Pharmacy Law and Ethics

By Nanati Legese, (B pharm, MSC, MPH, Assistant professor

of pharmacoepidemiology and social pharmacy)
 What is ethics?

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Ethics
• also known as moral philosophy
• is a branch of philosophy that involves
systematizing, defending, and recommending
concepts of right and wrong behavior
• is the branch of study dealing with what is the
proper course of action for man It answers
the question, "What do I do?"

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• is the study of right and wrong in human
endeavors (actions). At a more fundamental
level, it is the method by which we categorize
our values and pursue them
• is a branch of philosophy which seeks to
address questions about morality; that is,
about concepts such as good and bad, right
and wrong, justice, and virtue

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 Value, Morality and ethics
Values
• beliefs of a person or social group in which they
have an emotional investment (either for or against
something); "he has very conservatives values"
• are the standards by which we judge human
behavior
• are moral rules, promoting those things thought of
as good and minimizing or avoiding those things
thought of as bad

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• We usually learn these values at an early age, from
observing behavior and through secular (including
professional) and religious education.
• are the rules by which we make decisions about
– right and wrong,
– should and shouldn't,
– good and bad
• They also tell us which are more or less important,
which is useful when we have to trade off meeting
one value over another
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Morality
• motivation based on ideas of right and wrong
• Concerns itself with relations between people
and is made up of values and duties based on
beliefs shared by society or a section of
society; they tell those who share them what
is right and wrong.

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Ethics
• is the application of values and moral rules to
human activities;
• it centers on interpersonal relationships and
how best to manage them
• It is also concerned with the process of
making moral judgments.

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Difference between ethics
and law

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• Ethics achieved without the intervention of
government, by voluntary self discipline
• Law achieved through government
intervention

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BRANCHES OF ETHICS

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Meta-ethics
• deals about the theoretical meaning and
reference of moral propositions and how their
truth values (if any) may be determined
• is a field within ethics that seeks to understand
the nature of normative ethics
The focus of meta-ethics is on how we understand,
know about, and what we mean when we talk
about what is right and what is wrong
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Normative ethics
• A branch of ethics concerned with determining
whether an action is right or wrong.
• attempts to develop a set of rules (or norms)
governing human conduct
• It deals with what people should believe to be
right and wrong, unlike descriptive ethics, which
deals with what people actually believe to be
right and wrong.
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• about the practical means of determining a
moral course of action
• Traditionally, normative ethics (also known as
moral theory) was the study of what makes
actions right and wrong. These theories
offered an overarching moral principle one
could appeal to in resolving difficult moral
decisions

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Applied ethics
• Is a discipline of philosophy that attempts to
apply ethical theory to real-life situations
• Is about how moral outcomes can be achieved
in specific situations
• has many specialized fields, such as
Engineering Ethics, bioethics, medical ethics,
business ethics etc

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Medical ethics
• is primarily a field of applied ethics
• is the study of oral values and judgments as
they apply to medicine
• encompasses its practical application in
clinical settings as well as work on its history,
philosophy, theology, and sociology

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Professional ethics

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 What is professional ethics?
• Has been defined as “rules of conduct or
standards by which a particular group in
society regulates its actions and sets standards
for its members.”
• Focuses on explicit or implicit rules and
standards set by a professional subgroup of
society, and addresses the responsibilities of
only those who are members of that
subgroup.
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What is the advantage of
professional ethics?

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• Ethics make the decision making process so
efficient
• Individual professional occasionally may need
guidelines for directing their professional
behavior
• Professional ethics establishes a pattern of
behavior that clients come to expect from the
professional

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 Pharmaceutical ethics
• is a branch of medical ethics that provides a
framework for pharmacists to use in resolving
questions about what ought to be done in
pharmacy practice.
• is the beliefs and behaviors to which members of
the profession subscribe
• is a critical evaluation of assumptions and
arguments
• is a discussion about what ought to be done or not
to be done
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 Why is Ethics important?
• Ethics is a requirement for human life. It is our
means of deciding a course of action.
• Without Ethics, our actions would be random
and aimless.
• There would be no way to work towards a goal
because there would be no way to pick
between a limitless numbers of goals.

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• Even with an ethical standard, we may be
unable to pursue our goals with the possibility
of success. To the degree which a rational
ethical standard is taken, we are able to
correctly organize our goals and actions to
accomplish our most important values.
Any flaw in our ethics will reduce our ability to
be successful in our endeavors.

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Ethical theories

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• a broad term that refers to any philosophical
attempt to classify actions into right and
wrong/good and bad
• Ethical theories and principles are the
foundations of ethical analysis because they
are the viewpoints from which guidance can
be obtained along the pathway to a decision.

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 Deontological theory (Rights-Based Ethics)

• Right and wrong are determined by whether the

action is
– consistent with duty and
– from a motive of fulfilling one’s moral obligation
• Deontologists argue that morality is grounded in
pure reason and objectivity.

Decisions are ethically valid if they conform to a

proper moral rule, and wrong if they violate such a
rule
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• Deontology holds that the most important
aspects of our lives are governed by certain
unbreakable moral rules which may not be
broken, even if breaking them may improve an
outcome.
– One example of a list of "unbreakable" rules is the
Ten Commandments

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 Deontological theories do not consider
consequences to be important when
determining whether or not an action is
ethical
In other words, they may do the "right" thing,
even though the consequences of that action may
not be "good."

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The morally correct thing is always to be guided
by moral duties, rights and responsibilities.

some actions are:

• intrinsically immoral, irrespective of how
positive or beneficial the consequences might
be,
• while others are intrinsically moral, irrespective
of how negative the consequences.
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• A person who follows this theory will produce
very consistent decisions since they will be
based on the individual's set duties.
• Among the commonly accepted types of
moral rules are:
– telling the truth
– keeping promises
– respecting privacy
– helping others and protecting the right to life
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• Depending on the deontological theory, duties
may be
– absolute (no exceptions),
– prima facie (can only be overridden by a more
important duty), or
– conditional (only hold under specified
circumstances

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Immanuel Kant
• Claims that actions are only morally right when they are
done out of duty.
• sees moral duties as unchanging laws for human
conduct
– Believes that morality is derived from the ability to think
rationally, which enables beings to be free. If one is not free,
then one cannot be held responsible.

Thus only free individuals are moral agents and all free
individuals are capable of acting out of reason.
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Benefits
 Right and wrong actions are easily determined by
considering one's duties.
– In some cases, these are explicitly spelled out (i.e.
religion). However, the use of judgment is usually
necessary to determine which duties apply and how.
 Unlike utilitarianism, the end does not justify the
means. Deontological theories provide a sound
basis for inalienable rights and inherent value.

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 Since duties do not change, there is a greater
sense of security/predictability in the accepted
behavior of others.
– Right and wrong don’t vary with the
consequences, although there may be various
according to circumstances (i.e. in the case of
conflicting duties).
 Good motives are valued, even if the
outcome wasn’t what you expected.
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Problems
• There is no agreement on a single standard for
morality.
• Ignoring consequences can cause pain and
suffering.
• The imposition of a specific moral belief
system on others has been a cause of
significant harm throughout history.

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 Utilitarian /Consequentialist theory
• Right and wrong are determined by the utility or
consequences of an action; in most versions of this
theory, actions are right if they:-
– produce happiness or
– reduce pain.
• Consequences can be good, neutral, or evil.
• Jeremy Bentham and John Stuart Mill was both act
utilitarian’s. So they judged individual an action to
be good or bad depending on the actual
consequences of that action.
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• Bentham defined good as pleasure and evil as pain.
• Thus when choosing an action, according to
Bentham, one should select the action which
produces the greatest amount of pleasure
compared to pain for all affected.

