Test Bank Lehne's Pharmacology For Nursing Care 10Th Edition Author: Jacqueline Burchum| Laura

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

Chapterhi3:hiDrughiRegulation,hiDevelopment,hiNames,hiandhiInforma
tionhiTesthiBank



MULTIPLEhiCHOICE

1. Ahinursehieducatorhiishiconductinghiahicontinuinghieducationhiclasshionhipharmacology.hiTohie
valuatehithehilearninghiofhithehinurseshiinhithehiclass,hithehinursehieducatorhiasks,hi―Whichhi
drughinamehiishiahigenerichidrughiname?‖hiWhichhiishithehicorrecthiresponse?hia.hiAcetaminop
hen
b. Tylenol
c. Cipro
d. Motrin
ANS:hiA
Acetaminophenhiishithehigenerichiname.hiTylenol,hiCipro,hiandhiMotrinhiarehiallhitradehinames.

DIF:hiCognitivehiLevel:hiComprehension REF:hiTablehi3-
3:hiThehiThreehiTypeshiofhiDrughiNameshiTOP:hiNursinghiProcess:hiDiagnosis
MSC:hiNCLEXhiClienthiNeedshiCategory:hiPhysiologichiIntegrity:hiPharmacologichiandhiParenteralhiTherapi
es

2. ThehiFDAhiAmendmentshiActhi(FDAAA)hiwashipassedhiinhi2007hitohiaddresshiwhichhiaspect
hiofhidrughisafety?
a. Allowinghipharmaceuticalhicompanieshitohiidentifyhioff-
labelhiuseshiofhimedicationshiapprovedhiforhiotherhiuses
b. Evaluatinghidrughisafetyhiinformationhithathiemergeshiafterhiahidrughihashibeenhiapproved
hiandhiishiinhiuse
c. ExpeditinghithehiapprovalhiprocesshiofhithehiU.S.hiFoodhiandhiDrughiAdministrationhi(F
DA)hisohithathineededhidrugshicanhigethitohimarkethimorehiquickly
d. Requiringhimanufacturershitohinotifyhipatientshibeforehiremovinghiahidrughifromhithehimarket
ANS:hiB
ThehiFDAAAhiwashipassedhitohienablehithehiFoodhiandhiDrughiAdministrationhitohicontinuehiover
sighthiofhiahidrughiafterhigrantinghiithiapprovalhisohithathichangeshiinhilabelinghicouldhibehimadehi
ashinecessaryhiandhipostmarketinghiriskshicouldhibehitrackedhiandhiidentified.hiAhiprovisionhiofhit
hehiFDAhiModernizationhiActhi(FDAMA),hipassedhiinhi1997,hiallowshidrughicompanieshitohipro
motehitheirhiproductshiforhioff-
labelhiuseshiashilonghiashitheyhipromisehitohiconducthistudieshitohisupporthitheirhiclaims.hiRegulat
ionshitohipermithiacceleratedhiapprovalhiofhidrugshiforhilife-
threateninghidiseaseshiwerehiadoptedhiinhi1992hibyhithehiFDA.hiThehirequirementhithathidrughico
mpanieshinotifyhipatientshi6himonthshibeforehiremovinghiahidrughifromhithehimarkethiishiahiprovis
ionhiofhithehiFDAMA.

,TesthiBankhiLehne'shiPharmacologyhiforhiNursinghiCare,hi11thhiE
ditionhibyhiJacquelinehiBurchum,hiLaurahiRosenthalhiChapterhi1-
hi112|CompletehiGuidehiA+
DIF:hiCognitivehiLevel:hiComprehension
REF:hiLandmarkhiDrughiLegislati
onhiTOP:hiNursinghiProcess:hiEvaluation
MSC:hiNCLEXhiClienthiNeedshiCategory:hiPhysiologichiIntegrity:hiPharmacologichiandhiParenteralhiTherapi
es

,3. Ahinursinghistudenthiaskshiahinursehiabouthipharmaceuticalhiresearchhiandhiwantshitohiknowhithe
hipurposehiofhirandomizationhiinhidrughitrials.hiThehinursehiexplainshithathirandomizationhiishi
usedhito:
a. ensurehithathidifferenceshiinhioutcomeshiarehithehiresulthiofhitreatmenthiandhinothidiffer
enceshiinhisubjects.
b. comparehithehioutcomehicausedhibyhithehitreatmenthitohithehioutcomehicausedhibyhinohitreatment.

