Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
Psychopharmacology FINAL EXAM 3
Chapter 3: Drug Regulation, Development, Names, and Information
Test Bank
MULTIPLE CHOICE
1. A nurse educator\ is\ conducting\ a\ continuing\ education\ class\ on\ pharmacology.\ To\ evaluate\
the\ learning\ of\ the\ nurses\ in\ the\ class,\ the\ nurse\ educator\ asks,\ ―Which\ drug\ name\ is\ a\
generic\ drug\ name?‖\ Which\ is\ the\ correct\ response?\ a.\ Acetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:\ A
Acetaminophen\ is\ the\ generic\ name.\ Tylenol,\ Cipro,\ and\ Motrin\ are\ all\ trade\ names.
DIF:\ Cognitive\ Level:\ Comprehension REF:\ Table\ 3-3:\ The\ Three\ Types\ of\ Drug\
Names\ TOP:\ Nursing\ Process:\ Diagnosis
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
2. The\ FDA\ Amendments\ Act\ (FDAAA)\ was\ passed\ in\ 2007\ to\ address\ which\ aspect\ of\ drug\
safety?
a. Allowing\ pharmaceutical\ companies\ to\ identify\ off-label\ uses\ of\ medications\
approved\ for\ other\ uses
b. Evaluating\ drug\ safety\ information\ that\ emerges\ after\ a\ drug\ has\ been\ approved\ and\ is\
in\ use
c. Expediting\ the\ approval\ process\ of\ the\ U.S.\ Food\ and\ Drug\ Administration\ (FDA)\ so\
that\ needed\ drugs\ can\ get\ to\ market\ more\ quickly
d. Requiring\ manufacturers\ to\ notify\ patients\ before\ removing\ a\ drug\ from\ the\ market
ANS:\ B
The\ FDAAA\ was\ passed\ to\ enable\ the\ Food\ and\ Drug\ Administration\ to\ continue\ oversight\ of\
a\ drug\ after\ granting\ it\ approval\ so\ that\ changes\ in\ labeling\ could\ be\ made\ as\ necessary\ and\
postmarketing\ risks\ could\ be\ tracked\ and\ identified.\ A\ provision\ of\ the\ FDA\ Modernization\
Act\ (FDAMA),\ passed\ in\ 1997,\ allows\ drug\ companies\ to\ promote\ their\ products\ for\ off-label\
uses\ as\ long\ as\ they\ promise\ to\ conduct\ studies\ to\ support\ their\ claims.\ Regulations\ to\ permit\
accelerated\ approval\ of\ drugs\ for\ life-threatening\ diseases\ were\ adopted\ in\ 1992\ by\ the\ FDA.
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
The\ requirement\ that\ drug\ companies\ notify\ patients\ 6\ months\ before\ removing\ a\ drug\ from\
the\ market\ is\ a\ provision\ of\ the\ FDAMA.
DIF:\ Cognitive\ Level:\ Comprehension REF:\ Landmark\Drug\Legislation\
TOP:\ Nursing\ Process:\ Evaluation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
3. A\ nursing\ student\ asks\ a\ nurse\ about\ pharmaceutical\ research\ and\ wants\ to\ know\ the\ purpose\
of\ randomization\ in\ drug\ trials.\ The\ nurse\ explains\ that\ randomization\ is\ used\ to:
a. ensure\ that\ differences\ in\ outcomes\ are\ the\ result\ of\ treatment\ and\ not\ differences\ in\
subjects.
b. compare\ the\ outcome\ caused\ by\ the\ treatment \ to\ the\ outcome\ caused\ by\ no\ treatment.
c. make\ sure\ that\ researchers\ are\ unaware\ of\ which\ subjects\ are\ in\ which\ group.
d. prevent\ subjects\ from\ knowing\ which\ group\ they\ are\ in\ and\ prevent\ preconception\
bias.
ANS:\ A
Randomization\ helps\ prevent\ allocation\ bias,\ which\ can\ occur\ when\ researchers\ place\ subjects\
with\ desired\ characteristics\ in\ the\ study\ group\ and\ other\ subjects\ in\ the\ control\ group\ so\ that\
differences\ in\ outcome\ are\ actually\ the\ result\ of\ differences\ in\ subjects\ and\ not\ treatment.
