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Pharmaceutical Ethics
Jully,2014
1 5/24/2023
Introduction
2
Profession Vs Vocation
Profession: is a form of employment or a field that is
respected in the society ,requires extensive study and
mastery of specialization in knowledge.
5/24/2023
Intro…
3
 Characteristics of Profession:
 Specializing in knowledge
 Rigorous training and schooling, problem-solving skills
 Providing essential services to the society
 Deriving force: not fortune (gain) but rather the service they
render (ministering)
 High degree of self-control of behaviors
 Codes, guidelines, oaths, commitment statements, etc
 Mutual trust b/n professionals and the patron
b/c there is information asymmetry b/n the provider and the
receiver
 Social Sanction
professionals given exclusive right to practice the profession
 Professionals form an association
 Ever changing/growing field of study
5/24/2023
Intro…
4
Is pharmacy a true profession?????
Yes!!
Why? Because it assists the public and individuals make the best
usage of medications and fulfils the above basic feature of a
profession.
5/24/2023
Intro…
5
Professional Ethics
• Ethics is a science of moral value.
• A set of principles of right conduct
• The science of human duty
• The basic foundation of ethical behavior is the
basic perception that “DO GOOD & AVOID EVIL”
• Ethics and law are related in that both share the
social purpose: ENCOURAGE THE RIGHT
CONDUCT
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Ethical Theories
6
Two General Thoughts:
A. Consequentialism (Teleological)
 Looks at the consequences of acts
 The acts are right to the extent that they produce
good consequences
 The result that matters most
 Morality of an action consists of the ratio of good
to evil that the action produces
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7
B. Deontological or ‘duty-based’ ethics
 Root word: ‘deon’ from the Greek word meaning,
roughly, ‘one must’;
 Deontological ethics are especially concerned
with rules, duties and obligations
 Rightness and wrongness are inherent in the act
itself independent of the consequences
 The process matters more than the result/End
 The concern is which course of action, will do the
most good overall.
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8
Three features of Deontological Ethical theories:
1) Deontological ethical theories are Non-Consequentialist
 Consequentialists will argue that whether an action is right
or wrong depends upon the consequences of this action.
 Where as deontologists argue that it is not necessarily the
case that an action’s rightness or wrongness depends upon
the consequences
2. Deontological ethical theories claim morality and ethics are
to be understood as systems of rules meant to govern and
guide conduct
Moral rules take the form of commands or imperatives;
Three different kinds of rules are relevant.
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9
 Rules that make an action (morally) forbid
Rules that make an action (morally) obligatory
Rules that make an action (morally) permissible
3) Deontological Ethical theories are agent-relative as
opposed to agent-neutral;
 According to deontological ethical theories, at least
sometimes, a moral rule must refer to a particular agent.
 For example, I presumably have a duty to take care of my
family but it is not so clear you have a duty to take care
of my family or that I have a duty to take care of yours.
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Basic Principles of Bioethics
10
Bioethics
Is the study of typically Controversial Ethics brought about by
advances in Biology and Medicine.
All Ethical issues arise from the Three Pillars of Ethics
1. Respect for person
2. Beneficence/ Non‐Maleficience
3. Justice
 They are considered universal regardless of geographic,
economic, legal and political boundaries.
 Researchers are Obliged to assure that these principles are
followed while Conducting Research Involving Human
Participants.
5/24/2023
1. Respect for persons
11
 Respect for persons addresses two main ethical considerations.
a) respect for autonomy, and
b) protection of persons with diminished or impaired autonomy.
 To Respect autonomy is, therefore, to give weight to the considered
opinions and choices of the individual, while refraining from
obstructing his/her actions.
 Not every individual is, however, Capable of decision-making due to
o Lack of maturity (as in the case of children),
o Mental disability, or
o Circumstances that severely restrict liberty (as in the case of
prisoners),
 Prisoners may have the right to Volunteer for Research, but
on the other hand, they may be subtly Coerced or unduly
influenced to engage in research activities for which they would
not otherwise volunteer.
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12
 According to this principle, the study participants have the right to be well
informed and give consent.
 This process is termed to be Informed Consent.
The Roles of Informed Consent are:
 to respect individual rights
 to establish participatory research
Types of Informed Consent
a. Written: obtained for epidemiological research as much as possible. But for
clinical research, written consent is a must.
b. Verbal: Verbal consent may be opted where people are reluctant to put
their signature on official document. This, however, cannot be an excuse for
clinical studies.
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13
The informed consent process
 Informed consent can best be described as participants' bill of
rights. These Rights Demand three things:
i. Research subjects are told every thing about the study,
including risks.
ii. The information must be easy to understand.
iii. Research subjects who agree to participate must do so
Voluntarily, they must not be Pressurized or swayed into it.
The process of informed consent includes:
Whom to inform
 Research Participant
 Spouse: because of the nature of research which might affect
the family.
 Community:
 Government: If the government has to give permission for the
research to be conducted.
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14
Who to give Consent
 Research participant
 Spouse
 Community
 Government
How the information is to be Communicated
 In a language which the research participant easily understands
 Using visual aids whenever applicable to ease understanding and
discussion
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15
When to get consent
 Enough time has to be allocated for the research participant
prior to seeking his or her consent to participate for the
following reasons
 To get enough time to think about the cons and pros of
participation
 To allow him or her enough time to seek advice from family,
relatives, friends, colleagues acquaintances
Who to administer the process
 Investigators
 Trained employees for the research 5/24/2023
16
Informed Consent Form
 Therefore, an informed consent form is a signed contract
between a principal investigator and a research participant in
the presence or absence of witnesses.
 It is legally binding if the research participant claims that his or
her right is not protected according to the contract.
5/24/2023
Elements of an informed consent form
17
Considering the concerns of the study participant, the informed
consent form should have the following information:
Purpose of the study: The reason to carry out the study has to be
clearly indicated
Selection criteria: The reason for the selection of the participant for
the study has to be made clear
Procedures of the protocol: The procedure which the investigators
would like to follow has to be described to the research
participant.
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18
Such information includes:
 Duration of study: How long will the study last? The research
participant is not expected to continue participation in the
research for an indefinite period of time
 Justification for use of placebo: If the study uses a placebo,
strong scientific and ethical justification has to be given
 Assignment of placebo and treatment groups: Randomization to
groups has to be mentioned clearly in the form.
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Possible Risks or Discomforts during the study:
 These should be described transparently.
 Even if the risks are Minimal, they have to be known to the
Research Participant.
Benefits:
 The type of benefit which the research participant is going to
get should explicitly be described in the form.
 The benefits should not be so large as to induce the participant
to participate in the study purely for the anticipated benefit,
and not because he or she is convinced to do it.
