Pharmacy Law and

Ethics

Part I: Pharmacy Ethics

 Topics to be covered
2

• What is ethics?

• Ethical theories (Teleological/consequentialist –Vs.-

deontological/nonconsequentialist theories

• Ethical principles:
► Autonomy
► Beneficence
► Nonmaleficence
► Justice
 Topics
3

•
…
Professional ethics
• Ethical codes: FIP (Internationalpharmaceuticalfederation)
standards of ethical practices; code of ethics for
pharmacists practicing in Ethiopia
► Standards of practice for pharmacists practicing in
Ethiopia

• Ethical issues in health care: rationing; assisted

suicide; human drug experimentation
• The health professional–patient relationship
 Learning
4
Objectives
At the end of the lesson students will be able to:
 D e fi n e terms: profession, ethics, code of ethics…..
 L i s t characteristics of any profession
 D e s c r i b e difference and similarity b/n ethics and alw
 D e s c r i b e Ethical theories and principles
 C o m p a r e Ethiopian code of ethics with FIP andsrehto
 I d e n ti f y determinants for unethical practice

 D e s c r i b e ethical issues in health care and develop a Framework to

analyse ethical dilemmas
 Introductio
n
5

Pharmaceutical jurisprudence: Is the science or

philosophy of law governing pharmaceutical sector or
services

Pharmaceutical ethics: Ethical behavior which governs

pharmaceutical practice
6

What Does Profession

Means to You?

Take a few minutes and write down

your thoughts ……..
As a definition or description.
 What is
7
Profession?
 Form of employment or a field that respecte in
is
society and that extensive d and the
requires
of specialization in study mastery
knowledge

Characteristics of Profession ?
8
Characteristics of
 Profession
Specializing in knowledge
 Rigorous training and schooling, problem-solving
skills

 Providing essential services to the society

 Deriving force: not fortune but rather the ministering

 High degree of self-control of behavior/standard of

conducts
 Codes, guidelines, oaths, etc.
 Profession
9
…
Mutual trust b/n professionals and the patron
 Information asymmetry

Social sanction
 Professionals given exclusive right to practice the
profession

Representative body of practitioners/Association

(optional)
10

Pharmacy
 ?
Criteria?
“Constituting those attitudes and behaviors that
serve to maintain patient interest above
pharmacists Self-interest”
 Trade Vs. Profession

What is the difference b/n making a living from

selling one’s professional services and from buying
and selling of goods ?

 Is Pharmacy a trading or profession

(particularly retail)?

11
 Difference b/n trade and profession

 A trade person

 Concerned principally with profitability

 Holds the customer to be the best judges of

what they want & seeks to satisfy their
demands

12
 “Let the buyer beware”
 Difference …

 Professional People
 Judges what is best for their
clients/customers

 Provide services to practitioner’s own

fisadvantage

13
 Ethics and Morality
15

 Morality: what people believe to be right and good

 Ethics is science of moral principles that govern an

individual’s actions

“Do Good and Avoid Evil”

16
Law

 Societal rules that are obligatory to observe

 Set of principles enforced by the government

 Governed practice of healthcare professionals

17
Comparing Law and Ethics

Both share the social purpose of encouraging
the right conduct

 Enforcement
 Law: sovereign power of the state
 Are mandatory to all citizens (risk of liability)

 Ethics: without the intervention of government

19

Impacts of Ethical
Practices by Pharmacists
 Impacts of Ethical Practices by Pharmacists
20

 Impact on other health professionals

 Foster team work and ensure better outcome of

therapy

 Pharmacist gain better acceptance/recognition

21

 Impact on fellow professionals and the profession

 Professional:
Develop better confidence, Job satisfaction
Become more committed

 Profession: guarantees continuity

 Impacts Cont’d
22

 Impact on the patient and public

 Contributes to better treatment outcomes

 Minimize risk and cost

 Enables maintaining a healthy society …

…
.…
…
.
 Ethical Theories: Ideas and Actions
23

 Deontology (duty)
 Consequentialism (actions)
 Ethical Theories….
24

Deontology /duty driven/Nonconsequentialism

 Rightness and wrongness of act:

→Inherent in the act it self

→Independent of the consequence

 Process matters more than the result

 Ethical Theories….
25

 Looks to one’s obligation to determine what is ethical

and answers the question:
 What should I do and why should I do it?

E.g. Breaks of confidentiality (HIV info to partner) ??

 Wrong doing
 Ethical Theories….
26

Consequentialism/Teleological

 Actions are determined and justified by the

consequence of the act

 Consider all the consequences of what they

are
about to do prior to deciding a right action
 The result matters most
 Ethical Theories….
27

Informed consent ??

 Improved compliance and outcome

 G o o d Consequence
 Ethical Theories….
28

 Utilitarian Ethics: Considers the greatest

good for the largest number of people

 Governing ethical theory in public health

 Cultural Diversity and Ethics
30

 what is understood to be morally right by

an individual depends (at least in part) on
that person’s race, ethnicity, and culture

 Increased recognition, interest and respect

for diverse societal values. Why?

 Fundamental question: What place, if any, do

race, ethnicity, and culture have in moral theory?
 Ethical Principles
31

 Conflict is inevitable

 Ethical principles provide the framework/ tools

to resolve conflict in a fair and moral manner
 Ethical
32
principles…
Non-maleficeince (doing no harm)
 Actions are wrong as they induce bad consequence

 A pharmacist who fails to counsel patients, for fear that

the patients will discontinue using a drug if the info is
disclosed, is adhering to principle of nonmaleficence

 Prohibits both deliberate and unintentional harm

 Ethical
33
principles…
Beneficence (doing good)
 Actions are right if they produce benefits

 E.g. The pharmacist described above who neglects

to counsel patients is violating the principle of
beneficence; b/c info about medications generally
helps patients use their medications the correct
way
 Ethical
34
principles…
Justice (fairness)
 Address questions of distribution of scarce resources
 Equitable distribution of burdens and benefits

g. How to determine who qualifies for one available kidney?

 55 yrs old man with three children Vs a 13 yrs old girl?

 Ethical
35
principles…
 Comparative Justice
 M a k i n g a decision based on criteria and
outcomes

 Non-comparative Justice

 M e t h o d of distribution using lottery system

 Ethical
36
principles…
Autonomy (respect for
persons)
 The right to participate in and decide on a course of
action without undue influence

 The right of individuals to self rule/self-

determination

 Requires decision making capacity

 Lack should be proven not assumed
 Ethical
37
principles…
Veracity (truth telling)
 The patient has the right to the truth
Medical condition, course of the disease
Treatments

 Code of ethics states:

 A pharmacist: “has the duty to tell the truth and
to act with conviction of conscience”
 Ethical
38
principles…
Informed Consent

 Requires honesty and autonomy to exist

 A right of client to be informed and to

freely choose a course of action
 Ethical
39
principles…
 Informed consent exists when:
 All relevant information has been provided
 The patient understands the information
 Patient is capable of understanding the info
 Ethical
40
principles…
Confidentiality
 From patients perspective this is “self-
disclosure” and they should be the ones making
this decision

 Clients right to give/refuse consent to release

n
i fo

 Trust in confidentiality becomes very

important
 Ethical
41
principles…
Fidelity
 The right of patients to have practitioners provide
services that are in the patients best interest
 Example of Infidelity could be:
→Recommending vitamins patients don’t need
→Failing to confront prescriber with inappropriate Rx
out of fear that s/he will direct patients elsewhere
42

Code of Ethics
 Code of Ethics for
Pharmacists
43

 Principles that form the fundamental basis of the

roles and responsibilities of pharmacists

 Guide pharmacists in relationship with

 Their job
 Patients/clients
 Health professionals
 Society/public ……
 Why Code of
44
Ethics
• To define accepted/acceptable behavior
• A framework for behavior and responsibilities
• To promote high standards of practice
• To provide a benchmark for members to use for
self evaluation
• To foster good relationship (Phar, Pt, other HPs)
• As a vehicle for occupational identity
• As a mark of professional maturity
45

Code of Ethics for Pharmacists

Practicing in Ethiopia
 Pharmacist in relation to his/her
patient
46

 Always follow patient first or service first rule

 Therefore:
 Provide the service only when needed
 Provide the required service to the best of one’s
knowledge
 Be compassionate, confident and impartial
 Should not abuse his/her relationships for personal gains
 The Pharmacist in relation to the
47
public
 Always provide quality service
 Therefore:

