Lehne's Pharmacology for Nursing Care 10th Edition TEST
BANK(Chapter 1-110).
Chapter503:50Drug50Regulation,50Development,50Names,50and50Inform
ation50Test50Bank
MULTIPLE50CHOICE
1. A50nurse50educator50is50conducting50a50continuing50education50class50on50pharmacology.50T
o50evaluate50the50learning50of50the50nurses50in50the50class,50the50nurse50educator50asks,50
―Which50drug50name50is50a50generic50drug50name?‖50Which50is50the50correct50response?5
0a.50Acetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:50A
Acetaminophen50is50the50generic50name.50Tylenol,50Cipro,50and50Motrin50are50all50trade50names.
DIF:50Cognitive50Level:50Comprehension REF:50Table503-
3:50The50Three50Types50of50Drug50Names50TOP:50Nursing50Process:50Diagnosis
MSC:50NCLEX50Client50Needs50Category:50Physiologic50Integrity:50Pharmacologic50and50Parenteral50Ther
apies
2. The50FDA50Amendments50Act50(FDAAA)50was50passed50in50200750to50address50which50
aspect50of50dr50ug50safety?
a. Allowing50pharmaceutical50companies50to50identify
50off-
50label50uses50of50medications50approved50for50other
50uses
b. Evaluating50drug50safety50information50that50emerges50after50a50drug50has50been50ap
proved50and50is50in50use
c. Expediting50the50approval50process50of50the50U.S.50Food50and50Drug50Administratio
n50(FDA)50s50o50that50needed50drugs50can50get50to50market50more50quickly
d. Requiring50manufacturers5 0 to50 notify50patients5 0 before50 removing50 a50 drug50 from50 the5 0 mar
ket
ANS:50 B
The50FDAAA50was50passed50to50enable50the50Food5 0 and5 0 Drug50Administration50to50continu
e50oversight5 0 of50a50drug50after50granting50it50approval50so50that50changes50in50labeling50coul
d50be5 0 made50as50necessary5 0 and50postmarketing50risks50could50be50tracked50and50identified
.50A50provision50of50the50FDA50Moderniza50tion50 Act50(FDAMA),50passed50in5 0 1997,50allow
s50drug50companies50to50promote50their50products50for50of5 0 f-
label50uses50as50long50as50they50promise50to50conduct50studies50to50support50their50claims.50Re
gulations50to5 0 permit50accelerated50approval50of50drugs50for50life-
,Test50Bank50Lehne's50Pharmacology50for50Nursing50Care,5011th50
Edi50tion50by50Jacqueline50Burchum,50Laura50Rosenthal50Chapt
threatening50diseases50were50adopted50in50199250by50the50FDA.50The50requirement50that50dru
er501-50112|Complete50Guide50A+
g50compani5 0 es50notify50patients50650months50before50removing50a50drug50from50the50market
50is50a50provision50of50the50F50DAMA.
DIF:5 0 Cognitive5 0 Level:5 0 Comprehen
sion REF:50Landmark50Drug50Legislation
TOP:5 0 Nursing50 Process:5 0 Evaluation
MSC:50NCLEX50Client50Needs50Category:50 Physiologic50 Integrity:50 Pharmacologic50and50Parenteral50
Therapies
,3. A50nursing50student50asks50a50nurse50about50pharmaceutical50research50and50wants50to50kno
w50the50purpo50se50of5 0 randomization50in5 0 drug5 0 trials.5 0 The5 0 nurse5 0 explains50that5 0 ra
ndomization5 0 is50used5 0 to:
a. ensure50that50differences50in50outcomes50are50the50result50of50treatment50and50not5
0differences50in50subjects.
b. compare50 the5 0 outcome5 0 caused5 0 by50the50 treatment5 0 to5 0 the50 outcome50 caused5 0 by50no5 0 trea
tment.
, Test50Bank50Lehne's50Pharmacology50for50Nursing50Care,5011th50
Edi50tion50by50Jacqueline50Burchum,50Laura50Rosenthal50Chapt
er501-50112|Complete50Guide50A+
c. make50 sure50 that5 0 researchers5 0 are50 unaware50 of5 0 which5 0 subjects5 0 are50 in5 0 which5 0 group.
d. prevent50subjects50from50knowing50which50group50they50are50in50and50prevent50pr
econceptio50n50bias.
ANS:50 A
Randomization50helps50prevent50allocation50bias,50which50can50occur50when50researchers50pla
ce50subjec50ts50with50desired50characteristics50in50the50study50group50and50other50subjects50in5
0the50control50group50so50t50hat50 differences5 0 in50 outcome50 are50 actually50the5 0 result50 of50 di
fferences5 0 in5 0 subjects5 0 and50 not50 treatmen50t.
Comparing50treatment50 outcome50 to50 no50 treatment50 outcome50 is50 the50 definition50 of50 a50 contro
lled50 stud
y.50The50last50two50options50describe50the50use50of50blinding50in50studies;50blinding50ensures5
0that50researc50hers50or50subjects50(or50both)50are50unaware50of50which50subjects50are50in50wh
ich50group50so50that50preconc50eptions50about50benefits50and50risks50cannot50bias50the50results
.