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Confidentiality:
The informed consent should assure that confidentiality will be
maintained to protect participants from possible harm at the revelation
of such information.
The following information is important as far as confidentiality is
Concerned:
 The Mechanism should be sound enough to maintain confidentiality
like using Codes and locking them in Cabinets.
 By whom the information may be accessed has to be clearly indicated
i.e use of data for unstated purpose other that is Unethical.
 Measures to be taken to avoid stigmatization should also be
mentioned. 5/24/2023
21
Voluntary participation:
Is to ensure the principle “Respect for Persons”.
The following should be noted as far as Voluntary
Participation is concerned:
 The right to decide whether to participate in the research
should be respected.
 The right to Withdraw after involvement in the research
should be respected.
 The right to Refuse to answer any question needs to be
acknowledged.
Contact addresses: need to be provided.
Signatures: RP, PI and witness whenever applicable.
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Therefore, the Valid Informed Consent should be
given voluntarily.
free from coercion and undue influence.
Coercion occurs when an overt threat of harm is intentionally
presented by one person to another to obtain compliance.
Undue influence occurs through an offer of an excessive,
unwarranted, inappropriate or improper reward to obtain
compliance.
For instance, Undue influence could be manifested in the
following ways.
 Unjustifiable pressures abusing positions of authority &
 Manipulating a person’s choice through the controlling
influence of a close relative and
 Threatening to withdraw health services to which an
individual would otherwise be entitled.
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ANNEX IV: SAMPLE INFORMED CONSENT FORM
Hello, my name is [*]. I work for [*]. We are conducting a survey in [study location] to learn about
women’s health and life experiences. You have been chosen by chance (as in a lottery/raffle) to
participate in the study.
I want to assure you that all of your answers will be kept strictly secret. I will not keep a record of
your name or address. You have the right to stop the interview at
45
any time, or to skip any questions that you don’t want to answer. There are no right or wrong
answers. Some of the topics may be difficult to discuss, but many women have found it useful to have
the opportunity to talk.
Your participation is completely voluntary but your experiences could be very helpful to other women in
[country].
Do you have any questions?
(The interview takes approximately [*] minutes to complete). Do you agree to be interviewed?
NOTE WHETHER RESPONDENT AGREES TO INTERVIEW.
[] DOES NOT AGREE TO BE INTERVIEWED
THANK PARTICIPANT FOR HER TIME AND END
INTERACTION.
[] AGREES TO BE INTERVIEWED.
Is now a good time to talk?
It’s very important that we talk in private. Is this a good place to hold the interview, or is there
somewhere else that you would like to go?
TO BE COMPLETED BY INTERVIEWER
I CERTIFY THAT I HAVE READ THE ABOVE CONSENT PROCEDURE TO THE PARTICIPANT.
SIGNED:
11 Used in the WHO Multi-country Study on Women’s Health and Domestic Violence Against Women
(Ellsberg & Heise, 2005).
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23 5/24/2023
2. Beneficence/ Non-Maleficence
24
Beneficence—the provision of benefits—and Non-maleficence—
the avoidance of doing harm.
 refer to protection of study participants from harm and
making efforts to secure their well-being.
Two general rules have been formulated as Complementary
expressions of beneficence:
a) Do not harm: extended from Hippocratic oath that stated “do
no harm”, and
b) Maximize possible benefits and Minimize possible harms.
 The rules of beneficence affect both individual investigators
and the community.
 Beneficence has two components: Benefits and Risks
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2.1. Benefits
A researcher`s aim should always be to benefit humanity . And
humanity is each and everyone of us.
When one discusses the benefits given to research participants,
the following need to be considered:
 Beneficiaries
Research participants
Community
Country
 Forms of Benefits
 Monetary, i.e., Financial
 Health care
 Capacity Building: Research facility and Manpower
Development
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 Magnitude of Benefits
 Compensation, i.e., to compensate the time spent, the
expenses for the meal and transport
 Undue Inducement, i.e., to provide benefits for
participation more than they earn and more than they
deserve.
This might coerce participants to participate in the research
because of the big benefits they are going to get.
The level of payment should not be tied to the level of risk.
Duration of Benefits
 Short term, i.e., only for the study period
 Long term. i.e., extends beyond the study period
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2.2. Risks
The following points need to be noted with regard to risks:
 To Whom
 Research Participant: Is the risk limited only to the research
participant?
 Community: Does the risk extend to the Community?
 Types
 Physical: any damage to any of the organs, e.g., handicapped
 Social: resentment by the society, e.g., stigma
 Psychological: a feeling of discomfort, e.g., Stress
 Economic: loss of earning Capacity, e.g., loosing job because
of getting involved in a research which the employer does not
like.
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 Magnitude: the degree of Severity of the risk, i.e., Mild,
Moderate or Severe.
 Duration: How long the risk lasts, i.e., the risk may be
 For the period of the study only
 Extended further after the study is Completed
5/24/2023
3. Justice
29
 The Underlying Principle of justice is to treat each person in
accordance with what is Morally right and Proper.
 Refer to Fair and Equitable distribution of both the Burdens and
Benefits of participation in research.
 Such formulations include: to each person
i. an equal share
ii. according to individual need
iii. according to individual effort
iv. according to societal contribution
v. according to merit
Distributive justice
Concerns the fair, just or equitable distribution of benefits and
burdens.
5/24/2023
Summary
30
Respect for Persons/Autonomy Acknowledge a person’s right to
make choices, to hold views, and to
take actions based on personal
values and beliefs
Justice
Treat others equitably, distribute
benefits/burdens fairly.
Non-Maleficence (do not Harm)
Obligation not to inflict harm
intentionally; In medical ethics, the
physician’s guiding maxim is “First,
do no harm.”
Beneficence (Do Good)
Provide benefits to persons and
contribute to their welfare. Refers to
an action done for the benefit of
others.
5/24/2023
Assignment
5/24/2023
31
Read about
Application of Ethical principles to Operational
Research
Sources
 Journal of Empirical Research on Human Research
Ethics
 Ethics and Human Research Journal
Rationing and Priority Setting
32
 Given the Limitations on Healthcare Resources, there is
increased interest in assessing the value for money, or
Economic efficiency, of Healthcare Treatments and
Programs.
 This is achieved through Economic Evaluation, where
the costs and consequences of alternative treatment
strategies are compared.
 Priority Setting in Health care involves a process of
choice among alternative health care programs and
services
 If undertaken in a Systematic and explicit way, it is a
process that ranks the alternatives in accordance with
normative/standardized and technical rules. 5/24/2023
33
 Priority setting is in effect a way of allocating scarce
resources, and so is a form of Rationing.
