Chapter 01: Drug Definitions, Standards, and Information Sources
Willihnganz: Clayton’s Basic Pharmacology for Nurses, 19th Edition

MULTIPLE CHOICE

	1.	Which name identifies a drug listed by the US Food and Drug Administration (FDA)?
a.	Brand	
b.	Nonproprietary	
c.	Official	
d.	Trademark	

ANS:	C
The official name is the name under which a drug is listed by the FDA. The brand name, or trademark, is the name given to a drug by its manufacturer. The nonproprietary, or generic, name is provided by the United States Adopted Names Council.

DIF:	Cognitive Level: Knowledge	REF:	p. 9	OBJ:	1
NAT:	NCLEX Client Needs Category: Safe, Effective Care Environment
TOP:	Nursing Process Step: Assessment	CON:	Patient Education	

	2.	Which source contains information specific to nutritional supplements?
a.	USP Dictionary of USAN & International Drug Names	
b.	Natural Medicines Comprehensive Database	
c.	United States Pharmacopoeia/National Formulary (USP NF)	
d.	Drug Interaction Facts	

ANS:	C
United States Pharmacopoeia/National Formulary contains information specific to nutritional supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug names, pronunciation guide, and possible future FDA approved drugs; it does not include nutritional supplements. Natural Medicines Comprehensive Database contains evidence-based information on herbal medicines and herbal combination products; it does not include information specific to nutritional supplements. Drug Interaction Facts contains comprehensive information on drug interaction facts; it does not include nutritional supplements.

DIF:	Cognitive Level: Knowledge	REF:	p. 4	OBJ:	3
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Assessment	CON:	Nutrition | Patient Education

	3.	Which drug reference contains drug monographs that describe all drugs in a therapeutic class?
a.	Drug Facts and Comparisons	
b.	Drug Interaction Facts	
c.	Handbook on Injectable Drugs	
d.	Martindale—The Complete Drug Reference	

ANS:	A
Drug Facts and Comparisons contains drug monographs that describe all drugs in a therapeutic class. Monographs are formatted as tables to allow comparison of similar products, brand names, manufacturers, cost indices, and available dosage forms
Online version is available.

DIF:	Cognitive Level: Knowledge	REF:	p. 4 Table 1.2		
OBJ:	3	NAT:	NCLEX Client Needs Category: Physiological Integrity
TOP:	Nursing Process Step: Assessment	CON:	Safety | Patient Education | Clinical Judgment

	4.	Which drug reference contains monographs about virtually every single-entity drug available in the United States and describes therapeutic uses of drugs, including approved and unapproved uses?
a.	Martindale: The Complete Drug Reference	
b.	AHFS Drug Information	
c.	Drug Reference	
d.	Drug Facts and Comparisons	

ANS:	B
AHFS Drug Information contains monographs about virtually every single-entity drug available in the United States and describes therapeutic uses of drugs, including approved and unapproved uses.

DIF:	Cognitive Level: Knowledge	REF:	p. 4 Table 1.2		
OBJ:	3	NAT:	NCLEX Client Needs Category: Physiological Integrity
TOP:	Nursing Process Step: Planning	CON:	Safety | Patient Education | Clinical Judgment

	5.	Which online drug reference makes available to healthcare providers and the public a standard, comprehensive, up-to-date look up and downloadable resource about medicines?
a.	American Drug Index	
b.	American Hospital Formulary	
c.	DailyMed	
d.	Drug Reference	

ANS:	C
DailyMed makes available to healthcare providers and the public a standard, comprehensive, up-to-date look up and downloadable resource about medicines. The American Drug Index is not appropriate for patient use. The American Hospital Formulary is not appropriate for patient use. The drug reference is not appropriate for patient use.

