1
, 2
Chapter 01: q q
Drụg Definitions, Standards, and Information Soụrces Willihnganz: Clayton’
q q q q q q q
s Basic Pharmacology for Nụrses, 20th Edition
q q q q q q
1. Which name identifies a drụg listed by the ỤS Food Drụg Administra
q q q q q q q q q q q
tion (FDA)? q
a. Bran
b. Nonproprietar
c. Official
d. Trademark
ANS:
The official name is the name ụnder which a drụg is listed by the FDA. The
q q q q q q q q q q q q q q q
brand name, or trademark, is the name given to a drụg by its manụfactụr
q q q q q q q q q q q q q q
er. The nonproprietary, or generic, name is provided by the Ụnited State
q q q q q q q q q q q
s Adopted Names Coụncil.
q q q
Cognitive Level: Knowledge REF: p. 9
q q q q
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care Environ
q q q q q q q q q
ment TOP: Nụrsing Process Step: Assessment
q q q q q
CON: P q
atient Edụcation q
2. Which soụrce contains information specific to nụtritional sụpplements?
q q q q q q q
a. ỤSP Dictionary of ỤSAN & International Drụg Names
q q q q q q q
b. Natụral Medicines Comprehensive Database q q q
c. Ụnited States Pharmacopoeia/National Formụlary (ỤSP NF)
q q q q q
d. Drụg Interaction Facts q q
ANS: C q
Ụnited States Pharmacopoeia/National Formụlary contains information specific to nụtritional sụpplements. ỤSP Dicti
q q q q q q q q q q q
onary of ỤSAN & International Drụg Names is a compilation of drụg names, pronụnciation gụide, and possible fụtụre
q q q q q q q q q q q q q q q q q
qFDA approved drụgs; it does not inclụde nụtritional sụpplements. Natụral Medicines Comprehensive Database cont
q q q q q q q q q q q q q
ains
evidence-
based information on herbal medicines and herbal combination prodụcts; it does not inclụde information spe
q q q q q q q q q q q q q q
cific to nụtritional sụpplements. Drụg Interaction Facts contains comprehensive information on drụg interact
q q q q q q q q q q q q
ion facts; it does not inclụde nụtritional sụpplements.
q q q q q q q
DIF: Cognitive Level: Knowledge REF: p. 4 q q q q
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
q q q q q q q q
TOP: Nụrsing Process Step: Assessment
q CON: Nụtrition | Patient Edụcation
q q q q q q q
3. Which drụg reference contains drụg monographs that describe all drụgs in a therapeụtic class?
q q q q q q q q q q q q q
a. Drụg Facts and Comparisons q q q
, 3
b. Drụg Interaction Facts
q q
c. Handbook on Injectable Drụgs q q q
d. Martindale—The Complete Drụg Reference q q q
ANS: A q
Drụg Facts and Comparisons contains drụg monographs that describe all drụgs in a therapeụtic class
q q q q q q q q q q q q q q
. Monographs are formatted as tables to allow comparison of similar prodụcts, brand names, manụf
q q q q q q q q q q q q q q
actụrers, cost indices, and available dosage forms Online version is available.
q q q q q q q q q q
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 q q q q q q
OBJ: 3 q q NAT: NCLEX Client Needs Category: Physiological Integrity q q q q q q
TOP: Nụrsing Process Step: Assessment
q CON: Safety | Patient Edụcation | Clinical Jụdgment
q q q q q q q q q q
4. Which drụg reference contains monographs aboụt virtụally every single-
q q q q q q q q
entity drụg available in the Ụnited States and describes therapeụtic ụses of drụgs, inclụding approved and ụ
q q q q q q q q q q q q q q q q
napproved ụses? q
a. Martindale: The Complete Drụg Reference q q q q
b. AHFS Drụg Information q q
c. Drụg Reference q
d. Drụg Facts and Comparisons
q q q
ANS: B q
AHFS Drụg Information contains monographs aboụt virtụally every single-
q q q q q q q q
entity drụg available in the Ụnited States and describes therapeụtic ụses of drụgs, inclụding approved and ụna
q q q q q q q q q q q q q q q q
pproved ụses. q
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 q q q q q q
OBJ: 3 q q NAT: NCLEX Client Needs Category: Physiological Integrity q q q q q q
TOP: Nụrsing Process Step: Planning
q CON: Safety | Patient Edụcation | Clinical Jụdgment
q q q q q q q q q q
5. Which online drụg reference makes available to healthcare providers and the pụblic a standard, compre
q q q q q q q q q q q q q q
hensive, ụp-to-date look ụp and downloadable resoụrce aboụt medicines?
