Transcript Code of Ethics - Dr Ted Williams

Honesty and Ethics of Professions
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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?
• What would our profession be like
without ethical practitioners?
Why Regulate Healthcare?
• Laws exist because a purely marketdriven 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”
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
Senior Research Associate at the Center for the Study
of Ethics in Professions, Illinois Institute of Technology
Business vs. Profession
• Is Pharmacy a business or a
profession? Both?
• Differences between business and
profession?
• Are there “business/political ethics”?
– Enron, Global Crossing, Adelphia, Martha
Stewart, Jack Abramoff…
American Medical Association
Principles of Medical Ethics
I.
A physician shall be dedicated to providing competent medical
care, with compassion and respect for human dignity and
rights.
II.
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.
III. 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.
IV.
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.
American Medical Association
V.
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.
VI.
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.
VII. A physician shall recognize a responsibility to participate in
activities contributing to the improvement of the community
and the betterment of public health.
VIII. A physician shall, while caring for a patient, regard
responsibility to the patient as paramount.
IX.
A physician shall support access to medical care for all people.
Adopted by the AMA's House of Delegates June 17, 2001
Pharmacist Code of Ethics
• Adopted by APhA in 1994
• Endorsed by ASHP in 1996
• Actually read by very few practicing
pharmacists!
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.
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.
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.
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.
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.
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.
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.
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.
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.
APhA Conscience Clause
Pharmacist Conscience Clause
1. APhA recognizes the individual pharmacist’s right
to exercise conscientious refusal and supports the
establishment of systems to ensure patient’s access
to legally prescribed therapy without compromising
the pharmacist’s right of conscientious refusal.
2. APhA shall appoint a council on an as needed basis
to serve as a resource for the profession in
addressing and understanding ethical issues.
Choices!
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
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.
Hospital Ethics Committee
• Assists medical staff with difficult
cases
• Makes policy recommendations
• Provides education to physicians &
hospital staff
• Members:
– Physicians, chaplains, nurses, social
workers, public members
Veracity
• Comprehensive, accurate, and
objective transfer of information
• Depends on obligation of respect for
others
• Closely related to fidelity
• Essential for trusting relationship
Privacy
• A human right – the “Right to Privacy”
• Informational privacy
– Personal information
• Physical privacy
– Personal space
• Decisional privacy
– Personal choices
• Proprietary privacy
– Property (e.g. tissue samples)
Confidentiality
• Keeping information from being known
• “informational privacy”
• Medical confidentiality occurs upon
disclosure from one person to
another (usually patient to doctor)
• Information is private and imparted
in confidence and trust
Fidelity
•
•
•
•
•
Act in good faith
Keep vows and promises
Fulfill agreements
Maintain relationships
Discharge fiduciary responsibilities
(act in the patient’s best interest)
Parental Consent/Disclosure
• ORS 109.640
• Right to medical or dental treatment without parental consent;
physicians may provide birth control information to any person
• Any physician may provide birth control information and services to
any person without regard to the age of such person and a minor 15
years of age or older, may give consent to hospital care, medical or
surgical diagnosis or treatment by a physician licensed by the Board of
Medical Examiners for the State of Oregon, and dental or surgical
diagnosis or treatment by a dentist licensed by the Oregon Board of
Dentistry, without the consent of a parent or guardian, except as may
be provided by ORS 109.660.
Parental Consent/Disclosure
• ORS 109.680
• Disclosure without minor's consent; civil immunity
• A physician, psychologist, nurse practitioner, licensed clinical social worker or
community mental health and developmental disabilities program described in
ORS 109.675 may advise the parent or parents or legal guardian of any minor
described in ORS 109.675 of the diagnosis or treatment whenever the
disclosure is clinically appropriate and will serve the best interests of the
minor's treatment because the minor's condition has deteriorated or the risk of a
suicide attempt has become such that inpatient treatment is necessary, or the
minor's condition requires detoxification in a residential or acute care facility.
If such disclosure is made, the physician, psychologist, nurse practitioner,
licensed clinical social worker or community mental health and developmental
disabilities program shall not be subject to any civil liability for advising the
parent, parents or legal guardian without the consent of the minor.
