Ethics

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Ethics

• A set of principles of right conduct.
• A theory or a system of moral values An ethic
  of service is at war with a craving for gain
  (Gregg Easterbrook).
• ethics (used with a sing. verb) The study of the
  general nature of morals and of the specific
  moral choices to be made by a person moral
  philosophy.
• ethics (used with a sing. or pl. verb) The rules
  or standards governing the conduct of a person or
  the members of a profession medical ethics.

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Honesty and Ethics of ProfessionsPercentage
"very high" or "high"
Nov. 14-16, 2003
CNN/USA Today/Gallup
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Code of Ethics

• Ethics vs. Laws
• Is a code of ethics necessary?
• Does a code of ethics guide professional
  behavior?
• Is being a good person enough?

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Why have a Code of Ethics?

• The code is to protect each professional from
  certain pressures (for example, the pressure to
  cut corners to save money) by making it
  reasonably likely...that most other members of
  the profession will not take advantage of her
  good conduct. A code protects members of a
  profession from certain consequences of
  competition. A code is a solution to a
  coordination problem.

Michael Davis
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Business vs. Profession

• Is Pharmacy a business or a profession? Both?
• Differences between business and profession?
• Are there business ethics?
• Enron, Global Crossing, Adelphia, Martha Stewart,
  Rite Aid, Mutual Funds

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Why Regulate Healthcare?

• Laws exist because a purely market-driven system
  fails to protect the public health, safety, and
  welfare.
• Incentive to maximize profit can compromise and
  conflict with the best interest of
  patients/customers.
• The race to the bottom

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American Medical Association

• Principles of Medical Ethics 
• A physician shall be dedicated to providing
  competent medical care, with compassion and
  respect for human dignity and rights.    
• A physician shall uphold the standards of
  professionalism, be honest in all professional
  interactions, and strive to report physicians
  deficient in character or competence, or engaging
  in fraud or deception, to appropriate entities.
• A physician shall respect the law and also
  recognize a responsibility to seek changes in
  those requirements which are contrary to the best
  interests of the patient.
• A physician shall respect the rights of patients,
  colleagues, and other health professionals, and
  shall safeguard patient confidences and privacy
  within the constraints of the law.

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American Medical Association

• A physician shall continue to study, apply, and
  advance scientific knowledge, maintain a
  commitment to medical education, make relevant
  information available to patients, colleagues,
  and the public, obtain consultation, and use the
  talents of other health professionals when
  indicated.
• A physician shall, in the provision of
  appropriate patient care, except in emergencies,
  be free to choose whom to serve, with whom to
  associate, and the environment in which to
  provide medical care.
• A physician shall recognize a responsibility to
  participate in activities contributing to the
  improvement of the community and the betterment
  of public health. 
• A physician shall, while caring for a patient,
  regard responsibility to the patient as
  paramount.
• A physician shall support access to medical care
  for all people.
• Adopted by the AMA's House of Delegates June
  17, 2001

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Pharmacist Code of Ethics

• Adopted by APhA in 1994
• Endorsed by ASHP in 1996
• Actually read by very few practicing pharmacists!

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Code of Ethics for Pharmacists
PREAMBLE Pharmacists are health professionals who
assist individuals in making the best use of
medications. This Code, prepared and supported
by pharmacists, is intended to state publicly the
principles that form the fundamental basis of the
roles and responsibilities of pharmacists. These
principles, based on moral obligations and
virtues, are established to guide pharmacists in
relationships with patients, health
professionals, and society.
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Code of Ethics for Pharmacists
I. A pharmacist respects the covenantal
relationship between the patient and
pharmacist. Considering the patient-pharmacist
relationship as a covenant means that a
pharmacist has moral obligations in response to
the gift of trust received from society. In
return for this gift, a pharmacist promises to
help individuals achieve optimum benefit from
their medications, to be committed to their
welfare, and to maintain their trust.
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Code of Ethics for Pharmacists
II. A pharmacist promotes the good of every
patient in a caring, compassionate, and
confidential manner. A pharmacist places concern
for the well-being of the patient at the center
of professional practice. In doing so, a
pharmacist considers needs stated by the patient
as well as those defined by health science. A
pharmacist is dedicated to protecting the dignity
of the patient. With a caring attitude and a
compassionate spirit, a pharmacist focuses on
serving the patient in a private and confidential
manner.
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Code of Ethics for Pharmacists
III. A pharmacist respects the autonomy and
dignity of each patient. A pharmacist promotes
the right of self-determination and recognizes
individual self-worth by encouraging patients to
participate in decisions about their health. A
pharmacist communicates with patients in terms
that are understandable. In all cases, a
pharmacist respects personal and cultural
differences among patients.
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Code of Ethics for Pharmacists
IV. A pharmacist acts with honesty and integrity
in professional relationships. A pharmacist has
a duty to tell the truth and to act with
conviction of conscience. A pharmacist avoids
discriminatory practices, behavior or work
conditions that impair professional judgment, and
actions that compromise dedication to the best
interests of patients.
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Code of Ethics for Pharmacists
V. A pharmacist maintains professional
competence. A pharmacist has a duty to maintain
knowledge and abilities as new medications,
devices, and technologies become available and as
health information advances.
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Code of Ethics for Pharmacists
VI. A pharmacist respects the values and
abilities of colleagues and other health
professionals. When appropriate, a pharmacist
asks for the consultation of colleagues or other
health professionals or refers the patient. A
pharmacist acknowledges that colleagues and other
health professionals may differ in the beliefs
and values they apply to the care of the patient.

