Pharmaceutical Ethics

Nov, 2022

1 05/10/2023
 Pharmacy Law & Ethics Course
Course Name: Pharmacy Law & Ethics
Course Module: Pharmacy Practice
Course Code: Phar
Course EtCTs: 3 (2 ECTS)

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 Course description
Ethical decision making
health professional patient relationship
frameworks for ethical analysis ethical theories, principles
and moral values
ethical codes, laws, regulations and directives pertaining to
pharmaceutical services internationally and in Ethiopia
product registration and licensing requirements
regulations related to narcotic and psychotropic drugs,
Case-study practice scenarios will also be presented to
allow students make pharmaceutical care decisions based
upon ethico-legal reasoning

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 References
 Remington, J.P., 2006. Remington: the science and practice
of pharmacy (Vol. 1). Lippincott Williams & Wilkins.
 Dale and Appelbe's Pharmacy and Medicines Law, 12th
edition, Pharmaceutical Press, 2021
 De. Marco, C, T. Pharmacy & the law, Aspen Systems
Corp,, Rochville,MD, 1984,
 EFDR, Food and Medicine Administration Proclamation
No.1112/2019, 2019
 Updated Directives of EFDA

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 Objectives
List the theories and principles of ethics
Discuss the origin and history of medical ethics
Differentiate medical ethics and pharmacy ethics
Discuss the origin of legal profession and ethics
Define ethics, profession and professional ethics
List the necessary characteristics of profession
Discuss moral issues and dilemmas in health care

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 ETHICS
WHAT IS ETHICS?
Ethics is derived from the Greek word "ethos"
meaning custom or character
 Ethics can be defined as "" the branch of philosophy
dealing with standards of conduct and moral
judgment!’
Or simply it is a study of morality

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 Intro…
 It also refers to the expected standards as described in the
group's code of professional conduct “Professional Ethics ”
 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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 Ethics vs Morality
Morality is the science concerned with the distinction
between right and wrong.
A moral act is one that is carried out with at least some
degree of knowledge and freedom, proceeding from man's
rational nature. A moral act (a human act which involves
some principles of moral law), which is in conformity with
moral law, is called good but if opposed to moral law, it is
called bad
Ethics is careful and systematic reflection on and analysis of
moral decisions and behaviour". Or It is the study of morality
Ethics have been particularly associated with specific groups
in society that are deemed to have societal responsibility

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 Medical ethics & Law
Medical ethics is the branch of ethics that deals with
moral issues in medical practice a field of applied
ethics, the study of moral values and judgments as they
apply to medicine.
As a scholarly discipline, medical ethics encompasses
its practical application in clinical settings as well as
work on its history

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 Medical ethics…
a health professional must recognize responsibility to
patients first and foremost, as well as to society, to
other health professionals, and to self.
These are not laws, but standards of conduct which
define the essentials of honourable behaviour for the
clinicians (physicians, health officers and nurses)

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 Medical ethics…
Medical ethics is closely related to law.
In most countries there are laws that specify how HPs
are required to deal with ethical issues in patient care
and research.
In addition the medical licensing and regulatory
officials in each country can do and punish HPs for
ethical violations.

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 Ethics Vs Law
But ethics and law are not identical.
Ethics describes higher standards of behaviour than
does the law and occasionally ethics requires that HPs
disobey laws that demand unethical behaviour.
Moreover laws differ significantly from one country to
another while ethics is applicable across national
boundaries

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 who decides what is ethical?
The answer to the question, “who decides what is
ethical for people in general?" therefore varies from
one society to another and even within the same
society.
In liberal societies, individuals have greater deal of
freedom to decide for themselves what is ethical
although they will likely be influenced by their
families, friends, religion ,media and other external
sources. .

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 who decides what is ethical?.....
In more traditional societies, family and clan elders,
religious authorities and political leader have greater
role than individuals in determining what is ethical.
Despite these differences, it seems that most human
beings can agree on some fundamental ethical
principles, namely, the basic human rights proclaimed
in the United Nations Universal Declaration of
Human Rights and other widely accepted and officially
endorsed documents.