Parental Consent/Disclosure
• ORS 109.610
• Right to treatment for venereal disease without parental consent
• (1) Notwithstanding any other provision of law, a minor who may have come
into contact with any venereal disease may give consent to the furnishing of
hospital, medical or surgical care related to the diagnosis or treatment of such
disease, if the disease or condition is one which is required by law or regulation
adopted pursuant to law to be reported to the local or state health officer or
board. Such consent shall not be subject to disaffirmance because of minority.
• (2) The consent of the parent, parents, or legal guardian of such minor shall not
be necessary to authorize such hospital, medical or surgical care and without
having given consent the parent, parents, or legal guardian shall not be liable
for payment for any such care rendered.
Death With Dignity Act – 2004 Report
ETHICS CASES/EXAMPLES
Suspected Impairment
• You are an intern in a hospital pharmacy .
• You notice that the pharmacist you work
with in the IV Room frequently comes to
work with an odor of alcohol on his breath.
• You report your suspicions to the pharmacy
manager, who says that he will “talk to him”
Suspected Impairment
• Two weeks have passed and nothing
appears to have been done and the
pharmacist begins exhibiting bizarre
behavior.
• What options do you have?
Academic Ethics
• You are taking a pharmacology exam and
notice that one of your fellow students
appears to be referring to note cards in
her purse.
• The fellow student is also the wife of one
of the pharmacy faculty members.
• How would you handle this situation?
Institutional Review Board
• You are the member of an
Institutional Review Board reviewing
an proposal for a clinical trial of a
new blood pressure medication.
• The budget for the trial includes $30
per weekly visit for unreimbursed
expenses for the patient.
• Is this “coercive”?
Institutional Review Board
• You review a study for an FDA-approved
drug used for an “off-label” indication.
• The study protocol states that the patient
will be asked to pay for the drug.
• What “phase” clinical trial is this?
• Is it ethical to require the patient to pay
for the drug?
Genetic Testing
• Should the public have access to a
test to uncover all genetic
predisposion to disease?
• “Total body CT Scans”?
• The market-based system says “YES”
– if you can afford it, you can buy it!
Oregon Health Plan - Rationing
• Rationing not allowed under Federal
Medicaid rules
• Oregon received a waiver in early 90’s for
OHP
• List of diagnoses by “medical necessity”
• Covered to a specific level based on
funding
• Ways to cut costs
– decrease covered patients, diagnoses, payments
• Distributive justice issues?
®
Zevalin
• yttrium-90 (90Y) ibritumomab tiuxetan
• low-grade, follicular, and transformed nonHodgkin's lymphoma (NHL) - rare
• Approx. $30,000 per monthly treatment
• Longer duration of remission by
approximately 3 months
• No improvement in survival
®
Erbitux
• Treatment for colon cancer - common
• $17,000 per month
• No evidence of improved survival or
quality of life
• Shrinks tumors in 10% of patients
• Covered under most health plans
Ethics Case #1
• CC: AB is a 47 yof was admitted to the
hospital on 3/6 with recurrent seizures.
• HPI: This patient was diagnosed with
metastatic cervical carcinoma in January
and has been treated with comfort measures
only. She has had a progressive decline in
her ability to care for herself over the last
three weeks.
Ethics Case #1
• SH: Non-smoker, occasional EtOH, mother
– hypertension, father – prostate CA,
diabetes
• FH: She is married with two children in
their early twenties.
• PE/ROS: Neuro – patient lethargic and
confused. Unable to communicate.
Ethics Case #1
• AB was admitted to the oncology ward, “no code”
status per husband and POLST.
• Over the next several hours her seizures became
more frequent and severe. The family asked the
MD if “there is anything you can do to stop the
seizures”.
• The MD suggested a barbiturate (pentobarbital)
infusion to induce sleep and stop the seizures.
Ethics Case #1
• The physician writes an order for
“pentobarbital infusion per pharmacy –
titrate to comfort”
Ethics Case #1
• What ethical principles are involved
–
–
–
–
for the patient?
for the family?
for the physician?
for the pharmacist?