DIF:	Cognitive Level: Knowledge	REF:	p. 3 | p. 4	OBJ:	3
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Implementation		
CON:	Safety | Patient Education | Clinical Judgment

	6.	Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
a.	Federal Food, Drug, and Cosmetic Act (1938)	
b.	Durham Humphrey Amendment (1952)	
c.	Controlled Substances Act (1970)	
d.	Kefauver Harris Drug Amendment (1962)	

ANS:	A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of all drugs before marketing. Later amendments and acts helped tighten FDA control and ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used safely without medical supervision and restricts their sale to prescription by a licensed practitioner. The Controlled Substances Act addresses only controlled substances and their categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater drug safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products before marketing them.

DIF:	Cognitive Level: Knowledge	REF:	p. 5 Table l.3		
OBJ:	5	NAT:	NCLEX Client Needs Category: Physiological Integrity
TOP:	Nursing Process Step: Assessment	
CON:	Safety | Patient Education | Evidence | Health Care Law

	7.	Which classification does meperidine (Demerol) fall under?
a.	I	
b.	II	
c.	III	
d.	IV	

ANS:	B
Meperidine (Demerol) is a Schedule II drug; it has a high potential for abuse and may lead to severe psychological and physical dependence. Schedule I drugs have high potential for abuse and no recognized medical use. Schedule III drugs have some potential for abuse. Use may lead to low to moderate physical dependence or high psychological dependence. Schedule IV drugs have low potential for abuse. Use may lead to limited physical or psychological dependence.

DIF:	Cognitive Level: Knowledge	REF:	p. 10	OBJ:	2
NAT:	NCLEX Client Needs Category: Safe, Effective Care Environment
TOP:	Nursing Process Step: Assessment	CON:	Patient Education | Addiction | Pain

	8.	Which action would the FDA take to expedite drug development and approval for an outbreak of smallpox?
a.	List smallpox as a health orphan disease.	
b.	Omit the preclinical research phase.	
c.	Extend the clinical research phase.	
d.	Fast track the investigational drug.	

ANS:	D
Once the Investigational New Drug Application has been approved, the drug can receive highest priority within the agency, which is called fast tracking. A smallpox outbreak would become a priority concern in the world. Orphan diseases are not researched in a priority manner. Preclinical research is not omitted. Extending any phase of the research would mean a longer time to develop a vaccine. The FDA must ensure that all phases of the preclinical and clinical research phase have been completed in a safe manner.

DIF:	Cognitive Level: Knowledge	REF:	p. 7	OBJ:	5
NAT:	NCLEX Client Needs Category: Safe, Effective Care Environment
TOP:	Nursing Process Step: Assessment	
CON:	Health Care Law | Health Care Policy | Infection | Care Coordination

	9.	Which statement is true about over-the-counter (OTC) drugs?
a.	They are not listed in the USP NF.	
b.	A prescription from a healthcare provider is needed.	
c.	They are sold without a prescription.	
d.	They are known only by their brand names.	

ANS:	C
OTC medications do not require a prescription. A variety of names, both generic and trade, can be used for individual drugs sold OTC. OTC drugs are listed in the USP NF. Prescription drugs require an order by a health professional who is licensed to prescribe, such as a physician, nurse practitioner, physician assistant, or dentist.

DIF:	Cognitive Level: Comprehension	REF:	p. 2	OBJ:	2
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Planning	CON:	Patient Education	

	10.	Which is the most authoritative reference for medications that are injected?
a.	Martindale: The Complete	
b.	Handbook on Injectable Drugs	
c.	DailyMed	
d.	Handbook of Nonprescription Drugs	

ANS:	B
The Handbook on Injectable Drugs is the most comprehensive reference available on the topic of compatibility of injectable drugs. It is a collection of monographs for more than 300 injectable drugs that are listed alphabetically by generic name.

DIF:	Cognitive Level: Knowledge	REF:	p. 4	OBJ:	3
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Assessment	CON:	Clinical Judgment | Safety

	11.	Which statement is true about Lomotil?
a.	Abuse potential for this drug is low.	
b.	Psychological dependency is likely.	
c.	There is a high potential for abuse.	
d.	This drug is not a controlled substance.	

