April 10, 2025
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Pharmacy Law & Ethics
HARAR HEALTH SCIENSE COLLEGE,
DEPARTMENT OF PHARMACY
For 4th
Year BSc. Pharmacy Student
By:- Anteneh z
April 10, 2025
(Part I) Chapters view..
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1. What is Ethics?
2. Ethical theories
3. Ethical principles and moral rules
4. Ethical issues in health care
5. Framework for ethical analysis
6. Professional ethics
7. Ethical codes
8. Standards of practice
9. Health professional-patient relationship
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1. WHAT IS ETHICS?
 The term ethics derived from the Ancient Greek
word ethikos, which is derived from the word ethos
(habit, “custom”).
 Ethics is the systematic study of what is right and
wrong with respect to conduct and character.
WHAT IS ETHICS?
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WHAT IS ETHICS?
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 It refers to a method of inquiry that assists
people to understand the morality of human
behavior. (i.e. it is the study of morality).
 Ethics refers to the practices or beliefs of a
certain group (i.e. nursing ethics, Physicians'
ethics and pharmacy ethics).
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WHAT IS ETHICS?
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 Ethics, or moral philosophy, is the
branch of philosophy that involves
systematizing ,defending , and
recommending concepts of right
and wrong conduct.
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Common terms
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 Law : Law is the system of rules of conduct
established by the government of a society to maintain
stability and justice.
 Morals: Morals are a person’s ideas about right and
wrong.
 Values: Values are principles of worth and are
importance.
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Common terms
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 Moral principles: the principles of right and
wrong that are accepted by an individual or a
social group.
 Jurisprudence: It means study of fundamental
laws and in case of pharmaceutical Jurisprudence,
it is laws relating to pharmacy.
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Common terms
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 Pharmaceutical jurisprudence: A branch of
pharmacy, which deals with various legislations
pertaining to drugs and pharmaceuticals and
profession of pharmacy.
 Legislation:A group of laws that have the force of
authority by virtue of their promulgation by an
official organ of a state or other organization.
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Common terms
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 Professional ethics: Professional ethics encompass
the personal, organizational and corporate
standards of behaviour expected of professionals
 Code of ethics: The Code of Ethics sets out the
principles that you must follow as a pharmacist or
pharmacy technician.
 The Code is the Society’s core guidance on the
conduct, practice and professional performance
expected of you.
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Law Vs Ethics
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Laws
Laws are rules of behaviour
sanctioned by governments
that illustrate what people can or
cannot do in their workplace.
i.e. Simply, Law is something you
must obey.
Example: a pharmacist must be on
the premises at all times and oversee
all medicines being dispensed and
sold.
Ethics
Ethics means the
ability to
judge between
right and
wrong actions.
i.e. ethics is how
society expects
you to behave.
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Types of Ethics
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Descriptive:
It is also known as comparative ethics, is the study
of people’s beliefs about morality.
It is the description of the beliefs of various cultural,
religious or social groups about health and illness
 (What do people think is right?)
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Types of Ethics
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 Normative: a study of human activities in a
broad sense in an attempt to identify human
actions that are right or wrong and good
and bad qualities. (How should people act?)
 Applied: It is the study of how humans
applying it into practice. (How do we take
moral knowledge and put it into practice?)
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2. Ethical theories
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 Ethical theories may help us to view an ethical
problem.
Consequentialism : This theory can be simply
defined as 'the ends always justify the means'
Acts are considered right or wrong based on
how good or bad the outcomes of those acts are
(1).Consider a simple example:
A mother would like her daughter to focus on her
homework.
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Ethical theories
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To ensure this, the mother tells her daughter that the television
show her daughter watches daily will not be aired
tonight. However, this is not the truth.
The daughter focuses on her homework instead of
watching television, and completes her schoolwork as a
result.
According to the theory of consequentialism, it was
right for the mother to be dishonest, since the outcome
was a good one.
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Ethical theories
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 Deontology: The theory of deontology is 'the ends
never justify the means.'
 Acts are considered right or wrong intrinsically, regardless
of the outcomes.
 Considering the example given above of the mother and
daughter, the mother would have committed a wrong
act according to the theory of deontology.
 This is because the mother lied to her daughter, and lying
is considered unethical regardless of the outcome it
may lead to.
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3. Ethical principles and moral rules
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 Ethical Principles are basic ideas that are starting
points for understanding and working through a
problem.
 Ethical principles presuppose that pharmacists
should respect the value and uniqueness of
persons and consider others to be worthy of high
regard.
 These principles are tents that are important to
uphold in all situations.
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Ethical principles and moral rules
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 The major principles of health professionals’
ethics are:
Autonomy
Beneficence
Nonmaleficence
Justice
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Ethical principles and moral rules
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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
1. The autonomous person is respected
2. The autonomous person must be able to determine personal goals
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Ethical principles and moral rules
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Autonomy
 The autonomous person has the freedom to act upon the choices
 Right after admission patients are asked about personal and
private matters
Informed consent
 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
freely.
 It assures the legal protection of a patient’s right to personal
autonomy in regard to specific treatments and procedures.
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Ethical principles and moral rules
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Beneficence
 Beneficence is doing or promoting good.
This principle is the basis for all health care
providers.
The principle of beneficence has three components:
Promote health
Prevent harm
Remove evil or harm
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Ethical principles and moral rules
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Nonmaleficience
 Nonmaleficence is the converse of beneficence.
 It means to avoid doing harm.
 When working with clients, health care workers must not
cause injury or suffering to clients.
 It is to avoid causing deliberate harm, risk of harm, and
harm that occurs during the performance of beneficial
acts.
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Ethical principles and moral rules
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 Justice
 Justice is fair, equitable and appropriate treatment
 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.
 It would be unjust to make such decision based on how much he or she
likes each client
 Any health professional should treat all the patients equally
irrespective of sex, culture, race, religion, language, social status
and political status
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Ethical principles and moral rules
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Paternalism
 Restricting others autonomy to protect from perceived or
anticipated harm.
 The intentional limitation of another’s autonomy justified by
the needs of another.
 Thus, the prevention of any evil or harm is greater than any potential
evils caused by the interference of the individual’s autonomy or liberty.
 Paternalism is appropriate when the patient is judged to be
incompetent or to have diminished decision-making capacity.
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Ethical principles and moral rules
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Non-compliance
 Unwillingness of the patient to participate in health care
activities.
 Lack of participation in a regimen that has been planned by the
health care professionals to be carried out by the client.
Noncompliance may result from two factors:
 When plans seem unreasonable to the patient
 Patients may be unable to comply with plans for a variety of
reasons including resources, lack of knowledge, psychological
and cultural factors that are not consistent with the proposed plan
of care
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Ethical principles and moral rules
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Veracity
 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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Ethical principles and moral rules
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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
 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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Ethical principles and moral rules
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Confidentiality
 Confidentiality comes from Latin fide: trust.
 Confide as to “show trust by imparting secrets”; “tell in assurance of
secrecy ;
 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
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4. Ethical issues in health care
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 Medical ethics is also known as biomedical ethics.
 Ethical situations in health care can be divided into
two broad categories:
o“macro”
o“micro”
 Macro situations involve issues that are not specific to a
given health care practitioner;
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 These situations involve issues that must be
addressed by all health care practitioners
and society in general.
 It includes issues such as abortion, assisted
suicide, genomics, rationing of and access to
health care, organ transplantation, and in
vitro fertilization.
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Ethical Issues….
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 Micro situations are those that may confront
individual practitioners in the course of their
daily practice.
 In the case of pharmacists, they include the use
of placebos, patient confidentiality and
informed consent.
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Case scenario
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 What should a pharmacist do when a patient’s
prescription for heart medicine has been depleted, no
refills remain, and the prescriber is unavailable?
 What if the medication is a controlled substance used
for pain control in a critically ill patient?
He will give the medication
even if it is illegal in both cases
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Rationing
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 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
eg. List of essential drugs, Generic
prescription
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Essential medicines, as defined by the World Health
Organization(WHO) are "those drugs that satisfy
the health care needs of the majority of the
population;
They should therefore be available at all times in
adequate amounts and in appropriate dosage
forms, at a price the community can afford.“
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Generic name of a drug: The term "generic name" has
several meanings as regards drugs:
The chemical name of a drug.
