Pharmacy Law: Module 1 Review Flashcards
(154 cards)
1
Q
Any individual who helps a person to violate the law either directly or indirectly.
A
accessory
2
Q
Regulations set forth by governmental agencies, such as the Internal Revenue Service (IRS) and the Social Security Administration (SSA); also called regulatory law.
A
administrative law
3
Q
Tampering with or contaminating a product or substance.
A
adulterated
4
Q
rugs derived from barbituric acid, which act as central nervous system depressants.
A
barbiturates
5
Q
A discipline dealing with the ethical and moral implications of biological research and applications.
A
bioethics
6
Q
Rules and regulations that govern the relationship between individuals within society.
A
civil law
7
Q
A violation of the law.
A
crime
8
Q
An individual who violates the law.
A
criminal
9
Q
Rules and regulations that govern the relationship of the individual to society as a whole.
A
criminal law
10
Q
A federal law enforcement agency that combats illegal drug use and smuggling both within the United States and abroad.
A
Drug Enforcement Administration (DEA)
11
Q
A serious crime, such as murder, kidnapping, assault, or rape, that is punishable by imprisonment for more than one year.
A
felony
12
Q
The agency within the U.S. Department of Health and Human Services that is responsible for assurance of the safety, efficacy, and security of drugs used for humans and pets, biological products, medical devices, cosmetics, radioactive products, and the national food supply.
A
Food and Drug Administration (FDA)
13
Q
A rule or regulation established by a governing body.
A
law
14
Q
Professional misconduct, or the demonstration of an unreasonable lack of skill, resulting in injury, loss, or damage to a patient.
A
malpractice
15
Q
The discipline in which merits, risks, and social concerns are evaluated concerning the practice of medicine.
A
medical ethics
16
Q
Fraudulent labeling or marking.
A
misbranding
17
Q
A crime less serious than a felony, punishable by a fine or imprisonment for less than one year.
A
misdemeanor
18
Q
A unique and permanent product code assigned to each new drug as it becomes available in the marketplace; it identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging.
A
National Drug Code (NDC)
19
Q
A database of officially recognized drug names.
A
National Formulary (NF)
20
Q
A type of unintentional tort alleged when a person has performed, or failed to perform, an act that a reasonable person would, or would not, have performed in similar circumstances.
A
negligence
21
Q
A drug that is developed for small populations of people in need of the drug.
A
orphan drug
22
Q
Regulations set forth by governmental agencies. It is also called administrative law.
A
regulatory law
23
Q
Under HIPAA, “codes used to encode data elements, tables of terms, medical concepts, diagnostic codes, or medical procedures.” A code set includes the codes and the descriptors of the codes.
A
standard code sets
24
Q
Established by authority, custom, or general consent as a model or example; something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality.
A
standards
25
Rules and regulations resulting from decisions by legislatures.
statutes
26
A civil wrong committed against person or property.
tort
27
A crime less serious than a felony, punishable by a fine or imprisonment for less than one year.
Misdemeanors
28
A serious crime, such as murder, kidnapping, assault, or rape, that is punishable by imprisonment for more than one year.
Felonies
29
Any information about a patient’s health status, provision of health care, or payment for health care.
protected health information
30
The ____________________ are administrative agencies that are authorized to make rules and regulations for the enforcement and administration of pharmacy law.
Boards of Pharmacy
31
A Class II Drug Recall is one in which:
The use or exposure to the product may cause temporary or medically reversible adverse health hazards.
32
An ___________ is one that is intended for use in a few patients with a rare disease or condition affecting less than 200,000 people.
Orphan Drug Act
33
An example of an intentional tort is:
battery.
34
Pharmacies should make a complete and accurate record of all stocks of controlled substances on hand every:
two yeats
35
The purpose of the ___________ was to prohibit the interstate transportation or sale of adulterated and misbranded food and drugs.
Pure Food and Drug Act of 1906
36
Patient counseling, as required by the Omnibus Budget Reconciliation Act (OBRA) of 1990, should include:
the name and description of the drug.
37
laws that result from court decisions
judicial law
38
governs the relationship of the individual to society as a whole
criminal law
39
governs the relationship between individuals within society
civil law
40
results from action by the legislature
statutes
41
the rules and regulations established by agencies of the federal government
administrative law
42
The Pure Food and Drug Act of 1906 was believed to be inadequate for the following reasons, except:
this act did not extend to cosmetics.
this act did not permit the authority to ban unsafe drugs.
a manufacturer could not make false statements about a drug.
labels were not required to identify the contents
a manufacturer could not make false statements about a drug.
