PHARMACEUTICAL LAW AND ETHICS

(Phar4243)

1
 Part: I
Ethics

Outline
•What is ethics?
•Ethical theories
•Teleological (consequentialist) and
•deontological (non-consequentialist) theories

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 1. Ethics
1. What is Ethics?
Ethics_ from the Greek ethos, meaning custom or
character
•something like ‗morals‘
 is the science of moral value.

composed of moral beliefs and rules about right

and wrong
 is the systematic study of what is right and good with
respect to conduct.
 Its basic foundation is ―Do Good and Avoid Evil‖

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 Ethics….
 are rules transmitted by a profession or groups
•enforced upon all members of the profession by its
own organization.
 concerns the thoughts, judgments, and actions about
issues that have implications of moral right and wrong

 Providing information about the risks and side effects of

drug regimens is an ethical responsibility of physicians,
pharmacists, and nurses

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Ethics
 Concerned what ought to be, what is right, or
wrong, good or bad
 It is a formal reasoning process used to determine
the right conduct
 Inquiry or study of principles and values

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Morality and ethics
 Morality/morals =
•beliefs, views and attitudes of given individuals,
societies and groups
•example religious groups.

 Ethics = careful and Systematic reflections on

moral views and standards (values and norms) and
how one should assess actions, institutions and
character traits

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 2. Ethical theory
Definitions
 Society: Association of people organized under a sys-
tem of rules
 Rules: advance the good of members over time

 Morality: A society's rules of conduct, What people

ought / ought not to do in various situations

Ethics
∗ Rational examination of morality
∗ Evaluation of peoples behavior

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Definitions, …..
Moral Systems
– rules for guiding conduct
– principles for evaluating rules
Characteristics
– public
rules are known to all members
– informal
not like formal laws in a legal system
– rational
based on logic accessible to all
– impartial
does not favor any group or person
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Grounding Principles in a Moral System

• Religion
Murder is wrong because it offends God
• Law

Murder is wrong because it violates the law

• Philosophy

Murder is wrong because it is wrong

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 Ethical theories….
Why do we need Ethical theories?
 Ethical theories provide part of the decision making foundation
for Decision Making When Ethics Are In Play
•because these theories represent the viewpoints from which
individuals seek guidance as they make decisions.

 help people make decisions, understand why people act the way
they do, and provide a framework for what is considered ethical.
 Ethical theories help us to choose what is appropriate for the
given situation
The Structure of Ethical Theories

 An essential feature of theory in general is that it

guides us in our investigations.

 The purpose of ethical theory, like scientific

theory, is to provide us with a framework for
analyzing moral issues.

 Ideally, a good theory should be

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Types of ethical theories
 Consequence or End-based (Teleology)
 Duty or Rule-based (Deontology)
 Character-based (Virtue)
 Contract-based

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 Types of ethical theories

(i) Teleological theories (utilitarian theory)

 looks to the consequence of an action in judging whether that action is
right or wrong
 According to the utilitarian school of thought, right action is that which
has greatest utility or usefulness
 So if choosing between acts A or B, the morally correct action will be the
one that produces the most desirable outcome
 Utilitarian hold that no action in itself is good or bad, the only factor that
makes actions good or bad are the outcomes or end results that are
derived from them.
Teleological theories….
 Teleological theories are Value based theories = An act is
morally right if it promotes the good or what has value.
(a) Consequentialism (and utilitarianism)
 Whether an act is morally right depends solely on
consequences or the goodness of consequences.
(b) Virtue ethics
 Whether an act is morally right or good depends on whether
it is in conformity or conflict with certain virtues (or character
traits).

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Cont‘d
(ii) Deontological theories
 ‗Deontological‘ (from the Greek deon, ―duty‖ or
―obligation‖)
 Whether an act is morally right or wrong depends on
whether it is in conformity or conflict with moral duties and
rights.
 This theory proposes that the rightness or wrongness of an
action depends on the nature of the act rather than its
consequence.
Utilitarianism
 Utilitarian ethical theories are based on one‘s ability to
predict the consequences of an action.
 To a utilitarian, the choice that yields the greatest benefit to
the most people is the one that is ethically correct.
 There are two types of utilitarianism,
•act utilitarianism and
•rule utilitarianism.
 Cont‘d
Act utilitarianism –
 suggests that people choose actions that will in any given
circumstances increase the over all good.
 a person performs the acts that benefit the most people, regardless
of personal feelings or the societal constraints such as laws.
Rule utilitarianism
 Suggests that people choose rule that when followed consistently
will maximize the overall good
 takes into account the law and is concerned with fairness.