Since pleasure and pain were the foundation for good

and evil, “all affected” would include all sentient
things

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• J. S. Mill differed from Bentham in that he believed
that happiness and unhappiness were the basis for
good and evil.
• Under his evaluation then, while pleasure and pain
were important considerations, they were only the
basic minimum.
• This sets up ability for Mill to claim that
consequences to more sentient beings may be more
important than those to less sentient beings and to
characterize some pleasures as higher than others.
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• There are two types of utilitarianism:-
act utilitarianism and
rule utilitarianism.

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Act utilitarianism
• adheres exactly to the definition of utilitarianism as
described in the above section
• a person performs the acts that benefit the most
people, regardless of personal feelings or the societal
constraints such as laws
Rule utilitarianism
• takes into account the law and is concerned with
fairness
• seeks to benefit the most people but through the
fairest and most just means available
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Benefits and Problems Consequentialist theory

Benefits
• Consequentialism is grounded in actual effect. So,
moral action always improves life on earth (in some
manner). Acting morally can improve your lot in life.
So, there is an incentive to act morally even if you
do not believe in an afterlife.
• Consequentialist theories are often attentive
(helpful) to the particulars of the situation.
• These theories will allow for exceptions to the rule
when warranted by the outcome.
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• Utilitarianism follows the cause and effect
reasoning in science. It can be proven wrong
or right by referring to empirical evidence,
instead of a theoretical ideal.
• All sentient beings understand pain and
pleasure. Thus many have claimed that
utilitarianism is transcultural.

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Problems
• Consequences are difficult to predict. Your actions may
have good intentions and a high probability of causing
good results. But, if something happens and the
consequences are actually bad, then your action was
morally wrong. Also, as the situation involves more
people and alternatives, it becomes more difficult to
determine which action would produce the best
consequences. How can we ever know that we actually
chose the “best” alternative. There is no opportunity for
comparison of actual cases, just similar ones.
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• "Does the end always justify the means?" A
consequentialist theory would justify many actions that
we normally would consider wrong, if it turned out that
the consequences were good.
• This theory undermines trust in others and intimate
relationships since we can never be sure that the
consequences might not justify a betrayal of trust and in
many of these theories, each individual is treated the
same regardless of one's relationship. So, for example,
one’s duty to prevent pain to a stray cat would be equal
to one’s duty to prevent pain to one’s own cat.
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Virtue Theory
• Judges a person by his character rather than by the
action that may deviate from his normal behavior.

• determines the virtuous action according to what

an ideally virtuous person would do in a given
situation

• The virtue theory asks what a "good person" would

do in specific real-life situations.
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• This theory stems from the character traits
discussed by Aristotle, Plato, and Thomas
Aquinas.

• They discuss such timeless and cross-cultural

virtues as courage, temperance, wisdom,
justice, faith, and charity.

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• Deontological theories focus on acting in accordance with
moral duties and obligations.

• Virtue based theories focus on the character of the

person. According to virtue based theories, ethics is about
what sort of person one should strive to become.

The qualities that one should develop in oneself are called

virtues (ex. honesty, fairness, kindness, faithfulness,
generosity, prudence, integrity, bravery, etc.).

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Benefits
 This type of theory recognizes that individuals and
circumstances are unique. For example, the virtue of
compassion may be expressed by two people in two different
ways. Similarly, running into a burning building may be
courageous action for a fire professional but foolhardy for an
untrained individual with no protective equipment.

 Virtue ethics allows each individual to use his/her own

judgment when making difficult moral decisions, yet recognizes
certain common goals.

 Mistakes are expected and recognized as learning opportunities.

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Problems
 does not take into consideration a person's change in moral
character

 Some argue that too much is left to individual judgment, thus

opening the door to bias and prejudice.

 Similarly, virtues can be interpreted very differently. For

example, consider the many ways that fairness may be
interpreted.

 Virtue ethics depends on modeling for some of the education.

However, one may choose a poor role-model and therefore
develop a false sense of virtue.
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 Summary of ethical theories
Consequentialism Deontology Virtue Theory

example utilitarianism Kantian ethics Aristotle's moral theory

abstract description An action is right if it An action is right if it is An action is right if it is

promotes the best in accordance with a what a virtuous agent
consequences moral rule or principle would do in the
circumstances

more concrete The best consequences A moral rule is one that A virtuous agent is one
specification are those in which is required by who acts virtuously,
happiness is rationality. that is, one who has
maximized and exercises the
virtues. A virtue is a
character trait a human
being needs to flourish
or live well.

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Ethical principles
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• are the common goals that each theory tries
to achieve in order to be successful

• Pharmacists have an ethical obligation to care

for their patients

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Purpose
 To determine the right of patients under the
principles.
 To permit a decision about pharmacist duties that
correlate with those rights.
 To enable a pharmacist to justify to himself or
herself, and to others, the action taken in a given
situation.
 provide guidance for practitioners about what the
commitments of patient care entail
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1. Autonomy
• The principle of autonomy states an individual’s
liberty of choice, action, and thought is not to be
interfered with

• The patient has the right to refuse or choose their

treatment.

• In health care we think of autonomy as the right of

individuals to make decision about;
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 – what will happen to their bodies
– What choices will be made among competing options
and
– What they choose to take or not to take, into their
bodies

• Autonomous individuals are at liberty to perform

whatever actions they wish, as long as another
autonomous individual’s actions are not infringed, even
if the actions appear to be foolish or unwise based
upon conventional and generally accepted wisdom.
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Exception;
Medical paternalism-
• suggests that pharmacists and other health
care professionals (because of their education
and training ) know what is best for their
patient.

• Two types:-

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• Weak paternalism-if that individual is not or does not
appear to be autonomous or if minimal intervention is
necessary to determine whether the patient is
autonomous

• Strong paternalism-when you believe that they are

either making the wrong decision or a decision that will
cause harm to themselves

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For example
☎a patient with terminal cancer may prefer to live the rest of her
life without the medication that makes her constantly ill.

☎The physician, on the other hand, may convince the patient

and her family members to make the patient continue taking
her medication because the medication will prolong her life.

☎In this situation, the physician uses his or her authority to

manipulate the patient to choose the treatment that will
benefit him or her best medically.

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2. Informed consent
• The rule of informed consent directs that patients
must be fully informed about the benefits and
risks of the action which they are participating.

E.g. participation in a clinical trial, taking a

medication or electing to have surgery

• Informed consent can be formal or informal

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States that :-
the client has a right to be informed and to freely
choose a course of action; for example, informed
consent to receive a therapy or procedure

• Composed of five elements: disclosure,

understanding, voluntariness, competence and
consent
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3. Confidentiality
• is the presumption that what the patient tells the
health professional will not be revealed to any other
person or institution without the patient’s permission

• Keeping information private from others

• All medical information by nature is generally

considered to be confidential unless the patient grants
approval for its release
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• Addresses the individual client’s right to give or
refuse consent relative to release of privileged
information

• Exception- when keeping in private may harm others

or when the patient lacks autonomy

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4. Nonmaleficence
• The principle of nonmaleficence (doing no harm) requires
that pharmacists refrain from acting in ways that will
cause harm or injury to others

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

patients will discontinue using a drug if information about
the drug is disclosed, is adhering to the principle of
nonmaleficence, because it is through acts of commission
that this principle is violated.
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• Nonmaleficence prohibits both
– deliberate harmful action (substituting one
generic drug product for another without
authorization and without evidence of
bioequivalence) and
– unintentional harm (inadvertently using the sig
code for “take one tablet four times daily” for the
label of a digoxin prescription that has directed
the patient to take only one tablet daily.

