,Chapter 01: Drug Definitions, Standards, and Information Sources Willihngan
xs xs xs xs xs xs xs xs
z: Clayton’s Basic Pharmacology for Nurses, 20th Edition
xs xs xs xs xs xs xs
MULTIPLE CHOICE xs
1. Which name identifies a drug listed by the US Food an
xs xs xs xs xs xs xs xs xs xs
dDrug Administration (FDA)?
s
x xs xs
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C xs
The official name is the name under which a drug is listed
xs xs xs xs x s xs xs xs xs xs xs
by the FDA. The brand name, or trademark, is the name gi
xs xs xs xs xs xs xs xs xs xs xs xs
ven to a drug by its manufacturer. The nonproprietary, or g
xs xs xs xs xs xs xs xs xs xs
eneric, name is provided by the United States Adopted Na
xs xs xs xs xs xs xs xs xs
mes Council. xs
DIF: Cognitive Level: Knowledge REF: p. 9 xs xs xs xs
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Ca
xs xs xs xs xs xs xs xs
reEnvironment TOP: Nursing Process Step: Assessment
s
x xs x s xs xs xs
CON: xs
Patient Education xs
2. Which source contains information specific to nutritional supplements?
xs xs xs xs xs xs xs
a. USP Dictionary of USAN &International Drug Names
xs xs xs xs xs xs xs
b. Natural Medicines Comprehensive Database xs xs xs
c. United States Pharmacopoeia/National Formulary (USP NF)
xs xs xs xs xs
d. Drug Interaction Facts xs xs
ANS: C xs
United States Pharmacopoeia/National Formulary contains information specific to nutritional
xs xs xs xs xs xs xs xs s
x
supplements. USP Dictionary of USAN & International Drug Names is a compilation of dru
xs xs xs xs xs xs xs xs xs xs xs xs xs
gnames, pronunciation guide, and possible future FDA approved drugs; it does not include
s
x xs xs xs xs xs xs xs xs xs xs xs xs xs
nutritional supplements. Natural Medicines Comprehensive Database contains
xs xs xs xs xs xs
evidence-
based information on herbal medicines and herbal combination products; it does notinclude in
xs xs xs xs xs xs xs xs xs xs xs s
x xs
formation specific to nutritional supplements. Drug Interaction Facts contains comprehensi
xs xs xs xs xs xs xs xs xs
ve information on drug interaction facts; it does not include nutritional supplements.
xs xs xs xs xs xs xs xs xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 4 xs xs x s xs
OBJ: 3NAT: NCLEX Client Needs Category: Physiological Inte
xs xs xs xs xs xs xs xs
grity
TOP: Nursing Process Step: Assessment CON: Nutrition | Patient Education
x s xs xs xs x s xs xs xs
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
xs xs xs xs xs xs xs xs xs xs xs xs xs
a. Drug Facts and Comparisons xs xs xs
, 3
b. Drug Interaction Facts xs xs
c. Handbook on Injectable Drugs xs xs xs
d. Martindale—The Complete Drug Reference xs xs xs
ANS: A xs
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
xs xs xs xs xs xs xs xs xs xs xs xs s
x
therapeutic class. Monographs are formatted as tables to allow comparison of similar
xs xs xs xs xs xs xs xs xs xs xs s
x
products, brand names, manufacturers, cost indices, and available dosage forms Onl
xs xs xs xs xs xs xs xs xs xs
ine version is available.
xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 xs xs x s xs xs xs
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
xsxsx s x s xs xs xs xs xs
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment
x s xs xs xs x s xs xs xs xs xs xs
4. Which drug reference contains monographs about virtually every single-
xs xs xs xs xs xs xs xs
entity drug availablein the United States and describes therapeutic uses of drugs, including
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
approved and unapproved uses? xs xs xs
a. Martindale: The Complete Drug Reference xs xs xs xs
b. AHFS Drug Information xs xs
c. Drug Reference xs
d. Drug Facts and Comparisons xs xs xs
ANS: B xs
AHFS Drug Information contains monographs about virtually every single-
xs xs xs xs xs xs xs xs
entity drug available in the United States and describes therapeutic uses of drugs, including a
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
pproved andunapproved uses. xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 xs xs x s xs xs xs
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
xsxsx s x s xs xs xs xs xs
TOP: Nursing Process Step: Planning
x s CON: Safety | Patient Education | Clinical Judgment
xs xs xs x s xs xs xs xs xs xs
5. Which online drug reference makes available to healthcare providers and the public a st
xs xs xs xs xs xs xs xs xs xs xs xs xs
andard, comprehensive, up-to-date look up and downloadable resource about medicines?
