h h h h h h h h h h
y Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton Complet
h h h h h h h h h
e
,Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz
h h h h h h h h
: Clayton’s Basic Pharmacology for Nurses, 19th Edition
h h h h h h h
MULTIPLEhCHOICE
1. WhichhnamehidentifieshahdrughlistedhbyhthehUShFoodhandh
DrughAdministrationh(FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS:h C
Thehofficialhnamehishtheh namehunderhwhichhahdrughishlistedhby
hthehFDA.hThehbrandhname,horhtrademark,hishthehnamehgivenht
ohahdrughbyhitshmanufacturer.hThehnonproprietary,horhgeneric,h
namehishprovidedhbyhthehUnitedhStateshAdoptedhNameshCoun
cil.
DIF: CognitivehLevel:hKnowledge REF:h p.h9
OBJ:h1NAT:hNCLEXhClienthNeedshCategory:hSafe,hEffectivehCareh
EnvironmenthTOP:h NursinghProcesshStep:hAssessment
CON:h
PatienthEducation
2. Whichhsourcehcontainshinformationhspecifichtohnutritionalhsupplements?
a. USPhDictionaryhofhUSANh&hInternationalhDrughNames
b. NaturalhMedicineshComprehensivehDatabase
c. UnitedhStateshPharmacopoeia/NationalhFormularyh(USPhNF)
d. DrughInteractionhFacts
ANS:h C
UnitedhStateshPharmacopoeia/NationalhFormularyhcontainshinformationhspecifichtohnutritionalh
supplements.hUSPhDictionaryhofhUSANh&hInternationalhDrughNameshishahcompilationhofhdrughn
ames,hpronunciationhguide,handhpossiblehfuturehFDAhapprovedhdrugs;hithdoeshnothincludehnutriti
onalhsupplements.hNaturalhMedicineshComprehensivehDatabasehcontains
evidence-
basedhinformationhonhherbalhmedicineshandhherbalhcombinationhproducts;hithdoeshnothincludehinf
ormationhspecifichtohnutritionalhsupplements.hDrughInteractionhFactshcontainshcomprehensivehi
nformationhonhdrughinteractionhfacts;hithdoeshnothincludehnutritionalhsupplements.
DIF: CognitivehLevel:hKnowledge REF:h p.h4
OBJ:h3hNAT:h NCLEXhClienthNeedshCategory:hPhysiologicalhInteg
rity
TOP:h NursinghProcesshStep:hAssessment CON:h Nutritionh|hPatienthEducation
3. Whichhdrughreferencehcontainshdrughmonographshthathdescribehallhdrugshinhahtherapeutichclass?
a. DrughFactshandhComparisons
,TesthBankhForhClayton’shBasichPharmacologyhforhNursesh19thhEdition 3
b. DrughInteractionhFacts
c. HandbookhonhInjectablehDrugs
d. Martindale—ThehCompletehDrughReference
ANS:h A
DrughFactshandhComparisonshcontainshdrughmonographshthathdescribehallhdrugshinhahth
erapeutichclass.hMonographsharehformattedhashtableshtohallowhcomparisonhofhsimilarhpro
ducts,hbrandhnames,hmanufacturers,hcosthindices,handhavailablehdosagehformshOnlinehve
rsionhishavailable.
DIF: CognitivehLevel:hKnowledge REF:h p.h 4hTableh1.2
OBJ:h h 3 NAT:h NCLEXhClienthNeedshCategory:hPhysiologicalhIntegrity
TOP:h NursinghProcesshStep:hAssessment CON:h Safetyh|hPatienthEducationh|hClinicalhJudgment
4. Whichhdrughreferencehcontainshmonographshabouthvirtuallyheveryhsingle-
entityhdrughavailablehinhthehUnitedhStateshandhdescribeshtherapeutichuseshofhdrugs,hincludinghap
provedhandhunapprovedhuses?
a. Martindale:hThehCompletehDrughReference
b. AHFShDrughInformation
c. DrughReference
d. DrughFactshandhComparisons
ANS:h B
AHFShDrughInformationhcontainshmonographshabouthvirtuallyheveryhsingle-
entityhdrughavailablehinhthehUnitedhStateshandhdescribeshtherapeutichuseshofhdrugs,hincludinghappr
ovedhandhunapprovedhuses.
DIF: CognitivehLevel:hKnowledge REF:h p.h 4hTableh1.2
OBJ:h h 3 NAT:h NCLEXhClienthNeedshCategory:hPhysiologicalhIntegrity
TOP:h NursinghProcesshStep:hPlanning CON:h Safetyh|hPatienthEducationh|hClinicalhJudgment
5. Whichhonlinehdrughreferencehmakeshavailablehtohhealthcarehprovidershandhthehpublichahstand
ard,hcomprehensive,hup-to-datehlookhuphandhdownloadablehresourcehabouthmedicines?
a. AmericanhDrughIndex
b. AmericanhHospitalhFormulary
c. DailyMed
d. DrughReference
ANS:h C
DailyMedhmakeshavailablehtohhealthcarehprovidershandhthehpublichahstandard,hcomprehensive,h
up-to-
datehlookhuphandhdownloadablehresourcehabouthmedicines.hThehAmericanhDrughIndexhishnothapp
ropriatehforhpatienthuse.hThehAmericanhHospitalhFormularyhishnothappropriatehforhpatienthuse.h
Thehdrughreferencehishnothappropriatehforhpatienthuse.