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• Harm may be caused in many ways
– By some deliberate action
– By incorrect action(neglect or ignorance)
– Through omission by failing to prevent others
doing

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5. Beneficence
• The principle of beneficence (doing good)
requires positive action to
(1) Prevent what is bad
(2) Remove bad or evil and
(3) Do or promote good

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• Beneficence indicates that you act in a manner to do
good; a practitioner should act in the best interest of the
patient

• It is through acts of omission that this principle is

violated

• Nonmaleficence refers to taking due care or avoiding

harm;"first, do no harm"

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For example,
☎the pharmacist described above who neglects
to counsel patients is violating the principle of
beneficence, because information about
medications generally helps patients use their
medications the correct way

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6. Fidelity
• Fidelity requires that pharmacists act in such a
way as to demonstrate loyalty to their patients.

• addresses the responsibility to be trustworthy

and keep promises

• A type of bond or promise is established

between the practitioner and the patients
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• This professional relationship places on the
pharmacist the burden of acting in the best interest
of the patients

• Pharmacists have an obligation of fidelity to all their

patients regardless of the length of the professional
relationship

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For example
☎practitioners have same obligation to
show fidelity to an occasional patients as
they have for a regular customer

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7. Veracity
• Veracity is the ethical principle that instructs pharmacists
to be honest in their dealing with patients

• addresses the obligation to truth telling or honesty

• There may be times when the violation of veracity may

be ethically justifiable (as with the use of placebos), but
the violation of this principle for non-patient centered
reasons would appear to be unethical

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8. Distributive justice
• refers to the distribution of the benefits and the burdens of
society equally among all members of the society

• When health resources are allocated, a pharmacist is fair

and equitable, balancing the needs of patients and society

• concerns the distribution of scarce health resources, and the

decision of who gets what treatment (fairness and equality)

• People should be treated fairly (or equally) and not

differentiated on grounds such as gender, race or creed.
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 Code of ethics
is the rule of conduct based on moral values,
which are stated by a recognized association
of the particular profession

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 Why do we need code of ethics in
pharmacy?
• To ensure that standards of professional conduct are
maintained at all levels of pharmacy practice
• To state publicly the principles that forms the
fundamental basis of the duties and responsibilities
of pharmacists
• To safeguard the public from unethical and
substandard professional practice by raising the
awareness and commitment of professionals to the
stated principles and obligations of the code of ethics

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• To foster the good relationship that should
prevail among pharmacists, other health
professionals, patients and the society at large
• To enhance the awareness of pharmacy
professionals on the existing laws, rules and
regulations governing the profession

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 PHARMACIST CODE OF ETHICS
• Pharmacists are health professionals who assist
individuals in making the best use of medications.
• This Code, 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 and virtues,
are established to guide pharmacists in
relationships with patients, health professionals,
and society.
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 I. A pharmacist respects the covenantal
relationship between the patient and
pharmacist.
• Considering the patient-pharmacist relationship as a
covenant 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, and
to maintain their trust.

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II. A pharmacist promotes the good of every patient
in a caring, compassionate, and confidential manner.
• A pharmacist places concern for the well-being of the
patient at the center of professional practice. In
doing so, a pharmacist considers needs stated by the
patient as well as those defined by health science.

• A pharmacist is dedicated to protecting the dignity of

the patient.
• With a caring attitude and a compassionate spirit, a
pharmacist focuses on serving the patient in a private
and confidential manner.
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 III. A pharmacist respects the autonomy and
dignity of each patient.

• A pharmacist promotes the right of self-

determination and recognizes individual
self-worth by encouraging patients to
participate in decisions about their health.
• A pharmacist communicates with patients in
terms that are understandable. In all cases, a
pharmacist respects personal and cultural
differences among patients.

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 IV. A pharmacist acts with honesty and
integrity in professional relationships.
• A pharmacist has a duty to tell the truth and
to act with conviction of conscience.
• A pharmacist avoids discriminatory practices,
behavior or work conditions that impair
professional judgment, and actions that
compromise dedication to the best interests
of patients.

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 V. A pharmacist maintains professional
competence.
• A pharmacist has a duty to maintain
knowledge and abilities as new medications,
devices, and technologies become available
and as health information advances.

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 VI. A pharmacist respects the values and
abilities of colleagues and other health
professionals.
• When appropriate, a pharmacist asks for the
consultation of colleagues or other health
professionals or refers the patient.

• A pharmacist acknowledges that colleagues and

other health professionals may differ in the beliefs
and values they apply to the care of the patient.

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VII. A pharmacist serves individual, community,
and societal needs.
• The primary obligation of a pharmacist is to
individual patients. However, the obligations
of a pharmacist may at times extend beyond
the individual to the community and society.
In these situations, the pharmacist recognizes
the responsibilities that accompany these
obligations and acts accordingly.

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 VIII. A pharmacist seeks justice in the
distribution of health resources.
• When health resources are allocated, a
pharmacist is fair and equitable, balancing the
needs of patients and society.

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Health Professional-Patient
Relationship:
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 Consumerism Versus Paternalism
• Medical paternalism-the belief that the health care
professional knew best-was accepted as standard
practice by most health care professionals and their
patients.

• The medical rights of patients were not as widely

recognized as other rights they held, such as suffrage
or due process. Today, patients have become true
consumers of medical care. Patients wish, and have a
right, to be informed and asked for their consent.
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• For a health care professional to do harm would not
only be unprofessional and unethical, but also have
potential legal ramifications.

• Patients also expect a certain level of service. As

with sellers of other goods and services, health
professionals who fail to meet the demands of
medical consumers for care will quickly find
themselves without customers and, sometimes, with
legal problems.
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 Moral Rights Versus legal Rights
to Health Care
• Legal rights are either guaranteed
fundamentally in the Constitution (e.g., the
rights of free speech and assembly) or are
provided by laws and regulations.

• promulgated at the federal, state, or local

level. We sometimes confuse what are really
legal rights with our moral obligations.

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• Such rights might include the right to live without
fear of harm and the right to food and adequate
shelter.

• Moral rights are quite different from legal rights.

Granted, these rights may be reinforced by laws,
but their basis lies not in law but in ethical
principles.
• More recently, Americans have grappled with the
question of health care as a moral right.
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• As one might expect, moral rights and legal
rights may conflict.
• for example There is disagreement, over
whether issues such as abortion involve moral
rights or legal rights.

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 Patient's Rights
• When a patient seeks the care of a pharmacist, what
rights do they have? What can they reasonably
expect from pharmacists?
• Patients can expect that pharmacists will employ
their knowledge and experience in caring for them.
• They can expect that, as autonomous individuals,
pharmacists will respond to their wishes about their
treatment.
• Patients also have a right to treatment that is both
safe and effective
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 Medical Practitioners' Duty to Their
Patients
• What is the responsibility of medical practitioners?
• Some might argue that health care providers have
a Hippocratic responsibility to their patients, and
that this responsibility focuses solely on what is
best for the patient, irrespective of the
consequences to others.
• “a pharmacist promotes the good of every patient
in a caring, compassionate, and confidential
manner.” pharma code of ethics

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 Legal Responsibility Versus Moral Obligation

• All pharmacists practice under the practical

constraints of law that may limit their doing
whatever is necessary.
• Consequently, although they have a moral
obligation to care for their patients, this obligation
is constrained by law.

• Thus, patient rights and practitioner responsibility

may sometimes be in conflict, not on ethical
grounds but on legal ones.
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• Directing a pharmacist to assume an
individualistic approach and take an illegal, yet
ethical, action for a patient despite legal
consequences is asking the pharmacist to
subjugate his or her own interests to that of
the patient.

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 ETHICAL RESPONSIBILITY
• In traditional pharmacy practice, both the
legal and ethical obligations of pharmacists
centered around ensuring that the proper
medication as ordered by the prescriber was
delivered to the patient.