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 Cont…
The human rights that are especially important for
medical ethics include:
Right to life
Right to freedom from discrimination, torture
and cruel inhuman or degrading treatment
Right to medical care
Right to freedom of opinion and expression
to equal access to public service in one's
country, and to medical care.

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 Who decides what is ethical for HPs?
In many not most, countries medical association have
been responsible for developing and enforcing the
applicable ethical standard.
* Depending on the countries approach medical law,
these standards may have legal status.
The ethical directives of medical association are greater
in nature they can't deal with every situation that HPs
might face in their medical practice.
In most situations HPs have to decide to themselves
what is right way to act
Medical code of ethics and policy statements

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 Does medical ethics change?...
There can be tittle doubt that some aspects of medical ethics
have changed over the years.
Until recently HPs had the right and the duty to decide how
patients should be treated and there was no obligation to
obtain the patient’s informed consent.
 significant changes in recent times. While a HPs should always act
according to his/her conscience, and always in the best interests of the
patient, equal effort must be made to guarantee patient autonomy and
justice.”
Medical ethics has changed in other ways.
Participation in abortion was forbidden in medical code of
ethics but now it is legalized in many countries including
Ethiopia.

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 Ethical Theories

Two General Thoughts:

A. Consequentialism
 Also known as Teleology (utilitarian or end based theory)
 Looks at the consequences of acts
 The acts are right to the extent that they produce good
consequences
 The result that matters most
 According to the utilitarian school of thought, right action is
that which has greatest utility or usefulness
 No action in itself is good or bad, the only factor that makes
it good or bad is its outcome

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 B. Deontological or ‘duty-based’ ethics
 Root word: ‘deon’ from the Greek word meaning, roughly, ‘one
must’;
 Deontological ethics are especially concerned with rules and
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.
 you are acting rightly when you act according to duties and
rights

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 Deontological….
 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; three different
kinds of rules are relevant.
Rules that (morally) forbid an action
Rules that make an action (morally) obligatory
Rules that make an action (morally) permissible

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 The other theories are
C. Intuitions
The notion that people inherently know what is right
or wrong
determining what is not a matter of rational thought or
learning.
For example, pharmacists inherently known that it is
wrong to hurt the client with a drug, this does not need
to be taught or reasoned out.

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 D. The ethic of caring (case based theory)
Unlike the preceding theories that are based on the
concept of fairness (justice), an ethical caring is based
on relationships.
It stresses courage, generosity, commitment, and
responsibility.
Caring is a force for protecting and enhancing client
dignity

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Basic Principles of Bioethics/medical ethics
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

Respect for person/Autonomy
Beneficence/ non‐maleficience
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.
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 Respect for persons
 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.

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 Autonomy
Autonomy is the promotion of independent choice, self-
determination and freedom of action.
Autonomy means independence and ability to be self-
directed in healthcare
Autonomy is the basis for the client's right to self-
determination.
The term autonomy implies the following basic elements
The autonomous person is respected
The autonomous person has the freedom to act upon the
choices
Right after admission patients are asked about personal and
private matters

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 Autonomy…..
 Informed consent
 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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  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.
 So, informed consent is
 It is a process by which patients are informed of the possible
outcomes, alternatives and risks of treatments and are required to give
their consent personal autonomy in regard to specific treatments freely.

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 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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 Components of informed consent
Information
Specific items for disclosure
Understanding
Adapt the presentation to the subject’s needs
Voluntary agreement
No threat of harm (coercion) AND no
improper reward (undue influence)

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When to get consent
 Enough time has to be allocated for the patient/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.

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 Voluntary agreement denotes…. for example in a research
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.
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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.

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 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 allowed.

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 Incompetents to give IC
Patients competency can be affected either by age or
medical condition.
Minors/Children
16 and 17 year old children presumed to be competent
to give consent for any treatment that would otherwise
constitute a sequence on them.
Children under age of 16 are presumed to be
incompetent to consent and to treatment.