A term referring to the chemical makeup of a drug rather than
to the advertised brand name under which the drug is sold.
A term referring to any drug marketed under its chemical name
without advertising.
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Assisted Suicide
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 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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Human Drug Experimentation
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 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
The IRB is the body responsible for overseeing
all clinical research conducted within a given
institution.
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Drug experiment…
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 The IRB has two primary responsibilities:
1. To ensure the integrity and scientific rigor
of the proposed research study.
oIf 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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Group discussion
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 In which instances placebos are used?
 What is the ethical dilemma related with placebo?
 Which group is benefited from the drug experiment
(control (placebo) orTreatment (new drug) group)
 How can we solve the ethical dilemma related
with drug experiment?
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Drug formulary
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 A drug formulary is a list of drugs that are
approved for use either within an institution
or for reimbursement 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?
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Formulary…
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 Is the use of such substitution a violation of
informed consent?
 Does the use of formularies violate the ethical
principles of beneficence and nonmaleficence?
 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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5-Framework for ethical analysis
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 Ethical dilemmas appear in every
area of pharmacy practice.
 You cannot hide from them!
 Rather than hide, we should have
an approach to dealing with
these dilemmas, one that is
easily applicable to different types
of pharmacy practice.
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Step 1
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Respond to the SenseThat Something IsWrong
 Many times, the little nagging voice that will not
leave you alone is enough indication that
something is wrong.
But just to ensure that ethical dilemmas are not
passing you by in oblivion,
 you should ask yourself some questions to
make sure everything is ethically sound
when dealing with patients
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For example, consider asking yourself some of these
questions:
 Is the patient's autonomy being breached?
 Am I considering the patient's individual wishes and
values?
 Am I maximizing benefit while minimizing harm for
the patient
 If you find that some of the ethical principles
discussed earlier are being breached, then you
likely have an ethical dilemma on your hands.
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Step 2
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 Collect Information
 This is an essential step.
 Do not make an assumption concerning what exactly the
ethical dilemma is without gathering all relevant
information!
 Collect all the details surrounding the dilemma.
 Who is involved?
 When did this occur?
 How have others responded to the dilemma?
 Collect and organize all your facts.
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Step 3
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 .Identify the Ethical Problem/Moral Diagnosis
 At this point, you know something is wrong, and you have
all the facts surrounding the incident.
 Now is the time to ask yourself, 'What exactly is the
dilemma?'
 Identify what the source of the concern is.
 What is at the heart of the issue?
 Once you have defined exactly what the problem is, you
are on the right track to begin tackling the dilemma!
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Step 4
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Seek a Resolution
To resolve the dilemma, consider the following:
 4 principles of medical ethics (autonomy, justice,
beneficence, non-maleficence
 Laws (acts and regulations which govern the profession of
pharmacy)
 Financial concerns
 Commitments to friends and families
 There may be more factors to consider, or you may not find all
applicable to your situation. Use your judgement, but try to
consider all important factors.
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Step 5
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 Work with Others to Choose a Course of Action
Never make decisions regarding ethical dilemmas on your
own.
 Similar to the collaborative approach of solving drug
therapy problems,
 we should collaborate with other health care
providers when encountered with ethical dilemmas.
 Involving others in your decision-making process helps you to
filter out any personal biases you may have but do not
recognize (we all have them, don't beat yourself up about it too
much).
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 Ultimately, consulting with others protects you from
making any rash, uninformed, biased, or
paternalistic decisions.
 Instead, your decisions will be thoughtful, well-
informed, and sensitive to all members involved in the
ethical dilemma.
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Step 6
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"DOCUMENTATION!"
 Documentation is important!
 Documenting all the steps you have taken to reach a
decision demonstrates a thorough and logical
thought process.
 It also illustrates who you consulted with, and
what factors you considered to reach a final
decision.
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 If possible, also document what the final outcome
was of the ethical dilemma.
 Most importantly, documentation also serves as a
form of protection for you.
 If after all that straining of your ethical reasoning
skills, the outcome of the ethical dilemma was an
unfortunate one, that documentation will come in
handy.
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Case study
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 Mr.Tesfaye Gabrie, 70 yrs old in ICU (PE) & fractured his femur
in fall at the nursing home & awaiting surgery the next morning
when he developed dyspnea, tachypnea, & tachycardia.
 In ICU, another patient Mr.Yohannes Sileshi, 60 yrs old admitted
in next room with a history of liver cirrhosis from alcohol abuse.
He has ruptured esophageal varices.
 Abraham dereje, Pharm.D., was the pharmacy supervisor for 6
ICU in the hospital. He & other 2 pharmacists worked frantically
to fill all the orders for IV drugs & parenteral solutions that came
from ICU units.
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Continues...
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 Dr. Dereje decided to conduct rounds and noticed that Mr. Sileshi
had died. He noticed the IV bag included heparin not the
octreotide in the trash. He came to know that the Ivs were
inappropriately labeled.
 Dr. Dereje knew that its a critical case even though the mix-up
with the heparin may not have had anything to do with Mr. Sileshi’s
death, but he knew that such a patient should not receive Heparin.
 Next step should be to stop the octreotide IV & notify the
pharmacy to send up the right drug for Mr. Gabrie. Also he has to
inform to Dr. Mulalem, intensivist. But he knew that he can’t
tolerate mistakes & also about the issue of Mr. Sileshi’s family.
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Commentary
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 This case is complex but reveals potential ethical concerns.
As the pharmacist involved in the case, Dr. Dereje will need
to decide what he needs to do and why. The six-step model
can help Dr. Dereje work toward a justifiable resolution.
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1. Respond to the Sense That something is wrong
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 In this case, Dr. Derege happened to notice the discarded IV
bag that led to his discovery of a drug error that may or may
not have contributed to Mr. Sileshi’s death.
 Dr. Derege also experiences a sense of dread fear or anxiety
when he thinks about reporting the error to the intensivist in
charge of both patients
 These negative emotions are indications that an ethical
problem is present.
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2.Collect Information
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 To organize the numerous facts in the situation in which Dr.
Derege is involved, one can classify them into clinical and
situational information
 clinical information
In Mr. Sileshi’s case
His illness was acute and life-threatening. If not treated immediately
with appropriate drug therapy and other life-saving measures, Mr.
Sileshi would certainly die from hemorrhage and shock
The administration of heparin to a patient who is already
hemorrhaging would increase the risk of bleeding, but it may not
have hastened Mr. Sileshi’s death.
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2.Collect Information
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 Situational information includes data regarding the values and
perspectives of the principals involved; their authority; verbal and
nonverbal communication, including language barriers; cultural and
religious factors; setting and time constraints; and the relationships of
those immediately involved in the case.
 urgency and time constraints
 In other words, even if the clinical “facts” of a case remain constant,
changes in the situational or contextual factors, such as the values of a key
principal in the case, could change the ethical focus or intensify the
ethical conflict.
 Of all the situational data mentioned, the most important is the
identification and understanding of the value judgments involved in a case
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 In this case the principal involved are
 the two patients,
 any family involved,
 Dr. Derege,
 Dr. Mulalem,
 the pharmacist(s) who prepared the drugs,
 and members of the nursing staff responsible for hanging the IV
medications
We know specifically that Dr. Mulalem “. . . did not tolerate
mistakes
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 Each member’s responsibilities are distinct yet overlap.
 As part of the information-gathering step it is important to
sort out the various responsibilities, not for placing blame
but for identifying moral accountability
 In this case Dr. Derege may not be the one who mislabeled
the IV bags, but..
 as evening supervisor he has overarching responsibility for all
medications that leave the pharmacy.
 Second, he is the one who discovered the error. Knowledge
of the error carries its own responsibility.
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Identify the Ethical Problem/Moral
Diagnosis
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 The ethical principles most often involved in complex cases,
such as Dr. Derege’s situation, are:
 (1) patient and health professional autonomy,
 (2) beneficence and nonmaleficence, and
 (3) justice.