 A rule utilitarian seeks to benefit the most people but through the
fairest and most just means available.
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 Cont‘d
Both act and rule utilitarianism have disadvantages
 Uncertainty can lead to unexpected results making the
utilitarian decision maker appear unethical as time passes, as
the choice made did not benefit the most people as
predicted.
 Another assumption that a utilitarian decision maker must
make concerns his/her ability to compare the various types
of consequences against each other on a similar scale.
•But, comparing material gains, such as money, against intangible
gains, such as happiness, is very difficult since their qualities differ to
such a large extent.
Cont‘d
 An act utilitarian decision maker is concerned with
achieving the maximum good.
•Thus, one individual‘s rights may be infringed upon in
order to benefit a greater number of people.
 In other words, act utilitarianism is not always concerned
with justice, beneficence or autonomy for an individual if
oppressing the individual leads to the solution that benefits
a majority of people.
 Cont‘d
 Still another source of challenge with act utilitarian decision
makers occurs when an individual faces one set of variable
conditions and then suddenly experiences changes in those
conditions.
 The change in conditions may lead to a change in the original
decision being be nice to someone one moment and then dislike
them the next moment
• because the situation has changed, and liking the person is no longer
beneficial to the most people.
 In rule utilitarianism, there is the possibility of conflicting rules.

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 Cont‘d
 A major complication of this theory on a larger scale is that one
must decipher what the characteristics of a right are in a society.
 The society has to determine what rights it wants to uphold and
give to its citizens.
 In order for a society to determine what rights it wants to enact,
it must decide what the society‘s goals and ethical priorities are.
 Therefore, in order for the rights theory to be useful, it must be
used in conjunction with another ethical theory that will
consistently explain the goals of the society.
 Virtue (Character based theory)
 The virtue ethical theory judges a person by his/her character
rather than by an action that may deviate from his/her normal
behavior.
 It takes the person‘s morals, reputation, and motivation into
account when rating an unusual and irregular behavior that is
considered unethical.
 One weakness of virtue ethical theory is that it does not take into
consideration a person‘s change in moral character.
 Virtue….
 Virtue ethics(also sometimes called "character ethics") 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.
 To become an ethical person, more is required than simply
memorizing and deliberating on certain kinds of rules.
 Aristotle believed that to be a moral person, one had to acquire
the right virtues (strengths or excellences).
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 Virtue…
 Aristotle believed that through the proper training and acquisition
of good habits and character traits, one could achieve moral virtues
such as temperance, courage, and so forth that are need to "live
well.―
 Instead of asking, "what should I do in such and such a situation?",
a virtue ethicist asks: "what kind of person should I be?―
 The emphasis is on being a moral person - not simply
understanding what moral rules are and how they apply in certain
situations.
Whole deontological and utilitarian theories are "action-
oriented" and "rule-oriented," virtue ethics is "agent-oriented"
because it is centered on the agent him/her-self.
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Deontology
 People should adhere to their obligations and duties when
engaged in decision making when ethics are in play.
 This means that a person will follow his or her obligations
to another individual or society because upholding one‘s
duty is what is considered ethically correct.
 For instance, a deontologist will always keep his promises
to a friend and will follow the law.
 A person who adheres to deontological theory will produce
very consistent decisions since they will be based on the
individual‘s set duties.
Cont‘d
 Deontology contains many positive attributes, but it also
contains flaws.
 One flaw is that there is no rationale or logical basis for
deciding an individual‘s duties.
 For instance, a business person may decide that it is his/her
duty to always be on time to meetings.
•Although this appears to be something good, we do not
know why the person chose to make this his duty.
 Compressions….
 While consequentialists hold that we should choose the
available action with the best overall consequences,
deontologists hold that we should act in ways constrained
by moral rules or rights, and that these rules or rights are
defined (at least partly) independently of consequences.

 Whereas consequentialists claim that we should always

strive to promote the best consequences, deontologists
claim that our moral obligations (whatever they are) are in
some ways independent of consequences.
Cont‘d
??How do we determine whether lying or killing is morally
right or wrong?
 The consequentialist`s answer:

By appeal to consequences
 The rightness or wrongness of lying or killing must be
explained by its consequences: if it has good consequences,
then it may be right to lie or kill.
 On the other hand, if it has bad consequences, then it may
be wrong to lie or kill
Cont‘d
 The deontologist`s answer:
 By appeal to norms, rights or obligations
 The rightness or wrongness of lying or killing cannot be
explained simply by its consequences.
 The actions of lying or killing are (often) wrong in
themselves, independently of whether they have good
consequences.

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Question
Should I kill one innocent person in order to save five (is it
permissible for me to kill one innocent person in order to save
five)?

 The act utilitarian`s answer:

 The deontologist's answer:

 Question

 Should I kill one innocent person in order to save five (is it

permissible for me to kill one innocent person in order to save
five)?