43
The official DEA form that pharmacies use to document the destruction of controlled substances is form:
DEA-41.
44
What regulatory agency is responsible for the approval of drugs, over-the-counter (OTC) and prescription labeling, and standards for drug manufacturing?
Food and Drug Administration (FDA)
45
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.
Medicaid
46
T or F
A crime in a pharmacy in which the pharmacist was illegally selling prescription drugs without a prescription would be classified as a felony.
True
47
A pharmacy must maintain records of controlled substances dispensed for ____________________ years, although some states require pharmacies to maintain records for at least five years.
2
48
The FDA is a branch of the U.S. Department of Health and ____________________ Services.
Human
49
T or F
The Durham–Humphrey Amendment prohibits dispensing of legend drugs without a prescription.
True
50
T or F
The Accutane iPledge Program is intended to prevent use of the drug during pregnancy due to the high risk of birth defects.
True
51
branch of the Department of Health and Human Services that controls all drugs for legal use
Food and Drug Administration (FDA)
52
creates standards for child-resistant packaging
Consumer Product Safety Commission (CPSC)
53
federal agency that provides facilities and services for the investigation, identification, prevention, and control of disease
Centers for Disease Control and Prevention (CDC)
54
federal agency whose mission is to enforce the controlled substance laws and regulations
Drug Enforcement Administration (DEA)
55
mission is to ensure workplace safety and a healthy environment within the workplace
Occupational Safety and Health Administration (OSHA)
56
A DEA number consists of a two-letter prefix followed by:
seven digits
57
Which information does not have to be included on a DEA Form 222 when ordering controlled substances?
SSN
58
requires that drug products—both prescription and nonprescription—must be effective and safe
KefauverHarris Amendment of 1962
59
controls the manufacture, distribution, and dispensing of controlled substances
Comprehensive Drug Abuse
Prevention and Control Act of 1970
60
prohibits dispensing of legend drugs without a prescription
Durham-Humphrey Amendment of 1951
61
placed the burden of proof squarely on FDA with regard to the safeness of dietary supplements
Supplemental Health and Educational Act of 1994
62
prohibits the reimportation of a drug into the United States
Prescription Drug Marketing Act of 1987
63
prohibits the interstate distribution or sale of adulterated and misbranded food and drugs
Pure Food and Drug Act of 1906
64
offers tax breaks for companies to undertake the development and manufacture of drugs for uncommon diseases
Orphan Drug Act of 1983
65
created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file a New Drug Application with the FDA
Food, Drug, and Cosmetic Act of 1938
66
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?
Isotretinoin (Accutane)
67
The maximum amount of items that may be ordered on DEA Form 222 is:
10
68
The agency deeply involved in the war against the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) is the:
Centers for Disease Control and Prevention (CDC).
69
Which of the following amendments or acts required manufacturers to register and list their products?
Medical Device Amendment
70
_____ law governs relationships between individuals in society.
civil
71
_____ law governs the relationship between individuals and society as a whole.
→ Criminal
72
Judicial law results from _____ decisions.
court
73
____ are laws created by legislative bodies.
statutes
74
The _____ is the person against whom charges are brought in court.
defendant
75
A _____ is oral testimony taken outside the courtroom.
deposition
76
_____ is the authority of a court to hear a case and make a judgment.
Jurisdiction
77
The _____ is the person who initiates a civil legal action.
→ plaintiff
78
The _____ of limitations is the law that limits the time to sue.
statute
79
A _____ is a court order requiring a person to appear or provide testimony.
subpoena
80
A _____ is a rule or regulation created by a governing body.
law
81
_____ is the study of values governing personal relationships.
ethics
82
Medical ethics evaluates risks, merits, and _____ concerns of medical activity.
social
83
_____ are practice guidelines created by professional organizations.
standards
84
The principle of doing good is called _____.
beneficence
85
_____ is the principle of being loyal and keeping promises.
fidelity
86
_____ refers to telling the truth.
veracity
87
____ means giving people what is fair and due.
justice
88
_____ refers to respecting a person’s right to make their own decisions.
autonomy
89
Laws are upheld by federal, state, and _____ governments.
local
90
The three federal branches are legislative, executive, and _____.
judicial
91
As society evolves, _____ change to reflect current and future realities.
laws
92
Law types include civil, criminal, tort, administrative, and _____ law.
constitutional
93
Criminal law deals with violations against the _____ or state.
government
94
The right to _____ means a person may defend themselves against charges.