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Code of Ethics for Pharmacists
VII. A pharmacist serves individual, community,
and societal needs. The primary obligation of a
pharmacist is to individual patients. However,
the obligations of a pharmacist may at times
extend beyond the individual to the community and
society. In these situations, the pharmacist
recognizes the responsibilities that accompany
these obligations and acts accordingly.
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Code of Ethics for Pharmacists
VIII. A pharmacist seeks justice in the
distribution of health resources. When health
resources are allocated, a pharmacist is fair and
equitable, balancing the needs of patients and
society.
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Choice

• Ethical decisions occur when choices are made
  among all possible courses of action
• Not all choices involve ethical issues
• When they do, how do we make decisions?
• Using ethical principals
• Respect for autonomy
• Nonmaleficence
• Beneficence
• Justice

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Conflict of Interest

• Also called competing interests
• When an individual has an interest in two (or
  more) conflicting responsibilities, desires,
  goals, desired outcomes
• Examples Physician ownership of medical
  laboratories, pharmacies, or other services
• Authorship of an editorial review for a drug made
  by a company in which you own stock.

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Ethical Principals

• Respect for autonomy
• Autonomy self-rule
• Nonmaleficence
• Above all (or first), do no harm
• Beneficence
• Taking positive steps to help others
• Justice
• Fairness, equity

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Moral Norms

• Ethics
• Understanding and examining the moral life
• Normative vs. nonnormative
• Morality
• Right vs. wrong behavior in any given
  circumstance
• Common (universal) morality vs.
  community-specific morality

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Professional Morality

• Moral obligations not expected of the general
  public
• May be required by laws and professional
  standards/guidelines
• Professional codes of ethics

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Ethics Principles

• Respect for Autonomy
• Nonmaleficence
• Beneficence
• Justice

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Respect for Autonomy

• Autonomy self-rule or self-governance
• Freedom from controlling influence
• Freedom from inadequate understanding
• Lack of autonomy
• Prisoners, mentally incapable

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Respect for Autonomy

• patient autonomy refers to the capability and
  right of patients to control the course of their
  own medical treatment and participate in the
  treatment decision-making process.

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Respect for Autonomy

• Every human being of adult years and sound mind
  has a right to determine what shall be done with
  his own body and a surgeon who performs an
  operation without his patients consent commits
  assault, for which he is liable in damages
• Schloendorff vs. Society of New York Hospital,
  105 N.W. 92 (1914).

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Limitations of Autonomy

• Competence
• Psychologically or legally capable of
  decision-making
• Determined by health professionals and the courts
• A relative term that may vary over time

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Nonmaleficence

• Primum non nocere
• Above all or first do no harm.
• Often considered to be a corollary to the
  principle of beneficence.
• Sometimes interpreted as do no evil
• Harm is sometimes necessary for greater benefit
• The principle of double-effect allows harm to
  achieve greater benefit.

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Nonmaleficence

• Treatment vs. nontreatment
• Withholding (not starting) or withdrawing
  (stopping) life-sustaining treatment
• Extraordinary (or heroic) and ordinary treatment
• Artificial feeding and life-sustaining medical
  technologies
• Intended effects vs. foreseen effects

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Beneficence

• the first principle of morality is the dictum
  do good and avoid evil
• not a specific moral rule
• cannot by itself tell us what concrete actions
  constitute doing good and avoiding evil

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Combined

• Nonmaleficence
• One ought not to inflict evil or harm
• Beneficence
• One ought to prevent evil or harm
• One ought to remove evil or harm
• One ought to do or promote good

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Justice

• refers to what is owed or due to the individual
  members of society.
• varies according to philosophical and
  methodological presuppositions from which one
  approaches the issue.