• veracity, fidelity, and avoidance of killing are treated as
possible principles
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 All we know for certain is that the error deprived him of
drug therapy that could have provided benefit.
 The error may have caused harm to Mr. Gabriel as well. He
too was deprived, at least for a while, of a treatment that
could have helped him.
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Introduction
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 Pharmacy is the field of expertise that ensures the
availability, accessibility, and the responsible use of
medicines.
 The pharmacist is the professional who is particularly
competent within that field.
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Professional ethics - Definition
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 Professional ethics encompass the personal, organizational and
corporate standards of behaviour expected
of professionals.
 Professionals, and those working in acknowledged professions, exercise
specialist knowledge and skill.
 How the use of this knowledge should be governed when providing a service to
the public can be considered a moral issue and is termed professional ethics.
 .
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Professional ethics - Definition
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 Professionals are capable of making judgements, applying their
skills and reaching informed decisions in situations that the general
public cannot, because they have not received the relevant training.
 Profession;- A profession needs extensive training and specialized
knowledge.
 Occupation:-An occupation does not need any extensive training.
 A person with an occupation need not have
specialized knowledge of his trade
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•Guidelines for professional ethics are based on
principalism, which is the application of four distinct
moral principles.
•These principles function as a framework to express
general values of common morality.
• Respect for autonomy
• Non-maleficence
• Beneficence
• Justice
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 Also, veracity (truthfulness) is important; healthcare
providers should be truthful to patients and families.
 The four principles are applied to actions and
decision making, constituting the foundation for
professional ethics.
Qualities / Components of Ethical behaviour
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 Confidentiality: Confidentiality means keeping the
patient related informations secret.
 But there are times when the pharmacist or other
practitioners may unfold the information. E.g. If the
patient is willing, If unfolding the information is much better
or useful to the society than otherwise.
 Adaptability: Is the ability to adjust one self to new or
changed circumstances/conditions .
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 Cooperation: Is a co-working system;
 The work of pharmacy is insignificant unless it is
augmented by other health practitioners.
 There fore health practice must be team work.
 Dependability: This is a condition in which one
develops to depend on others.
 In health practice there are more things to learn from
people who have a lot of experience .
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 Honest (Being loyal) : For the people to be
beneficiary and activities to be accomplished
successfully being an honest is the primary asset to
achieve .
 Responsibility:- Is the condition or the fact that one can
shoulder obligations.
 Accountability: - Is the condition or fact that one can be
called to answer for his wrong doings .
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Transparency: - This is a case in which things must run
by the book (based on rules, regulations etc.) rather than
by what is comfortable and beneficial to one self .
 Maintaining good report : It is important to prepare
good report on the activities performed at each level
Prescription handling: Prescriptions should
be properly documented so that they can be used for
auditing, reporting on drug use, and to make
investigation on which drugs have been dispensed to a
patient.
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Continues…
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Components of unethical behavior
1. Corruption – dishonest
2. Smuggling
3. Mistreating the patient
4. Behavioral
 Theft
 Drug dependence
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Code of Ethics
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 A code of ethics for a health professional is a system of
principles intended to govern behaviour of those
entrusted with providing care to the sick.
 . This code of ethics is based on the moral obligations
and designed to establish guidelines for professional
ethical behaviour.
 EPA authored the Code of Ethics for Pharmacists
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Code of Ethics
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1. Ethical principles and obligations of the
pharmacist with respect to other stake
holders during his/her professional practice
2. Ethical principles and standards in
Pharmacy practices
3. Ethical principles and Obligations on Special
Ethical Issues
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Relation to his/her patients
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I. Respects the covenantal relationship
II. Be morally obliged in a response to the gift of
trust received from the society
III. Not show partiality between his patrons.
IV. Not abuse his/her relationship with the patient
for personal gain.
V. Dedicate himself/herself to protecting the dignity
of the patient
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Relation to the public
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 At all times, act in a manner which promotes and
safeguards the interest of the public .
 Offer services in premises .
 Being an information provider and health
educator .
 Accountable for any damage that may be
inflicted on the patron as a result of negligence
or breach of professional conduct .
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Relation to the Fellow professionals
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I. Extend all support, respect &
cooperation
II. Expose any act of misconduct or
malpractice committed by a fellow
professional
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Relation to other Health professionals
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 Respect the skills and competence of other
health care providers and strive to develop a
team work spirit
 Strive to maintain and develop the role of
pharmacist
 Do Not recommend a particular medical
practitioner to the patient
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 Strive to maintain the confidence and trust
placed in other health professionals by patients
 Expose any acts of malpractice
 Do Not enter into any secret arrangement or
negotiation
 Do Not be an accomplice to any act of malpractice
April 10, 2025
As an Active professional member
82
 Actively seek to update his / her knowledge
skills of pharmacy
 Strive to join and participate in the activities
of professional associations & scientific
societies
April 10, 2025
As a Member of the Community
83
 Keep his/her honour and demonstrate a high
standard of personal integrity in the
community
 Be a law-abiding citizen
 Participating in social development activities
April 10, 2025
Dispensing of Medications in Pharmacy
84
 Personally fill all prescriptions or ensure appropriate
filling or orders
 Accept prescription only in writing except under an
emergency or compelling conditions
 Ensure that medicines and health care products are
approved for sale
 Not dispense Prescription only drugs without
prescriptions.
April 10, 2025
85
 Inform the prescriber for due correction or clarification
 Not dispense both prescription &/or OTC drugs to
patients who are apparently not in their right mental
state
 Promote that medicines would be dispensed as original
packs
 Ethically free to make generic substitution of
prescription drugs
April 10, 2025
86
 Provide an effective and accurate patient
education and counselling
 Know his/her patients with regard to cultures
 Give ample verbal and written information
 Ensure about the comfortable environment for
counselling
 Ensure about the design and layout of the pharmacy
April 10, 2025
Compounding and Manufacturing pharmaceuticals
87
 Make sure about authorized personnel involving
in the compounding
 Ensure that the compounding personnel are free
from any ailments
 Have written procedures for the compounding
drug products
 Have working procedures, cleaning
procedures/SOP
April 10, 2025
Handling of Narcotic, Psychotropic and other
dangerous drugs
88
 Keep separate and strict security storage
area
 Dispense through special prescription paper
approved by Drug regulatory authority
 Keep proper registration and submit records
to the control authorities
April 10, 2025
89
 Properly label, mark, store and dispense
poisons
 Immediately report breakage, loss or theft
 Keep expired and damaged products
separately
 Refrain from abuse of controlled substances
April 10, 2025
Quality assurance
90
 Ensure all standards are followed
 Ensure about the batch processing records
 Do Not make available for sale or distribute
substandard or adulterated products
April 10, 2025
Promotion and advertisement
91
 Don’t do self advertisement
 Refrain from misinforming the pubic or other
HCP
 Not to come under commercial pressure by drug
manufacturers
 Not participate in any promotional methods or
campaign
April 10, 2025
Pharmaceutical care practice
92
 Have good understanding of the concept
 Play a major role in promotion and
implementation of the concept
 Strive to initiate and maintain good
relationships
April 10, 2025
93
 Realizing the importance of team work and
patient participation
 Keep in mind that the patient is the main source
of information
 Ensure the pharmaceutical care provided is
having optimum quality
 Respect the rights of privacy, confidentiality and
dignity of the patient
April 10, 2025
Right to confidentiality
94
 Only use or disclose personal health
information with the consent of the patient
 Disclose to those who have a legitimate right
 Ensure that consent is obtained in writing
 Upon request of the patient, allow the
patients to inspect records
 Comply with existing laws
April 10, 2025
HCP – Patient relationship: Consumerism Vs Paternalism
97
 Medical paternalism —the belief that the health care
professional knew best—was accepted as standard practice by
most health care professionals and their patients.
 The medical rights of patients were not as widely
recognized as other rights (such as suffrage or due
process).
 Consumerism- Today, patients have become true consumers of
medical care.
 Patients wish—and have a right—to be informed and to be
asked for their consent.
April 10, 2025
PATIENTS’ RIGHTS
98
 When patients seek the care of health care
providers,
 what rights do they have?
