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1. Uruk University
College of Pharmacy
3th Stage
2nd course
Mohammed Hasan, MSc.
Master in pharmacology and toxicology / University of Toledo/United States
Assistant Lecturer at college of Pharmacy
Uruk University
2019-2020

2. Ethics and morals
• The word ethics is derived from the Greek word ethos, which means a person’s character, nature or
disposition (
‫ر‬ّ‫ي‬‫تغ‬
)
• Ethics is the branch of philosophy that deals with the moral (
‫األخالق‬
) dimension of human life
• Ethics deals with what is right and wrong, good or bad. Culture and religion often play a dominant
role in determining ethical behavior.
❖ Bioethics )biology and medicine)
❖ Medical ethics (clinical medicine)
❖ Professional ethics ( person or groups in business environment)
• Morality is the differentiation of intentions, decisions and actions between those that are
distinguished as proper and those that are improper

3. Ethics and morals
• Values are those ideas, beliefs, attitudes and characteristics considered to be valuable and
worthwhile by an individual, a group or society in general
Ethics and morals ( Are they same ? )
• relate to “right” and “wrong” conduct. While they are sometimes used interchangeably, they
are different;
ethics refer to rules provided by an external source, e.g., codes of conduct in workplaces or
principles in religions. Morals refer to an individual's own principles regarding right and wrong

4. Laws and ethics
• Laws establish minimum standards of behavior that everyone must meet, and it is influenced by
moral and ethical principles.
• Three main areas of laws criminal law ( protecting the community) , civil law ( issues between
individual ) and administrative law ( procedures ensure that systems are regulated)
• Medical ethics is also closely related to law, because ethical standards need to be precisely defined
but is subjected to individual interpretation; However, ethics and law are not identical, laws differ
significantly from one country to another while ethics is applicable across national boundaries
• Example ( pharmacist act in emergency )

5. Ethics studying
• The study of ethics grouped into 3 areas
❖ Descriptive (Study of people belief, people opinion)
❖ Metaehics ( nature of ethical statements and language )
❖ Normative (study of ethical action, what is morally right and wrong)
Ethics Theories
• They provide a framework within which the acceptability of actions can be assessed.
• Absolutist theories depend on the assumption that there is an absolute right or wrong.

6. Ethics theories
Normative theories of ethics
They are different types depend on the way in which they provide ethical guidance
❑ Virtue ethics
It emphasis on the character of the person performing the action rather than on the action itself. It
concentrate on the importance of inner character traits like honesty, courage, faithfulness and
trustworthiness
• Example: treating patients with deadly infectious diseases where there is substantial risk involved for
the health care practitioner and his or her family
❑ Consequentialist theories :
evaluate actions by reference to their outcomes.
The action is morally right or wrong depend on it’s usefulness. )For example, undergoing or performing
an abortion may not be considered by anyone to be intrinsically good, but many people would
occasionally consider it extrinsically valuable as a means to another end, such as the restoration of an ill
woman to a state of health)

7. Ethics theories
Normative theories of ethics
They are different types depend on the way in which they provide ethical guidance
❑ Deontological theories :
They deal with actions as they are intrinsically right or wrong regardless of their consequences.
So we have a duty to perform acts that are intrinsically good (good in them) and a duty to refrain from
intrinsically bad acts.
Kantianism theory
Kant argues that to act in the morally right way, people must act from duty and that it was not the
consequences of actions that make them right or wrong but the motives of the person who carries
out the action

8. Ethicalprinciples
• It identifies 4 moral commitments relevant in health care and compatible with the major ethical
theories
(principlism introduced in late 1970s)
• The 4 ethical principlesare:
✓ Autonomy – self governance and respect for persons
✓ Non – Maleficence – avoiding harm
✓ Beneficence – providing good
✓ Justice – Fairness

9. Ethicalprinciples
❑ Autonomy
• Refers to the moral right of patients to make their own decisions
• often referred to as first among equals because it contributes to the other three principles, is described as
“the ability to think for oneself about the way one wishes to lead one’s life based on that thinking, and then to
enact those decisions.” ‫كقانون‬ ‫جعلها‬
❑ Beneficence
means TO DO good and avoid harm, and includes an obligation to help patients
❑ Justice
sometimes referred to as distributive justice, is the principle that people in similar situations should be treated
equitably

10. Ethicalprinciples
❑ Nonmaleficence
• Means to do no harm and is interpreted to mean ensuring that potential benefits outweigh the potential risks
• Nonmaleficence is the principle of not doing harm. So while beneficence is an action you
take, nonmaleficence is when you avoid an action. Don't give someone a cigarette if they're trying to quit
• refusal of a pharmacist to sell a medication if the pharmacist thought it was being purchased for wrong
reason

11. Ethicalissues
• Ethical issues in health care
• There is a need for increased ethical awareness in healthcare professionals due to
1) Advances and changes in health care and medical technology
2) The changing relationship between professional and patient
In recent times medical ethics has been greatly influenced by developments inhuman rights, for example
Participation in abortion was forbidden in medical codes of ethics until recently but now is tolerated under
certain conditions by the medical profession in many countries

12. Ethicalissues
Ethics in pharmacy practice involve variousissues like :
Pharmacist – Patient relationship
Empathy
Responsibility
Privacy and confidentially
Responding to errors
Supply of emergency contraception
Supply of unlicensed medications
Abortion
Assisted suicide
Euthanasia
Performance enhancement (e.g., steroids)
Risk-benefit limitations(e.g., clozapine)
Substance abuse and dependence

