n
, Chapter 1: Drug Definitions, Standards, and Information SourcesTest Bank
n n n n n n n n
MULTIPLEnCHOICE
1. nWhatnisnthennamenundernwhichnandrugnisnlistednbynthenU.S.nFoodnandnDrugnAdministrationn(
FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS:n C
ThenofficialnnamenisnthennamenundernwhichnandrugnisnlistednbynthenFDA.nThenbrandnname,norntr
ademark,nisnthennamengivenntonandrugnbynitsnmanufacturer.nThennonproprietary,norngeneric,nna
menisnprovidednbynthenU.S.nAdoptednNamesnCouncil.
DIF:nCognitivenLevel:nKnowledgenREF:np.n1nOBJ:n2TOP:n NursingnPr
ocessnStep:nAssessment
MSC:n NCLEXnClientnNeedsnCategory:nSafe,nEffectivenCarenEnvironment
2. Whichnsourcencontainsninformationnspecificntonnutritionalnsupplements?
a. USPnDictionarynofnUSANn&nInternationalnDrugnNames
b. NaturalnMedicinesnComprehensivenDatabase
c. UnitednStatesnPharmacopoeia/NationalnFormularyn(USPnNF)
d. DrugnInteractionnFacts
ANS:n C
UnitednStatesnPharmacopoeia/NationalnFormularyncontainsninformationnspecificntonnutritionaln
supplements.nUSPnDictionarynofnUSANn&nInternationalnDrugnNamesnisnancompilationnofndrugnn
ames,npronunciationnguide,nandnpossiblenfuturenFDAnapprovedndrugs;nitndoesnnotnincludennutriti
onalnsupplements.nNaturalnMedicinesnComprehensivenDatabasencontainsnevidencenbasedninform
ationnonnherbalnmedicinesnandnherbalncombinationnproducts;nitndoesnnotnincludeninformationnspe
cificntonnutritionalnsupplements.nDrugnInteractionnFactsncontainsncomprehensiveninformationno
nndrugninteractionnfacts;nitndoesnnotnincludennutritionalnsupplements.
DIF:nCognitivenLevel:nKnowledgenREF:np.n2nOBJ:n4TOP:n NursingnPr
ocessnStep:nAssessment
MSC:n NCLEXnClientnNeedsnCategory:nPhysiologicalnIntegrity
3. Whatnisnthenmostncomprehensivenreferencenavailablentonresearchnandrugninteraction?
a. DrugnFactsnandnComparisons
b. DrugnInteractionnFacts
c. HandbooknonnInjectablenDrugs
d. Martindale—ThenCompletenDrugnReference
ANS:n B
Firstnpublishedninn1983,nDrugnInteractionnFactsnisnthenmostncomprehensivenbooknavailablenond
rugninteractions.nInnadditionntonmonographsnlistingnvariousnaspectsnofndrugninteractions,nthisninf
ormationnisnreviewednandnupdatednbynanninternationallynrenownedngroupnofnphysiciansnandphar
macistsnwithnclinicalnandnscientificnexpertise.
DIF:nCognitivenLevel:nComprehensionnREF:np.n3nOBJ:n3TOP:
, NursingnProcessnStep:nAssessment
MSC:n NCLEXnClientnNeedsnCategory:nPhysiologicalnIntegrity
4. Thenphysiciannhasnwrittennannordernfornandrugnwithnwhichnthennursenisnunfamiliar.nWhichnsectio
nnofnthenPhysicians’nDesknReferencen(PDR)nisnmostnhelpfulntongetninformationnaboutnthisndrug?
a. Manufacturer’snsection
b. BrandnandnGenericnNamensection
c. ProductnCategorynsection
d. ProductnInformationnsection
n ANS:nB
DIF:nCognitivenLevel:nComprehensionnREF:np.n3nOBJ:n4TOP:
NursingnProcessnStep:nPlanning
MSC:n NCLEXnClientnNeedsnCategory:nPhysiologicalnIntegrity
5. Whichnonlinendrugnreferencenmakesnavailablentonhealthncarenprovidersnandnthenpublicnanstan
dard,ncomprehensive,nupntondatenlooknupnandndownloadablenresourcenaboutnmedicines?
a. AmericannDrugnIndex
b. AmericannHospitalnFormulary
c. DailyMed
d. Physicians’nDesknReferencen(PDR)
ANS:n C
DailyMednmakesnavailablentonhealthncarenprovidersnandnthenpublicnanstandard,ncomprehensive,nu
pntondatenlooknupnandndownloadablenresourcenaboutnmedicines.nThenAmericannDrugnIndexnisnnot
nappropriatenfornpatientnuse.nThenAmericannHospitalnFormularynisnnotnappropriatenfornpatientnus
e.nThenPDRnisnnotnappropriatenfornpatientnuse.