 The act utilitarian`s answer: Yes, you should (it is permissible

and sometimes even obligatory).

 The deontologist's answer: No, you should not (it is

impermissible to do so). It is a violation of the duty not to harm
the innocent and the innocent person's right to life
 3. Ethical Principles and Moral Values
 The fundamental ethical principles underlying Western
medical practice have not changed since they were first
enunciated by Hippocrates (460–377 bc).

 provide the tools which facilitate to resolve conflict in a fair

manner.

 Presuppose that health professionals should respect the value

and uniqueness of persons and consider others to be worthy
and high regard.
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Principles ….
The major principles are
•Autonomy -- Right of determination
•Informed consent--Right for full information
•Confidentiality--secrecy
•Non maleficence --Preventing harm
•Beneficence -- The Duty to Do Good
•Fidelity --Best interest of patient
•Justice -- Equality with everyone
•Veracity – Honesty without deception
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 1. Autonomy
 This principle states that decision making should focus on
allowing people to be autonomous to be able to make
decisions that apply to their lives.

 Is the promotion of independent choice, self determination

and freedom of action.

 Thus, people should have control over their lives as much

as possible because they are the only people who
completely understand their chosen type of lifestyle.
Cont‘d
 The autonomous person is respected
 A patient can decide to
•take a medication (or not)
• have surgery (or not)
•try alternative treatments
•Patients are asked about personal and private matters

 Exceptions- mentally ill, confused patients (Why)

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 2. Informed Consent
 Patients have the right to full information of all relevant facts
and must give explicit consent before t/t
 It assures the legal protection of a patient‘s right to personal
autonomy in regard to specific treatments and procedures.
 Informed consent exists when:
•all relevant data has been provided
•the patient understands the information
•consent is freely given and there is no coercion

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Informed Consent…
In medical cases, the patient
 Has knowledge of the nature or extent of the harm or
risk
 Appreciates and understands the nature of the harm or
risk
 Consented the harm or assumed the risk

 Understands that the consent is comprehensive, i.e.

extends to the entire procedure, including its
consequences.

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Treatments without consent in cases of emergency
 Where a person whose life or health is in serious danger as a
result of injury, disease or ill-health is unable to give consent
 An operation he or she may be given emergency treatment
provided it is not against the patient‘s will
When is emergency treatment justified?
 If there is an emergency
 If the patient is unable to communicate
 If the treatment is not against the patient‘s will
 If the treatment is in the best interests of the patient
 Where an operation is extended to save the patient‘s life

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 Case scenarios
 A doctor is treating an 8 years old boy who requires a blood
transfusion. For religious reasons, his parents are not
prepared to give consent.
What should the doctor do?
 A doctor is diagnosed her patient as suffering from ca. She
knows that her patient is subject to bouts of depression and
that if she informs the patient that she is suffering from ca,
she will go into a deep depression that will undermine the
treatment.
Should the doctor reveal the diagnosis in order to obtain an
informed consent to treat the condition?
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3. Confidentiality
 The protection and maintenance of strict privacy and
secrecy in relationships between professionals and
their patients or clients.

 from the patients perspective this is ―self disclosure‖

• they should be the ones making this decision
•situations to deny confidentiality
•STD, HIV, Drug abuse, Domestic violence

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 Case scenario
Case: A pharmacist is consulted by a patient who has been diagnosed as
HIV positive. The patient is married but having sexual intercourse with
another woman with whom he is having an affair. The doctor advises the
patient that the later should tell both his wife and the other woman that he
is HIV positive and to ensure that precautions are taken. For religious
reasons the patient is not prepared to use the condom. He also does not
wish to inform his wife because she may divorce him, and does not want
the other woman to know in case she ends their relationships.

Question: what should the pharmacist do?

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 When confidentiality may be breached?
It is a professional duty to maintain confidentiality unless
 A court of law orders to make a disclosure

 An act of parliament requires them to make a disclosure

 There is a moral or legal obligation on the doctor to make a

disclosure to a person or agency that has a reciprocal moral
or legal obligation to receive the information (e.g, where a
patients threatens to kill some one)
 The patient consents to the disclosure being made

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 4. Beneficence
 This principle means “doing good” for others
 The principle of beneficence guides the decision maker to do
what is right and good.
 This principle stipulates that ethical theories should strive to
achieve the greatest amount of good because people benefit
from the most good.
 Has three components
•Promote health
•Prevent harm
•Remove evil or harm
Case scenario

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 5. Non maleficence
 decision makers seek to choose to do the least harm possible and to
do harm to the fewest people.
 This principle means that the professional must avoid actions
detrimental to the patient and protect individuals who are unable to
protect themselves
 It is to avoid causing deliberate harm or risk

