N N N N N N N N
BANK(Chapter 1-110). N
Chapter N3:NDrug NRegulation,NDevelopment,NNames,NandNInformation
NTest NBank
MULTIPLENCHOICE
1. A NnurseNeducatorNisNconductingNaNcontinuingNeducationNclassNonNpharmacology.NToNevaluat
eNtheNlearningNof NtheNnursesNinNtheNclass,NtheNnurseNeducatorNasks,N―WhichNdrugNnameNisN
aNgenericNdrugNname?‖ NWhichNisNtheNcorrect Nresponse?Na.NAcetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:NA
AcetaminophenNisNtheNgenericNname.NTylenol,NCipro,Nand NMotrinNareNallNtradeNnames.
DIF:NCognitiveNLevel:NComprehension REF:NTableN3-
3:NTheNThreeNTypesNof NDrugNNamesNTOP:NNursingNProcess:NDiagnosis
MSC:NNCLEXNClientNNeedsNCategory:NPhysiologic NIntegrity:NPharmacologic Nand NParenteralNTherapies
2. TheNFDA NAmendmentsNAct N(FDAAA)NwasNpassed NinN2007NtoNaddressNwhichNaspect Nof Ndr
ugNsafety?
a. AllowingNpharmaceuticalNcompaniesNtoNidentifyNoff-
labelNusesNof NmedicationsNapproved NforNotherNuses
b. EvaluatingNdrugNsafetyNinformationNthatNemergesNafterNaNdrugNhasNbeenNapproved NandN
isNinNuse
c. ExpeditingNtheNapprovalNprocessNof NtheNU.S.NFoodNandNDrugNAdministrationN(FDA)Ns
oNthat Nneeded NdrugsNcanNget NtoNmarket NmoreNquickly
d. RequiringNmanufacturersNtoNnotifyNpatientsNbeforeNremovingNaNdrugNfromNtheNmarket
ANS:NB
TheNFDAAA NwasNpassed NtoNenableNtheNFoodNand NDrugNAdministrationNtoNcontinueNoversight N
of NaNdrugNafterNgrantingNit NapprovalNsoNthat NchangesNinNlabelingNcould NbeNmadeNasNnecessaryNa
nd NpostmarketingNrisksNcould NbeNtracked Nand Nidentified.NANprovisionNof NtheNFDA NModernizati
onNAct N(FDAMA),Npassed NinN1997,NallowsNdrugNcompaniesNtoNpromoteNtheirNproductsNforNoff-
labelNusesNasNlongNasNtheyNpromiseNtoNconduct NstudiesNtoNsupport NtheirNclaims.NRegulationsNtoN
permit Naccelerated NapprovalNof NdrugsNforNlife-
threateningNdiseasesNwereNadopted NinN1992NbyNtheNFDA.NTheNrequirement Nthat NdrugNcompanie
sNnotifyNpatientsN6NmonthsNbeforeNremovingNaNdrugNfromNtheNmarket NisNaNprovisionNof NtheNFD
AMA.
DIF:NCognitiveNLevel:NComprehension
REF:NLandmark NDrugNLegislatio
n NTOP:NNursingNProcess:NEvaluation
MSC:NNCLEXNClientNNeedsNCategory:NPhysiologic NIntegrity:NPharmacologic Nand NParenteralNTherapies
,Test Bank Lehne's Pharmacology for Nursing Care, 11th Edit
N N N N N N N N
ion by Jacqueline Burchum, Laura Rosenthal Chapter 1-
N N N N N N N
112|Complete Guide A+
N N N
3. A NnursingNstudent NasksNaNnurseNabout NpharmaceuticalNresearchNand NwantsNtoNknow NtheNpurpo
seNof NrandomizationNinNdrugNtrials.NTheNnurseNexplainsNthat NrandomizationNisNused Nto:
a. ensureNthat NdifferencesNinNoutcomesNareNtheNresult Nof Ntreatment NandNnot NdifferencesNi
nNsubjects.
b. compareNtheNoutcomeNcaused NbyNtheNtreatment NtoNtheNoutcomeNcaused NbyNnoNtreatment.