 In recent years, Priority Setting has received an
increasing amount of attention in many Countries,
owing to the growing realization that traditional
rationing practices, which have been implicit or hidden,
are inadequate to solve the resource allocation
problem.
 In economics, Rationing refers to Distribution under
conditions where a supply that is limited by
considerations of cost confronts a demand that is not
constrained by considerations of price.
 Rationing is a way of distributing scarce goods when
there is no market to perform the task.
 Priority Setting makes a Relative Ranking of Goods.
5/24/2023
Assisted Suicide
34
 A Suicide is an Intentional, Self-caused/ Inflicted Death.
 Assisted Suicide, a person’s Voluntary Suicide with help
from another individual.
 The term assisted suicide may also refer to the act of
providing an individual with the means to commit
Suicide.
 If a Doctor provides Medications or other means of
Committing Suicide, this action is referred to as
Physician-assisted Suicide. 5/24/2023
Euthanasia
35
 Euthanasia, practice of Mercifully Ending a Person’s Life in order
to release the person from an incurable disease, intolerable
Suffering, or Undignified Death.
 The word euthanasia derives from the Greek for “good death”
and originally referred to Intentional Mercy Killing.
 The term euthanasia refer to
 assistance of the person to terminate life
 lack of action to prevent death.
5/24/2023
36
 It could be performed Voluntarily & In-Voluntarily.
 In Voluntary euthanasia,
 a person asks to die (by either active or passive euthanasia).
 Non-Voluntary euthanasia
 refers to ending the life of a person who is not mentally competent to
make an informed request to die, such as a comatose patient.
 Active euthanasia involves painlessly putting individuals to death for
Merciful Reasons,
 Eg. a doctor administers a lethal dose of medication to a patient.
 Death is Caused by an act of Commission and is a Case of Killing a
person.
5/24/2023
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 Passive euthanasia involves not doing something to prevent
death, as when doctors refrain from using an artificial respirator
to keep alive a terminally ill patient.
 When a person is allowed to die, death is a result of an act of
Omission, the omission is an instance of Passive euthanasia.
 In both cases, the motive is the person’s own good.
Question:
Does the difference between passive and active euthanasia, which
reduces to a difference in how death comes about, make any moral
difference?
5/24/2023
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To My Family, My Physician, My Clergyman, and My Lawyer:
If the time Comes when I can no longer take part in Decsions about my own
future, let this statement stand as testament of my wishes: If there is no
reasonable expectation of my recovery from physical or mental disability,
I, ________, request that I be allowed to die and not be kept alive by artificial
means
or heroic measures. Death is as much a reality as birth, growth, maturity, and
old age—it is the one certainty. I do not fear death as much as I fear the
indignity of deterioration, dependence, and hopeless pain. I ask that drugs be
mercifully administered to me for the terminal suffering even if they hasten
the moment of death.
This request is made after careful consideration. Although this document is
not legally binding, you who care for me will, I hope, feel morally bound to
follow its mandate. I recognize that it places a heavy burden of responsibility
upon you, and it is with the intention of sharing that responsibility and of
mitigating any feelings of guilt that this statement is made.
Signed: ______________________________
Date: _______________________________
Witnessed by:
____________________________________
____________________________________ 5/24/2023
Ethics and Professionalism
39
Systematic Construction of Ethical framework for
western Civilization was begun 2000 years ago by
Socrates.
His principle was formulated as: “ Ethics is a science and
can be governed by principles of universal validity: “so
that what is good for one was good for all and what was
my neighbor's duty was my duty too.”
No Set of Ethical Principles, no matter how carefully
thought or well constructed can provide the individual
professional with guidance for each decision. 5/24/2023
40
Separate analysis of possible outcomes from different actions
and weighing of right and wrong is important.
Being pharmacy , Professional Ethics:
Principles that form the fundamental basis of the Roles and
Responsibilities of pharmacists
The pharmacist is the one who is supposed to resolve the ever-
increasing Ethical dilemmas in Medicine including Patients,
Family Members, Physicians, Nurses, Hospital Administrators
and Policy Makers.
5/24/2023
Professional characteristics of pharmacists
41
A. Possession of specialized body of knowledge:
Enables the practitioner to perform highly useful Social
function for:
• Advising patients and prescribers
• Detecting potential drug-drug interactions
• Selecting proper products and product Sources
• Exercising professional judgment
B. Sets of specific attitudes that influence professional
behavior manifested by Altruism: an Unselfish Concern
for the welfare of others. 5/24/2023
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 The decision he/she makes in the course of the career is
based on his/her sense of what is right and not on
estimation of what is profitable.
C. Social Sanction: whether the society views it as a
measure of social sanction; granting of exclusive right of
practice through the licensing power of the country.
Licensing: Protects the Public from Incompetent
Practitioners and Creates a relationship of trust between
the Society and Professional.
5/24/2023
Code of Ethics
43
These are Rules of Conduct based on Moral Values,
which are stated by a recognized association.
Pharmacists are Health professionals who assist
individuals in making the best use of Medications.
The pharmacy Code of Ethics is intended to state the
principles that form the fundamental basis of the Roles
and Responsibilities of pharmacists based on moral
obligations and virtues established to guide pharmacists
with Patients, Health Professionals and Society.
5/24/2023
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Why code of ethics?
 To define accepted/unacceptable behaviors
 To promote high Standards of practice
 To provide a benchmark for members to use for self
evaluation
 A framework for Behavior and Responsibilities
 As a Vehicle for Occupational identity
 As a mark of Professional Maturity
5/24/2023
Basic Code of Ethics for Pharmacists by FIP and
EPA in Ethiopia
45
1. A pharmacist respects the Covenantal Relationship
between the Patient and the pharmacist
 Moral Obligation in response to gift of trust from the
Society.
2. 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.
 Protect the Dignity of the Patient. 5/24/2023
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3. A pharmacist respects the autonomy and dignity of each
patient.
 A pharmacist respects personal and cultural
differences among patients.
4. A pharmacist acts with honesty and integrity in
professional relationship.
 Has a duty to tell the truth and to act with conviction
of conscience.
5. A pharmacist maintains professional competence as new
medications, devices, technological advances and health
information are being increasing. 5/24/2023
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6. A pharmacist respects the values and abilities of
colleagues and other health care professionals.
7. A pharmacist serves individuals, community and societal
needs.
8. A pharmacist seeks justice in the distribution of health
care resources
 Fair and equitable health resource distribution balancing
needs of patients and the society.
5/24/2023
Oath of a Pharmacist
48
I vow to Devote my Professional life to the Service of Mankind through the
Profession of pharmacy.
I will Consider the Welfare of Humanity and Relief of Human Suffering my
Primary Concerns.