13. Ethicalissues
You are the pharmacist covering the MedicalFloor in an acute care community hospital.Patient JR on the MedicalFloor has
requested to speak to you regarding two newly-startedmedications. The medicationsare Zytiga (abiraterone),which is used
in the treatment of prostatecancer, and prednisone,which is given as adjunctivetherapy to Zytiga. After prescribing these
medicationsfor JR, the physiciangave JR an extensive pamphletoutliningall the adverse effects and instructionsfor use.
Upon discussion with the patient, you realize that he is uncomfortable starting these two new medications.He is worried
about all the adverse effects, and the stringent instructions for use which could reduce his qualityof life. He seems upset
about starting these medications,but states, "I know I need to do what I'm told."
Your task:
Consider if this is an ethicaldilemma
If this is an ethicaldilemma, what are the key ethical principles involved?
Case Discussion
Ethicalprinciples ?

14. Uruk University
College of Pharmacy
3rd Stage
2nd course
Mohammed Hasan, MSc.
Assistant Lecturer at college of Pharmacy
Uruk University
2019-2029

15. Code of ethics
 Is a public pledge to meet certain responsibilities and perform duties for those who do not share:
 The knowledge
 Expertise
 Professional mandate ‫التفويض‬ ‫أصحاب‬
 These codes exist to:
 Encourage optimal behavior
 Promote a sense of community between members
 They also provide more guidance for the professional practitioners.
 They assist in the resolution of professional challenges.
 Professional is person in responsibility; PHARMACIST

16. Code of ethics
 Pharmacist Code of ethics, prepared and supported by pharmacists, is intended to state publicly the
principles that form the fundamental basis of the roles and responsibilities of pharmacists. These
principles, based on moral obligations ‫األخالقي‬ ‫األلتزام‬and virtues (
‫الصدق‬
) , are established to guide pharmacists
in relationships with patients, health professionals, and society
 Q1/All the following is true regarding code of ethics EXCEPT:
o It is based on moral obligations and virtues
o Pharmacy code of ethics provide a good relation between professionals and society
o Pharmacy code of ethics prepared and supported by pharmacists
o For people who do not share expertise and knowledge
o None of above
o ANSWER IS :

17. History
 Pharmacy code of ethics has a long history starting when the Philadelphia College of Pharmacy
adopted a Code of Ethics in 1848. This early pharmacy code of ethics states the responsibility
of the pharmacist to the patient and recognizes the professional relationship between
pharmacists and physicians. Since the first legislation of the American Pharmacy Code of Ethics
as far back as 1852, the code has been revised in 1922, 1952, 1969, 1981 and 1994
 The revised 1994 code of ethics provides principles based on “moral obligations and virtues” rather
than practice-specific guidelines
 Q2/T or F
o The 1848 pharmacy code of ethics was based on moral obligations and virtues

18.  Q3/(Which code of ethics depend on practice – specific
guidelines ?)
A. 1848
B. 1922
C. 1981
D. 1994
E. A,B and C

19.  The principles of the 1994 revised pharmacist code of ethics include:
I. A pharmacist respects the relationship between the patient and pharmacist
• A pharmacist should not abuse the trust and respect of individuals and society
• This means that a pharmacist has moral obligations in response to the gift of trust received from
society. In return for this gift, a pharmacist promises to help individuals achieve optimum benefit from
their medications, to be committed to their welfare ‫رفاهية‬

20. Continue
• II. A pharmacist promotes the good of every patient in a caring, compassionate ‫رحمة‬, and
confidential ‫سرية‬ manner
 The pharmacist must make the care of patients his/her 1st concern
 A pharmacist places concern for the well being of the patient at the center of professional practice
 A pharmacist is dedicated‫مخصص‬ to protecting the dignity ‫كرامة‬ of the patient. With a caring attitude
and a compassionate spirit, a pharmacist focuses on serving the patient in a private and
confidential manner

21. Continue
III. A pharmacist respects the autonomy of each patient
 Pharmacist should encourage patients to participate in decisions about their care
 A pharmacist communicates with patients in terms that are understandable . A pharmacist need to
explain options available for treatment and help individuals to make informed decisions about
whether they wish to use particular services or treatment options

22. QUESTION
 Q4/ Which of the following is TRUE regarding 1994 revised pharmacy code of ethics
principles?
o A pharmacist should not abuse the trust and respect of individuals and society
o a pharmacist focuses on serving the patient in a private and confidential manner
o A pharmacist communicates with patients in terms that are understandable
o All of above

23. Describe the situation in terms of code of ethics
A patient participate in choosing her medication (anti histamine drug) Choose between sedating and non sedating, short
and long acting, between brand and generic and between different prices

24. Continue
 Additionally it is important to ensure consumers understand both risks and benefits associated with
the chosen options of medication management and care . A pharmacist should respect a patient’s
right to refuse to receive treatment
 Pharmacist views about a person’s lifestyle, beliefs, race, gender, age, sexuality, disability or other
perceived status SHOULD NOT prejudice ‫تضر‬ their treatment or care.
 If religious or moral beliefs ‫واالخالقية‬ ‫الدينية‬ ‫المعتقدات‬ prevent a pharmacist from providing a particular
professional service, the relevant persons or authorities are informed of this and patients are referred
to alternative providers for the service they require.

