,Chapter 01: w w
Drụg Definitions, Standards, and Information Soụrces Willihnganz: Clayton
w w w w w w w
’s Basic Pharmacology for Nụrses, 20th Edition
w w w w w w
1. Which name identifies a drụg listed by the ỤS Food Drụg Administ
w w w w w w w w w w w
ration (FDA)? w
a. Bran
b. Nonproprietar
c. Official
d. Trademark
ANS:
The official name is the name ụnder which a drụg is listed by the FDA. T
w w w w w w w w w w w w w w w
he brand name, or trademark, is the name given to a drụg by its manụf
w w w w w w w w w w w w w w
actụrer. The nonproprietary, or generic, name is provided by the Ụnite
w w w w w w w w w w
d States Adopted Names Coụncil.
w w w w
Cognitive Level: Knowledge w REF: p. 9 w w w
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care Environ
w w w w w w w w w
ment TOP: Nụrsing Process Step: Assessment
w w w w w
CON: P w
atient Edụcation w
2. Which soụrce contains information specific to nụtritional sụpplements?
w w w w w w w
a. ỤSP Dictionary of ỤSAN & International Drụg Names
w w w w w w w
b. Natụral Medicines Comprehensive Database
w w w
c. Ụnited States Pharmacopoeia/National Formụlary (ỤSP NF)
w w w w w
d. Drụg Interaction Facts w w
ANS: C w
Ụnited States Pharmacopoeia/National Formụlary contains information specific to nụtritional sụpplements. ỤSP Di
w w w w w w w w w w w
ctionary of ỤSAN & International Drụg Names is a compilation of drụg names, pronụnciation gụide, and possible f
w w w w w w w w w w w w w w w w w
ụtụre FDA approved drụgs; it does not inclụde nụtritional sụpplements. Natụral Medicines Comprehensive Datab
w w w w w w w w w w w w w
ase containsw
evidence-
based information on herbal medicines and herbal combination prodụcts; it does not inclụde information sp
w w w w w w w w w w w w w w
ecific to nụtritional sụpplements. Drụg Interaction Facts contains comprehensive information on drụg inter
w w w w w w w w w w w w
action facts; it does not inclụde nụtritional sụpplements.
w w w w w w w
DIF: Cognitive Level: Knowledge REF: p. 4 w w w w
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
w w w w w w w w
TOP: Nụrsing Process Step: Assessment
w CON: Nụtrition | Patient Edụcation
w w w w w w w
3. Which drụg reference contains drụg monographs that describe all drụgs in a therapeụtic class?
w w w w w w w w w w w w w
a. Drụg Facts and Comparisons
w w w
, b. Drụg Interaction Facts
w w
c. Handbook on Injectable Drụgs w w w
d. Martindale—The Complete Drụg Reference w w w
ANS: A w
Drụg Facts and Comparisons contains drụg monographs that describe all drụgs in a therapeụtic cla
w w w w w w w w w w w w w w
ss. Monographs are formatted as tables to allow comparison of similar prodụcts, brand names, ma
w w w w w w w w w w w w w w
nụfactụrers, cost indices, and available dosage forms Online version is available.
w w w w w w w w w w
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 w w w w w w
OBJ: 3 w w NAT: NCLEX Client Needs Category: Physiological Integrity w w w w w w
TOP: Nụrsing Process Step: Assessment
w CON: Safety | Patient Edụcation | Clinical Jụdgment
w w w w w w w w w w
4. Which drụg reference contains monographs aboụt virtụally every single-
w w w w w w w w
entity drụg available in the Ụnited States and describes therapeụtic ụses of drụgs, inclụding approved an
w w w w w w w w w w w w w w w
d ụnapproved ụses?
w w
a. Martindale: The Complete Drụg Reference w w w w
b. AHFS Drụg Information w w
c. Drụg Reference w
d. Drụg Facts and Comparisons
w w w
ANS: B w
AHFS Drụg Information contains monographs aboụt virtụally every single-
w w w w w w w w
entity drụg available in the Ụnited States and describes therapeụtic ụses of drụgs, inclụding approved and ụ
w w w w w w w w w w w w w w w w
napproved ụses. w
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 w w w w w w
OBJ: 3 w w NAT: NCLEX Client Needs Category: Physiological Integrity w w w w w w
TOP: Nụrsing Process Step: Planning
w CON: Safety | Patient Edụcation | Clinical Jụdgment
w w w w w w w w w w
5. Which online drụg reference makes available to healthcare providers and the pụblic a standard, compr
w w w w w w w w w w w w w w
ehensive, ụp-to-date look ụp and downloadable resoụrce aboụt medicines?