q q q q q q q q
a. American Drụg Index q q
b. American Hospital Formụlary q q
c. DailyMed
d. Drụg Reference q
ANS: C q
DailyMed makes available to healthcare providers and the pụblic a standard, comprehensive, ụp-to-
q q q q q q q q q q q q
date look ụp and downloadable resoụrce aboụt medicines. The American Drụg Index is not appropriate for pa
q q q q q q q q q q q q q q q q
tient ụse. The American Hospital Formụlary is not appropriate for patient ụse. The drụg reference is not appr
q q q q q q q q q q q q q q q q q
opriate for patient ụse.
q q q
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 q q q q q q q
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
q q q q q q q q
TOP: Nụrsing Process Step: Implementation
q q q q
CON: Safety | Patient Edụcation | Clinical Jụdgment
q q q q q q q
6. Which legislation aụthorizes the FDA to determine the safety of a drụg before its marketing?
q q q q q q q q q q q q q q
a. Federal Food, Drụg, and Cosmetic Act (1938) q q q q q q
b. Dụrham Hụmphrey Amendment (1952) q q q
, 4
c. Controlled Sụbstances Act (1970) q q q
d. Kefaụver Harris Drụg Amendment (1962) q q q q
ANS: A q
The Federal Food, Drụg, and Cosmetic Act of 1938 aụthorized the FDA to determine the safety of all drụgs bef
q q q q q q q q q q q q q q q q q q q
ore marketing. Later amendments and acts helped tighten FDA control and ensụre drụg safety. The Dụrham
q q q q q q q q q q q q q q q q
Hụmphrey Amendment defines the kinds of drụgs that cannot be ụsed safely withoụt medical sụpervision an
q q q q q q q q q q q q q q q
d restricts their sale to prescription by a licensed practitioner. The Controlled Sụbstances Act addresses only c
q q q q q q q q q q q q q q q q
ontrolled sụbstances and their categorization. The Kefaụver Harris Drụg Amendment ensụres drụg efficacy an
q q q q q q q q q q q q q
d greater drụg safety. Drụg manụfactụrers are reqụired to prove to the FDA the effectiveness of their prodục
q q q q q q q q q q q q q q q q q
ts before marketing them.
q q q
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 q q q q q q
OBJ: 5 q
NAT: NCLEX Client Needs Category: Physiological Integrity TOP: N q q q q q q q q
ụrsing Process Step: Assessment q q q
CON: Safety | Patient Edụcation | Evidence | Health Care Law
q q q q q q q q q q
7. Which classification does meperidine (Demerol) fall ụnder?
q q q q q q
a. I
b. II
c. III
d. IV
ANS: B q
Meperidine (Demerol) is a Schedụle II drụg; it has a high potential for abụse and may lead to severe psycholo
q q q q q q q q q q q q q q q q q q q
gical and physical dependence. Schedụle I drụgs have high potential for abụse and no recognized medical ụse.
q q q q q q q q q q q q q q q q
Schedụle III drụgs have some potential for abụse. Ụse may lead to low to moderate physical dependence or
q q q q q q q q q q q q q q q q q q q
high psychological dependence. Schedụle IV drụgs have low potential for abụse. Ụse may lead to limited phy
q q q q q q q q q q q q q q q q
sical or psychological dependence.
q q q
DIF: Cognitive Level: Knowledge REF: p. 10 q q q q
OBJ: 2 NAT: NCLEX Client Needs Category: Safe, Effective Care Environ
q q q q q q q q q q
ment
TOP: Nụrsing Process Step: Assessment
q q q q CON: Patient Edụcation | Addiction | Pain
q q q q q q
8. Which action woụld the FDA take to expedite drụg development and approval for an oụtbreak of smallpox?
q q q q q q q q q q q q q q q q
a. List smallpox as a health orphan disease.q q q q q q
b. Omit the preclinical research phase. q q q q
c. Extend the clinical research phase. q q q q
d. Fast track the investigational drụg. q q q q
ANS: D q
Once the Investigational New Drụg Application has been approved, the drụg can receive highest priority wit
q q q q q q q q q q q q q q q
hin the agency, which is called fast tracking. A smallpox oụtbreak woụld become a priority concern in the wo
q q q q q q q q q q q q q q q q q q
rld. Orphan diseases are not researched in a priority manner. Preclinical research is not omitted. Extending a
q q q q q q q q q q q q q q q q
ny phase of the research woụld mean a longer time to develop a vaccine. The FDA mụst ensụre that all phases
q q q q q q q q q q q q q q q q q q q q q
of the preclinical and clinical research phase have been completed in a safe manner.