Comparing\ treatment\ outcome\ to\ no\ treatment\ outcome\ is\ the\ definition\ of\ a\ controlled\ study.\
The\ last\ two\ options\ describe\ the\ use\ of\ blinding\ in\ studies;\ blinding\ ensures\ that\ researchers\
or\ subjects\ (or\ both)\ are\ unaware\ of\ which\ subjects\ are\ in\ which\ group\ so\ that\ preconceptions\
about\ benefits\ and\ risks\ cannot\ bias\ the\ results.
DIF:\ Cognitive\ Level:\ Comprehension REF:\ The\ Randomized\ Drug\ Trial\
TOP:\ Nursing\ Process:\ Implementation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
4. Someone\ asks\ a\ nurse\ about\ a\ new\ drug\ that\ is\ in\ preclinical\ testing\ and\ wants\ to\ know\ why\ it
cannot\ be\ used\ to\ treat\ a\ friend‘s\ illness.\ Which\ statement\ by\ the\ nurse\ is\ correct?
a. ―A\ drug\ at\ this\ stage\ of\ development \ can\ be\ used\ only\ in\ patients\ with\ serious\ disease.‖
b. ―At\ this\ stage\ of\ drug\ development,\ the\ safety\ and\ usefulness\ of\ the\ medication\ is
unknown.‖
c. ―Clinical\ trials\ must\ be\ completed\ to\ make\ sure\ the\ drug\ is\ safe\ to\ use\ in\ humans.‖
d. ―Until\ postmarketing\ surveillance\ data\ are\ available,\ the\ drug\ cannot\ be\ used.‖
ANS:\ B
Preclinical\ testing\ must\ be\ completed\ before\ drugs\ can\ be\ tested\ in\ humans.\ In\ this\ stage,\
drugs\ are\ evaluated\ for\ toxicities,\ pharmacokinetic\ properties,\ and\ potentially\ useful\ effects.\
Some\ drugs\ can\ be\ used\ in\ patients\ before\ completion\ of\ Phase\ III\ studies,\ but\ this\ is\ after\
preclinical\ testing\ is\ complete.\ Clinical\ trials\ proceed\ in\ stages,\ and\ each\ stage\ has\ guidelines\
defining\ how\ a\ new\ drug\ may\ be\ used\ and\ which\ patients\ may\ receive\ it.\ Postmarketing\
surveillance\ takes\ place\ after\ a\ drug\ is\ in\ general\ use.
DIF:\ Cognitive\ Level:\ Comprehension
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
REF:\ Landmark\ Drug\ Legislation\ |\ Stages\ of\ Drug\ Development\
TOP:\ Nursing\ Process:\ Implementation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Reduction\ of\ Risk\ Potential
5. A\ patient\ asks\ a\ nurse\ why\ drugs\ that\ have\ been\ approved\ by\ the\ FDA\ still\ have\ unknown\
side\ effects.\ The\ nurse\ tell\ the\ patient\ that:
a. testing\ for\ all\ side\ effects\ of\ a\ medication\ would\ be\ prohibitively\ expensive.
b. patients\ in\ drug\ trials\ often\ are\ biased\ by\ their\ preconceptions\ of\ a\ drug‘s\ benefits.
c. researchers\ tend\ to\ conduct\ studies\ that\ will\ prove\ the\ benefits\ of\ their\ new\ drugs.
d. subjects\ in\ drug\ trials\ do\ not\ always\ represent\ the\ full\ spectrum\ of\ possible\ patients.
ANS:\ D
All\ drug\ trials\ are\ limited\ by\ a\ relatively\ small\ group\ of\ subjects\ who\ may\ not\ have\ all\ the\
characteristics\ of\ people\ who\ will\ be\ using\ the\ drug;\ therefore,\ some\ side\ effects\ go\
undetected\ until\ the\ drug\ is\ in\ use.\ Although\ drug\ trials\ are\ very\ expensive,\ this\ is\ only\ an\
indirect\ reason\ they\ do\ not\ detect\ all\ side\ effects\ before\ approval.\ In\ theory,\ well-designed\
drug\ trials,\ using\ blinded\ studies,\ minimize\ or\ eliminate\ subject\ bias.\ Designing\ studies\ to\
prove\ desired\ results\ is\ unethical.