DIF:5 0 Cognitive5 0 Level:5 0 Comprehensi
on REF:50The50Randomized50Drug50Tria
l5 0 TOP:5 0 Nursing5 0 Process:5 0 Implemen
tation
MSC:50NCLEX50Client50Needs50Category:50 Physiologic50 Integrity:50 Pharmacologic50and50Parenteral50
Therapies
4. Someone50asks50 a50nurse50 about50a50new50drug50that50is50 in50preclinical50 testing50and5 0 wan
ts50to50know50 wh5 0 y50it5 0 cannot5 0 be5 0 used5 0 to5 0 treat5 0 a5 0 friend‘s5 0 illness.5 0 Which5 0 st
atement5 0 by5 0 the5 0 nurse5 0 is5 0 correct?
a. ―A50 drug50 at50 this50 stage50 of50 development5 0 can5 0 be50 used50 only50in50 patients50 with50 seri
ous50 disease.‖
b. ―At50this50stage50of50drug50development,50the50safety50and50usefulness50of50the50
medication50is50unknown.‖
c. ―Clinical50 trials50 must50 be50 completed50 to50 make50 sure5 0 the50 drug50 is50 safe50 to50 use50 in5 0
humans.‖
d. ―Until50 postmarketing50 surveillance50 data50 are50 available,50 the50 drug50 cannot5 0 be50 used.‖
ANS:50 B
Preclinical50testing50must50be50completed50before50drugs50can50be50tested50in50humans.50In5
0this50stage,50drugs5 0 are5 0 evaluated5 0 for50 toxicities,50 pharmacokinetic5 0 properties,5 0 and5 0
potentially50 useful5 0 effect
s.50Some50drugs50can50be50used50in50patients50before50completion50of50Phase50III50studies,50
but50this50is50af5 0 ter50preclinical50testing50is50complete.50Clinical50trials50proceed50in50stage
s,50and50each50stage50has50guid50elines50defining50how50a50new50drug50may50be50used50and50
which50patients50may50receive50it.50Postmark50eting50surveillance50takes50place50after50a50dr
ug50is50in50general50use.
DIF:50 Cognitive50 Level:50 Comprehension
REF:50Landmark50Drug50Legislation50|50Stages50of50Drug50Develop
ment50T50OP:50Nursing50Process:50Implementation
BANK(Chapter 1-110).
Chapter503:50Drug50Regulation,50Development,50Names,50and50Inform
ation50Test50Bank
MULTIPLE50CHOICE
1. A50nurse50educator50is50conducting50a50continuing50education50class50on50pharmacology.50T
o50evaluate50the50learning50of50the50nurses50in50the50class,50the50nurse50educator50asks,50
―Which50drug50name50is50a50generic50drug50name?‖50Which50is50the50correct50response?5
0a.50Acetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:50A
Acetaminophen50is50the50generic50name.50Tylenol,50Cipro,50and50Motrin50are50all50trade50names.
DIF:50Cognitive50Level:50Comprehension REF:50Table503-
3:50The50Three50Types50of50Drug50Names50TOP:50Nursing50Process:50Diagnosis
MSC:50NCLEX50Client50Needs50Category:50Physiologic50Integrity:50Pharmacologic50and50Parenteral50Ther
apies
2. The50FDA50Amendments50Act50(FDAAA)50was50passed50in50200750to50address50which50
aspect50of50dr50ug50safety?
a. Allowing50pharmaceutical50companies50to50identify
50off-
50label50uses50of50medications50approved50for50other
50uses
b. Evaluating50drug50safety50information50that50emerges50after50a50drug50has50been50ap
proved50and50is50in50use
c. Expediting50the50approval50process50of50the50U.S.50Food50and50Drug50Administratio
n50(FDA)50s50o50that50needed50drugs50can50get50to50market50more50quickly
d. Requiring50manufacturers5 0 to50 notify50patients5 0 before50 removing50 a50 drug50 from50 the5 0 mar
ket
ANS:50 B
The50FDAAA50was50passed50to50enable50the50Food5 0 and5 0 Drug50Administration50to50continu
e50oversight5 0 of50a50drug50after50granting50it50approval50so50that50changes50in50labeling50coul
d50be5 0 made50as50necessary5 0 and50postmarketing50risks50could50be50tracked50and50identified
.50A50provision50of50the50FDA50Moderniza50tion50 Act50(FDAMA),50passed50in5 0 1997,50allow
s50drug50companies50to50promote50their50products50for50of5 0 f-
label50uses50as50long50as50they50promise50to50conduct50studies50to50support50their50claims.50Re
gulations50to5 0 permit50accelerated50approval50of50drugs50for50life-
,Test50Bank50Lehne's50Pharmacology50for50Nursing50Care,5011th50
Edi50tion50by50Jacqueline50Burchum,50Laura50Rosenthal50Chapt
threatening50diseases50were50adopted50in50199250by50the50FDA.50The50requirement50that50dru
er501-50112|Complete50Guide50A+
g50compani5 0 es50notify50patients50650months50before50removing50a50drug50from50the50market
50is50a50provision50of50the50F50DAMA.