xs xs xs xs xs xs xs xs xs
a. American Drug Index xs xs
b. American Hospital Formulary xs xs
c. DailyMed
d. Drug Reference xs
ANS: C xs
DailyMed makes available to healthcare providers and the public a standard, comprehensive
xs xs xs xs xs xs xs xs xs xs xs
,up-to-
s
x
date look up and downloadable resource about medicines. The American Drug Index isnot a
xs xs xs xs xs xs xs xs xs xs xs xs s
x xs
ppropriate for patient use. The American Hospital Formulary is not appropriate for patient
xs xs xs xs xs xs xs xs xs xs xs xs xs
use. The drug reference is not appropriate for patient use.
xs xs xs xs xs xs xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 xs xs x s xs xs xs xs
OBJ: 3NAT: NCLEX Client Needs Category: Physiological Inte
xs xs xs xs xs xs xs xs
grity
TOP: Nursing Process Step: Implementation
xs xs xs xs
CON: Safety | Patient Education | Clinical Judgment
x s xs xs xs xs xs xs
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
a. Federal Food, Drug, and Cosmetic Act (1938) xs xs xs xs xs xs
b. Durham Humphrey Amendment (1952) xs xs xs
, 4
c. Controlled Substances Act (1970) xs xs xs
d. Kefauver Harris Drug Amendment (1962) xs xs xs xs
ANS: A xs
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the sa
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs
fety of all drugs before marketing. Later amendments and acts helped tighten FDA control a
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
nd ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
cannot be used safely without medical supervision and restricts their sale to prescription by
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
a licensed practitioner. The Controlled Substances Act addresses only controlled substances a
xs xs xs xs xs xs xs xs xs xs xs
ndtheir categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and gre
s
x xs xs xs xs xs xs xs xs xs xs xs
aterdrug safety. Drug manufacturers are required to prove to the FDA the effectiveness of t
s
x xs xs xs xs xs xs xs xs xs xs xs xs xs xs
heir products before marketing them.
xs xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 xs xs xs xs xs xs
OBJ: 5 x s
NAT: NCLEX Client Needs Category: Physiological Integrit xs xs xs xs xs xs
yTOP: Nursing Process Step: Assessment
s
x xs xs xs xs
CON: Safety | Patient Education | Evidence | Health Care Law
x s xs xs xs xs xs xs xs xs xs
7. Which classification does meperidine (Demerol) fall under?
xs xs xs xs xs xs
a. I
b. II
c. III
d. IV
ANS: B xs
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs
tosevere psychological and physical dependence. Schedule I drugs have high potential for ab
s
x xs xs xs xs xs xs xs xs xs xs xs xs
useand no recognized medical use. Schedule III drugs have some potential for abuse. Use
s
x xs xs xs xs xs xs xs xs xs xs xs xs xs xs
may lead to low to moderate physical dependence or high psychological dependence. Sched
xs xs xs xs xs xs xs xs xs xs xs xs
ule IVdrugs have low potential for abuse. Use may lead to limited physical or psychologica
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs
l dependence.
xs
DIF: Cognitive Level: Knowledge REF: p. 10 xs xs x s xs
OBJ: 2NAT: NCLEX Client Needs Category: Safe, Effective Ca
xs xs xs xs xs xs xs xs xs
re Environment
xs
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain
x s xs xs xs x s xs xs xs xs xs
8. Which action would the FDA take to expedite drug development and approval for an outbrea
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
kof smallpox?
s
x xs
a. List smallpox as a health orphan disease.
xs xs xs xs xs xs
b. Omit the preclinical research phase. xs xs xs xs
c. Extend the clinical research phase. xs xs xs xs
d. Fast track the investigational drug. xs xs xs xs
ANS: D xs
Once the Investigational New Drug Application has been approved, the drug can receive hi
xs xs xs xs xs xs xs xs xs xs xs xs xs
ghest priority within the agency, which is called fast tracking. A smallpox outbreak would b
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
ecome a priority concern in the world. Orphan diseases are not researched in a priority man
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs
ner. Preclinical research is not omitted. Extending any phase of the research would meana lo
xs xs xs xs xs xs xs xs xs xs xs xs xs s xs
x
nger time to develop a vaccine. The FDA must ensure that all phases of the preclinical andcli
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs s
x
nical research phase have been completed in a safe manner.