I will use my Knowledge and Skills to the best of my Ability in Serving the
Public and other Health Professionals.
I will do my best to keep Abreast of Developments and Maintain
Professional Competency.
I will obey Laws governing the Practice of Pharmacy and will Support
Enforcement of such Laws.
I will maintain the highest standards of moral and ethical conduct.
I take these Laws Voluntarily with the full Realization of the Trust
and Responsibility with which I am Empowered by the Public.
5/24/2023
Ethical Principles and Obligations during
Practicing Pharmacy in Relation to other Stakeholders
49
I. Pharmacist in Relation to his/her patients
‘’Always follow Patient first or Service first Rule’’
Good pharmacy practice and Relationship between the patient
and the Pharmacist has significant Contribution to better
treatment Outcomes.
Obligations
The Pharmacist should:
 Respect the covenantal relationship with the patient
 Be Morally Obliged in response to the trust received from
the Society 5/24/2023
50
 Not Show partiality between the patrons
 Not abuse his/her relationship with the patient for personal gain
 Dedicate him/her self to protect the dignity of the patient
Therefore:
Provide the Service only when needed
Provide the required service to the best of one’s knowledge
Be Compassionate
Be Confidential
Be Impartial
5/24/2023
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II. The pharmacist in Relation to the Public
‘’Always provide quality service’’
Therefore , the Pharmacist should:
 Act at all times in a manner which Promotes and Safeguards
the interest of the Public
 Be Responsible for Providing Appropriate Public Health
Education and Pharmaceutical Services
 Rational drug use
 The profession in general
5/24/2023
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 Maintain Good Personal Qualities:
 Be on duty with Clear Mind
 Be Presentable
 Master good Communication Skills
 Be Knowledgeable
 Provide Accurate and Appropriate Information
 Always Update Yourself
 Offer Services in Premises which Reflect the Professional
Character of Pharmacy
 Clean environment
 Paint/color/lighting
 Controlled substances in a safe
 Price clearly labeled
5/24/2023
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III. Pharmacist in Relation to Fellow Professionals
The pharmacist should extend all support, respect
and cooperation to fellow members of his/her
profession during needs for scientific and technical
information
The pharmacist shall have the responsibility to
expose any act of misconduct or malpractice
committed by fellow professionals.
5/24/2023
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IV. Pharmacist in Relation to other Health Professionals
The pharmacist should:
Respect the Skills and Competencies of other health
care providers and endeavor to work cooperatively
Not recommend a particular Medical Practitioner to
the Patient
Maintain the Confidence and Trust placed in other
Health Professionals by Patients
5/24/2023
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Expose any act of malpractice committed by other
health professionals through the appropriate
channels
Things not to do:
 Not enter into any secret arrangement or
Negotiations with any Health Professional by way
of giving any offer, commission, etc.
 Favorism
 Partiality
5/24/2023
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V. Pharmacists as Active Professional Member
 Actively participate in professional association
VI. The pharmacist in Relation to his/her Job
 Practice the profession after being registered and/or licensed
 Give comprehensive service
 Immediately report any observed unwanted reactions, side
effects, ADRs
 Carry responsibility within his/her professional responsibility
 Maintain professional competence
 Provide current drug information
5/24/2023
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VII. Pharmacists as a Member of the Community
 Be a good citizen!
 Be a person of high principles and integrity
 Be law abiding citizen
 Conform to the positive norms and values of the society
 Actively participate in community services and social
development activities
 Address the needs of special groups society such as under aged,
disabled people. Mentally ill
 Always maintain high standards of professional conduct
5/24/2023
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VIII. Management and utilization of pharmaceuticals
 Manufacture Pharmaceuticals of Good Quality, Safety and
Efficacy
 Do not make available for sale substandard, counterfeit,
deteriorated & mislabeled pharmaceuticals
 Confirm legibility of prescription
 Accept prescription only in written form except in emergency
 Give Advice and Counselling
 Do not fill prescription of drugs written for prescriber his/her
personal use
 Properly procure, distribute and use drugs
5/24/2023
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 Keep records properly
 Not self advertise
 Do not promote products of a particular manufacturer
IX. The pharmacist in relation to his/her trade
 Do not promote unethically
 Promote fair distribution of pharmaceuticals
 Do not put medical samples for sale
 Obtain pharmaceuticals from genuine source
 Have strong moral obligation not to come under commercial
pressure
5/24/2023
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Conflict of Interest
 Conflict of interest is a set of conditions in which professional
judgment concerning a primary interest (research objective)
tends to be unduly influenced by a secondary interest (e.g.
Financial)
 Its Severity rely on
 the likelihood that professional judgment will be influenced
 the Seriousness of the harm likely to result from such
influence.
It could be prevented by
 Educating researchers,
 Supervising research and
 Disclosing the conflict of interest
Example:
A study was carried to see the relationship b/n Homosexuality
and the Spread of HIV/AIDS. The study indicated that there
was no Association between Homosexuality and HIV/AIDS
5/24/2023
61
The Investigators were Homosexuals.
The results may not be reliable as PI could be biased due to
conflict of interest.
Approaches to Solving Ethical Dilemmas:
A. Principalist Approach
• It is the process of resolving a dilemma through an appeal to a
set principles
• It presupposes that in the patient-health professional
relationship, ethical dilemmas are the responsibility of the
health professional. In contrast the patient is assumed to be
largely passive .
5/24/2023
62
Accepted principles
Non-Maleficeince (avoiding unnecessary harm)
Beneficence (do good)
Autonomy (respect the autonomy of the patient)
 Confidentiality (respect the confidential and private
information of the patient)
 Informed Consent (provide adequate and relevant
information about the research)
Justice (treat subjects equally and fairly; respect similarities
and differences between subjects)
5/24/2023
63
B. Disclose Ethics Approach
This is an approach to prevention and resolution of
ethical dilemma through open debate and discussion
between the health professional and the patient
5/24/2023
The health Professional–Patient Relationship
64
The general rule accepted as a fundamental medical ethical
norm, “As to disease, make a habit of two things—to help or, at least,
to do no harm”.
The Patient-Professional Relation
 is the Central focus of Ethical Concerns,
 built on Ethical Confidentiality, Trust and Honesty
 first consider the Welfare of the Patient as the basis of all ethical
judgments
 founded on the three pillars of ethics (beneficence, autonomy and
justice)
The Closeness between the Provider and Patient
 often enriches relationships,
 fosters trust, and
 deepens understanding.
5/24/2023
65
What is Unethical???
 Providing and Seeking Compensation for therapies that have
no Benefit to the patient.
