b b b b b b b 1
19th
Chapter 01: Drug Definitions, Standards, and Information Sources
b b b b b b b
Willihnganz: Clayton’s Basic Pharmacology for Nurses, 19th Edition
b b b b b b b b
MULTIPLE
CHOICE
1. Which name identifies a drug listed by the US
b b b b b b b b
Food andDrug Administration (FDA)?
b b b b b
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C
The official name is the name under which a drug is
b b b b b b b b b
listed by the FDA. The brand name, or trademark, is
b b b b b b b b b b
the name given to a drug by its manufacturer. The
b b b b b b b b b b
nonproprietary, or generic, name is provided by the
b b b b b b b b
United States AdoptedNames Council.
b b b b b
DIF: Cognitive Level: Knowledge REF: p. 9 b b b b b
OBJ: 1NAT: NCLEX Client Needs Category: Safe, b b b b b b
Effective CareEnvironment TOP:
b Nursing Process Step: b b b b b
Assessment CON:
b b
Patient Education 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
b b b b b b b
nutritionalsupplements. USP Dictionary of USAN & International Drug Names is a
b b b b b b b b b b b
compilation of drugnames, pronunciation guide, and possible future FDA approved
b b b b b b b b b b
drugs; it does not include nutritional supplements. Natural Medicines
b b b b b b b b b
Comprehensive Database contains
b b b
evidence-based information on herbal medicines and herbal combination products; it b b b b b b b b b
does notinclude information specific to nutritional supplements. Drug Interaction
b b b b b b b b b
Facts contains comprehensive information on drug interaction facts; it does not
b b b b b b b b b b b
include nutritional supplements.
b b b
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: b b b
3NAT: NCLEX Client Needs Category: Physiological Integrity
b b b b b b b b
TOP: Nursing Process Step: Assessment CON: Nutrition | Patient Education b b b b b b
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic
b b b b b b b b b b b b
b class?
a. Drug Facts and Comparisons b b b
,Test Bank For Clayton’s Basic Pharmacology for Nurses
b b b b b b b 2
19th
b. Drug Interaction Facts b b
c. Handbook on Injectable Drugs b b b
d. Martindale—The Complete Drug Reference b b b
ANS: A b
Drug Facts and Comparisons contains drug monographs that describe all
b b b b b b b b b
drugs in atherapeutic class. Monographs are formatted as tables to allow
b b b b b b b b b b b
comparison of similarproducts, brand names, manufacturers, cost indices, and
b b b b b b b b b
available dosage forms Online version is available.
b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 b b b b b b
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity b b b b b b b
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment b b b b b b b b b
4. Which drug reference contains monographs about virtually every single-entity drug
b b b b b b b b b
availablein the United States and describes therapeutic uses of drugs, including
b b b b b b b b b b b
approved and unapproved uses?
b b b b
a. Martindale: The Complete Drug Reference b b b b
b. AHFS Drug Information b b
c. Drug Reference b
d. Drug Facts and Comparisons b b b
ANS: B b
AHFS Drug Information contains monographs about virtually every single-entity
b b b b b b b b
drug available in the United States and describes therapeutic uses of drugs,
b b b b b b b b b b b b
including approved andunapproved uses.
b b b b
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 b b b b b b
OBJ: 3 NAT: NCLEX Client Needs Category: Physiological Integrity b b b b b b b
TOP: Nursing Process Step: Planning CON: Safety | Patient Education | Clinical Judgment b b b b b b b b b
5. Which online drug reference makes available to healthcare providers and the
b b b b b b b b b b
public a standard, comprehensive, up-to-date look up and downloadable resource
b b b b b b b b b b
about medicines?
b b
a. American Drug Index b b
b. American Hospital Formulary b b
c. DailyMed
d. Drug Reference b
ANS: C b
DailyMed makes available to healthcare providers and the public a standard,
b b b b b b b b b b
comprehensive,up-to-date look up and downloadable resource about medicines. The
b b b b b b b b b b
American Drug Index isnot appropriate for patient use. The American Hospital
b b b b b b b b b b b
Formulary is not appropriate for patient use. The drug reference is not appropriate
b b b b b b b b b b b b b
for patient use.
b b b
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 OBJ: b b b b b b b
3NAT: NCLEX Client Needs Category: Physiological Integrity
b b b b b b b
TOP: Nursing Process Step: Implementation
b b b b b
CON: Safety | Patient Education | Clinical Judgment 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
,Test Bank For Clayton’s Basic Pharmacology for Nurses
b b b b b b b 3
19th
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
b b b b b b b b b b b b b
b the safety of all drugs before marketing. Later amendments and acts helped tighten
b b b b b b b b b b b b
b FDA control and ensure drug safety. The Durham Humphrey Amendment defines the
b b b b b b b b b b b
bkinds of drugs that cannot be used safely without medical supervision and restricts
b b b b b b b b b b b b
btheir sale to prescription by a licensed practitioner. The Controlled Substances Act
b b b b b b b b b b b
baddresses only controlled substances andtheir categorization. The Kefauver Harris
b b b b b b b b
bDrug Amendment ensures drug efficacy and greaterdrug safety. Drug
b b b b b b b b
b 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 before marketing b
them.