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 VEATCH'S FRAMEWORK FOR ETHICAL
ANALYSIS
• Robert Veatch has suggested a framework for ethical
analysis that can be used by pharmacists to
determine the ethical course of action to follow in a
given situation. His four-step approach involves
(l) ensuring adequate knowledge of all the pertinent
facts involved in a given situation, and
The application of
(2)moral rules,
(3) ethical principles, and
(4) ethical theories.
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• Veatch contends that some ethical situations
can be solved without the application of moral
rules, ethical principles, or ethical theories.

• Sometimes an ethical dilemma can be solved

by simply ensuring all the facts are known
about a case (step 1).

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• For example, a question of whether to break patient
confidentiality might be moot if the patient has already
agreed to allow the health professional to divulge such
information.

• If step 1 does not provide an answer, the professional may

proceed to step 2, the application of moral rules.
• The rules of confidentiality and/or consent (informed
consent) may offer some guidance.
• If a dilemma still exists, ethical principles may be employed
(step 3). These include autonomy, beneficence,
nonmaleficence, veracity, fidelity, and justice.
• Ethical theories, Veatch suggests, are the ultimate arbiter of
ethical dilemmas (step 4).
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ETHICAL CONFLICTS AND
ISSUES IN HEALTH CARE

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• The conflict between the personal interests of
the professional and the duty to subordinate
these interests to the benefit of the patient
presents one of the major unresolved
problems of the professions.

• In addition, changing patterns in pharmacy

and health care delivery present additional
ethical conflicts.
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• Conflicts continue to occur for many
pharmacists when they find themselves faced
with dispensing
– placebogenic agents,
– oral contraceptives,
– drugs for lethal injections, and
– drugs for controlling certain types of behavior.

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• The whole process of modern drug
development probably will continue to
generate a wide variety of ethical concerns.

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1. Law and Ethics
• Many of the laws, regulations, and other rules
that govern our daily life are an outgrowth of
our morality and ethics.
• Those laws that prevent homicide, robbery,
and other offenses are simply a codification of
the values we share as members of society.
• Unfortunately, laws and regulations cannot be
promulgated to cover every eventuality,
nuance, condition, or situation.
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• They are created in such a way as to provide
legal guidelines for the usual or most common
situation.

• What should be done, therefore, when such a

situation (e.g. committing homicide in self-
defense) arises, especially if the legal course of
action is inconsistent with the ethical course
of action?
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 2.Rationing of Health Care Services

• As the cost of providing health care services

continues to grow, some have suggested and
even attempted to implement a system that
would ration the availability of health care.
• But it contradicts with the belief that “all that
can be done for each patient ought to be
done.”

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 3.Assisted Suicide

• Medical euthanasia (mercy killing) has long

been an ethical issue.
• Dr Jack Kevorkian-The activities of assisted
suicide.
• Several states have considered the legality of
assisted suicide; some have rejected it, while
others have accepted it within strict
guidelines.

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• There is no constitutionally guaranteed right
to assisted suicide. The states must decide the
legality of assisted suicide on their own.

• From an ethical perspective it violates the

principle “to do no harm”

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• Those who are advocators of assisted suicide
suggests that
“allowing a patient to continue to experience
unrelenting pain is doing harm.”
They suggest that patients have the right to make
an autonomous decision to end their life.
• However, their opponents worry that legal
assisted suicide would be abused.

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 4. Human Drug Experimentation

• Two important ethical aspects of human drug

experimentation are
 the role of the institutional review board (IRB)
and
 the use of placebos.

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• The lRB is the body responsible for overseeing
all clinical research conducted within a given
institution.
• has two primary responsibilities
1. ensure the integrity and scientific rigor of the
proposed research study( Evaluate the risk
benefit ratio for the study participants)
2. evaluate and approve informed consent forms
used in conjunction with the research
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• Placebos have two roles in medicine:
(1) as part of the research methodology(In
clinical drug research); and
(2) as a means for providing a therapeutic
response in selected patient situations
Ethically problematic in situations like:
– Medical paternalism( HP knows best)
– Can be considered as a direct violation of patient
autonomy and informed consent.
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 5. Drug Formularies

• Restrictive use of formularies has led to a number

of important ethical questions.
For example,
– does the use of generic and/or therapeutic substitution
violate the autonomy of the patient and/or prescriber?
– Is the use of such substitution a violation of informed
consent?
– Does the use of formularies violate the ethical
principles of beneficence (do good) and
nonmaleficence (avoid harm)

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Standards of practice for
pharmacists practicing in
Ethiopia
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1. Dispensing of medications in pharmacy
Dispensing includes the selection, preparation,
and transfer of one or more doses of a drug
to a client.
Moreover, it involves cognitive component
including assessing the therapeutic
appropriateness of a prescription and
making appropriate recommendations,
providing effective counseling.

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• Obligations:-
– Personally fill all prescriptions or ensure appropriate
filling of orders.
– Accept prescriptions only in writing except in
emergency or compelling conditions.
– Ensure that products are approved for sale by
national FMHACA.
– Not dispense prescription only drugs without
prescriptions.
– Immediately Inform prescribers for due correction or
clarification if prescription is found to be illegal/wrong
– Not dispense both prescription&/OTC drugs to
patients who are apparently not in their right mental
state.
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 – Promote that medicines would be dispensed as original packs
or if parts are required then it should be appropriately labeled.
– Be ethically free to make generic substitution of prescription
drugs.
– Not add, omit or substitute any ingredient or alter the
composition of a prescription without the consent of the
prescriber.
– Not fill prescription of drugs written by a prescriber for his
own use.
– Have the knowledge &skills that meet the standards
– Know about his/her patients for effective counseling.
– Give ample verbal and written information about the
medications
– Ensure conducive environment for patient education and
counseling
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2. Compounding and manufacturing of p’cals
Obligations: a compounding pharmacist should:
– Foster the triad relationship b/n patient,
prescriber and pharmacist
– Only authorized personnel should be involved in
drug- compounding
– Have written procedures for compounding or SOP

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3. Manufacturing of drugs and medical supplies
Obligation: Pharmacist working in this area should:
– Ensure safety, efficacy and quality of p’cal products
– Ensure that products carry unique batch no.,
manufacturing &expiry date.
– Maintain records of all key processes from production
to delivery.
– Respect the professional character of the establishment
– Ensure that all processes are in accordance with the
national CGMP.
– Should develop clearly written SOP and cleaning
procedure.
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4. p’cal supply management and rational drug use.
Obligations:
– Properly select and quantify p’cals
– Import or obtain only those p’cals whose safety,
efficacy and quality are ensured
– Procure p’cals following appropriate methods of
procurement so as to ensure their affordability,
availability and distribution.
– Not abuse procurement for him/herself
– Undertake physical inspection upon receipt of p’cals
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 – Ensure availability of appropriate storage facilities
and special storage facilities for substances of
abuse, radio p’cals, poisons, flammables…etc
– Distribute p’cals only to authorized institutions
– promote rational use of p’cals

