e e e e e e e e e 1
Chapter 01: Drug Definitions, Standards, and Information Sources
e e e e e e e
Willihnganz: Clayton’s Basic Pharmacology for Nurses, 19th Edition
e e e e e e e e
MULTIPLE CHOICE e
1. Which name identifies a drug listed by the US Food and
e e e e e e e e e e
Drug Administration (FDA)?
e e e
a. Brand
b. Nonproprietary
c. Official
d. Trademark
ANS: C e
The official name is the name under which a drug is listed
e e e e e e e e e e e
by the FDA. The brand name, or trademark, is the name
e e e e e e e e e e e
given to a drug by its manufacturer. The nonproprietary, or
e e e e e e e e e e
generic, name is provided by the United States Adopted
e e e e e e e e e
Names Council.
e e
DIF: Cognitive Level: Knowledge REF: p. 9 e e e e
OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care
e e e e e e e e
Environment TOP: Nursing Process Step: Assessment
e e CON: e e e e
Patient Education
e e
2. Which source contains information specific to nutritional supplements?
e e e e e e e
a. USP Dictionary of USAN & International Drug Names
e e e e e e e
b. Natural Medicines Comprehensive Database e e e
c. United States Pharmacopoeia/National Formulary (USP NF)
e e e e e
d. Drug Interaction Facts e e
ANS: C e
United States Pharmacopoeia/National Formulary contains information specific to nutritional
e e e e e e e e
supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug
e e e e e e e e e e e e e e
names, pronunciation guide, and possible future FDA approved drugs; it does not include
e e e e e e e e e e e e e
nutritional supplements. Natural Medicines Comprehensive Database contains
e e e e e e e
evidence-based information on herbal medicines and herbal combination products; it does not
e e e e e e e e e e e
include information specific to nutritional supplements. Drug Interaction Facts contains
e e e e e e e e e e
comprehensive information on drug interaction facts; it does not include nutritional
e e e e e e e e e e e
supplements.
e
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 3 e e e e e
NAT: NCLEX Client Needs Category: Physiological Integrity
e e e e e e e
TOP: Nursing Process Step: Assessment CON: Nutrition | Patient Education
e e e e e e e e
3. Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
e e e e e e e e e e e e e
a. Drug Facts and Comparisons e e e
Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition
e e e e e e e e e
,Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition
e e e e e e e e e 2
b. Drug Interaction Facts e e
c. Handbook on Injectable Drugs e e e
d. Martindale—The Complete Drug Reference e e e
ANS: A e
Drug Facts and Comparisons contains drug monographs that describe all drugs in a
e e e e e e e e e e e e
therapeutic class. Monographs are formatted as tables to allow comparison of similar
e e e e e e e e e e e e
products, brand names, manufacturers, cost indices, and available dosage forms
e e e e e e e e e e
Online version is available.
e e e e
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 e e e e e e
OBJ: 3 e NAT: NCLEX Client Needs Category: Physiological Integrity
e e e e e e e
TOP: Nursing Process Step: Assessment CON: Safety | Patient Education | Clinical Judgment
e e e e e e e e e e e
4. Which drug reference contains monographs about virtually every single-entity drug available
e e e e e e e e e e
in the United States and describes therapeutic uses of drugs, including approved and
e e e e e e e e e e e e e
unapproved uses?
e e
a. Martindale: The Complete Drug Reference e e e e
b. AHFS Drug Information e e
c. Drug Reference e
d. Drug Facts and Comparisons e e e
ANS: B e
AHFS Drug Information contains monographs about virtually every single-entity drug
e e e e e e e e e
available in the United States and describes therapeutic uses of drugs, including approved and
e e e e e e e e e e e e e e
unapproved uses.
