c c c c c c c c
ANK(Chapter 1-110). c
Chapter 3: Drug Regulation, Development, Names, and Information
c c c c c c c c
Test Bank
c
MULTIPLEcCHOICE
1. Acnurseceducatorciscconductingcaccontinuingceducationcclassconcpharmacology.cTocevaluatecth
eclearningcofcthecnursescincthecclass,cthecnurseceducatorcasks,c―Whichcdrugcnameciscacgenericc
drugcname?‖cWhichcisctheccorrectcresponse?ca.cAcetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:cA
Acetaminophenciscthecgenericcname.cTylenol,cCipro,candcMotrincarecallctradecnames.
DIF:cCognitivecLevel:cComprehension REF:cTablec3-
3:cThecThreecTypescofcDrugcNamescTOP:cNursingcProcess:cDiagnosis
MSC:cNCLEXcClientcNeedscCategory:cPhysiologiccIntegrity:cPharmacologiccandcParenteralcTherapies
2. ThecFDAcAmendmentscActc(FDAAA)cwascpassedcinc2007ctocaddresscwhichcaspectcofcdrugcsa
fety?
a. Allowingcpharmaceuticalccompaniesctocidentifycoff-
labelcusescofcmedicationscapprovedcforcothercuses
b. Evaluatingcdrugcsafetycinformationcthatcemergescaftercacdrugchascbeencapprovedcandciscin
cuse
c. ExpeditingcthecapprovalcprocesscofcthecU.S.cFoodcandcDrugcAdministrationc(FDA)csocth
atcneededcdrugsccancgetctocmarketcmorecquickly
d. Requiringcmanufacturersctocnotifycpatientscbeforecremovingcacdrugcfromcthecmarket
ANS:cB
ThecFDAAAcwascpassedctocenablecthecFoodcandcDrugcAdministrationctoccontinuecoversightcofcac
drugcaftercgrantingcitcapprovalcsocthatcchangescinclabelingccouldcbecmadecascnecessarycandcpostm
arketingcrisksccouldcbectrackedcandcidentified.cAcprovisioncofcthecFDAcModernizationcActc(FDA
MA),cpassedcinc1997,callowscdrugccompaniesctocpromotectheircproductscforcoff-
labelcusescasclongcasctheycpromisectocconductcstudiesctocsupportctheircclaims.cRegulationsctocperm
itcacceleratedcapprovalcofcdrugscforclife-
threateningcdiseasescwerecadoptedcinc1992cbycthecFDA.cThecrequirementcthatcdrugccompaniescn
otifycpatientsc6cmonthscbeforecremovingcacdrugcfromcthecmarketciscacprovisioncofcthecFDAMA.
DIF:cCognitivecLevel:cComprehension
REF:cLandmarkcDrugcLegislationc
TOP:cNursingcProcess:cEvaluation
MSC:cNCLEXcClientcNeedscCategory:cPhysiologiccIntegrity:cPharmacologiccandcParenteralcTherapies
,Test Bank Lehne's Pharmacology for Nursing Care, 11th Editio
c c c c c c c c
n by Jacqueline Burchum, Laura Rosenthal Chapter 1-
c c c c c c c
112|Complete Guide A+
c c c
3. Acnursingcstudentcaskscacnursecaboutcpharmaceuticalcresearchcandcwantsctocknowcthecpurposecof
crandomizationcincdrugctrials.cThecnursecexplainscthatcrandomizationciscusedcto:
a. ensurecthatcdifferencescincoutcomescarecthecresultcofctreatmentcandcnotcdifferencescincs
ubjects.
b. comparecthecoutcomeccausedcbycthectreatmentctocthecoutcomeccausedcbycnoctreatment.
,Lehne's Pharmacology for Nursing Care 10th Edition TESTB
c c c c c c c c
ANK(Chapter 1-110). c
c. makecsurecthatcresearcherscarecunawarecofcwhichcsubjectscarecincwhichcgroup.
d. preventcsubjectscfromcknowingcwhichcgroupctheycarecincandcpreventcpreconceptioncb
ias.
ANS:cA
Randomizationchelpscpreventcallocationcbias,cwhichccancoccurcwhencresearcherscplacecsubjectscw
ithcdesiredccharacteristicscincthecstudycgroupcandcothercsubjectscinctheccontrolcgroupcsocthatcdiffer
encescincoutcomecarecactuallycthecresultcofcdifferencescincsubjectscandcnotctreatment.
Comparingctreatmentcoutcomectocnoctreatmentcoutcomeciscthecdefinitioncofcaccontrolledcstudy.cT
heclastctwocoptionscdescribecthecusecofcblindingcincstudies;cblindingcensurescthatcresearcherscorcs
ubjectsc(orcboth)carecunawarecofcwhichcsubjectscarecincwhichcgroupcsocthatcpreconceptionscaboutc
benefitscandcrisksccannotcbiascthecresults.