 What can they reasonably expect from health care
providers?
 Patients can expect that clinicians will employ their
knowledge and experience in caring for them.
 As autonomous individuals, patients can expect that
health care providers will respond to their wishes
about their treatment.
April 10, 2025
HEALTH CARE PRACTITIONERS’ DUTY TO THEIR PATIENTS
100
 Some might argue that health care providers have a
Hippocratic responsibility to their patients and that
this responsibility focuses solely on what is best for
the patient, irrespective of the consequences to
others.
 The code of ethics also suggests that a pharmacist
serves individual, community and societal needs.
April 10, 2025
Thank you…
101

Chapter 1 pharmacy and Ethics for pharmacy students.pptx

  • 1.
    April 10, 2025 1 PharmacyLaw & Ethics HARAR HEALTH SCIENSE COLLEGE, DEPARTMENT OF PHARMACY For 4th Year BSc. Pharmacy Student By:- Anteneh z
  • 2.
    April 10, 2025 (PartI) Chapters view.. 2 1. What is Ethics? 2. Ethical theories 3. Ethical principles and moral rules 4. Ethical issues in health care 5. Framework for ethical analysis 6. Professional ethics 7. Ethical codes 8. Standards of practice 9. Health professional-patient relationship
  • 3.
    April 10, 2025 3 1.WHAT IS ETHICS?  The term ethics derived from the Ancient Greek word ethikos, which is derived from the word ethos (habit, “custom”).  Ethics is the systematic study of what is right and wrong with respect to conduct and character. WHAT IS ETHICS?
  • 4.
    April 10, 2025 WHATIS ETHICS? 4  It refers to a method of inquiry that assists people to understand the morality of human behavior. (i.e. it is the study of morality).  Ethics refers to the practices or beliefs of a certain group (i.e. nursing ethics, Physicians' ethics and pharmacy ethics).
  • 5.
    April 10, 2025 WHATIS ETHICS? 5  Ethics, or moral philosophy, is the branch of philosophy that involves systematizing ,defending , and recommending concepts of right and wrong conduct.
  • 6.
    April 10, 2025 Commonterms 6  Law : Law is the system of rules of conduct established by the government of a society to maintain stability and justice.  Morals: Morals are a person’s ideas about right and wrong.  Values: Values are principles of worth and are importance.
  • 7.
    April 10, 2025 Commonterms 7  Moral principles: the principles of right and wrong that are accepted by an individual or a social group.  Jurisprudence: It means study of fundamental laws and in case of pharmaceutical Jurisprudence, it is laws relating to pharmacy.
  • 8.
    April 10, 2025 Commonterms 8  Pharmaceutical jurisprudence: A branch of pharmacy, which deals with various legislations pertaining to drugs and pharmaceuticals and profession of pharmacy.  Legislation:A group of laws that have the force of authority by virtue of their promulgation by an official organ of a state or other organization.
  • 9.
    April 10, 2025 Commonterms 9  Professional ethics: Professional ethics encompass the personal, organizational and corporate standards of behaviour expected of professionals  Code of ethics: The Code of Ethics sets out the principles that you must follow as a pharmacist or pharmacy technician.  The Code is the Society’s core guidance on the conduct, practice and professional performance expected of you.
  • 10.
    April 10, 2025 LawVs Ethics 10 Laws Laws are rules of behaviour sanctioned by governments that illustrate what people can or cannot do in their workplace. i.e. Simply, Law is something you must obey. Example: a pharmacist must be on the premises at all times and oversee all medicines being dispensed and sold. Ethics Ethics means the ability to judge between right and wrong actions. i.e. ethics is how society expects you to behave.
  • 11.
    April 10, 2025 Typesof Ethics 11 Descriptive: It is also known as comparative ethics, is the study of people’s beliefs about morality. It is the description of the beliefs of various cultural, religious or social groups about health and illness  (What do people think is right?)
  • 12.
    April 10, 2025 Typesof Ethics 12  Normative: a study of human activities in a broad sense in an attempt to identify human actions that are right or wrong and good and bad qualities. (How should people act?)  Applied: It is the study of how humans applying it into practice. (How do we take moral knowledge and put it into practice?)
  • 13.
    April 10, 2025 2.Ethical theories 13  Ethical theories may help us to view an ethical problem. Consequentialism : This theory can be simply defined as 'the ends always justify the means' Acts are considered right or wrong based on how good or bad the outcomes of those acts are (1).Consider a simple example: A mother would like her daughter to focus on her homework.
  • 14.
    April 10, 2025 Ethicaltheories 14 To ensure this, the mother tells her daughter that the television show her daughter watches daily will not be aired tonight. However, this is not the truth. The daughter focuses on her homework instead of watching television, and completes her schoolwork as a result. According to the theory of consequentialism, it was right for the mother to be dishonest, since the outcome was a good one.
  • 15.
    April 10, 2025 Ethicaltheories 15  Deontology: The theory of deontology is 'the ends never justify the means.'  Acts are considered right or wrong intrinsically, regardless of the outcomes.  Considering the example given above of the mother and daughter, the mother would have committed a wrong act according to the theory of deontology.  This is because the mother lied to her daughter, and lying is considered unethical regardless of the outcome it may lead to.
  • 16.
    April 10, 2025 3.Ethical principles and moral rules 16  Ethical Principles are basic ideas that are starting points for understanding and working through a problem.  Ethical principles presuppose that pharmacists should respect the value and uniqueness of persons and consider others to be worthy of high regard.  These principles are tents that are important to uphold in all situations.
  • 17.
    April 10, 2025 Ethicalprinciples and moral rules 17  The major principles of health professionals’ ethics are: Autonomy Beneficence Nonmaleficence Justice
  • 18.
    April 10, 2025 Ethicalprinciples and moral rules 18 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 1. The autonomous person is respected 2. The autonomous person must be able to determine personal goals
  • 19.
    April 10, 2025 Ethicalprinciples and moral rules 19 Autonomy  The autonomous person has the freedom to act upon the choices  Right after admission patients are asked about personal and private matters Informed consent  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 freely.  It assures the legal protection of a patient’s right to personal autonomy in regard to specific treatments and procedures.
  • 20.
    April 10, 2025 Ethicalprinciples and moral rules 20 Beneficence  Beneficence is doing or promoting good. This principle is the basis for all health care providers. The principle of beneficence has three components: Promote health Prevent harm Remove evil or harm
  • 21.
    April 10, 2025 Ethicalprinciples and moral rules 21 Nonmaleficience  Nonmaleficence is the converse of beneficence.  It means to avoid doing harm.  When working with clients, health care workers must not cause injury or suffering to clients.  It is to avoid causing deliberate harm, risk of harm, and harm that occurs during the performance of beneficial acts.
  • 22.
    April 10, 2025 Ethicalprinciples and moral rules 22  Justice  Justice is fair, equitable and appropriate treatment  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.  It would be unjust to make such decision based on how much he or she likes each client  Any health professional should treat all the patients equally irrespective of sex, culture, race, religion, language, social status and political status
  • 23.
    April 10, 2025 Ethicalprinciples and moral rules 23 Paternalism  Restricting others autonomy to protect from perceived or anticipated harm.  The intentional limitation of another’s autonomy justified by the needs of another.  Thus, the prevention of any evil or harm is greater than any potential evils caused by the interference of the individual’s autonomy or liberty.  Paternalism is appropriate when the patient is judged to be incompetent or to have diminished decision-making capacity.
  • 24.
    April 10, 2025 Ethicalprinciples and moral rules 24 Non-compliance  Unwillingness of the patient to participate in health care activities.  Lack of participation in a regimen that has been planned by the health care professionals to be carried out by the client. Noncompliance may result from two factors:  When plans seem unreasonable to the patient  Patients may be unable to comply with plans for a variety of reasons including resources, lack of knowledge, psychological and cultural factors that are not consistent with the proposed plan of care
  • 25.
    April 10, 2025 Ethicalprinciples and moral rules 25 Veracity  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
  • 26.
    April 10, 2025 Ethicalprinciples and moral rules 26 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  Pharmacists must use good judgment when making promises to client  Fidelity means not only keeping commitment but also keeping or maintaining our obligation
  • 27.