25. IV. A pharmacist acts with honesty and integrity ‫والنزاهة‬ ‫الصدق‬ in professional relationships .
 Be honest and trustworthy A pharmacist has a duty to tell the truth . A pharmacist avoids behavior or
work conditions that impair professional judgment, and actions that compromise the best decision for
the patient.
 Not only with patients, the pharmacist should be accurate and impartial when teaching others and
when providing or publishing information to ensure that you do not mislead others.
V. A pharmacist maintains professional competence ‫المهنية‬ ‫الكفاءة‬.
 A pharmacist has a duty to maintain knowledge and abilities as new medications, devices, and
technologies become available and as health information advances .
 Moreover, the pharmacist must develop his/her professional knowledge and competence so the
pharmacist must ensure that his/her knowledge, skills and performance are of a high quality, up to
date and relevant to his/her field of practice.

26. QUESTION
Q6/ T or F
o Regarding 1994 adjusted code of ethics, sometimes pharmacist view about disability and gender of a
patient may prejudice the treatment or care
o The pharmacy principles of code of ethics is not only concerned with patients but it include the
relation with others when providing information and advices
o ANSWER:

27. VI. A pharmacist respects the values and abilities of colleagues and other health professionals .
 In other words the pharmacist must show respect for others . Remember that Team working is a
key feature of everyday professional practice and requires respect, co-operation and communication
with colleagues from your own and other professions .
 When appropriate, a pharmacist asks for the consultation of colleagues or other health professionals
or refers the patient.

28.  The new additions to pharmacists code of ethics
 In the early 2000s, two new accountabilities were incorporated into the Code of Ethics
for pharmacists.
 The first of these is concerned with disclosure ‫افشاء‬ of information about others involved
in healthcare whose conduct may jeopardies ‫السلوك‬
‫قد‬
‫يعرض‬
‫للخطر‬ patient safety – the so-
called whistleblower requirement. ‫شرط‬
‫المبلغين‬
 The second is a similar obligation to report oneself to the authorities ‫ابالغ‬
‫السلطات‬ if ‘you
have good reason to believe that you may not be fit to practice for reasons of health,
conduct or competence’. ‫ابلغ‬
‫السلطات‬
‫عند‬
‫االعتقاد‬
‫بعدم‬
‫القدرة‬
‫او‬
‫الكفاءة‬

29. 1- relationship between the patient and pharmacist
2- patient in a caring, compassionate, and confidential manner
3- autonomy of each patient
4- honesty and integrity
5- competence
6- values and abilities of colleagues and other health professionals

30. Common Ethical Considerations in
Pharmaceutical Care Practice
Uruk University
College of Pharmacy
3rd Stage
2nd course
Mohammed Hasan, MSc.
Assistant Lecturer at college of Pharmacy
Uruk University
2019-2020

31. Ethical issues in pharmaceutical care practice can be divided into 2 parts:
(1) Issues which occur daily during the patient/practitioner interaction and include:
• privacy and confidentiality
• conflict of interest
• respect for patient autonomy
• duty to warn
• veracity and fidelity
• value conflicts
(2) Those which involve the allocation ‫توزيع‬ of resources, rationing, justice, and competency, are more episodic
and patient-specific, and occur in the institutional context

32.  Patient Confidentiality and Privacy Issues
 Confidentiality and privacy issues is a general duty recognized by professional ethical codes and they are
based on ethical principle of autonomy (rights of individual patient)
 Privacy is allowing individuals to limit access to information about themselves
 Confidentiality is allowing individuals to control access to information they have shared.
 Pharmaceutical care practitioners deal with patient-specific information that is personal and sensitive,
therefore patient confidentiality and privacy must be maintained at all times. This includes all written
documents and records, as well as all verbal discussions.
 It would be considered unethical to discuss or disclose personal health-related information about your
patient with one of your friends or family members who is not a health care provider and who is not
involved in the care of that patient

33.  Example: from (Ruth Rodgers. Etal. Fast track, Law and Ethics in Pharmacy Practice, 2010)
• Suppose that a pharmacist knew that an unmarried woman had a positive pregnancy test and then
gossiped‫ثرثرة‬ , with inappropriate rude remarks, about this to other staff or customers in the shop. The
woman might then have a claim against the pharmacist for breach ‫خرق‬ of confidence and for making
defamatory‫أفترائي‬ remarks about her that tended to lower her standing in the eyes of others
 Discussions with patients and discussions about specific patient cases should be held in private settings,
such as consultation rooms, conference rooms, or other private areas
 Q1/Discuss the following case in terms of maintaining privacy, how would you behave ?
 An infected person with AIDS that you know his history as a professional and you had been
asked about his health issues if he had or not by his fiancé before their marriage. How do you
behave ?
 A situation with public health benefit

34.  Conflicts of Interest
 An individual has a conflict of interest when a personal, financial, or political interest exists that undermines
his or her ability to meet or fulfill primary professional, ethical, or legal obligations.
 Doing good for the patient may or may not benefit the practitioner. (?) on the part of a health care
practitioner means that all the work, decisions, and actions taken are intended to benefit someone else
( Patient ). Keeping the patient's best interest in mind sometimes requires that a practitioner set his/her own
interest aside.
 Self-interest and the interests of employers or institutions, should not be placed before those of the suffering.
Practitioners must critically examine all patient care decisions to expose any conflict of interest issues that
may harm the patient.

