WorksheetsExCPT Chapter 3: Pharmacy Law, Ethics, and Regulatory Agencies
Total questions: 81
Worksheet time: 41mins
Name
Class
Date
1.
The study of values or principles governing personal relationships is called:
a)
laws.
b)
standards.
c)
ethics.
d)
etiquette.
2.
An oral testimony taken by a court reporter at a location outside the courtroom, subject to the same requirements for truth as court testimony is called:
a)
subpoena.
b)
deposition.
c)
litigation.
d)
summons.
3.
The branch of the government that is responsible for creating laws is the:
a)
executive branch.
b)
legislative branch.
c)
judicial branch.
d)
court branch.
4.
What regulatory agency is responsible for the approval of drugs, over-the-counter (OTC) and prescription labeling, and standards for drug manufacturing?
a)
Board of Pharmacy
b)
United States Pharmacopeia (USP)
c)
Drug Enforcement Administration (DEA)
d)
Food and Drug Administration (FDA)
5.
The Model State Pharmacy Practice Act (MSPPA), which can provide a greater degree of uniformity between states with regard to the practice of pharmacy, was developed by the
a)
Boards of Pharmacy.
b)
Food and Drug Administration (FDA).
c)
National Associations of Boards of Pharmacy (NABP).
d)
Department of Health and Human Services.
6.
Which drug is an example of a Schedule V drug that requires a prescription?
a)
Lomotil
b)
Morphine
c)
Cough syrup with codeine (10 mg/5 ml)
d)
Imodium
7.
Applications for re-registration for a DEA license should be mailed approximately how many days prior to the expiration date?
a)
14 days
b)
30 days
c)
60 days
d)
120 days
8.
A pharmacist must be registered with the DEA if he:
a)
works in a pharmacy that dispenses controlled drugs.
b)
owns a pharmacy that is incorporated.
c)
owns a pharmacy as a sole proprietor.
d)
never needs to be registered with the DEA.
9.
Pharmacies should make a complete and accurate record of all stocks of controlled substances on hand every:
a)
month.
b)
year.
c)
two years.
d)
three years.
10.
Prescriptions for Schedule II controlled substances can be refilled:
a)
one time in six months.
b)
up to five times in six months.
c)
an unlimited number of times for up to a year.
d)
No refills are allowed.
11.
Prescriptions for Schedules III and IV controlled substances can be refilled:
a)
one time in six months.
b)
up to five times in six months.
c)
an unlimited number of times for up to a year.
d)
No refills are allowed.
12.
The Pure Food and Drug Act of 1906 was believed to be inadequate for the following reasons, except:
a)
this act did not extend to cosmetics.
b)
this act did not permit the authority to ban unsafe drugs.
c)
a manufacturer could not make false statements about a drug.
d)
labels were not required to identify the contents.
13.
The official DEA form that pharmacies use to document the destruction of controlled substances is form:
a)
DEA-222.
b)
DEA-41.
c)
DEA-106.
d)
DEA-510.
14.
Patient counseling, as required by the Omnibus Budget Reconciliation Act (COBRA) of 1990, should include:
a)
the name and description of the drug.
b)
all possible side effects of the drug.
c)
the name of the manufacturer.
d)
the pharmacokinetics of the drug.
15.
Which schedule is the opiate morphine, which may result in severe psychological and physical dependence when abused?
a)
Schedule I
b)
Schedule II
c)
Schedule IV
d)
Schedule V
16.
Schedule IV controlled substances include drugs with:
a)
a high abuse potential and no accepted medical use.
b)
a high abuse potential with a legitimate medical use.
c)
a low abuse potential such as certain hypnotics and minor tranquilizers.
d)
the lowest abuse potential such as some narcotic drugs generally used for their antitussive properties.
17.
Who creates the standards for child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA)?
a)
Food and Drug Administration (FDA)
b)
Drug Enforcement Agency (DEA)
c)
Consumer Product Safety Commission (CPSC)
d)
United States Pharmacopeia (USP)
18.
A Class II Drug Recall is one in which:
a)
the use or exposure to the product will cause severe adverse reactions or death.
b)
the use or exposure to the product may cause temporary or medically reversible adverse health hazards.
c)
the use or exposure to the product is not likely to cause adverse health hazards.
d)
None of the options.
19.
The agency deeply involved in the war against the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) is the:
a)
Food and Drug and Administration (FDA).
b)
Centers for Disease Control and Prevention (CDC).
c)
Drug Enforcement Agency (DEA).
d)
Department of Health and Human Services (HHS).
20.