 Is avoiding harm as a consequence of good. In that case, the harm

must be weighed against the expected benefit
 At least, do not harm

Checking for
•drug interaction harmful side effects
•Overdoses early or late on refills
 6. Justice
 This principle states that decision makers should focus on
actions that are fair to those involved.
 It is the basis for the obligation to treat all clients in an
equal and fair way.
 Any health professional should treat all the patients equally
irrespective of sex, culture, race, religion, language, social
and political status
 treat patients equitably and fairly
•not favouring some individuals/groups over others
Cont‘d
 Comparative justice

•Making a decision based on criteria and outcomes

•E.g. how to determine who qualifies for one available
kidney.
•55 year old male with three children Vs a 13 year old girl

 Non comparatabive justice

• a method of distributing needed resources using a
lottery system

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 7. Fidelity
 This principle requires loyalty, fairness, truthfulness,
advocacy, and dedication to our patients.

 It involves an agreement to keep our promises.

 Fidelity refers to the concept of keeping a commitment

and is based upon the virtue of caring.

 Fidelity is the means not only keeping commitment but

also keeping or maintaining our obligations
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Cont‘d
 Infidelity from the practitioner could be:
•recommending vitamins to patients who don‘t
need
•failing to confront a physician with an
inappropriate prescription out of fear that the
physician will direct his/her patients elsewhere

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 8. Veracity/Honesty
 Veracity means telling the truth

 The professional does not withhold necessary information

from the patient or lie to the patient about the nature or
seriousness of his or her condition.

 The right to self determination becomes meaningless if the

client does not receive accurate, unbiased, and
understandable information.

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 9. Paternalism

 Restricting others autonomy to protect from perceived or

anticipated harm

 Is the intentional limitation of another‘s autonomy justified

by the needs of the another

 Paternalism is appropriate when the patient is judged to be

incompetent or to have diminished decision making
capacity (children, unconscious patients and mentally ills)
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 4. Ethical issues in health care:
Law and ethics; rationing; assisted
suicide; human drug
experimentation; drug formularies

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Ethical issues in healthcare

 Ethical issues provide an international platform for

critical reflection on moral obligations of
biomedical researchers,
health professionals, and
society in preventing disease and injury and meeting
the needs of the sick and injured.

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 Ethical issues in healthcare….
 Biomedical ethics is a specialized field of ethics,
which focuses on a wide array of emerging ethical
issues raised by medicine and biomedical research

 From debates over the boundaries of life to the

allocation of scarce healthcare resources, to human
subject research in medicine, and the limits of
consent.

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Biomedical research
Research ethics
• involves the application of fundamental ethical
principles to a variety of topics involving research,
including scientific research.
• These include the design and implementation of
research involving human experimentation, animal
experimentation…
• Research ethics is most developed as a concept in
medical research.
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 Human Subjects in biomedical research
A living individual about whom an investigator
conducting research to obtain
 data through intervention or interaction with the
individual or
identifiable private information
 Ethics of Research Involving Human Subjects is of
about the dignity, safety and well-being of the human
subject

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 Researcher‘s Responsibilities
Should investigators be responsible for research ethics?

Two events salient and influential of subsequent

development in research ethics

1. Nazi experiments on POW & Nuremberg Trial

similar experiments by Japanese physicians

2. Tuskegee Syphilis study

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 Cont…
Ethical issues:

• Inadequate disclosure of information

• Subjects believed they were getting free treatment

• Told that spinal tap was therapy

• US Gov‘t actively prevented men from receiving penicillin

• In 1972 press reports caused the U.S. Gov‘t to stop the

study
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Researcher‘s Responsibilities…
 Educate the participants about risks and benefits
 Obtain consent before involving participants in the
research
 Keep participants informed
 Confidentiality
 Responsible Publication
 Non-Discrimination
 Human Subjects Protection
 Honesty
 Legality

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 Principles of biomedical ethics
The classical principles of biomedical ethics are built on four
clusters of norms
 Respect for autonomy—the decision making capacities of
autonomous persons should be respected.
 Non maleficence ––do not harm.

 Beneficence––do good.

 Justice––people should be treated equally and fairly, and it

should be ensured that they are accorded their full rights

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 Cont‘d
 To deal with the relationship between the individual patient
and the physician in clinical practice, as well as the
relationships in clinical research.
 However, debate has emerged concerning whether these
principles are still appropriate for dealing with questions that
arise in the rather dynamic genomic era.
 Early in the Human Genome Project (HGP) era, Knoppers
and Chadwick identified five basic principles underlying the
international consensus on the need for harmonization of
national regulation on topics related to human genome
research:
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Cont‘d
 Autonomy––participating in genetic testing should be an
autonomous choice of an informed participant.