    April 10, 2025 Ethicalprinciples and moral rules 27 Confidentiality  Confidentiality comes from Latin fide: trust.  Confide as to “show trust by imparting secrets”; “tell in assurance of secrecy ;  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
  • 28.
    April 10, 2025 4.Ethical issues in health care 28  Medical ethics is also known as biomedical ethics.  Ethical situations in health care can be divided into two broad categories: o“macro” o“micro”  Macro situations involve issues that are not specific to a given health care practitioner;
  • 29.
    April 10, 2025 29 These situations involve issues that must be addressed by all health care practitioners and society in general.  It includes issues such as abortion, assisted suicide, genomics, rationing of and access to health care, organ transplantation, and in vitro fertilization.
  • 30.
    April 10, 2025 EthicalIssues…. 30  Micro situations are those that may confront individual practitioners in the course of their daily practice.  In the case of pharmacists, they include the use of placebos, patient confidentiality and informed consent.
  • 31.
    April 10, 2025 Casescenario 31  What should a pharmacist do when a patient’s prescription for heart medicine has been depleted, no refills remain, and the prescriber is unavailable?  What if the medication is a controlled substance used for pain control in a critically ill patient? He will give the medication even if it is illegal in both cases
  • 32.
    April 10, 2025 Rationing 32 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 eg. List of essential drugs, Generic prescription
  • 33.
  • 34.
    April 10, 2025 34 Essentialmedicines, as defined by the World Health Organization(WHO) are "those drugs that satisfy the health care needs of the majority of the population; They should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford.“
  • 35.
    April 10, 2025 35 Genericname of a drug: The term "generic name" has several meanings as regards drugs: The chemical name of a drug. A term referring to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold. A term referring to any drug marketed under its chemical name without advertising.
  • 36.
    April 10, 2025 AssistedSuicide 36  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
  • 37.
  • 38.
    April 10, 2025 HumanDrug Experimentation 38  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 The IRB is the body responsible for overseeing all clinical research conducted within a given institution.
  • 39.
    April 10, 2025 Drugexperiment… 39  The IRB has two primary responsibilities: 1. To ensure the integrity and scientific rigor of the proposed research study. oIf 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
  • 40.
    April 10, 2025 Groupdiscussion 40  In which instances placebos are used?  What is the ethical dilemma related with placebo?  Which group is benefited from the drug experiment (control (placebo) orTreatment (new drug) group)  How can we solve the ethical dilemma related with drug experiment?
  • 41.
    April 10, 2025 Drugformulary 41  A drug formulary is a list of drugs that are approved for use either within an institution or for reimbursement 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?
  • 42.
    April 10, 2025 Formulary… 42 Is the use of such substitution a violation of informed consent?  Does the use of formularies violate the ethical principles of beneficence and nonmaleficence?  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).
  • 43.
    April 10, 2025 5-Frameworkfor ethical analysis 43  Ethical dilemmas appear in every area of pharmacy practice.  You cannot hide from them!  Rather than hide, we should have an approach to dealing with these dilemmas, one that is easily applicable to different types of pharmacy practice.
  • 44.
  • 45.
    April 10, 2025 Step1 45 Respond to the SenseThat Something IsWrong  Many times, the little nagging voice that will not leave you alone is enough indication that something is wrong. But just to ensure that ethical dilemmas are not passing you by in oblivion,  you should ask yourself some questions to make sure everything is ethically sound when dealing with patients
  • 46.
    April 10, 2025 46 Forexample, consider asking yourself some of these questions:  Is the patient's autonomy being breached?  Am I considering the patient's individual wishes and values?  Am I maximizing benefit while minimizing harm for the patient  If you find that some of the ethical principles discussed earlier are being breached, then you likely have an ethical dilemma on your hands.
  • 47.
    April 10, 2025 Step2 47  Collect Information  This is an essential step.  Do not make an assumption concerning what exactly the ethical dilemma is without gathering all relevant information!  Collect all the details surrounding the dilemma.  Who is involved?  When did this occur?  How have others responded to the dilemma?  Collect and organize all your facts.
  • 48.
    April 10, 2025 Step3 48  .Identify the Ethical Problem/Moral Diagnosis  At this point, you know something is wrong, and you have all the facts surrounding the incident.  Now is the time to ask yourself, 'What exactly is the dilemma?'  Identify what the source of the concern is.  What is at the heart of the issue?  Once you have defined exactly what the problem is, you are on the right track to begin tackling the dilemma!
  • 49.
    April 10, 2025 Step4 49 Seek a Resolution To resolve the dilemma, consider the following:  4 principles of medical ethics (autonomy, justice, beneficence, non-maleficence  Laws (acts and regulations which govern the profession of pharmacy)  Financial concerns  Commitments to friends and families  There may be more factors to consider, or you may not find all applicable to your situation. Use your judgement, but try to consider all important factors.
  • 50.
    April 10, 2025 Step5 50  Work with Others to Choose a Course of Action Never make decisions regarding ethical dilemmas on your own.  Similar to the collaborative approach of solving drug therapy problems,  we should collaborate with other health care providers when encountered with ethical dilemmas.  Involving others in your decision-making process helps you to filter out any personal biases you may have but do not recognize (we all have them, don't beat yourself up about it too much).
  • 51.
    April 10, 2025 51 Ultimately, consulting with others protects you from making any rash, uninformed, biased, or paternalistic decisions.  Instead, your decisions will be thoughtful, well- informed, and sensitive to all members involved in the ethical dilemma.
  • 52.
    April 10, 2025 Step6 52 "DOCUMENTATION!"  Documentation is important!  Documenting all the steps you have taken to reach a decision demonstrates a thorough and logical thought process.  It also illustrates who you consulted with, and what factors you considered to reach a final decision.
  • 53.
    April 10, 2025 53 If possible, also document what the final outcome was of the ethical dilemma.  Most importantly, documentation also serves as a form of protection for you.  If after all that straining of your ethical reasoning skills, the outcome of the ethical dilemma was an unfortunate one, that documentation will come in handy.
  • 54.
    April 10, 2025 Casestudy 54  Mr.Tesfaye Gabrie, 70 yrs old in ICU (PE) & fractured his femur in fall at the nursing home & awaiting surgery the next morning when he developed dyspnea, tachypnea, & tachycardia.  In ICU, another patient Mr.Yohannes Sileshi, 60 yrs old admitted in next room with a history of liver cirrhosis from alcohol abuse. He has ruptured esophageal varices.  Abraham dereje, Pharm.D., was the pharmacy supervisor for 6 ICU in the hospital. He & other 2 pharmacists worked frantically to fill all the orders for IV drugs & parenteral solutions that came from ICU units.
  • 55.
    April 10, 2025 Continues... 55 Dr. Dereje decided to conduct rounds and noticed that Mr. Sileshi had died. He noticed the IV bag included heparin not the octreotide in the trash. He came to know that the Ivs were inappropriately labeled.  Dr. Dereje knew that its a critical case even though the mix-up with the heparin may not have had anything to do with Mr. Sileshi’s death, but he knew that such a patient should not receive Heparin.  Next step should be to stop the octreotide IV & notify the pharmacy to send up the right drug for Mr. Gabrie. Also he has to inform to Dr. Mulalem, intensivist. But he knew that he can’t tolerate mistakes & also about the issue of Mr. Sileshi’s family.
  • 56.
    April 10, 2025 Commentary 56 This case is complex but reveals potential ethical concerns. As the pharmacist involved in the case, Dr. Dereje will need to decide what he needs to do and why. The six-step model can help Dr. Dereje work toward a justifiable resolution.
  • 57.
    April 10, 2025 1.Respond to the Sense That something is wrong 57  In this case, Dr. Derege happened to notice the discarded IV bag that led to his discovery of a drug error that may or may not have contributed to Mr. Sileshi’s death.  Dr. Derege also experiences a sense of dread fear or anxiety when he thinks about reporting the error to the intensivist in charge of both patients  These negative emotions are indications that an ethical problem is present.
  • 58.