35.  Example
 There is a potential for a conflict of interest if the practitioner is in a position to personally benefit from the
selection and use of a particular drug product unless that product is unique and no acceptable alternatives
exist. In either case, the practitioner needs to disclose his/her personal interest in that product to the
patient

36.  Patient Autonomy
 Autonomy means creating one’s own legislation, so this means that a person is free to choose his own life
plan and act on this plan independent of external or internal constraints.
 To make an autonomous choice by a patient: Enough information should be given to the patient to compare
alternative courses and know about the risks and benefits. Additionally All of the information about drug
therapies that practitioners share with patients must be accurate and true
 Example
 It would be considered a breech of your patient's autonomy to provide misleading drug information or
withhold information in order to convince your patient to use the pharmacotherapy you are
recommending.

38.  Patient Autonomy
 In adults with lacked autonomy ( unconscious) it is necessary to determine who is authorized to speak for
the individual, while health professionals does not automatically have this authority. However, In patients
who are critically ill, it is often the responsibility of the practitioner to make decisions that are deemed to
be in the best interest of the patient.
 Q2: T OR F
 Violating patient autonomy is acceptable in limited cases to ensure beneficence to the patient

39.  Patient Autonomy
 Example In a case in which the patient’s capacity to reason and sense of values may be affected by his or
her illness or some transitory mood and treatment would bring about an irreversible state
 This called medical paternalism

40. Consent
o Consent is to express agreement or willingness to a proposition.
o According to pharmacist code of ethics, pharmacist should respect others and this include
the legal and professional duty to obtain consent from patients for any service or treatment
provided for them.
o For a consent to be valid, Individual who is consenting:
o Must be deemed to be capable of making the decision
o Must be provided with sufficient information
o Able to weighing up this information and must be acting voluntarily

41.  Q3:Which of the following cases is considered ETHICAL ? Select all that
apply
 Discussion a patient situation with critical illness with your relative who is a medical provider
 Talking about specific details from what you faced with your organization for promotional purposes
 Telling a relative of a TB patient that he suffered from tuberculosis
 Undermine patient belief if you find that beneficence principle is the case regardless to his/ her choice

42. Ethical consideration and
ethical problems and their resolution
Uruk University
College of Pharmacy
3rd Stage
2nd course
Mohammed Hasan, MSc.
Assistant Lecturer at college of Pharmacy
Uruk University
2019-2020

43. Patient Autonomy (Cont.)
 Generally adults and children above 16 years (are competent ‫)مؤهل‬ and can be assumed to
provide consent. However, a person under the age of 16 can give a consent if he or she has
sufficient understanding and intelligence to enable him /her to understand fully what is
proposed
 Example: emergency contraception for girls < 16 years old (H.W)
 Factors to consider incompetence: inability to express preference, inability to understand
one’s situation and its consequences, inability to understand relevant information, inability to
give a reason, inability to give a rational reason, inability to give risk/benefit reasons, inability
to reach a reasonable decision

44.  Patient autonomy and consent should not be violated so for ethical decision making for
incompetent patient:
1. The medical practitioner must consult the patient’s living will if there is one.
2. If there is no living will or the living will provides no clear guidance, the medical practitioner
must consult a surrogate decision maker ‫وصي‬: either one designated by a durable power of
attorney, or a family member, in order of priority. the surrogate for health care decision-making
may make a substituted judgment and determine what the patient would prefer, given the facts
of his or her case where he or she competent to decide.
If there is no sufficient basis to make a substituted judgment, then the physician or surrogate
must decide based on his or her judgment about what would be in the best interest of the patient

45. 3. Evidence of known prior preferences can be determined by consulting the patient’s chart and
by consulting people who know the patient and his or her preferences. And used as a source for
guiding physician and pharmacist in choosing a treatment.
4. Emergencies: If the patient is not competent and no surrogate is available and his or her
advance wishes are not known and there is danger to life or danger of serious impairment to
health, and immediate treatment is necessary to avert these dangers, then the obligation to seek
informed consent is waived ‫لغى‬ُ‫ت‬
5. Non-emergencies with incompetent patients. If there is no surrogate available and no living
will, the courts should be used to appoint a guardian

46.  Duty to Warn
 Drugs can save lives, improve health, and prevent illness. However, they can also cause
harm. Some of the harm caused by drug therapies is unpredictable, but many of the harmful
effects of medications can be expected and are therefore predictable. Pharmaceutical care
practitioners are the most knowledgeable clinicians in areas such as pharmacology,
toxicology, and pharmacotherapeutics. So practitioners who treat patients with medications
have a duty to warn patients of the known risks associated with drug therapies.
 Example It would be considered a failure of your duty to warn not to inform your patient of the
potential harmful effects of drinking alcohol while taking a course of metronidazole to treat an
infection.
 Pharmacist autonomy is also closely related to the duty of the pharmacist to warn on
pharmaceutical issues and products. Warning a patient has to be balanced with the doctor’s
instructions and a conflicting situation need to be avoided.