e e
DIF: Cognitive Level: Knowledge REF: p. 4 Table 1.2 e e e e e e
OBJ: 3 e NAT: NCLEX Client Needs Category: Physiological Integrity
e e e e e e e
TOP: Nursing Process Step: Planning
e CON: Safety | Patient Education | Clinical Judgment
e e e e e e e e e e
5. Which online drug reference makes available to healthcare providers and the public a
e e e e e e e e e e e e
estandard, comprehensive, up-to-date look up and downloadable resource about medicines?
e e e e e e e e e
a. American Drug Index e e
b. American Hospital Formulary e e
c. DailyMed
d. Drug Reference e
ANS: C e
DailyMed makes available to healthcare providers and the public a standard, comprehensive,
e e e e e e e e e e e
up-to-date look up and downloadable resource about medicines. The American Drug Index is
e e e e e e e e e e e e e
not appropriate for patient use. The American Hospital Formulary is not appropriate for
e e e e e e e e e e e e e
patient use. The drug reference is not appropriate for patient use.
e e e e e e e e e e e
DIF: Cognitive Level: Knowledge REF: p. 3 | p. 4 e e e e e e e OBJ: 3 e
NAT: NCLEX Client Needs Category: Physiological Integrity
e e e e e e e
TOP: Nursing Process Step: Implementation
e e e e
CON: Safety | Patient Education | Clinical Judgment
e e e e e e e
6. Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
e e e e e e e e e e e e e e
a. Federal Food, Drug, and Cosmetic Act (1938) e e e e e e
b. Durham Humphrey Amendment (1952) e e e
Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition
e e e e e e e e e e
,Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition
e e e e e e e e e 3
c. Controlled Substances Act (1970) e e e
d. Kefauver Harris Drug Amendment (1962) e e e e
ANS: A e
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the
e e e e e e e e e e e e e e
safety of all drugs before marketing. Later amendments and acts helped tighten FDA control
e e e e e e e e e e e e e e
and ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that
e e e e e e e e e e e e e e
cannot be used safely without medical supervision and restricts their sale to prescription by a
e e e e e e e e e e e e e e e
licensed practitioner. The Controlled Substances Act addresses only controlled substances and
e e e e e e e e e e e
their categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater
e e e e e e e e e e e e
drug safety. Drug manufacturers are required to prove to the FDA the effectiveness of their
e e e e e e e e e e e e e e e
products before marketing them.
e e e e
DIF: Cognitive Level: Knowledge REF: p. 5 Table l.3 e e e e e e
OBJ: 5 eNAT: NCLEX Client Needs Category: Physiological Integrity e e e e e e
TOP: Nursing Process Step: Assessment
e e e e e
CON: Safety | Patient Education | Evidence | Health Care Law
e e e e e e e e e e
7. Which classification does meperidine (Demerol) fall under?
e e e e e e
a. I
b. II
c. III
d. IV
ANS: B e
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to
e e e e e e e e e e e e e e e e e
severe psychological and physical dependence. Schedule I drugs have high potential for abuse
e e e e e e e e e e e e e
and no recognized medical use. Schedule III drugs have some potential for abuse. Use may
e e e e e e e e e e e e e e e
lead to low to moderate physical dependence or high psychological dependence. Schedule IV
e e e e e e e e e e e e e
drugs have low potential for abuse. Use may lead to limited physical or psychological
e e e e e e e e e e e e e e
dependence.
e
DIF: Cognitive Level: Knowledge REF: p. 10 OBJ: 2 e e e e e
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
e e e e e e e e e
TOP: Nursing Process Step: Assessment CON: Patient Education | Addiction | Pain
e e e e e e e e e e
8. Which action would the FDA take to expedite drug development and approval for an outbreak
e e e e e e e e e e e e e e
of smallpox?
e e
a. List smallpox as a health orphan disease.
