Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Pharmacy Law > Midterm Study Guide > Flashcards

Midterm Study Guide Flashcards

You may prefer our related Brainscape-certified flashcards:
MBE flashcards MPRE flashcards Civil Procedure 1L flashcards
1
Q

what are the three branches of federal government?

A

Legislative, Executive, and Judicial

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

what comprises the federal legislative branch?

A

house and senate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

what comprises the federal executive branch?

A

President

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

what comprises the federal judicial branch?

A

supreme court

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

what are the three federal agencies that regulate pharmacy laws?

A

US congress (house & senate)
DEA
FDA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

what are the two main state agencies that regulate pharmacy laws? (for Oregon) where do they incorporate changes in laws?

A

State legislature: Oregon Revised Statutes (ORS)

Oregon BOP: Oregon Administrative Rules (OAR)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Who grants power to BOP?

A

State legislature

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

BOP board members are appointed by who? they are approved by?

A

governer

senate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

BOP reports to?

A

governer

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

define liability

A

responsibility for actions of yourself & others

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

define Vicarious Liability

A

employers are responsible for actions of employees

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

define negligence
is negligence considered a tort?
specifically for a pharmacist, define what it means

A

failure to behave or perform in the correct way
yes
a legal standard for your behavior as a licensed professional

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

define malpractice
examples where malpractice can occur in the pharmacy include? (multiple options)
a. counseling someone who is not the patient
b. quality of drug dispensed
c. incorrect drug
d. different NDC of the same drug
e. incorrect quantity or dosage
f. technician counting a controlled substance
g. failure of duty to warn/inadequate counseling

A

negligence occurring in the practice of professionals

b,c,e,g

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

what four factors must be proven for legal liability of negligence?

A

duty owed
breach of duty
causation
damages

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

explain comparative negligence

A

plaintiff could’ve avoided the consequences of negligence such as a patient knowingly taking a medication they thought was incorrect

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

define statute of limitations

A

time limit when a malpractice claim must be filed

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

define tort

A

a civil wrong that unfairly causes someone harm resulting in legal liability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Differences between ORS and OAR:

A

ORS: signed by governor, changes require vote
OAR: laws passes by state agencies like BOP, written and passed by BOP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

what type of lawsuit is criminal?

a. government (the people) vs. person
b. person vs. person
c. agency vs. licensee

A

a

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

what type of lawsuit is civil?

a. government (the people) vs. person
b. person vs. person
c. agency vs. licensee

A

b

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

what type of lawsuit is administrative?

a. government (the people) vs. person
b. person vs. person
c. agency vs. licensee

A

c

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

define burden of proof

requirements for criminal, civil, and administrative cases?

A

level of evidence required to prove charges

criminal: beyond a reasonable doubt
civil: preponderance of evidence (50% chance claim is true)
administrative: preponderance of evidence (50% chance claim is true)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

what is the purpose of antitrust laws?

A

protect consumers from predatory business practices and ensure fair competition

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

what was the Sherman Antitrust Act?

what was the main goal?

A

Prohibits competitors from entering into agreements that inhibit competition

help markets remain competitive and keep prices low via competition

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

what was the Robinson-Patman Act?

A

prevent discriminatory pricing to similar competitors

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

what main impact did the Pure Food and Drug Act have on patient health & safety
what was its flaw?

A

Protect public from adulterated & misbranded food & drugs

had no regulation of drug safety

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

what main impact did the Food Drug and Cosmetic Act have on patient health & safety

A

FDA regulates safety of products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

what was the main impact of the Durham-Humphrey Amendment to the Food Drug and Cosmetic Act?

A

establishment of OTC category of drugs (created two categories of drugs: prescription and OTC)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

what was the main impact of the Kefauver-Harris Amendment to the Food Drug and Cosmetic Act?

A

required proof of safety and efficacy and established GMPs

30
Q

what was the main impact of the Orphan Drug Act to the Food Drug and Cosmetic Act?

A

created incentives to manufacture drugs for diseases affecting a small population of Americans

31
Q

what was the main impact of the Waxman-Hatch Amendment (aka Drug Price Competition and Patent-Term Restoration Act) to the Food Drug and Cosmetic Act?

A

accelerated the generic drug approval process

32
Q

what was the main impact of the Prescription Drug User Fee Act (PDUFA) to the Food Drug and Cosmetic Act?

A

drug manufacturers pay fees for product applications to fund FDA reviewers and speed up review/approval

33
Q

what was the main impact of the Dietary Supplement Health & Education Act (DSHEA) to the Food Drug and Cosmetic Act?

A
  • establish specific labeling requirements
  • authorize FDA to pass GMP regulations for dietary supps.
  • manufacturer is responsible for dietary supp. safety before marketing (FDA approval not required)
34
Q

what was the main impact of the Food and Drug Administration Modernization Act (FDAMA) to the Food Drug and Cosmetic Act?

A

fast-track drug approval for serious diseases and regulate advertising of approved drugs & devices

35
Q

what was the main impact of the Food and Drug Administration Amendments Act (FDAAA) to the Food Drug and Cosmetic Act?