 Maintain good personal quality:

 Be on duty with clear mind
 Be presentable
 Master good communication skills
 Be knowledgeable
 Provide accurate and appropriate I
tenfo
 Public
48
…
 Maintain standard premises
 Clean environment
 Paint/color/lighting
 Controlled substance in a safe
 Price clearly labeled

 Strive to create public awareness

 Rational drug use
 The profession in general
 Public
49 …
Be accountable and liable:
 For one action and
 For services rendered under his/her supervision

 Keep the secrecy of all confidential documents

 Notbe involved in clinical trials that do not get

prior ethical clearance
 Public
50
…
 Immediately report any AEs when the volunteer’s
health is in danger (involved in clinical trials)

 Not participate in the use of drugs for the

purpose of euthanasia in human
being
 Pharmacists as member of the
51
community
 Be good citizen !
 Be a person of high principles and integrity
 Conform to positive norms and values of the society
 Actively participate in community services and
social development activities
 Address the needs of special groups society such
as underaged, disabled and mentally ill people
 Always maintain high standards of professional
conduct
 Pharmacists in relation to
52
professional
fellow
s
 Always: respect, support, cooperate and
correct
 Have the responsibility to expose an act of
misconduct or malpractice

 Actively participate in professional association

and scientific societies with objective of promoting
profession
 Pharmacists in relation to
53
other professional
s respect, support, cooperate,
 Things to do:

communicate and correct

 Respect the reputation of the prescriber to his/her patient
 Expose deliberate act of malpractice through
appropriate channel
 Give professional consultancy on the appropriate use
of pharmaceuticals
 Strive for teamwork spirit and promotion & expansion
of health service
54
Relation to other
professionals….
 Things not to do: Favorism,
partiality…

Х Recommend a particular medical practitioner to
patient

Х Enter to
any secret arrangement or negotiation with a
medical practitioner

Х Collaborate with health professional for malpractice

 Pharmacists in relation to his/her
55
job
 Primary concern should be to promote the health and well
being of the patient and the public
 Practice his/her profession after being registered and/or licensed
 Give comprehensive service in his/her profession.
 Not delegate his/her subordinate tasks, which should be performed
personally.
 Immediately report any observed unwanted reactions, side effects,
and adverse reactions.
 Carry his/her responsibility with in his/her professional
competence.
 Update his/her knowledge & maintain professional competence
 Provide current drug info to the public & health professionals.
 Pharmacists in relation to management
and utilization of pharmaceuticals
56

 Manufacture pharmaceuticals of good quality, safety,

and efficacy
 Don’t make available for sale substandard,
counterfeit, deteriorated and mislabeled
pharmaceuticals
 Confirm legibility of prescription
 Accept prescription only in written form except in
emergency
 Give written and oral advise and counseling
57

 Don’t fill prescription of drugs written for

prescriber for his/her personal use
 Not dispense prescription drugs without
prescription
 Properly procure, store, distribute and use drugs
 Keep records properly
 No self advertise contrary to the regulation
 Don’t promote products of a particular
manufacturer
 Pharmacists in relation to his/her
58
trade
 Don’t promote unethically
 Promote fair distribution of pharmaceuticals
 Don’t put for sale medical samples
 Obtain pharmaceuticals from genuine and
legal source
 Have strong moral obligation not to come
under commercial pressure
59

Group
Assignment
Compare and contrast the
Ethiopian code of ethics for
pharmacists with FIP and other
code of ethics
60

Selected Ethical Issues

in Healthcare
 Ethics of Health Disparities
61

 Healthcare’s Major
Influences
• Disability, death
• Pain and Suffering
 Quality and quantity of life
 Health
Disparities…
62

 Disparities in Health Status and

Healthcare
• Tragic, horrendous
• Moral problems of the first order
• Ethically unacceptable
 Health
Disparities…
63

 Source of ethical dilemma:

Demand Vs. Supply of

Pharmaceuticals
What is needed? Rationing?

