,Chapter 1: Drug Definitions, Standards, and Information Sources Test Bank
MULTIPLE CHOICE
1. What is the name under which a drug is listed by the U.S. Food and Drug Administration
(FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C
The official name is the name under which a drug is listed by the FDA. The brand name, or
trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic,
name is provided by the U.S. Adopted Names Council.
DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: 2TOP: Nursing
Process Step: Assessment
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
2. Which source contains information specific to nutritional supplements?
a. USP Dictionary of USAN & International Drug Names
b. Natural Medicines Comprehensive Database
c. United States Pharmacopoeia/National Formulary (USP NF)
d. Drug Interaction Facts
ANS: C
United States Pharmacopoeia/National Formulary contains information specific to nutritional
supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
names, pronunciation guide, and possible future FDA approved drugs; it does not include
nutritional supplements. Natural Medicines Comprehensive Database contains evidence based
information on herbal medicines and herbal combination products; it does not include
information specific to nutritional supplements. Drug Interaction Facts contains
comprehensive information on drug interaction facts; it does not include nutritional
supplements.
DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: 4TOP: Nursing
Process Step: Assessment
MSC: NCLEX Client Needs Category: Physiological Integrity
3. What is the most comprehensive reference available to research a drug interaction?
a. Drug Facts and Comparisons
b. Drug Interaction Facts
c. Handbook on Injectable Drugs
d. Martindale—The Complete Drug Reference
ANS: B
First published in 1983, Drug Interaction Facts is the most comprehensive book available
ondrug interactions. In addition to monographs listing various aspects of drug interactions,
this information is reviewed and updated by an internationally renowned group of physicians
andpharmacists with clinical and scientific expertise.
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 3TOP:
, Nursing Process Step: Assessment
MSC: NCLEX Client Needs Category: Physiological Integrity
4. The physician has written an order for a drug with which the nurse is unfamiliar. Which
section of the Physicians’ Desk Reference (PDR) is most helpful to get information about this
drug?
a. Manufacturer’s section
b. Brand and Generic Name section
c. Product Category section
d. Product Information section
ANS: B
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 4TOP:
Nursing Process Step: Planning
MSC: NCLEX Client Needs Category: Physiological Integrity
5. Which online drug reference makes available to health care providers and the public a
standard, comprehensive, up to date look up and downloadable resource about medicines?
a. American Drug Index
b. American Hospital Formulary
c. DailyMed
d. Physicians’ Desk Reference (PDR)
ANS: C
DailyMed makes available to health care providers and the public a standard, comprehensive,
up to date look up and downloadable resource about medicines. The American Drug Index is
not appropriate for patient use. The American Hospital Formulary is not appropriate for
patient use. The PDR is not appropriate for patient use.
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 5TOP: Nursing
Process Step: Implementation
MSC: NCLEX Client Needs Category: Physiological Integrity
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
a. Federal Food, Drug, and Cosmetic Act (1938)
b. Durham Humphrey Amendment (1952)
c. Controlled Substances Act (1970)
d. Kefauver Harris Drug Amendment (1962)
ANS: A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the
safety of all drugs before marketing. Later amendments and acts helped tighten FDA control
and ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that
cannot be used safely without medical supervision and restricts their sale to prescription by a
licensed practitioner. The Controlled Substances Act addresses only controlled substances and
their categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater
drug safety. Drug manufacturers are required to prove to the FDA the effectiveness of their
products before marketing them.
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 8TOP: Nursing
Process Step: Assessment
MSC: NCLEX Client Needs Category: Physiological Integrity
7. Meperidine (Demerol) is a narcotic with a high potential for physical and psychological
, dependency. Under which classification does this drug fall?
a. I
b. II
c. III
d. IV
ANS: B
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to
severe psychological and physical dependence. Schedule I drugs have high potential for abuse
and no recognized medical use. Schedule III drugs have some potential for abuse. Use may
lead to low to moderate physical dependence or high psychological dependence. Schedule IV
drugs have low potential for abuse. Use may lead to limited physical or psychological
dependence.
DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: 7TOP:
Nursing Process Step: Assessment
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
8. What would the FDA do to expedite drug development and approval for an outbreak of
smallpox, for which there is no known treatment?
a. List smallpox as a health orphan disease.
b. Omit the preclinical research phase.
c. Extend the clinical research phase.
d. Fast track the investigational drug.
ANS: D
Once the Investigational New Drug Application has been approved, the drug can receive
highest priority within the agency, which is called fast tracking. A smallpox outbreak would
become a priority concern in the world. Orphan diseases are not researched in a priority
manner. Preclinical research is not omitted. Extending any phase of the research would mean
a longer time to develop a vaccine. The FDA must ensure that all phases of the preclinical and
clinical research phase have been completed in a safe manner.
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 8TOP: Nursing
Process Step: Assessment
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
9. Which statement is true about over the counter (OTC) drugs?
a. They are not listed in the USP NF.
b. A prescription from a health care provider is needed.
c. They are sold without a prescription.
d. They are known only by their brand names.
ANS: C
OTC medications do not require a prescription. A variety of names, both generic and trade,
can be used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription
drugs require an order by a health professional who is licensed to prescribe, such as a
physician, nurse practitioner, physician assistant, or dentist.
DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: 2TOP:
Nursing Process Step: Planning
MSC: NCLEX Client Needs Category: Physiological Integrity
10. Which is the most authoritative reference for medications that are injected?
MULTIPLE CHOICE
1. What is the name under which a drug is listed by the U.S. Food and Drug Administration
(FDA)?
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C
The official name is the name under which a drug is listed by the FDA. The brand name, or
trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic,
name is provided by the U.S. Adopted Names Council.
DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: 2TOP: Nursing
Process Step: Assessment
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
2. Which source contains information specific to nutritional supplements?
a. USP Dictionary of USAN & International Drug Names
b. Natural Medicines Comprehensive Database
c. United States Pharmacopoeia/National Formulary (USP NF)
d. Drug Interaction Facts
ANS: C
United States Pharmacopoeia/National Formulary contains information specific to nutritional
supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
names, pronunciation guide, and possible future FDA approved drugs; it does not include
nutritional supplements. Natural Medicines Comprehensive Database contains evidence based
information on herbal medicines and herbal combination products; it does not include
information specific to nutritional supplements. Drug Interaction Facts contains
comprehensive information on drug interaction facts; it does not include nutritional
supplements.
DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: 4TOP: Nursing
Process Step: Assessment
MSC: NCLEX Client Needs Category: Physiological Integrity
3. What is the most comprehensive reference available to research a drug interaction?
a. Drug Facts and Comparisons
b. Drug Interaction Facts
c. Handbook on Injectable Drugs
d. Martindale—The Complete Drug Reference
ANS: B
First published in 1983, Drug Interaction Facts is the most comprehensive book available
ondrug interactions. In addition to monographs listing various aspects of drug interactions,
this information is reviewed and updated by an internationally renowned group of physicians
andpharmacists with clinical and scientific expertise.
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 3TOP:
, Nursing Process Step: Assessment
MSC: NCLEX Client Needs Category: Physiological Integrity
4. The physician has written an order for a drug with which the nurse is unfamiliar. Which
section of the Physicians’ Desk Reference (PDR) is most helpful to get information about this
drug?
a. Manufacturer’s section
b. Brand and Generic Name section
c. Product Category section
d. Product Information section
ANS: B
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 4TOP:
Nursing Process Step: Planning
MSC: NCLEX Client Needs Category: Physiological Integrity
5. Which online drug reference makes available to health care providers and the public a
standard, comprehensive, up to date look up and downloadable resource about medicines?
a. American Drug Index
b. American Hospital Formulary
c. DailyMed
d. Physicians’ Desk Reference (PDR)
ANS: C
DailyMed makes available to health care providers and the public a standard, comprehensive,
up to date look up and downloadable resource about medicines. The American Drug Index is
not appropriate for patient use. The American Hospital Formulary is not appropriate for
patient use. The PDR is not appropriate for patient use.
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 5TOP: Nursing
Process Step: Implementation
MSC: NCLEX Client Needs Category: Physiological Integrity
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
a. Federal Food, Drug, and Cosmetic Act (1938)
b. Durham Humphrey Amendment (1952)
c. Controlled Substances Act (1970)
d. Kefauver Harris Drug Amendment (1962)
ANS: A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the
safety of all drugs before marketing. Later amendments and acts helped tighten FDA control
and ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that
cannot be used safely without medical supervision and restricts their sale to prescription by a
licensed practitioner. The Controlled Substances Act addresses only controlled substances and
their categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater
drug safety. Drug manufacturers are required to prove to the FDA the effectiveness of their
products before marketing them.
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 8TOP: Nursing
Process Step: Assessment
MSC: NCLEX Client Needs Category: Physiological Integrity
7. Meperidine (Demerol) is a narcotic with a high potential for physical and psychological
, dependency. Under which classification does this drug fall?
a. I
b. II
c. III
d. IV
ANS: B
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to
severe psychological and physical dependence. Schedule I drugs have high potential for abuse
and no recognized medical use. Schedule III drugs have some potential for abuse. Use may
lead to low to moderate physical dependence or high psychological dependence. Schedule IV
drugs have low potential for abuse. Use may lead to limited physical or psychological
dependence.
DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: 7TOP:
Nursing Process Step: Assessment
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
8. What would the FDA do to expedite drug development and approval for an outbreak of
smallpox, for which there is no known treatment?
a. List smallpox as a health orphan disease.
b. Omit the preclinical research phase.
c. Extend the clinical research phase.
d. Fast track the investigational drug.
ANS: D
Once the Investigational New Drug Application has been approved, the drug can receive
highest priority within the agency, which is called fast tracking. A smallpox outbreak would
become a priority concern in the world. Orphan diseases are not researched in a priority
manner. Preclinical research is not omitted. Extending any phase of the research would mean
a longer time to develop a vaccine. The FDA must ensure that all phases of the preclinical and
clinical research phase have been completed in a safe manner.
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 8TOP: Nursing
Process Step: Assessment
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
9. Which statement is true about over the counter (OTC) drugs?
a. They are not listed in the USP NF.
b. A prescription from a health care provider is needed.
c. They are sold without a prescription.
d. They are known only by their brand names.
ANS: C
OTC medications do not require a prescription. A variety of names, both generic and trade,
can be used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription
drugs require an order by a health professional who is licensed to prescribe, such as a
physician, nurse practitioner, physician assistant, or dentist.
DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: 2TOP:
Nursing Process Step: Planning
MSC: NCLEX Client Needs Category: Physiological Integrity
10. Which is the most authoritative reference for medications that are injected?