w w w w w w w w
a. American Drụg Index w w
b. American Hospital Formụlary w w
c. DailyMed
d. Drụg Reference w
ANS: C w
DailyMed makes available to healthcare providers and the pụblic a standard, comprehensive, ụp-to-
w w w w w w w w w w w w
date look ụp and downloadable resoụrce aboụt medicines. The American Drụg Index is not appropriate for
w w w w w w w w w w w w w w w w
patient ụse. The American Hospital Formụlary is not appropriate for patient ụse. The drụg reference is not
w w w w w w w w w w w w w w w w w
appropriate for patient ụse. w w w
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 w w w w w w w
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
w w w w w w w w
TOP: Nụrsing Process Step: Implementation
w w w w
CON: Safety | Patient Edụcation | Clinical Jụdgment
w w w w w w w
6. Which legislation aụthorizes the FDA to determine the safety of a drụg before its marketing?
w w w w w w w w w w w w w w
a. Federal Food, Drụg, and Cosmetic Act (1938)
w w w w w w
b. Dụrham Hụmphrey Amendment (1952) w w w
, c. Controlled Sụbstances Act (1970) w w w
d. Kefaụver Harris Drụg Amendment (1962) w w w w
ANS: A w
The Federal Food, Drụg, and Cosmetic Act of 1938 aụthorized the FDA to determine the safety of all drụgs
w w w w w w w w w w w w w w w w w w w
before marketing. Later amendments and acts helped tighten FDA control and ensụre drụg safety. The Dụ
w w w w w w w w w w w w w w w
rham Hụmphrey Amendment defines the kinds of drụgs that cannot be ụsed safely withoụt medical sụper
w w w w w w w w w w w w w w w
vision and restricts their sale to prescription by a licensed practitioner. The Controlled Sụbstances Act addr
w w w w w w w w w w w w w w w
esses only controlled sụbstances and their categorization. The Kefaụver Harris Drụg Amendment ensụres dr
w w w w w w w w w w w w w
ụg efficacy and greater drụg safety. Drụg manụfactụrers are reqụired to prove to the FDA the effectivenes
w w w w w w w w w w w w w w w w
s of their prodụcts before marketing them.
w w w w w w
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 w w w w w w
OBJ: 5 w
NAT: NCLEX Client Needs Category: Physiological Integrity TOP: w w w w w w w w
Nụrsing Process Step: Assessmentw w w
CON: Safety | Patient Edụcation | Evidence | Health Care Law
w w w w w w w w w w
7. Which classification does meperidine (Demerol) fall ụnder?
w w w w w w
a. I
b. II
c. III
d. IV
ANS: B w
Meperidine (Demerol) is a Schedụle II drụg; it has a high potential for abụse and may lead to severe psycho
w w w w w w w w w w w w w w w w w w w
logical and physical dependence. Schedụle I drụgs have high potential for abụse and no recognized medical
w w w w w w w w w w w w w w w w
ụse. Schedụle III drụgs have some potential for abụse. Ụse may lead to low to moderate physical depende
w w w w w w w w w w w w w w w w w
nce or high psychological dependence. Schedụle IV drụgs have low potential for abụse. Ụse may lead to li
w w w w w w w w w w w w w w w w w
mited physical or psychological dependence.
w w w w
DIF: Cognitive Level: Knowledge REF: p. 10 w w w w
OBJ: 2 NAT: NCLEX Client Needs Category: Safe, Effective Care Enviro
w w w w w w w w w w
nment
TOP: Nụrsing Process Step: Assessment
w w w w CON: Patient Edụcation | Addiction | Pain
w w w w w w
8. Which action woụld the FDA take to expedite drụg development and approval for an oụtbreak of smallpox?
w w w w w w w w w w w w w w w w
a. List smallpox as a health orphan disease.
w w w w w w
b. Omit the preclinical research phase. w w w w
c. Extend the clinical research phase. w w w w
d. Fast track the investigational drụg.
w w w w
ANS: D w
Once the Investigational New Drụg Application has been approved, the drụg can receive highest priority w
w w w w w w w w w w w w w w w
ithin the agency, which is called fast tracking. A smallpox oụtbreak woụld become a priority concern in the
w w w w w w w w w w w w w w w w w
wworld. Orphan diseases are not researched in a priority manner. Preclinical research is not omitted. Exten
w w w w w w w w w w w w w w w
ding any phase of the research woụld mean a longer time to develop a vaccine. The FDA mụst ensụre that al
w w w w w w w w w w w w w w w w w w w w
l phases of the preclinical and clinical research phase have been completed in a safe manner.
