TestBank
b
, Chapter1: Drug Definitions, Standards,and Information Sources Test Bank
b b b b b b b b b
MULTIPLE CHOICE b
1. What is the name under which a drug is listed by the U.S. Food and Drug Administration
b b b b b b b b b b b b b b b b
(FDA)?
b
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C b
The official name is the name under which a drug is listed by the FDA. The brand name, or
b b b b b b b b b b b b b b b b b b
trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic,
b b b b b b b b b b b b b b b
name is provided by the U.S. Adopted Names Council.
b b b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: 2TOP: Nursing
b b b b b b b b b
Process Step: Assessment
b b b
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
b b b b b b b b
2. Which source contains information specific to nutritional supplements?
b b b b b b b
a. USP Dictionary of USAN & International Drug Names
b b b b b b b
b. Natural Medicines Comprehensive Database b b b
c. United States Pharmacopoeia/National Formulary (USP NF) b b b b b
d. Drug Interaction Facts b b
ANS: C b
United States Pharmacopoeia/National Formulary contains information specific to nutritional
b b b b b b b b
supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
b b b b b b b b b b b b b b
names, pronunciation guide, and possible future FDA approved drugs; it does not include
b b b b b b b b b b b b b
nutritional supplements. Natural Medicines Comprehensive Database contains evidence based
b b b b b b b b b
information on herbal medicines and herbal combination products; it does not include information
b b b b b b b b b b b b b
specific to nutritional supplements. Drug Interaction Facts contains comprehensive information
b b b b b b b b b b
on drug interaction facts; it does not include nutritional supplements.
b b b b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: 4TOP: Nursing
b b b b b b b b b
Process Step: Assessment
b b b
MSC: NCLEXClient Needs Category: Physiological Integrity
b b b b b b
3. What is the most comprehensive reference available to research a drug interaction?
b b b b b b b b b b b
a. Drug Facts and Comparisons b b b
b. Drug Interaction Facts b b
c. Handbook on Injectable Drugs b b b
d. Martindale—The Complete Drug Reference b b b
ANS: B b
First published in 1983, Drug Interaction Facts is the most comprehensive book available
b b b b b b b b b b b b
ondrug interactions. In addition to monographs listing various aspects of drug interactions, this
b b b b b b b b b b b b b
information is reviewed and updated by an internationally renowned group of physicians
b b b b b b b b b b b b
andpharmacists with clinical and scientific expertise.
b b b b b b
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 3TOP:
b b b b b b b b
, Nursing Process Step: Assessment b b b
MSC: NCLEXClient Needs Category: Physiological Integrity
b b b b b b
4. The physician has written an order for a drug with which the nurse is unfamiliar. Which section of
b b b b b b b b b b b b b b b b b
the Physicians’ Desk Reference (PDR) is most helpful to get information about this drug?
b b b b b b b b b b b b b b
a. Manufacturer’s section b
b. Brand and Generic Name section b b b b
c. Product Category section b b
d. Product Information section b b
b ANS: B b
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 4TOP:
b b b b b b b b
Nursing Process Step: Planning b b b
MSC: NCLEX Client Needs Category: Physiological Integrity
b b b b b b
5. Which online drug reference makes available to health care providers and the public a
b b b b b b b b b b b b b
standard, comprehensive, up to date look up and downloadable resource about medicines?
b b b b b b b b b b b b
a. American Drug Index b b
b. American Hospital Formulary b b
c. DailyMed
d. Physicians’ Desk Reference (PDR) b b b
ANS: C b
DailyMed makes available to health care providers and the public a standard, comprehensive, up
b b b b b b b b b b b b b
to date look up and downloadable resource about medicines. The American Drug Index is not
b b b b b b b b b b b b b b b
appropriate for patient use. The American Hospital Formulary is not appropriate for patient use.
b b b b b b b b b b b b b b
The PDR is not appropriate for patient use.
