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