 Not Respecting person and Cultural difference
 Creating Partiality among clients
 Sexual Misconduct on part of the Professional
 the abuse of professional power and violation of the
professional ethical conduct
Therefore, any Sexual Contact or Romantic Relationship b/n
the Heath Care Provider and the Patient is Unethical.
Reading Assignment
Take as many Pharmaceutical Cases as possible
which are considered to exhibit ethical dilemma
and discuss them.
5/24/2023

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  • 2. Introduction 2 Profession Vs Vocation Profession: is a form of employment or a field that is respected in the society ,requires extensive study and mastery of specialization in knowledge. 5/24/2023
  • 3. Intro… 3  Characteristics of Profession:  Specializing in knowledge  Rigorous training and schooling, problem-solving skills  Providing essential services to the society  Deriving force: not fortune (gain) but rather the service they render (ministering)  High degree of self-control of behaviors  Codes, guidelines, oaths, commitment statements, etc  Mutual trust b/n professionals and the patron b/c there is information asymmetry b/n the provider and the receiver  Social Sanction professionals given exclusive right to practice the profession  Professionals form an association  Ever changing/growing field of study 5/24/2023
  • 4. Intro… 4 Is pharmacy a true profession????? Yes!! Why? Because it assists the public and individuals make the best usage of medications and fulfils the above basic feature of a profession. 5/24/2023
  • 5. Intro… 5 Professional Ethics • Ethics is a science of moral value. • A set of principles of right conduct • The science of human duty • The basic foundation of ethical behavior is the basic perception that “DO GOOD & AVOID EVIL” • Ethics and law are related in that both share the social purpose: ENCOURAGE THE RIGHT CONDUCT 5/24/2023
  • 6. Ethical Theories 6 Two General Thoughts: A. Consequentialism (Teleological)  Looks at the consequences of acts  The acts are right to the extent that they produce good consequences  The result that matters most  Morality of an action consists of the ratio of good to evil that the action produces 5/24/2023
  • 7. 7 B. Deontological or ‘duty-based’ ethics  Root word: ‘deon’ from the Greek word meaning, roughly, ‘one must’;  Deontological ethics are especially concerned with rules, duties and obligations  Rightness and wrongness are inherent in the act itself independent of the consequences  The process matters more than the result/End  The concern is which course of action, will do the most good overall. 5/24/2023
  • 8. 8 Three features of Deontological Ethical theories: 1) Deontological ethical theories are Non-Consequentialist  Consequentialists will argue that whether an action is right or wrong depends upon the consequences of this action.  Where as deontologists argue that it is not necessarily the case that an action’s rightness or wrongness depends upon the consequences 2. Deontological ethical theories claim morality and ethics are to be understood as systems of rules meant to govern and guide conduct Moral rules take the form of commands or imperatives; Three different kinds of rules are relevant. 5/24/2023
  • 9. 9  Rules that make an action (morally) forbid Rules that make an action (morally) obligatory Rules that make an action (morally) permissible 3) Deontological Ethical theories are agent-relative as opposed to agent-neutral;  According to deontological ethical theories, at least sometimes, a moral rule must refer to a particular agent.  For example, I presumably have a duty to take care of my family but it is not so clear you have a duty to take care of my family or that I have a duty to take care of yours. 5/24/2023
  • 10. Basic Principles of Bioethics 10 Bioethics Is the study of typically Controversial Ethics brought about by advances in Biology and Medicine. All Ethical issues arise from the Three Pillars of Ethics 1. Respect for person 2. Beneficence/ Non‐Maleficience 3. Justice  They are considered universal regardless of geographic, economic, legal and political boundaries.  Researchers are Obliged to assure that these principles are followed while Conducting Research Involving Human Participants. 5/24/2023
  • 11. 1. Respect for persons 11  Respect for persons addresses two main ethical considerations. a) respect for autonomy, and b) protection of persons with diminished or impaired autonomy.  To Respect autonomy is, therefore, to give weight to the considered opinions and choices of the individual, while refraining from obstructing his/her actions.  Not every individual is, however, Capable of decision-making due to o Lack of maturity (as in the case of children), o Mental disability, or o Circumstances that severely restrict liberty (as in the case of prisoners),  Prisoners may have the right to Volunteer for Research, but on the other hand, they may be subtly Coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. 5/24/2023
  • 12. 12  According to this principle, the study participants have the right to be well informed and give consent.  This process is termed to be Informed Consent. The Roles of Informed Consent are:  to respect individual rights  to establish participatory research Types of Informed Consent a. Written: obtained for epidemiological research as much as possible. But for clinical research, written consent is a must. b. Verbal: Verbal consent may be opted where people are reluctant to put their signature on official document. This, however, cannot be an excuse for clinical studies. 5/24/2023
  • 13. 13 The informed consent process  Informed consent can best be described as participants' bill of rights. These Rights Demand three things: i. Research subjects are told every thing about the study, including risks. ii. The information must be easy to understand. iii. Research subjects who agree to participate must do so Voluntarily, they must not be Pressurized or swayed into it. The process of informed consent includes: Whom to inform  Research Participant  Spouse: because of the nature of research which might affect the family.  Community:  Government: If the government has to give permission for the research to be conducted. 5/24/2023
  • 14. 14 Who to give Consent  Research participant  Spouse  Community  Government How the information is to be Communicated  In a language which the research participant easily understands  Using visual aids whenever applicable to ease understanding and discussion 5/24/2023
  • 15. 15 When to get consent  Enough time has to be allocated for the research participant prior to seeking his or her consent to participate for the following reasons  To get enough time to think about the cons and pros of participation  To allow him or her enough time to seek advice from family, relatives, friends, colleagues acquaintances Who to administer the process  Investigators  Trained employees for the research 5/24/2023
  • 16. 16 Informed Consent Form  Therefore, an informed consent form is a signed contract between a principal investigator and a research participant in the presence or absence of witnesses.  It is legally binding if the research participant claims that his or her right is not protected according to the contract. 5/24/2023
  • 17. Elements of an informed consent form 17 Considering the concerns of the study participant, the informed consent form should have the following information: Purpose of the study: The reason to carry out the study has to be clearly indicated Selection criteria: The reason for the selection of the participant for the study has to be made clear Procedures of the protocol: The procedure which the investigators would like to follow has to be described to the research participant. 5/24/2023