DIF:\ Cognitive\ Level:\ Analysis REF:\ Failure\ to\ Detect\ All\ Adverse\ Effects\
TOP:\ Nursing\ Process:\ Implementation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
6. A\ nurse\ is\ teaching\ nursing\ students\ about\ the\ use\ of\ nonproprietary\ names\ for\ drugs.\ The\
nurse\ tells\ them\ which\ fact\ about\ nonproprietary\ names?
a. They\ are\ approved\ by\ the\ FDA\ and\ are\ easy\ to\ remember.
b. They\ are\ assigned\ by\ the\ U.S.\ Adopted\ Names\ Council.
c. They\ clearly\ identify\ the\ drug‘s\ pharmacological\ classification.
d. They\ imply\ the\ efficacy\ of\ the\ drug\ and\ are\ less\ complex.
ANS:\ B
Nonproprietary,\ or\ generic,\ names\ are\ assigned\ by\ the\ U.S.\ Adopted\ Names\ Council,\ which\
ensures\ that\ each\ drug\ has\ only\ one\ name.\ Trade\ names,\ or\ brand\ names,\ are\ approved\ by\ the\
FDA\ and\ are\ easier\ to\ remember.\ Some\ nonproprietary\ names\ contain\ syllables\ that\ identify\
the\ classification,\ although\ not\ all\ do.\ Drug\ names\ are\ not\ supposed\ to\ identify\ the\ use\ for\ the\
drug,\ although\ some\ brand\ names\ do\ so.
DIF:\ Cognitive\ Level:\ Comprehension\ REF:\ Drug\ Names:\ The\ Three\ Types\ of\ Drug\ Names\ TOP:\
Nursing\ Process:\ Diagnosis
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Reduction\ of\ Risk\ Potential
Chapter\4:\Pharmacokinetics\
Test\ Bank
MULTIPLE\ CHOICE
1. A\ patient\ tells\ the\ nurse\ that\ the\ oral\ drug\ that\ has\ been\ prescribed\ has\ caused\ a\ lot\ of\ stomach\
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
discomfort\ in\ the\ past.\ What\ will\ the\ nurse\ ask\ the\ prescriber?
a. Whether\ a\ sublingual\ form\ of\ the\ medication\ can\ be\ given
b. Whether\ the\ medication\ can\ be\ given\ by\ a\ parenteral\ route\ instead
c. To\ order\ an\ enteric-coated\ form\ of\ the\ drug
d. Whether\ the\ patient\ can\ receive\ a\ sustained-release\ preparation\ of\ the\ drug
ANS:\ C
Enteric-coated\ drugs\ are\ preparations\ that\ have\ been\ coated\ with\ a\ material\ that\ dissolves\ in\
the\ intestines,\ not\ the\ stomach.\ This\ coating\ is\ used\ either\ to\ protect\ the\ drug\ from\ stomach\
acid\ and\ pepsin\ or\ to\ protect\ the\ stomach\ from\ a\ drug\ that\ can\ cause\ gastric\ upset.\ Sublingual\
forms\ often\ are\ used\ for\ drugs\ that\ undergo\ rapid\ inactivation\ during\ the\ first\ pass\ through\ the\
hepatic\ circulation\ so\ that\ the\ drug\ can\ be\ absorbed\ directly\ into\ the\ systemic\ circulation.
Parenteral\ routes\ are\ more\ costly\ and\ less\ safe\ than\ oral\ administration\ and\ should\ not\ be\ used\
unless\ necessary.\ A\ sustained-release\ preparation\ is\ used\ to\ release\ the\ drug\ into\ the\ body\
over\ a\ specific\ period\ to\ reduce\ the\ number\ of\ daily\ doses\ required\ to\ sustain\ therapeutic\
drug\ levels.