,Lehne's Pharmacology for Nursing Care 10th Edition TEST
N N N N N N N N
BANK(Chapter 1-110). N
c. makeNsureNthat NresearchersNareNunawareNof NwhichNsubjectsNareNinNwhichNgroup.
d. prevent NsubjectsNfromNknowingNwhichNgroupNtheyNareNinNand Nprevent Npreconceptio
nNbias.
ANS:NA
RandomizationNhelpsNprevent NallocationNbias,NwhichNcanNoccurNwhenNresearchersNplaceNsubject
sNwithNdesired NcharacteristicsNinNtheNstudyNgroupNand NotherNsubjectsNinNtheNcontrolNgroupNsoNth
at NdifferencesNinNoutcomeNareNactuallyNtheNresult Nof NdifferencesNinNsubjectsNand Nnot Ntreatment.
ComparingNtreatment NoutcomeNtoNnoNtreatment NoutcomeNisNtheNdefinitionNofNaNcontrolled Nstudy
.NTheNlast NtwoNoptionsNdescribeNtheNuseNof NblindingNinNstudies;NblindingNensuresNthat Nresearche
rsNorNsubjectsN(orNboth)NareNunawareNof NwhichNsubjectsNareNinNwhichNgroupNsoNthat Npreconcepti
onsNabout NbenefitsNand NrisksNcannot NbiasNtheNresults.
DIF:NCognitiveNLevel:NComprehension
REF:NTheNRandomizedNDrugNTria
lNTOP:NNursingNProcess:NImplementation
MSC:NNCLEXNClientNNeedsNCategory:NPhysiologic NIntegrity:NPharmacologic Nand NParenteralNTherapies
4. SomeoneNasksNaNnurseNabout NaNnew NdrugNthat NisNinNpreclinicalNtestingNand NwantsNtoNknow Nwhy
Nit Ncannot NbeNused NtoNtreat NaNfriend‘sNillness.NWhichNstatement NbyNtheNnurseNisNcorrect?
a. ―A NdrugNat NthisNstageNof Ndevelopment NcanNbeNused NonlyNinNpatientsNwithNseriousNdisease.‖
b. ―At NthisNstageNof NdrugNdevelopment,NtheNsafetyNandNusefulnessNof NtheNmedicationN
isNunknown.‖
c. ―ClinicalNtrialsNmust NbeNcompleted NtoNmakeNsureNtheNdrugNisNsafeNtoNuseNinNhumans.‖
d. ―UntilNpostmarketingNsurveillanceNdataNareNavailable,NtheNdrugNcannot NbeNused.‖
ANS:NB
PreclinicalNtestingNmust NbeNcompleted NbeforeNdrugsNcanNbeNtested NinNhumans.NInNthisNstage,Nd
rugsNareNevaluated NforNtoxicities,NpharmacokineticNproperties,Nand NpotentiallyNusefulNeffects.N
SomeNdrugsNcanNbeNused NinNpatientsNbeforeNcompletionNof NPhaseNIIINstudies,Nbut NthisNisNafterN
preclinicalNtestingNisNcomplete.NClinicalNtrialsNproceed NinNstages,Nand NeachNstageNhasNguidelin
esNdefiningNhowNaNnew NdrugNmayNbeNused Nand NwhichNpatientsNmayNreceiveNit.NPostmarketing
NsurveillanceNtakesNplaceNafterNaNdrugNisNinNgeneralNuse.
DIF:NCognitive NLevel:NComprehension
REF:NLandmarkNDrugNLegislation N|NStagesNofNDrugNDevelopmentNT
OP:NNursingNProcess:NImplementation
MSC:NNCLEXNClientNNeedsNCategory:NPhysiologic NIntegrity:NReduction Nof NRisk NPotential
5. A Npatient NasksNaNnurseNwhyNdrugsNthat NhaveNbeenNapproved NbyNtheNFDA NstillNhaveNunkno
wnNsideNeffects.NTheNnurseNtellNtheNpatient Nthat:
a. testingNforNallNsideNeffectsNof NaNmedicationNwould NbeNprohibitivelyNexpensive.
b. patientsNinNdrugNtrialsNoftenNareNbiased NbyNtheirNpreconceptionsNof NaNdrug‘sNbenefits.
c. researchersNtend NtoNconduct NstudiesNthat NwillNproveNtheNbenefitsNof NtheirNnew Ndrugs.
d. subjectsNinNdrugNtrialsNdoNnot NalwaysNrepresent NtheNfullNspectrumNof NpossibleNpatients.