  • 18. 18 Such information includes:  Duration of study: How long will the study last? The research participant is not expected to continue participation in the research for an indefinite period of time  Justification for use of placebo: If the study uses a placebo, strong scientific and ethical justification has to be given  Assignment of placebo and treatment groups: Randomization to groups has to be mentioned clearly in the form. 5/24/2023
  • 19. 19 Possible Risks or Discomforts during the study:  These should be described transparently.  Even if the risks are Minimal, they have to be known to the Research Participant. Benefits:  The type of benefit which the research participant is going to get should explicitly be described in the form.  The benefits should not be so large as to induce the participant to participate in the study purely for the anticipated benefit, and not because he or she is convinced to do it. 5/24/2023
  • 20. 20 Confidentiality: The informed consent should assure that confidentiality will be maintained to protect participants from possible harm at the revelation of such information. The following information is important as far as confidentiality is Concerned:  The Mechanism should be sound enough to maintain confidentiality like using Codes and locking them in Cabinets.  By whom the information may be accessed has to be clearly indicated i.e use of data for unstated purpose other that is Unethical.  Measures to be taken to avoid stigmatization should also be mentioned. 5/24/2023
  • 21. 21 Voluntary participation: Is to ensure the principle “Respect for Persons”. The following should be noted as far as Voluntary Participation is concerned:  The right to decide whether to participate in the research should be respected.  The right to Withdraw after involvement in the research should be respected.  The right to Refuse to answer any question needs to be acknowledged. Contact addresses: need to be provided. Signatures: RP, PI and witness whenever applicable. 5/24/2023
  • 22. 22 Therefore, the Valid Informed Consent should be given voluntarily. free from coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another to obtain compliance. Undue influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward to obtain compliance. For instance, Undue influence could be manifested in the following ways.  Unjustifiable pressures abusing positions of authority &  Manipulating a person’s choice through the controlling influence of a close relative and  Threatening to withdraw health services to which an individual would otherwise be entitled. 5/24/2023
  • 23. ANNEX IV: SAMPLE INFORMED CONSENT FORM Hello, my name is [*]. I work for [*]. We are conducting a survey in [study location] to learn about women’s health and life experiences. You have been chosen by chance (as in a lottery/raffle) to participate in the study. I want to assure you that all of your answers will be kept strictly secret. I will not keep a record of your name or address. You have the right to stop the interview at 45 any time, or to skip any questions that you don’t want to answer. There are no right or wrong answers. Some of the topics may be difficult to discuss, but many women have found it useful to have the opportunity to talk. Your participation is completely voluntary but your experiences could be very helpful to other women in [country]. Do you have any questions? (The interview takes approximately [*] minutes to complete). Do you agree to be interviewed? NOTE WHETHER RESPONDENT AGREES TO INTERVIEW. [] DOES NOT AGREE TO BE INTERVIEWED THANK PARTICIPANT FOR HER TIME AND END INTERACTION. [] AGREES TO BE INTERVIEWED. Is now a good time to talk? It’s very important that we talk in private. Is this a good place to hold the interview, or is there somewhere else that you would like to go? TO BE COMPLETED BY INTERVIEWER I CERTIFY THAT I HAVE READ THE ABOVE CONSENT PROCEDURE TO THE PARTICIPANT. SIGNED: 11 Used in the WHO Multi-country Study on Women’s Health and Domestic Violence Against Women (Ellsberg & Heise, 2005). 45 45 23 5/24/2023
  • 24. 2. Beneficence/ Non-Maleficence 24 Beneficence—the provision of benefits—and Non-maleficence— the avoidance of doing harm.  refer to protection of study participants from harm and making efforts to secure their well-being. Two general rules have been formulated as Complementary expressions of beneficence: a) Do not harm: extended from Hippocratic oath that stated “do no harm”, and b) Maximize possible benefits and Minimize possible harms.  The rules of beneficence affect both individual investigators and the community.  Beneficence has two components: Benefits and Risks 5/24/2023
  • 25. 25 2.1. Benefits A researcher`s aim should always be to benefit humanity . And humanity is each and everyone of us. When one discusses the benefits given to research participants, the following need to be considered:  Beneficiaries Research participants Community Country  Forms of Benefits  Monetary, i.e., Financial  Health care  Capacity Building: Research facility and Manpower Development 5/24/2023
  • 26. 26  Magnitude of Benefits  Compensation, i.e., to compensate the time spent, the expenses for the meal and transport  Undue Inducement, i.e., to provide benefits for participation more than they earn and more than they deserve. This might coerce participants to participate in the research because of the big benefits they are going to get. The level of payment should not be tied to the level of risk. Duration of Benefits  Short term, i.e., only for the study period  Long term. i.e., extends beyond the study period 5/24/2023
  • 27. 27 2.2. Risks The following points need to be noted with regard to risks:  To Whom  Research Participant: Is the risk limited only to the research participant?  Community: Does the risk extend to the Community?  Types  Physical: any damage to any of the organs, e.g., handicapped  Social: resentment by the society, e.g., stigma  Psychological: a feeling of discomfort, e.g., Stress  Economic: loss of earning Capacity, e.g., loosing job because of getting involved in a research which the employer does not like. 5/24/2023
  • 28. 28  Magnitude: the degree of Severity of the risk, i.e., Mild, Moderate or Severe.  Duration: How long the risk lasts, i.e., the risk may be  For the period of the study only  Extended further after the study is Completed 5/24/2023
  • 29. 3. Justice 29  The Underlying Principle of justice is to treat each person in accordance with what is Morally right and Proper.  Refer to Fair and Equitable distribution of both the Burdens and Benefits of participation in research.  Such formulations include: to each person i. an equal share ii. according to individual need iii. according to individual effort iv. according to societal contribution v. according to merit Distributive justice Concerns the fair, just or equitable distribution of benefits and burdens. 5/24/2023
  • 30. Summary 30 Respect for Persons/Autonomy Acknowledge a person’s right to make choices, to hold views, and to take actions based on personal values and beliefs Justice Treat others equitably, distribute benefits/burdens fairly. Non-Maleficence (do not Harm) Obligation not to inflict harm intentionally; In medical ethics, the physician’s guiding maxim is “First, do no harm.” Beneficence (Do Good) Provide benefits to persons and contribute to their welfare. Refers to an action done for the benefit of others. 5/24/2023
  • 31. Assignment 5/24/2023 31 Read about Application of Ethical principles to Operational Research Sources  Journal of Empirical Research on Human Research Ethics  Ethics and Human Research Journal
  • 32. Rationing and Priority Setting 32  Given the Limitations on Healthcare Resources, there is increased interest in assessing the value for money, or Economic efficiency, of Healthcare Treatments and Programs.  This is achieved through Economic Evaluation, where the costs and consequences of alternative treatment strategies are compared.  Priority Setting in Health care involves a process of choice among alternative health care programs and services  If undertaken in a Systematic and explicit way, it is a process that ranks the alternatives in accordance with normative/standardized and technical rules. 5/24/2023
