Test Bank for Pharmacology for Nurses A Pathophysiologic Approach 6th Edition by Adams.pdf

DOWNLOAD THE Test Bank for Pharmacology for Nurses 6th Edition Adams
m m m m m m m m m m




PharmacologymformNurses,m6em(Adams)mChapt
erm2m DrugmApprovalmandmRegulation

1) Ampharmaceuticalmrepresentativemcomesmtomthemphysician'smofficemandmsaysmhismcompany'sm
pharmaceuticalmlaboratorymismmarketingmamdrugmthatmdoesmnotmneedmapprovalmbymthemFoodm
andmDrugmAdministrationm(FDA).mWhatmismthembestmresponsembymthemnurse?
1. "AnympharmaceuticalmlaboratoryminmAmericammustmhavemapprovalmfrommthemFoodmandmD
rugmAdministrationm(FDA)mbeforemmarketingmamdrug."
2. "Ismthismanmover-the-
counterm(OTC)mdrug?mTheymdomnotmneedmapprovalmbymthemFoodmandmDrugmAdministr
ationm(FDA)."
3. "Ismyourmpharmaceuticalmlaboratorymprivate?mOnlympublicmpharmaceuticalmlaboratori
esmneedmapprovalmfrommthemFoodmandmDrugmAdministrationm(FDA)."
4. "Yourmpharmaceuticalmlaboratorymmustmbeminvolvedminmacademicmresearchmbecausemth
eymaremexemptmfrommapprovalmbymthemFoodmandmDrugmAdministrationm(FDA)."
Answer:m 1mExplanatio
n:
1. AnympharmaceuticalmlaboratorymmustmobtainmapprovalmfrommthemFoodmandmDr
ugmAdministrationm(FDA)mbeforemmarketingmamdrug.
2. Pharmaceuticalmlaboratoriesmthatmmanufacturemover-the-
counterm(OTC)mdrugsmmustmobtainmapprovalmfrommthemFoodmandmDrugmAdministrationm
(FDA)mbeforemmarketingmthesemdrugs.
3. PrivatempharmaceuticalmlaboratoriesmmustmobtainmapprovalmfrommthemFoodmandmDr
ugmAdministrationm(FDA)mbeforemmarketingmamdrug.
4. Pharmaceuticalmlaboratoriesminvolvedminmacademicmresearchmmustmobtainmapprovalmfro
mmthemFoodmandmDrugmAdministrationm(FDA)mbeforemmarketingmamdrug.
PagemRef:m12-
13m CognitivemLevel:m Appl
ying
ClientmNeed/Sub:m PhysiologicalmIntegrity:mPharmacologicalmandmParenteralmTherapiesm Standar
ds:m QSENmCompetencies:mV.B.1mDemonstratemeffectivemusemofmtechnologymandmstandardizedm
practicesmthatmsupportmsafetymandmquality.m|mAACNmEssentialmCompetencies:mV.1mDemonstrat
embasicmknowledgemofmhealthcarempolicy,mfinancemandmregulatorymenvironments;mincludingmloc
al,mstate,mnational,mandmglobalmhealthcaremtrends.m|mNLNmCompetencies:mQualitymandmSafety:mP
oliciesmandmprocedures.m|mNursing/IntegratedmConcepts:mNursingmProcess:mAnalysismLearningm
Outcome:m 2-
2mDiscussmthemrolemofmthemU.S.mFoodmandmDrugmAdministrationm(FDA)minmthemdrugmapprovalmpr
ocess.
MNLmLearningmOutcome:m 2.2mExaminemthemrolemofmthemU.S.mFoodmandmDrugmAdministrationminmthe
mprocessmofmdrugmapprovalmandmdrugmsafety.




