Test Bank Lehne-s Pharmacology for Nursing Care- 10th 11th Edition by Jacqueline Burchum-

Lehne's Pharmacology for Nursing Care 10th Edition TEST B
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ANK(Chapter 1-110). f




Chapter 3: Drug Regulation, Development, Names, and Information T
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est Bank
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MULTIPLEfCHOICE

1. Afnursefeducatorfisfconductingfafcontinuingfeducationfclassfonfpharmacology.fTofevaluatefthef
learningfoffthefnursesfinfthefclass,fthefnursefeducatorfasks,f―Whichfdrugfnamefisfafgenericfdru
gfname?‖fWhichfisfthefcorrectfresponse?fa.fAcetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:fA
Acetaminophenfisfthefgenericfname.fTylenol,fCipro,fandfMotrinfarefallftradefnames.

DIF:fCognitivefLevel:fComprehension REF:fTablef3-
3:fThefThreefTypesfoffDrugfNamesfTOP:fNursingfProcess:fDiagnosis
MSC:fNCLEXfClientfNeedsfCategory:fPhysiologicfIntegrity:fPharmacologicfandfParenteralfTherapies

2. ThefFDAfAmendmentsfActf(FDAAA)fwasfpassedfinf2007ftofaddressfwhichfaspectfoffdrugfsafe
ty?
a. Allowingfpharmaceuticalfcompaniesftofidentifyfoff-
labelfusesfoffmedicationsfapprovedfforfotherfuses
b. Evaluatingfdrugfsafetyfinformationfthatfemergesfafterfafdrugfhasfbeenfapprovedfandfisfinfu
se
c. ExpeditingfthefapprovalfprocessfoffthefU.S.fFoodfandfDrugfAdministrationf(FDA)fsofthat
fneededfdrugsfcanf getftofmarketfmorefquickly

d. Requiringfmanufacturersftofnotifyfpatientsfbeforefremovingfafdrugffromfthefmarket
ANS:fB
ThefFDAAAfwasfpassedftofenablefthefFoodfandfDrugfAdministrationftofcontinuefoversightfoffafdr
ugfafterfgrantingfitfapprovalfsofthatfchangesfinflabelingfcouldfbefmadefasfnecessaryfandfpostmarke
tingfrisksfcouldfbeftrackedfandfidentified.fAfprovisionfoffthefFDAfModernizationfActf(FDAMA),f
passedfinf1997,fallowsfdrugfcompaniesftofpromoteftheirfproductsfforfoff-
labelfusesfasflongfasftheyfpromiseftofconductfstudiesftofsupportftheirfclaims.fRegulationsftofpermitf
acceleratedfapprovalfoffdrugsfforflife-
threateningfdiseasesfwerefadoptedfinf1992fbyfthefFDA.fThefrequirementfthatfdrugfcompaniesfnoti
fyfpatientsf6fmonthsfbeforefremovingfafdrugffromfthefmarketfisfafprovisionfoffthefFDAMA.

DIF:fCognitivefLevel:fComprehension
REF:fLandmarkfDrugfLegislationf
TOP:fNursingfProcess:fEvaluation
MSC:fNCLEXfClientfNeedsfCategory:fPhysiologicfIntegrity:fPharmacologicfandfParenteralfTherapies

,Test Bank Lehne's Pharmacology for Nursing Care, 11th Editio
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n by Jacqueline Burchum, Laura Rosenthal Chapter 1-
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112|Complete Guide A+
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3. Afnursingfstudentfasksfafnursefaboutfpharmaceuticalfresearchfandfwantsftofknowfthefpurposefoffra
ndomizationfinfdrugftrials.fThefnursefexplainsfthatfrandomizationfisfusedfto:
a. ensurefthatfdifferencesfinfoutcomesfarefthefresultfofftreatmentfandfnotfdifferencesfinfsubj
ects.
b. comparefthefoutcomefcausedfbyftheftreatmentftofthefoutcomefcausedfbyfnoftreatment.

,Lehne's Pharmacology for Nursing Care 10th Edition TEST B
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ANK(Chapter 1-110). f




c. makefsurefthatfresearchersfarefunawarefoffwhichfsubjectsfarefinfwhichfgroup.
d. preventfsubjectsffromfknowingfwhichfgroupftheyfarefinfandfpreventfpreconceptionfbia
s.
ANS:fA
Randomizationfhelpsfpreventfallocationfbias,fwhichfcanfoccurfwhenfresearchersfplacefsubjectsfwithf
desiredfcharacteristicsfinfthefstudyfgroupfandfotherfsubjectsfinfthefcontrolfgroupfsofthatfdifferencesfi
nfoutcomefarefactuallyfthefresultfoffdifferencesfinfsubjectsfandfnotftreatment.
Comparingftreatmentfoutcomeftofnoftreatmentfoutcomefisfthefdefinitionfoffafcontrolledfstudy.fThef
lastftwofoptionsfdescribefthefusefoffblindingfinfstudies;fblindingfensuresfthatfresearchersforfsubject
sf(orfboth)farefunawarefoffwhichfsubjectsfarefinfwhichfgroupfsofthatfpreconceptionsfaboutfbenefitsf
andfrisksfcannotfbiasfthefresults.

