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PHA6123 LEC Pharmacy Informatics > Ethical and Legal Aspects of Drug Information > Flashcards

Ethical and Legal Aspects of Drug Information Flashcards

1
Q

philosophical inquiry of the moral dimensions of human conduct

A

ethics

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2
Q

ethics is often used synonymously with the term ____________

A

moral

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3
Q

describe an action or decision as good or right

A

moral (ethics)

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4
Q

Ethical deliberations may be differentiated from other endeavors by 3 characteristics

A
  1. ultimate or fundamental
  2. issue is universal
  3. deliberation takes into account the welfare of all involved
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5
Q

Levels of Ethical Judgment in the Health Care Setting

A
  1. micro level
  2. meso level
  3. macro level
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6
Q

involves decisions made at the INDIVIDUAL PROFESSIONAL-PATIENT level of health care

A

micro level

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7
Q

occurring at the INSTITUTIONAL/ORGANIZATIONAL level or at COMMUNITY/REGIONAL levels

A

meso level

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8
Q

sets POLICY for the health system, as a standard established for an entire PROFESSION, or through GOVERNMENT as law/regulation for the society as a whole.

A

macro level

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9
Q
A

FALSE

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10
Q

rules of conduct imposed by society on its members

A

law

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11
Q

rules of conduct or standards by which a particular group in society regulates its actions and sets standards for its members

A

professional ethics

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12
Q

Health Professional must be able to ___________________, _________________, __________________, and _________________ pertinent ethical rules and principles applicable to different ethical dilemmas.

A

identify, interpret, specify, and balance

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13
Q

what is the objective of ethical deliberation?

A

determine and justify what a professional should consider as the right decision or the best course of action for each specific ethical situation

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14
Q

used to justify a particular judgment; basically action guides can range from ethical theory to principles to particular set of rules.

A

action guides

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15
Q

4 principles of healthcare ethics according to Nicki Drysdale (March 21, 2021)

A
  1. autonomy
  2. non-maleficence
  3. beneficience
  4. justice
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16
Q

respects a person’s freedom to choose what is right for them

A

autonomy

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17
Q

do no harm

A

non-maleficence

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18
Q

all choices for a patient are made with the intent to do good

A

beneficience

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19
Q

treat and provide care fairly to all patients

A

justice

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20
Q

To justify judgment as to not tell others about a patient’s condition is covered by __________________ and guided by _________________

A

covered by the rule of confidentiality; guided by the principle of respect for autonomy

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21
Q

right to consent prior to release of privileged information

A

rule of confidentiality

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22
Q

patient’s right to decide on personal issues

A

principle of respect for autonomy

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23
Q

what are the ethical theories?

A
  1. consequentialist
  2. deontological
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24
Q

determines if actions or decisions are morally right or wrong based on their consequences

A

consequentialist

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25
Q

what are the cardinal principles of consequentialist theory?

A

beneficence (duty to promote good outcomes) and nonmaleficence (duty to minimize bad outcomes)

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26
Q

this theory looks more to the intrinsic quality of an act or decision to assert its moral rightness or wrongness

A

deontological

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27
Q

steps to do when an ethical dilemma arises

A
  1. Understand the facts of the case
  2. Identify, analyze, and present reasons for judgment
  3. Deliberation must be made based on moral intuition and application of ethical theories, rules, principles leading to a balanced resolution of the dilemma
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28
Q

action guides in medical inquiry

A
  1. nonmaleficence
  2. beneficence
  3. respecting physician-patient relationship
  4. respect for autonomy
  5. consent
  6. confidentiality
  7. privacy
  8. respect for persons
  9. veracity
  10. fidely
  11. justice
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29
Q

Actions taken by professionals must be beneficial to all parties in the dilemma

A

nonmaleficence

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30
Q

principle or duty to promote good

A

beneficence

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31
Q

issue with beneficence

A

what constitutes good for one individual vs. the larger societal group may differ significantly

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32
Q

a moral rule that indicates that the physician’s primary duty is to the patient

A

respecting physician-patient relationship

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33
Q

principle which refers to the right of an individual to self-rule

A

respect for autonomy

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34
Q

moral rules related to principle of autonomy

A

consent, confidentiality

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35
Q

Every individual has the right to be informed and to freely choose a course of action for their particular medical concerns

A

consent

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36
Q

Every individual has the right to give or refuse consent relative to release of privileged information

A

confidentiality

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37
Q

a rule within the principle of autonomy

A

privacy

38
Q

Every individual has the right to
control his or her own affairs without interference from or knowledge of outside parties

A

privacy

39
Q

deliberations on rights of individual with AIDS vs those of their potential sexual contacts is an example of

A

privacy

40
Q

the principle or duty to the welfare of the individual, expressed within the dignity of life or sanctity of human life principles

A

respect for persons

41
Q

obligation to truth telling or honesty

A

veracity

42
Q

Veracity is an ethical principle within
__________________________

A

deontological theory

43
Q

principle of having responsibility to be trustworthy and keep promises

A

fidelity

44
Q

Fidelity relates to the ______________________________, where consideration of the other’s point of view must also be provided prior to any judgment

A

duty of reciprocity

45
Q

refers to fairness and tendering what is due

A

justice

46
Q

appropriate resource allocation and providing that to which the individual is entitled

A

justice

47
Q

an implicit contract between the client and the health care provider that broadly describes the relationship involved whenever a pharmacist provides drug information

A

ethical covenant

48
Q

With ethical covenant, patients have the:

A
  1. Right to receive competently-provided information and respectful treatment
  2. Obligation to provide background information needed by the pharmacist
49
Q

With ethical covenant, health care providers (pharmacist) have the:

A
  1. Right to request for adequate background information
  2. Obligation to deliver competent, trustworthy, and caring service
50
Q

Support for Ethical Decision-Making

A
  1. Ethics committees
  2. Policies and procedures
  3. Organizational policies
  4. Foundational ethics education
51
Q

to inform and support the clinician in overall client interactions and in ethical analysis and decision making

A

Policies and procedures

52
Q

to avoid or at least address what constitute infringement on the domain of personal ethics

A

Organizational policies

53
Q
A

TRUE

54
Q
A

TRUE

55
Q

body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others

A

tort law

56
Q

perdrugson who sustains injury or suffers pecuniary damage as the result of tortious conduct

A

plaintiff

57
Q

person who is responsible for inflicting the injury and incurs liability for the damage

A

defendant or tortfeasor

58
Q

DI specialist functions with legal obligations of proper performance:

A
  1. online searching
  2. monitoring or recommending drug therapy
  3. preparing drug alerts and pharmacybulletins
  4. participating in pharmacy and therapeutics (P&T) committees
  5. conducting medication use evaluations (MUE)
  6. writing and revising medication policies
  7. training residents, pharmacy students, and pharmacy staff
  8. identifying adverse drug events
59
Q

the pharmacy profession is assuming an increased legal responsibility to provide DI in the daily practice of pharmacist-supervised patient care

A

tort law

60
Q

these are showing a trend in pharmacist liability

A

Failure to counsel or warn cases

61
Q
A

FALSE

62
Q

ways in which tort liability can relate to the provision of drug information

A
  1. Incomplete information
  2. Inappropriate quality information
  3. Outdated information
  4. Inappropriate analysis / dissemination of information
63
Q
A

TRUE

64
Q

enumerate the defences for individuals

A
  1. comparative negligence
  2. concurrent negligence
  3. vicarious liability
65
Q

ALLOCATION of responsibility for damages incurred between the plaintiff and the defendant, based on the RELATIVE NEGLIGENCE of the two

A

comparative negligence

66
Q

wrongful acts or omissions of two or more persons acting INDEPENDENTLY, but causing the SAME INJURY

A

concurrent negligence

67
Q

attribution of LIABILITY ON ONE PERSON for the ACTIONS OF ANOTHER

A

vicarious liability

68
Q

[defences for employers]

proposition that the employer is responsible for the negligent acts of its agents or employees

A

respondeat superior

69
Q

[defences for employers]

injured parties may also sue the employer for its negligence in ___________________________________ the employee

A

hiring or supervising

70
Q

SHARING OF LIABILITIES among a group of people collectively and also individually

A

joint and several liability

71
Q

[joint and several liability]

injured party may sue ____________________ defendants together, or each one separately and may collect ____________________________ from each

A

some or all defendants together; equal or unequal amounts

72
Q

[defences against malpractice]

methods to protect against lawsuits

A
  1. contracts covering financial arrangements
  2. adequate documentation
  3. disclaimers
  4. insurance
73
Q

[defences against malpractice]

best way to avoid omission negligence is to ________________________________, anticipate mistakes that may appear in databases, and keep abreast of changes in DI sources

A

learn from experience

74
Q

[defences against malpractice]

adequate documentation includes ___________________, as well as a ___________________________ taken in a search

A

response to inquiries, as well as a record of steps

75
Q
A

FALSE: can help avoid

76
Q

three key areas of liability

A
  1. learned intermediary rule
  2. doctrine of over-promotion
  3. promotion of off-label use or FDA-unapproved indications
77
Q

involves magazine, TV, website, cell phone, and text ads, suggesting use of various prescription drugs for medical conditions the viewer might experience

A

direct-to-consumer advertising (DTCA)

78
Q

suggest viewer to ask their physician if the medication would be appropriate for them

A

DTCA

79
Q
A

TRUE

80
Q

involves use for indications not specifically approved by the FDA

A

off-label use

81
Q

for off-label use:

A

TRUE

82
Q

particularly important in areas of oncology and AIDS

A

off-label use

83
Q

off-label use from ___________________ has been restricted

A

manufacturers

84
Q

manufacturer promotion of off-label use constitutes ____________________ under FDCA (Federal Food, Drug, and Cosmetic Act)

A

misbranding

85
Q

informed consent laws vary but usually require discussion of the _______________, _________, ______________, and _____________________________________ of treatment

A

nature, risks, benefits, and alternative modes

86
Q

currently being obtained from a number of Wikis, blogs, and search engines and there is a possibility of liability for information obtained from other internet soures

A

Drug information

87
Q

DTCA on the internet is considered _________________, rather than advertising and as such, the FDA has the principal authority to regulate it

A

labeling

88
Q
A

FALSE: need to consult other non-web-based references

89
Q

use of TELECOMMUNICATIONS and INTERACTIVE VIDEO technology to provide health care services to patients who are AT A DISTANCE

A

telemedicine

90
Q

Cybermedicine is a broader concept that includes ______________________, ______________________, ___________, ___________________, and _____________________ pharmaceuticals and devices in cyberspace

A

marketing, relationship creation, advice, prescribing, and selling

91
Q

what can be done to avoid malpractice and other causes of action?

A
  1. always strive for excellence
  2. have good relations with requestors and make sure they are aware of alterations/modifications in info systems and sources
  3. make no outrageous claims about the accuracy and thoroughness of info
  4. pharmacists should carry their own malpractice insurance policy
92
Q

It is important that health practitioners keep in mind that their ______________________________________ and at the same time balancing these principles with existing rules and laws to promote the best outcomes for every patient

A

basic principles of morality and ethics

PHA6123 LEC Pharmacy Informatics (4 decks)

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