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Specification

• The process of making abstract principles
  specific to a situation
• Ethical principles do not by themselves guide
  specific action
• They only make sense when applied to a specific
  set of circumstances
• The possibilities are infinite!

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Nuremberg Code

• Directives for Human Experimentation - 1949
• Established after war crimes trials of the Nazis
• The voluntary consent of the human subject is
  absolutely essential
• The experiment should be such as to yield
  fruitful results for the good of society
• The experiment should be so designed and based on
  the results of animal experimentation and a
  knowledge of the natural history of the disease
  or other problem under study that the anticipated
  results will justify the performance of the
  experiment.

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Nuremberg Code

• The experiment should be so conducted as to avoid
  all unnecessary physical and mental suffering and
  injury.
• No experiment should be conducted where there is
  an a priori reason to believe that death or
  disabling injury will occur except, perhaps, in
  those experiments where the experimental
  physicians also serve as subjects.
• The degree of risk to be taken should never
  exceed that determined by the humanitarian
  importance of the problem to be solved by the
  experiment.

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Nuremberg Code

• Proper preparations should be made and adequate
  facilities provided to protect the experimental
  subject against even remote possibilities of
  injury, disability, or death
• The experiment should be conducted only by
  scientifically qualified persons. The highest
  degree of skill and care should be required
  through all stages of the experiment of those who
  conduct or engage in the experiment.

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Nuremberg Code

• During the course of the experiment the human
  subject should be at liberty to bring the
  experiment to an end if he has reached the
  physical or mental state where continuation of
  the experiment seems to him to be impossible.
• During the course of the experiment the scientist
  in charge must be prepared to terminate the
  experiment at any stage, if he has probable cause
  to believe, in the exercise of the good faith,
  superior skill and careful judgment required of
  him that a continuation of the experiment is
  likely to result in injury, disability, or death
  to the experimental subject.

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Nuremberg Code

• Reprinted from Trials of War Criminals before the
  Nuremberg Military Tribunals under Control
  Council Law No. 10, Vol. 2, pp. 181-182..
  Washington, D.C. U.S. Government Printing
  Office, 1949.
• Link to full document

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Declaration of Helsinki

• WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
• Ethical Principles for Medical Research Involving
  Human Subjects
• Adopted in 1964
• Last updated in 2000
• Link to full document

41
Belmont Report

• In 1975, The National Commission for the
  Protection of Human Subjects of Biomedical and
  Behavioral Research, the first national
  commission on bioethics, outlined three basic
  ethical principles to be used in research
  involving human subjects
• Link to Full Report

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Belmont Report

• (1) Respect for persons
• (2) Beneficence and
• (3) Justice.
• Application of these general principles to the
  conduct of research leads to requirements of
  informed consent, burden/benefit assessment, and
  the equitable selection of research subjects.
• The Belmont Report became the basis for
  Institutional Review Boards (IRBs).

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Institutional Review Boards

• An interdisciplinary institutional committee
  responsible for reviewing proposed and ongoing
  research projects to ensure that they are
  ethically sound and adhere to federal regulations
  regarding research experiments involving human
  subjects

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Institutional Review Boards

• Seven criteria that need to be satisfied in order
  for an IRB to approve a research proposal
• 1) risks to subjects must be minimized
• 2) risks to subjects must be reasonable in
  relation to anticipated benefits
• 3) selection of subjects must be equitable

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Institutional Review Boards

• 4) enough information must be disclosed in order
  for participants to be able to give informed
  consent
• 5) informed consent must be documented
• 6) the research proposal must include provisions
  for monitoring safety of the participants
• 7) privacy and confidentiality of participant
  information must be maintained appropriately.

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Informed Consent

• Elements of Informed Consent
• Competence
• Disclosure
• Understanding
• Voluntariness
• Consent

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Controversies

• Medically administered nutrition and hydration
• Artificial ventilation
• Abortion/stem cell research
• Assisted suicide/euthanasia
• Rule of double effect
• Rationing of healthcare
• Slow codes
• and many, many more!