DIF:cCognitivecLevel:cComprehension
REF:cThecRandomizedcDrugcTrialc
TOP:cNursingcProcess:cImplementation
MSC:cNCLEXcClientcNeedscCategory:cPhysiologiccIntegrity:cPharmacologiccandcParenteralcTherapies
4. Someonecaskscacnursecaboutcacnewcdrugcthatciscincpreclinicalctestingcandcwantsctocknowcwhycitcca
nnotcbecusedctoctreatcacfriend‘scillness.cWhichcstatementcbycthecnursecisccorrect?
a. ―Acdrugcatcthiscstagecofcdevelopmentccancbecusedconlycincpatientscwithcseriouscdisease.‖
b. ―Atcthiscstagecofcdrugcdevelopment,cthecsafetycandcusefulnesscofcthecmedicationciscu
nknown.‖
c. ―Clinicalctrialscmustcbeccompletedctocmakecsurecthecdrugciscsafectocusecinchumans.‖
d. ―Untilcpostmarketingcsurveillancecdatacarecavailable,cthecdrugccannotcbecused.‖
ANS:cB
Preclinicalctestingcmustcbeccompletedcbeforecdrugsccancbectestedcinchumans.cIncthiscstage,cdrugs
carecevaluatedcforctoxicities,cpharmacokineticcproperties,candcpotentiallycusefulceffects. cSomecd
rugsccancbecusedcincpatientscbeforeccompletioncofcPhasecIIIcstudies,cbutcthisciscaftercpreclinicalct
estingcisccomplete.cClinicalctrialscproceedcincstages,candceachcstagechascguidelinescdefiningchowc
acnewcdrugcmaycbecusedcandcwhichcpatientscmaycreceivecit.cPostmarketingcsurveillancectakescpl
acecaftercacdrugciscincgeneralcuse.
DIF:cCognitivecLevel:cComprehension
REF:cLandmarkcDrugcLegislationc|cStagescofcDrugcDevelopmentc
TOP:cNursingcProcess:cImplementation
MSC:cNCLEXcClientcNeedscCategory:cPhysiologiccIntegrity:cReductioncofcRiskcPotential
5. AcpatientcaskscacnursecwhycdrugscthatchavecbeencapprovedcbycthecFDAcstillchavecunknowncsi
deceffects.cThecnursectellcthecpatientcthat:
a. testingcforcallcsideceffectscofcacmedicationcwouldcbecprohibitivelycexpensive.
b. patientscincdrugctrialscoftencarecbiasedcbyctheircpreconceptionscofcacdrug‘scbenefits.
c. researchersctendctocconductcstudiescthatcwillcprovecthecbenefitscofctheircnewcdrugs.
d. subjectscincdrugctrialscdocnotcalwayscrepresentcthecfullcspectrumcofcpossiblecpatients.
, Test Bank Lehne's Pharmacology for Nursing Care, 11th Editio
c c c c c c c c
n by Jacqueline Burchum, Laura Rosenthal Chapter 1-
c c c c c c c
112|Complete Guide A+
c c c
ANS:cD
Allcdrugctrialscareclimitedcbycacrelativelycsmallcgroupcofcsubjectscwhocmaycnotchavecallcthecch
aracteristicscofcpeoplecwhocwillcbecusingcthecdrug;ctherefore,csomecsideceffectscgocundetected
cuntilcthecdrugciscincuse.cAlthoughcdrugctrials carecverycexpensive,cthiscisconlycancindirectcreaso
nctheycdocnotcdetectcallcsideceffectscbeforecapproval.cInctheory,cwell-
designedcdrugctrials,cusingcblindedcstudies,cminimizecorceliminatecsubjectcbias.cDesigningcstu
diesctocprovecdesiredcresultsciscunethical.
DIF:cCognitivecLevel:cAnalysis
REF:cFailurectocDetectcAllcAdversecEffectsc
TOP:cNursingcProcess:cImplementation
MSC:cNCLEXcClientcNeedscCategory:cPhysiologiccIntegrity:cPharmacologiccandcParenteralcTherapies
6. Acnurseciscteachingcnursingcstudentscaboutcthecusecofcnonproprietarycnamescforcdrugs.cThecn
ursectellscthemcwhichcfactcaboutcnonproprietarycnames?
a. TheycarecapprovedcbycthecFDAcandcareceasyctocremember.
b. TheycarecassignedcbycthecU.S.cAdoptedcNamescCouncil.
c. Theycclearlycidentifycthecdrug‘scpharmacologicalcclassification.
d. Theycimplycthecefficacycofcthecdrugcandcareclessccomplex.
ANS:cB
Nonproprietary,corcgeneric,cnamescarecassignedcbycthecU.S.cAdoptedcNamescCouncil,cwhichcens
urescthatceachcdrugchasconlyconecname.cTradecnames,corcbrandcnames,carecapprovedcbycthecFDAc
andcareceasierctocremember.cSomecnonproprietarycnamesccontaincsyllablescthatcidentifycthecclas
sification,calthoughcnotcallcdo.cDrugcnamescarecnotcsupposedctocidentifycthecusecforcthecdrug,calth
oughcsomecbrandcnamescdocso.
DIF:cCognitivecLevel:cComprehensioncREF:cDrugcNames:cThecThreecTypescofcDrugcNamescTOP:cNursing
cProcess:cDiagnosis
MSC:cNCLEXcClientcNeedscCategory:cPhysiologiccIntegrity:cReductioncofcRiskcPotential
Chapter 1: Orientation to Pharmacology
c c c c c
Test Bank
c
MULTIPLEcCHOICE
1. Thecnurseciscteachingcacpatientchowcacmedicationcworksctoctreatcancillness.cTocdocthis,cthecnu
rsecwillcrelyconcknowledgecof:ca.c clinicalcpharmacology.
b. drugcefficacy.
c. pharmacokinetics.
d. pharmacotherapeutics.
ANS:cD