DIF:\ Cognitive\ Level:\ Application
REF:\ Comparing\ Oral\ Administration\ with\ Parenteral\ Administration\
TOP:\ Nursing\ Process:\ Implementation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
2. A\ patient\ claims\ to\ get\ better\ effects\ with\ a\ tablet\ of\ Brand\ X\ of\ a\ drug\ than\ with\ a\ tablet\ of\
Brand\ Y\ of\ the\ same\ drug.\ Both\ brands\ contain\ the\ same\ amount\ of\ the\ active\ ingredient.\
What\ does\ the\ nurse\ know\ to\ be\ most\ likely?
a. Advertising\ by\ pharmaceutical\ companies\ can\ enhance\ patient\ expectations\ of\ one\ brand\
over\ another,\ leading\ to\ a\ placebo\ effect.
b. Because\ the\ drug\ preparations\ are\ chemically\ equivalent,\ the\ effects\ of\ the\ two\ brands\
must\ be\ identical.
c. Tablets\ can\ differ\ in\ composition\ and\ can\ have\ differing\ rates\ of\ disintegration\ and
dissolution,\ which\ can\ alter\ the\ drug‘s\ effects\ in\ the\ body.
d. The\ bioavailability\ of\ a\ drug\ is\ determined\ by\ the\ amount\ of\ the\ drug\ in\ each\ dose.
ANS:\ C
Even\ if\ two\ brands\ of\ a\ drug\ are\ chemically\ equivalent\ (i.e.,\ they\ have\ identical\ amounts\ of\
the\ same\ chemical\ compound),\ they\ can\ have\ different\ effects\ in\ the\ body\ if\ they\ differ\ in\
bioavailability.\ Tablets\ made\ by\ different\ manufacturers\ contain\ different\ binders\ and\ fillers,\
which\ disintegrate\ and\ dissolve\ at\ different\ rates\ and\ affect\ the\ bioavailability\ of\ the\ drug.
Two\ brands\ may\ be\ chemically\ equivalent\ and\ still\ differ\ in\ bioavailability,\ which\ is\ not\
determined\ by\ the\ amount\ of\ drug\ in\ the\ dose.
DIF:\ Cognitive\ Level:\ Application
REF:\ Pharmaceutical\ Preparations\ for\ Oral\ Administration TOP:\ Nursing\ Process:\ Diagnosis\
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
Psychopharmacology FINAL EXAM 3
Chapter 3: Drug Regulation, Development, Names, and Information
Test Bank
MULTIPLE CHOICE
1. A nurse educator\ is\ conducting\ a\ continuing\ education\ class\ on\ pharmacology.\ To\ evaluate\
the\ learning\ of\ the\ nurses\ in\ the\ class,\ the\ nurse\ educator\ asks,\ ―Which\ drug\ name\ is\ a\
generic\ drug\ name?‖\ Which\ is\ the\ correct\ response?\ a.\ Acetaminophen
b. Tylenol
c. Cipro
d. Motrin
ANS:\ A
Acetaminophen\ is\ the\ generic\ name.\ Tylenol,\ Cipro,\ and\ Motrin\ are\ all\ trade\ names.
DIF:\ Cognitive\ Level:\ Comprehension REF:\ Table\ 3-3:\ The\ Three\ Types\ of\ Drug\
Names\ TOP:\ Nursing\ Process:\ Diagnosis
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
2. The\ FDA\ Amendments\ Act\ (FDAAA)\ was\ passed\ in\ 2007\ to\ address\ which\ aspect\ of\ drug\
safety?
a. Allowing\ pharmaceutical\ companies\ to\ identify\ off-label\ uses\ of\ medications\
approved\ for\ other\ uses
b. Evaluating\ drug\ safety\ information\ that\ emerges\ after\ a\ drug\ has\ been\ approved\ and\ is\
in\ use
c. Expediting\ the\ approval\ process\ of\ the\ U.S.\ Food\ and\ Drug\ Administration\ (FDA)\ so\
that\ needed\ drugs\ can\ get\ to\ market\ more\ quickly
d. Requiring\ manufacturers\ to\ notify\ patients\ before\ removing\ a\ drug\ from\ the\ market
ANS:\ B
The\ FDAAA\ was\ passed\ to\ enable\ the\ Food\ and\ Drug\ Administration\ to\ continue\ oversight\ of\
a\ drug\ after\ granting\ it\ approval\ so\ that\ changes\ in\ labeling\ could\ be\ made\ as\ necessary\ and\
postmarketing\ risks\ could\ be\ tracked\ and\ identified.\ A\ provision\ of\ the\ FDA\ Modernization\
Act\ (FDAMA),\ passed\ in\ 1997,\ allows\ drug\ companies\ to\ promote\ their\ products\ for\ off-label\
uses\ as\ long\ as\ they\ promise\ to\ conduct\ studies\ to\ support\ their\ claims.\ Regulations\ to\ permit\
accelerated\ approval\ of\ drugs\ for\ life-threatening\ diseases\ were\ adopted\ in\ 1992\ by\ the\ FDA.