47.  Conflicts in Value Systems
 Patients and practitioners often come from different backgrounds, religions, educational
systems, and cultures. It is important to understand that each patient can have a different set
of values and that in some cases, the patient's way of acting or deciding will be very different
from the practitioner's. The professional responsibility is to avoid practice in situations where
personal value system will conflict with practice obligations.
 In case of conflict between personal and professional values, the practitioner is bound by the
requirements of professional code of ethics to put interests of his or her patient 1st , this
problem can be easily overcome by signposting a patient to nearby pharmacy, but if there is
no nearby pharmacy, so the pharmacist must have a duty of care to the patient, if this duty
breached and harm is caused as a result, a practitioner might be subjected to the civil claim
of negligence.
 Example Practitioners who hold personal beliefs that all forms of contraception are wrong
have the obligation to see that patients requiring contraceptive pharmacotherapy have
access to those products and associated drug ‫مخدرات‬ information

48.  Veracity and fidelity ‫واالخالص‬ ‫الصدق‬
 Veracity is the obligation to tell the truth and it is an essential component of informed consent and hence
respect for autonomy. it is necessary for open and meaningful communication that is an absolute necessity
in any moral relationship between 2 persons. The relation ship between healthcare professional and
patient need to be based on mutual trust and honesty.
 Pharmacist must put in his mind that lying‫الكذب‬ may harm the patient, and even to himself specially if a lie
was found out‫اكتشفت‬, then pharmacist credibility and respect will be damaged. However veracity is not
absolute and deceiving ‫الخداع‬could be justified when veracity conflicts with other principles such as non –
maleficence.
 Example: Telling the truth to a patient who may not know that his illness is likely to be fatal is not
acceptable because telling the truth in such a case may lead a patient to be depressed and may seek a way
to end his own life, so concealing the truth is justifiable since it is in the patient’s best interests
(Beneficence), this way may be considered as a white lie

49.  Fidelity: Is the obligation of faithfulness‫االخالص‬ and is concerned with acting in a good faith, promises and
fulfilling agreements, integrity and honesty. Among the duties of fidelity is the duty of loyalty and an
obligation to put the patient’s interest first. Issues can arise when there are conflicts of interests or dividing
loyalties.
 Among the promises that made by pharmacists is the promise to keep patient information confidential

50.  Justice is about equal access to health care. Or it is the equitable distribution of benefits and
burdens (harms) unless exceptional conditions apply . So for example Justice mean that two
patients with the same medical condition need ought not be treated differently, but not all
patients have an equal need and it is not always possible to provide the same level of care to
all patients at all times. Consequently, a system has to be established to provide care as fairly
as possible.
 There is no justice in using very expensive drug that has a limited benefit to treat a patient
with rare disease which is not life threatening and can be managed with simple preventive
measures, since high cost medication are not life saving and decrease available money that
needed to be spent on drugs that treat life threatening disease, however the same example
may be considered justice if the drug is the only available drug and it is life saving
 H.W
 It would be (ethical or unethical) for a pharmacist to directly advice against a doctor’s
instruction to a patient without informing the doctor involved
Which consideration applied ?

51. Ethical problems and their resolution
Uruk University
College of Pharmacy
3rd Stage
2nd course
Mohammed Hasan, MSc.
Assistant Lecturer at college of Pharmacy
Uruk University
2019-2020

52.  Ethical problem in pharmacy can be defined as the conflict between moral obligations or
norms that can put in danger the pharmacological treatment that is best for the patient
 In general, there are two origins of ethical problems:
1-Those originating from doubts about the morality of the act in itself in the face of strongly
opposed arguments. Example Man Stealing a drug that he doesn’t have enough money to save
his child life !!!
2-Those originating from doubt about the decision whether to do one thing or another, both
being mutually exclusive events can’t occur simultaneously, and implying a moral obligation.

53.  Identifying Ethical Problems
 Identifying an ethical problem is not always an easy task. Identifying and addressing ethical
problems would be easier if they were not so often confused with clinical and legal issues.
 As a general rule, clinical problems should be identified and resolved first, followed by legal
issues, and if an ethical problem remains, it can then be resolved effectively
 Identifying ethical issues is a central part of communication , this means that knowing the
patient is the first step to achieving any success at authentic ‫حقيقي‬ caring. Through:
 discussion with the patient the practitioner can gather information from the patient
 thereby establishing some measure of patient's desires, values, expectations, beliefs, and
needs.
 Additionally pharmacists must not presume that their cultural is the same as that of patients'
or colleagues

54.  Therefore (1)socio-cultural understanding, along with (2) that of ethical understanding and
(3)clinical knowledge, are to be seen as prerequisites to the provision of patient care *********
 Emotional arousal ‫العواطف‬ ‫أثارة‬ can trigger identification of a moral dilemma and encourage a
tendency towards prescriptive moral judgments. In this respect many researches found that
male gender may be less sensitive than women to recognize ethical dilemmas . A dilemma
arises from fundamental conflicts among (1)beliefs,(2) duties and(3) principles

55.  Decision making in solving problems
 Pharmacists must put in their mind that the decision making procedure is not seen as a moral
algorithm and ethical decision making in not an exact science, In hard cases, ethical
principles may not determine the right outcome, but they do provide assurance that we have
done the best we could, especially if applied in a trustworthy way.
 Moreover decision by pharmacists are only a part of solving problems, some problems are
simple and easy to solve like the strength or dose of a medicine provided can the pharmacist
found it in a medical reference book, while other ethical problems are difficult and a solution
may require the processing of significant amounts of information, which will take time but
may ultimately yield a clear answer.
 The majority of pharmacists take decisions at great speed and with little reflection****,
however it is possible to slow down the process and break it up into stages and steps that, in
reality, may have been addressed in a matter of minutes or less.
 A good professional decision should be underpinned ‫يرتكز‬
‫أو‬
‫يتعزز‬ by reason and rationality.

56.  So for ethical decision making :Pharmacist should **********
o Identify the principles involved in the case
o Judge which should take priority
o Consider as many outcomes as possible
o Decide which outcome is the best
 Factors that affect decision making process include:
o The presence of legal facts or any law in such a case.
o The Professional knowledge and competence.
 Ethical problems in pharmacotherapy ‫الدوائي‬ ‫العالج‬include
1. Problems with pharmacotherapeutics ‫العالجيات‬ decisions
2. Discrimination‫والتفريق‬ ‫التمييز‬

57.  A 30 years old female which act in TV advertisement were diagnosed to have Hodgkin lymphoma was
admitted to hospital and treated by single chemotherapy and radiation , during conversation with her
she told you that she notice a hair loss but her physician told her that it is temporary and she asked
him to refuse any treatment that cause loss of hair since she planned to continue her work , and her
appearance is very important in her work. But now her physician decided to start ABVD
chemotherapy with her which is a best therapy for her case without mention the hair loss SE, she
welcomed the idea and come to the pharmacy to fill her prescription, The pharmacist asked this
patient if her doctor told her about these drug side effects and found out that the doctor told her about
hematological and GIT side effects.
AS A PHARMACIST WHAT ARE ETHICAL
PROBLEMS IN THIS CASE ? POSSIBLE
OUTCOMES ? AND DECISION AND WHY
********************

58.  ETHICAL PROBLEMS
 In correct consent about the use of drug because some of the drug side effects were withheld. ( Veracity violated and
not achieved )
 Patient autonomy not respected ( since don’t like to loose her hair)
 Conflict between Physician and pharmacist ethics since physician see that benefit for the patient will be higher by
misleading information about drug side effects, while the pharmacist has moral obligation to warn the patient and
respect her ideas ( Autonomy)
 CONFLICTS BETWEEN PRINCIPLES
Beneficence ( by treat the disease with ABVD) , non maleficence ( not cause alopecia “hair loss”) and autonomy ( Avoid
alopecia)

59.  POSSIBLE OUTCOMES
 Shift to ABVD improve survival ( Beneficence )
 Telling the patient about side effects ( Veracity ) will maintain confidence and autonomy of the patient but mean that
the patient will refuse taking the ABVD--- a harm will occur
 DECISION
 So if we choose beneficence we prefer the doctor idea of shifting,
Withholding the truth, will have negative consequences , since the patient confidence with pharmacist and physician will
be lost at the time side effects occur ( Hair loss) and may lead to patient non compliance and refusal to continue with any
medication
 If we choose autonomy and tell the patient about hair loss , the patient may refuse taking ABVD and subject herself to
disease mortality ( not best choice, this mean Autonomy conflict with non maleficence )
So best thing beneficence ( choosing ABVD) but on the same side we need to discuss this with the patient and tell him
about disease consequence which may be fatal, additionally we can tell the patient that hair loss will be temporary during
ABVD courses and hair will regrow again, if the patient accept this would be the best choice

60. Ethics in drug advertisement and medical research
Uruk University
College of Pharmacy
3rd Stage
2nd course
Mohammed Hasan, MSc.
Assistant Lecturer at college of Pharmacy
Uruk University
2018-2019

61.  Advertisement: is an art used to familiarize the public with product by informing its description, use, price and its
superiority over other brands. It makes potential buyers aware of new products that are available in the market
 Medias for advertisement
 Print media ( Newspaper, magazines and Journals)
 Audio advertisement ( Radio)
 Audiovisual media ( TV, CDs)
 Outdoor advertisement ( Posters, Cards, wall writing, road painting, banners ... )
 Mail advertisement ( to physicians , customer or retailers)
 Personal contact ( Sales representatives , medical representatives )
 Promotion
 It refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to
induce the prescription, supply, purchase and/or use of medicinal drugs. It is a part of advertisement

62. General principles of drug advertisement
1 No person may issue an advertisement for a relevant medicinal product unless that product has a marketing
authorization.
2 No person shall issue an advertisement relating to a relevant medicinal product unless that advertisement:
a complies with the particulars listed in the Summary of Product Characteristics, and
b encourages the rational use of that product by presenting it objectively and without exaggerating its properties
3 No person shall issue a misleading advertisement relating to a relevant medicinal product ( Misleading advertisement is
not acceptable)
4 No person shall issue an advertisement which is likely to lead to the use of a relevant medicinal product or substance or
article for the purpose of inducing an abortion in women. ( Advertisement about drugs that induce abortion is not
acceptable)

63. PHYSICIANS-TARGETED PROMOTIONS
The majority of Big Pharma’s marketing budget is targeted at doctors and others with prescribing power, who are
effectively the gatekeepers to drug sales********
In Iraq, physicians usually change their drug prescribing pattern from one company to another by attendance of medical
representatives, this behavior causing irrational prescribing pattern in most out patient clinic in Iraq

64.  Medical Sale representative
 Pharmaceutical companies use the service of sales representatives in marketing their products. These sales
representatives need to be adequately trained and possess sufficient medical and technical knowledge to present
information about the products in an accurate and responsible manner.
 The sales representative should not only be able to provide accurate information, but should also not to exaggerate
the capabilities of the product******. He or she should be able to talk about the property of the product or the mode
of action of the drug and possible side effects
 in Iraq even specialist physicians showed a high reliance on promotional drug information despite their knowledge of
its bias , however academic physicians are less reliance than non academic physicians who work in Iraqi hospitals

65.  Doctor-targeted promotion takes a variety of forms:
 Gifts, such as free samples, travel to conferences and educational events, and, some argue, cash ( cash is unethical)
and sponsorship of conferences and educational events
 Although physicians appeared to believe that most of these activities do not pose major ethical problems but some
physicians appear to believe that even inexpensive or educational gifts may influence clinical judgment or pose
conflicts of interest.
 It has been found that the acceptance of gifts in virtually any form violates fundamental duties of the physician of
nonmaleficence, fidelity, justice, and self-improvement. *******
 In 1991, the Council on Ethical and Judicial Affairs of the American Medical Association (AMA) published a
statement entitled “Gifts to Physicians From Industry.” This statement includes guidelines permitting gifts that are not
“of substantial value,” as long as the gifts “entail a benefit to patients” or are “related to the physician’s work.”

66.  Items of general utility such as stationery (e.g. pens, pads) and clinical items (e.g. surgical gloves, tissues) are
acceptable, whereas items of personal benefit or for use in the home or car are not.
 In Iraq 41% of physicians found that high cost recreational gifts (I pad, mobile, laptop, ..) are acceptable ****
 For example, pads and pens are of trivial ‫بسيط‬ value and can be considered as related to the physician’s work.
However, the guidelines fail to emphasize that distribution of these items, which are conspicuously labeled with the
names of new drugs, is essentially a form of inexpensive advertising. When these items saturate the workplace, they
increase product recognition and likely increase the probability that physicians will prescribe the advertised drug
*********

67. Ethical problems for prescribing in case of physicians who accept gifts from companies include: ***********
 Inability to identify inaccurate claims about medications
 Rapid adoption and prescription of new drugs, (77% of specialist physicians in Iraq prefer prescribing new
medications)
 Formulary requests for medications without important advantages over existing listed medicines
 Non rational prescribing behaviors
 Increased prescribing rates, and
 Prescribing of fewer generics and more expensive new medications at no demonstrated advantage.
 Direct to consumer advertisement
 Heavy direct-to-consumer (DTC) advertising strongly correlates with increased sales for the promoted drugs but, in
terms of both money and health, may not be in the best interest of patients.

68.  Ethical issues in DTCA
1. New drugs are heavily promoted and they are the ones with least well understood safety profiles. This means that
new drugs are not time tested; their long-term effects are unknown; many patients who can be just as effectively
treated with less expensive, older drugs are risking their health when using newer drugs.
 Vioxx (rofecoxib), a COX-2 inhibitor, were intended to replace non-steroidal anti-inflammatory drugs (NSAIDs), such
as ibuprofen, as a superior temporary pain reliever that does not have the side effect of gastrointestinal bleeding. This
side effect is an even greater danger to those who had previously suffered serious gastrointestinal conditions such as
ulcers, because in these patients, life-threatening side effects can occur even if the drug is taken for only a short period
of time.. However, as with any new drug, there is the potential for side effects that had remained un-discovered
during clinical trials (which focus on short-term efficacy and side effects); prescriptions for the new class of drugs
should only have been written for those at risk from NSAIDs.

69.  Disease mongering ‫المتاجرة‬: Is the inappropriate prescription of drugs to patients whose symptoms do not merit such
extreme therapies, by exaggerating the severity and/or frequency of conditions to expand markets *****
 Example on misleading advertisement and disease mongering***
 Promotion of Viagra in June 2000. They found that the product claims made were in many cases inappropriate since
they did not offer enough clarity. The Pfizer ad in New Zealand was as follows “About 52% of men aged 40 to 70 are
affected by erectile dysfunction …..In clinical trials 78% of men reported improvements in their erections. So Viagra
will work in about 4 out of 5 men.” Problems with this advertisements are as follow:
• The 52% figure was inaccurate and misleading and had no basis in fact. It was rather the extrapolation of a very
limited related clinical trial.
• This claim could affect men with confidence rather than medical problems – they argue that “exaggerating the severity
and/or frequency of conditions to expand markets has been described as disease mongering”
• That “will work” was misleading since it might give the impression that Viagra would “work well enough to enable suc-
cessful sex” which was not always true. They point to clinical studies which suggest that the success rate of Viagra was in
fact 44%.

70.  So For ethical DTCA
Scheduled narcotic and psychotropic drugs should not be advertised to the general public.
Drug advertisements should not be directed at children.
Language that brings about fear or distress should not be used as in Viagra example
Medicinal product, substance, or article for the purpose of inducing an abortion in women should not be advertised

71.  For ethical and lawful drug promotion WHO states that *******
Claims concerning medicinal drugs should be:
 reliable, ‫موثوق‬
 accurate,
 truthful,
 informative,
 balanced,
 up-to-date,
 capable of substantiation and in good taste.
 They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable
drug use or to give rise to undue ‫مفرط‬risks.