  • 33. 33  Priority setting is in effect a way of allocating scarce resources, and so is a form of Rationing.  In recent years, Priority Setting has received an increasing amount of attention in many Countries, owing to the growing realization that traditional rationing practices, which have been implicit or hidden, are inadequate to solve the resource allocation problem.  In economics, Rationing refers to Distribution under conditions where a supply that is limited by considerations of cost confronts a demand that is not constrained by considerations of price.  Rationing is a way of distributing scarce goods when there is no market to perform the task.  Priority Setting makes a Relative Ranking of Goods. 5/24/2023
  • 34. Assisted Suicide 34  A Suicide is an Intentional, Self-caused/ Inflicted Death.  Assisted Suicide, a person’s Voluntary Suicide with help from another individual.  The term assisted suicide may also refer to the act of providing an individual with the means to commit Suicide.  If a Doctor provides Medications or other means of Committing Suicide, this action is referred to as Physician-assisted Suicide. 5/24/2023
  • 35. Euthanasia 35  Euthanasia, practice of Mercifully Ending a Person’s Life in order to release the person from an incurable disease, intolerable Suffering, or Undignified Death.  The word euthanasia derives from the Greek for “good death” and originally referred to Intentional Mercy Killing.  The term euthanasia refer to  assistance of the person to terminate life  lack of action to prevent death. 5/24/2023
  • 36. 36  It could be performed Voluntarily & In-Voluntarily.  In Voluntary euthanasia,  a person asks to die (by either active or passive euthanasia).  Non-Voluntary euthanasia  refers to ending the life of a person who is not mentally competent to make an informed request to die, such as a comatose patient.  Active euthanasia involves painlessly putting individuals to death for Merciful Reasons,  Eg. a doctor administers a lethal dose of medication to a patient.  Death is Caused by an act of Commission and is a Case of Killing a person. 5/24/2023
  • 37. 37  Passive euthanasia involves not doing something to prevent death, as when doctors refrain from using an artificial respirator to keep alive a terminally ill patient.  When a person is allowed to die, death is a result of an act of Omission, the omission is an instance of Passive euthanasia.  In both cases, the motive is the person’s own good. Question: Does the difference between passive and active euthanasia, which reduces to a difference in how death comes about, make any moral difference? 5/24/2023
  • 38. 38 To My Family, My Physician, My Clergyman, and My Lawyer: If the time Comes when I can no longer take part in Decsions about my own future, let this statement stand as testament of my wishes: If there is no reasonable expectation of my recovery from physical or mental disability, I, ________, request that I be allowed to die and not be kept alive by artificial means or heroic measures. Death is as much a reality as birth, growth, maturity, and old age—it is the one certainty. I do not fear death as much as I fear the indignity of deterioration, dependence, and hopeless pain. I ask that drugs be mercifully administered to me for the terminal suffering even if they hasten the moment of death. This request is made after careful consideration. Although this document is not legally binding, you who care for me will, I hope, feel morally bound to follow its mandate. I recognize that it places a heavy burden of responsibility upon you, and it is with the intention of sharing that responsibility and of mitigating any feelings of guilt that this statement is made. Signed: ______________________________ Date: _______________________________ Witnessed by: ____________________________________ ____________________________________ 5/24/2023
  • 39. Ethics and Professionalism 39 Systematic Construction of Ethical framework for western Civilization was begun 2000 years ago by Socrates. His principle was formulated as: “ Ethics is a science and can be governed by principles of universal validity: “so that what is good for one was good for all and what was my neighbor's duty was my duty too.” No Set of Ethical Principles, no matter how carefully thought or well constructed can provide the individual professional with guidance for each decision. 5/24/2023
  • 40. 40 Separate analysis of possible outcomes from different actions and weighing of right and wrong is important. Being pharmacy , Professional Ethics: Principles that form the fundamental basis of the Roles and Responsibilities of pharmacists The pharmacist is the one who is supposed to resolve the ever- increasing Ethical dilemmas in Medicine including Patients, Family Members, Physicians, Nurses, Hospital Administrators and Policy Makers. 5/24/2023
  • 41. Professional characteristics of pharmacists 41 A. Possession of specialized body of knowledge: Enables the practitioner to perform highly useful Social function for: • Advising patients and prescribers • Detecting potential drug-drug interactions • Selecting proper products and product Sources • Exercising professional judgment B. Sets of specific attitudes that influence professional behavior manifested by Altruism: an Unselfish Concern for the welfare of others. 5/24/2023
  • 42. 42  The decision he/she makes in the course of the career is based on his/her sense of what is right and not on estimation of what is profitable. C. Social Sanction: whether the society views it as a measure of social sanction; granting of exclusive right of practice through the licensing power of the country. Licensing: Protects the Public from Incompetent Practitioners and Creates a relationship of trust between the Society and Professional. 5/24/2023
  • 43. Code of Ethics 43 These are Rules of Conduct based on Moral Values, which are stated by a recognized association. Pharmacists are Health professionals who assist individuals in making the best use of Medications. The pharmacy Code of Ethics is intended to state the principles that form the fundamental basis of the Roles and Responsibilities of pharmacists based on moral obligations and virtues established to guide pharmacists with Patients, Health Professionals and Society. 5/24/2023
  • 44. 44 Why code of ethics?  To define accepted/unacceptable behaviors  To promote high Standards of practice  To provide a benchmark for members to use for self evaluation  A framework for Behavior and Responsibilities  As a Vehicle for Occupational identity  As a mark of Professional Maturity 5/24/2023
  • 45. Basic Code of Ethics for Pharmacists by FIP and EPA in Ethiopia 45 1. A pharmacist respects the Covenantal Relationship between the Patient and the pharmacist  Moral Obligation in response to gift of trust from the Society. 2. 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.  Protect the Dignity of the Patient. 5/24/2023
  • 46. 46 3. A pharmacist respects the autonomy and dignity of each patient.  A pharmacist respects personal and cultural differences among patients. 4. A pharmacist acts with honesty and integrity in professional relationship.  Has a duty to tell the truth and to act with conviction of conscience. 5. A pharmacist maintains professional competence as new medications, devices, technological advances and health information are being increasing. 5/24/2023
  • 47. 47 6. A pharmacist respects the values and abilities of colleagues and other health care professionals. 7. A pharmacist serves individuals, community and societal needs. 8. A pharmacist seeks justice in the distribution of health care resources  Fair and equitable health resource distribution balancing needs of patients and the society. 5/24/2023