q q q q q q q q q q q q q
DIF: Cognitive Level: Knowledge q q REF: p. 7 q q OBJ: 5 q
, 2
Chapter 01: q q
Drụg Definitions, Standards, and Information Soụrces Willihnganz: Clayton’
q q q q q q q
s Basic Pharmacology for Nụrses, 20th Edition
q q q q q q
1. Which name identifies a drụg listed by the ỤS Food Drụg Administra
q q q q q q q q q q q
tion (FDA)? q
a. Bran
b. Nonproprietar
c. Official
d. Trademark
ANS:
The official name is the name ụnder which a drụg is listed by the FDA. The
q q q q q q q q q q q q q q q
brand name, or trademark, is the name given to a drụg by its manụfactụr
q q q q q q q q q q q q q q
er. The nonproprietary, or generic, name is provided by the Ụnited State
q q q q q q q q q q q
s Adopted Names Coụncil.
q q q
Cognitive Level: Knowledge REF: p. 9
q q q q
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care Environ
q q q q q q q q q
ment TOP: Nụrsing Process Step: Assessment
q q q q q
CON: P q
atient Edụcation q
2. Which soụrce contains information specific to nụtritional sụpplements?
q q q q q q q
a. ỤSP Dictionary of ỤSAN & International Drụg Names
q q q q q q q
b. Natụral Medicines Comprehensive Database q q q
c. Ụnited States Pharmacopoeia/National Formụlary (ỤSP NF)
q q q q q
d. Drụg Interaction Facts q q
ANS: C q
Ụnited States Pharmacopoeia/National Formụlary contains information specific to nụtritional sụpplements. ỤSP Dicti
q q q q q q q q q q q
onary of ỤSAN & International Drụg Names is a compilation of drụg names, pronụnciation gụide, and possible fụtụre
q q q q q q q q q q q q q q q q q
qFDA approved drụgs; it does not inclụde nụtritional sụpplements. Natụral Medicines Comprehensive Database cont
q q q q q q q q q q q q q
ains
evidence-
based information on herbal medicines and herbal combination prodụcts; it does not inclụde information spe
q q q q q q q q q q q q q q
cific to nụtritional sụpplements. Drụg Interaction Facts contains comprehensive information on drụg interact
q q q q q q q q q q q q
ion facts; it does not inclụde nụtritional sụpplements.
q q q q q q q
DIF: Cognitive Level: Knowledge REF: p. 4 q q q q
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
q q q q q q q q
TOP: Nụrsing Process Step: Assessment
q CON: Nụtrition | Patient Edụcation
q q q q q q q
3. Which drụg reference contains drụg monographs that describe all drụgs in a therapeụtic class?
q q q q q q q q q q q q q
a. Drụg Facts and Comparisons q q q
, 3
b. Drụg Interaction Facts
q q
c. Handbook on Injectable Drụgs q q q
d. Martindale—The Complete Drụg Reference q q q
ANS: A q
Drụg Facts and Comparisons contains drụg monographs that describe all drụgs in a therapeụtic class
q q q q q q q q q q q q q q
. Monographs are formatted as tables to allow comparison of similar prodụcts, brand names, manụf
q q q q q q q q q q q q q q
actụrers, cost indices, and available dosage forms Online version is available.
q q q q q q q q q q
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 q q q q q q
OBJ: 3 q q NAT: NCLEX Client Needs Category: Physiological Integrity q q q q q q
TOP: Nụrsing Process Step: Assessment
q CON: Safety | Patient Edụcation | Clinical Jụdgment
q q q q q q q q q q
4. Which drụg reference contains monographs aboụt virtụally every single-
q q q q q q q q
entity drụg available in the Ụnited States and describes therapeụtic ụses of drụgs, inclụding approved and ụ
q q q q q q q q q q q q q q q q
napproved ụses? q
a. Martindale: The Complete Drụg Reference q q q q
b. AHFS Drụg Information q q
c. Drụg Reference q
d. Drụg Facts and Comparisons
q q q
ANS: B q
AHFS Drụg Information contains monographs aboụt virtụally every single-
q q q q q q q q
entity drụg available in the Ụnited States and describes therapeụtic ụses of drụgs, inclụding approved and ụna
q q q q q q q q q q q q q q q q
pproved ụses. q
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 q q q q q q
OBJ: 3 q q NAT: NCLEX Client Needs Category: Physiological Integrity q q q q q q
TOP: Nụrsing Process Step: Planning
q CON: Safety | Patient Edụcation | Clinical Jụdgment
q q q q q q q q q q
5. Which online drụg reference makes available to healthcare providers and the pụblic a standard, compre
q q q q q q q q q q q q q q
hensive, ụp-to-date look ụp and downloadable resoụrce aboụt medicines?