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,DOWNLOAD THE Test Bank for Pharmacology for Nurses 6th Edition Adams
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2) AmnursemismemployedmbymthemFoodmandmDrugmAdministrationm(FDA)mandmisminvolvedminmcli
nicalminvestigation.mThemnurse'smprimarymroleminmthismphasemofmthemFDAmreviewmandmappr
ovalmismtomperformmtestsmonmwhichmofmthemfollowing?
1. Thempopulation-at-large
2. Variousmspeciesmofmanimals
3. Humanmcellsmculturedminmthemlaboratory
4. Humanmclients
Answer:m 4mExplanatio
n:
1. Performingmtestsmonmthempopulation-at-largemismthemstagemofmpostmarketingmsurveillance.
2. Performingmtestsmonmvariousmspeciesmofmanimalsmismthempreclinicalminvestigationmstage.
3. Performingmtestsmonmhumanmcellsmculturedminmthemlaboratorymismthempreclini
calminvestigationmstage.
4. Clinicalminvestigationmincludesmperformingmtestsmonmhealthymvolunteers,mandmlater,m
onmselectedmclientsmwithmamparticularmdisease.
PagemRef:m13
CognitivemLevel:m Applying
ClientmNeed/Sub:m PhysiologicalmIntegrity:mPharmacologicalmandmParenteralmTherapiesmStandar
ds:m QSENmCompetencies:mV.B.1mDemonstratemeffectivemusemofmtechnologymandmstandardizedm
practicesmthatmsupportmsafetymandmquality.m|mAACNmEssentialmCompetencies:mV.4mExaminemlegi
slativemandmregulatorymprocessesmrelevantmtomthemprovisionmofmhealthcare.m|mNLNmCompetenc
ies:mQualitymandmSafety:mPoliciesmandmprocedures.m|mNursing/IntegratedmConcepts:mNursingmPr
ocess:mImplementation
LearningmOutcome:m 2-
3mExplainmthemfourmphasesmofmapprovalmformtherapeuticmandmbiologicalmdrugs.
MNLmLearningmOutcome:m 2.2mExaminemthemrolemofmthemU.S.mFoodmandmDrugmAdministrationminmthe
mprocessmofmdrugmapprovalmandmdrugmsafety.




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,DOWNLOAD THE Test Bank for Pharmacology for Nurses 6th Edition Adams
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3) AmstudentmnursemismtakingmampharmacologymcoursemandmstudyingmaboutmthemFoodmandmDrug
mAdministrationm(FDA).mWhichmstatementmindicatesmthemstudentmunderstandsmhowmthemFDAm

hasmdecreasedmthemamountmofmtimeminvolvedminmbringingmamnewmdrugmtomthemmarket?
1. "ThemFoodmandmDrugmAdministrationm(FDA)mismnotmasmstrictmasmitmoncemwasmwithmregar
dmtomdrugmapproval."
2. "Sincemconsumersmhavemdemandedmmoremdrugs,mthemFoodmandmDrugmAdministrationm(F
DA)mhasmstreamlinedmthemreview/approvalmprocess."
3. "Drugmmanufacturersmaremrequiredmtompaymyearlymusermfees,mwhichmallowmthemFoodm
andmDrugmAdministrationm(FDA)mtomhiremmorememployeesmtomincreasemitsmefficiency.
"
4. "DrugmmanufacturersmaremrequiredmbymthemFoodmandmDrugmAdministrationm(FDA)mtomt
estmmoremdrugsmonmanmannualmbasis."
Answer:m 3mExplanatio
n:
1. ThemFoodmandmDrugmAdministrationm(FDA)mismjustmasmstrictmnowmasmitmalwaysmwasm
withmregardmtomdrugmapproval.
2. ThemFoodmandmDrugmAdministrationm(FDA)mhasmnotmstreamlinedmthemreview/appro
valmprocess.
3. Inm1992,mthemPrescriptionmDrugmUsermFeemActmwasmpassed.mThismrequiredmdrugmmanufac
turersmtomprovidemyearlymproductmusermfeesmsomthemFoodmandmDrugmAdministrationm(FDA
)mcouldmrestructure,mhiremmorememployees,mandmoperatemmoremefficiently.
4. ThemFoodmandmDrugmAdministrationm(FDA)mdoesmnotmrequiremdrugmmanufacturersmtomt
estmmoremdrugsmonmanmannualmbasis.
PagemRef:m15
CognitivemLevel:m Applying
ClientmNeed/Sub:m PhysiologicalmIntegrity:mPharmacologicalmandmParenteralmTherapiesmStandar
ds:m QSENmCompetencies:mV.B.1mDemonstratemeffectivemusemofmtechnologymandmstandardizedm
practicesmthatmsupportmsafetymandmquality.m|mAACNmEssentialmCompetencies:mV.4mExaminemlegi
slativemandmregulatorymprocessesmrelevantmtomthemprovisionmofmhealthcare.m|mNLNmCompetenc
ies:mQualitymandmSafety:mPoliciesmandmprocedures.m|mNursing/IntegratedmConcepts:mNursingmPr
ocess:mEvaluation
LearningmOutcome:m 2-
4mDiscussmhowmthemFDAmhasmincreasedmthemspeedmwithmwhichmnewmdrugsmreachmconsumers.
MNLmLearningmOutcome:m 2.2mExaminemthemrolemofmthemU.S.mFoodmandmDrugmAdministrationminmthe
mprocessmofmdrugmapprovalmandmdrugmsafety.