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
The\ requirement\ that\ drug\ companies\ notify\ patients\ 6\ months\ before\ removing\ a\ drug\ from\
the\ market\ is\ a\ provision\ of\ the\ FDAMA.
DIF:\ Cognitive\ Level:\ Comprehension REF:\ Landmark\Drug\Legislation\
TOP:\ Nursing\ Process:\ Evaluation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
3. A\ nursing\ student\ asks\ a\ nurse\ about\ pharmaceutical\ research\ and\ wants\ to\ know\ the\ purpose\
of\ randomization\ in\ drug\ trials.\ The\ nurse\ explains\ that\ randomization\ is\ used\ to:
a. ensure\ that\ differences\ in\ outcomes\ are\ the\ result\ of\ treatment\ and\ not\ differences\ in\
subjects.
b. compare\ the\ outcome\ caused\ by\ the\ treatment \ to\ the\ outcome\ caused\ by\ no\ treatment.
c. make\ sure\ that\ researchers\ are\ unaware\ of\ which\ subjects\ are\ in\ which\ group.
d. prevent\ subjects\ from\ knowing\ which\ group\ they\ are\ in\ and\ prevent\ preconception\
bias.
ANS:\ A
Randomization\ helps\ prevent\ allocation\ bias,\ which\ can\ occur\ when\ researchers\ place\ subjects\
with\ desired\ characteristics\ in\ the\ study\ group\ and\ other\ subjects\ in\ the\ control\ group\ so\ that\
differences\ in\ outcome\ are\ actually\ the\ result\ of\ differences\ in\ subjects\ and\ not\ treatment.
Comparing\ treatment\ outcome\ to\ no\ treatment\ outcome\ is\ the\ definition\ of\ a\ controlled\ study.\
The\ last\ two\ options\ describe\ the\ use\ of\ blinding\ in\ studies;\ blinding\ ensures\ that\ researchers\
or\ subjects\ (or\ both)\ are\ unaware\ of\ which\ subjects\ are\ in\ which\ group\ so\ that\ preconceptions\
about\ benefits\ and\ risks\ cannot\ bias\ the\ results.
DIF:\ Cognitive\ Level:\ Comprehension REF:\ The\ Randomized\ Drug\ Trial\
TOP:\ Nursing\ Process:\ Implementation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
4. Someone\ asks\ a\ nurse\ about\ a\ new\ drug\ that\ is\ in\ preclinical\ testing\ and\ wants\ to\ know\ why\ it
cannot\ be\ used\ to\ treat\ a\ friend‘s\ illness.\ Which\ statement\ by\ the\ nurse\ is\ correct?
a. ―A\ drug\ at\ this\ stage\ of\ development \ can\ be\ used\ only\ in\ patients\ with\ serious\ disease.‖
b. ―At\ this\ stage\ of\ drug\ development,\ the\ safety\ and\ usefulness\ of\ the\ medication\ is
unknown.‖
c. ―Clinical\ trials\ must\ be\ completed\ to\ make\ sure\ the\ drug\ is\ safe\ to\ use\ in\ humans.‖
d. ―Until\ postmarketing\ surveillance\ data\ are\ available,\ the\ drug\ cannot\ be\ used.‖
ANS:\ B
Preclinical\ testing\ must\ be\ completed\ before\ drugs\ can\ be\ tested\ in\ humans.\ In\ this\ stage,\
drugs\ are\ evaluated\ for\ toxicities,\ pharmacokinetic\ properties,\ and\ potentially\ useful\ effects.\
Some\ drugs\ can\ be\ used\ in\ patients\ before\ completion\ of\ Phase\ III\ studies,\ but\ this\ is\ after\
preclinical\ testing\ is\ complete.\ Clinical\ trials\ proceed\ in\ stages,\ and\ each\ stage\ has\ guidelines\
defining\ how\ a\ new\ drug\ may\ be\ used\ and\ which\ patients\ may\ receive\ it.\ Postmarketing\
surveillance\ takes\ place\ after\ a\ drug\ is\ in\ general\ use.