ANS:	A
Lomotil, a Schedule V drug, has an abuse potential of limited physical or psychological dependence liability compared with drugs in Schedule IV. Because abuse potential is low with a Schedule V drug, a prescription may not be required. Psychological dependency is not likely with a Schedule V drug. Schedule V drugs are classified as controlled substances.

DIF:	Cognitive Level: Knowledge	REF:	p. 5 Box 1.1	OBJ:	2
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Assessment	CON:	Clinical Judgment | Safety | Patient Education

	12.	Which medication ordered for a patient with a substance abuse history has the greatest risk for abuse?
a.	Lomotil	
b.	Diazepam	
c.	Phenobarbital	
d.	Lortab	

ANS:	D
Lortab is a Schedule III drug with a high potential for abuse but less so than drugs in Schedules I and II. Lomotil is a Schedule V drug with a low potential for abuse compared with those in Schedule V. Diazepam is a Schedule IV drug with a low potential for abuse compared with those in schedule III. Phenobarbital is a Schedule IV drug with a low potential for abuse compared with those in Schedule III.

DIF:	Cognitive Level: Application	REF:	p. 5 Box 1.1	OBJ:	2
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Assessment	CON:	Addiction | Patient Education | Safety

	13.	An older adult experiencing shortness of breath is brought to the hospital by her daughter. While obtaining the medication history from the patient and her daughter, the nurse discovers that neither has a list of the patient’s current medications or prescriptions. The patient has is a weekly pill dispenser that contains four different pills. The prescriptions are filled through the local pharmacy. Which resource would be appropriate to use in determining the medication names and doses?
a.	Martindale—The Complete Drug Reference	
b.	Drugs and Facts Comparisons	
c.	Senior citizens’ center	
d.	Patient’s home pharmacy	

ANS:	D
The patient’s pharmacy would have an accurate account of all the medications the client is currently taking. Martindale—The Complete Drug Reference has written information on medications and would not be an appropriate resource. Drugs and Facts Comparisons contains drug monographs that describe all drugs in a therapeutic class but would not help identify medications by photograph. The senior citizens’ center is not likely to have specific patient medication information.

DIF:	Cognitive Level: Application	REF:	p. 2	OBJ:	3
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Assessment	
CON:	Care Coordination | Safety | Patient Education | Clinical Judgment	

MULTIPLE RESPONSE

	1.	Which statement(s) will be included when planning patient teaching regarding drug names? (Select all that apply.)
a.	Most drug companies place their products on the market under generic names.	
b.	The official name is the name under which the drug is listed by the US Food and Drug Administration (FDA).	
c.	Brand names are easier to pronounce, spell, and remember.	
d.	The first letter of the generic name is not capitalized.	
e.	The chemical name is most meaningful to the patient.	

ANS:	B, C, D
The official name is the name under which the drug is listed by the FDA. Brand names are easier to pronounce, spell, and remember. The first letter of the generic name is not capitalized. Most drug companies place their products on the market under brand names instead of generic names. The chemical name is most meaningful to the chemist.

DIF:	Cognitive Level: Comprehension	REF:	p. 2 | p. 9	OBJ:	1
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Planning	CON:	Patient Education | Clinical Judgment | Safety

	2.	Which drug(s) would be considered to be in the category Schedule II? (Select all that apply.)
a.	Marijuana	
b.	Percodan	
c.	Amphetamines	
d.	Fiorinal	
e.	Flurazepam	

ANS:	B, C
Schedule II drugs have a high potential for abuse, they are currently accepted in the United States, and use may lead to severe psychological or physical dependence. Percodan and amphetamines are considered Schedule II drugs. Marijuana is a Schedule I drug. Fiorinal is a Schedule III drug. Flurazepam is a Schedule IV drug.

DIF:	Cognitive Level: Comprehension	REF:	p. 5 Box 1.1	OBJ:	2
NAT:	NCLEX Client Needs Category: Physiological Integrity	
TOP:	Nursing Process Step: Assessment	CON:	Addiction | Clinical Judgment | Patient Education