PROFESSIONAL ETHICS

Overview of Pharmaceutical Ethics

Terminologies
 Profession – is an occupation that requires extensive
training and the study and mastery of a specialized
knowledge has:-
 A professional associations.
 Ethical code and
 Process of certification and licensing.
 Vocation – is an occupation that requires usually skills
and education program range from short units (ten
weeks or less) to long term program up to two years
length.
 Ethics – is the science of moral value. It is composed
of moral beliefs and rules about right and wrong.
The ethical principles are:
 Autonomy (respect for persons).
 Non- maleficence (avoiding harm).
 Beneficence (doing good).
 Justice (fairness).
 Professional ethics – is the moral principle which
should guide members of the professions in their
dealings with:-
 Each other
 Their patients
 The patrons
 The state, etc…
 Elements of profession
- An intellectual discipline and standard of
knowledge.
- A representative body of practitioners.
- Standard of conduct.
- Service and advice, in the interest of the
patient or client.
 Is Pharmacy a profession?
yes
- An intellectual discipline and standard of
knowledge
 A university degree and a practical training
- A representative body of practitioners
 EPA (Ethiopian Pharmaceutical Association)
- Standard of conduct
 There are standard of conducts known throughout the
profession.
- Service and advice
 Province service and advice in the interest of the patients
Rights and obligation of pharmacy personnel

The seven principles

As a pharmacist or pharmacy technician you must:
1. Make The Care Of Patients Your First Concern
 -Take steps to safeguard the well-being of patients,

particularly children and other vulnerable

individuals
 -Seek to ensure safe and timely access to medicines

 - Encourage the effective use of medicines

 - Promote the health of patients

2. Exercise your professional judgment in the interests of
Patients and the public
 Make sure that your professional judgment is not

impaired by personal or commercial interests, incentives,

targets or similar measures
 Be prepared to challenge the judgment of colleagues and

other health or social care professionals if you have

reason to believe that their decisions could compromise
the safety or care of others
 Conduct research and development
3 Show Respect For Others
 Recognize diversity and respect the cultural

differences, values and beliefs of others

 Make sure your views about a person’s lifestyle,

beliefs, race, gender, age, disability or other

perceived status do not prejudice their treatment
or care
 Take all reasonable steps to prevent accidental

disclosure or unauthorized access to

confidential information
 Take all reasonable steps to ensure appropriate levels
of privacy for patient consultations
 Maintain proper professional boundaries in the
relationships you have with patients and other
individuals that you come into contact with during the
course of your professional practice
 4. Encourage Patients To Participate In Decisions
About Their Care
 Patients have a right to be involved in decisions about

their treatment and care

 When possible, work in partnership with patients and

other healthcare professionals to manage the patient’s

treatment and care.
 Explain the options available and help individuals to

make informed decisions about whether they wish to

use particular services or treatment options
 Respect a patient’s right to refuse or to receive
treatment, care or other professional services.
 Ensure that reasonable steps are taken to meet the
particular communication needs of the patient.
 5. Develop Your Professional Knowledge And
Competence
 At all stages of your professional working life you must
ensure that your knowledge, skills and performance are of:-
 a high quality,
 up to date and
 relevant to your field of practice.
 You must:
 Maintain and improve the quality of your work by

keeping your knowledge and skills up to date, evidence-

based and relevant to your role and responsibilities
 Recognize the limits of your professional competence;

practice only in those areas in which you are competent

to do so and refer to others where necessary
 Apply your knowledge and skills appropriately to your

professional responsibilities.
6. Be Honest And Trustworthy
 Patients, colleagues and the public at large place

their trust in you as a pharmacy professional.

 You must behave in a way that justifies this trust

and maintains the reputation of your profession.

 You must:
 Uphold public trust and confidence in your profession

by acting with honesty and integrity

 Be accurate and impartial when teaching others and

when providing or publishing information to ensure

that you do not mislead others
 Respond honestly, openly and courteously to

complaints and criticism.

 7. Take Responsibility For Your Working
Practices
 Communicate and work effectively with colleagues
from your own and other professions .
 ensure that both you and those you employ or
supervise have sufficient language competence to do
this.
 Take responsibility for all work done by you or under
your supervision
 Ensure that you are able to comply with your legal
and professional obligations and that your workload
or working conditions do not compromise patient care
or public safety
 Raise concerns if policies, systems, working
conditions, or the actions, professional performance or
health of others may compromise patient care or
public safety
 Components of unethical behavior
 Smuggling or trafficking

 Illegal transport of goods, in particular across a border

OR/ bypass customs

 Taking from one country to another country unlawfully,

especially goods without paying necessary tax.