Balance

Equit Utility/Efficiency
64
 Utility Considerations – Maximize
65
Benefit
 Likelihood of benefit for a vaccinated person (for ex.
age)

 Likelihood of benefit for community in terms of disease

burden

 Maintain health care services ( priority to HWs)

 Maintaining essential services and minimize societal and

economic impact (priority to essential functions)
 Equity
Considerations
66

Equity considerations – might sometimes

conflict with utility
 Priority to the worst-off (for ex.
economically)
 Vaccine - poorest countries first

 Vulnerable populations may need more

resources
 Priority to those at greatest risk of dying
 Example
s
67

1.Priority for health care workers

 Utilitarian approach: HWs should have
priority

 Reciprocal obligation of policy-makers to

give priority

 Difficulties in exact definition of HWs:

- Health care professions vs. other professions
 Examples…….
68
.
2. Age as a Priority Criterion

 Equity Argument: Priority to children

(vulnerable)

 Utility Argument (QALYs, DALYs) (Qualityadjusted

lifeyear,disabilityadjustedlifeyears)
 Life-cycle principle – save the most life years
Potential priority to infants

69

In any case, Priority setting

should:
 Respect human rights

 Not discriminate against individuals

 Communicate the public on priority
criteria
 Model: Ethical/Moral
70
Practice
Understand Strategize Act

What should What we

be done? should do?

Practice
Internal to External to
our profession our
Institution/org
profession
 Crucial:
Intersectional
Approaches
71

Stakeholder
s
Communities
Disciplines
Professional
s
Institutions &
Organizations
72
Assisted
Suicide
Death with Dignity or
Murder?
 Question?
?
73

Do human beings have the right to

make decisions on when to end
their lives?
74
Assisted
Suicide
Euthanasia:
 Death caused by an intentionally lethal dose of
medication ordered by a legal prescriber and
administered by a health care professional(s)

(Direct and intentional medical

killing)
 Assisted
suicide…
75

General term for helping a patient to

terminate their life
 Types of Assisted
76
Suicide
Euthanasia Professional-Assisted Suicide

 Physician prescribe the  Physician prescribe the

treatment treatment

 Professional directly  Patient but NOT providers

administers the administers the
treatment to the treatment
patient
 Types
77
…
Active Passive
 Administering  Withholding from
treatment to end treatment that sustains
life life
Voluntary Involuntary
 Patient consents to  Patient is unable to
treatment consent to
treatment
 Legalit
y
78

 Euthanasia:
 Illegal in Ethiopia, USA,
Canada
 Legal in Belgium, Netherlands

 Assisted suicide:
 Illegal in Ethiopia
 Legal in some states of USA (Oregon,
Washington…), Belgium, Netherlands
 Example: Professional-Assisted Suicide
79
http://www.bloomberg.com/news/2011-01-
18/suicide-tourists-make-swiss-minister-uneasy-

as-terminally-ill-seek-escape.html
81
Why Assisted
Suicide?
 Experience of a tragic death
 Witness of terrible suffering
 Fear about suffering and pain

 Fear of being a burden

 Depression at end of life

 Fear about loss of control and

dignity
82
Ethics in Pharmaceutical R & D
 Source of ethical dilemma:
• Problem solving research Vs. Research for personal gain

• Patient and public may have different understanding of the

nature, purpose and priorities of research than held by the
researcher

• Participants of research are liable to harm in

research processes

• Assuring the liability of the research

 Historical Perspective
83

Nazi War Crimes and the Nuremberg Code

 Prior to and during the World War II (1940s):

experiments done on prisoners without their
consent

 Many involved exposing subjects to extreme

suffering for observational purposes such as:
 Historical
…
84

Determine time to death: submerged in freezing

water
Determine ability of subjects to withstand high altitude
conditions: forcing them into low-pressure chambers
Other experiments
– Deliberately inflicting wounds or burns
– Infecting subjects
– Poisoning them
… to test various treatments or to perform autopsies
 Historical
…
86

 Nuremberg Military Tribunals at the end of WW-II:

– scientists were held accountable for their actions

– many issues in research ethics received public

scrutiny….
 Historical
…
87

• Nazi atrocities drew attention to lack of international

ethical standards and led to formulation of Nuremburg
Code

 The first modern ethical code

♥ 10 principles

♥ Famous principle: ”Voluntary consent of the

human subject is absolutely essential”
 Tuskegee Syphilis Study: 1932-1972
88

• In 1932 the U.S Public Health Service began a study of

natural
course of untreated syphilis among black males, Alabama

• Enroll 400 men with syphilis and 200 uninfected controls

• NO Informed consent was obtained

• Transport, meals, free medical care were provided

• Pts not aware that they are in a research study

• Pts were told that they are treated for “bad blood” and was
left intentionally untreated
 Tuskegee Syphilis….
89
 Tuskegee Syphilis….
90

• 1945: Penicillin was found to be

effective, but treatment was denied

• When participants diagnosed as having

syphilis by other physicians, researchers
intervened to prevent treatment.

 Halted in 1972

 Prompt public outcry arms of human guinea pigs

Study was revealed in the New York Times

on 26 July 1972
 Historical
…
91

 By the time the study was stopped:

 Dozens of the participants had died of

syphilis
 Many of their wives had been infected

 Many children born with congenital syphilis

 Tuskegee Syphilis….
92

 President Clinton issued formal apology to the pts and

their families - in 1997

 Most famous of all

research scandals in US
history

 Often cited as reasons

to distrust researchers
 Belmont Report
93

 Promulgated by US National Commission for the

Protection of Human Subjects of Biomedical and
Behavioral Research in 1979

 Addressed the three basic ethical principles, i.e., respect for

persons, beneficence and justice

 Identified three components of informed consent:

information, comprehension and voluntariness
 National Health Research Ethics
94
Review Guidelines of
Ethiopia
 Formulated in 1995 and revised in 1997 and 2004
 Amended on several occasions in order to
accommodate the new ethical challenges

 They are intended to:

 Develop the capacity of health researchers in
health research ethics
 Serve as a guide for the various ethics
review committees of different levels in the
country
 IRB Decision Matrix : Basic Principles
95

BENEFICENCE JUSTICE
Risk/Benefit Analysis Subject selection
Experimental Inclusion/exclusion
Design Recruitment
Qualifications of PI
RESPECT FOR PERSONS

Informed consent Protection of subjects

Surrogate consent (especially
Assent vulnerable
populations)
96
Justice !!
•! Local participation right from the inception to
preparation of the proposal
• Involvement of the community in the planning and
implementation of the study
• Fair research participant selection
• Compensation of research participants
• Clear procedure for results dissemination
• Memorandum of understanding
• Post trial responsibilities
• Permission for sample transport
97

Paternalism and Consumerism

 History of the P-P
Relationship
98

30+ years ago... Over the last 30 years

• Lower rates of education • Higher rates of education
• Less access to medical care • Medical advice on
internet/libraries
• Provider trusted completely
• Better access and choice of
• Provider advice/medication
good medical care
and patient would take it
• High profile cases of providers
• Patients’ ideas, concerns &
not acting professionally-
expectations not asked general mistrust of providers
about
• Pts want to make own
• Provider-Centred decisions
Approach
99
Pharmacist-Patient
Relationship
 Pharmacist-patient interaction is shaped by their
differing social roles and their different
needs

Pharmacist - Patient interaction

social roles needs

 What is the pharmacist-patient
100
relationship?
 Central in P-P encounter is communication:
Exchange of information

 Certain sensitive relationships involving unequal

parties demand a higher motivation than self-
interest
 Types of P- P
Relationship
101

Pharmacist control
Patient Low
Control High

Lo Defaul Paternalis
w t t
Hig Consumeris Mutuality
h t
102
The Consumerist
Approach

 Less authoritarian

 Patients take the active role and pharmacist

passive
 Patient controlled consultation

 “Buyer and seller” relationship

 Consumerist
103
…
Consumerist

“You’re paid to do
what I tell you!!”
 The Paternalistic
104
Approach
“If I’ve told you once, I
told you 1,000 times,
 Traditional P-P Stop Smoking!!”
relationship
 Autocratic model

 Patient submissive

 Dominant
pharmacist
 What can be
done?
105

Cultivate a patient-centered partnership

♥ Mutuality

 “The patient
desires to be known as a human
being, not merely to be recognized as the outer
wrappings for a disease”.
End