A
  • Expanded PDUFA
  • Expanded FDA authority to mandate label changes, req. clinical trial data reporting, and req. post market clinical studies
36
Q

what was the main impact of the Drug Quality & Security Act to the Food Drug and Cosmetic Act?

A

-regulated compounding and drug supply chain

37
Q

Class I recall:

A

could cause serious health problems or death

38
Q

Class II recall:

A

might cause temporary health problems

39
Q

Class III recall:

A

unlikely to cause adverse reactions, but violate FDA labeling/manufacturing laws

40
Q

what is MedWatch?

A

FDA program to report drugs/products

41
Q

Is reporting on MedWatch a responsibility of pharmacists & physicians?
Patients?

A

Yes

No, voluntary

42
Q

What is VAERS?

A

Vaccine Adverse Event Reporting Systems

43
Q

Which of the following is NOT considered adulteration of a drug?

a. If it consists in whole or in part of any filthy, putrid or decomposed substance
b. If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health
c. If it has been tampered with and intentionally altered by a third-party post-marketing
d. If the strength differs, or quality or purity fall below label standards

A

c

44
Q

misbranding of a drug occurs when?

A

the label is false or misleading

45
Q

Risk Evaluation & Management Strategies (REMS):

A

uses risk minimization strategies to ensure benefits outweigh risks of prescription drugs

46
Q 
for class III and IV prescriptions, what is the maximum number of refills allowed on one prescription? How long does the prescription last?
how many times can they be transferred from pharmacy-pharmacy?
A

5 refills
6 months from issue date
once

47
Q

what is the form 222 used for?

A

ordering controlled substances

48
Q

what is CSOS?

A

DEA Controlled-Substance Ordering System

49
Q

During July 1 - June 30 of each biennial licensing cycle, pharmacist must complete what for their continuing education?

A

3 continuing pharmacy education cred`its

50
Q

During July 1 - June 30 of each biennial licensing cycle, COPhT must complete what for their continuing education?

A

20 continuing pharmacy education hours

51
Q

Pharmacy technician:
how long does license last?
can it be renewed?

A

2 years

no

52
Q

Certified Oregon Pharmacy Technician:
how long does license last?
can it be renewed?
what is required to become certified?

A

2 years
yes
passing nation certification exam

53
Q

what is the mission statement of the BOP?

A

to promote, preserve, and protect public health, safety, and welfare by ensuring high standards in the practice of pharmacy and by regulating the quality, manufacture, sale, and distribution of drugs

54
Q

once the board finds licensee guilty of violation, what are the different repercussions they can invoke?

A 
Civil penalties/fines (limits in ORS)
Probation (time-limited)
Suspension (time-limited)
Conditions (time-limited)
Revocation (permanent, almost)
55
Q

who/how many of whom comprise the BOP?

A

5 pharmacists, 2 licensed pharmacy technicians, and 2 public members (are not a spouse, partner, child, parent or sibling of a pharmacist)

56
Q

what are the three licensing exams?

A

NAPLEX
MPJE
FPGEE

57
Q

what manages the licensing exams?

A

National Association of Boards of Pharmacy (NABP)

58
Q

what is Category 1 compounding?

risk level?

A

non-sterile, simple (not compounding)
ex. adding water to make a suspension
zero

59
Q

what is Category 2 compounding?

risk level?

A

non-sterile, complex
ex. making a solution by mixing certain amounts of ingredients
zero

60
Q

what is Category 3 compounding?

risk level?

A

low risk, sterile, up to 3 sterile ingredients combined

risk level I

61
Q

what is Category 4 compounding?

risk level?

A

medium risk, sterile, more than 3 sterile ingredients combined
risk level II

62
Q

what is Category 5 compounding?

risk level?

A

high risk, non-sterile ingredients combined then sterilized

risk level III

63
Q

OAR 855-006 Definition of Interpretation and evaluation of prescription orders

A

review of the order for therapeutic and legal correctness

64
Q

OAR 855-006 Definition of oral counseling

A

communication process b/w pharmacist and patient to gain info from patient to give them advice for safe and effective use of the prescription drug

65
Q

OAR 855-006 Definition of drug utilization review

A

evaluating a prescription drug order based on information from patient and patient’s record to identify potential problems

66
Q

what information is in USP Chapter 795?

A

pharmaceutical compounding of non-sterile preparations

67
Q

what information is in USP Chapter 797?

A

pharmaceutical compounding of sterile preparations

68
Q

what information is in USP Chapter 800?

A

provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment

69
Q

what was the poison prevention packaging act?

A

requires child resistant packaging for OTC and prescription meds

70
Q

what is the purple book?

A

FDA approved list of drugs determined to be biosimilar or interchangeable

71
Q

what dose of methadone is for opioid use disorder?
any licensed pharmacy can dispense methadone, but only for what use?
can a pharmacy dispense 40mg?

A

40mg
analgesic purposes
no

72
Q

what was the main impact of the Drug Supply Chain Security Act to the Food Drug and Cosmetic Act?

A

Requires records for all prescription drug sales

Pharmacy Law (2 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions