Edition
By Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton
Complete
,Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz:
v v v v v v v v v
Clayton’s Basic Pharmacology for Nurses, 19th Edition
v v v v v v
MULTIPLEvCHOICE
1. WhichvnamevidentifiesvavdrugvlistedvbyvthevUSvFoodvandv
DrugvAdministrationv(FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS:v C
Thevofficialvnamevisvthev namevundervwhichvavdrugvisvlistedvby
vthevFDA.vThevbrandvname,vorvtrademark,visvthevnamevgivenvt
ovavdrugvbyvitsvmanufacturer.vThevnonproprietary,vorvgeneric,v
namevisvprovidedvbyvthevUnitedvStatesvAdoptedvNamesvCoun
cil.
DIF: CognitivevLevel:vKnowledge REF:v p.v9
OBJ:v1NAT:vNCLEXvClientvNeedsvCategory:vSafe,vEffectivevCarev
EnvironmentvTOP:v NursingvProcessvStep:vAssessment
CON:v
PatientvEducation
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.vNaturalvMedicinesvComprehensivevDatabasevcontains
evidence-
basedvinformationvonvherbalvmedicinesvandvherbalvcombinationvproducts;vitvdoesvnotvincludevinf
ormationvspecificvtovnutritionalvsupplements.vDrugvInteractionvFactsvcontainsvcomprehensivevi
nformationvonvdrugvinteractionvfacts;vitvdoesvnotvincludevnutritionalvsupplements.
DIF: CognitivevLevel:vKnowledge REF:v p.v4
OBJ:v3vNAT:v NCLEXvClientvNeedsvCategory:vPhysiologicalvInteg
rity
TOP:v NursingvProcessvStep:vAssessment CON:v Nutritionv|vPatientvEducation
3. Whichvdrugvreferencevcontainsvdrugvmonographsvthatvdescribevallvdrugsvinvavtherapeuticvclass?
a. DrugvFactsvandvComparisons
,TestvBankvForvClayton’svBasicvPharmacologyvforvNursesv19thvEdition 3
b. DrugvInteractionvFacts
c. HandbookvonvInjectablevDrugs
d. Martindale—ThevCompletevDrugvReference
ANS:v A
DrugvFactsvandvComparisonsvcontainsvdrugvmonographsvthatvdescribevallvdrugsvinvavth
erapeuticvclass.vMonographsvarevformattedvasvtablesvtovallowvcomparisonvofvsimilarvpro
ducts,vbrandvnames,vmanufacturers,vcostvindices,vandvavailablevdosagevformsvOnlinevve
rsionvisvavailable.
DIF: CognitivevLevel:vKnowledge REF:v p.v4vTablev1.2
OBJ:v v 3 NAT:v NCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrity
TOP:v NursingvProcessvStep:vAssessment CON:v Safetyv|vPatientvEducationv|vClinicalvJudgment
4. Whichvdrugvreferencevcontainsvmonographsvaboutvvirtuallyveveryvsingle-
entityvdrugvavailablevinvthevUnitedvStatesvandvdescribesvtherapeuticvusesvofvdrugs,vincludingvap
provedvandvunapprovedvuses?
a. Martindale:vThevCompletevDrugvReference
b. AHFSvDrugvInformation
c. DrugvReference
d. DrugvFactsvandvComparisons
ANS:v B
AHFSvDrugvInformationvcontainsvmonographsvaboutvvirtuallyveveryvsingle-
entityvdrugvavailablevinvthevUnitedvStatesvandvdescribesvtherapeuticvusesvofvdrugs,vincludingvappr
ovedvandvunapprovedvuses.
DIF: CognitivevLevel:vKnowledge REF:v p.v4vTablev1.2
OBJ:v v 3 NAT:v NCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrity
TOP:v NursingvProcessvStep:vPlanning CON:v Safetyv|vPatientvEducationv|vClinicalvJudgment
5. Whichvonlinevdrugvreferencevmakesvavailablevtovhealthcarevprovidersvandvthevpublicvavstand
ard,vcomprehensive,vup-to-datevlookvupvandvdownloadablevresourcevaboutvmedicines?
a. AmericanvDrugvIndex
b. AmericanvHospitalvFormulary
c. DailyMed
d. DrugvReference
ANS:v C
DailyMedvmakesvavailablevtovhealthcarevprovidersvandvthevpublicvavstandard,vcomprehensive,v
up-to-
datevlookvupvandvdownloadablevresourcevaboutvmedicines.vThevAmericanvDrugvIndexvisvnotvapp
ropriatevforvpatientvuse.vThevAmericanvHospitalvFormularyvisvnotvappropriatevforvpatientvuse.v
Thevdrugvreferencevisvnotvappropriatevforvpatientvuse.