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 Incompetents…….
Mental status
Mental illness may impair a patients capacity to
provide valid consent
Belief/Religon
Those with the greatest depth of faith refuse
blood(blood product) transfusion, even if this lead to
personal harm or death believing that to receive
transfusion will result in their eternal damnation

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 Consent in the case of minors
A minor a person under the age of 18 years requires
the consent of his or her parent or guardian to enter into
certain legal agreements.
Discussion
1. List circumstances where consent of parent or
guardian is not required?
2. How informed consent is obtained in the case of mentally
ill persons?

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 Assent
Children <7: No Assent
Children 7-12: Separate Assent Form
Teens 13-17 and Incompetent Adults:

Assent is the agreement of someone not able to

give legal consent to participate in the activity.

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 Case-scenario
Case 1: A physician at a provincial hospital is treating an
eight year old boy who requires a blood transfusion. For
religious reasons his parents are not prepared to give consent.
What should the physician do?
Case 2: A physician has diagnosed her patient as suffering
from cancer. She knows that her patient is subject to bouts of
depression and that if she informs the patient that she is
suffering from cancer, she will go into a deep depression that
will undermine the treatment
Should the physician reveal the diagnosis in order to obtain
an informed consent to treat the condition?

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 Case-scenario
Case 3: A life saving cancer medication was 1 month
beyond the expire day in a pharmacy stock and the
medication is stockout elsewhere in the contry. The
physician and pharmacist was discussing to administer
the medication to give it a try saving the child’s life. if
they informs the patient’s parents they fear the parents
will will undermine the treatment.
What should they do?

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 Medical treatment 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 to medical treatment or
An operation he or she may be given emergency
treatment provided.

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 2. Beneficence/ nonmaleficence

Beneficence—the provision of benefits—and nonmaleficence—the

avoidance of doing harm.
refer to protection 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.
Beneficence has two components: benefits and risks

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 Nonmaleficience……
It is to avoid causing deliberate harm, risk of harm, and harm
that occurs during the performance of beneficial acts.
Nonmaleficence also means avoiding harm as a consequence
of good. In that case, the harm must be weighed against the
expected benefit
When working with clients, health care workers must not
cause injury or suffering to clients.
For example,
The difference between killing and letting die (active and
passive euthanasia)
Withholding or withdrawing life-sustaining treatment (O2,
Glucose , IV drug)

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 Case-scenario
 A doctor works in a mission hospital in a rural part of the country where the
incidence of HIV-positive people is very high. She leaves to drive to the
city on the weekend to attend her son’s wedding. As she is off duty and
expecting to relax she leaves behind her medical bag which contains
universal precautions against HIV infection. While she is still in the high
risk area, an hour's drive away from the mission hospital, she comes
across a bus accident with bodies lying scattered in the road. She is
feeling overworked, and also needs to hurry to reach the city in time for
her son's wedding. She decides not to stop but uses her cell phone to call
the mission hospital with a request that they send help immediately. Three
people die from loss of blood which could have been prevented if she
had stopped and assisted.
 Did the doctor act ethically? Why or why not?
 Did the doctor act legally? Why or why not?

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 3.Justice
 Refer to fair and equitable distribution of both the burdens and
benefits
 It is the basis for the obligation to treat all clients in an equal and
fair way.
 Just decision is based on client need and fair distribution of
resources
 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

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 Other ethical principles
Veracity
Fidelity
Confidentiality
Veracity means telling the truth, which is essential to
the integrity of the client-provider relationship
Health care providers obliged to be honest with clients
The right to self-determination becomes meaningless if the
client does not receive accurate, unbiased, and
understandable information

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 Other ethical principles……
 Fidelity
Fidelity means being faithful to one’s commitments and
promises
Pharmacists commitment to clients include providing safe
care and maintaining competence in the practice
In some instances, a promise is made to a client in an over
way
Pharmacists must use good judgment when making
promises to client
Fidelity means not only keeping commitment but also
keeping or maintaining our obligation