Corruption
 It is a general concept describing any organized and

interdependent system in which part of the system is not

performing duty.
 It was originally intended to, or performing them in an

improper way to the determinant of the system’s

original purpose.
 Mistreating the patient
 with drug
 behavioral

 Drug dependence
 The comprehensive use of psychoactive drugs, to that

point where the user has no effective choice but to

continue use.
 Quiz
1. Write the difference between profession
and vocation.
2. Write the elements of a profession.
3. What is smuggling?
4. List at least four ethical principles.
5. Ethical dilemma occurs when the answer
of a certain ethical question is false. Say
true or false
INTERNATIONAL PHARMACEUTICAL
FEDERATION(IPF) STATEMENT OF
PROFESSIONAL STANDARDS:
CODES OF ETHICS FOR
PHARMACISTS
IPF………….

 Introduction:
 A profession is identified by the willingness of
individual practitioners to comply with ethical &
professional standards.
 The pharmacist continues to be the health
professional who is the expert on medicines.
 Pharmacists are also given the responsibility to:
- help people to maintain good health.
- avoid ill health.
- promote the rational use of medicines and
- assist patients to acquire, and gain maximum
therapeutic benefit from their medicines.
Cont’d…

 The role of the pharmacist is continuing to develop.

 These obligations, based on moral principles &
values, are provided to enable national associations
of pharmacists, via their individual codes of ethics,
to guide pharmacists in their r/ships with pts, other
health professionals & society generally.
 Cont’d…


Based on this background, the IPF recommends that:

1. In every country, the appropriate association of

pharmacists should
 produce a Code of Ethics for pharmacists setting out
their professional obligations
 take steps to ensure that pharmacists comply with
the provisions of that Code.
2. The obligations of pharmacists set out in these
codes should include:
 to act with fairness and equity in the allocation of

any health resources made available to them.

 to ensure that their priorities are the safety,

well being & best interests of those to whom they

provide professional services.

 to collaborate with other health professionals to
ensure that the best possible quality of healthcare
is provided both to individuals & the community
at large.
Cont’d…

 To respect the rights of individual patients to

participate in decisions about their rx with
medicinal products & to encourage them to do so.
 To recognize & respect the cultural differences,
beliefs & values of pts, particularly as they may
Affect a pt’s attitude to suggested rx.
 To ensure that they keep their knowledge &
professional skills up-to-date through continuing
Professional development.
 To respect and protect the confidentiality of
information.
 To ensure that information about an individual is not
disclosed to others except with the informed consent
Of that individual or in specified exceptional cases.
 To act in accordance with professional standards &
scientific principles.
 To act with honesty & integrity in their r/ships with
other health professionals, including pharmacist
Colleagues
 Not engage in any behavior or activity which
undermine public confidence in the profession.
 To ensure that members of support staff to whom tasks
are delegated have the competencies necessary for the
efficient & effective undertaking of these tasks.
Cont’d…

 ensure the integrity of the supply chain for medicines by

purchasing only from reputable sources.
 to ensure that all information provided to pts, other
members of the public & other health professionals is
accurate & objective, & is given in a manner designed to
ensure that it is understood.
Cont’d…

 To treat all those who seek their services with respect.

 To ensure the continuity of provision of professional
services.
 Ethiopian Code of Ethics in Pharmacy

 Objectives
 To promote high standard of conduct and practice among
 Pharmacy professionals

 patients and Pharmacy professionals

 with other health professionals.

 To state publicly the principles that forms the

fundamental basis of the duties and responsibilities of

the Pharmacists.
 To safeguard the public from unethical and
substandard professional practice.
Definition
 Code of ethics of pharmacy –

 Moral principle

 Should guide members of the pharmacy

profession
 In their dealing with their job, patients,

fellow professionals, public and other

profession in management of pharmaceuticals.
 It is a governing conduct of all pharmacy personnel both

within and outside the practice of pharmacy.

A, Pharmacist in relation to his/her patients
 Always follow the rule: Patient first or Service first.