The “Administrative Simplification” provision of the Health Insurance Portability and Accountability Act (HIPAA) consists of:
a)
Electronic Health Transaction Standards.
b)
Standards for setting insurance premiums.
c)
Privacy and Confidentiality Standards.
d)
Electronic Health Transaction Standards & Privacy and Confidentiality Standards.
21.
Which of the following amendments or acts required manufacturers to register and list their products?
a)
Medical Device Amendment
b)
Kefauver–Harris Amendment
c)
Durham–Humphrey Amendment
d)
Omnibus Budget Reconciliation Act
22.
Doctors and pharmacists are now required by the FDA to register and use a specific Web site in order to receive which of the following medications?
a)
Ibuprofen (Motrin)
b)
Isoniazid (Isoniazid)
c)
Isotretinoin (Accutane)
d)
Isoflurane (Forane)
23.
Which of the following laws is an extension of the Patriot Act?
a)
Medicare Modernization Act
b)
Combat Methamphetamine Epidemic Act
c)
Dietary Supplement Health and Education Act
d)
Anabolic Steroid Control Act
24.
An example of an intentional tort is:
a)
negligence.
b)
malpractice
c)
libel.
d)
battery.
25.
Orphan drugs are used for all of the following disorders or conditions, except
a)
snakebite.
b)
cystic fibrosis.
c)
peptic ulcer.
d)
blepharospasm.
26.
Which act prohibits the reimportation of a drug into the United States by anyone but the manufacturer?
a)
Prescription Drug Marketing Act
b)
Anabolic Steroids Control Act
c)
Drug Price Competition and Patent Term Restoration Act
d)
Orphan Drug Act
27.
A DEA number consists of a two-letter prefix followed by:
a)
three digits.
b)
five digits.
c)
seven digits.
d)
nine digits.
28.
Which information does not have to be included on a DEA Form 222 when ordering controlled substances?
a)
Company name and address
b)
Social security number
c)
Ordering date
d)
Signature of purchaser
29.
When a controlled substance is stolen or lost from a pharmacy, the nearest DEA office must be notified using which of the following DEA forms?
a)
222
b)
224
c)
106
d)
41
30.
The maximum amount of items that may be ordered on DEA Form 222 is:
a)
3
b)
5
c)
10
d)
15
31.
The relationship between individuals within society is governed by ____________________ law.
a)
civil
b)
criminal
c)
misdemeanor
d)
felony
32.
A court order that requires the individual to appear as a witness in court or to make herself available to be deposed is called a(n) ____________________.
a)
subpoena
b)
deposition
c)
arbitration
d)
warrant
33.
The federal regulatory agency for the field of pharmacy is the ____________________.
a)
FDA
b)
CDC
c)
UF/NPC
d)
NIH
34.
A crime in a pharmacy in which the pharmacist was illegally selling prescription drugs without a prescription would be classified as a(n) ____________________.
a)
felony
b)
misdemeanor
c)
warning
d)
ticket
35.
The ____________________ are administrative agencies that are authorized to make rules and regulations for the enforcement and administration of pharmacy law.
a)
boards of pharmacy
b)
boards of medicine
c)
boards of formulary
d)
boards of pharmacy technicians
36.
Schedule ____________________ control substances have no accepted medical use in the United States and can only be used for research purposes by properly registered people.
a)
one (I)
b)
two (II)
c)
three (III)
d)
four (IV)
37.
Most Schedule V drugs are ____________________ preparations that may be sold without a prescription.
a)
over-the-counter
b)
prescription
c)
recommended
d)
illegal
38.
A pharmacy must maintain records of controlled substances dispensed for ____________________ years, although some states require pharmacies to maintain records for at least five years.
a)
two
b)
three
c)
four
d)
one
39.
Pharmacies utilize DEA form ____________________ to report loss or theft of significant amounts of controlled substances.
a)
DEA-106
b)
DEA-10
c)
DEA-22
d)
DEA-40
40.
The ____________________ is a unique and permanent product code that identifies the manufacturer or distributor, the drug formulation, and the size and type of packaging.
a)
National Drug Code (NDC)
b)
National Danger Code (NDC)
c)
Food and Drug Code (FDC)
d)
United Formulary Code (UFC)
41.
Orphan drugs are developed to be used for diseases that affect fewer than ____________________ people in the country.
a)
200,000
b)
100,000
c)
500,000
d)
10,000
42.
It is unlawful for any person to provide nuclear pharmaceutical services unless under the supervision of a(n) ____________________.
a)
nuclear pharmacist
b)
community pharmacist
c)
advanced pharmacist
d)
hospital pharmacist
43.
