b b b b b b b b
ANK(Chapter 1-110). b
Chapter 3: Drug Regulation, Development, Names, and Information
b b b b b b b b
Test Bank
b
MULTIPLEbCHOICE
1. Abnursebeducatorbisbconductingbabcontinuingbeducationbclassbonbpharmacology.bTobevaluatebt
heblearningbofbthebnursesbinbthebclass,bthebnursebeducatorbasks,b―Whichbdrugbnamebisbabgener
icbdrugbname?‖bWhichbisbthebcorrectbresponse?ba.bAcetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:bA
Acetaminophenbisbthebgenericbname.bTylenol,bCipro,bandbMotrinbareballbtradebnames.
DIF:bCognitivebLevel:bComprehension REF:bTableb3-
3:bThebThreebTypesbofbDrugbNamesbTOP:bNursingbProcess:bDiagnosis
MSC:bNCLEXbClientbNeedsbCategory:bPhysiologicbIntegrity:bPharmacologicbandbParenteralbTherapies
2. ThebFDAbAmendmentsbActb(FDAAA)bwasbpassedbinb2007btobaddressbwhichbaspectbofbdrugbs
afety?
a. Allowingbpharmaceuticalbcompaniesbtobidentifyboff-
labelbusesbofbmedicationsbapprovedbforbotherbuses
b. Evaluatingbdrugbsafetybinformationbthatbemergesbafterbabdrugbhasbbeenbapprovedbandbisbi
nbuse
c. ExpeditingbthebapprovalbprocessbofbthebU.S.bFoodbandbDrugbAdministrationb(FDA)bsobt
hatbneededbdrugsbcanbgetbtobmarketbmorebquickly
d. Requiringbmanufacturersbtobnotifybpatientsbbeforebremovingbabdrugbfrombthebmarket
ANS:bB
ThebFDAAAbwasbpassedbtobenablebthebFoodbandbDrugbAdministrationbtobcontinueboversightbofbab
drugbafterbgrantingbitbapprovalbsobthatbchangesbinblabelingbcouldbbebmadebasbnecessarybandbpost
marketingbrisksbcouldbbebtrackedbandbidentified.bAbprovisionbofbthebFDAbModernizationbActb(F
DAMA),bpassedbinb1997,ballowsbdrugbcompaniesbtobpromotebtheirbproductsbforboff-
labelbusesbasblongbasbtheybpromisebtobconductbstudiesbtobsupportbtheirbclaims.bRegulationsbtobper
mitbacceleratedbapprovalbofbdrugsbforblife-
threateningbdiseasesbwerebadoptedbinb1992bbybthebFDA.bThebrequirementbthatbdrugbcompaniesbn
otifybpatientsb6bmonthsbbeforebremovingbabdrugbfrombthebmarketbisbabprovisionbofbthebFDAMA.
DIF:bCognitivebLevel:bComprehension
REF:bLandmarkbDrugbLegislationb
TOP:bNursingbProcess:bEvaluation
MSC:bNCLEXbClientbNeedsbCategory:bPhysiologicbIntegrity:bPharmacologicbandbParenteralbTherapies
,Test Bank Lehne's Pharmacology for Nursing Care, 11th Editi
b b b b b b b b
on by Jacqueline Burchum, Laura Rosenthal Chapter 1-
b b b b b b b
112|Complete Guide A+
b b b
3. Abnursingbstudentbasksbabnursebaboutbpharmaceuticalbresearchbandbwantsbtobknowbthebpurposebo
fbrandomizationbinbdrugbtrials.bThebnursebexplainsbthatbrandomizationbisbusedbto:
a. ensurebthatbdifferencesbinboutcomesbarebthebresultbofbtreatmentbandbnotbdifferencesbinbs
ubjects.
b. comparebtheboutcomebcausedbbybthebtreatmentbtobtheboutcomebcausedbbybnobtreatment.
,Lehne's Pharmacology for Nursing Care 10th Edition TESTB
b b b b b b b b
ANK(Chapter 1-110). b
c. makebsurebthatbresearchersbarebunawarebofbwhichbsubjectsbarebinbwhichbgroup.
d. preventbsubjectsbfrombknowingbwhichbgroupbtheybarebinbandbpreventbpreconceptionb
bias.
ANS:bA
Randomizationbhelpsbpreventballocationbbias,bwhichbcanboccurbwhenbresearchersbplacebsubjectsb
withbdesiredbcharacteristicsbinbthebstudybgroupbandbotherbsubjectsbinbthebcontrolbgroupbsobthatbdif
ferencesbinboutcomebarebactuallybthebresultbofbdifferencesbinbsubjectsbandbnotbtreatment.
Comparingbtreatmentboutcomebtobnobtreatmentboutcomebisbthebdefinitionbofbabcontrolledbstudy.bT
heblastbtwoboptionsbdescribebthebusebofbblindingbinbstudies;bblindingbensuresbthatbresearchersborbs
ubjectsb(orbboth)barebunawarebofbwhichbsubjectsbarebinbwhichbgroupbsobthatbpreconceptionsbabout
bbenefitsbandbrisksbcannotbbiasbthebresults.