72.  Ethics in medical Research
 Research refers to “an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop
or contribute to generalizable knowledge
 The requirement of ethics committee approval is a stringent requirement for medical related research where there
may be use of animal or human subjects. All clinical trials need to be approved by the national institutional ethics
committee (IEC) in the country where they are carried out
 The importance of clinical research
1. Even the most widely accepted treatments need to be monitored and evaluated to determine whether they are effective
for specific patients and, for that matter, for patients in general. This is one of the functions of medical research
2. Research is the only means of answering questions about causes of diseases, best ways to prevent or cure diseases
3. Researches results useful in daily clinical practice for pharmacists.

73.  Ethical issues in drug development
 Formal validation involves testing both in animals and in humans.
 In the first instance, there is a requirement for testing in animals for evidence of potential activity, mode of action,
metabolic route and toxicity. (Preclinical studies). Once empirical safety and activity are confirmed, subsequent testing
in human beings is undertaken to determine basic pharmacokinetics, pharmacodynamics, and to evaluate
effectiveness and freedom from adverse effects. All human beings and non-human animals have interests, for instance
in not being harmed, and this is at the heart of ethical considerations

74.  Ethical issues in drug development
 Gold standard of clinical trials in drug research and development
 Blinded study occur of 2 types either single blinded at which only participant don’t know whether he receives the drug
or placebo while in double blinded study both the participant and the investigator don’t know whether the participant
is given the drug or placebo.
 Studies are ‘blinded’ to eliminate the risk (as far as is possible) of bias that could call into question the reliability of a
study and its conclusions
 Without Randomization = select to give placebo for example to those with sever resistant disease and the drug to
those with less sever disease to ensure drug effectiveness.
 Therefore, only a randomized double blind, placebo-controlled study can answer the question whether a drug in a trial
really work, these studies are the gold standard for ethical non biased clinical research

75.  Ethical issues in drug development
 When the placebo considered ethically acceptable?
 Commonly ethics committees have reservations on the use of a placebo as it is seems to be very unethical to give
subjects with the disease condition a placebo. So placebo will only be used if ethically acceptable for example if the
new treatment is given in addition to the existing treatment
 Placebo controls can be justified if the trial is conducted in an area that falls within one of four broad categories:
1. Conditions for which no standard therapy exists at all
2. Conditions for which standard therapy has been shown to be no better than placebo
3. Conditions for which standard therapy has been called into question by new evidence, creating doubt concerning its
presumed net therapeutic advantage

76. Ethical issues in research
 1. Respect for persons (autonomy)
1. Inform patients of the procedures, purpose, and risks of the study
2. Present information in a manner that the patient would understand
3. Allow patients to make their own decision without feeling pressured into participating in the study
 2. Beneficence
This principle requires that researchers maximize benefits and minimize harms or risks associated with research.
Research-related risks must be reasonable in light of expected benefits
 3. Justice
This principle focuses on the need to ensure fairness and equity in the selection of research participants and in the
distribution of the costs and benefits of research
 4.Nonemaleficience

77.  Problems with unethical experimentations and research
Veracity: withholding the truth or lying on the patient about the risks of participating in the study
Consent: failure to get participant consent or do a study without consent
Beneficence and non maleficence : Participants were not given any treatment or withholding treatment from the patient
to found the disease complication and prognosis
Autonomy : Forcing vulnerable persons to participate in researches like prisoners or hospital admitted patients

78. Ethical research according to Nuremberg code should involve the following 10 points:
1. Voluntary informed consent is essential.
2. Experiment results should be for the good of society and not obtained by other methods or means of study
3. Experiment should be based on prior animal studies and knowledge of the disease or other problem being studied.
4. Avoid all unnecessary physical and mental suffering and injury.
5. There should be no expectation that death or disabling injury will occur from the experiment.
6. Degree of risk should never exceed the benefits of the experiment.
7. Adequate preparations and facilities should be provided to protect human subjects from injury, disability, or death.
8. Only scientifically qualified individuals should conduct the experiment.
9. The human subjects should be at liberty to terminate their involvement in the experiment at any time
10. Scientist in charge of the experiment must be prepared to terminate the experiment at any stage if there is probable
cause of injury to the human subject.

79.  Dr. R, a general practitioner in a small rural town, is approached by a contract research organization (C.R.O.) to
participate in a clinical trial of a new non-steroidal anti-inflammatory drug (NSAID) for osteoarthritis. She is offered
a sum of money for each patient that she enrolls in the trial. The C.R.O. representative assures her that the trial has
received all the necessary approvals, including one from an ethics review committee. Dr. R has never participated in a
trial before and is pleased to have this opportunity, especially with the extra money. She accepts without inquiring
further about the scientific or ethical aspects of the trial
 Comment
Dr. R should not have accepted so quickly. She should first find out more about the project and ensure that it meets all
the requirements for ethical research.
In particular, she should ask to see the protocol that was submitted to the ethics review committee and any comments or
conditions that the committee put on the project. She should only participate in projects in her area of practice, and she
should satisfy herself about the scientific merit and social value of the project. She must be able to explain the
alternatives to her patients so they can give fully informed consent to participate or not to participate. She should not
agree to enroll a fixed number of patients as subjects since this could lead her to pressure patients to agree, perhaps
against their best interests. She should carefully monitor the patients in the study for unexpected adverse events and be
prepared to adopt rapid corrective action.
Finally, she should communicate to her patients the results of the research as they become available