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5.Handling of narcotics, psychotropic and other
dangerous drugs
• These substances are such that they are toxic
and dangerous in small doses and can be used
for unlawful acts; or are mood altering&/or
habit forming.
• These substances need great care to make
sure that they are used solely for their
legitimate medical purposes.
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Pharmacist handling such products have the following
obligations:
– Keep in separate and strict security storage to avoid access
to unauthorized staff.
– Dispense these substances through special prescription
paper.
– Keep proper registration of these products and submit
records to the control authorities.
– Properly label, mark, store and dispense poisons to avoid
harm
– Immediately report breakage, loss or theft of these
substances to regulatory authority
– Not fill prescription signed by a prescriber for self use.
– Refrain from abuse
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of controlled substances.
pharmacy law and ethics 127
6.Quality assurance of p’cals
Purpose: to make certain that each drug reaching the
patient is safe, effective and of the required
quality.
Obligations:
– Ensure that all standards( CGMP) are followed.
– Ensure that each batch of manufactured drugs must
have a batch processing record.
– Not make available for sale or distribution products
which he believes, are substandard, mislabeled or
adulterated or expired
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7. Promotion and advertisement of p’cals
Obligations:
– Not do self advertisement involving his/her professional
service nor shall avail himself in any way
– Not promote the product of a particular manufacturer
unless he/she is a direct employee
– Not display materials, which are indemnifying to the
profession and in any way indicate promises of curing
disease.
– Refrain from misinforming the public or other health
professionals for purposes of drug promotion.
– Not participate in encouraging a person or the public to
buy more of a medicine product than the amount needed.
– Ensure that prescription medicines would not be included
in pharmacy- window
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displays or advertised to the public.
pharmacy law and ethics 129
8. Disposal of unfit for use products
Obligations;
– Ensure that all reasonable care is taken when
disposing medicinal products and chemicals.
– Keep ‘unfit for use drugs’ in a segregated areas.
– Ensure that aerosols, cytotoxics and other
controlled and dangerous substances are
segregated from other unfit products until
disposal.
– Ensure the availability of a suitable and adequate
means of waste disposal.
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9. p’cal regulatory services
Includes various regulatory activities such as the
following:
– Setting of specifications and standards for products,
premises and procedures
– Marketing/ use authorization,
– Licensing of premises,
– Inspection of p’cal establishment,
– Laboratory testing/ analysis
– Control of clinical trials
– Provision of information and control of promotion
– Control of drugs of abuse, radio p’cals, poisons
– Promoting rational use of drugs
03/17/2024 pharmacy law and ethics 131
Obligations;
– Make decisions and act solely in the public interest not
individual interest
– Make sure to justify actions taken and promote transparency
– Not disclose information of confidential or private nature
– Avoid conflict of interest( not work in other p’cal
establishment)
– Not issue or renew certificate of competence of drug trade or
service without adequate investigation
– Be free from deceit, bribes &/or nepotism
– Be dedicated to uphold the p’cal laws and regulations
– Exercise legitimate powers and authority only within scope of
his/her institution
– Participate in promotion
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of rational use of drugs.
pharmacy law and ethics 132
10. Drug research and development
Obligations;
– Be committed to his proposal and agreements; act with
sincerity; strive for consistency of thought and action.
– Strive to avoid bias in experimental design, data analysis and
interpretation
– Honor patents, copyrights and other forms of intellectual
property
– Protect confidential communications such as papers or grants
submitted for publication
– Strive to promote social good and prevent or mitigate social
harm through research, education and advocacy.
– Avoid discrimination while selecting subjects
– Give proper respect and care for animals in research
03/17/2024 pharmacy law and ethics 133
Research involving human subjects;
– Not coerce people to participate in research
– Keep prospective research participants fully informed about
the procedures and risks involved.
– Not put participants in a risk of harm as a result of their
participation.
– Guarantee the participants confidentiality
– Participants should remain anonymous
– Objectively select research participants avoiding bias
– Strictly follow international and national ethical guidelines

03/17/2024 pharmacy law and ethics 134

11. Pharmacy education
Pharmacy education is responsible for preparing
students to enter into a career in pharmacy
and function as professionals and responsible
citizens in improving health care systems.
• The following are areas of ethical concern with
respect to pharmacy training programmes in
institutions of higher education in Ethiopia.

03/17/2024 pharmacy law and ethics 135

• The pharmacist in a training institute should ensure
that:
– Basic (first degree) education programmes should
provide pharmacy students and graduates with a sound
and balanced ground in the natural p’cal and health
care sciences.
– The program maintains balancing scientific knowledge
with practical training.
– Education programmes are based on a research
oriented environment at a university.
– Educational outcomes reflect the needs of society
developing the practice of pharmacy in Ethiopia
– Assessment and quality assurance should be conducted
to guarantee professional competence
03/17/2024 pharmacy law and ethics 136
 – Ensure the moral development and ethical
behavior of students.
– Schools and faculties of pharmacy develop close
alliances with educators of health professionals
– Personnel involved in pharmacy teaching are
knowledgeable and show good conduct
– Personnel involved in pharmacy teaching do not
use their authority for personal gain

03/17/2024 pharmacy law and ethics 137

Pharmacy law
 What is law ?
• Law is the body of principles that govern
conduct and observance of which can be
enforced in courts or that which must be
obeyed by citizens.
• Law demarcates what is permissible from
what is not.
• It must be obeyed and followed by citizens
and is subject to legal sanctions or
consequences.
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• In order to appreciate law, try to imagine what
happens if there is no traffic law??????

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 The nature of law
• Law is the body of official rules and
regulations, generally found in constitutions,
legislation, judicial opinions, and the like, that
is used to govern a society and to control the
behavior of its members.
• The nature and functions of law have varied
throughout history.
• In modern societies, some authorized body
such as a legislature or a court makes the law.
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 The functions of law
Law serves a variety of functions.
 Laws against crimes, for example, help to maintain a peaceful,
orderly, relatively stable society. Courts contribute to social
stability by resolving disputes in a civilized fashion.
 Property and contract laws facilitate business activities and
private planning.
 Laws limiting the powers of government help to provide some
degree of freedom that would not otherwise be possible.
 Law has also been used as a mechanism for social change : for
instance at various times laws have been passed to inhibit
social discrimination and to improve the quality of individual
life in matters of health, education, and welfare.
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 Pharmacy law
• Pharmaceutical jurisprudence is the science or
philosophy of law governing pharmaceutical
sector or services.
• Pharmacy law is a rule of human conduct
binding upon all persons engaged in the
practice of pharmacy.
– It is also restrictive like other laws.

03/17/2024 pharmacy law and ethics 143

• Pharmacy law gives certain rights of a
pharmacy professional and it takes away
freedom for it says a professional must
possess certain training, be registered and
licensed to practice the profession.

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 Need for pharmacy law
Pharmacy law is needed for the following major reasons :
• To ensure proper implementation of pharmaceutical
policy.
• To determine the role of
– Pharmacy law executive agency - Whole sale / distributors
– Medical practitioners - Retail out lets
– Pharmacy personnel - Health institutions, etc
– Manufacturers
• On the quality assurance, proper storage, distribution
and use of pharmaceuticals.
• To ensure that the final consumers receive
pharmaceuticals of proven quality , safety, and efficacy.
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• To ensure the implementation of the pharmaceutical
sector to the required standard i.e.
– Manufacturing ,
– Import / export,
– Local procurement,
– Storage,
– Inventory control,
– Use (prescribing , dispensing, patient use ),
– Administration and control (registration , licensing,
marketing authorization,
– Inspection post marketing surveillance, promotion and
advertisement.
– Controlled substances.
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Etc )
pharmacy law and ethics 146
 The History of Pharmacy Law
• Pharmacy is an old profession that traces its
history back at least 4,000 years ago.

• In nineteenth century drugs unregulated

– medicines did not require proof that they were
either safe or effective

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• Traveling medicine shows proclaimed “miracle
cures”
– no regulations on labeling
– no research to support claims
 Federal regulation of drugs began only in 1906
with passage of the Pure Food and Drug Act.
– This legislation was a classic example of “indirect
regulation,” because it merely provided that
labeling on medications be truthful and not
adulterated, allowing consumers to make
decisions for themselves.
– It did not prevent the marketing of dangerous
chemicals as drugs.

03/17/2024 pharmacy law and ethics 149

• In 1937 a Tennessee drug company advertized
a new sulfanilamide elixir specifically aimed
toward children. The toxic solvent went
untested (per the current laws) and over 100
people, mostly children, died. It turned out the
solvent was similar to antifreeze, which is
deadly to humans.