xs xs xs xs xs xs xs xs xs
DIF: Cognitive Level: Knowledge xs xs REF: p. 7 xsxsxs xs OBJ: 5 xs
xs xs xs xs xs xs xs xs
z: Clayton’s Basic Pharmacology for Nurses, 20th Edition
xs xs xs xs xs xs xs
MULTIPLE CHOICE xs
1. Which name identifies a drug listed by the US Food an
xs xs xs xs xs xs xs xs xs xs
dDrug Administration (FDA)?
s
x xs xs
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C xs
The official name is the name under which a drug is listed
xs xs xs xs x s xs xs xs xs xs xs
by the FDA. The brand name, or trademark, is the name gi
xs xs xs xs xs xs xs xs xs xs xs xs
ven to a drug by its manufacturer. The nonproprietary, or g
xs xs xs xs xs xs xs xs xs xs
eneric, name is provided by the United States Adopted Na
xs xs xs xs xs xs xs xs xs
mes Council. xs
DIF: Cognitive Level: Knowledge REF: p. 9 xs xs xs xs
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Ca
xs xs xs xs xs xs xs xs
reEnvironment TOP: Nursing Process Step: Assessment
s
x xs x s xs xs xs
CON: xs
Patient Education xs
2. Which source contains information specific to nutritional supplements?
xs xs xs xs xs xs xs
a. USP Dictionary of USAN &International Drug Names
xs xs xs xs xs xs xs
b. Natural Medicines Comprehensive Database xs xs xs
c. United States Pharmacopoeia/National Formulary (USP NF)
xs xs xs xs xs
d. Drug Interaction Facts xs xs
ANS: C xs
United States Pharmacopoeia/National Formulary contains information specific to nutritional
xs xs xs xs xs xs xs xs s
x
supplements. USP Dictionary of USAN & International Drug Names is a compilation of dru
xs xs xs xs xs xs xs xs xs xs xs xs xs
gnames, pronunciation guide, and possible future FDA approved drugs; it does not include
s
x xs xs xs xs xs xs xs xs xs xs xs xs xs
nutritional supplements. Natural Medicines Comprehensive Database contains
xs xs xs xs xs xs
evidence-
based information on herbal medicines and herbal combination products; it does notinclude in
xs xs xs xs xs xs xs xs xs xs xs s
x xs
formation specific to nutritional supplements. Drug Interaction Facts contains comprehensi
xs xs xs xs xs xs xs xs xs
ve information on drug interaction facts; it does not include nutritional supplements.
xs xs xs xs xs xs xs xs xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 4 xs xs x s xs
OBJ: 3NAT: NCLEX Client Needs Category: Physiological Inte
xs xs xs xs xs xs xs xs
grity
TOP: Nursing Process Step: Assessment CON: Nutrition | Patient Education
x s xs xs xs x s xs xs xs
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
xs xs xs xs xs xs xs xs xs xs xs xs xs
a. Drug Facts and Comparisons xs xs xs
, 3
b. Drug Interaction Facts xs xs
c. Handbook on Injectable Drugs xs xs xs
d. Martindale—The Complete Drug Reference xs xs xs
ANS: A xs
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
xs xs xs xs xs xs xs xs xs xs xs xs s
x
therapeutic class. Monographs are formatted as tables to allow comparison of similar
xs xs xs xs xs xs xs xs xs xs xs s
x
products, brand names, manufacturers, cost indices, and available dosage forms Onl
xs xs xs xs xs xs xs xs xs xs
ine version is available.
xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 xs xs x s xs xs xs
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
xsxsx s x s xs xs xs xs xs
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment
x s xs xs xs x s xs xs xs xs xs xs
4. Which drug reference contains monographs about virtually every single-
xs xs xs xs xs xs xs xs
entity drug availablein the United States and describes therapeutic uses of drugs, including
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
approved and unapproved uses? xs xs xs
a. Martindale: The Complete Drug Reference xs xs xs xs
b. AHFS Drug Information xs xs
c. Drug Reference xs
d. Drug Facts and Comparisons xs xs xs
ANS: B xs
AHFS Drug Information contains monographs about virtually every single-
xs xs xs xs xs xs xs xs
entity drug available in the United States and describes therapeutic uses of drugs, including a
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
pproved andunapproved uses. xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 xs xs x s xs xs xs
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity
xsxsx s x s xs xs xs xs xs
TOP: Nursing Process Step: Planning
x s CON: Safety | Patient Education | Clinical Judgment
xs xs xs x s xs xs xs xs xs xs
5. Which online drug reference makes available to healthcare providers and the public a st
xs xs xs xs xs xs xs xs xs xs xs xs xs
andard, comprehensive, up-to-date look up and downloadable resource about medicines?
