WHY REGULATE HEALTH CARE AND CLINICS.ppt

This presentation shows the importance of regulating healthcare in order to prevent malpractices and legal matters

1. HEALTH CARE REGULATION

2. 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”

3. 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 nottake advantage
of her/his good conduct.
A code protects members of a profession from certain
consequences of competition.
A code is a solution to a coordination problem.”

4. Business vs. Profession
•Is Pharmacy a business or a profession? Both?
•Differences between business and profession?
•Are there “business/political ethics”?

5. MISSION OF PHARMACY
Provision of Pharmaceutical care

6. Principles of Medical Ethics
 A practitioner shall be dedicated to providing competent medical
care, with compassion and respect for human dignity and rights.
 A practitioner shall uphold the standards of professionalism, be
honest in all professional interactions, and strive to report
practitioner deficient in character or competence, or engaging in
fraud or deception, to appropriate entities.
 A practitioner 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 practitioner shall respect the rights of patients, colleagues, and
other health professionals, and shall safeguard patient confidences
and privacy within the constraints of the law.

7. Principles of Medical Ethics
 A practitioner 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 practitioner 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 practitioner shall recognize a responsibility to participate
in activities contributing to the improvement of the
community and the betterment of public health.
 A practitioner shall, while caring for a patient, regard
responsibility to the patient as paramount.
 A practitioner shall support access to medical care for all
people.


8. Pharmacist Code of Ethics
•Vary from country to country but the
principles are the same

9. Code of Ethics for Pharmacists
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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. Conscience
Pharmacist Conscience Clause
1 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. The professional societyshall appoint a council on an
as needed basis to serve as a resource for the profession
in addressing and understanding ethical issues.

19. Choices
•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

20. 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.

21. Veracity
•Comprehensive, accurate, and objective
transfer of information
•Depends on obligation of respect for others
•Closely related to fidelity
•Essential for trusting relationship

22. 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)

23. 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

24. Fidelity
•Act in good faith
•Keep vows and promises
•Fulfill agreements
•Maintain relationships
•Discharge fiduciary responsibilities (act
in the patient’s best interest)

25. ETHICS CASES/EXAMPLES

26. 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”

27. 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?

28. 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?

29. Institutional Review Board
•You are the member of an Institutional
Review Board reviewing a 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”?

30. Institutional Review Board
•You review a study for an PPB -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?

31. 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!

32. 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?

33. Zevalin
®
•yttrium-90 (90Y) ibritumomab tiuxetan
•low-grade, follicular, and transformed non-
Hodgkin's lymphoma (NHL) -rare
•Approx. $30,000 per monthly treatment
•Longer duration of remission by
approximately 3 months
•No improvement in survival

34. 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

35. 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.

36. 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.

37. 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.

38. Ethics Case #1
•The physician writes an order for
“pentobarbital infusion per pharmacy –titrate
to comfort”

39. Ethics Case #1
•What ethical principles are involved
–for the patient?
–for the family?
–for the physician?
–for the pharmacist?

40. 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

41. 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?

42. 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.

43. 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?

44. 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

45. 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
year-old daughter?

46. 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.

47. Ethics Case #4
•What steps should the pharmacist take in this
situation?

48. 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??