This document provides an overview of an introductory pharmacy law and ethics course at the University of Gondar in Ethiopia. The course is offered in the 2019/2020 academic year to 4th year Bpharm students. It is worth 2 credit hours and covers topics like definitions of ethics, ethical theories, principles and rules, ethical issues in healthcare, and codes of ethics for pharmacists. The course is divided into two parts - Part I focuses on ethics and Part II will cover pharmacy law.

1. Introduction to Pharmacy Law & Ethics
(Phar 4173)
Instructor’s Name: Berhanemeskel W/Gerima
Email: aberhaneth@gmail.com
Cell Phone: +251912024213
Academic Year: 2019/2020 Semester: II
Category and Year of Study: Bpharm. 4th Year Reg.
Credit Hours: 2 EtCTS: 3 Course Hours: 81hours
Department of Pharmaceutics
School of Pharmacy
College of Medicine and Health Sciences
University of Gondar
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2. Part I. Ethics
1. Introduction to ethics?
1.1. Definition of Ethics
1.2. Ethical Theories
1.3. Ethical Principles and Moral Rules
2. Ethical Issues in Health Care
3. Framework for Ethical Analysis
4. Professional Ethics
5. Ethical Codes
5.1. Background
5.2. FIP Standards of Ethical Practices
5.3. Code of Ethics for Pharmacists Practicing in Ethiopia
6. The Health Professional–Patient Relationship
7. Standards of Practice for Pharmacists Practicing in Ethiopia
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3. Part I. Ethics
1. Introduction to Ethics?
1.1. Definition of Ethics
1.2. Ethical Theories
1.3. Ethical Principles and Moral Rules
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4. 4
1. Introduction to Ethics

5. 1.1. Definitions
Ethics
• Ethics is a science of morals, moral philosophy.
• Ethical rules are only morally binding.
– It is simply voluntary self-discipline of professionals.
– ‘Do Good and Avoid Evil’
• Ethics is the system or code of morals of a particular person, religion, group,
profession, etc.
• Ethics is a generic term for various ways of understanding and examining the
moral life
• Ethics requires us to go beyond ‘I’ and ‘you’
– To the universal law,
– To the universal sable judgment,
– To the standpoint of the impartial spectator or ideal observer, or whatever we choose to call it
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6. 1. Introduction to ethics
Morality
• Morality is usually construed as meaning what is right and wrong.
‘The term morality refers to social conventions about right and wrong
human conduct that are so widely shared that they form a stable
(although usually incomplete) communal consensus, whereas ethics is
a general term referring to both morality and ethical theory’
• Nevertheless, the words ‘ethics’ and ‘morality’ are often used
interchangeably.
Law
• Law – the rules of conduct established and enforced by the
authority, legislation or custom of a given community, state or
other group.
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7. 1. Introduction to ethics
Ethics Informs the Law
• Our laws reflect our ethical choices and priorities.
• Not all ethical choices are embodied in the law.
• Unless an ethical choice is imposed by one person or group upon another person or
group,
– it is simply a matter of personal ethics.
Morals Versus Ethics in the Workplace
• The pharmacist has a clear responsibility to the patient on many levels
• Ethics are morals in the workplace and in the public domain
• Work ethics will guide your behavior
• Working within pharmacy guidelines will ensure that patients are getting the best
service possible
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8. 1.2. Ethical Theories
• Different ethical theories exist and theories can be applied to different
situations
– To inform our thinking and
– To Support decision making
• Ethical theories act as key tools in developing
– All ethical principals and frameworks
• Key ethical theories applicable to healthcare are
1. Consequentialism
2. Deontology
3. Virtue Ethics
4. Principlism
5. Casuistry
• Examples of each ethical theories in healthcare are seen in
– Codes of conduct and
– Guidance developed by professional regulators.
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9. 1.2. Ethical theories
1. Consequentialism or Teleological
• Can be simply defined as 'the ends always justify the means'
• Acts are considered right or wrong based on how good or bad the
outcomes of those acts are.
• Consequentialist ethics holds the view that the correct moral response is
related to the outcome, or consequence, of the act.
Consider a simple example:
A mother would like to her daughter to focus on her homework. To ensure this, the mother
tells her daughter that the television show her daughter watches daily will not be aired
tonight. However, this is not the truth. The daughter focuses on her homework instead of
watching television, and completes her schoolwork as a result.
• According to the theory of consequentialism
– It was right for the mother to be dishonest,
– Since the outcome was a good one.
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10. 1.2. Ethical theories
2. Deontology
• The theory of deontology is summarized as follows: 'the ends never justify the means.'
• Acts are considered right or wrong intrinsically, regardless of the outcomes.
• Considering the example given above of the mother and daughter, the mother would have committed
a wrong act according to the theory of deontology.