    April 10, 2025 2.CollectInformation 58  To organize the numerous facts in the situation in which Dr. Derege is involved, one can classify them into clinical and situational information  clinical information In Mr. Sileshi’s case His illness was acute and life-threatening. If not treated immediately with appropriate drug therapy and other life-saving measures, Mr. Sileshi would certainly die from hemorrhage and shock The administration of heparin to a patient who is already hemorrhaging would increase the risk of bleeding, but it may not have hastened Mr. Sileshi’s death.
  • 59.
    April 10, 2025 2.CollectInformation 59  Situational information includes data regarding the values and perspectives of the principals involved; their authority; verbal and nonverbal communication, including language barriers; cultural and religious factors; setting and time constraints; and the relationships of those immediately involved in the case.  urgency and time constraints  In other words, even if the clinical “facts” of a case remain constant, changes in the situational or contextual factors, such as the values of a key principal in the case, could change the ethical focus or intensify the ethical conflict.  Of all the situational data mentioned, the most important is the identification and understanding of the value judgments involved in a case
  • 60.
    April 10, 2025 60 In this case the principal involved are  the two patients,  any family involved,  Dr. Derege,  Dr. Mulalem,  the pharmacist(s) who prepared the drugs,  and members of the nursing staff responsible for hanging the IV medications We know specifically that Dr. Mulalem “. . . did not tolerate mistakes
  • 61.
    April 10, 2025 61 Each member’s responsibilities are distinct yet overlap.  As part of the information-gathering step it is important to sort out the various responsibilities, not for placing blame but for identifying moral accountability  In this case Dr. Derege may not be the one who mislabeled the IV bags, but..  as evening supervisor he has overarching responsibility for all medications that leave the pharmacy.  Second, he is the one who discovered the error. Knowledge of the error carries its own responsibility.
  • 62.
    April 10, 2025 Identifythe Ethical Problem/Moral Diagnosis 62  The ethical principles most often involved in complex cases, such as Dr. Derege’s situation, are:  (1) patient and health professional autonomy,  (2) beneficence and nonmaleficence, and  (3) justice. • veracity, fidelity, and avoidance of killing are treated as possible principles
  • 63.
    April 10, 2025 63 All we know for certain is that the error deprived him of drug therapy that could have provided benefit.  The error may have caused harm to Mr. Gabriel as well. He too was deprived, at least for a while, of a treatment that could have helped him.
  • 64.
  • 65.
    April 10, 2025 Introduction 65 Pharmacy is the field of expertise that ensures the availability, accessibility, and the responsible use of medicines.  The pharmacist is the professional who is particularly competent within that field.
  • 66.
    April 10, 2025 Professionalethics - Definition 66  Professional ethics encompass the personal, organizational and corporate standards of behaviour expected of professionals.  Professionals, and those working in acknowledged professions, exercise specialist knowledge and skill.  How the use of this knowledge should be governed when providing a service to the public can be considered a moral issue and is termed professional ethics.  .
  • 67.
    April 10, 2025 Professionalethics - Definition 67  Professionals are capable of making judgements, applying their skills and reaching informed decisions in situations that the general public cannot, because they have not received the relevant training.  Profession;- A profession needs extensive training and specialized knowledge.  Occupation:-An occupation does not need any extensive training.  A person with an occupation need not have specialized knowledge of his trade
  • 68.
    April 10, 2025 68 •Guidelinesfor professional ethics are based on principalism, which is the application of four distinct moral principles. •These principles function as a framework to express general values of common morality. • Respect for autonomy • Non-maleficence • Beneficence • Justice
  • 69.
    April 10, 2025 69 Also, veracity (truthfulness) is important; healthcare providers should be truthful to patients and families.  The four principles are applied to actions and decision making, constituting the foundation for professional ethics.
  • 70.
    Qualities / Componentsof Ethical behaviour April 10, 2025 70  Confidentiality: Confidentiality means keeping the patient related informations secret.  But there are times when the pharmacist or other practitioners may unfold the information. E.g. If the patient is willing, If unfolding the information is much better or useful to the society than otherwise.  Adaptability: Is the ability to adjust one self to new or changed circumstances/conditions .
  • 71.
    April 10, 2025 71 Cooperation: Is a co-working system;  The work of pharmacy is insignificant unless it is augmented by other health practitioners.  There fore health practice must be team work.  Dependability: This is a condition in which one develops to depend on others.  In health practice there are more things to learn from people who have a lot of experience .
  • 72.
    April 10, 2025 72 Honest (Being loyal) : For the people to be beneficiary and activities to be accomplished successfully being an honest is the primary asset to achieve .  Responsibility:- Is the condition or the fact that one can shoulder obligations.  Accountability: - Is the condition or fact that one can be called to answer for his wrong doings .
  • 73.
    April 10, 2025 73 Transparency:- This is a case in which things must run by the book (based on rules, regulations etc.) rather than by what is comfortable and beneficial to one self .  Maintaining good report : It is important to prepare good report on the activities performed at each level Prescription handling: Prescriptions should be properly documented so that they can be used for auditing, reporting on drug use, and to make investigation on which drugs have been dispensed to a patient.
  • 74.
    April 10, 2025 Continues… 74 Componentsof unethical behavior 1. Corruption – dishonest 2. Smuggling 3. Mistreating the patient 4. Behavioral  Theft  Drug dependence
  • 75.
    April 10, 2025 Codeof Ethics 75  A code of ethics for a health professional is a system of principles intended to govern behaviour of those entrusted with providing care to the sick.  . This code of ethics is based on the moral obligations and designed to establish guidelines for professional ethical behaviour.  EPA authored the Code of Ethics for Pharmacists
  • 76.
    April 10, 2025 Codeof Ethics 76 1. Ethical principles and obligations of the pharmacist with respect to other stake holders during his/her professional practice 2. Ethical principles and standards in Pharmacy practices 3. Ethical principles and Obligations on Special Ethical Issues
  • 77.
    April 10, 2025 Relationto his/her patients 77 I. Respects the covenantal relationship II. Be morally obliged in a response to the gift of trust received from the society III. Not show partiality between his patrons. IV. Not abuse his/her relationship with the patient for personal gain. V. Dedicate himself/herself to protecting the dignity of the patient
  • 78.
    April 10, 2025 Relationto the public 78  At all times, act in a manner which promotes and safeguards the interest of the public .  Offer services in premises .  Being an information provider and health educator .  Accountable for any damage that may be inflicted on the patron as a result of negligence or breach of professional conduct .
  • 79.
    April 10, 2025 Relationto the Fellow professionals 79 I. Extend all support, respect & cooperation II. Expose any act of misconduct or malpractice committed by a fellow professional
  • 80.
    April 10, 2025 Relationto other Health professionals 80  Respect the skills and competence of other health care providers and strive to develop a team work spirit  Strive to maintain and develop the role of pharmacist  Do Not recommend a particular medical practitioner to the patient
  • 81.
    April 10, 2025 81 Strive to maintain the confidence and trust placed in other health professionals by patients  Expose any acts of malpractice  Do Not enter into any secret arrangement or negotiation  Do Not be an accomplice to any act of malpractice
  • 82.
    April 10, 2025 Asan Active professional member 82  Actively seek to update his / her knowledge skills of pharmacy  Strive to join and participate in the activities of professional associations & scientific societies
  • 83.
    April 10, 2025 Asa Member of the Community 83  Keep his/her honour and demonstrate a high standard of personal integrity in the community  Be a law-abiding citizen  Participating in social development activities
  • 84.
    April 10, 2025 Dispensingof Medications in Pharmacy 84  Personally fill all prescriptions or ensure appropriate filling or orders  Accept prescription only in writing except under an emergency or compelling conditions  Ensure that medicines and health care products are approved for sale  Not dispense Prescription only drugs without prescriptions.
  • 85.
    April 10, 2025 85 Inform the prescriber for due correction or clarification  Not dispense both prescription &/or OTC drugs to patients who are apparently not in their right mental state  Promote that medicines would be dispensed as original packs  Ethically free to make generic substitution of prescription drugs
  • 86.
    April 10, 2025 86 Provide an effective and accurate patient education and counselling  Know his/her patients with regard to cultures  Give ample verbal and written information  Ensure about the comfortable environment for counselling  Ensure about the design and layout of the pharmacy
  • 87.
    April 10, 2025 Compoundingand Manufacturing pharmaceuticals 87  Make sure about authorized personnel involving in the compounding  Ensure that the compounding personnel are free from any ailments  Have written procedures for the compounding drug products  Have working procedures, cleaning procedures/SOP
  • 88.
    April 10, 2025 Handlingof Narcotic, Psychotropic and other dangerous drugs 88  Keep separate and strict security storage area  Dispense through special prescription paper approved by Drug regulatory authority  Keep proper registration and submit records to the control authorities
  • 89.
    April 10, 2025 89 Properly label, mark, store and dispense poisons  Immediately report breakage, loss or theft  Keep expired and damaged products separately  Refrain from abuse of controlled substances
  • 90.
    April 10, 2025 Qualityassurance 90  Ensure all standards are followed  Ensure about the batch processing records  Do Not make available for sale or distribute substandard or adulterated products
  • 91.
    April 10, 2025 Promotionand advertisement 91  Don’t do self advertisement  Refrain from misinforming the pubic or other HCP  Not to come under commercial pressure by drug manufacturers  Not participate in any promotional methods or campaign
  • 92.
    April 10, 2025 Pharmaceuticalcare practice 92  Have good understanding of the concept  Play a major role in promotion and implementation of the concept  Strive to initiate and maintain good relationships
  • 93.
    April 10, 2025 93 Realizing the importance of team work and patient participation  Keep in mind that the patient is the main source of information  Ensure the pharmaceutical care provided is having optimum quality  Respect the rights of privacy, confidentiality and dignity of the patient
  • 94.
    April 10, 2025 Rightto confidentiality 94  Only use or disclose personal health information with the consent of the patient  Disclose to those who have a legitimate right  Ensure that consent is obtained in writing  Upon request of the patient, allow the patients to inspect records  Comply with existing laws
  • 95.
    April 10, 2025 HCP– Patient relationship: Consumerism Vs Paternalism 97  Medical paternalism —the belief that the health care professional knew best—was accepted as standard practice by most health care professionals and their patients.  The medical rights of patients were not as widely recognized as other rights (such as suffrage or due process).  Consumerism- Today, patients have become true consumers of medical care.  Patients wish—and have a right—to be informed and to be asked for their consent.
  • 96.
    April 10, 2025 PATIENTS’RIGHTS 98  When patients seek the care of health care providers,  what rights do they have?  What can they reasonably expect from health care providers?  Patients can expect that clinicians will employ their knowledge and experience in caring for them.  As autonomous individuals, patients can expect that health care providers will respond to their wishes about their treatment.
  • 97.
    April 10, 2025 HEALTHCARE PRACTITIONERS’ DUTY TO THEIR PATIENTS 100  Some might argue that health care providers have a Hippocratic responsibility to their patients and that this responsibility focuses solely on what is best for the patient, irrespective of the consequences to others.  The code of ethics also suggests that a pharmacist serves individual, community and societal needs.
  • 98.

Editor's Notes

  • #1 Pharmacy is a noble and sacred profession. Because it is one of the profession which provides health care to the human beings. The pharmacist is health care practitioner who is a vital link between a physician and patient. He is charged with the responsibility of providing professional services to the community like production of a medicine (quality) and their sale and distribution to the consumers. The pharmacist of today is a drug-maker, drug-dispenser, drug-custodian, patient-counsellor, drug-researcher and drug-educator and above all a honest and patriotic citizen. In the current status, the role of pharmacist has shifted from the drug oriented to patient oriented. In order to ensure this professional role of pharmacist, there has to be an ethical framework within which a pharmacist is supposed to function. He/she should be familiar with the types of laws governing his/her profession and also the developments that have contributed to the current status of pharma education, pharmacy practice and pharmaceutical industry. Because in this tidy profession, wherever an error occurs which will affect directly or indirectly the life of a human being. For instance, We routinely handle substances where an error in dispensing can be fatal and an error in distribution, shipping or purchasing could result in dangerous drugs being available on the street through illegal, unregulated channels. Most of these laws, regulations, act and ethics have resulted from the problems that occured in the past, or have been put into place in an effort to avoid improper events. Hence It is important for a pharmacy personnel to understand pharmacy law and ethics. There are two main reasons for pharmacy personnel to study law and ethics: The first is to help you function at the highest professional level by providing competent, compassionate health care to patients, and the second is to help you avoid legal problems that can threaten your ability to earn a living.
  • #3 At its simplest, ethics is a system of moral principles. They affect how people make decisions and lead their lives. Ethics is concerned with what is good for individuals and society and is also described as moral philosophy. 1st & 2nd point’s explanation: The word "ethics" in English can mean several things. As a branch of philosophy, ethics investigates the questions “What is the best way for people to live?” and “What actions are right or wrong in particular circumstances?” 3rd point’s explanation: In practice, ethics seeks to resolve questions of human morality, by defining concepts such as good and evil, right and wrong, virtue and vice, justice and crime. (Moral principles : the principles of right and wrong that are accepted by an individual or a social group)
  • #5 Ethics is concerned with morality, and hence is often called Moral philosophy. Ethics is a philosophical study of good, bad, right and wrong.
  • #10 Law is the system of rules of conduct established by the government of a society to maintain stability and justice. Law defines the legal rights and duties of the people and provides the means of enforcing these rights and duties. Governments enact laws to keep society running smoothly and to control behavior that could threaten public safety. Ethics is considered a standard of behavior and a concept of right and wrong beyond what the legal consideration is in any given situation. Moral values serve as a basis for ethical conduct. Moral values are formed through the influence of the family, culture, and society.
  • #11  Descriptive (comparative): It is the description of the beliefs of various cultural, religious or social groups about health and illness Normative (prescriptive): a study of human activities in a broad sense in an attempt to identify human actions that are right or wrong and good and bad qualities. (How should people act?) Applied : How do we take moral knowledge and put it into practice?
  • #31 He will give the medication even if it is illegal in both cases
  • #33 Essential medicines, as defined by the World Health Organization(WHO) are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford.“ Generic name, drug: The term "generic name" has several meanings as regards drugs: The chemical name of a drug. A term referring to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold. A term referring to any drug marketed under its chemical name without advertising. "Diazepam" is an example of the chemical (generic) name of a sedative. It is marketed by some companies under its generic name and by other companies under brand names such as Valium or Vazepam. Generic drugs marketed without brand names are less expensive than brand-name drugs even though they are chemically identical to brand-name drugs and meet U.S. Food and Drug Administration (FDA) standards for safety, purity and effectiveness.
  • #35 "Diazepam" is an example of the chemical (generic) name of a sedative. It is marketed by some companies under its generic name and by other companies under brand names such as Valium or Vazepam. Generic drugs marketed without brand names are less expensive than brand-name drugs even though they are chemically identical to brand-name drugs and meet U.S. Food and Drug Administration (FDA) standards for safety, purity and effectiveness.
  • #40 Placebos have 2 major roles in medicine: (1) in clinical drug research, and (2) as a means of decreasing the dose of or weaning a patient off a drug to which a patient has become dependent.
  • #44 A few important steps have been added to ensure that you consider every factor from beginning to end: 
  • #45 Many times, the little nagging voice that will not leave you alone is enough indication that something is wrong. But just to ensure that ethical dilemmas are not passing you by in oblivion, you should ask yourself some questions to make sure everything is ethically sound when dealing with patients. For example, consider asking yourself some of these questions: Is the patient's autonomy being breached? Am I considering the patient's individual wishes and values? (Principle of autonomy)  Am I maximizing benefit while minimizing harm for the patient (Principles of beneficence and non-maleficence)  If you find that some of the ethical principles discussed earlier are being breached, then you likely have an ethical dilemma on your hands.
  • #49 Easier said (or written) than done, right? This is the meat and flesh of it all, but do not become daunted by the task when you've come so far! When you factor in additional pieces to the puzzle, finding the best solution for everyone involved becomes easier to tease out. 