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4) Amclientmhasmskinmlesionsmthatmhavemnotmrespondedmtomprescriptionmdrugs.mHemtellsmthemnurs
emhemhasmheardmaboutmsomemresearchmgoingmonmwithmamnewmdrugmandmasksmwhymhemcan'tmta
kemit.mWhatmismthembestmresponsembymthemnurse?
1. "Imknowmitmismfrustrating,mbutmthemFoodmandmDrugmAdministrationm(FDA)mapprovalmproces
smisminmplacemtomensuremthatmdrugsmaremsafe."
2. "ThemFoodmandmDrugmAdministrationm(FDA)mhasmverymstrictmrulesmaboutmnewmdrugs;m
itmismimportantmtombempatientmregardingmthemreview/approvalmprocess."
3. "Yourmskinmlesionsmreallymaren'tmthatmbad,mbutmmaybemthemnewmdrugmwillmbemavailablemsoon."
4. "Maybemyoumcouldmcontactmthemdrugmcompanymaboutmbecomingminvolvedminmamclinicalmtri
al."mAnswer:m 1
Explanation:
1. Althoughmthempublicmismanxiousmtomreceivemnewmdrugs,mthemfundamentalmprioritymofmthe
mFoodmandmDrugmAdministrationm(FDA)mismtomensuremthatmdrugsmaremsafe.mAlso,mtellingmth

emclientmthatmthemnursemknowsmhemismfrustratedmismtherapeuticmbecausemitmcommunicate
smthatmthemnursemrecognizesmwhatmhemismfeeling.
2. Tellingmthemclientmtombempatientmismamcondescendingmresponse;mthemclientmwantsmreliefmfr
ommthemskinmcondition.
3. Tellingmthemclientmhismskinmlesions"aren'tmthatmbad"mismamnontherapeuticmresponse;m
themclient'smperceptionmismhismreality.
4. Themclientmcouldmcontactmthemdrugmcompany,mbutmthismresponsemfostersmfalsemhopemas
mhemmaymnotmbemamviablemcandidatemformthismdrug.

PagemRef:m13
CognitivemLevel:m Applying
ClientmNeed/Sub:m PhysiologicalmIntegrity:mPharmacologicalmandmParenteralmTherapiesmStandar
ds:m QSENmCompetencies:mV.B.1mDemonstratemeffectivemusemofmtechnologymandmstandardizedm
practicesmthatmsupportmsafetymandmquality.m|mAACNmEssentialmCompetencies:mV.4mExaminemlegi
slativemandmregulatorymprocessesmrelevantmtomthemprovisionmofmhealthcare.m|mNLNmCompetenc
ies:mQualitymandmSafety:mPoliciesmandmprocedures.m|mNursing/IntegratedmConcepts:mNursingmPr
ocess:mImplementation
LearningmOutcome:m 2-
2mDiscussmthemrolemofmthemU.S.mFoodmandmDrugmAdministrationm(FDA)minmthemdrugmapprovalmpr
ocess.
MNLmLearningmOutcome:m 2.2mExaminemthemrolemofmthemU.S.mFoodmandmDrugmAdministrationminmthe
mprocessmofmdrugmapprovalmandmdrugmsafety.




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