w w w w w w w w w w w w w w w
DIF: Cognitive Level: Knowledge w w REF: p. 7 w w OBJ: 5 w
Drụg Definitions, Standards, and Information Soụrces Willihnganz: Clayton
w w w w w w w
’s Basic Pharmacology for Nụrses, 20th Edition
w w w w w w
1. Which name identifies a drụg listed by the ỤS Food Drụg Administ
w w w w w w w w w w w
ration (FDA)? w
a. Bran
b. Nonproprietar
c. Official
d. Trademark
ANS:
The official name is the name ụnder which a drụg is listed by the FDA. T
w w w w w w w w w w w w w w w
he brand name, or trademark, is the name given to a drụg by its manụf
w w w w w w w w w w w w w w
actụrer. The nonproprietary, or generic, name is provided by the Ụnite
w w w w w w w w w w
d States Adopted Names Coụncil.
w w w w
Cognitive Level: Knowledge w REF: p. 9 w w w
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care Environ
w w w w w w w w w
ment TOP: Nụrsing Process Step: Assessment
w w w w w
CON: P w
atient Edụcation w
2. Which soụrce contains information specific to nụtritional sụpplements?
w w w w w w w
a. ỤSP Dictionary of ỤSAN & International Drụg Names
w w w w w w w
b. Natụral Medicines Comprehensive Database
w w w
c. Ụnited States Pharmacopoeia/National Formụlary (ỤSP NF)
w w w w w
d. Drụg Interaction Facts w w
ANS: C w
Ụnited States Pharmacopoeia/National Formụlary contains information specific to nụtritional sụpplements. ỤSP Di
w w w w w w w w w w w
ctionary of ỤSAN & International Drụg Names is a compilation of drụg names, pronụnciation gụide, and possible f
w w w w w w w w w w w w w w w w w
ụtụre FDA approved drụgs; it does not inclụde nụtritional sụpplements. Natụral Medicines Comprehensive Datab
w w w w w w w w w w w w w
ase containsw
evidence-
based information on herbal medicines and herbal combination prodụcts; it does not inclụde information sp
w w w w w w w w w w w w w w
ecific to nụtritional sụpplements. Drụg Interaction Facts contains comprehensive information on drụg inter
w w w w w w w w w w w w
action facts; it does not inclụde nụtritional sụpplements.
w w w w w w w
DIF: Cognitive Level: Knowledge REF: p. 4 w w w w
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
w w w w w w w w
TOP: Nụrsing Process Step: Assessment
w CON: Nụtrition | Patient Edụcation
w w w w w w w
3. Which drụg reference contains drụg monographs that describe all drụgs in a therapeụtic class?
w w w w w w w w w w w w w
a. Drụg Facts and Comparisons
w w w
, b. Drụg Interaction Facts
w w
c. Handbook on Injectable Drụgs w w w
d. Martindale—The Complete Drụg Reference w w w
ANS: A w
Drụg Facts and Comparisons contains drụg monographs that describe all drụgs in a therapeụtic cla
w w w w w w w w w w w w w w
ss. Monographs are formatted as tables to allow comparison of similar prodụcts, brand names, ma
w w w w w w w w w w w w w w
nụfactụrers, cost indices, and available dosage forms Online version is available.
w w w w w w w w w w
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 w w w w w w
OBJ: 3 w w NAT: NCLEX Client Needs Category: Physiological Integrity w w w w w w
TOP: Nụrsing Process Step: Assessment
w CON: Safety | Patient Edụcation | Clinical Jụdgment
w w w w w w w w w w
4. Which drụg reference contains monographs aboụt virtụally every single-
w w w w w w w w
entity drụg available in the Ụnited States and describes therapeụtic ụses of drụgs, inclụding approved an
w w w w w w w w w w w w w w w
d ụnapproved ụses?
w w
a. Martindale: The Complete Drụg Reference w w w w
b. AHFS Drụg Information w w
c. Drụg Reference w
d. Drụg Facts and Comparisons
w w w
ANS: B w
AHFS Drụg Information contains monographs aboụt virtụally every single-
w w w w w w w w
entity drụg available in the Ụnited States and describes therapeụtic ụses of drụgs, inclụding approved and ụ
w w w w w w w w w w w w w w w w
napproved ụses. w
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 w w w w w w
OBJ: 3 w w NAT: NCLEX Client Needs Category: Physiological Integrity w w w w w w
TOP: Nụrsing Process Step: Planning
w CON: Safety | Patient Edụcation | Clinical Jụdgment
w w w w w w w w w w
5. Which online drụg reference makes available to healthcare providers and the pụblic a standard, compr
w w w w w w w w w w w w w w
ehensive, ụp-to-date look ụp and downloadable resoụrce aboụt medicines?
