Pharmacy Law and Regulations (Domain 2) Flashcards
(78 cards)
1
Q
What is the meaning of the acronym “DEA”?
A
drug enforcement administration
2
Q
What is the meaning of the acronym “FDA”?
A
food and drug administration
3
Q
How long is a Schedule III valid from the time it is written?
A
6 months
4
Q
How many refills are permitted on an Accutane prescription?
A
0
5
Q
How many Controlled Substance Schedules exist?
A
5
6
Q
What is the meaning of “C II”?
A
schedule II medication
7
Q
How many hours are considered readily retrievable?
A
72
8
Q
What is the meaning of “CIII”?
A
schedule III medication
9
Q
How many refills are permitted on a prescription for Accutane?
A
0
10
Q
What is the meaning of “CIV”?
A
schedule IV medication
11
Q
How many refills are permitted on Schedule II medications?
A
0
12
Q
What is the meaning of “CV”?
A
schedule V medication
13
Q
How many refills are permitted on Schedule III medications?
A
5
14
Q
What is the maximum number of different CII medications that can be ordered on a DEA Form 222?
A
10
15
Q
How often is a biennial inventory taken?
A
every 2 years
16
Q
How often may one purchase an exempt narcotic?
A
every 48 hours
17
Q
What government agency oversees controlled substances?
A
Drug Enforcement Administration (DEA)
18
Q
How old must one be to purchase an exempt narcotic?
A
18 years old
19
Q
Which government agency oversees safety in the workplace?
A
OSHA
20
Q
What form is used to destroy controlled substances?
A
DEA Form 41
21
Q
What organization oversees the practice of pharmacy within a state?
A
State Board of Pharmacy
22
Q
What form is used to order Schedule II medications?
A
DEA Form 222
23
Q
What is the maximum number of refills permitted on a Schedule III control Substance?
A
5
24
Q
What form is used to report the theft of controlled substances?
A
DEA Form 106
25
What is the maximum number of refills permitted for a Schedule II medication?
0
26
What is the maximum number of different Schedule II medications that may be ordered at one time?
10
27
How long is a prescription with "prn" refills valid?
one year from the date it is written (12 months)
28
What letter must be stamped on an invoice or a prescription for a Schedule III medication?
a red C
29
How many times may a controlled substance be transferred from one pharmacy to another pharmacy?
one time
30
Who may counsel a patient?
a pharmacist
31
Within how many days must an Accutane prescription be filled?
7
32
What is the meaning of the acronym "HIPAA"?
Health Insurance Portability and Accountability Act
33
What piece of legislation is known as the "prescription drug amendment"?
Durham-Humphrey Amendment
34
Which law is being violated if a prescription is dispensed without a valid prescription?
Durham-Humphrey Amendment
35
Which act introduced the terms "adulteration" and "misbranding"?
The Pure Drug Act
36
What pharmacy law clearly DEFINED adulteration and misbranding?
the Food, Drug, and Cosmetic Act of 1938
37
Which law mandated Drug Utilization be performed on every prescription?
OBRA '90
38
Which law required that an offer to counsel must be made to every patent regarding his or her medication?
OBRA '90
39
How much pseudoephedrine may be purchased at one time?
The Combat Methamphetamine Act allows an individual to purchase 3.6 g per day or a maximum of 9 g per month
40
Which law requires that a pharmacy maintain accurate information on durable medical equipment?
FDA Safe Medical Device Act of 1990
41
Which organization is responsible for overseeing the policies and procedures in handling hazardous substances in the pharmacy to protect the employee?
OSHA
42
Which form is required to dispense controlled substances?
Form 224
43
Which pharmacy law prohibits the sale or trading of drug samples or the distribution of samples to persons other than those licensed to prescribe them?
Prescription Drug Marketing Act of 1987
44
Which law established standards of care for nursing homes?
OBRA '87
45
Which government agency oversees OSHA?
Department of Labor
46
Which drug law stated that all drugs must be pure, safe, and effective?
Kefauver-Harris Amendment
47
What is an orphan drug used to treat?
rare diseases
48
What term in civil law refers to personal injuries?
a tort
49
What is negligence?
a type of tort in which the minimum standard of care was not met
50
What is malpractice?
a form of negligence in which the standard of care was not met
51
What is "standard of care"?
the expected level of care to be provided
52
Which pharmacy law classified herbal products as dietary supplements rather than medications?
DSHEA 1994 (Dietary Supplement Health and Education Act)
53
Which of the following drugs requires prescribers, pharmacists, and patients to register with the FDA iPledge program?
Isotretinoin
54
Which piece of legislation requires a pharmacy to maintain a patient profile for each patient who has had a prescription filled?
OBRA '90
55
What does OBRA stand for?
Omnibus Budget Reconciliation Act
56
Which law is being violated if a pharmacist prepares a medication under unsanitary conditions?
FDCA of 1938
57
How much time is considered "readily retrievable"?
72 hours
58
What is the Federal Legend that must appear on all prescriptions?
"Caution: Federal law prohibits dispensing without a prescription"
59
What law required that the Federal Legend ("Federal law prohibits the dispensing of this medication without a prescription") appear on all prescription medication containers?
The Durham-Humphrey Amendment of 1951
60
What law requires that the statement "Caution: Federal law prohibits the transfer of this prescription to anyone other than the intended" appear on all prescriptions of controlled substances?
Controlled Substance Act of 1970
61
What statement is required on any OTC product that is not in a child-resistant package?
"Package Not Child Resistant"
62
What law requires "Package Not Child Resistant" to be on any OTC product that is not in a child-resistant package?
Poison Control Act of 1970
63
What act required the cautionary statement ""Warning—May be habit forming"?
Food, Drug and Cosmetic Act of 1938
64
What is the maximum number of refills for a Schedule IV drug if authorized by the physician?
5
65
Which pharmacy law prevents a prescription drug plan from requiring participants to use mail-order pharmacy only?
Prescription Drug Equity Act
66
What is the purpose of the Any Willing Provider Law?
it allows any pharmacy to participate in an insurance plan as long as it is willing to meet the conditions of the contract
67
What does the Freedom of Choice Law do?
allows participants to ask a pharmacy to participate in an insurance plan, but the pharmacy must agree to the conditions of the plan
68
What do the Sherman Antitrust Laws promote?
free trade
69
Whose regulations require that a long-term care facility must ensure that is free of significant medication error rates?
CMS
70
What is included in protected patient information? (11)
Protected patient information includes the patient's name, address info, phone numbers and emails; patient's date of birth, sex, and race; National Health Service number; name of the residential or nursing home (if appropriate); doctor's name; and details of dispensed medications,
71
Which piece of legislation required that pharmaceutical manufacturers submit a New Drug Application with the FDA?
Food, Drug, and Cosmetic Act (FDCA)
72
Which organization was responsible for the development of the Model State Pharmacy Practice Act (MSPPA)?
National Association of Boards of Pharmacy (NABP)
73
Which piece of legislation distinguished the difference between prescription and over-the-counter medications?
Durham-Humphrey Ammendment
74
A compounding pharmacy does not have a proper eyewash station on site. Which regulatory agency would cite the pharmacy with a violation?
OSHA
75
Which piece of pharmacy legislation makes it illegal for anyone but the drug manufacturer to reimport a drug into the United States?
Prescription Drug Marketing Act of 1987
76
Which pharmacy law addressed the treatment of patients in long-term facilities?
OBRA '87
77
Which pharmacy law addressed adulteration and misbranding?
FDCA 1938
78
Which pharmacy law addressed the portability of health insurance and patient confidentiality?
HIPAA