03/17/2024 pharmacy law and ethics 150

 In 1938, the Food, Drug & Cosmetic Act (FDCA)
was passed. This act, forms the basis of drug
regulation today.
– The 1938 law required that new drugs be shown to
be safe prior to their marketing.
– Thus, this was a first step toward “direct regulation,”
because it made decisions for consumers.
– Several subsequent amendments have added
requirements to the FDCA.

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 In 1952, the prescription-only requirement
became effective, creating two classes of
drugs: those available without a prescription
and those available only with a prescription.

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 In 1961, an amendment required proof of efficacy,
in addition to safety, prior to marketing of a new
drug.
The 1984 amendment made it easier to market
generic equivalents of drugs, but granted patent
term extension to the innovators of new drugs,
under certain conditions.
The FDA Modernization Act of 1997 is the most
recent amendment to clarify pharmacist
responsibilities in drug distribution.
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Food, Drug & Cosmetic Act

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• the FDCA serves as the basis for drug regulation first
amended in 1938.
• The FDCA is both simple and complex at the same
time.
• The simplicity is that it specifies only three basic
illegal acts; adulteration, misbranding, and the
placing into interstate commerce of an unapproved
new drug.
• The complexity is that many activities are included
under the umbrella of these three basic illegal acts.
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 Food, Drug, and Cosmetic (FDC) Act of
1938
• The most important piece of legislation in
pharmaceutical history

• Created the FDA

• Required pharmaceutical manufacturers to file a

new drug application (NDA) with each new drug
before marketing

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 Food, Drug, and Cosmetic (FDC) Act of
1938
• Extended and clarified the definitions of
adulterated and misbranded drugs

• Defined the relevant “official compendia” as the

United States Pharmacopeia and the National
Formulary

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 Food, Drug, and Cosmetic (FDC) Act of
1938
• Gave FDA the power to conduct inspections of
manufacturing plants to ensure compliance

• Act applied to interstate transactions, as well as to

intrastate transactions

• Required only that drugs be safe for human

consumption NOT that they be effective or useful
for the purpose for which they were sold

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 Durham-Humphrey Amendment of
1951
• States drug containers do not have to include
“adequate directions for use” as long as they
include “Caution: Federal Law Prohibits
Dispensing Without Prescription”
• Distinguished between legend (prescription)
drugs and over-the-counter (OTC)
(nonprescription) drugs
• Authorized
– verbal prescriptions
– prescription refills
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 Kefauver-Harris Amendment of
1962
• Extended the FDC Act of 1938 to require that
drugs not only be safe for humans but also be
effective
• Requires drug manufacturers file an
investigational new drug application (INDA) with
the FDA before initiating a clinical trial in humans
• Once proven safe and effective, manufacturer
may submit an NDA seeking approval to market
the product

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 Main topics of FDCA
1. Definitions (Section 321, Title 21 of FDCA)
• Its important to know how the FDCA defines
the terms to which it frequently refers.
• Because whether an activity falls outside or
inside a definition under the act may well
determine whether the activity is lawful or
unlawful.
• Some of the most important definitions are as
follows:
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The term "drug" means
(A) articles recognized in the official Pharmacopoeia, official
Homoeopathic Pharmacopoeia, or official National
Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man
or other animals; and
(C) articles (other than food) intended to affect the
structure or any function of the body of man or other
animals; and
(D) articles intended for use as a component of any article
specified in clause (A), (B), or (C)

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 The term "device" . . . means
– an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other
similar or related article, including any component,
part, or accessory, which is--
(1) recognized in the Formulary, or Pharmacopeia,
(2) intended for use in the diagnosis of disease or
other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or
other animals, or
03/17/2024 pharmacy law and ethics 163
(3) intended to affect the structure or any
function of the body of man or other animals,
and which does not achieve its primary
intended purposes through chemical action
within or on the body of man or other animals
and which is not dependent upon being
metabolized for the achievement of its primary
intended purposes

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The term "cosmetic" means
(1) articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or
otherwise applied to the human body or any
part thereof for cleansing, beautifying,
promoting attractiveness, or altering the
appearance, and
(2) articles intended for use as a component of
any such articles;
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The term "official compendium" means
• the official Pharmacopoeia, official
Homoeopathic Pharmacopoeia, official
National Formulary, or any supplement to any
of them.
• Official Compendia set standards with which
those who are responsible for drug
formulation and distribution must comply.

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The term "label" means
• a display of written, printed, or graphic matter
upon the immediate container of any article.
The term "labeling" means
• all labels and other written, printed, or graphic
matters
(1) upon any article or any of its containers or
wrappers, or
(2) accompanying such article.
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2. Adulteration (Section 351, Title 21 of FDCA)
• A drug may be adulterated either because it is
actually adulterated or because it is deemed
to be adulterated due to some requirement
for proper storage or handling not having
been met.

03/17/2024 pharmacy law and ethics 168

A drug or device shall be deemed to be adulterated--
(a)(1) If it consists in whole or in part of any filthy,
putrid, or decomposed substance; or
(2) (A) if it has been prepared, packed, or
held under insanitary conditions whereby it
may have been contaminated with filth, or
whereby it may have been rendered injurious to
health; or
(B) if it has been prepared not in accordance
with GMP.
03/17/2024 pharmacy law and ethics 169
(b) If its strength differs from, or its quality or
purity falls below the standard set forth in
compendium. . . .

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C. Misbranding
• The FDCA requires that any information a
manufacturer places on the label of a drug be
truthful and not misleading.
A drug or device shall be deemed to be
misbranded:
(a) If its labeling is false or misleading in any
particular

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(b) If in package form unless it bears a label
containing
(1) the name and place of business of the manufacturer,
packer, or distributor; and
(2) an accurate statement of the quantity of the contents
(c)If any word, statement, or other information
required by or under authority of this Act to appear
on the label or labeling is not prominently placed
(d) Unless its labeling bears
(3) adequate directions for use; and
(4) such adequate warnings against use
03/17/2024 pharmacy law and ethics 172
4. New Drug Approval
• “No person shall introduce or deliver for
introduction into interstate commerce any new
drug, unless an approval of an application
filed.”
• FDA reviewers require additional information
to maintain a “comfort zone” regarding
product safety and efficacy.

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5. Prescription Exemption
• The FDCA specifies the conditions and characteristics
that will cause a drug to be classified as Rx or OTC.
Rx only drugs shall be dispensed only
(i) upon a written prescription of a practitioner licensed
by law to administer such drug, or
(ii) upon an oral prescription of such practitioner which
is reduced promptly to writing and filed by the
pharmacist,
(iii) by refilling any such written or oral prescription if
such refilling is authorized by the prescriber.
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Two ways for a product to be classified as prescription-
only:
(1) lack of safety if used without medical supervision, and
(2) the sponsor’s request for prescription-only
classification in the products New Drug Approval
Three ways in which a prescription may be authorized by
a prescriber;
(3) in writing,
(4) verbal authorization, and
(5) refilling a written or verbal order.
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• Note that drugs may be switched from
prescription to non-prescription status.
• They must contain the federal legend, which is
now “Rx Only,” but used to be “Caution:
Federal law prohibits dispensing without a
prescription.”
• If the label of a non-prescription drug contains
this federal legend, then the drug is
misbranded.
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6. Prohibited Acts
• the FDCA contains within it provisions to
penalize those who fail to voluntarily comply
with the law.
• These penalties vary in severity, and can be
used as necessary to protect the public health.
• The following acts and the causing thereof are
hereby prohibited:

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(a) The introduction or delivery for introduction into
interstate commerce of any food, drug, device, or
cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food,
drug, device, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food,
drug, device, or cosmetic that is adulterated or
misbranded, and the delivery or proffered
delivery thereof for pay or otherwise.
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• FDA Can force manufacturer to recall a drug product if it is
contaminated, of poor quality, or causes serious adverse
reactions
Recall Classes for Drugs

Class Type of Drug

Class I (C-I) A reasonable probability exists that use of the product
will cause or lead to serious adverse health events or
death.
Class II (C-II) The probability exists that use of the product will cause
adverse health events that are temporary or medically
reversible.
Class III (C-III) The use of the product will probably not cause an
adverse health event.
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 Food Drug and Cosmetic Act of 1938 Summary

• 1938: 107 deaths from sulfanilamide elixir mixed with diethylene

glycol (anti-freeze)
• No “new drug” could be introduced into interstate commerce
unless first proven ‘safe’ for labeled indication.
– Established New Drug Application/Approval Process (NDA)
– Required ‘adequate directions for use’
• Unless dispensed pursuant to prescription from state-
authorized prescriber
– Required labeling for habit-forming drugs
• Applies to Cosmetics and medical devices as well as food and
drugs
• Established Food and Drug Administration
• Labels, labeling, manufacturers label, pharmacy label, patient
information label

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The Controlled Substances Act

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• The federal Controlled Substances Act (CSA)
establishes rules to assure that drugs intended
for medical use are not diverted to nonmedical
uses.

