Ethical and Legal Aspects of Drug Information Flashcards
(92 cards)
1
Q
philosophical inquiry of the moral dimensions of human conduct
A
ethics
2
Q
ethics is often used synonymously with the term ____________
A
moral
3
Q
describe an action or decision as good or right
A
moral (ethics)
4
Q
Ethical deliberations may be differentiated from other endeavors by 3 characteristics
A
- ultimate or fundamental
- issue is universal
- deliberation takes into account the welfare of all involved
5
Q
Levels of Ethical Judgment in the Health Care Setting
A
- micro level
- meso level
- macro level
6
Q
involves decisions made at the INDIVIDUAL PROFESSIONAL-PATIENT level of health care
A
micro level
7
Q
occurring at the INSTITUTIONAL/ORGANIZATIONAL level or at COMMUNITY/REGIONAL levels
A
meso level
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
9
Q
A
FALSE
10
Q
rules of conduct imposed by society on its members
A
law
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
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
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
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
15
Q
4 principles of healthcare ethics according to Nicki Drysdale (March 21, 2021)
A
- autonomy
- non-maleficence
- beneficience
- justice
16
Q
respects a person’s freedom to choose what is right for them
A
autonomy
17
Q
do no harm
A
non-maleficence
18
Q
all choices for a patient are made with the intent to do good
A
beneficience
19
Q
treat and provide care fairly to all patients
A
justice
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
21
Q
right to consent prior to release of privileged information
A
rule of confidentiality
22
Q
patient’s right to decide on personal issues
A
principle of respect for autonomy
23
Q
what are the ethical theories?
A
- consequentialist
- deontological
24
Q
determines if actions or decisions are morally right or wrong based on their consequences
A
consequentialist
25
what are the cardinal principles of consequentialist theory?
beneficence (duty to promote good outcomes) and nonmaleficence (duty to minimize bad outcomes)
26
this theory looks more to the intrinsic quality of an act or decision to assert its moral rightness or wrongness
deontological
27
steps to do when an ethical dilemma arises
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
28
action guides in medical inquiry
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
29
Actions taken by professionals must be beneficial to all parties in the dilemma
nonmaleficence
30
principle or duty to promote good
beneficence
31
issue with beneficence
what constitutes good for one individual vs. the larger societal group may differ significantly
32
a moral rule that indicates that the physician’s primary duty is to the patient
respecting physician-patient relationship
33
principle which refers to the right of an individual to self-rule
respect for autonomy
34
moral rules related to principle of autonomy
consent, confidentiality
35
Every individual has the right to be informed and to freely choose a course of action for their particular medical concerns
consent
36
Every individual has the right to give or refuse consent relative to release of privileged information
confidentiality
37
a rule within the principle of autonomy
privacy
38
Every individual has the right to
control his or her own affairs without interference from or knowledge of outside parties
privacy
39
deliberations on rights of individual with AIDS vs those of their potential sexual contacts is an example of
privacy
40
the principle or duty to the welfare of the individual, expressed within the dignity of life or sanctity of human life principles
respect for persons
41
obligation to truth telling or honesty
veracity
42
Veracity is an ethical principle within
__________________________
deontological theory
43
principle of having responsibility to be trustworthy and keep promises
fidelity
44
Fidelity relates to the ______________________________, where consideration of the other’s point of view must also be provided prior to any judgment
duty of reciprocity
45
refers to fairness and tendering what is due
justice
46
appropriate resource allocation and providing that to which the individual is entitled
justice
47
an implicit contract between the client and the health care provider that broadly describes the relationship involved whenever a pharmacist provides drug information
ethical covenant
48
With ethical covenant, patients have the:
1. Right to receive competently-provided information and respectful treatment
2. Obligation to provide background information needed by the pharmacist
49
With ethical covenant, health care providers (pharmacist) have the:
1. Right to request for adequate background information
2. Obligation to deliver competent, trustworthy, and caring service
50
Support for Ethical Decision-Making
1. Ethics committees
2. Policies and procedures
3. Organizational policies
4. Foundational ethics education
51
to inform and support the clinician in overall client interactions and in ethical analysis and decision making
Policies and procedures
52
to avoid or at least address what constitute infringement on the domain of personal ethics
Organizational policies
53
[T/F]: There are a myriad of legal issues confronting the various facets of drug information.