DIF:fCognitivefLevel:fComprehension
REF:fThefRandomizedfDrugfTrialf
TOP:fNursingfProcess:fImplementation
MSC:fNCLEXfClientfNeedsfCategory:fPhysiologicfIntegrity:fPharmacologicfandfParenteralfTherapies

4. Someonefasksfafnursefaboutfafnewfdrugfthatfisfinfpreclinicalftestingfandfwantsftofknowfwhyfitfcann
otfbefusedftoftreatfaffriend‘sfillness.fWhichfstatementfbyfthefnursefisfcorrect?
a. ―Afdrugfatfthisfstagefoffdevelopmentfcanfbefusedfonlyfinfpatientsfwithfseriousfdisease.‖
b. ―Atfthisfstagefoffdrugfdevelopment,fthefsafetyfandfusefulnessfoffthefmedicationfisfunk
nown.‖
c. ―Clinicalftrialsfmustfbefcompletedftofmakefsurefthefdrugfisfsafeftofusefinfhumans.‖
d. ―Untilfpostmarketingfsurveillancefdatafarefavailable,fthefdrugfcannotfbefused.‖
ANS:fB
Preclinicalftestingfmustfbefcompletedfbeforefdrugsfcanfbeftestedfinfhumans.fInfthisfstage,fdrugsfare
fevaluatedfforftoxicities,fpharmacokineticfproperties,fandfpotentiallyfusefulfeffects.fSomefdrugsfc

anfbefusedfinfpatientsfbeforefcompletionfoffPhasefIIIfstudies,fbutfthisfisfafterfpreclinicalftestingfisfc
omplete.fClinicalftrialsfproceedfinfstages,fandfeachfstagefhasfguidelinesfdefiningfhowfafnewfdrugfm
ayfbefusedfandfwhichfpatientsfmayfreceivefit.fPostmarketingfsurveillanceftakesfplacefafterfafdrugfi
sfinfgeneralfuse.

DIF:fCognitivefLevel:fComprehension
REF:fLandmarkfDrugfLegislationf|fStagesfoffDrugfDevelopmentfTOP:f
NursingfProcess:fImplementation
MSC:fNCLEXfClientfNeedsfCategory:fPhysiologicfIntegrity:fReductionfoffRiskfPotential

5. AfpatientfasksfafnursefwhyfdrugsfthatfhavefbeenfapprovedfbyfthefFDAfstillfhavefunknownfsidef
effects.fThefnurseftellfthefpatientfthat:
a. testingfforfallfsidefeffectsfoffafmedicationfwouldfbefprohibitivelyfexpensive.
b. patientsfinfdrugftrialsfoftenfarefbiasedfbyftheirfpreconceptionsfoffafdrug‘sfbenefits.
c. researchersftendftofconductfstudiesfthatfwillfprovefthefbenefitsfofftheirfnewfdrugs.
d. subjectsfinfdrugftrialsfdofnotfalwaysfrepresentftheffullfspectrumfoffpossiblefpatients.

, Test Bank Lehne's Pharmacology for Nursing Care, 11th Editio
f f f f f f f f



n by Jacqueline Burchum, Laura Rosenthal Chapter 1-
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112|Complete Guide A+ f f f




ANS:fD
Allfdrugftrialsfareflimitedfbyfafrelativelyfsmallfgroupfoffsubjectsfwhofmayfnotfhavefallfthefcharacter
isticsfoffpeoplefwhofwillfbefusingfthefdrug;ftherefore,fsomefsidefeffectsfgofundetectedfuntilfthefdru
gfisfinfuse.fAlthoughfdrugftrialsfarefveryfexpensive,fthisfisfonlyfanfindirectfreasonftheyfdofnotfdetectf
allfsidefeffectsfbeforefapproval.fInftheory,fwell-
designedfdrugftrials,fusingfblindedfstudies,fminimizeforfeliminatefsubjectfbias.fDesigningfstudiesft
ofprovefdesiredfresultsfisfunethical.

DIF:fCognitivefLevel:fAnalysis
REF:fFailureftofDetectfAllfAdversefEffectsfT
OP:fNursingfProcess:fImplementation
MSC:fNCLEXfClientfNeedsfCategory:fPhysiologicfIntegrity:fPharmacologicfandfParenteralfTherapies

6. Afnursefisfteachingfnursingfstudentsfaboutfthefusefoffnonproprietaryfnamesfforfdrugs.fThefnurs
eftellsfthemfwhichffactfaboutfnonproprietaryfnames?
a. TheyfarefapprovedfbyfthefFDAfandfarefeasyftofremember.
b. TheyfarefassignedfbyfthefU.S.fAdoptedfNamesfCouncil.
c. Theyfclearlyfidentifyfthefdrug‘sfpharmacologicalfclassification.
d. Theyfimplyfthefefficacyfoffthefdrugfandfareflessfcomplex.
ANS:fB
Nonproprietary,forfgeneric,fnamesfarefassignedfbyfthefU.S.fAdoptedfNamesfCouncil,fwhichfensur
esfthatfeachfdrugfhasfonlyfonefname.fTradefnames,forfbrandfnames,farefapprovedfbyfthefFDAfandfa
refeasierftofremember.fSomefnonproprietaryfnamesfcontainfsyllablesfthatfidentifyfthefclassificatio
n,falthoughfnotfallfdo.fDrugfnamesfarefnotfsupposedftofidentifyfthefusefforfthefdrug,falthoughfsomef
brandfnamesfdofso.

DIF:fCognitivefLevel:fComprehensionf REF:fDrugfNames:fThefThreefTypesfoffDrugfNamesfTOP:fNursingf
Process:fDiagnosis
MSC:fNCLEXfClientfNeedsfCategory:fPhysiologicfIntegrity:fReductionfoffRiskfPotential

Chapter 1: Orientation to Pharmacology T
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est Bank
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MULTIPLEfCHOICE

1. Thefnursefisfteachingfafpatientfhowfafmedicationfworksftoftreatfanfillness.fTofdofthis,fthefnurs
efwillfrelyfonfknowledgefof:fa.fclinicalfpharmacology.
b. drugfefficacy.
c. pharmacokinetics.
d. pharmacotherapeutics.
ANS:fD