Ethical and Legal Aspects of Drug Information Flashcards
philosophical inquiry of the moral dimensions of human conduct
ethics
ethics is often used synonymously with the term ____________
moral
describe an action or decision as good or right
moral (ethics)
Ethical deliberations may be differentiated from other endeavors by 3 characteristics
- ultimate or fundamental
- issue is universal
- deliberation takes into account the welfare of all involved
Levels of Ethical Judgment in the Health Care Setting
- micro level
- meso level
- macro level
involves decisions made at the INDIVIDUAL PROFESSIONAL-PATIENT level of health care
micro level
occurring at the INSTITUTIONAL/ORGANIZATIONAL level or at COMMUNITY/REGIONAL levels
meso level
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.
macro level
FALSE
rules of conduct imposed by society on its members
law
rules of conduct or standards by which a particular group in society regulates its actions and sets standards for its members
professional ethics
Health Professional must be able to ___________________, _________________, __________________, and _________________ pertinent ethical rules and principles applicable to different ethical dilemmas.
identify, interpret, specify, and balance
what is the objective of ethical deliberation?
determine and justify what a professional should consider as the right decision or the best course of action for each specific ethical situation
used to justify a particular judgment; basically action guides can range from ethical theory to principles to particular set of rules.
action guides
4 principles of healthcare ethics according to Nicki Drysdale (March 21, 2021)
- autonomy
- non-maleficence
- beneficience
- justice
respects a person’s freedom to choose what is right for them
autonomy
do no harm
non-maleficence
all choices for a patient are made with the intent to do good
beneficience
treat and provide care fairly to all patients
justice
To justify judgment as to not tell others about a patient’s condition is covered by __________________ and guided by _________________
covered by the rule of confidentiality; guided by the principle of respect for autonomy
right to consent prior to release of privileged information
rule of confidentiality
patient’s right to decide on personal issues
principle of respect for autonomy
what are the ethical theories?
- consequentialist
- deontological
determines if actions or decisions are morally right or wrong based on their consequences
consequentialist
what are the cardinal principles of consequentialist theory?
beneficence (duty to promote good outcomes) and nonmaleficence (duty to minimize bad outcomes)
this theory looks more to the intrinsic quality of an act or decision to assert its moral rightness or wrongness
deontological
steps to do when an ethical dilemma arises
- Understand the facts of the case
- Identify, analyze, and present reasons for judgment
- Deliberation must be made based on moral intuition and application of ethical theories, rules, principles leading to a balanced resolution of the dilemma
action guides in medical inquiry
- nonmaleficence
- beneficence
- respecting physician-patient relationship
- respect for autonomy
- consent
- confidentiality
- privacy
- respect for persons
- veracity
- fidely
- justice
Actions taken by professionals must be beneficial to all parties in the dilemma
nonmaleficence
principle or duty to promote good
beneficence
issue with beneficence
what constitutes good for one individual vs. the larger societal group may differ significantly
a moral rule that indicates that the physician’s primary duty is to the patient
respecting physician-patient relationship
principle which refers to the right of an individual to self-rule
respect for autonomy
moral rules related to principle of autonomy
consent, confidentiality
Every individual has the right to be informed and to freely choose a course of action for their particular medical concerns
consent
Every individual has the right to give or refuse consent relative to release of privileged information
confidentiality
a rule within the principle of autonomy
privacy
Every individual has the right to
control his or her own affairs without interference from or knowledge of outside parties
privacy
deliberations on rights of individual with AIDS vs those of their potential sexual contacts is an example of
privacy
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
obligation to truth telling or honesty
veracity
Veracity is an ethical principle within
__________________________
deontological theory
principle of having responsibility to be trustworthy and keep promises
fidelity
Fidelity relates to the ______________________________, where consideration of the other’s point of view must also be provided prior to any judgment
duty of reciprocity
refers to fairness and tendering what is due
justice
appropriate resource allocation and providing that to which the individual is entitled
justice
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
With ethical covenant, patients have the:
- Right to receive competently-provided information and respectful treatment