DIF:nCognitivenLevel:nKnowledgenREF:np.n4nOBJ:n5TOP:n NursingnPr
ocessnStep:nImplementation
MSC:n NCLEXnClientnNeedsnCategory:nPhysiologicalnIntegrity
6. WhichnlegislationnauthorizesnthenFDAntondeterminenthensafetynofnandrugnbeforenitsnmarketing?
a. FederalnFood,nDrug,nandnCosmeticnActn(1938)
b. DurhamnHumphreynAmendmentn(1952)
c. ControllednSubstancesnActn(1970)
d. KefauvernHarrisnDrugnAmendmentn(1962)
ANS:n A
ThenFederalnFood,nDrug,nandnCosmeticnActnofn1938nauthorizednthenFDAntondeterminenthensafetyn
ofnallndrugsnbeforenmarketing.nLaternamendmentsnandnactsnhelpedntightennFDAncontrolnandnensur
endrugnsafety.nThenDurhamnHumphreynAmendmentndefinesnthenkindsnofndrugsnthatncannotnbenuse
dnsafelynwithoutnmedicalnsupervisionnandnrestrictsntheirnsalentonprescriptionnbynanlicensednpractiti
oner.nThenControllednSubstancesnActnaddressesnonlyncontrollednsubstancesnandntheirncategorizati
on.nThenKefauvernHarrisnDrugnAmendmentnensuresndrugnefficacynandngreaterndrugnsafety.nDrugn
manufacturersnarenrequiredntonproventonthenFDAntheneffectivenessnofntheirnproductsnbeforenmarke
tingnthem.
DIF:nCognitivenLevel:nKnowledgenREF:np.n4nOBJ:n8TOP:n NursingnPr
ocessnStep:nAssessment
MSC:n NCLEXnClientnNeedsnCategory:nPhysiologicalnIntegrity
7. Meperidinen(Demerol)nisnannarcoticnwithnanhighnpotentialnfornphysicalnandnpsychological
, dependency.nUndernwhichnclassificationndoesnthisndrugnfall?
a. I
b. II
c. III
d. IV
ANS:n B
Meperidinen(Demerol)nisnanSchedulenIIndrug;nitnhasnanhighnpotentialnfornabusenandnmaynleadntonse
verenpsychologicalnandnphysicalndependence.nSchedulenIndrugsnhavenhighnpotentialnfornabusenandn
nonrecognizednmedicalnuse.nSchedulenIIIndrugsnhavensomenpotentialnfornabuse.nUsenmaynleadntonl
owntonmoderatenphysicalndependencenornhighnpsychologicalndependence.nSchedulenIVndrugsnhav
enlownpotentialnfornabuse.nUsenmaynleadntonlimitednphysicalnornpsychologicalndependence.
DIF:nCognitivenLevel:nComprehensionnREF:np.n4n|np.n5nOBJ:n7TOP:nN
ursingnProcessnStep:nAssessment
MSC:n NCLEXnClientnNeedsnCategory:nSafe,nEffectivenCarenEnvironment
8. WhatnwouldnthenFDAndontonexpeditendrugndevelopmentnandnapprovalnfornannoutbreaknofns
mallpox,nfornwhichntherenisnnonknownntreatment?
a. Listnsmallpoxnasnanhealthnorphanndisease.
b. Omitnthenpreclinicalnresearchnphase.
c. Extendnthenclinicalnresearchnphase.
d. Fastntrackntheninvestigationalndrug.
ANS:n D
OncenthenInvestigationalnNewnDrugnApplicationnhasnbeennapproved,nthendrugncannreceivenhighe
stnprioritynwithinnthenagency,nwhichnisncallednfastntracking.nAnsmallpoxnoutbreaknwouldnbecome
nanprioritynconcernninnthenworld.nOrphanndiseasesnarennotnresearchedninnanprioritynmanner.nPrecli
nicalnresearchnisnnotnomitted.nExtendingnanynphasenofnthenresearchnwouldnmeannanlongerntimenton
developnanvaccine.nThenFDAnmustnensurenthatnallnphasesnofnthenpreclinicalnandnclinicalnresearchn
phasenhavenbeenncompletedninnansafenmanner.
DIF:nCognitivenLevel:nKnowledgenREF:np.n7nOBJ:n8TOP:n NursingnPr
ocessnStep:nAssessment
MSC:n NCLEXnClientnNeedsnCategory:nSafe,nEffectivenCarenEnvironment
9. Whichnstatementnisntruenaboutnovernthencountern(OTC)ndrugs?
a. TheynarennotnlistedninnthenUSPnNF.
b. Anprescriptionnfromnanhealthncarenprovidernisnneeded.
c. Theynarensoldnwithoutnanprescription.
d. Theynarenknownnonlynbyntheirnbrandnnames.
ANS:n C
OTCnmedicationsndonnotnrequirenanprescription.nAnvarietynofnnames,nbothngenericnandntrade,ncan
nbenusednfornindividualndrugsnsoldnOTC.nOTCndrugsnarenlistedninnthenUSPnNF.nPrescriptionndrug
snrequirenannordernbynanhealthnprofessionalnwhonisnlicensedntonprescribe,nsuchnasnanphysician,nnur
senpractitioner,nphysiciannassistant,norndentist.
DIF:nCognitivenLevel:nComprehensionnREF:np.n2nOBJ:n2TOP:nNursin
gnProcessnStep:nPlanning
MSC:n NCLEXnClientnNeedsnCategory:nPhysiologicalnIntegrity
10. Whichnisnthenmostnauthoritativenreferencenfornmedicationsnthatnareninjected?