Related to Pharmacy

1. BIOETHICS
&
BIOSAFETY
Anirban Saha
M.Pharm (Pharmaceutics)
Year- 2nd , Semester- 3
Amity University .
AMITY INSTITUTE
OF PHARMACY
1

2. CONTENTS
 INTRODUCTION
 ETHICS AND MORALS
 IMPORTANCE OF BIOETHICS
 HEALTH & MEDICAL ETHICS
 IMPORTANCE
 PRINCIPLES
 BIOETHICS IN PATIENT CARE
 PROFESSIONAL ATTRIBUTE
 BIOETHICS IN TEAMWORK
 UNESCO BIOETHICS PRINCIPLE
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3. INTRODUCTION
The study of the ethical and moral implications of
new biological discoveries and biomedical advances,
as in the fields of genetic engineering and drug
research is bioethics.
The term “bioethics” was introduced in the 70’s by
Van Rensselaer Potter for a study aiming at ensuring
the preservation of the biosphere.
It was later used to refer a study of the ethical issues
arising from health care, biological and medical
sciences.
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4. ETHICS
Discipline concerned with right or wrong
conduct.
Guides to moral behavior.
Making choices or judgments.
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5. ETHICS vs MORALS
Morals are an individual frame work for decision
making that includes personal values.
Ethics are a generalized conceptual frame
work for decision making.
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6. IMPORTANCE OF BIOETHICS
Bioethics education for medical practice is essential
in today’s complex world because:
 Medical policies and patient rights legislation are
ever-changing.
 Health care systems function differently than
before.
 Clinical practice now involves decision-making
about many new issues.
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7. Health Ethics
The rules or standards governing the
conduct of a person or the members of a
profession relating to the study or practice
of medicine.
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8. Patients are entitled to good standards of practice and care from
their doctors.
Essential elements of this are professional competence, good
relationships with patients and colleagues and observance of
professional ethical obligations.”
(From Good Medical Practice, GMP)
competences of Indonesian doctors” (SKDI, 2012)
Ethics in Medical Science
(Medical Ethics)
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9.  Nowadays, conflicts of interests between the
government and medical institutions, between
medical institutions and medical personnel,
between physicians and patients are getting more
and more serious and complex.
 High technologies not only brought us hopes of
cure but have also created a heavy economic
burden.
 The ethical dilemmas of prescribing high
technology medicine, organ transplantation, and
concerns about quality of life-have become
increasingly prominent.
Why Bioethics has Become Important?
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10. There are 4 (four) principles of
Bioethics
Autonomy- Right of self-determination
Beneficence – To do well and to promote well-being
Non-maleficence – To do no harm or to avoid doing
harm.
Justice – Treat everyone alike
(Beauchamp and Childress, 2001.)
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11. BIOETHICS IN PATIENT CARE
Bioethics involves making the best possible health care
decisions with attention to more than just medical factors -
especially when there is disagreement about an appropriate
course of action.
Decisions
Making decisions can be difficult. Bioethics helps to consider
life-sustaining treatments (including cardio-pulmonary
resuscitation, artificial ventilation and artificial methods of
providing food and fluids) and discusses aspects of their use.
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12. Ethical and Regulatory Aspects of
Clinical Research
 Utilize a systematic framework for evaluating the ethics
of a clinical research protocol.
 Apply appropriate codes, regulations, and other
documents governing the ethical conduct of human
subject research to their own research.
 Discuss controversial issues relating to human subject
research, including Phase 1 research, randomization,
children in research, international research, etc.
 Identify the critical elements of informed consent and
strategies for implementing informed consent for clinical
research.
 Describe the purpose, function, and challenges of IRBs.
 Appreciate the experience of human subjects who
have participated in research protocols.
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13. PROFESSIONAL ATTRIBUTES &
BIOETHICS
Displaying honesty and integrity
• Never misrepresent or falsify information and/or
actions (cheating).
• Do not engage in other unethical behavior.
Showing respect for patient's dignity and rights
• Make appropriate attempt to establish rapport with
patients or families.
• Show sensitivity to the patients' or families' feelings,
needs, or wishes.
• Demonstrate appropriate empathy.
• Show respect for patient autonomy.
• Maintain confidentiality of patient information.
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14. CONTINUED..
Maintaining a professional demeanor
• Maintain professional demeanor even when
stressed; not verbally hostile, abusive, dismissive or
inappropriately angry.
• Never expresses anger physically.
• Accept professionally accepted boundaries for
patient relationships.
• Not to be arrogant or insolent.
•Proper Appearance, dress, professional behavior.
Follow generally accepted professional norms.
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15. BIOETHICS IN TEAM WORK
Responding to supervision
• Accept and incorporates feedback in a non-resistant and
non-defensive manner.
• Accept responsibility for failure or errors.
Demonstrating dependability and appropriate initiative
• Complete tasks in a timely fashion (papers, reports,
examinations, appointments, patient notes, patient care tasks)
• Do not need reminders about academic responsibilities,
responsibilities to patients or to other health care
professionals in order to complete them.
• Appropriately available for professional responsibilities (ie
required activities, available on clinical service)
• Take on appropriate responsibilities willingly (not resistant or
defensive)
• Take on appropriate patient care activities (does not "turf"
patients or responsibilities)
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16. CONTINUED..
Interacting with other members of the team
• Communicate with other members of the health care team in a
timely manner
• Show sensitivity to the needs, feelings, wishes of health care
team members
• Relate and cooperates well with members of the health care
team
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17. UNESCO’s 15 Bioethical principles
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