DIF: CognitivevLevel:vKnowledge REF:v p.v3v|vp.v4
OBJ:v3vNAT:v NCLEXvClientvNeedsvCategory:vPhysiologicalvInteg
rity
TOP:v NursingvProcessvStep:vImplementation
CON:v Safetyv|vPatientvEducationv|vClinicalvJudgment
6. WhichvlegislationvauthorizesvthevFDAvtovdeterminevthevsafetyvofvavdrugvbeforevitsvmarketing?
a. FederalvFood,vDrug,vandvCosmeticvActv(1938)
b. DurhamvHumphreyvAmendmentv(1952)
, TestvBankvForvClayton’svBasicvPharmacologyvforvNursesv19thvEdition 4
c. ControlledvSubstancesvActv(1970)
d. KefauvervHarrisvDrugvAmendmentv(1962)
ANS:v A
ThevFederalvFood,vDrug,vandvCosmeticvActvofv1938vauthorizedvthevFDAvtovdeterminevthevsafet
yvofvallvdrugsvbeforevmarketing.vLatervamendmentsvandvactsvhelpedvtightenvFDAvcontrolvandven
surevdrugvsafety.vThevDurhamvHumphreyvAmendmentvdefinesvthevkindsvofvdrugsvthatvcannotvbe
vusedvsafelyvwithoutvmedicalvsupervisionvandvrestrictsvtheirvsalevtovprescriptionvbyvavlicensedvpr
actitioner.vThevControlledvSubstancesvActvaddressesvonlyvcontrolledvsubstancesvandvtheirvcatego
rization.vThevKefauvervHarrisvDrugvAmendmentvensuresvdrugvefficacyvandvgreatervdrugvsafety.v
DrugvmanufacturersvarevrequiredvtovprovevtovthevFDAvtheveffectivenessvofvtheirvproductsvbefore
vmarketingvthem.
DIF: CognitivevLevel:vKnowledge REF:v p.v5vTablevl.3
OBJ:v 5
NAT:vNCLEXvClientvNeedsvCategory:vPhysiologicalvIntegrityv
TOP:v NursingvProcessvStep:vAssessment
CON:v Safetyv|vPatientvEducationv|vEvidencev|vHealthvCarevLaw
7. Whichvclassificationvdoesvmeperidinev(Demerol)vfallvunder?
a. I
b. II
c. III
d. IV
ANS:v B
Meperidinev(Demerol)visvavSchedulevIIvdrug;vitvhasvavhighvpotentialvforvabusevandvmayvleadvtovse
verevpsychologicalvandvphysicalvdependence.vSchedulevIvdrugsvhavevhighvpotentialvforvabusevand
vnovrecognizedvmedicalvuse.vSchedulevIIIvdrugsvhavevsomevpotentialvforvabuse.vUsevmayvleadvtov
lowvtovmoderatevphysicalvdependencevorvhighvpsychologicalvdependence.vSchedulevIVvdrugsvha
vevlowvpotentialvforvabuse.vUsevmayvleadvtovlimitedvphysicalvorvpsychologicalvdependence.
DIF: CognitivevLevel:vKnowledge REF:v p.v10
OBJ:v2vNAT:v NCLEXvClientvNeedsvCategory:vSafe,vEffectivevCar
evEnvironment
TOP:v NursingvProcessvStep:vAssessment CON:v PatientvEducationv|vAddictionv|vPain
8. WhichvactionvwouldvthevFDAvtakevtovexpeditevdrugvdevelopmentvandvapprovalvforvanvoutbreakvo
fvsmallpox?
a. Listvsmallpoxvasvavhealthvorphanvdisease.
b. Omitvthevpreclinicalvresearchvphase.
c. Extendvthevclinicalvresearchvphase.
d. Fastvtrackvthevinvestigationalvdrug.
ANS:v D
OncevthevInvestigationalvNewvDrugvApplicationvhasvbeenvapproved,vthevdrugvcanvreceivevhigh
estvpriorityvwithinvthevagency,vwhichvisvcalledvfastvtracking.vAvsmallpoxvoutbreakvwouldvbeco
mevavpriorityvconcernvinvthevworld.vOrphanvdiseasesvarevnotvresearchedvinvavpriorityvmanner.vPr
eclinicalvresearchvisvnotvomitted.vExtendingvanyvphasevofvthevresearchvwouldvmeanvavlongervtim
evtovdevelopvavvaccine.vThevFDAvmustvensurevthatvallvphasesvofvthevpreclinicalvandvclinicalvresea
rchvphasevhavevbeenvcompletedvinvavsafevmanner.
DIF: CognitivevLevel:vKnowledge REF:v v p.v7 OBJ:v 5