 Privacy––the privacy of the individual and the

confidentiality of genetic information should be respected.

 Justice––people should be treated equally and fairly, and it

should be ensured that they are accorded their full rights.

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Cont‘d
 Equity––equity of access to genetic research, testing, and
information; equal costs; equal resources; and equal
sharing of information should be ensured.

 Quality of respect for human dignity––accredited and

licensed laboratories and personnel, professional oversight
and monitoring and ethical review are required.

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Physician-Assisted Suicide and Euthanasia
What is Euthanasia?
 It is an act or practice of ending a life of a person
either by a lethal injection or suspension of medical
treatment
 In other terms, it also means ‗gentle and easy‘ death

 It is really means, intentionally ending the life in order

to relieve pain and suffering.

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Types of Euthanasia

1. Active
 When death is brought by an act

 Used to end a person‘s life either by oneself or by the

aid of a physician

Example: Taking a high dose of drugs

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 Types of Euthanasia….
2. Passive
 Intentionally letting the patient die by withholding
artificial life support such as feeding tube

 Sometimes described as limiting life sustaining treatments

so that a person passes more quickly

Example: a doctor may prescribe high dose of pain killers

that may be toxic over time
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 Types of Euthanasia….
3. Voluntary
 It is conducted with the consent of the patient
4. non-voluntary
 It involves that someone else (close family member) is making
the decision to end someone‘s life
 Done when someone is completely unconscious or
permanently incapacitated
5. Involuntary:
 patient in position to give consent, but decision taken by
relatives and physician

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 Types of Euthanasia….
6. Direct
 This means providing treatments, mainly to reduce pain
that has a side effect of shortening the patient‘s life
7. Indirect
 Usually refers to cases where the persons who are going
to die and need help to kill themselves and ask for it

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Causes of euthanasia

 Sufferable pain

 People should not be forced to stay alive

 Physical disability

 Advance terminal illness

 Unforeseen mishap/unpredicted unfortunate accident

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Challenges of euthanasia
 It demeans and devaluates the sanctity of human life

 It amounts to murder and it is the only God who can

only take away human life

 It discourages scientists who are looking for a cure for

incurable ailment

 It is an irreversible damage

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 Law
 Since March 2018, passive euthanasia is legal in India under
strict guideline
 In Belgium, euthanasia is allowed if the patient is only an adult
 In Netherland, it is allowed for children aged between 12 and
16 with the consent of their parents or guardians and for
individuals 16 years or over
 Inactive or assisted euthanasia is legal in 3 US states
Oregon
Washington
Montana
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 Religion perspectives of Euthanasia
Most religions disapprove euthanasia for a number of
reasons

a. God has forbidden (that says you must not kill)

b. Human life is sacred

c. Human beings are made in God‘s image

d. God gives people life, so only God has the right to take it
away
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Euthanasia…
Euthanasia in Ethiopia ?????

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Human Drug Experimentation
 Clinical trial means series of investigations consisting of
administration of medicinal products to humans/
animals
•to prove the safety & efficacy of the medicinal
product

 No clinical trial shall be carried out on

humans/animals without getting permission from
concerned drug regulatory authorities

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Cont‘d
 The Authority should:
•prepare directives governing clinical trials
•monitor the process
•evaluate the results
•authorize the use of the result in a way beneficial to
the country
 Participants have the right to full information of all
relevant facts and must give explicit consent

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 Drug formularies
 Formulary is a continually updated, official, or authorized
publication of an approved list of medicines for use in
hospitals
Types of formularies
 International; used in more than one country

 National; for one nation only

 Hospital; specific for a particular hospital

 Open; no limitation to access to medication, generally large

 Closed; limited list of medication lists to specific physicians,

disease…
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 Drug formularies…
Reasons to develop formularies
 To ensure quality and appropriateness of drugs used in a
particular practice
 To teach appropriate drug therapy especially to junior
practitioners
 To promote evidence based and cost effective drug
therapy
 To encourage the use of therapeutic protocols

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 Drug formularies
Contents of Formulary

 Introduction

 Basic information about the drug

 Supplementary information on each drug

 Prescribing and dispensing guidelines

 General drug use advice

 Miscellaneous sections
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 5. Professional Ethics
 Profession – is an occupation that requires extensive
training and the study and mastery of a specialized
knowledge and usually has a professional associations,
ethical code and process of certification and licensing.
 Vocation – is an occupation that requires usually skills
and education program range from short units (ten weeks
or less) to long term program up to two years length.
 Professional ethics – is the moral principle which should
guide members of the professions in their dealings with
each other and their patients, the patrons, the state, etc…
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professional ethics…

 The ethical values and principles used to make

decisions within a professional organisation

 Governs relationships with and responsibilities to

colleagues and anyone who uses one's professional
services or who these services might affect

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Components of professional Ethics

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 Ethics in the workplace
Ethical behaviour in the workplace will mean:
•Acting in a way that shows your belief in the basic values
of ethical behaviour
•Conducting your daily activities objectively, uninfluenced
by your emotions or personal prejudices
•Providing objective and constructive help or information
to all people, regardless of your personal feelings
•Helping the public understand how they can help
achieving objective and ethical behaviour in the
workplace

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Characteristics/Elements of a profession

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What is a professional?