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 Confidentiality
 meaning, “Confide” with regard to "show trust by
imparting secrets; while confidential or in confidence is
“a secret or private matter not to be disclosed to others
Confidentiality in the health care context is the
requirement of health professionals (HPs) to keep
information obtained in the course of their work
Professional codes of ethics will often have statements
about professions maintaining confidentiality
(Hippocratic Oath)

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 When confidentiality may be breached?
There is a professional duty to maintain confidentiality
unless:
A court of law orders them to make a disclosure, (e.g. in a
paternity dispute)
 An Act of Parliament requires them to make a disclosure,
(e.g. reporting child abuse)
There is a moral or legal obligation on the HP 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
patient threatens to kill someone)
The patient consents to the disclosure being made

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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 is
having sexual intercourse with another woman with whom
he is having an affair. The doctor advises the patient that
the latter 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 a 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 relationship.
Question: What should the pharmacist do?

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 summary
Acknowledge a person’s right to make choices, to
Respect for Persons/Autonomy hold views, and to take actions based on personal
values and beliefs

Treat others equitably, distribute

Justice
benefits/burdens fairly.

Obligation not to inflict harm intentionally; In

medical ethics, the HPs guiding maxim is “First,
Nonmaleficence (do no harm)
do no harm.”

Provide benefits to persons and contribute to

their welfare. Refers to an action done for the
Beneficence (do good)
benefit of others.

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 Health research and Ethics
Medicine is not an exact science. It does have many
genera! principles that are valid most of the time.
Thus, medicine is inherently experimental.
Even the most widely accepted treatments need to be
monitored and evaluated to determine whether they are
effective for specific patients and, for that matter, for
patients in general

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 History of unethical research on human
The Tuskegee Syphilis study conducted in the US between 1932 and
1972 (longest study) on a large group of black men.
Aimed at discovering how blacks react to syphilis and how long a human
being can live with untreated syphilis.
Subjects were denied treatment, even after penicillin was available in the mid-
1940s.
They were ill informed of having “bad blood” and were promised free care.
The study was finally stopped in 1972 after a public outrage.
The study raised several ethical issues in that era among which were informed
consent, racism, unfair subject selection, maleficence, truth-telling and justice,
etc.
All this outrage led to the development of the National Research Act (1974)

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 Unethical research….
Nazi doctor’s medical experiments (In WWII)
On Jews, gypsies and political prisoners.
High altitude experiments- conducted in low
pressure chambers that approximate pressure at
extremely high altitudes.
Freezing experiments- subjects remained in ice tanks
for 3 hours, severely chilled and rewarmed.
Malaria experiments- infected healthy humans with
infected mosquitoes

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 Nazi’s Unethical research…..
 Bone, nerve, muscle transplantation from one person to another
 Sterilization of subjects by means of x-ray, surgery and drugs.
 Spotted fever (typhus) germs infected healthy subjects to
develop vaccine.
 Poison mixed with food or subjects shot with poison bullets to
investigate effects of various poisons.
 Inflammatory bomb experiments- Burns inflicted on subjects
by using phosphorous from bombs then treated with various
drug preparations.
 These experiments were condemned and led to the
development of Nuremberg Code (1947).

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 The Nuremberg Code

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 Ethical issues in health care
Ethical Dilemmas
Ethical dilemmas occur when there are
disagreements on ethical behaviour or
application of ethical principles.
Ethical dilemmas can occur between
pharmacists and clients, pharmacists and
physicians, and among pharmacists because the
values, sense of justice and fairness of each party
may differ.

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 Ethical issues
Ethical situations in health care can be divided into two
broad categories:
"macro“
"micro"
Macro situations involve issues that are not specific to a
given health care practitioner; these situations involve
issues that must be addressed by all health care
practitioners and society in general.
abortion, assisted suicide,
E.g. It includes issues such as
genomics, rationing of and access to health care,
organ transplantation, and in vitro fertilization.

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 Ethical issues
Micro situations are those that may confront individual
practitioners in the course of their daily practice.
e.g. In the case of pharmacists, these may include the use
of placebos, patient confidentiality and informed consent.