The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requires that pharmacists offer to discuss information about new and refill prescriptions with Medicare and ____________________ recipients.
a)
Medicaid
b)
Medicare
c)
TRICARE
d)
CHAMPS
44.
Guidelines for practice of a profession developed by professional organizations are also called ____________________.
a)
standards
b)
protocols
c)
regulations
d)
guidelines
45.
The Poison Prevention Packaging Act specifies that the majority of OTC and legend drugs cannot be opened by ____________________% of children under 5 years of age.
a)
80
b)
90
c)
60
d)
50
46.
The discipline dealing with the ethical and moral implications of biological research and applications, especially as they relate to life and death is called ____________________.
a)
bioethics
b)
biomorality
c)
biovalues
d)
bioprinciples
47.
The regulation of the practice of pharmacy is primarily a function of the ____________________ and not the federal government.
a)
state
b)
local
c)
county
d)
region
48.
Drug standards that set the requirements for the formulation of drug substances, ingredients, and dosage forms are contained in the ____________________ and the ____________________.
a)
USP, NF
b)
FDA, NIH
c)
DEA, FDA
d)
USP, NIH
49.
Retail pharmacies may request DEA permission to destroy outdated or damaged controlled substances ____________________ per year.
a)
once
b)
twice
c)
three times
d)
four times
50.
Anabolic steroids are hormonal substances that are related to ____________________, ____________________, ____________________, and corticosteroids.
a)
testosterone
b)
estrogen
c)
progestin
d)
oxytocin
51.
The Medicare Prescription Drug, Improvement, and Modernization Act was designed to provide senior citizens and ____________________ individuals with a prescription drug benefit.
a)
disabled
b)
abled
c)
geriatric
d)
bariatric
52.
Controlled substances have been categorized according to their potential for ____________________ and their ____________________ abilities.
a)
abuse, addictive
b)
abuse, non-addictive
c)
dependency, addictive
d)
dependency, non-addictive
53.
The Accutane iPledge Program is intended to prevent use of the drug during ____________________ due to the high risk of ____________________.
a)
pregnancy, birth defects
b)
adolescence, death
c)
adolescence, severe illness
d)
pregnancy, death
54.
The FDA is a branch of the U.S. Department of ____________________ and ____________________ Services.
a)
Health, Human
b)
Human, Health
c)
Diet, Health
d)
Health, Diet
55.
When the use of or exposure to a drug will cause severe adverse reactions or death, and the drug is recalled, it is classified as a(n) ____________________ drug recall.
a)
Class 1
b)
Class 2
c)
Class 3
d)
Class 4
56.
The mission of the DEA is to enforce ____________________ laws and regulations.
a)
controlled substance
b)
monitored substance
c)
uncontrolled substance
d)
OTC substance
57.
The Durham–Humphrey Amendment prohibits dispensing of ____________________ drugs without a(n) ____________________.
a)
legend, prescription
b)
controlled, prescription
c)
OTC, prescription
d)
orphan, prescription
58.
The DEA is part of the U.S. Department of ____________________.
a)
Justice
b)
Education
c)
Health
d)
Service
59.
The Food, Drug, and Cosmetic Act created the ____________________ and required pharmaceutical manufacturers to file New Drug Applications with the FDA.The DEA is part of the U.S. Department of ____________________.
a)
FDA
b)
CDC
c)
NIH
d)
USP, NF
60.
The patient asks that he have counseling with the pharmacist regarding the prescription. What law requires that the pharmacist consult with the patient regarding this medication?
a)
Omnibus Budget Reconciliation Act of 1990
b)
Pure Food and Drug act of 1906
c)
Affordable Care Act of 2010
d)
Health Insurance and Portability Act of 1996
61.
governs the relationship of the individual to society as a whole
a)
civil law
b)
criminal law
c)
judicial law
d)
statutes
e)
administrative law
62.
governs the relationship between individuals within society
a)
civil law
b)
criminal law
c)
judicial law
d)
statutes
e)
administrative law
63.
results from action by the legislature
a)
civil law
b)
criminal law
c)
judicial law
d)
statutes
e)
administrative law
64.
the rules and regulations established by agencies of the federal government
a)
civil law
b)
criminal law
c)
judicial law
d)
statutes
e)
administrative law
65.