 A professional is a person who is qualified to pursue

a certain profession

 A professional has to meet extensive educational,

ethical and regulatory requirements set by their
profession before they can provide their service to the
public

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 Qualities of a professional
 Pay attention to detail and take pride in doing a job well
 Be dissatisfied with substandard results, and will try to put things right
as soon as possible
 Always try to be polite and remain calm when interacting with
customers, superiors or co-workers
 Always be prepared to acknowledge mistakes and learn from them
 Show respect to those who consult them in a professional capacity
 Always uphold the reputation of the profession
 Respect authority and the rules of law when managing or employing
others
 Develop and improve their skills and remain up to date with the latest
developments in their field
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 Why is professionalism important?
Maintains Promotes Minimises Establishes
accountability respect conflict boundaries
• Ensures that • Ensures that • Minimises • Ensures
organisations all members conflict clear
take are treated between boundaries
responsibility with respect, members between
for their regardless of with diverse what is
actions no their backgrounds appropriate
matter what background behaviour
the outcome or position and what is
not

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 Is Pharmacy a profession?
 Yes!! Why???
•An intellectual discipline and standard of knowledge
•A university degree and a practical training
•A representative body of practitioners
•EPA (Ethiopian Pharmaceutical Association)
•Standard of conduct
•There are standard of conducts known throughout the
profession.
•Service and advice
•Province service and advice in the interest of the patients
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 What do Pharmacists do?
 Pharmacists are experts in medicines and as one of the
fastest growing areas of healthcare play a key role in
improving the health of the nation, and ensuring patient
safety.
 They work in a number of different settings:
–develop new medicines;
–supply medicines;
–provide advice about medicines;
– offer health services.
 Pharmacists also work in other roles where there may be less
direct contact with patients, for example in universities,
regulation,
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88
Rights and obligations of pharmacy personnel
 As a pharmacist or pharmacy technician you must:
•Make the care of patients your first concern
•Exercise your professional judgments in the interests of
patients and the public
•Show respect for others
•Encourage patients to participate in decisions about their
care
•Develop your professional knowledge and competence
•Be honest and trustworthy
•Take responsibility for your working practices
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 6. FIP STATEMENT OF PROFESSIONAL STANDARDS
and CODES OF ETHICS
Code of Ethics
 Is a set of principles that guide how people and organizations
should behave in a professional or personal capacity
 Provide more guidance for the practitioner
 However, no code of ethics can contain
All the necessary details to address all issues
 Rather, it is to be seen as a statement on
The overall ethical mandate of a profession
 makes a public statement concerning a collective commitment to
contain
Values
Principles and
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Duties 90
 To whom does the code of ethics apply to?
 Code of ethics applies to all members of the professional
association, in accordance with their scope of practice,
including registered pharmacists, pharmacy students and
pharmacy technicians

 Applicable in all pharmacy

•Pharmacy practice
•Pharmacy education
•Pharmacy research environments
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 FIP standards of ethical practice
The international pharmaceutical federation (FIP)
 FIP is the global body representing pharmacy and
pharmaceutical science.
 founded in 1912.
 Is an NGO that has been in official relations with WHO in
1948.
 Works to support the development of the pharmacy
profession, through practice and emerging scientific
innovations, in order to meet the world‘s health care needs
and expectations.
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 FIP standards of ethical practice…
 A profession is identified by the willingness of individual
practitioners to comply with ethical and professional
standards, which exceed minimum legal requirements.
 The pharmacist continues to be the health professional
who is the expert on medicines.
 Pharmacists are also given the responsibility to help people
to maintain good health, to avoid ill health and, where
medication is appropriate, to promote the rational use of
medicines and to assist patients to acquire, and gain
maximum therapeutic benefit from, their medicines.
Cont‘d
The FIP recommends;
In every country, the appropriate association of
pharmacists should produce a Code of Ethics
 for pharmacists setting out their professional obligations
and take steps to ensure that pharmacists comply with
the provisions of that Code.
 Principles of Code of Ethics for Pharmacists
1. 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
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.