DIF:bCognitivebLevel:bComprehension
REF:bThebRandomizedbDrugbTrialb
TOP:bNursingbProcess:bImplementation
MSC:bNCLEXbClientbNeedsbCategory:bPhysiologicbIntegrity:bPharmacologicbandbParenteralbTherapies
4. Someonebasksbabnursebaboutbabnewbdrugbthatbisbinbpreclinicalbtestingbandbwantsbtobknowbwhybitbc
annotbbebusedbtobtreatbabfriend‘sbillness.bWhichbstatementbbybthebnursebisbcorrect?
a. ―Abdrugbatbthisbstagebofbdevelopmentbcanbbebusedbonlybinbpatientsbwithbseriousbdisease.‖
b. ―Atbthisbstagebofbdrugbdevelopment,bthebsafetybandbusefulnessbofbthebmedicationbisbu
nknown.‖
c. ―Clinicalbtrialsbmustbbebcompletedbtobmakebsurebthebdrugbisbsafebtobusebinbhumans.‖
d. ―Untilbpostmarketingbsurveillancebdatabarebavailable,bthebdrugbcannotbbebused.‖
ANS:bB
Preclinicalbtestingbmustbbebcompletedbbeforebdrugsbcanbbebtestedbinbhumans.bInbthisbstage,bdrug
sbarebevaluatedbforbtoxicities,bpharmacokineticbproperties,bandbpotentiallybusefulbeffects.bSomeb
drugsbcanbbebusedbinbpatientsbbeforebcompletionbofbPhasebIIIbstudies,bbutbthisbisbafterbpreclinical
btestingbisbcomplete.bClinicalbtrials bproceedbinbstages,bandbeachbstagebhasbguidelinesbdefiningbho
wbabnewbdrugbmaybbebusedbandbwhichbpatientsbmaybreceivebit.bPostmarketingbsurveillancebtake
sbplacebafterbabdrugbisbinbgeneralbuse.
DIF:bCognitivebLevel:bComprehension
REF:bLandmarkbDrugbLegislationb|bStagesbofbDrugbDevelopmentb
TOP:bNursingbProcess:bImplementation
MSC:bNCLEXbClientbNeedsbCategory:bPhysiologicbIntegrity:bReductionbofbRiskbPotential
5. AbpatientbasksbabnursebwhybdrugsbthatbhavebbeenbapprovedbbybthebFDAbstillbhavebunknownbsi
debeffects.bThebnursebtellbthebpatientbthat:
a. testingbforballbsidebeffectsbofbabmedicationbwouldbbebprohibitivelybexpensive.
b. patientsbinbdrugbtrialsboftenbarebbiasedbbybtheirbpreconceptionsbofbabdrug‘sbbenefits.
c. researchersbtendbtobconductbstudiesbthatbwillbprovebthebbenefitsbofbtheirbnewbdrugs.
d. subjectsbinbdrugbtrialsbdobnotbalwaysbrepresentbthebfullbspectrumbofbpossiblebpatients.
, Test Bank Lehne's Pharmacology for Nursing Care, 11th Editi
b b b b b b b b
on by Jacqueline Burchum, Laura Rosenthal Chapter 1-
b b b b b b b
112|Complete Guide A+ b b b
ANS:bD
Allbdrugbtrialsbareblimitedbbybabrelativelybsmallbgroupbofbsubjectsbwhobmaybnotbhaveballbthebc
haracteristicsbofbpeoplebwhobwillbbebusingbthebdrug;btherefore,bsomebsidebeffectsbgobundetect
edbuntilbthebdrugbisbinbuse.bAlthoughbdrugbtrialsbarebverybexpensive,bthisbisbonlybanbindirectbre
asonbtheybdobnotbdetectballbsidebeffectsbbeforebapproval.bInbtheory,bwell-
designedbdrugbtrials,busingbblindedbstudies,bminimizeborbeliminatebsubjectbbias.bDesigningbst
udiesbtobprovebdesiredbresultsbisbunethical.
DIF:bCognitivebLevel:bAnalysis
REF:bFailurebtobDetectbAllbAdversebEffectsb
TOP:bNursingbProcess:bImplementation
MSC:bNCLEXbClientbNeedsbCategory:bPhysiologicbIntegrity:bPharmacologicbandbParenteralbTherapies
6. Abnursebisbteachingbnursingbstudentsbaboutbthebusebofbnonproprietarybnamesbforbdrugs.bThebn
ursebtellsbthembwhichbfactbaboutbnonproprietarybnames?
a. TheybarebapprovedbbybthebFDAbandbarebeasybtobremember.
b. TheybarebassignedbbybthebU.S.bAdoptedbNamesbCouncil.
c. Theybclearlybidentifybthebdrug‘sbpharmacologicalbclassification.
d. Theybimplybthebefficacybofbthebdrugbandbareblessbcomplex.
ANS:bB
Nonproprietary,borbgeneric,bnamesbarebassignedbbybthebU.S.bAdoptedbNamesbCouncil,bwhichben
suresbthatbeachbdrugbhasbonlybonebname.bTradebnames,borbbrandbnames,barebapprovedbbybthebFD
Abandbarebeasierbtobremember.bSomebnonproprietarybnamesbcontainbsyllablesbthatbidentifybthebc
lassification,balthoughbnotballbdo.bDrugbnamesbarebnotbsupposedbtobidentifybthebusebforbthebdrug,b
althoughbsomebbrandbnamesbdobso.
DIF:bCognitivebLevel:bComprehensionbREF:bDrugbNames:bThebThreebTypesbofbDrugbNamesbTOP:bNursin
gbProcess:bDiagnosis
MSC:bNCLEXbClientbNeedsbCategory:bPhysiologicbIntegrity:bReductionbofbRiskbPotential
Chapter 1: Orientation to Pharmacology
b b b b b
Test Bank
b
MULTIPLEbCHOICE
1. Thebnursebisbteachingbabpatientbhowbabmedicationbworksbtobtreatbanbillness.bTobdobthis,bthebn
ursebwillbrelybonbknowledgebof:ba.bclinicalbpharmacology.
b. drugbefficacy.
c. pharmacokinetics.
d. pharmacotherapeutics.
ANS:bD