– This is because the mother lied to her daughter, and lying is considered unethical regardless of the
outcome it may lead to.
• Deontological views are quite prominent in many religions and circles of belief.
• The Ten Commandments are a quintessential example of a deontological viewpoint.
– The commandments of 'thou shalt not lie' and 'thou shalt not kill' are considered right in every
situation, without concern for the outcome.
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11. 2. Deontology cont’d
• Deontology is based on duties and rights, and respects individuals as ends in
themselves.
• It places value on
– the intentions of the individual (rather than the outcomes of any action) and
– focuses on rules, obligations and duties.
• Deontology requires
– absolute adherence to these obligations and
– acting from duty is viewed as acting ethically.
• One of the key criticisms in healthcare is that applying a strictly deontological
approach to healthcare can lead to
– conflicts of interest between equally entitled individuals which can be difficult or
even seemingly impossible to resolve.
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12. 3. Virtue Ethics
• Virtue ethics also sometimes called "character ethics“
• It emphasizes the moral character, or virtues of the individual.
• It ignores the roles that consequences, duties, and social contracts play
in moral systems
– in determining the appropriate standard for evaluating moral behavior.
• Virtue ethics focuses on criteria
– having to do with the character development of individuals and
– their acquisition of good character traits from the kinds of habits they develop.
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13. 4. Principlism or Ethical Principals
• It is a commonly used ethical approach in healthcare.
• It emphasizes four key ethical principles (Autonomy, Beneficence, Non-
maleficence, and Justice)
– which most ethical theories share and
– blends these with virtues and practical wisdom.
• This is an attempt to bring together the best elements of ethical theories
which are compatible with most
– Societal
– Individual or
– Religious belief systems.
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14. 5. Casuistry
• Casuistry, or case based reasoning, does not focus on rules and
theories but rather on practical decision-making in particular cases
based on precedent.
– So first the particular features of a case would be identified, and then
• a comparison would be made with other similar cases and prior experiences,
• attempting to determine not only the similarities but also the differences.
– So if a clinical ethics committee were asked to consider whether it was
ethical for a clinician to breach his / her duty of confidence,
• the committee would identify key factors, like the health risks to others if information
was not disclosed.
– It would then make a comparison with other similar cases, identifying the relative
risks of non-disclosure.
• Casuistry should not be divorced from consequentialism, deontology, or
virtue ethics but complement them.
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15. 1.3. Ethical Principles and Moral Rules
• There are 4 key ethical principles supplemented by 4 rules which stem from
the ethical theories of Consequentialism and Deontology.
• 4 Key Ethical Principles are:
– Autonomy
– Justice
– Beneficence
– Non-maleficence
• 4 Ethical Rules are:
– Informed consent
– Confidentiality
– Fidelity
– Privacy
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16. Autonomy
• The principle of autonomy stems from the theory of deontology.
• Autonomy views the rights of an individual to self-determination.
– This is rooted in society's respect for individuals' ability to make informed decisions about
personal matters.
• Autonomy has become more important
– as social values have shifted to define medical quality in terms of outcomes that are
important to the patient rather than medical professionals.
• The increasing importance of autonomy can be seen as
– A social reaction to a "paternalistic" tradition within healthcare.
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17. Autonomy Cont’d
• Concerned with individuality and a person's unique wishes and
values.
– Respecting a person's right to be involved in their own health care is
embedded in the principle of autonomy.
• Includes:
– Respect a person’s right to make their own decisions
– Teach people to be able to make their own choices
– Support people in their individual choices
– Do not force or coerce people to do things
– ‘Informed Consent’ is an important outcome of this principle
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18. Justice
• Justice is often considered to be synonymous with fairness.
• Refers to the healthcare professional’s obligation to respect and honor the intrinsic
worth and dignity of every patient as a human being and to treat all patients fairly
and equitably.
• Justice concerns
– the distribution of scarce health resources, and
– the decision of who gets what treatment (fairness and equality).
There are 3 forms of justice considered in medial ethics:
1. Distributive justice - distribution of scarce resources in a fair manner
2. Rights based justice - respect for a person's rights
3. Legal justice - respect for laws that are morally acceptable
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19. Justice Cont’d
• Justice in ethics includes:
– Treating people fairly
– Not favouring some individuals/groups over others
– Acting in a non–discriminatory / non-prejudicial way
– Respect for peoples rights
– Respect for the law
• To ensure that you are considering the principle of justice when faced with
an ethical dilemma,
– Ask yourself the following question:
"Is the patient being treated fairly, and are his/her needs
able to be satisfied?".
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20. Beneficence (to do good)
• Refers to the healthcare professional’s obligation to actively and positively serve
and benefit the patient and society.
• Beneficence stresses the importance of acting in the patient's best interest.