b b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 5TOP: Nursing
b b b b b b b b b
Process Step: Implementation
b b b
MSC: NCLEX Client Needs Category: Physiological Integrity
b b b b b b
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
b b b b b b b b b b b b b b
a. Federal Food, Drug, and Cosmetic Act (1938) b b b b b b
b. Durham Humphrey Amendment (1952) b b b
c. Controlled Substances Act (1970) b b b
d. Kefauver Harris Drug Amendment (1962) b b b b
ANS: A b
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of
b b b b b b b b b b b b b b b b
all drugs before marketing. Later amendments and acts helped tighten FDA control and ensure
b b b b b b b b b b b b b b
drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used
b b b b b b b b b b b b b b b
safely without medical supervision and restricts their sale to prescription by a licensed
b b b b b b b b b b b b b
practitioner. The Controlled Substances Act addresses only controlled substances and their
b b b b b b b b b b b
categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater drug
b b b b b b b b b b b b
safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products
b b b b b b b b b b b b b b b
before marketing them.
b b b
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 8TOP: Nursing
b b b b b b b b b
Process Step: Assessment
b b b
MSC: NCLEXClient Needs Category: Physiological Integrity
b b b b b b
7. Meperidine (Demerol) is a narcotic with a high potential for physical and psychological
b b b b b b b b b b b b
, dependency. Under which classification does this drug fall? b b b b b b b
a. I
b. II
c. III
d. IV
ANS: B b
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to severe
b b b b b b b b b b b b b b b b b b
psychological and physical dependence. Schedule Idrugs have high potential forabuse and no
b b b b b b b b b b b b b b
recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to low to
b b b b b b b b b b b b b b b b b
moderate physical dependence or high psychological dependence. Schedule IV drugs have low
b b b b b b b b b b b b
potential for abuse. Use may lead to limited physical or psychological dependence.
b b b b b b b b b b b b
DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: 7TOP:
b b b b b b b b b b b
Nursing Process Step: Assessment
b b b b
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
b b b b b b b b
8. What would the FDA do to expedite drug development and approval for an outbreak of
b b b b b b b b b b b b b b
smallpox, for which there is no known treatment?
b b b b b b b b
a. List smallpox as a health orphan disease.
b b b b b b
b. Omit the preclinical research phase. b b b b
c. Extend the clinical research phase. b b b b
d. Fast track the investigational drug.
b b b b
ANS: D b
Once the Investigational New Drug Application has been approved, the drug can receive highest
b b b b b b b b b b b b b
priority within the agency, which is called fast tracking. A smallpox outbreak would become a
b b b b b b b b b b b b b b b
priority concern in the world. Orphan diseases are not researched in a priority manner. Preclinical
b b b b b b b b b b b b b b b
research is not omitted. Extending any phase of the research would mean a longer time to develop
b b b b b b b b b b b b b b b b b
a vaccine. The FDA must ensure that all phases of the preclinical and clinical research phase have
b b b b b b b b b b b b b b b b b
been completed in a safe manner.
b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 8TOP: Nursing
b b b b b b b b b
Process Step: Assessment
b b b
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
b b b b b b b b
9. Which statement is true about over the counter (OTC) drugs?
b b b b b b b b b
a. They are not listed in the USP NF. b b b b b b b
b. A prescription from a health care provider is needed.
b b b b b b b b
c. They are sold without a prescription. b b b b b
d. They are known only by their brand names. b b b b b b b
ANS: C b
OTC medications do not require a prescription. A variety of names, both generic and trade, can be
b b b b b b b b b b b b b b b b
used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription drugs
b b b b b b b b b b b b b b b b
require an order by a health professional who is licensed to prescribe, such as a physician, nurse
b b b b b b b b b b b b b b b b b
practitioner, physician assistant, or dentist.
b b b b b
DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: 2TOP: Nursing
b b b b b b b b b
Process Step: Planning
b b b
MSC: NCLEXClient Needs Category: Physiological Integrity
b b b b b b
10. Which is the most authoritative reference for medications that are injected?
b b b b b b b b b b
b
, Chapter1: Drug Definitions, Standards,and Information Sources Test Bank
b b b b b b b b b
MULTIPLE CHOICE b
1. What is the name under which a drug is listed by the U.S. Food and Drug Administration
b b b b b b b b b b b b b b b b
(FDA)?