DIF:5 0 Cognitive5 0 Level:5 0 Comprehen
sion REF:50Landmark50Drug50Legislation
TOP:5 0 Nursing50 Process:5 0 Evaluation
MSC:50NCLEX50Client50Needs50Category:50 Physiologic50 Integrity:50 Pharmacologic50and50Parenteral50
Therapies
,3. A50nursing50student50asks50a50nurse50about50pharmaceutical50research50and50wants50to50kno
w50the50purpo50se50of5 0 randomization50in5 0 drug5 0 trials.5 0 The5 0 nurse5 0 explains50that5 0 ra
ndomization5 0 is50used5 0 to:
a. ensure50that50differences50in50outcomes50are50the50result50of50treatment50and50not5
0differences50in50subjects.
b. compare50 the5 0 outcome5 0 caused5 0 by50the50 treatment5 0 to5 0 the50 outcome50 caused5 0 by50no5 0 trea
tment.
, Test50Bank50Lehne's50Pharmacology50for50Nursing50Care,5011th50
Edi50tion50by50Jacqueline50Burchum,50Laura50Rosenthal50Chapt
er501-50112|Complete50Guide50A+
c. make50 sure50 that5 0 researchers5 0 are50 unaware50 of5 0 which5 0 subjects5 0 are50 in5 0 which5 0 group.
d. prevent50subjects50from50knowing50which50group50they50are50in50and50prevent50pr
econceptio50n50bias.
ANS:50 A
Randomization50helps50prevent50allocation50bias,50which50can50occur50when50researchers50pla
ce50subjec50ts50with50desired50characteristics50in50the50study50group50and50other50subjects50in5
0the50control50group50so50t50hat50 differences5 0 in50 outcome50 are50 actually50the5 0 result50 of50 di
fferences5 0 in5 0 subjects5 0 and50 not50 treatmen50t.
Comparing50treatment50 outcome50 to50 no50 treatment50 outcome50 is50 the50 definition50 of50 a50 contro
lled50 stud
y.50The50last50two50options50describe50the50use50of50blinding50in50studies;50blinding50ensures5
0that50researc50hers50or50subjects50(or50both)50are50unaware50of50which50subjects50are50in50wh
ich50group50so50that50preconc50eptions50about50benefits50and50risks50cannot50bias50the50results
.
DIF:5 0 Cognitive5 0 Level:5 0 Comprehensi
on REF:50The50Randomized50Drug50Tria
l5 0 TOP:5 0 Nursing5 0 Process:5 0 Implemen
tation
MSC:50NCLEX50Client50Needs50Category:50 Physiologic50 Integrity:50 Pharmacologic50and50Parenteral50
Therapies
4. Someone50asks50 a50nurse50 about50a50new50drug50that50is50 in50preclinical50 testing50and5 0 wan
ts50to50know50 wh5 0 y50it5 0 cannot5 0 be5 0 used5 0 to5 0 treat5 0 a5 0 friend‘s5 0 illness.5 0 Which5 0 st
atement5 0 by5 0 the5 0 nurse5 0 is5 0 correct?
a. ―A50 drug50 at50 this50 stage50 of50 development5 0 can5 0 be50 used50 only50in50 patients50 with50 seri
ous50 disease.‖
b. ―At50this50stage50of50drug50development,50the50safety50and50usefulness50of50the50
medication50is50unknown.‖
c. ―Clinical50 trials50 must50 be50 completed50 to50 make50 sure5 0 the50 drug50 is50 safe50 to50 use50 in5 0
humans.‖
d. ―Until50 postmarketing50 surveillance50 data50 are50 available,50 the50 drug50 cannot5 0 be50 used.‖
ANS:50 B
Preclinical50testing50must50be50completed50before50drugs50can50be50tested50in50humans.50In5
0this50stage,50drugs5 0 are5 0 evaluated5 0 for50 toxicities,50 pharmacokinetic5 0 properties,5 0 and5 0
potentially50 useful5 0 effect
s.50Some50drugs50can50be50used50in50patients50before50completion50of50Phase50III50studies,50
but50this50is50af5 0 ter50preclinical50testing50is50complete.50Clinical50trials50proceed50in50stage
s,50and50each50stage50has50guid50elines50defining50how50a50new50drug50may50be50used50and50
which50patients50may50receive50it.50Postmark50eting50surveillance50takes50place50after50a50dr
ug50is50in50general50use.
DIF:50 Cognitive50 Level:50 Comprehension
REF:50Landmark50Drug50Legislation50|50Stages50of50Drug50Develop
ment50T50OP:50Nursing50Process:50Implementation