DIF: CognitivehLevel:hKnowledge REF:h p.h3h|hp.h4
OBJ:h3hNAT:h NCLEXhClienthNeedshCategory:hPhysiologicalhInteg
rity
TOP:h NursinghProcesshStep:hImplementation
CON:h Safetyh|hPatienthEducationh|hClinicalhJudgment
6. WhichhlegislationhauthorizeshthehFDAhtohdeterminehthehsafetyhofhahdrughbeforehitshmarketing?
a. FederalhFood,hDrug,handhCosmetichActh(1938)
b. DurhamhHumphreyhAmendmenth(1952)
, TesthBankhForhClayton’shBasichPharmacologyhforhNursesh19thhEdition 4
c. ControlledhSubstanceshActh(1970)
d. KefauverhHarrishDrughAmendmenth(1962)
ANS:h A
ThehFederalhFood,hDrug,handhCosmetichActhofh1938hauthorizedhthehFDAhtohdeterminehthehsafet
yhofhallhdrugshbeforehmarketing.hLaterhamendmentshandhactshhelpedhtightenhFDAhcontrolhandhen
surehdrughsafety.hThehDurhamhHumphreyhAmendmenthdefineshthehkindshofhdrugshthathcannothbe
husedhsafelyhwithouthmedicalhsupervisionhandhrestrictshtheirhsalehtohprescriptionhbyhahlicensedhpr
actitioner.hThehControlledhSubstanceshActhaddresseshonlyhcontrolledhsubstanceshandhtheirhcatego
rization.hThehKefauverhHarrishDrughAmendmenthensureshdrughefficacyhandhgreaterhdrughsafety.h
DrughmanufacturersharehrequiredhtohprovehtohthehFDAhtheheffectivenesshofhtheirhproductshbefore
hmarketinghthem.
DIF: CognitivehLevel:hKnowledge REF:h p.h 5hTablehl.3
OBJ:h 5
NAT:hNCLEXhClienthNeedshCategory:hPhysiologicalhIntegrityh
TOP:h NursinghProcesshStep:hAssessment
CON:h Safetyh|hPatienthEducationh|hEvidenceh|hHealthhCarehLaw
7. Whichhclassificationhdoeshmeperidineh(Demerol)hfallhunder?
a. I
b. II
c. III
d. IV
ANS:h B
Meperidineh(Demerol)hishahSchedulehIIhdrug;hithhashahhighhpotentialhforhabusehandhmayhleadhtohse
verehpsychologicalhandhphysicalhdependence.hSchedulehIhdrugshhavehhighhpotentialhforhabusehand
hnohrecognizedhmedicalhuse.hSchedulehIIIhdrugshhavehsomehpotentialhforhabuse.hUsehmayhleadhtoh
lowhtohmoderatehphysicalhdependencehorhhighhpsychologicalhdependence.hSchedulehIVhdrugshha
vehlowhpotentialhforhabuse.hUsehmayhleadhtohlimitedhphysicalhorhpsychologicalhdependence.
DIF: CognitivehLevel:hKnowledge REF:h p.h10
OBJ:h2hNAT:h NCLEXhClienthNeedshCategory:hSafe,hEffectivehCar
ehEnvironment
TOP:h NursinghProcesshStep:hAssessment CON:h PatienthEducationh|hAddictionh|hPain
8. WhichhactionhwouldhthehFDAhtakehtohexpeditehdrughdevelopmenthandhapprovalhforhanhoutbreakho
fhsmallpox?
a. Listhsmallpoxhashahhealthhorphanhdisease.
b. Omiththehpreclinicalhresearchhphase.
c. Extendhthehclinicalhresearchhphase.
d. Fasthtrackhthehinvestigationalhdrug.
ANS:h D
OncehthehInvestigationalhNewhDrughApplicationhhashbeenhapproved,hthehdrughcanhreceivehhigh
esthpriorityhwithinhthehagency,hwhichhishcalledhfasthtracking.hAhsmallpoxhoutbreakhwouldhbeco
mehahpriorityhconcernhinhthehworld.hOrphanhdiseasesharehnothresearchedhinhahpriorityhmanner.hPr
eclinicalhresearchhishnothomitted.hExtendinghanyhphasehofhthehresearchhwouldhmeanhahlongerhtim
ehtohdevelophahvaccine.hThehFDAhmusthensurehthathallhphaseshofhthehpreclinicalhandhclinicalhresea
rchhphasehhavehbeenhcompletedhinhahsafehmanner.
DIF: CognitivehLevel:hKnowledge REF:h h p.h7 OBJ:h 5