xs xs xs xs xs xs xs xs xs
a. American Drug Index xs xs
b. American Hospital Formulary xs xs
c. DailyMed
d. Drug Reference xs
ANS: C xs
DailyMed makes available to healthcare providers and the public a standard, comprehensive
xs xs xs xs xs xs xs xs xs xs xs
,up-to-
s
x
date look up and downloadable resource about medicines. The American Drug Index isnot a
xs xs xs xs xs xs xs xs xs xs xs xs s
x xs
ppropriate for patient use. The American Hospital Formulary is not appropriate for patient
xs xs xs xs xs xs xs xs xs xs xs xs xs
use. The drug reference is not appropriate for patient use.
xs xs xs xs xs xs xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 xs xs x s xs xs xs xs
OBJ: 3NAT: NCLEX Client Needs Category: Physiological Inte
xs xs xs xs xs xs xs xs
grity
TOP: Nursing Process Step: Implementation
xs xs xs xs
CON: Safety | Patient Education | Clinical Judgment
x s xs xs xs xs xs xs
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
a. Federal Food, Drug, and Cosmetic Act (1938) xs xs xs xs xs xs
b. Durham Humphrey Amendment (1952) xs xs xs
, 4
c. Controlled Substances Act (1970) xs xs xs
d. Kefauver Harris Drug Amendment (1962) xs xs xs xs
ANS: A xs
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the sa
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs
fety of all drugs before marketing. Later amendments and acts helped tighten FDA control a
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
nd ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
cannot be used safely without medical supervision and restricts their sale to prescription by
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
a licensed practitioner. The Controlled Substances Act addresses only controlled substances a
xs xs xs xs xs xs xs xs xs xs xs
ndtheir categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and gre
s
x xs xs xs xs xs xs xs xs xs xs xs
aterdrug safety. Drug manufacturers are required to prove to the FDA the effectiveness of t
s
x xs xs xs xs xs xs xs xs xs xs xs xs xs xs
heir products before marketing them.
xs xs xs xs
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 xs xs xs xs xs xs
OBJ: 5 x s
NAT: NCLEX Client Needs Category: Physiological Integrit xs xs xs xs xs xs
yTOP: Nursing Process Step: Assessment
s
x xs xs xs xs
CON: Safety | Patient Education | Evidence | Health Care Law
x s xs xs xs xs xs xs xs xs xs
7. Which classification does meperidine (Demerol) fall under?
xs xs xs xs xs xs
a. I
b. II
c. III
d. IV
ANS: B xs
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs
tosevere psychological and physical dependence. Schedule I drugs have high potential for ab
s
x xs xs xs xs xs xs xs xs xs xs xs xs
useand no recognized medical use. Schedule III drugs have some potential for abuse. Use
s
x xs xs xs xs xs xs xs xs xs xs xs xs xs xs
may lead to low to moderate physical dependence or high psychological dependence. Sched
xs xs xs xs xs xs xs xs xs xs xs xs
ule IVdrugs have low potential for abuse. Use may lead to limited physical or psychologica
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs
l dependence.
xs
DIF: Cognitive Level: Knowledge REF: p. 10 xs xs x s xs
OBJ: 2NAT: NCLEX Client Needs Category: Safe, Effective Ca
xs xs xs xs xs xs xs xs xs
re Environment
xs
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain
x s xs xs xs x s xs xs xs xs xs
8. Which action would the FDA take to expedite drug development and approval for an outbrea
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
kof smallpox?
s
x xs
a. List smallpox as a health orphan disease.
xs xs xs xs xs xs
b. Omit the preclinical research phase. xs xs xs xs
c. Extend the clinical research phase. xs xs xs xs
d. Fast track the investigational drug. xs xs xs xs
ANS: D xs
Once the Investigational New Drug Application has been approved, the drug can receive hi
xs xs xs xs xs xs xs xs xs xs xs xs xs
ghest priority within the agency, which is called fast tracking. A smallpox outbreak would b
xs xs xs xs xs xs xs xs xs xs xs xs xs xs
ecome a priority concern in the world. Orphan diseases are not researched in a priority man
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs
ner. Preclinical research is not omitted. Extending any phase of the research would meana lo
xs xs xs xs xs xs xs xs xs xs xs xs xs s xs
x
nger time to develop a vaccine. The FDA must ensure that all phases of the preclinical andcli
xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs xs s
x
nical research phase have been completed in a safe manner.
xs xs xs xs xs xs xs xs xs
DIF: Cognitive Level: Knowledge xs xs REF: p. 7 xsxsxs xs OBJ: 5 xs