b
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C b
The official name is the name under which a drug is listed by the FDA. The brand name, or
b b b b b b b b b b b b b b b b b b
trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic,
b b b b b b b b b b b b b b b
name is provided by the U.S. Adopted Names Council.
b b b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 1 OBJ: 2TOP: Nursing
b b b b b b b b b
Process Step: Assessment
b b b
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
b b b b b b b b
2. Which source contains information specific to nutritional supplements?
b b b b b b b
a. USP Dictionary of USAN & International Drug Names
b b b b b b b
b. Natural Medicines Comprehensive Database b b b
c. United States Pharmacopoeia/National Formulary (USP NF) b b b b b
d. Drug Interaction Facts b b
ANS: C b
United States Pharmacopoeia/National Formulary contains information specific to nutritional
b b b b b b b b
supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
b b b b b b b b b b b b b b
names, pronunciation guide, and possible future FDA approved drugs; it does not include
b b b b b b b b b b b b b
nutritional supplements. Natural Medicines Comprehensive Database contains evidence based
b b b b b b b b b
information on herbal medicines and herbal combination products; it does not include information
b b b b b b b b b b b b b
specific to nutritional supplements. Drug Interaction Facts contains comprehensive information
b b b b b b b b b b
on drug interaction facts; it does not include nutritional supplements.
b b b b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 2 OBJ: 4TOP: Nursing
b b b b b b b b b
Process Step: Assessment
b b b
MSC: NCLEXClient Needs Category: Physiological Integrity
b b b b b b
3. What is the most comprehensive reference available to research a drug interaction?
b b b b b b b b b b b
a. Drug Facts and Comparisons b b b
b. Drug Interaction Facts b b
c. Handbook on Injectable Drugs b b b
d. Martindale—The Complete Drug Reference b b b
ANS: B b
First published in 1983, Drug Interaction Facts is the most comprehensive book available
b b b b b b b b b b b b
ondrug interactions. In addition to monographs listing various aspects of drug interactions, this
b b b b b b b b b b b b b
information is reviewed and updated by an internationally renowned group of physicians
b b b b b b b b b b b b
andpharmacists with clinical and scientific expertise.
b b b b b b
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 3TOP:
b b b b b b b b
, Nursing Process Step: Assessment b b b
MSC: NCLEXClient Needs Category: Physiological Integrity
b b b b b b
4. The physician has written an order for a drug with which the nurse is unfamiliar. Which section of
b b b b b b b b b b b b b b b b b
the Physicians’ Desk Reference (PDR) is most helpful to get information about this drug?
b b b b b b b b b b b b b b
a. Manufacturer’s section b
b. Brand and Generic Name section b b b b
c. Product Category section b b
d. Product Information section b b
b ANS: B b
DIF: Cognitive Level: Comprehension REF: p. 3 OBJ: 4TOP:
b b b b b b b b
Nursing Process Step: Planning b b b
MSC: NCLEX Client Needs Category: Physiological Integrity
b b b b b b
5. Which online drug reference makes available to health care providers and the public a
b b b b b b b b b b b b b
standard, comprehensive, up to date look up and downloadable resource about medicines?
b b b b b b b b b b b b
a. American Drug Index b b
b. American Hospital Formulary b b
c. DailyMed
d. Physicians’ Desk Reference (PDR) b b b
ANS: C b
DailyMed makes available to health care providers and the public a standard, comprehensive, up
b b b b b b b b b b b b b
to date look up and downloadable resource about medicines. The American Drug Index is not
b b b b b b b b b b b b b b b
appropriate for patient use. The American Hospital Formulary is not appropriate for patient use.
b b b b b b b b b b b b b b
The PDR is not appropriate for patient use.