 Therefore, the Pharmacist should

 Be morally obliged to the gift of trust received from

the patients.
 Not show partiality between his customers.
 Nationality

 Color

 Religion

 Social status

 Political standards, etc…

 Not abuse his/her relationship with the patient for
personal use.
 Dedicate himself/herself to protect the dignity of
the patient. He/she should respect the patient right
not to take a drug unless the disease condition
requires.
b. Pharmacists in relation to the public
Always provide quality service.

Therefore the Pharmacist should:

Maintain good personal qualities.

- Be on duty with clear mind.
- Be presentable/tidy and attractive.
- Master communication skills.
- Be knowledgeable.
- Always provide accurate and appropriate information.
- Always update him/her self.
Strive to create public awareness on
- Rational use of drugs.
- The profession in general.
Be accountable for
- Ones action.
- Services rendered under his/her supervision.
Maintain standard premises
- clean environment
- order
- paint/color, lighting
- handling of controlled substances
- price clearly labeled
 c. Pharmacists in relation to other health
professionals
The Pharmacist should:

- respect the skills and competencies of other

health care providers and endeavor to work

cooperatively with them.
- Not to recommend a particular medical practitioner to the
patient.
- Endeavor to maintain the confidence and trust placed in
other health professionals by patients.
- Expose any act of malpractice committed by other health
professionals through the appropriate channel.
Just accept that we are not alone; so play your position
well and leave others play theirs.

 Drug without proper diagnosis is simply a shot in the

dark.
 Drug without proper care is a bed room without bed.
d .Pharmacists in relation to fellow professionals
The pharmacist should:

- Extend all support, respect and cooperation to fellow

members of his/her profession during needs for scientific

and technical information.
- Have responsibility to expose any act of misconduct or

malpractice committed by a fellow professional.

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

- Get involved in the profession only after having been

registered to practice and legal license to operate a

pharmaceutical establishment.
- Not delegate his/her subordinate and/or assistant to

tasks which he/she should perform personally.

- Immediately report any observed unwanted reactions,
side effects to the attending physician and/or patient
authority.
- Update his/her knowledge and maintain professional
competence directly related to his/her specific area of
practice.
- Provide current drug information to the public as well
as to other health professionals./DIS
Ethical standards of practice in Ethiopia

1. Dispensing of medication in Pharmacy

a. Prescription handling
 The pharmacist should,
- Personally fill all prescriptions or ensure
appropriate filling of orders.
- Accept prescriptions only in written form except
under emergency or compelling conditions.
- Handle only products approved by FMHACA.
- Not dispense prescription only drugs without
prescriptions.
- immediately inform the prescriber due correction or
clarification if the prescription has been found to be
illegible or appears to be wrong.
eg. Chlorpromazine and carbamazepine
- Not dispense any drug to patients who do not appear in
right mental state.
- Not alter prescriptions in any way.
 It is free to make generic substitution
- Do not dispense for prescribers self use.
- Dispense medications as original packs whenever
possible; if not repack materials should be
labeled appropriately.
 Labels should contain
 Name of medicine

 Batch number

 Expiry date

 Strength

 Dose

 Frequency of dosing

 Duration of treatment
 b. Instructing, educating and counseling patients
 The Pharmacist should,
- Have appropriate knowledge and skills for
patient education and counseling.
- Adapt messages to fit patients.
- Give ample verbal and written information on
dispensed drugs.
- Conduct counseling or education in a conductive
environment/ avoid any physical barrier.
 c. Premises
 The pharmacist should maintain the premises
that fulfill the following.
- The external and internal appearances of the

pharmacy should be inspiring and attractive.

- Premises should permit
 Flow of work.
 Communication and supervision.
 Cleaning and maintenance.
 Minimization and avoidance of
o Cross contamination.
o Adverse effect on the quality of the product,

service and health of the public.

 d. Special segments of public
- Premises should allow ease access and service
and to disabled persons.
- Do not supply any medicinal products to
children unless satisfied that the product will be
used safely
2 , Compounding and manufacturing of
pharmaceuticals
A, Compounding
- Only authorized personnel should be involved in

compounding.
- Only healthy, mentally and physically fit personnel should

be involved in compounding.
- Have procedures for compounding.
- Have working procedures for every technical operation,
cleaning (SOP).
- Label products properly.
 Product identity.
 Strength.
 Route of administration/application.
 Instruction of use.
 Beyond use date.
 Name of the institution.
 B, Manufacturing of drugs and medical supplies in
Ethiopia
The Pharmacist should,

- give due consideration to safety, efficacy and quality.