  • 48. Oath of a Pharmacist 48 I vow to Devote my Professional life to the Service of Mankind through the Profession of pharmacy. I will Consider the Welfare of Humanity and Relief of Human Suffering my Primary Concerns. I will use my Knowledge and Skills to the best of my Ability in Serving the Public and other Health Professionals. I will do my best to keep Abreast of Developments and Maintain Professional Competency. I will obey Laws governing the Practice of Pharmacy and will Support Enforcement of such Laws. I will maintain the highest standards of moral and ethical conduct. I take these Laws Voluntarily with the full Realization of the Trust and Responsibility with which I am Empowered by the Public. 5/24/2023
  • 49. Ethical Principles and Obligations during Practicing Pharmacy in Relation to other Stakeholders 49 I. Pharmacist in Relation to his/her patients ‘’Always follow Patient first or Service first Rule’’ Good pharmacy practice and Relationship between the patient and the Pharmacist has significant Contribution to better treatment Outcomes. Obligations The Pharmacist should:  Respect the covenantal relationship with the patient  Be Morally Obliged in response to the trust received from the Society 5/24/2023
  • 50. 50  Not Show partiality between the patrons  Not abuse his/her relationship with the patient for personal gain  Dedicate him/her self to protect the dignity of the patient Therefore: Provide the Service only when needed Provide the required service to the best of one’s knowledge Be Compassionate Be Confidential Be Impartial 5/24/2023
  • 51. 51 II. The pharmacist in Relation to the Public ‘’Always provide quality service’’ Therefore , the Pharmacist should:  Act at all times in a manner which Promotes and Safeguards the interest of the Public  Be Responsible for Providing Appropriate Public Health Education and Pharmaceutical Services  Rational drug use  The profession in general 5/24/2023
  • 52. 52  Maintain Good Personal Qualities:  Be on duty with Clear Mind  Be Presentable  Master good Communication Skills  Be Knowledgeable  Provide Accurate and Appropriate Information  Always Update Yourself  Offer Services in Premises which Reflect the Professional Character of Pharmacy  Clean environment  Paint/color/lighting  Controlled substances in a safe  Price clearly labeled 5/24/2023
  • 53. 53 III. Pharmacist in Relation to Fellow Professionals The pharmacist should extend all support, respect and cooperation to fellow members of his/her profession during needs for scientific and technical information The pharmacist shall have the responsibility to expose any act of misconduct or malpractice committed by fellow professionals. 5/24/2023
  • 54. 54 IV. Pharmacist in Relation to other Health Professionals The pharmacist should: Respect the Skills and Competencies of other health care providers and endeavor to work cooperatively Not recommend a particular Medical Practitioner to the Patient Maintain the Confidence and Trust placed in other Health Professionals by Patients 5/24/2023
  • 55. 55 Expose any act of malpractice committed by other health professionals through the appropriate channels Things not to do:  Not enter into any secret arrangement or Negotiations with any Health Professional by way of giving any offer, commission, etc.  Favorism  Partiality 5/24/2023
  • 56. 56 V. Pharmacists as Active Professional Member  Actively participate in professional association VI. The pharmacist in Relation to his/her Job  Practice the profession after being registered and/or licensed  Give comprehensive service  Immediately report any observed unwanted reactions, side effects, ADRs  Carry responsibility within his/her professional responsibility  Maintain professional competence  Provide current drug information 5/24/2023
  • 57. 57 VII. Pharmacists as a Member of the Community  Be a good citizen!  Be a person of high principles and integrity  Be law abiding citizen  Conform to the positive norms and values of the society  Actively participate in community services and social development activities  Address the needs of special groups society such as under aged, disabled people. Mentally ill  Always maintain high standards of professional conduct 5/24/2023
  • 58. 58 VIII. Management and utilization of pharmaceuticals  Manufacture Pharmaceuticals of Good Quality, Safety and Efficacy  Do not make available for sale substandard, counterfeit, deteriorated & mislabeled pharmaceuticals  Confirm legibility of prescription  Accept prescription only in written form except in emergency  Give Advice and Counselling  Do not fill prescription of drugs written for prescriber his/her personal use  Properly procure, distribute and use drugs 5/24/2023
  • 59. 59  Keep records properly  Not self advertise  Do not promote products of a particular manufacturer IX. The pharmacist in relation to his/her trade  Do not promote unethically  Promote fair distribution of pharmaceuticals  Do not put medical samples for sale  Obtain pharmaceuticals from genuine source  Have strong moral obligation not to come under commercial pressure 5/24/2023
  • 60. 60 Conflict of Interest  Conflict of interest is a set of conditions in which professional judgment concerning a primary interest (research objective) tends to be unduly influenced by a secondary interest (e.g. Financial)  Its Severity rely on  the likelihood that professional judgment will be influenced  the Seriousness of the harm likely to result from such influence. It could be prevented by  Educating researchers,  Supervising research and  Disclosing the conflict of interest Example: A study was carried to see the relationship b/n Homosexuality and the Spread of HIV/AIDS. The study indicated that there was no Association between Homosexuality and HIV/AIDS 5/24/2023
  • 61. 61 The Investigators were Homosexuals. The results may not be reliable as PI could be biased due to conflict of interest. Approaches to Solving Ethical Dilemmas: A. Principalist Approach • It is the process of resolving a dilemma through an appeal to a set principles • It presupposes that in the patient-health professional relationship, ethical dilemmas are the responsibility of the health professional. In contrast the patient is assumed to be largely passive . 5/24/2023
  • 62. 62 Accepted principles Non-Maleficeince (avoiding unnecessary harm) Beneficence (do good) Autonomy (respect the autonomy of the patient)  Confidentiality (respect the confidential and private information of the patient)  Informed Consent (provide adequate and relevant information about the research) Justice (treat subjects equally and fairly; respect similarities and differences between subjects) 5/24/2023
  • 63. 63 B. Disclose Ethics Approach This is an approach to prevention and resolution of ethical dilemma through open debate and discussion between the health professional and the patient 5/24/2023
  • 64. The health Professional–Patient Relationship 64 The general rule accepted as a fundamental medical ethical norm, “As to disease, make a habit of two things—to help or, at least, to do no harm”. The Patient-Professional Relation  is the Central focus of Ethical Concerns,  built on Ethical Confidentiality, Trust and Honesty  first consider the Welfare of the Patient as the basis of all ethical judgments  founded on the three pillars of ethics (beneficence, autonomy and justice) The Closeness between the Provider and Patient  often enriches relationships,  fosters trust, and  deepens understanding. 5/24/2023
  • 65. 65 What is Unethical???  Providing and Seeking Compensation for therapies that have no Benefit to the patient.  Not Respecting person and Cultural difference  Creating Partiality among clients  Sexual Misconduct on part of the Professional  the abuse of professional power and violation of the professional ethical conduct Therefore, any Sexual Contact or Romantic Relationship b/n the Heath Care Provider and the Patient is Unethical. Reading Assignment Take as many Pharmaceutical Cases as possible which are considered to exhibit ethical dilemma and discuss them. 5/24/2023