DIF:\ Cognitive\ Level:\ Comprehension
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
REF:\ Landmark\ Drug\ Legislation\ |\ Stages\ of\ Drug\ Development\
TOP:\ Nursing\ Process:\ Implementation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Reduction\ of\ Risk\ Potential
5. A\ patient\ asks\ a\ nurse\ why\ drugs\ that\ have\ been\ approved\ by\ the\ FDA\ still\ have\ unknown\
side\ effects.\ The\ nurse\ tell\ the\ patient\ that:
a. testing\ for\ all\ side\ effects\ of\ a\ medication\ would\ be\ prohibitively\ expensive.
b. patients\ in\ drug\ trials\ often\ are\ biased\ by\ their\ preconceptions\ of\ a\ drug‘s\ benefits.
c. researchers\ tend\ to\ conduct\ studies\ that\ will\ prove\ the\ benefits\ of\ their\ new\ drugs.
d. subjects\ in\ drug\ trials\ do\ not\ always\ represent\ the\ full\ spectrum\ of\ possible\ patients.
ANS:\ D
All\ drug\ trials\ are\ limited\ by\ a\ relatively\ small\ group\ of\ subjects\ who\ may\ not\ have\ all\ the\
characteristics\ of\ people\ who\ will\ be\ using\ the\ drug;\ therefore,\ some\ side\ effects\ go\
undetected\ until\ the\ drug\ is\ in\ use.\ Although\ drug\ trials\ are\ very\ expensive,\ this\ is\ only\ an\
indirect\ reason\ they\ do\ not\ detect\ all\ side\ effects\ before\ approval.\ In\ theory,\ well-designed\
drug\ trials,\ using\ blinded\ studies,\ minimize\ or\ eliminate\ subject\ bias.\ Designing\ studies\ to\
prove\ desired\ results\ is\ unethical.
DIF:\ Cognitive\ Level:\ Analysis REF:\ Failure\ to\ Detect\ All\ Adverse\ Effects\
TOP:\ Nursing\ Process:\ Implementation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
6. A\ nurse\ is\ teaching\ nursing\ students\ about\ the\ use\ of\ nonproprietary\ names\ for\ drugs.\ The\
nurse\ tells\ them\ which\ fact\ about\ nonproprietary\ names?
a. They\ are\ approved\ by\ the\ FDA\ and\ are\ easy\ to\ remember.
b. They\ are\ assigned\ by\ the\ U.S.\ Adopted\ Names\ Council.
c. They\ clearly\ identify\ the\ drug‘s\ pharmacological\ classification.
d. They\ imply\ the\ efficacy\ of\ the\ drug\ and\ are\ less\ complex.
ANS:\ B
Nonproprietary,\ or\ generic,\ names\ are\ assigned\ by\ the\ U.S.\ Adopted\ Names\ Council,\ which\
ensures\ that\ each\ drug\ has\ only\ one\ name.\ Trade\ names,\ or\ brand\ names,\ are\ approved\ by\ the\
FDA\ and\ are\ easier\ to\ remember.\ Some\ nonproprietary\ names\ contain\ syllables\ that\ identify\
the\ classification,\ although\ not\ all\ do.\ Drug\ names\ are\ not\ supposed\ to\ identify\ the\ use\ for\ the\
drug,\ although\ some\ brand\ names\ do\ so.
DIF:\ Cognitive\ Level:\ Comprehension\ REF:\ Drug\ Names:\ The\ Three\ Types\ of\ Drug\ Names\ TOP:\
Nursing\ Process:\ Diagnosis
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Reduction\ of\ Risk\ Potential
Chapter\4:\Pharmacokinetics\
Test\ Bank
MULTIPLE\ CHOICE
1. A\ patient\ tells\ the\ nurse\ that\ the\ oral\ drug\ that\ has\ been\ prescribed\ has\ caused\ a\ lot\ of\ stomach\
, Test Bank Lehne's Pharmacology for Nursing Care, 11th
Edition by Jacqueline Burchum, Laura Rosenthal Chapter 1-
112|Complete Guide A+
discomfort\ in\ the\ past.\ What\ will\ the\ nurse\ ask\ the\ prescriber?