, TesthiBankhiLehne'shiPharmacologyhiforhiNursinghiCare,hi11thhiE
ditionhibyhiJacquelinehiBurchum,hiLaurahiRosenthalhiChapterhi1-
hi112|CompletehiGuidehiA+

c. makehisurehithathiresearchershiarehiunawarehiofhiwhichhisubjectshiarehiinhiwhichhigroup.
d. preventhisubjectshifromhiknowinghiwhichhigrouphitheyhiarehiinhiandhipreventhiprecon
ceptionhibias.
ANS:hiA
Randomizationhihelpshipreventhiallocationhibias,hiwhichhicanhioccurhiwhenhiresearchershiplacehis
ubjectshiwithhidesiredhicharacteristicshiinhithehistudyhigrouphiandhiotherhisubjectshiinhithehicontro
lhigrouphisohithathidifferenceshiinhioutcomehiarehiactuallyhithehiresulthiofhidifferenceshiinhisubject
shiandhinothitreatment.
Comparinghitreatmenthioutcomehitohinohitreatmenthioutcomehiishithehidefinitionhiofhiahicontrolled
histudy.hiThehilasthitwohioptionshidescribehithehiusehiofhiblindinghiinhistudies;hiblindinghiensureshi
thathiresearchershiorhisubjectshi(orhiboth)hiarehiunawarehiofhiwhichhisubjectshiarehiinhiwhichhigrou
phisohithathipreconceptionshiabouthibenefitshiandhiriskshicannothibiashithehiresults.

DIF:hiCognitivehiLevel:hiComprehension
REF:hiThehiRandomizedhiDrughiTr
ialhiTOP:hiNursinghiProcess:hiImplementation
MSC:hiNCLEXhiClienthiNeedshiCategory:hiPhysiologichiIntegrity:hiPharmacologichiandhiParenteralhiTherapi
es

4. Someonehiaskshiahinursehiabouthiahinewhidrughithathiishiinhipreclinicalhitestinghiandhiwantshitohikn
owhiwhyhiithicannothibehiusedhitohitreathiahifriend‘shiillness.hiWhichhistatementhibyhithehinursehi
ishicorrect?
a. ―Ahidrughiathithishistagehiofhidevelopmenthicanhibehiusedhionlyhiinhipatientshiwithhiserioushidisea
se.‖
b. ―Athithishistagehiofhidrughidevelopment,hithehisafetyhiandhiusefulnesshiofhithehimedic
ationhiishiunknown.‖
c. ―Clinicalhitrialshimusthibehicompletedhitohimakehisurehithehidrughiishisafehitohiusehiinhihumans.‖
d. ―Untilhipostmarketinghisurveillancehidatahiarehiavailable,hithehidrughicannothibehiused.‖
ANS:hiB
Preclinicalhitestinghimusthibehicompletedhibeforehidrugshicanhibehitestedhiinhihumans.hiInhithishi
stage,hidrugshiarehievaluatedhiforhitoxicities,hipharmacokinetichiproperties,hiandhipotentiallyhiu
sefulhieffects.hiSomehidrugshicanhibehiusedhiinhipatientshibeforehicompletionhiofhiPhasehiIIIhistu
dies,hibuthithishiishiafterhipreclinicalhitestinghiishicomplete.hiClinicalhitrialshiproceedhiinhistages,hi
andhieachhistagehihashiguidelineshidefininghihowhiahinewhidrughimayhibehiusedhiandhiwhichhipat
ientshimayhireceivehiit.hiPostmarketinghisurveillancehitakeshiplacehiafterhiahidrughiishiinhigenera
lhiuse.

DIF:hiCognitivehiLevel:hiComprehension
REF:hiLandmarkhiDrughiLegislationhi|hiStageshiofhiDrughiDevelopme
nthiTOP:hiNursinghiProcess:hiImplementation
MSC:hiNCLEXhiClienthiNeedshiCategory:hiPhysiologichiIntegrity:hiReductionhiofhiRiskhiPotential

5. AhipatienthiaskshiahinursehiwhyhidrugshithathihavehibeenhiapprovedhibyhithehiFDAhistillhihave
hiunknownhisidehieffects.hiThehinursehitellhithehipatienthithat:
a. testinghiforhiallhisidehieffectshiofhiahimedicationhiwouldhibehiprohibitivelyhiexpensive.