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Principles of Code of Ethics for Pharmacists….
3. 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.
4. 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.

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Principles of Code of Ethics for Pharmacists….
5. 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.
6. 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.

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Principles of Code of Ethics for Pharmacists….
7. 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.
8. 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.

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 Ethiopian Code of Ethics in Pharmacy
Definition
 Code of ethics of Pharmacy – is the moral principle
which should guide members of the Pharmacy
profession in their dealing with their job, patients,
fellow professionals, public and other profession in
management of pharmaceuticals.
 It is a governing conduct of all Pharmacy personnel
both within and outside the practice of Pharmacy.

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 Objectives
 To promote high standard of conduct and practice among
Pharmacy professionals and patients and Pharmacy
professionals and other health professionals.
 To state publicly the principles that forms the fundamental basis
of the duties and responsibilities of the Pharmacists.
 To safeguard the public from unethical and substandard
professional practice.
 To foster the good relationship that would prevail among
Pharmacists, other health professionals and patient or the
society.

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1. Pharmacist in relation to his/her patients

 Always follow the rule: Patient first or Service first.

 Therefore, the Pharmacist should

•be morally obliged to the gift of trust received from

the patients,

•be responsible to help individuals to achieve

optimum benefit from their medications.

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Cont‘d
 not show partiality between his patrons.
•He/she should not discriminate between patients by
nationality, color, religion, social status, political standards,
etc…
 not abuse his/her relationship with the patients for
personal use.
 dedicate himself/herself to protect the dignity of the
patient.
•He/she should respect the patient right not to take a drug
unless the disease condition requires other wise by law.

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2. Pharmacists in relation to the public
Always provide quality service.
 Therefore the Pharmacist should:
 Maintain good personal qualities.
•Be on duty with clear mind.
•Be presentable.
•Master communication skills.
•Be knowledgeable.
•Always provide accurate and appropriate information.
•Always update him/her self.

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Cont‘d
 Strive to create public awareness on
•rational use of drugs.
•the profession in general.
 Be accountable for
•ones action.
•services rendered under his/her supervision.

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Cont‘d
 Maintain standard premises
•clean environment
•order
•paint/color, lighting
•handling of controlled substances
•price clearly labeled

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3. Pharmacists in relation to other health professionals
The Pharmacist should:

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4. Pharmacists 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.
 have responsibility to expose any act of misconduct or
malpractice committed by a fellow professional to keep
up the honor and integrity of the profession and to
cooperate with the enforcement of law.

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5. Pharmacists in relation to his/her job
The pharmacist should

 get involved in the profession/vocation only after

having been registered to practice and legal license to
operate a pharmaceutical establishment.

 not delegate his/her subordinate and/or assistant to

tasks which he/she should perform personally.

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Cont‘d
 immediately report any observed unwanted reactions,
side effects and adverse reactions to the attending
physician and/or patient authority.
 update his/her knowledge and maintain professional
competence directly related to his/her specific area of
practice.
 provide current drug information to the public as well
as to other health professionals.

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 7. Ethical standards of practice in Ethiopia
1.Dispensing of medication in Pharmacy
Prescription handling
•The pharmacist should,
 personally fill all prescriptions or ensure appropriate
filling of orders.
 accept prescriptions only in written form except
under emergency or compelling conditions.
 sell only products approved by FMHACA.

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 Cont‘d
 not dispense prescription only drugs without prescriptions.
 immediately inform the prescriber due correction or
clarification if the prescription has been found to be
illegible or appears to be wrong.
 not dispense any drug to patients who do not appear in
right mental state.
 dispense medications as original packs whenever possible;
if not repack materials should be labeled appropriately.

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Cont‘d
Labels should contain
•name of medicine
•batch number
•expiry date
•strength
•dose
•frequency of dosing
•duration of treatment

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Cont‘d
 It is free to make generic substitution.
 not alter prescriptions in any way.
 not fill prescriptions of drugs written by a prescriber
for his own use.
 do not dispense for prescribers self use.

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2. Instructing, educating and counseling patients
The Pharmacist should,
 have appropriate knowledge and skills for patient
education and counseling.
 adapt messages to fit patients.

 give ample verbal and written information on

dispensed drugs.
 conduct counseling or education in a conductive
environment.

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Premises

 The pharmacist should maintain the premises that

fulfill the following.
 The external and internal appearances of the
pharmacy should be inspiring and attractive.

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Cont‘d
 Premises should permit
•flow of work.
•communication and supervision.
•cleaning and maintenance.
•minimization and avoidance of
•cross contamination.
•adverse effect on the quality of the product, service
and health of the public.