Case scenario
What will be your decision if the medication is a controlled
substance used for pain control in a critically ill patient but
if there is no prescription order for the drug?
I will provide the medication even if it is illegal
I do nothing

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 Rationing
Rationing is another term for resource allocation
As the cost of providing health care services continues
to grow, some have suggested and even attempted to
implement a system that would ration the availability
of health care
e.g. List of essential drugs, Generic prescription, STG
Discussion
Patent right Vs essential drug access (patent Vs public
health priority)

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 Rationing….

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 Beginning-of-life Issues
Contraception: Requests for contraceptives from minors and
explaining the risks of different methods of
contraception.
Assisted reproduction: For couples (and individuals) who
cannot conceive naturally there are various techniques of
assisted reproduction, such as
 Artificial insemination Artificial insemination (AI) is the manual
placement of semen in the reproductive tract of the female by a
method other than natural mating
In-vitro fertilization
From July 25 1978 with the birth of Louise Joy Brown -up to
Now= above 4 million babies are born with IVF

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 Beginning-of-life……..
 Embryo transfer
The process by which an embryo is collected (flushed)
from one female (the donor) and transferred to another
female (the recipient) to complete the gestation period.
 Surrogate or substitute gestation
A gestational carrier (surrogate mother) is a woman who
agrees to have an embryo generated from the sperm of a man
through the process of IVF who is not her husband. A
gestational carrier's pregnancy does not involve her own egg
(Religion, Norm, Culture……….. ??)

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 Beginning-of-life……..
 Prenatal genetic screening: genetic tests are available to
determine the embryo or foetus genetic abnormalities and whether
it is male or female.
 Depending on the findings, a decision can be made whether or not to
proceed with pregnancy.
 Abortion: This has long been one of the most divisive issues in
medical ethics, for health professionals, religious leaders and for
public authorities.
 Question:
 Do you agree on the legalization of abortion in Ethiopia? (Rape, pregnancy

from relatives, risk for the mother health)

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 Euthanasia and Assisted Suicide
(End-of-life Issues)
 Euthanasia=knowingly and intentionally performing an act that is
clearly intended to end another person's life
 Although medical euthanasia ("mercy killing") has long been an
ethical issue, it has only been in recent years that the question of
assisted suicide has been examined.
 From an ethical perspective, the key issue remains whether assisted
suicide violates the Hippocratic responsibilities of health care
practitioners to "do no harm.“
 Those who advocate its availability to patients suggest that allowing
a patient to continue to experience persistent pain is "to do harm"

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 Euthanasia….
 It could be performed voluntarily & involuntarily.
 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.

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 Euthanasia…….
 Active euthanasia involves painlessly putting individuals
to death for merciful reasons,
 Eg. a doctor administers a lethal dose of medication to a
patient
 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.

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 Euthanasia……
 In both cases, the motive is the person’s own good.
 Does the difference between passive and active euthanasia,
which reduces to a difference in how death comes about,
make any moral difference?

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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 decisions 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:
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____________________________________
 Euthanasia….
Belgium, Netherlands, and Luxembourg legalized
euthanasia
In Belgium, To make a legitimate euthanasia request, the
patient must be an adult, must be conscious and legally
competent at the moment of making the request.
Assisted suicide is legal in Switzerland. Germany,
Albania. Colombia, Japan and in the US states of
Washington, Oregon, Vermont, New Mexico and
Montana

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 Human Drug Experimentation
 Two important ethical aspects including human drug
experimentation and the use of placebos are the role of the
institutional review board (IRB) E.g.
 Syphilis Experiment : Experiment to determine the natural course of
untreated, latent syphilis in black males.
 Stanford Prison Experiment
 Drug and Gas and racial experiment on Jewish by Germen (Nazi)

scientists

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 Drug experiment...
The IRB is the body responsible for overseeing all
clinical research conducted within a given institution.
» The IRB has two primary responsibilities:
1. To ensure the integrity and scientific rigor of the
proposed research study. If the risks outweigh benefits,
the IRB would likely reject the proposal.
2. To evaluate and approve informed consent forms used in
conjunction with the research

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 Discussion
What is the ethical dilemma related with placebo?
What make the use of placebo rationale?
Describe disease conditions that enforce researchers to
design a study that provides placebo to the treatment arm
in clinical trial?