Ethics Case #1
• The pentobarbital infusion was started and
the patient’s seizures stopped and she was
deeply sedated
• After four hours of pentobarbital infusion,
the patient stopped breathing and was
pronounced dead
Ethics Case #1
• What distinguishes this case from assisted
suicide?
• Might some people legitimately consider
this assisted suicide?
• Could the physician be investigated by the
DEA?
Ethics Case #2
• You read an article in the morning paper that half
of this year’s flu vaccine will be lost due to a
manufacturer’s violation of GMP.
• Fortunately, your community pharmacy did not
contract with the manufacturer involved and you
have received 1000 doses of vaccine.
• The State Health Division tells vaccine providers
that vaccinating patients who are not in a “high
risk” category will be fined $500 per vaccination.
Ethics Case #2
• The local hospital calls and says that they
are unable to get vaccine because they
contracted with the violating manufacturer
and ask (beg!) for as many doses as you can
spare.
• What is your answer?
• Any ethics issues involved?
Ethics Case #3
• You are working in a busy community
pharmacy and the technician calls you over
to counsel on a new prescription.
• The customer is a woman picking up her
own prescriptions and there is also one for
her husband that she had not known about.
• The technician set it out for the pharmacist
with the woman’s prescriptions
Ethics Case #3
• The prescription for her husband was an antiviral
drug commonly used for herpes infection.
• What should the pharmacist do in this situation?
• What if the prescription was for their sixteen yearold daughter?
Ethics Case #4
• A customer brings a prescription bottle to the
pharmacy counter and tells the clerk that he would
like to speak with the pharmacist.
• The pharmacist approaches the counter and the
patient gives her the bottle and says he thinks that
a mistake has been made.
• The pharmacist discovers that the bottle was
labeled for ibuprofen 600 mg tablets (#30) and
contained warfarin 5 mg tablets.
Ethics Case #4
• What steps should the pharmacist take in
this situation?
Ethics Case #4
• The customer gives you additional
information that their 13 year-old son has
taken six tablets over the last four days for
pain related to a sprained ankle.
• Now what??
HHS division questions ethics of PolyHeme blood-substitute trial
03/10/2006
The federal Office for Human Research Protections (OHRP) is expressing concern about an ongoing
study of Northfield Laboratories’ PolyHeme blood substitute, citing “urgent ethical concerns” over its use in
trauma patients who have not given their consent to participate, the Wall Street Journal reports. The OHRP, a
“little-known” division of HHS that monitors research practices in government trials, today is expected to meet
with representatives from the Senate Finance Committee to discuss the concerns. For the study in question,
360 “badly injured and hemorrhaging trauma patients” will receive the blood substitute and 360 control
subjects will receive saline solution in the field followed by donor blood upon arrival at the hospital. In a
previous study of PolyHeme in patients undergoing aneurysm surgery, 10 of the 81 participants given
PolyHeme had heart attacks and two of those patients died, compared with no heart attacks or deaths among
the 71 patients given saline and donor blood. Northfield attributed the increased number of heart attacks and
deaths to “an excess of total fluids given to PolyHeme patients” and discontinued the trial but failed to
disclose the results to most hospitals and communities involved in the current study. Despite the previous
results, the FDA authorized Northfield to conduct the new trial without patient consent, saying that trauma
care, by nature, is often provided to patients who are unconscious and therefore incapable of providing
consent. The FDA maintains that “medical, legal, and ethical safeguards [are] in place for these types of
research endeavors,” adding that it will continue to explore methods to improve oversight of such studies.
However, a social medicine professor at the University of North Carolina School of Medicine writes in the
current issue of Ethics and Human Research that the study of trauma patients does not meet existing nonconsent trial criteria because the standard therapy of providing saline in the field followed by donor blood at
the hospital has not been “unproven or unsatisfactory.” Meanwhile, Senate Finance Committee Chairman
Charles Grassley (R-Iowa) is leading an investigation to determine whether patients in the new study are
aware of the increases in risk of heart attack or death among patients in the previous study and whether it is
appropriate to allow the trial to proceed without patient consent. A Northfield spokesperson says PolyHeme is
being “evaluated as a potential better alternative” to donor blood and maintains that the study currently
underway was designed on “strong scientific, legal, and ethical ground” (Burton, 3/10).