due process
95
_____ are crimes usually punished by fines or jail time under a year.
misdemeanors
96
Lesser misdemeanors are called _____.
infractions
97
_____ are serious crimes punishable by long-term imprisonment or large fines.
→ Felonies
98
Felonies may result in the loss of many _____ rights.
citizenship
99
_____ is the most serious crime, involving attempts to overthrow the government.
treason
100
Felonies are serious crimes punishable by over _____ year(s) of imprisonment.
one
101
Convicted felons often lose many of their _____ rights.
civil
102
_____ law focuses on noncriminal acts between individuals and organizations.
civil
103
Civil law is also commonly referred to as _____ law.
case
104
_____ law allows individuals harmed by others to seek monetary remedies.
tort
105
Medical malpractice is regulated under _____ law.
tort
106
Intentional torts involve purposeful infringement; unintentional torts include negligence and _____.
malpractice
107
_____ law involves agreements that create obligations between parties.
contract
108
The _____ Commercial Code affects contract law.
uniform
109
Administrative law is also called _____ law.
regulatory
110
Laws made by legislatures are called _____ law.
statutory
111
A person who helps commit a crime is called an _____.
accsessory
112
_____ is dishonest or deceitful practice in pharmacy.
fraud
113
_____ is defamatory writing, while slander is defamatory speech.
libel
114
_____ is the failure to use reasonable care.
negligence
115
_____ is the improper use of a substance or service.
abuse
116
Pharmacy regulation is mainly handled by _____ governments.
state
117
Federal pharmacy regulation began with the _____ of 1906.
pure food and drug act
118
The 1906 act prohibited sale of adulterated or _____ drugs.
misbranded
119
In 1912, Congress expanded misbranding to include false or _____ claims.
fraudulent
120
The Harrison Narcotics Act of 1914 addressed the recreational use of _____.
opium
121
The 1938 FD&C Act created the _____ and required NDAs.
FDA
122
The Durham-Humphrey Amendment classified drugs as prescription or _____.
OTC
123
The Kefauver-Harris Amendment required drugs to be _____ and safe.
effective
124
The CSA of 1970 replaced previous narcotic laws and created _____ Schedules.
five
125
Schedule I drugs have no accepted _____ use in the U.S.
medical
126
Schedule II prescriptions must be _____ (with limited exceptions).
written
127
Schedule III drugs have _____ potential for abuse than Schedules I & II.
lower
128
Schedule IV includes drugs like _____ and minor tranquilizers.
barbiturates
129
Schedule V drugs are often used for _____ or antidiarrheal purposes.
antituussive
130
Schedule I examples: heroin, LSD, _____.
marijuana
131
Schedule II examples: codeine, methamphetamine, _____.
cocaine
132
Schedule III includes drugs compounded with small amounts of _____.
narcotics
133
Schedule IV includes diazepam and _____.
chloral hydrate
134
Schedule V includes cough syrups with _____ and diphenoxylate HCl.
codeine
135
Controlled substance manufacturers must register with the _____ unless exempt.
DEA
136
DEA Form _____ is required to order Schedule I and II substances.
222
137
Theft or loss of controlled substances is reported using DEA Form _____.
106
138
Expired controlled substances require DEA Form _____ and a cover letter.
41
139
Schedule II returns also require DEA Form _____.
222
140
Schedule II records must be kept _____ from other records.
separately
141
Inventory of controlled substances must be completed every _____ years.
two
142
No prescription for a Schedule II substance may be _____.
refilled
143
The _____ Act of 1970 created child-resistant packaging standards.
poison prevention packaging
144
Material Safety Data Sheets must include storage, handling, and _____ procedures.
emergency
145
The Drug Listing Act of 1972 assigned a permanent _____ to each drug.
NDC
146
The Orphan Drug Act provides incentives for drugs affecting fewer than _____ people.
200,000
147
The HIPAA Privacy Rule limits nonconsensual use of _____ health information.
protected
148
The Controlled Substances Act classifies drugs into _____ schedules.
five
149
Schedule I drugs have no accepted _____ use in the United States.
medical
150
The _____ Act of 2003 established Medicare Part D.
Medicare Prescription Drug, Improvement, and Modernization
151
The _____ Act of 2005 targets methamphetamine and related drug trafficking.
Combat Methamphetamine Epidemic
152
The _____ oversees the legal use of all drugs in the U.S.
FDA
153
The _____ oversees controlled substances and drug trafficking.
DEA
154
Drug recall Class _____ is used when a product may cause death.
I