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 Drug formulary
A drug formulary is a list of drugs that are approved for
use either within an institution or for reimbursement
(refund) by a third-party payer.
The restrictive nature of formularies has led to a number
of important ethical questions.
Does the use of generics violate the autonomy of the patient
or prescriber?
Is the use of such substitution a violation of informed
consent?
Does the use of formularies violate the ethical principles of
beneficence and nonmaleficence?

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 Formulary…..
However, one could argue that the use of formularies
and the resultant constraint on drug costs helps to
ensure affordable access to quality health care for more
people (distributive justice).

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 Professional ethics

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 Professional ethics
A profession is an occupation that requires special
knowledge and skilled preparation.
An occupation especially one requiring advanced
education and special training, e.g. law, medicine.
An employment not mechanical & requiring some
degree of learning.
A profession is generally distinguished from other kinds
of occupation by:
Its requirement of prolonged specialized training
An orientation of the individual towards service, either to
community or to organization

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 Profession Vs Vocation
 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 behavior
Codes, guidelines, oaths, commitment statements, etc

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 Profession...
 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

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 Vocation….
Vocation
Training is given for short time; mainly to develop
habitual skills
Vocational skills are useful under stable conditions
where the problems are routine
Vocational education is highly dogmatic

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 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.

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 Ethics and Professionalism
Code of Ethics
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.

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  Why code of ethics?

To define accepted/acceptable behavior

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

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 Standards of practice for pharmacists practicing
in Ethiopia (Pharmacy code of Ethics)
Introduction: pharmacy is a health profession with
diversified disciplines within it. It is the profession
dealing with the overall aspects of drugs and its clinical
applications
Definition
 The practice of pharmacy is defined as
o Preparing, compounding, preserving or the dispensing of drugs,
medicines & medical devices on the basis of prescriptions or
other legal authority
o Giving Clinical/patient care i.e rendering a health service by
concerning itself with knowledge about drugs and their effects
on human.

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 Basic code of ethics for pharmacists by FIP and EPA
in Ethiopia
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.

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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.

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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.

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 Oath of a pharmacist
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.

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 Oath of a pharmacist…
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.

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 Ethical principles and obligations during
practicing pharmacy in relation to other stakeholders
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

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 Be morally obliged in response to the trust received from the
 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

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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
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 Be liable to any damage on the patron as a result of

negligence or breach of professional conduct.

Be accountable to any damage inflicted on the patron due

to obstruction to perform professional obligations by non-

pharmacist owner or employer.

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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

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  Offer services in premises which reflect the professional
character of pharmacy
 Clean environment
 Paint/color/lighting
 Controlled substances in a safe
 Price clearly labeled

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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.

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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.

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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

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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

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05/10/2023
 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

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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 counseling

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  Do not fill prescription of drugs written for prescriber
his/her personal use
 Properly procure, distribute and use drugs
 Keep records properly
 Not self advertise
 Do not promote products of a particular manufacturer

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 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

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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(eg. Financial
 Its severity rely on
 the likelihood that professional judgment will be influenced
 the seriousness of the harm likely to result from such influence.

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 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.
The investigators were homosexuals.
The results may not be reliable as PI could be biased due to
conflict of interest.

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 Approaches to Solving Ethical Dilemmas:
A. Principlist 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 .

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 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)

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 B. Discourse 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

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 The health professional–patient relationship

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.

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 What is Unethical???
Providing and seeking compensation for therapies that
have no benefit to the patient.
Not respecting person and cultural difference
Creating impartiality 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.

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 Reading Assignment

Take as many pharmaceutical cases as possible which

are considered to exhibit ethical dilemma and discuss
them.

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