthevnursevisvunfamiliar.vWhichvsectio
nvofvthevPhysicians’vDeskvReferencev(PDR)visvmostvhelpfulvtovgetvinformationvaboutvthisvdrug?
a. Manufacturer’svsection
b. BrandvandvGenericvNamevsection
c. ProductvCategoryvsection
d. ProductvInformationvsection
vANS:vB
DIF:vCognitivevLevel:vComprehensionvREF:vp.v3vOBJ:v4TOP:
NursingvProcessvStep:vPlanning
MSC:v NCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrity
5. Whichvonlinevdrugvreferencevmakesvavailablevtovhealthvcarevprovidersvandvthevpublicvavstan
dard,vcomprehensive,vupvtovdatevlookvupvandvdownloadablevresourcevaboutvmedicines?
a. AmericanvDrugvIndex
b. AmericanvHospitalvFormulary
c. DailyMed
d. Physicians’vDeskvReferencev(PDR)
ANS:v C
DailyMedvmakesvavailablevtovhealthvcarevprovidersvandvthevpublicvavstandard,vcomprehensive,vu
pvtovdatevlookvupvandvdownloadablevresourcevaboutvmedicines.vThevAmericanvDrugvIndexvisvnotv
appropriatevforvpatientvuse.vThevAmericanvHospitalvFormularyvisvnotvappropriatevforvpatientvuse
.vThevPDRvisvnotvappropriatevforvpatientvuse.
DIF:vCognitivevLevel:vKnowledgevREF:vp.v4vOBJ:v5TOP:v NursingvPr
ocessvStep:vImplementation
MSC:v NCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrity
6. WhichvlegislationvauthorizesvthevFDAvtovdeterminevthevsafetyvofvavdrugvbeforevitsvmarketing?
a. FederalvFood,vDrug,vandvCosmeticvActv(1938)
b. DurhamvHumphreyvAmendmentv(1952)
c. ControlledvSubstancesvActv(1970)
d. KefauvervHarrisvDrugvAmendmentv(1962)
ANS:v A
ThevFederalvFood,vDrug,vandvCosmeticvActvofv1938vauthorizedvthevFDAvtovdeterminevthevsafety
vofvall vdrugsvbeforevmarketing.vLatervamendmentsvandvactsvhelpedvtightenvFDAvcontrolvandvensu
revdrugvsafety.vThevDurhamvHumphreyvAmendmentvdefinesvthevkindsvofvdrugsvthatvcannotvbevus
edvsafelyvwithoutvmedicalvsupervisionvandvrestrictsvtheirvsalevtovprescriptionvbyvavlicensedvpracti
tioner.vThevControlledvSubstancesvActvaddressesvonlyvcontrolledvsubstancesvandvtheirvcategoriza
tion.vThevKefauvervHarrisvDrugvAmendmentvensuresvdrugvefficacyvandvgreatervdrugvsafety.vDru
gvmanufacturersvarevrequiredvtovprovevtovthevFDAvtheveffectivenessvofvtheirvproductsvbeforevmar
ketingvthem.
DIF:vCognitivevLevel:vKnowledgevREF:vp.v4vOBJ:v8TOP:v NursingvPr
ocessvStep:vAssessment
MSC:v NCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrity
7. Meperidinev(Demerol)visvavnarcoticvwithvavhighvpotentialvforvphysicalvandvpsychological
, dependency.vUndervwhichvclassificationvdoesvthisvdrugvfall?
a. I
b. II
c. III
d. IV
ANS:v B
Meperidinev(Demerol)visvavSchedulevIIvdrug;vitvhasvavhighvpotentialvforvabusevandvmayvleadvtovse
verevpsychologicalvandvphysicalvdependence.vSchedulevIvdrugsvhavevhighvpotentialvforvabusevand
vnovrecognizedvmedical vuse.vSchedulevIIIvdrugsvhavevsomevpotentialvforvabuse.vUsevmayvlead vtovl
owvtovmoderatevphysicalvdependencevorvhighvpsychologicalvdependence.vSchedulevIVvdrugsvhav
evlowvpotentialvforvabuse.vUsevmayvleadvtovlimitedvphysicalvorvpsychologicalvdependence.
DIF:vCognitivevLevel:vComprehensionvREF:vp.v4v|vp.v5vOBJ:v7TOP:vN
ursingvProcessvStep:vAssessment
MSC:v NCLEXvClientvNeedsvCategory:vSafe,vEffectivevCarevEnvironment
8. WhatvwouldvthevFDAvdovtovexpeditevdrugvdevelopmentvandvapprovalvforvanvoutbreakvofvs
mallpox,vforvwhichvtherevisvnovknownvtreatment?
a. Listvsmallpoxvasvavhealthvorphanvdisease.
b. Omitvthevpreclinicalvresearchvphase.
c. Extendvthevclinicalvresearchvphase.
d. Fastvtrackvthevinvestigationalvdrug.
ANS:v D
OncevthevInvestigationalvNewvDrugvApplicationvhasvbeenvapproved,vthevdrugvcanvreceivevhighe
stvpriorityvwithinvthevagency,vwhichvisvcalledvfastvtracking.vAvsmallpoxvoutbreakvwouldvbecome
vavpriorityvconcernvinvthevworld.vOrphanvdiseasesvarevnotvresearchedvinvavpriorityvmanner.vPrecli
nicalvresearchvisvnotvomitted.vExtendingvanyvphasevofvthevresearchvwouldvmeanvavlongervtimevtov
developvavvaccine.vThevFDAvmustvensurevthatvallvphasesvofvthevpreclinicalvandvclinicalvresearchv
phasevhavevbeenvcompletedvinvavsafevmanner.
DIF:vCognitivevLevel:vKnowledgevREF:vp.v7vOBJ:v8TOP:v NursingvPr
ocessvStep:vAssessment
MSC:v NCLEXvClientvNeedsvCategory:vSafe,vEffectivevCarevEnvironment
9. Whichvstatementvisvtruevaboutvovervthevcounterv(OTC)vdrugs?
a. TheyvarevnotvlistedvinvthevUSPvNF.
b. Avprescriptionvfromvavhealthvcarevprovidervisvneeded.
c. Theyvarevsoldvwithoutvavprescription.
d. Theyvarevknownvonlyvbyvtheirvbrandvnames.
ANS:v C
OTCvmedicationsvdovnotvrequirevavprescription.vAvvarietyvofvnames,vbothvgenericvandvtrade,vcanv
bevusedvforvindividualvdrugsvsoldvOTC.vOTCvdrugsvarevlistedvinvthevUSPvNF.vPrescriptionvdrugsv
requirevanvordervbyvavhealthvprofessionalvwhovisvlicensedvtovprescribe,vsuchvasvavphysician,vnurse
vpractitioner,vphysician vassistant,vorvdentist.
DIF:vCognitivevLevel:vComprehensionvREF:vp.v2vOBJ:v2TOP:vNursin
gvProcessvStep:vPlanning
MSC:v NCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrity
10. Whichvisvthevmostvauthoritativevreferencevforvmedicationsvthatvarevinjected?