- Obligation to provide background information needed by the pharmacist
With ethical covenant, health care providers (pharmacist) have the:
- Right to request for adequate background information
- Obligation to deliver competent, trustworthy, and caring service
Support for Ethical Decision-Making
- Ethics committees
- Policies and procedures
- Organizational policies
- Foundational ethics education
to inform and support the clinician in overall client interactions and in ethical analysis and decision making
Policies and procedures
to avoid or at least address what constitute infringement on the domain of personal ethics
Organizational policies
TRUE
TRUE
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
perdrugson who sustains injury or suffers pecuniary damage as the result of tortious conduct
plaintiff
person who is responsible for inflicting the injury and incurs liability for the damage
defendant or tortfeasor
DI specialist functions with legal obligations of proper performance:
- online searching
- monitoring or recommending drug therapy
- preparing drug alerts and pharmacybulletins
- participating in pharmacy and therapeutics (P&T) committees
- conducting medication use evaluations (MUE)
- writing and revising medication policies
- training residents, pharmacy students, and pharmacy staff
- identifying adverse drug events
the pharmacy profession is assuming an increased legal responsibility to provide DI in the daily practice of pharmacist-supervised patient care
tort law
these are showing a trend in pharmacist liability
Failure to counsel or warn cases
FALSE
ways in which tort liability can relate to the provision of drug information
- Incomplete information
- Inappropriate quality information
- Outdated information
- Inappropriate analysis / dissemination of information
TRUE
enumerate the defences for individuals
- comparative negligence
- concurrent negligence
- vicarious liability
ALLOCATION of responsibility for damages incurred between the plaintiff and the defendant, based on the RELATIVE NEGLIGENCE of the two
comparative negligence
wrongful acts or omissions of two or more persons acting INDEPENDENTLY, but causing the SAME INJURY
concurrent negligence
attribution of LIABILITY ON ONE PERSON for the ACTIONS OF ANOTHER
vicarious liability
[defences for employers]
proposition that the employer is responsible for the negligent acts of its agents or employees
respondeat superior
[defences for employers]
injured parties may also sue the employer for its negligence in ___________________________________ the employee
hiring or supervising
SHARING OF LIABILITIES among a group of people collectively and also individually
joint and several liability
[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
[defences against malpractice]
methods to protect against lawsuits
- contracts covering financial arrangements
- adequate documentation
- disclaimers
- insurance
[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
[defences against malpractice]
adequate documentation includes ___________________, as well as a ___________________________ taken in a search
response to inquiries, as well as a record of steps
FALSE: can help avoid
three key areas of liability
- learned intermediary rule
- doctrine of over-promotion
- promotion of off-label use or FDA-unapproved indications
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)
suggest viewer to ask their physician if the medication would be appropriate for them
DTCA
TRUE
involves use for indications not specifically approved by the FDA
off-label use
for off-label use:
TRUE
particularly important in areas of oncology and AIDS
off-label use
off-label use from ___________________ has been restricted
manufacturers
manufacturer promotion of off-label use constitutes ____________________ under FDCA (Federal Food, Drug, and Cosmetic Act)
misbranding
informed consent laws vary but usually require discussion of the _______________, _________, ______________, and _____________________________________ of treatment
nature, risks, benefits, and alternative modes
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
DTCA on the internet is considered _________________, rather than advertising and as such, the FDA has the principal authority to regulate it
labeling
FALSE: need to consult other non-web-based references
use of TELECOMMUNICATIONS and INTERACTIVE VIDEO technology to provide health care services to patients who are AT A DISTANCE
telemedicine
Cybermedicine is a broader concept that includes ______________________, ______________________, ___________, ___________________, and _____________________ pharmaceuticals and devices in cyberspace
marketing, relationship creation, advice, prescribing, and selling
what can be done to avoid malpractice and other causes of action?
- always strive for excellence
- have good relations with requestors and make sure they are aware of alterations/modifications in info systems and sources
- make no outrageous claims about the accuracy and thoroughness of info
- pharmacists should carry their own malpractice insurance policy
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