b b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 5TOP: Nursing
b b b b b b b b b
Process Step: Implementation
b b b
MSC: NCLEX Client Needs Category: Physiological Integrity
b b b b b b
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
b b b b b b b b b b b b b b
a. Federal Food, Drug, and Cosmetic Act (1938) b b b b b b
b. Durham Humphrey Amendment (1952) b b b
c. Controlled Substances Act (1970) b b b
d. Kefauver Harris Drug Amendment (1962) b b b b
ANS: A b
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of
b b b b b b b b b b b b b b b b
all drugs before marketing. Later amendments and acts helped tighten FDA control and ensure
b b b b b b b b b b b b b b
drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used
b b b b b b b b b b b b b b b
safely without medical supervision and restricts their sale to prescription by a licensed
b b b b b b b b b b b b b
practitioner. The Controlled Substances Act addresses only controlled substances and their
b b b b b b b b b b b
categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater drug
b b b b b b b b b b b b
safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products
b b b b b b b b b b b b b b b
before marketing them.
b b b
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 8TOP: Nursing
b b b b b b b b b
Process Step: Assessment
b b b
MSC: NCLEXClient Needs Category: Physiological Integrity
b b b b b b
7. Meperidine (Demerol) is a narcotic with a high potential for physical and psychological
b b b b b b b b b b b b
, dependency. Under which classification does this drug fall? b b b b b b b
a. I
b. II
c. III
d. IV
ANS: B b
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to severe
b b b b b b b b b b b b b b b b b b
psychological and physical dependence. Schedule Idrugs have high potential forabuse and no
b b b b b b b b b b b b b b
recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to low to
b b b b b b b b b b b b b b b b b
moderate physical dependence or high psychological dependence. Schedule IV drugs have low
b b b b b b b b b b b b
potential for abuse. Use may lead to limited physical or psychological dependence.
b b b b b b b b b b b b
DIF: Cognitive Level: Comprehension REF: p. 4 | p. 5 OBJ: 7TOP:
b b b b b b b b b b b
Nursing Process Step: Assessment
b b b b
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
b b b b b b b b
8. What would the FDA do to expedite drug development and approval for an outbreak of
b b b b b b b b b b b b b b
smallpox, for which there is no known treatment?
b b b b b b b b
a. List smallpox as a health orphan disease.
b b b b b b
b. Omit the preclinical research phase. b b b b
c. Extend the clinical research phase. b b b b
d. Fast track the investigational drug.
b b b b
ANS: D b
Once the Investigational New Drug Application has been approved, the drug can receive highest
b b b b b b b b b b b b b
priority within the agency, which is called fast tracking. A smallpox outbreak would become a
b b b b b b b b b b b b b b b
priority concern in the world. Orphan diseases are not researched in a priority manner. Preclinical
b b b b b b b b b b b b b b b
research is not omitted. Extending any phase of the research would mean a longer time to develop
b b b b b b b b b b b b b b b b b
a vaccine. The FDA must ensure that all phases of the preclinical and clinical research phase have
b b b b b b b b b b b b b b b b b
been completed in a safe manner.
b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 7 OBJ: 8TOP: Nursing
b b b b b b b b b
Process Step: Assessment
b b b
MSC: NCLEX Client Needs Category: Safe, Effective Care Environment
b b b b b b b b
9. Which statement is true about over the counter (OTC) drugs?
b b b b b b b b b
a. They are not listed in the USP NF. b b b b b b b
b. A prescription from a health care provider is needed.
b b b b b b b b
c. They are sold without a prescription. b b b b b
d. They are known only by their brand names. b b b b b b b
ANS: C b
OTC medications do not require a prescription. A variety of names, both generic and trade, can be
b b b b b b b b b b b b b b b b
used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription drugs
b b b b b b b b b b b b b b b b
require an order by a health professional who is licensed to prescribe, such as a physician, nurse
b b b b b b b b b b b b b b b b b
practitioner, physician assistant, or dentist.
b b b b b
DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: 2TOP: Nursing
b b b b b b b b b
Process Step: Planning
b b b
MSC: NCLEXClient Needs Category: Physiological Integrity
b b b b b b
10. Which is the most authoritative reference for medications that are injected?
b b b b b b b b b b