TRUE
54
[T/F]: Pharmacists can and will be held liable for their conduct relating to the provision of drug information.
TRUE
55
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
tort law
56
perdrugson who sustains injury or suffers pecuniary damage as the result of tortious conduct
plaintiff
57
person who is responsible for inflicting the injury and incurs liability for the damage
defendant or tortfeasor
58
DI specialist functions with legal obligations of proper performance:
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
the pharmacy profession is assuming an increased legal responsibility to provide DI in the daily practice of pharmacist-supervised patient care
tort law
60
these are showing a trend in pharmacist liability
Failure to counsel or warn cases
61
[T/F]: most cases does not maintain the pharmacist has no duty to warn
FALSE
62
ways in which tort liability can relate to the provision of drug information
1. Incomplete information
2. Inappropriate quality information
3. Outdated information
4. Inappropriate analysis / dissemination of information
63
[T/F]: under uniformed content, the defendant could assert that the patient knowingly assumed the risk for a new or experimental therapy or regimen
TRUE
64
enumerate the defences for individuals
1. comparative negligence
2. concurrent negligence
3. vicarious liability
65
ALLOCATION of responsibility for damages incurred between the plaintiff and the defendant, based on the RELATIVE NEGLIGENCE of the two
comparative negligence
66
wrongful acts or omissions of two or more persons acting INDEPENDENTLY, but causing the SAME INJURY
concurrent negligence
67
attribution of LIABILITY ON ONE PERSON for the ACTIONS OF ANOTHER
vicarious liability
68
[defences for employers]
proposition that the employer is responsible for the negligent acts of its agents or employees
respondeat superior
69
[defences for employers]
injured parties may also sue the employer for its negligence in ___________________________________ the employee
hiring or supervising
70
SHARING OF LIABILITIES among a group of people collectively and also individually
joint and several liability
71
[joint and several liability]
injured party may sue ____________________ defendants together, or each one separately and may collect ____________________________ from each
some or all defendants together; equal or unequal amounts
72
[defences against malpractice]
methods to protect against lawsuits
1. contracts covering financial arrangements
2. adequate documentation
3. disclaimers
4. insurance
73
[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
learn from experience
74
[defences against malpractice]
adequate documentation includes ___________________, as well as a ___________________________ taken in a search
response to inquiries, as well as a record of steps
75
[T/F]: designing and following procedures to document the research process does not help avoid negligence
FALSE: can help avoid
76
three key areas of liability
1. learned intermediary rule
2. doctrine of over-promotion
3. promotion of off-label use or FDA-unapproved indications
77
involves magazine, TV, website, cell phone, and text ads, suggesting use of various prescription drugs for medical conditions the viewer might experience
direct-to-consumer advertising (DTCA)
78
suggest viewer to ask their physician if the medication would be appropriate for them
DTCA
79
[T/F]: DTCA should follow specific set of regulations approved by regulatory agencies
TRUE
80
involves use for indications not specifically approved by the FDA
off-label use
81
for off-label use:
[T/F]: once FDA approves a drug for marketing, a physician's discretionary use of that product is NOT RESTRICTED to the uses indicated on FDA-regulating labeling
TRUE
82
particularly important in areas of oncology and AIDS
off-label use
83
off-label use from ___________________ has been restricted
manufacturers
84
manufacturer promotion of off-label use constitutes ____________________ under FDCA (Federal Food, Drug, and Cosmetic Act)
misbranding
85
informed consent laws vary but usually require discussion of the _______________, _________, ______________, and _____________________________________ of treatment
nature, risks, benefits, and alternative modes
86
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
Drug information
87
DTCA on the internet is considered _________________, rather than advertising and as such, the FDA has the principal authority to regulate it
labeling
88
[T/F]: web information may provide a quick starting point for an answer, thus there is no need to consult other non-web-based references
FALSE: need to consult other non-web-based references
89
use of TELECOMMUNICATIONS and INTERACTIVE VIDEO technology to provide health care services to patients who are AT A DISTANCE
telemedicine
90
Cybermedicine is a broader concept that includes ______________________, ______________________, ___________, ___________________, and _____________________ pharmaceuticals and devices in cyberspace
marketing, relationship creation, advice, prescribing, and selling
91
what can be done to avoid malpractice and other causes of action?
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
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
basic principles of morality and ethics