  • #50 Never make decisions regarding ethical dilemmas on your own. Similar to the collaborative approach of solving drug therapy problems, we should collaborate with other health care providers when encountered with ethical dilemmas. This is encouraged in the OCP Code of Ethics:  Principle Seven: Each member collaborates with other health care professionals to achieve the best possible outcomes for the patient, understanding the individual roles and contributions of other health care providers and consulting with or referring to them as appropriate. Involving others in your decision-making process helps you to filter out any personal biases you may have but do not recognize (we all have them, don't beat yourself up about it too much). Ultimately, consulting with others protects you from making any rash, uninformed, biased, or paternalistic decisions. Instead, your decisions will be thoughtful, well-informed, and sensitive to all members involved in the ethical dilemma.
  • #52 Phew. Steps 1-5 were a lot of work. Don't you wish you could put that down on paper and store all that hard work? Well you should! And I am certain your professors have hammered this into your minds. Mine most definitely have. A constant stream of yells and shouts over the past 4 years, all harmoniously coming together like your fifth grade choir group: "DOCUMENTATION, DOCUMENTATION, DOCUMENTATION!"  I am quite happy to tell you that it is no different with ethical dilemmas. Documentation is important! Documenting all the steps you have taken to reach a decision demonstrates a thorough and logical thought process. It also illustrates who you consulted with, and what factors you considered to reach a final decision. If possible, also document what the final outcome was of the ethical dilemma.   Most importantly, documentation also serves as a form of protection for you. If after all that straining of your ethical reasoning skills, the outcome of the ethical dilemma was an unfortunate one, that documentation will come in handy. A Documentation Tool for Ethical Dilemmas is available on this website. You can click on the link below to access it. 
  • #58 Even if the treatment was effective in managing the bleeding, it would not resolve the underlying problem of cirrhosis
  • #61 These are only some of the facts affecting ethical decision-making in this case.
  • #64 Pharmacy is the field of expertise that ensures the availability, accessibility, and the responsible use of medicines. The pharmacist is the professional who is particularly competent within that field. In a number of aspects pharmacy practice in Ethiopia has been developing differently compared to other countries. Also Pharmacists in Ethiopia started to behave autonomously, can delegate tasks in a professional and responsible manner to competent assistants, are trained in pharmacotherapy and have easy access to prescribers, are accustomed to working as part of a team, and experience significant patient loyalty. However, the role and position in society of the pharmacist as a professional are not self-evident. The professional should be more aware than ever before of his actions in situations that require his expertise, but in which decisions are not made exclusively by him or in which he himself cannot give a unanimous opinion based solely on his own competences and expertise. Such dilemma’s and issues are a natural part of the existence of a professional. This demands a foundation for the profession.
  • #66 Professionals, and those working in acknowledged professions, exercise specialist knowledge and skill. How the use of this knowledge should be governed when providing a service to the public can be considered a moral issue and is termed professional ethics. Professionals are capable of making judgements, applying their skills and reaching informed decisions in situations that the general public cannot, because they have not received the relevant training. One of the earliest examples of professional ethics is the Hippocratic oath to which medical doctors still adhere to this day.
  • #68 The words occupation and profession are interchangeable. Profession and occupation are almost the same, with only minor differences between them. The difference between occupation and profession can be stated with a simple example: Designing a building would be called a profession, whereas, constructing a building is an occupation.
  • #69 Guidelines for professional ethics are based on principalism, which is the application of four distinct moral principles. These principles function as a framwork to express general values of common morality. The four principles are as follows:
  • #75 EPA authored the Code of Ethics for Pharmacists. This code of ethics is based on the moral obligations and designed to establish guidelines for professional ethical behaviour.
  • #77 For the better treatment outcomes
  • #78 To help the people and society make the best use of them
  • #79 For information gathering
  • #80 An effective provision of healthcare service is based on multidisciplinary approach.
  • #82 Participation in different professional associations for the development of the community & the pharmacy profession
  • #83 Actively participate in the community services
  • #97 THE HEALTH PROFESSIONAL–PATIENT RELATIONSHIP: CONSUMERISM VERSUS PATERNALISM   Not long ago, when patients were instructed by their physician or pharmacist to have an operation, go for a laboratory test, or take a medication, they did so without question. Medical paternalism—the belief that the health care professional knew best—was accepted as standard practice by most health care professionals and their patients. The medical rights of patients were not as widely recognized as other rights (such as suffrage or due process). Today, patients have become true consumers of medical care. Patients wish—and have a right—to be informed and to be asked for their consent. To do otherwise would be both unprofessional and unethical—not to mention the potential legal ramifications. Patients expect a certain level of service. As with sellers of other goods and services, health professionals who fail to meet the demands of health care consumers may lose customers or experience legal problems
  • #98 PATIENTS’ RIGHTS   When patients seek the care of health care providers, what rights do they have? What can they reasonably expect from health care providers? Patients can expect that clinicians will employ their knowledge and experience in caring for them. As autonomous individuals, patients can expect that health care providers will respond to their wishes about their treatment. At first glance, the American health care system seems fundamentally based upon ensuring the rights of patients. Patients generally choose their own physician, pharmacy, and hospital. Patients are allowed to choose from multiple options for treatment when they exist (such as surgery versus drug therapy). Patients must give their approval, through the process of informed consent, prior to the initiation of care. All of the preceding presupposes that treatment is available and that the patient has the economic wherewithal to pay for that treatment. For patients who are uninsured or lack the ability to pay (like Leo), the right to choose the nature of their health care is meaningless. As Mappes and Zembaty argue, the United Nations (UN) Declaration of Human Rights may state “that all persons have a right to medical treatment” (1991, p. 36), but “A citizen of the United States . . . cannot walk into a hospital, demand and receive treatment simply on the basis of the claim that the UN Declaration proclaims his or her right to such care” (1991, p. 37). Patients also have a right to treatment that is both safe and effective within given parameters. The fundamental question that must be posed prior to considering any medical or surgical treatment for a patient is, “Is the treatment safe and effective?” Such a legal standard for drugs has been in effect since the early part of last century (Musto, 1987). Not only must a drug be shown to be effective—that is, able to produce the effect for which it was administered—but it must do so with a certain degree of safety.
  • #99 MORAL RIGHTS VERSUS LEGAL RIGHTS TO HEALTH CARE It is important in any discussion of health care ethics to be clear about what is meant by the term rights. In contemporary U.S. society, one frequently refers to the legal rights of individuals. These are rights that are guaranteed fundamentally in the U.S. Constitution (such as the right of free speech and the right of assembly) or are provided by laws and regulations promulgated at the federal, state, or local level. We sometimes confuse what is really a legal duty (such as providing free elementary and secondary school education) with our moral obligation to do something (such as our responsibility to ensure that the next generation of Americans is provided with an adequate education). Moral rights may be strengthened by laws, but their basis lies not in the law, but in ethical principles. Such rights might include the right to live without fear of harm and the right to food and adequate shelter. More recently, Americans have grappled with the question of health care as a moral right. Do Leo and his children, for example, have a moral right to adequate health care? As one might expect, moral rights and legal rights may be in conflict. There is disagreement over whether issues like abortion involve moral rights or legal rights. The question of the right to die has been played out in the media across the country. Dr. Jack Kevorkian and his so-called suicide machine have forced this society to deal with a moral question in legal terms.
  • #100 HEALTH CARE PRACTITIONERS’ DUTY TO THEIR PATIENTS   What is the responsibility of health care practitioners? As Mappes and Zembaty point out, “The [Hippocratic] oath requires physicians to act so as to ‘benefit’ the sick and ‘keep them from harm’” (1991, p. 45). Some might argue that health care providers have a Hippocratic responsibility to their patients and that this responsibility focuses solely on what is best for the patient, irrespective of the consequences to others. This view is supported by the Code of Ethics of the APhA, which states, “A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner” (APhA, 1995, p. 2131). The code suggests that pharmacists have a moral obligation to do whatever they deem necessary in the interest of their patients. But the code goes on to state, “A pharmacist serves individual, community and societal needs.” Therefore, how far does a pharmacist’s or another health care professional’s duty to his or her patients go? Is it the health care professional’s moral obligation to care for patients without exception?