, Test Bank Lehne's Pharmacology for Nursing Care, 11th Edit
N N N N N N N N
ion by Jacqueline Burchum, Laura Rosenthal Chapter 1-
N N N N N N N
112|Complete Guide A+
N N N
ANS:ND
AllNdrugNtrialsNareNlimited NbyNaNrelativelyNsmallNgroupNof NsubjectsNwhoNmayNnot NhaveNallNtheNc
haracteristicsNof NpeopleNwhoNwillNbeNusingNtheNdrug;Ntherefore,NsomeNsideNeffectsNgoNundetect
ed NuntilNtheNdrugNisNinNuse.NAlthoughNdrugNtrialsNareNveryNexpensive,NthisNisNonlyNanNindirect Nr
easonNtheyNdoNnot Ndetect NallNsideNeffectsNbeforeNapproval.NInNtheory,Nwell-
designed NdrugNtrials,NusingNblinded Nstudies,NminimizeNorNeliminateNsubject Nbias.NDesigningNst
udiesNtoNproveNdesired NresultsNisNunethical.
DIF:NCognitiveNLevel:NAnalysis
REF:NFailureNto NDetectNAllNAdverseNEffect
sNTOP:NNursingNProcess:NImplementation
MSC:NNCLEXNClientNNeedsNCategory:NPhysiologic NIntegrity:NPharmacologic Nand NParenteralNTherapies
6. ANnurseNisNteachingNnursingNstudentsNabout NtheNuseNof NnonproprietaryNnamesNforNdrugs.NT
heNnurseNtellsNthemNwhichNfact Nabout NnonproprietaryNnames?
a. TheyNareNapproved NbyNtheNFDA Nand NareNeasyNtoNremember.
b. TheyNareNassigned NbyNtheNU.S.NAdopted NNamesNCouncil.
c. TheyNclearlyNidentifyNtheNdrug‘sNpharmacologicalNclassification.
d. TheyNimplyNtheNefficacyNof NtheNdrugNand NareNlessNcomplex.
ANS:NB
Nonproprietary,NorNgeneric,NnamesNareNassigned NbyNtheNU.S.NAdopted NNamesNCouncil,NwhichN
ensuresNthat NeachNdrugNhasNonlyNoneNname.NTradeNnames,NorNbrand Nnames,NareNapproved NbyNth
eNFDA Nand NareNeasierNtoNremember.NSomeNnonproprietaryNnamesNcontainNsyllablesNthat Nidenti
fyNtheNclassification,NalthoughNnot NallNdo.NDrugNnamesNareNnot Nsupposed NtoNidentifyNtheNuseNfo
rNtheNdrug,NalthoughNsomeNbrand NnamesNdoNso.
DIF:NCognitiveNLevel:NComprehensionN REF:NDrugNNames:NTheNThreeNTypesNofNDrugNNamesNTOP:NNu
rsingNProcess:NDiagnosis
MSC:NNCLEXNClientNNeedsNCategory:NPhysiologic NIntegrity:NReduction Nof NRisk NPotential
Chapter N1:NOrientationNtoNPharmacology N
TestNBank
MULTIPLENCHOICE
1. TheNnurseNisNteachingNaNpatient Nhow NaNmedicationNworksNtoNtreat NanNillness.NToNdoNthis,Nt
heNnurseNwillNrelyNonNknowledgeNof:Na.NclinicalNpharmacology.
b. drugNefficacy.
c. pharmacokinetics.
d. pharmacotherapeutics.
ANS:ND