- make sure every operation is in accordance to the

national current GMP standards.

- maintain records and keep track of all key processes

- ensure that products carry unique batch number,

manufacturing date and expiry date.

- look after the needs of his employees.
 Space
 Safety and comfort
 Professional respect and independence
- Only engage in fair, transparent and free competition.
- Have working procedures for every technical operation,
and cleaning (SOP).
- Proactively, protect and support the environment in
accordance with the national guideline.
 Siggarate smoking
 Any waste
 Avoid any flammable substance.
- Correct or expose any malpractice through the
appropriate channel.
 3. Pharmaceutical supply management and rational
drug use
- Set your priority according to national need.
- Circulate only products approved by FMHACA.
- Always acquire pharmaceuticals through appropriate
procurement procedures.
- Legal bids
- Inspect product s up on receipt/receiving.
- Store drugs and other substances as per the current Good
Storage Practice throughout the supply system.
- Distribute pharmaceuticals
 only to authorized clients.
 in fair and equitable manner.
- Distribute free sample to health professionals only.
- Maintain records and keep track of sold products.
- Promote rational drug use.
 4. Handling of narcotics, psychotropic and other
dangerous drugs
- Store these substances in a separate secured area.
- Only the pharmacist himself/herself should carry of
the dispensing.
- Dispense through only prescription paper approved
by FMHACA.
- Handle properly poisonous substances to prevent any
injury to the public.
- Immediately report breakage, loss or theft to
FMHACA.
- Store securely and separately expired and damaged
products and dispose according to the procedure set
by FMHACA.
 5. Drug research and development
 The Pharmacist should:
- strive to direct research focus to address national
need.
- be committed to one’s proposal and agreement.
- be honest.
- strive to uphold the sprit of cooperation.
- avoid bias.
- honor patents, copy rights and other forms of
intellectual properties.
- adhere strictly to international institutional protocols
experimental animals handling.
> Not put participants in a situation where they might
be at risk of harms as a result of their participation.
> Guarantee the participates’ confidentiality whenever
necessary.
> When situation demands, participants should remain
anonymous throughout the study even to the
researchers themselves.
Quality Assurance(Q/A) of Pharmaceuticals

• The purpose is that to make certain that each drug

reaching the pt. is:
Safe
Effective & of required quality.
• A Pharmacist engaged in these area should:
 Ensure that all standards, including those of cGMP
& Good Laboratory Practices are followed.
 Ensure that each batch of manufactured drugs must
Have a batch processing record based on the master
manufacturing formula & instruction.
 Make all efforts to incorporate Q/A concepts in all
the components of drug supply cycle.
 Not make available for sale/distribution of products,
W/h he/she believes,
 Sub-standard
 Expired,
 Mislabeled
 Adulterated.
 Disposal of Unfit for Use Products
 you should ensure that all reasonable care is taken when
disposing medicinal products & chemicals.
 Disposal should carried out in accordance with the
procedure set by the DRA.
 Keep “unfit for use drugs” in segregated areas
separated from other stocks & maintain proper records
until appropriate action is taken.
 Pharmaceutical Regulatory Service:
 You should make decisions & act solely in the public
Interest & not in the interest of the individual.
 Be as open as possible while making decisions,
making Sure to justify actions taken & promote
transparency of the institution in w/h you works.
 Establish & implement mechanisms & procedures
For handling complaints about actions taken & for
Appealing against their decisions.
 Not disclose information of confidential or private
nature unless you are forced to do so by law. Nor use
such information with the intent to have financial gains.
 Be free from misleading, bribes & /or nepotism.
 Not work in, & own or have any business or financial
association with any pharmaceutical establishment, where
you have a supervisory or regulatory power, to avoid
conflict of interest.
 Cont’d….

 Not issue & renew certificate of competence without

making adequate evaluation or investigation of their
quality.
 Drug
 Trade or service & authorize the use or
 Distribution of drugs or raw & packaging
materials
 Exercise legitimate powers & authority, only within
the
scope of your institution’s legal responsibilities,
giving respect to human right & privacy.
 Participate in the promotion of rational use of drugs.
Pharmacy Education: in a training institute you
should:

¡ Ensure that basic (first degree) education programmes

should provide pharmacy students & graduates with a
sound & balanced ground.
¡ Ensure that the programme maintains the university
character of education,
balancing:
Scientific knowledge
With practical training.
Cont’d….