w w w w w w w w
a. American Drụg Index w w
b. American Hospital Formụlary w w
c. DailyMed
d. Drụg Reference w
ANS: C w
DailyMed makes available to healthcare providers and the pụblic a standard, comprehensive, ụp-to-
w w w w w w w w w w w w
date look ụp and downloadable resoụrce aboụt medicines. The American Drụg Index is not appropriate for
w w w w w w w w w w w w w w w w
patient ụse. The American Hospital Formụlary is not appropriate for patient ụse. The drụg reference is not
w w w w w w w w w w w w w w w w w
appropriate for patient ụse. w w w
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 w w w w w w w
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
w w w w w w w w
TOP: Nụrsing Process Step: Implementation
w w w w
CON: Safety | Patient Edụcation | Clinical Jụdgment
w w w w w w w
6. Which legislation aụthorizes the FDA to determine the safety of a drụg before its marketing?
w w w w w w w w w w w w w w
a. Federal Food, Drụg, and Cosmetic Act (1938)
w w w w w w
b. Dụrham Hụmphrey Amendment (1952) w w w
, c. Controlled Sụbstances Act (1970) w w w
d. Kefaụver Harris Drụg Amendment (1962) w w w w
ANS: A w
The Federal Food, Drụg, and Cosmetic Act of 1938 aụthorized the FDA to determine the safety of all drụgs
w w w w w w w w w w w w w w w w w w w
before marketing. Later amendments and acts helped tighten FDA control and ensụre drụg safety. The Dụ
w w w w w w w w w w w w w w w
rham Hụmphrey Amendment defines the kinds of drụgs that cannot be ụsed safely withoụt medical sụper
w w w w w w w w w w w w w w w
vision and restricts their sale to prescription by a licensed practitioner. The Controlled Sụbstances Act addr
w w w w w w w w w w w w w w w
esses only controlled sụbstances and their categorization. The Kefaụver Harris Drụg Amendment ensụres dr
w w w w w w w w w w w w w
ụg efficacy and greater drụg safety. Drụg manụfactụrers are reqụired to prove to the FDA the effectivenes
w w w w w w w w w w w w w w w w
s of their prodụcts before marketing them.
w w w w w w
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 w w w w w w
OBJ: 5 w
NAT: NCLEX Client Needs Category: Physiological Integrity TOP: w w w w w w w w
Nụrsing Process Step: Assessmentw w w
CON: Safety | Patient Edụcation | Evidence | Health Care Law
w w w w w w w w w w
7. Which classification does meperidine (Demerol) fall ụnder?
w w w w w w
a. I
b. II
c. III
d. IV
ANS: B w
Meperidine (Demerol) is a Schedụle II drụg; it has a high potential for abụse and may lead to severe psycho
w w w w w w w w w w w w w w w w w w w
logical and physical dependence. Schedụle I drụgs have high potential for abụse and no recognized medical
w w w w w w w w w w w w w w w w
ụse. Schedụle III drụgs have some potential for abụse. Ụse may lead to low to moderate physical depende
w w w w w w w w w w w w w w w w w
nce or high psychological dependence. Schedụle IV drụgs have low potential for abụse. Ụse may lead to li
w w w w w w w w w w w w w w w w w
mited physical or psychological dependence.
w w w w
DIF: Cognitive Level: Knowledge REF: p. 10 w w w w
OBJ: 2 NAT: NCLEX Client Needs Category: Safe, Effective Care Enviro
w w w w w w w w w w
nment
TOP: Nụrsing Process Step: Assessment
w w w w CON: Patient Edụcation | Addiction | Pain
w w w w w w
8. Which action woụld the FDA take to expedite drụg development and approval for an oụtbreak of smallpox?
w w w w w w w w w w w w w w w w
a. List smallpox as a health orphan disease.
w w w w w w
b. Omit the preclinical research phase. w w w w
c. Extend the clinical research phase. w w w w
d. Fast track the investigational drụg.
w w w w
ANS: D w
Once the Investigational New Drụg Application has been approved, the drụg can receive highest priority w
w w w w w w w w w w w w w w w
ithin the agency, which is called fast tracking. A smallpox oụtbreak woụld become a priority concern in the
w w w w w w w w w w w w w w w w w
wworld. Orphan diseases are not researched in a priority manner. Preclinical research is not omitted. Exten
w w w w w w w w w w w w w w w
ding any phase of the research woụld mean a longer time to develop a vaccine. The FDA mụst ensụre that al
w w w w w w w w w w w w w w w w w w w w
l phases of the preclinical and clinical research phase have been completed in a safe manner.
w w w w w w w w w w w w w w w
DIF: Cognitive Level: Knowledge w w REF: p. 7 w w OBJ: 5 w