Professional Documents
Culture Documents
Ethics 2024
Ethics 2024
Ethics 2024
1 06/13/2024
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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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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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 ), which is in conformity with moral
law, is called good but if opposed to moral law, it is called
bad
Ethics is systematic analysis of moral decisions and
behaviour". Or It is the study of morality
Ethics have been particularly associated with specific
groups in society.
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Medical ethics
Medical ethics is the branch of ethics that deals with
moral issues in medical practice
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, pharmacists, 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
Ethics and law are not identical.
Ethics describes higher standards of behaviour than
does the law.
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?"
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 can't
deal with every situation that HPs might face
So in most situations HPs have to decide to themselves
what is right way to act
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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.”
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
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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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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
A. Respect for person/ Autonomy
B. Beneficence/ non‐maleficience
C. Justice
They are considered universal regardless of geographic, economic,
legal and political boundaries.
Researchers/HPs are obliged to assure that these principles are
followed while conducting anything involving human
participants.
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A. Respect for persons
Respect for persons addresses two main ethical
considerations.
I. Respect for autonomy,
II. 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
The term autonomy implies the following basic
elements
The autonomous person is respected
The autonomous person has the freedom to act upon the
choices
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Autonomy…..
Before giving care, patients should be asked to give their consent
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 forced or improperly influenced to
engage in research activities for which they would not otherwise
volunteer.
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According to this principle, the patients or research 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
Then they are required to give their consent personal autonomy in
regard to specific treatments freely.
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Types of Informed Consent
a. Written: especially for clinical research, written
consent is a must.
b. Verbal: Verbal consent may be used where people are
reluctant to put their signature on official document.
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Components of informed consent
Information
Specific items for disclosure
Understanding
Familiarize the information to the patent’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 prior to
seeking his or her consent for the following reasons:
To get enough time to think about the risks and benefits
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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 assumed 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
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 country. 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 undermine the treatment.
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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
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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.
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
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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
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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 law 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 that 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
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Health research and Ethics
Medicine is not an exact science..
Thus, medicine is inherently experimental.
Thus when conducting experiments the whole
procedure have to be ethical.
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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 among which were,
informed consent, racism, unfair subject selection, maleficence, truth-telling and
justice, etc.
All this scandal 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…..
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.
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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 issues in health care can be divided into two
broad categories:
"macro“
"micro"
Macro issues involve issues that are not specific to a
given health care practitioner;
It involve issues that must be addressed by all health care
practitioners and society in general.
E.g. It includes issues such as abortion, assisted suicide,
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Ethical issues
Micro issues 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 who cannot conceive naturally there are various
techniques of assisted reproduction, such as
I. 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
II. In-vitro fertilization
From July 25, 1978 with the birth of Louise Joy Brown -up to Now=
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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.
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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,
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(End-of-life Issues)
Euthanasia and Assisted Suicide
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,
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.
An act of omission.
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Euthanasia……
Discussion/Question
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 issues include
human drug experimentation and
the use of placebos
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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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Professional ethics
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Professional ethics
A profession is an occupation that requires special knowledge
and skilled preparation.
An occupation is
Especially one requiring advanced education and special training,
e.g. law, medicine, pharmacy…...
An employment that is not mechanical & requiring some degree of
learning.
A profession is generally distinguished from other kinds of
occupation by:
Its requirement of prolonged specialized training
By having a tendency toward serving either their community or an
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)
Codes, guidelines, oaths, commitment statements,
etc
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Profession...
Social Sanction
professionals given exclusive right to practice the
profession
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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Question
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.
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Standards of practice for pharmacists practicing
in Ethiopia (Pharmacy code of Ethics)
Definition
The practice of pharmacy is defined as
Preparing, compounding, preserving or the
dispensing of drugs, medicines & medical
devices on the basis of prescriptions or other
legal authority
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
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Ethiopian code of ethics for
pharmacists………….
among patients.
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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
Obligations
society
Not show partiality between the clients
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Not abuse his/her relationship with the patient for personal gain
II. The pharmacist in relation to the public
Always provide quality service
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III. Pharmacist in relation to 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
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
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V. The pharmacist in relation to his/her job
Practice the profession after being registered
and/or licensed
Immediately report any observed unwanted
reactions, side effects, ADRs
Carry responsibility
Maintain professional competence
Provide current drug information
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VI. Pharmacists as a member of the community
Be a good citizen!
Be a person of high principles and integrity
Be law abiding citizen
Actively participate in community services
Address the needs of special groups society such
as under aged, disabled people mentally ill
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VII. Management and utilization of pharmaceuticals
Do not sale substandard, counterfeit, deteriorated & mislabeled
pharmaceuticals
Confirm legibility of prescription
Accept prescription only in written form except in emergency
Give advice and counseling
Do not fill prescription of drugs written for prescriber his/her
personal use
Keep records properly
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The health professional–patient relationship
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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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Thank You
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