¡ Education programs are based on a research oriented

environment at a university or institute.
¡ Educational programs & curricula are designed to be
consistent with required educational outcomes.
Ethical Principles & Obligations on Special Ethical Issues

The Right to Confidentiality: The pharmacist:

 Should only use or disclose personal health

information
With the consent of the pt.
 May disclose personal health information only to those
Who have a legitimate right to that information.
 Should ensure that consent is obtained in writing.
 Up on request of the pt, is obligated to allow the pt to
inspect records carrying personal health information &
provide a copy.
Euthanasia & Abortion: you should not:
• participate in the use of drugs & chemicals for the
purpose of euthanasia in human beings & shall refuse to
participate in this practice.
• participate in the use of drugs for the purpose of
abortion except in cases where abortion should be
conducted for medical reasons.
• But this does not bar the pharmacist from supplying
drugs for avoiding conception immediately after
forced sexual abuses.
Procedures in the Execution of Breach of Code of Ethics:
ᴥ The prime concern of a professional association should
be safety of the public & the reputation of the profession.
ᴥ The association should do its best to establish
mechanisms of building professional ethics.
Such mechanisms include:
1. Educational mechanisms, w/h should be implemented
via basic & continuous education process to inculcate
professional ethics.
2. Encouragement mechanisms, w/h should be
expressed in terms of system of rewards.
3. Binding mechanisms, w/h is a system of enforcement
of the Articles of Code of ethics when ever breach is
observed.
ᴥ The EPA is a due legalized body registered by the Ministry
of Justice with an approved constitution.
ᴥ The associations has established standards of conduct
known to all professionals & approved by its General
Assembly.
ᴥ These standards of conduct are expressed in the Articles
of the Code of Ethics, w/h represent the collective views
of the members.
ᴥ The constitution of EPA has also established an Ethical
Committee and will take disciplinary measures in case of
breach of the Articles in the Code of Conduct.
 Rationale ,Clinical Pharmacy Services Ethiopian
Context
Pharmaceutical Care in Ethiopia:
 Curricular revision 2008: nation wide
 Pharmacy undergraduate curriculum:

- more patient oriented (4 years + 1 internship).

 More than 40% of courses under new pt oriented

curriculum are clinical pharmacy courses.

 Post Graduates training
JU
AAU.
 FMoH: EHRIG May 2010
 FMHACA : Hospital Pharmaceutical Services
Minimum requirements.
 Transition/shift

 Drug product  Drug therapy

 Pharmacy  Bedside
 Dispenser  Caregiver
 Solo  Team
 Knowledge  Information
 As ordered
 As best prescribed
 Hospital Pharmaceutical Services Minimum
requirements ( FMHACA):

The pharmacist shall attend and participate:

 at multidisciplinary ward rounds
 morning meetings
 contribute to patient care through the provision of
medicine information(DIS),
 dose calculations & adjustment,
 assisting in the rational prescribing decision,
alternative regimens & reducing the frequency &
duration of medication errors.
Clinical Pharmaceutical Services:
 patient-oriented services
 promote the rational use of medicines

 Right drug
 Right indication
 Right time
 Right dose
 Right duration
 Right pt.
 Right cost
Clinical pharmacy service at schools
 Seminars
 Morning sessions

 Preparing drug monographs

 Bed sides and ward rounds

The Health Professional–Patient
Relationship
• Paternalistic model
– Emphasizes health and well-being than respect for
autonomy and patient choice
– Patient is selectively given information
Examples:
– Giving blood to a Jehovah's witness, a religious group
that forbids the use of human blood.
– In a true emergency where it may be necessary to act
and t/t before true informed consent is obtained
 Evolution of newer decision-making models
• Independent choice
– leaves the decision of healthcare to the patient
• Enhanced autonomy
– gives some decision-making to the patient (enhanced
autonomy)
– but the ultimate decision still lies with the healthcare
professional.
 Evolution of newer …cont’d

• Informative
– Provides information to a patient and allow patient to
consider information.
– Healthcare professional serves as information provider
• Deliberative
– The health care professional works with the patient to
come to a decision on a course of t/t.
– They weigh options together instead of only the
professional making the decision
 Evolution of newer decision…cont’d

• Interpretive
– The healthcare professional helps the patient interpret
the information and is open to questions from the
patient

– The role of the professional is to provide answers to a

patient and help the patient understand the results of
tests, risks and benefits of a t/t.

– Interprets the health terminology and tests in a way

that the patient can understand.