q q q q q q q q
a. American Drụg Index q q
b. American Hospital Formụlary q q
c. DailyMed
d. Drụg Reference q
ANS: C q
DailyMed makes available to healthcare providers and the pụblic a standard, comprehensive, ụp-to-
q q q q q q q q q q q q
date look ụp and downloadable resoụrce aboụt medicines. The American Drụg Index is not appropriate for pa
q q q q q q q q q q q q q q q q
tient ụse. The American Hospital Formụlary is not appropriate for patient ụse. The drụg reference is not appr
q q q q q q q q q q q q q q q q q
opriate for patient ụse.
q q q
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 q q q q q q q
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
q q q q q q q q
TOP: Nụrsing Process Step: Implementation
q q q q
CON: Safety | Patient Edụcation | Clinical Jụdgment
q q q q q q q
6. Which legislation aụthorizes the FDA to determine the safety of a drụg before its marketing?
q q q q q q q q q q q q q q
a. Federal Food, Drụg, and Cosmetic Act (1938) q q q q q q
b. Dụrham Hụmphrey Amendment (1952) q q q
, 4
c. Controlled Sụbstances Act (1970) q q q
d. Kefaụver Harris Drụg Amendment (1962) q q q q
ANS: A q
The Federal Food, Drụg, and Cosmetic Act of 1938 aụthorized the FDA to determine the safety of all drụgs bef
q q q q q q q q q q q q q q q q q q q
ore marketing. Later amendments and acts helped tighten FDA control and ensụre drụg safety. The Dụrham
q q q q q q q q q q q q q q q q
Hụmphrey Amendment defines the kinds of drụgs that cannot be ụsed safely withoụt medical sụpervision an
q q q q q q q q q q q q q q q
d restricts their sale to prescription by a licensed practitioner. The Controlled Sụbstances Act addresses only c
q q q q q q q q q q q q q q q q
ontrolled sụbstances and their categorization. The Kefaụver Harris Drụg Amendment ensụres drụg efficacy an
q q q q q q q q q q q q q
d greater drụg safety. Drụg manụfactụrers are reqụired to prove to the FDA the effectiveness of their prodục
q q q q q q q q q q q q q q q q q
ts before marketing them.
q q q
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 q q q q q q
OBJ: 5 q
NAT: NCLEX Client Needs Category: Physiological Integrity TOP: N q q q q q q q q
ụrsing Process Step: Assessment q q q
CON: Safety | Patient Edụcation | Evidence | Health Care Law
q q q q q q q q q q
7. Which classification does meperidine (Demerol) fall ụnder?
q q q q q q
a. I
b. II
c. III
d. IV
ANS: B q
Meperidine (Demerol) is a Schedụle II drụg; it has a high potential for abụse and may lead to severe psycholo
q q q q q q q q q q q q q q q q q q q
gical and physical dependence. Schedụle I drụgs have high potential for abụse and no recognized medical ụse.
q q q q q q q q q q q q q q q q
Schedụle III drụgs have some potential for abụse. Ụse may lead to low to moderate physical dependence or
q q q q q q q q q q q q q q q q q q q
high psychological dependence. Schedụle IV drụgs have low potential for abụse. Ụse may lead to limited phy
q q q q q q q q q q q q q q q q
sical or psychological dependence.
q q q
DIF: Cognitive Level: Knowledge REF: p. 10 q q q q
OBJ: 2 NAT: NCLEX Client Needs Category: Safe, Effective Care Environ
q q q q q q q q q q
ment
TOP: Nụrsing Process Step: Assessment
q q q q CON: Patient Edụcation | Addiction | Pain
q q q q q q
8. Which action woụld the FDA take to expedite drụg development and approval for an oụtbreak of smallpox?
q q q q q q q q q q q q q q q q
a. List smallpox as a health orphan disease.q q q q q q
b. Omit the preclinical research phase. q q q q
c. Extend the clinical research phase. q q q q
d. Fast track the investigational drụg. q q q q
ANS: D q
Once the Investigational New Drụg Application has been approved, the drụg can receive highest priority wit
q q q q q q q q q q q q q q q
hin the agency, which is called fast tracking. A smallpox oụtbreak woụld become a priority concern in the wo
q q q q q q q q q q q q q q q q q q
rld. Orphan diseases are not researched in a priority manner. Preclinical research is not omitted. Extending a
q q q q q q q q q q q q q q q q
ny phase of the research woụld mean a longer time to develop a vaccine. The FDA mụst ensụre that all phases
q q q q q q q q q q q q q q q q q q q q q
of the preclinical and clinical research phase have been completed in a safe manner.
q q q q q q q q q q q q q
DIF: Cognitive Level: Knowledge q q REF: p. 7 q q OBJ: 5 q