• Maximizing benefit for the patient is essential to the principle of beneficence.
Includes:
– Our actions must aim to ‘benefit’ people – health, welfare, comfort, well-being, improve a
person’s potential, improve quality of life
– ‘Benefit’ should be defined by the person themselves. It’s not what we think that is
important.
– Act on behalf of ‘vulnerable’ people to protect their rights
– Prevent harm
– Create a safe and supportive environment
– Help people in crises
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21. Non – maleficence (to do no harm)
• Refers to the healthcare professional’s obligation to protect their patients and
society from harm.
• Non-maleficence is considered synonymous with the belief "above all, do no
harm".
• This is the oldest of all principles, and derives from the Hippocratic oath.
• This principle is nearly impossible to achieve in any given form of medical
therapy,
– since all therapeutic and pharmacological options are associated with side effects.
– There are risks associated with almost every form of therapy
• from an adverse drug reaction as seemingly trivial as diarrhea, to something more serious such as
drug-induced ototoxicity
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22. Non – maleficence Cont’d
Includes:
– not to inflict harm on people
– do not cause pain or suffering
– do not incapacitate
– do not cause offence
– do not deprive people
– do not kill
• So how do we rectify the conflict between the principles of beneficence and non-
maleficence? We balance the benefits and harm.
• Ask yourselves the question:
"What can be done for the patient and what are the benefits and harms?"
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23. Informed consent
• It is the agreement by a person to a procedure or intervention
• Informed consent in ethics usually refers to the idea that a person must be fully
informed about and understand the potential benefits and risks of their choice of
treatment.
o An uninformed person is at risk of mistakenly making a choice not reflective of his or
her values or wishes.
• The concept of informed consent has increased in importance
o since the historical events of the Doctors' Trial of the Nuremberg trials and Tuskegee
syphilis experiment.
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24. Informed consent Cont’d
• The value of informed consent is closely related to the values of
• Autonomy and
• Truth telling or veracity
• Form of consent (implied or explicit)
• Legal: Intention, Voluntariness, Competence
• Autonomy: Understanding, Freedom from coercion, Capacity
• Treatment without consent could lead to charge of battery (criminal or civil law)
or negligence (civil law)
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25. Informed consent Cont’d
• It does not specifically mean the process of obtaining consent, or the
specific legal requirements, which vary from place to place, for
capacity to consent.
• Patients can elect to make their own medical decisions, or
• can delegate decision-making authority to another party.
• If the patient is incapacitated laws around the world designate
different processes for obtaining informed consent, typically by
• having a person appointed by the patient or
• their next of kin make decisions for them.
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26. Informed consent Cont’d
To have capacity to consent, patient must be able to
• Understand in simple language what the medical treatment is, its purpose
and why it is being proposed
• Understand its principal benefits, risks and alternatives
• Understand in broad terms what will be the consequences of not receiving
the proposed treatment
• Retain the information for long enough to use it and weigh it in the balance in
order to arrive at a decision
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27. Informed consent Cont’d
Who is ‘competent’ (has capacity to consent)?
• People over 16 presumed to be competent
– unless there is evidence to the contrary
• Under 16s are only considered competent if they have
– sufficient intelligence and
– understanding to understand fully what is proposed
• Parent can consent on behalf of anyone under 18 who lacks capacity
• If someone over 18 lacks competence, no one can consent on their behalf -
decision to be made by medical team ‘in the best interests of the patient’;
consulting relatives considered good practice to help medical team make
decision
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28. Confidentiality
• Only sharing private information on a ‘need to know basis’
• Confidentiality is an important issue in primary care ethics,
• where physicians care for many patients from the same family and community, and
• where third parties often request information from the considerable medical database
typically gathered in primary health care.
• All personal info given to a health professional must be treated confidentially
except in particular circumstances
– This includes friends and relatives
• Duty of confidentiality continues after death
• Most breaches of confidentiality are inadvertent
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29. Confidentiality Cont.
Underlying ethical principals for Confidentiality:
• Non-maleficence: damage to relationship, career etc
• Autonomy: the right of the patient to determine want information is passed on
and to whom
• Societal Justice: where serious harm may be prevented by disclosure without
consent
Exceptions to Confidentiality
• Patient’s consent
• Need to know
• Statutory duty
• Instruction from Judge (in Court or via a warrant under Police and Criminal Evidence Act
• Wider public interest
• Child protection
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30. 1.3. Ethical principles and moral rules
Fidelity
• Also called ethical principle of Accountability
• refers to the healthcare professional’s fiduciary duty to be a responsible and
faithful custodian of the public trust
• Loyalty, maintaining the duty to care for all
• No matter who they are or what they may have done
Privacy
• A persons right to remain private, to not disclose information
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