a. Whether\ a\ sublingual\ form\ of\ the\ medication\ can\ be\ given
b. Whether\ the\ medication\ can\ be\ given\ by\ a\ parenteral\ route\ instead
c. To\ order\ an\ enteric-coated\ form\ of\ the\ drug
d. Whether\ the\ patient\ can\ receive\ a\ sustained-release\ preparation\ of\ the\ drug
ANS:\ C
Enteric-coated\ drugs\ are\ preparations\ that\ have\ been\ coated\ with\ a\ material\ that\ dissolves\ in\
the\ intestines,\ not\ the\ stomach.\ This\ coating\ is\ used\ either\ to\ protect\ the\ drug\ from\ stomach\
acid\ and\ pepsin\ or\ to\ protect\ the\ stomach\ from\ a\ drug\ that\ can\ cause\ gastric\ upset.\ Sublingual\
forms\ often\ are\ used\ for\ drugs\ that\ undergo\ rapid\ inactivation\ during\ the\ first\ pass\ through\ the\
hepatic\ circulation\ so\ that\ the\ drug\ can\ be\ absorbed\ directly\ into\ the\ systemic\ circulation.
Parenteral\ routes\ are\ more\ costly\ and\ less\ safe\ than\ oral\ administration\ and\ should\ not\ be\ used\
unless\ necessary.\ A\ sustained-release\ preparation\ is\ used\ to\ release\ the\ drug\ into\ the\ body\
over\ a\ specific\ period\ to\ reduce\ the\ number\ of\ daily\ doses\ required\ to\ sustain\ therapeutic\
drug\ levels.
DIF:\ Cognitive\ Level:\ Application
REF:\ Comparing\ Oral\ Administration\ with\ Parenteral\ Administration\
TOP:\ Nursing\ Process:\ Implementation
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
2. A\ patient\ claims\ to\ get\ better\ effects\ with\ a\ tablet\ of\ Brand\ X\ of\ a\ drug\ than\ with\ a\ tablet\ of\
Brand\ Y\ of\ the\ same\ drug.\ Both\ brands\ contain\ the\ same\ amount\ of\ the\ active\ ingredient.\
What\ does\ the\ nurse\ know\ to\ be\ most\ likely?
a. Advertising\ by\ pharmaceutical\ companies\ can\ enhance\ patient\ expectations\ of\ one\ brand\
over\ another,\ leading\ to\ a\ placebo\ effect.
b. Because\ the\ drug\ preparations\ are\ chemically\ equivalent,\ the\ effects\ of\ the\ two\ brands\
must\ be\ identical.
c. Tablets\ can\ differ\ in\ composition\ and\ can\ have\ differing\ rates\ of\ disintegration\ and
dissolution,\ which\ can\ alter\ the\ drug‘s\ effects\ in\ the\ body.
d. The\ bioavailability\ of\ a\ drug\ is\ determined\ by\ the\ amount\ of\ the\ drug\ in\ each\ dose.
ANS:\ C
Even\ if\ two\ brands\ of\ a\ drug\ are\ chemically\ equivalent\ (i.e.,\ they\ have\ identical\ amounts\ of\
the\ same\ chemical\ compound),\ they\ can\ have\ different\ effects\ in\ the\ body\ if\ they\ differ\ in\
bioavailability.\ Tablets\ made\ by\ different\ manufacturers\ contain\ different\ binders\ and\ fillers,\
which\ disintegrate\ and\ dissolve\ at\ different\ rates\ and\ affect\ the\ bioavailability\ of\ the\ drug.
Two\ brands\ may\ be\ chemically\ equivalent\ and\ still\ differ\ in\ bioavailability,\ which\ is\ not\
determined\ by\ the\ amount\ of\ drug\ in\ the\ dose.
DIF:\ Cognitive\ Level:\ Application
REF:\ Pharmaceutical\ Preparations\ for\ Oral\ Administration TOP:\ Nursing\ Process:\ Diagnosis\
MSC:\ NCLEX\ Client\ Needs\ Category:\ Physiologic\ Integrity:\ Pharmacologic\ and\ Parenteral\ Therapies