• The law requires pharmacists to do their best

to assure that the drugs pharmacists control do
not end up in the wrong hands.
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• The basic structure of the CSA is to place all
potentially abused drugs in one of five
schedules.

• People and places that are authorized to

possess these drugs are then required to be
registered with the drug regulatory body.

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A. Definitions
• The CSA uses specific words and phrases in
ways that might not be anticipated from their
ordinary day-to-day meaning.
(1) The term "addict" means any individual who
habitually uses any narcotic drug so as to
endanger the public morals, health, safety, or
welfare, or
who have lost the power of self-control with
reference to his addiction.
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(2) The term "administer" refers to the direct
application of a controlled substance to the
body of a patient or research subject by--
(A) a practitioner (or, in his presence, by his
authorized agent), or
(B) the patient or research subject at the
direction and in the presence of the
practitioner,

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3. The term "controlled substance" means a
drug or other substance, or immediate
precursor, included in schedule I, II, III, IV, or V.
NB: The term does not include distilled spirits, wine,
malt beverages, or tobacco

4. The terms "deliver" or "delivery" mean the

actual, constructive, or attempted transfer of a
controlled substance
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B. Controlled Substance Schedules
• controlled substances are categorized into five
categories known as Schedules I through V.
• The restrictions on controlled substances vary
according the schedule.
• Controlled substances in Schedule I are the
most restrictively controlled, and controlled
substances in Schedule V are the least
restrictively controlled.

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(1) SCHEDULE I.
A) The drug or other substance has a high potential
for abuse.

B) The drug or other substance has no currently

accepted medical use in treatment

C) There is a lack of accepted safety for use of the

drug or other substance under medical
supervision.

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(2) SCHEDULE II
A) The drug or other substance has a high potential
for abuse.

B) The drug or other substance has a currently

accepted medical use in treatment or a currently
accepted medical use with severe restrictions.

C) Abuse of the drug or other substances may lead

to severe psychological or physical dependence.

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3) SCHEDULE III
(A) The drug or other substance has a potential for
abuse less than the drugs or other substances in
schedules I and II.

(B) The drug or other substance has a currently

accepted medical use in treatment.

(C) Abuse of the drug or other substance may lead

to moderate or low physical dependence or high
psychological dependence.
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(4) SCHEDULE IV
(A) The drug or other substance has a low potential for
abuse relative to the drugs or other substances in
schedule III.

(B) The drug or other substance has a currently accepted

medical use in treatment.

(C) Abuse of the drug or other substance may lead to

limited physical dependence or psychological
dependence relative to the drugs or other substances in
schedule III.
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(5) SCHEDULE V
A) The drug or other substance has a low potential
for abuse relative to the drugs or other substances
in schedule IV.

B) The drug or other substance has a currently

accepted medical use in treatment.

C) Abuse of the drug or other substance may lead to

limited physical dependence or psychological
dependence relative to the drugs or other
substances in schedule IV.
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 Comprehensive Drug Abuse Prevention
and Control Act of 1970
Schedule Medical Use Examples
I For research only Heroin, LSD(lysergic
acid diethylamide)
II Dispensing severely Morphine, oxycodone,
restricted meperidine
III Prescriptions can be refilled Codeine with aspirin,
up to 5 times in 6 months anabolic steroids
IV Same as for Schedule III Benzodiazepines,
meprobamate
V Some sold w/o a Liquid codeine
prescription; must be 18 combination preps.
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C. Registration
• Under the CSA, only certain parties are permitted to
possess controlled substances legally.

• These parties must be registered.

• A separate registration shall be required at each

principal place of business or professional practice
where the applicant manufactures, distributes, or
dispenses controlled substances or list chemicals.
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D. Records
• Every transaction in which controlled substances
change hands must be recorded.

Based on records kept of controlled substances, it

should be possible to discern, for any registrant,
what controlled substances are on hand, where they
came from, and where controlled substances have
gone to.
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E. Prescriptions
• The most frequent method through which
controlled substances are dispersed by a pharmacy
is through a prescription, issued by a licensed
prescriber and filled for a patient.

• These rules are intended to assure that all

prescriptions filled by pharmacists for controlled
substances have been issued for a medical purpose,
and will not result in diversion to nonmedical use.
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 Poison Prevention Packaging Act of
1970
• Passed to prevent accidental childhood poisonings
from prescription and nonprescription products.
• Requires most over-the-counter (OTC) and legend
drugs be packaged in child-resistant containers
 cannot be opened by 80% of children under five
 can be opened by 90% of adults
• Older patients may request a non-child-resistant
container;

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 Drug Listing Act of 1972

• Gives the FDA the authority to compile a list of

currently marketed drugs
• Each drug is assigned a unique and permanent product
code
– known as a National Drug Code (NDC)
– ten characters that identify manufacturer or distributor, drug
formulation, size and type of packaging
• FDA requests, but does not require, the NDC appear
on all drug labels

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 Orphan Drug Act of 1983
• An orphan drug is one that is intended for use in
a few patients with a rare disease or condition
– developing such a drug would be prohibitively
expensive, given the small market
• The Orphan Drug Act encourages the
development of orphan drugs by:
– providing tax incentives
– granting manufacturers exclusive license
• Over 250 orphan drugs have been approved by
the FDA

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 Law of Agency and Contracts
• A contract is made in the pharmacy when the
technician receives a prescription from the patient at
the window
– by agreeing to get the prescription filled an implied contract
now exists:
• pharmacy and pharmacist are obligated to provide the patient
with a service
• if a mistake is made, the pharmacy and/or pharmacist may be
held liable, even though he or she was not the one who
entered into the contract to provide service
– The pharmacist must “answer” for all of the acts of the
employees

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 Tort law

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 Torts
• Tort is the term that refers to personal injuries (a wrong that
one citizen commits against another)
• Definition of a tort: violation of a duty imposed by
law on an individual based upon a relationship to
another individual.
• In a tort, the injured party sues the party that caused the
injury
• Governments do not take part in tort lawsuits
– the wrong was between two citizens and not against the
government and/or its laws and regulations
• The simplest tort is the “broken” contract
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 Torts
• Standard of care is a level of care expected
to be provided by various healthcare
providers
• Used to judge the type of care provided to
a patient based on two criteria always
taken into account include:
– the level of training of the healthcare provider
– normal practices for the geographical area in
which the healthcare provider works

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 Torts

A pharmacy technician is not expected to provide

the same service or standard of care to a patient as
the pharmacist. Similarly, a cardiologist would be
expected to provide a different service or standard
of care than that of a nurse practitioner at his office.