Dishonest and deceitful practices undertaken in order to induce someone to part with something valuable or a legal right
a)
abuse
b)
negligence
c)
slander
d)
libel
e)
fraud
66.
defamatory spoken words
a)
abuse
b)
negligence
c)
slander
d)
libel
e)
fraud
67.
improper use of equipment, a substance, or a service
a)
abuse
b)
negligence
c)
slander
d)
libel
e)
fraud
68.
failure to use a reasonable amount of care to prevent injury or damage to another
a)
abuse
b)
negligence
c)
slander
d)
libel
e)
fraud
69.
failure to use a reasonable amount of care to prevent injury or damage to another
a)
abuse
b)
negligence
c)
slander
d)
libel
e)
fraud
70.
requires that drug products—both prescription and nonprescription—must be effective and safe
a)
Kefauver–Harris Amendment of 1962
b)
Pure Food and Drug Act of 1906
c)
Food, Drug, and Cosmetic Act of 1938
d)
Durham–Humphrey Amendment of 1951
e)
Supplemental Health and Educational Act of 1994
71.
controls the manufacture, distribution, and dispensing of controlled substances
a)
Comprehensive Drug Abuse Prevention and Control Act of 1970
b)
Pure Food and Drug Act of 1906
c)
Food, Drug, and Cosmetic Act of 1938
d)
Durham–Humphrey Amendment of 1951
e)
Kefauver–Harris Amendment of 1962
72.
prohibits dispensing of legend drugs without a prescription
a)
Durham–Humphrey Amendment of 1951
b)
Pure Food and Drug Act of 1906
c)
Food, Drug, and Cosmetic Act of 1938
d)
Kefauver–Harris Amendment of 1962
e)
Supplemental Health and Educational Act of 1994
73.
placed the burden of proof squarely on FDA with regard to the safeness of dietary supplements
a)
Supplemental Health and Educational Act of 1994
b)
Pure Food and Drug Act of 1906
c)
Food, Drug, and Cosmetic Act of 1938
d)
Durham–Humphrey Amendment of 1951
e)
Kefauver–Harris Amendment of 1962
74.
prohibits the reimportation of a drug into the United States
a)
Prescription Drug Marketing Act of 1987
b)
Pure Food and Drug Act of 1906
c)
Food, Drug, and Cosmetic Act of 1938
d)
Durham–Humphrey Amendment of 1951
e)
Kefauver–Harris Amendment of 1962
75.
prohibits the interstate distribution or sale of adulterated and misbranded food and drugs
a)
Pure Food and Drug Act of 1906
b)
Food, Drug, and Cosmetic Act of 1938
c)
Durham–Humphrey Amendment of 1951
d)
Kefauver–Harris Amendment of 1962
e)
Supplemental Health and Educational Act of 1994
76.
offers tax breaks for companies to undertake the development and manufacture of drugs for uncommon diseases
a)
Orphan Drug Act of 1983
b)
Pure Food and Drug Act of 1906
c)
Food, Drug, and Cosmetic Act of 1938
d)
Durham–Humphrey Amendment of 1951
e)
Kefauver–Harris Amendment of 1962
77.
created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file a New Drug Application with the FDA
a)
Food, Drug, and Cosmetic Act of 1938
b)
Pure Food and Drug Act of 1906
c)
Durham–Humphrey Amendment of 1951
d)
Kefauver–Harris Amendment of 1962
e)
Supplemental Health and Educational Act of 1994
78.
branch of the Department of Health and Human Services that controls all drugs for legal use
a)
Occupational Safety and Health Administration (OSHA)
b)
Drug Enforcement Administration (DEA)
c)
Food and Drug Administration (FDA)
d)
Centers for Disease Control and Prevention (CDC)
e)
Consumer Product Safety Commission (CPSC)
79.
federal agency that provides facilities and services for the investigation, identification, prevention, and control of disease
a)
Occupational Safety and Health Administration (OSHA)
b)
Drug Enforcement Administration (DEA)
c)
Food and Drug Administration (FDA)
d)
Centers for Disease Control and Prevention (CDC)
e)
Consumer Product Safety Commission (CPSC)
80.
federal agency whose mission is to enforce the controlled substance laws and regulations
a)
Occupational Safety and Health Administration (OSHA)
b)
Drug Enforcement Administration (DEA)
c)
Food and Drug Administration (FDA)
d)
Centers for Disease Control and Prevention (CDC)
e)
Consumer Product Safety Commission (CPSC)
81.
mission is to ensure workplace safety and a healthy environment within the workplace
a)
Occupational Safety and Health Administration (OSHA)
b)
Drug Enforcement Administration (DEA)
c)
Food and Drug Administration (FDA)
d)
Centers for Disease Control and Prevention (CDC)
e)
Consumer Product Safety Commission (CPSC)
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