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Special segments of public
 Premises should allow ease access and service and
to disabled persons.
 Do not supply any medicinal products to children
unless satisfied that the product will be used safely

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3. Compounding and manufacturing of pharmaceuticals
Compounding
 Only authorized personnel should be involved in
compounding.
 Only healthy, mentally and physically fit personnel should
be involved in compounding.
 Have procedures for compounding.
 Have working procedures for every technical operation,
cleaning (SOP).
 Label products properly.

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4. Manufacturing of drugs and medical supplies in Ethiopia
The Pharmacist should,
 give due consideration to safety, efficacy and quality.

 make sure every operation is in accordance to the national

current GMP standards.
 maintain records and keep track of all key processes (from
concept to all the way delivery).
 ensure that products carry unique batch number,
manufacturing date and expiry date.

8/9/2025 119
 Cont‘d
 look after the needs of his employees.
•Space
•Safety and comfort
•Professional respect and independence
 Only engage in fair, transparent and free competition.
 Have working procedures for every technical operation, cleaning
(SOP).
 Proactively, protect and support the environment in accordance
with the national guideline.
 Correct or expose any malpractice through the appropriate
channel.
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5. Pharmaceutical supply management and rational drug use
The pharmacist should
 Set the priority according to national need.
 Circulate only products approved by FMHACA.
 Always acquire pharmaceuticals through appropriate
procurement procedures.
 Inspect products up on receipt.
 Store drugs and other substances as per the current
Good Storage Practice throughout the supply system.

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Cont‘d
 Distribute pharmaceuticals

•only to authorized clients.

•in fair and equitable manner.
 Distribute free sample to health professionals only.

 Maintain records and keep track of sold products.

 Promote rational drug use.

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 6. Handling of narcotics, psychotropic and
other dangerous drugs
 Store these substances in a separate secured area.
 Only the pharmacist himself/herself should carry of the
dispensing.
 Dispense through only prescription paper approved by
FMHACA.
 Handle properly poisonous substances to prevent any injury
to the public.
 Immediately report breakage, loss or theft to FMHACA.
 Store securely and separately expired and damaged products
and dispose according to the procedure set by FMHACA.
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 7. Drug research and development
The Pharmacist should:
 strive to direct research focus to address national need.
 be committed to one‘s proposal and agreement.
 be honest.
 strive to uphold the sprit of cooperation.
 avoid bias.
 honor patents, copy rights and other forms of intellectual
properties.
 adhere strictly to international institutional protocols
experimental animals handling.
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8. Professional-Patient Relationship
 Is a bond of trust between the patient and the medical
professional who is performing treatment.

 The professional trusts the patient or client to disclose all

the information that may be relevant to his or her
condition or illness, and to be truthful while disclosing it.

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 Professional-Patient Relationship...
 In return, the patient or client trusts the health care
professional to maintain high standards of competence;
to protect the confidentiality of private information;
and to carry out his or her work in the best interests of
the patient rather than taking advantage of the patient's
vulnerability.
 Rapport— The relation between professional and
patient, particularly one that is harmonious and
empathic.

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 Paternalism
 Healthcare professionals make decisions about diagnosis,
therapy, and prognosis for the patient.
 Based upon the health care professional‘s belief about what
is in the best interest of the patient, he/she chooses to reveal
or withhold patient information.
 This principle is heavily laden as an application of power
over the patient.
Consumerism
 The protection or promotion of the interest of
consumers
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 Paternalism Vs consumerism

 Paternalism focuses on obligations; consumerism focuses

on rights.

 Paternalism assumes the doctor is beneficent;

consumerism assumes the doctor is self-centered.

 Paternalism implies the existence of trust; consumerism

replaces trust with accountability.

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 Paternalism Vs consumerism….
 Paternalism assumes that principles of good medical
care override individual treatment preferences;
consumerism presumes that the patient's health care
values dominate.

 Paternalism assumes that third-party intervention is

inappropriate whereas consumerism may require third-
party supervision.
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Evolution of newer decision-making models
Independent choice
•leaves the decision of healthcare to the patient

Enhanced autonomy
•gives some decision-making to the patient (enhanced
autonomy)
•but the ultimate decision still lies with the healthcare
professional

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 Cont‘d
Informative
•Provides information to a patient and allow patient to
consider information
•Healthcare professional serves as information provider
Deliberative
•The health care professional works with the patient to
come to a decision on a course of t/t.
•They weigh options together instead of only the
professional making the decision

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 Cont‘d
Interpretive
•The healthcare professional helps the patient interpret
the information and is open to questions from the
patient
•The role of the professional is to provide answers to a
patient and help the patient understand the results of
tests, risks and benefits of a t/t
•Interprets the health terminology and tests in a way
that the patient can understand.

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 Thank You

8/9/2025 133