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 b b b b b b
OBJ: 5 NAT: NCLEX Client Needs Category: b b b b
bPhysiological IntegrityTOP: Nursing Process Step: Assessment b b b b b b
CON: Safety | Patient Education | Evidence | Health Care Law b b b b b b b b b
7. Which classification does meperidine (Demerol) fall under?
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 b b b b b b b b b b b b b
band may lead tosevere psychological and physical dependence. Schedule I drugs have
b b b b b b b b b b b
bhigh potential for abuseand no recognized medical use. Schedule III drugs have some
b b b b b b b b b b b b
potential for abuse. Use may lead to low to moderate physical dependence or high
b b b b b b b b b b b b b b
bpsychological dependence. Schedule IVdrugs have low potential for abuse. Use may b b b b b b b b b b b
lead to limited physical or psychological dependence.
b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 10 OBJ: b b b
b2NAT: NCLEX Client Needs Category: Safe, Effective Care
b b b b b b b b
bEnvironment
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain b b b b b b b b
8. Which action would the FDA take to expedite drug development and approval for an
b b b b b b b b b b b b b
boutbreakof smallpox? 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
b b b b b b b b b b b
breceive highest priority within the agency, which is called fast tracking. A smallpox
b b b b b b b b b b b b
boutbreak would become a priority concern in the world. Orphan diseases are not
b b b b b b b b b b b b
bresearched in a priority manner. Preclinical research is not omitted. Extending any b b b b b b b b b b b
bphase of the research would meana longer time to develop a vaccine. The FDA
b b b b b b b b b b b b b
bmust ensure that all phases of the preclinical andclinical research phase have
b b b b b b b b b b b
b been completed in a safe manner.
b b b b b
DIF: Cognitive Level: Knowledge b b REF: p. 7 b OBJ: 5 b
, Test Bank For Clayton’s Basic Pharmacology for Nurses
b b b b b b b 4
19th
NAT: NCLEX Client Needs Category: Safe, Effective Care
b b b b b b b
EnvironmentTOP: Nursing Process Step: Assessment
b b b b b b
CON: Health Care Law | Health Care Policy | Infection | Care Coordination b b b 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
a. They are not listed in the USP NF. b b b b b b b
b. A prescription from a healthcare provider is needed.
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
b b b b b b b b b b b b
and trade, can be used for individual drugs sold OTC. OTC drugs are listed in
b b b b b b b b b b b b b b b
the USP NF. Prescriptiondrugs require an order by a health professional who is
b b b b b b b b b b b b b
licensed to prescribe, such as a physician, nurse practitioner, physician assistant,
b b b b b b b b b b b
or dentist.
b b
DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: b b b
2NAT: NCLEX Client Needs Category: Physiological Integrity
b b b b b b b b
TOP: Nursing Process Step: Planning CON: Patient Education
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
a. Martindale: The Complete b b
b. Handbook on Injectable Drugs b b b
c. DailyMed
d. Handbook of Nonprescription Drugs b b b
ANS: B b
The Handbook on Injectable Drugs is the most comprehensive reference available
b b b b b b b b b b
on the topic of compatibility of injectable drugs. It is a collection of monographs
b b b b b b b b b b b b b b
for more than 300injectable drugs that are listed alphabetically by generic name.
b b b b b b b b b b b b b
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: b b b
3NAT: NCLEX Client Needs Category: Physiological Integrity
b b b b b b b b
TOP: Nursing Process Step: Assessment CON: Clinical Judgment | Safety b b b b b b b b
11. Which statement is true about Lomotil? b b b b b
a. Abuse potential for this drug is low. b b b b b b
b. Psychological dependency is likely. b b b
c. There is a high potential for abuse. b b b b b b
d. This drug is not a controlled substance. b b b b b b
ANS: A b
Lomotil, a Schedule V drug, has an abuse potential of limited physical or
b b b b b b b b b b b b
psychological dependence liability compared with drugs in Schedule IV. Because abuse
b b b b b b b b b b b
potential is low witha Schedule V drug, a prescription may not be required.
b b b b b b b b b b b b b
Psychological dependency is not likelywith a Schedule V drug. Schedule V drugs are b b b b b b b b b b b b
classified as controlled substances.
b b b b
DIF: Cognitive Level: Knowledge REF: p. 5 Box 1.1 b b b b b
OBJ: 2NAT: NCLEX Client Needs Category:
b b b b b b b
Physiological b
Integrity
TOP: Nursing Process Step: Assessment CON: Clinical Judgment | Safety | Patient Education b b b b b b b b b