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 Torts
• Malpractice a form of negligence in which
the standard of care was not met

• In a case of negligence or malpractice, the

burden of proof is on the plaintiff to prove
the four Ds of negligence:
– duty – damages
– dereliction – direct cause

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 Torts
• The majority of malpractice cases involving
pharmacists and technicians are simple
dispensing errors:
– wrong drug, wrong strength, wrong label
information, and so on.

• All pharmacies, most practicing pharmacists, and

some pharmacy technicians carry professional
liability insurance to protect their business and
personal assets
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• Elements of a tort claim
 Duty
 Breach
 Causation
 Damages (or harm)

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Defining pharmacist’s duty
• Traditional view encompasses a technical responsibility to
fill prescriptions accurately:
– Correct drug, strength, directions
– Label correctly
– Drug within manufacturer’s expiration date (easy to overlook!!
—some drug are actually toxic past their expiration dates)
– Drug dispensed to correct patient
– Duty of the pharmacist to verify, or refuse to fill, a prescription
that contains obvious errors
– Duty of the pharmacist to clarify illegible or poorly written
prescriptions
– Currently move is from technical model to pharmaceutical care
model.
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2. Breach of duty
• Plaintiff can show negligence per se if
pharmacist violated a statute or regulation.
For example, failure to provide patient
information is a violation and is negligence per
se.
If established, plaintiff only needs to prove
causation and damages

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3. Causation
• Actual vs. proximate cause
Proximate cause: event sufficiently related to a
legally recognizable injury to be held the cause
of that injury

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4. Damages: economic
Economic damages:- objectively verifiable
monetary damages, including medical
expenses, lost wages, loss of employment, loss
of business or opportunity cost.

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Noneconomic damages:- subjective,
nonmonetary losses, including emotional
injury, “pain and suffering”, disability or
disfigurement, loss of society and
companionship.

• Difficult to establish.

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Control of Advertisement

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• Advertisement is any presentation, by means
whatsoever, for promoting directly the
manufacture, sale, or dispensing of any
pharmaceutical

• Promotion shall refer to all informational and

persuasive activities by manufacturers and
distributors the effect of which is to induce the
prescription.
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The Information provided shall be :
– Accurate, fair, objective and good taste and
presented in such a way as to conform not only to
legal requirement but also to ethical standards.
– Based on up- to- date evaluation of all the available
scientific evidence and shall be presented in a
manner appropriate to the intended recipient.
– Honest, faithful and verifiable and must conform to
the facts in the up- to – date and approved dossier.
– Sufficient to the therapeutic use fullness of the
preparation.
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• The information shall not contain misleading or
unverifiable statement or omission. Likely to induce
medically unjustifiable use or to give rise to undue
risks.

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 Requirements
• All the information or promotional materials must be
consistent with the information provided in the product
monograph approved by the authority.

• No additional claims outside of this shall be made.

• Sample of informational and promotional material must be

submitted to the Authority for approval prior to any
promotional activity.

• Advertising claims shall be consistent with body of scientific

and medical evidence pertaining to the pharmaceutical
preparation
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The pharmacy law shall :
 Decide the mode of advertisement to be used
 Decide the type of pharmaceuticals not to be
advertised to the general public
 Decide the content of information used to
advertise to :
– Health professionals
– General public

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 Advertisement to health professionals
The advertisement shall :
• Contain essential information compatible with the
summary of product characteristics
• Contain the following particulars
– The name, strength, dosage form, indication, dosage,
method of use of the product.
– List of active ingredients
– License / Registration number
– Name and address of the marketing authorization
holder
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 – Classification of the product
• Prescription only
• Pharmacy only
• Over the counter
• General sale list
– Side effects, precautions, and relevant contraindications
– Advertisement includes every form of advertising, whether
– In a publication, or
– By means of any catalogue, or
– Other document
– By words inscribed on any article, or
– By the exhibition of a photograph …… etc.
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Mode of Advertisement to health professionals
– Audio- visual advertisement
– Radio, TV Cinema …..
– Promotional Aids
• The advertisement consists solely of the name
product
• The advertisement is intended only as
remainder
• Written material accompanying promotions.
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The written material shall :
– Contain essential information
– Classification of the product
– Be accurate, up- to – date, verifiable and complete
Free sample
– Free samples are supplied only to a persons qualified to
prescribe medical product and /or pharmacy personnel.
– Free sample of Narcotic Drugs and psychotropic
substances is not allowed.
– The free sample must be marked ‘’ Free medical sample –
Not for sale ‘’
– Every free sample must be accompanies by a company of
the summary product characteristics.
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 Advertisement to the general public

• No advertisement may be issued, which is likely to lead

to the use of medical product, on :
– Narcotic Drugs and psychotropic substances
– Drug which is for human use and is prescription only
– Medicinal product or any other substance or article of the
purpose of inducing of abortion.
– Drug for the purpose of treatment prevention or diagnosis
of certain diseases.
– No person who is a marketing authorization holder or
wholesaler may sell or supplies to the public for promotional
purposes any unsolicited relevant medicinal product.

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Pharmaceutical Inspection

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• FMHACA should assign persons, with
adequate knowledge and experience of the
sector, policy, Law, regulations and directives,
as inspectors.

 Inspectors, having produced the credential if

requested to do so, are empowered :-

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 Inspectors duty and responsibility
 To enter any premises, to ascertain whether there has been
a contravention of the act/ law or general for the purposes
of performing the function of the enforcing authority.
 To enter any ship, air craft or hover vehicle to ascertain
whether there is in it any article or substance imported to
contravention of the law.
 To take sample (by purchase or otherwise ) of any
medicinal product sold or supplied or any substance to be
used in the manufacture of pharmaceutical.
 To take copies of any entry in any such books or documents

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 Inspectors duty……cont’d
 To require the production of any books or documents
relating to the business
 To seize and detain any substance or articles or any
document which they have
 Reasonable cause to believe may be required for
proceedings under the law.

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 Type of Inspection
• Pre- licensing Inspection is the type of inspection
undertaken in order to ensure the fulfillment of
requirements by pharmacy establishment before a
license is issued.
• Post- licensing Inspection it is the type of
inspection undertaken on licensed pharmacy
establishments in order to ascertain whether there
has been a contravention of the law.
1. Emergency Inspection
2. Regular Inspection
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• It is an offence willfully :
 To obstruct a duly authorized person / inspector or
 To fail to comply with any proper request by inspector
 Without reasonable cause to fail to give them
information or any assistance they may reasonably
require
 To give to inspectors false information

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Obligations of inspector
They should keep the trade secrecy of the
premises s/he inspected.
They should give due respect to the right of
the individual / premises.
They should give receipt for the sample,
documents they have taken and seized.

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Legal proceedings
 Inspectors should write inspection report showing
the strong and weak sides of the inspected
Premises. The report should also include directives
given at the site. All necessary evidences have to be
attached.
 Take an action in response to the inspection
 An appropriate action should be taken on individual
or premises that match to the mistake/ offence
committed.
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• The actions could be :
– Educational
– Suspension or revocation of license, professional
registration certificate, product registration
certificate.
• Depending on the right given to the Law
enforcing agency
– The action could be taken by the agency
– The action could be taken by taking the case into
court
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 The seven principles (Summary)
As a pharmacist or pharmacy technician you must:
1. MAKE THE CARE OF PATIENTS YOUR FIRST CONCERN
2. EXERCISE YOUR PROFESSIONAL JUDGEMENT IN THE
INTERESTS OF PATIENTS AND THE PUBLIC
3. SHOW RESPECT FOR OTHERS
4. ENCOURAGE PATIENTS TO PARTICIPATE IN DECISIONS
ABOUT THEIR CARE
5. DEVELOP YOUR PROFESSIONAL KNOWLEDGE AND
COMPETENCE
6. BE HONEST AND TRUSTWORTHY
7. TAKE RESPONSIBILITY FOR YOUR WORKING PRACTICES
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Be a good pharmacist !!!!

The end!

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