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