e e e e e e
b. Omit the preclinical research phase. e e e e
c. Extend the clinical research phase. e e e e
d. Fast track the investigational drug.e e e e
ANS: D e
Once the Investigational New Drug Application has been approved, the drug can receive
e e e e e e e e e e e e
highest priority within the agency, which is called fast tracking. A smallpox outbreak would
e e e e e e e e e e e e e e
become a priority concern in the world. Orphan diseases are not researched in a priority
e e e e e e e e e e e e e e e
manner. Preclinical research is not omitted. Extending any phase of the research would mean
e e e e e e e e e e e e e e
a longer time to develop a vaccine. The FDA must ensure that all phases of the preclinical and
e e e e e e e e e e e e e e e e e e
clinical research phase have been completed in a safe manner.
e e e e e e e e e e
DIF: Cognitive Level: Knowledge e e REF: p. 7 e e e OBJ: 5 e
Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition
e e e e e e e e e e
, Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition
e e e e e e e e e 4
NAT: NCLEX Client Needs Category: Safe, Effective Care Environment
e e e e e e e e
TOP: Nursing Process Step: Assessment
e e e e e
CON: Health Care Law | Health Care Policy | Infection | Care Coordination
e e e e e e e e e e e e
9. Which statement is true about over-the-counter (OTC) drugs?
e e e e e e e
a. They are not listed in the USP NF. e e e e e e e
b. A prescription from a healthcare provider is needed.
e e e e e e e
c. They are sold without a prescription.e e e e e
d. They are known only by their brand names.
e e e e e e e
ANS: C e
OTC medications do not require a prescription. A variety of names, both generic and trade,
e e e e e e e e e e e e e e
can be used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription
e e e e e e e e e e e e e e e e e
drugs require an order by a health professional who is licensed to prescribe, such as a
e e e e e e e e e e e e e e e e
physician, nurse practitioner, physician assistant, or dentist.
e e e e e e e
DIF: Cognitive Level: Comprehension REF: p. 2 OBJ: 2 e e e e e
NAT: NCLEX Client Needs Category: Physiological Integrity
e e e e e e e
TOP: Nursing Process Step: Planning
e CON: Patient Education e e e e e
10. Which is the most authoritative reference for medications that are injected?
e e e e e e e e e e
a. Martindale: The Complete e e
b. Handbook on Injectable Drugs e e e
c. DailyMed
d. Handbook of Nonprescription Drugs e e e
ANS: B e
The Handbook on Injectable Drugs is the most comprehensive reference available on the
e e e e e e e e e e e e
topic of compatibility of injectable drugs. It is a collection of monographs for more than 300
e e e e e e e e e e e e e e e e
injectable drugs that are listed alphabetically by generic name.
e e e e e e e e e
DIF: Cognitive Level: Knowledge REF: p. 4 OBJ: 3 e e e e e
NAT: NCLEX Client Needs Category: Physiological Integrity
e e e e e e e
TOP: Nursing Process Step: Assessment CON: Clinical Judgment | Safety
e e e e e e e e
11. Which statement is true about Lomotil?
e e e e e
a. Abuse potential for this drug is low. e e e e e e
b. Psychological dependency is likely. e e e
c. There is a high potential for abuse. e e e e e e
d. This drug is not a controlled substance.
e e e e e e
ANS: A e
Lomotil, a Schedule V drug, has an abuse potential of limited physical or psychological
e e e e e e e e e e e e e
dependence liability compared with drugs in Schedule IV. Because abuse potential is low with
e e e e e e e e e e e e e e
a Schedule V drug, a prescription may not be required. Psychological dependency is not likely
e e e e e e e e e e e e e e e
with a Schedule V drug. Schedule V drugs are classified as controlled substances.
e e e e e e e e e e e e e
DIF: Cognitive Level: Knowledge REF: p. 5 Box 1.1 OBJ: 2 e e e e e e e
NAT: NCLEX Client Needs Category: Physiological Integrity
e e e e e e e
TOP: Nursing Process Step: Assessment CON: Clinical Judgment | Safety | Patient Education
e e e e e e e e e e e