CHAPTER 9: ETHICAL ASPECTS OF DRUG

INFORMATION PRACTICE

WHAT ETHICS IS AND WHAT IT IS NOT
Ethics Course Content Committee of the American
Association of Colleges of Pharmacy
Philosophical inquiry into the moral dimensions of
human conduct
Aristotle taught ethics as an eminently practical
discipline dealing with concrete judgments in
situations in which action must be taken despite
uncertainty.
Ethics is not values clarification
Not the study of moral development
Is not the law
Differentiation from other endeavors of ethical
deliberations by Veatch
1. They are ultimate or fundamental
a. there is no higher standard against which
to measure the rightness of the decision
or action
2. They are universal
a. The parties in disagreement do not
consider it simply a difference of opinion
or taste
b. Each party believes there is a right or
wrong answer, even if he is not sure what
the answer is
3. The deliberation takes into account the welfare of
all involved or affected by the judgment at hand
An ethical or moral issue involves judgments
between right and wrong human conduct or
praiseworthy and blameworthy human character
Professional ethics
Rules of conduct or standards by which a
particular group in society regulates its actions
and sets standards for its members
Focuses on written 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
Often impossible to fully regulate by law
Law
Defined as rules of conduct imposed by society on
its members.
Involves written rules set by the whole society (or
its representatives) that address responsibilities
of that societys members.
May institutionalize certain ethical standards of a
given profession by the whole society
Represents one aspect of the culture within which
ethical issues are considered
SETTINGS WHERE DRUG INFORMATION IS PROVIDED
Contains case scenarios that can identify, for the
student of practitioner, what might constitute an ethical
issue
The scenarios can also be used to demonstrate
analysis of ethical dilemmas confronted by the pharmacist
providing drug information
All pharmacists provide drug information and must
address the ethical dilemmas that arise in the course of
providing this service
The community pharmacist who is asked by a
patient at the counter to critique a physicians
prescription
The home health care pharmacist who is
recommending a therapeutic plan to a physician
and who must consider payment constraints
imposed by a third party payer
The pharmacist, working for a managed care
system, who assesses the literature and
subsequently must approve or deny coverage of a
drug used for an unlabeled indication
The hospital practitioner who is confronted by a
physician or an administrator demanding a
certain formulary recommendation that may not
be appropriate
The drug information specialist who is asked by a
lay person or another health professional to
provide information that could be misused
These ethical dilemmas tend to relate to the perceived
rights and/or responsibilities of the pharmacist, relative to
the rights and responsibilities of the client, other directly
affected clients (for example, a child, other relatives, or
significant others affected by the client), other health
professionals, society at large, and any higher power
recognized by the pharmacist

BASICS OF ETHICS ANALYSIS
Definitions used in the field of ethics
Ethics [as stated by Beauchamp and Childress]
A generic term for several ways of examining the
moral life
When we deliberate about whether a judgment is
morally right, we are considering which judgment
is morally justified
Particular judgments are justified by moral rules,
which in turn are justified by principles, which
may ultimately are defended by an ethical theory
1. Ethical theories ]
2. Principles ] [Action guides]
3. Rules ]
4. Particular judgments and actions

They describe a rule of ethics as specific to context and
relatively restricted in some principles are more broad and
fundamental in scope. They describe ethical theories as
integrated bodies of principles and rules that may
include mediating rules that govern cases of conflicts.
These authors refer to all of the hierarchical tiers, by
specifically rules and principles, as action-guides. They
indicate that often there is no straightforward application
of theory in particular judgments in the context of moral
problems that impact health professionals. However,
theory is invoked to help develop action-guides that are
more specific and fit the context. These action-guides can
help pharmacists assess ethical dilemmas that arise in the
course of providing drug information

OVERVIEW OF A PROCESS OF ANALYSIS TO BE USED
WHEN AN ETHICAL DILEMMA ARISES
A particular ethical decision may often be reached
without a great deal of conscious deliberation through
ones moral intuition and without subsequent challenge
from any external party. However, on occasion, when
pondering a certain ethical judgment, one is called on
(internally or externally), to analyze and justify the basis
for a conviction.
Progression through four stages of analysis by
which one may analyze and present reasons for a
judgment- reasons that are even more fundamental and
universal.
1. First Stage
a. Involves identification of pertinent
background information to ensure that the
facts of the specific cases are understood.
b. Deserves careful consideration and research
c. Once one knows the facts of a case, moral
intuition may be enough to resolve the
dilemma
d. If the matter remains an ethical issue once the
facts are clarified, involved party/ies can
proceed as far as necessary through three
more successive stages of general moral
reflection
i. the level of moral rules
ii. the level of ethical principles
iii. the level of ethical theory
e. two additional steps that are often useful in
clarifying potential ethical issues
i. one should identify who is affected by
the issue
ii. determine the cultural perspectives
of any involved parties
2. Second Stage
a. Requires reflection on whose rights and
responsibilities are at issue in the case
b. The pharmacist, direct client, other indirect
but individual clients, other health
professionals, society as a whole, and any
higher power recognized by the pharmacist
may all have rights and/or responsibilities
that should be considered
c. The pharmacist must consider all affected
parties as he or she proceeds to analyze the
ethical dilemma
3. Third stage
a. When considering any ethical issue, the
pharmacist takes into account the cultures of
the affected parties
b. The ethical obligations of medical
professionals vary in the caring for those with
difficult cultures
c. Sometimes culturally based actions may
conflict with the professionals goal to avoid
harm and promote benefit
d. An extended discussion of how awareness of a
differing cultural perspective might affect the
ethical decision making process
e. The pharmacist should be aware of and
sensitive to the cultural perspectives of the
affected parties when contemplating an
ethical dilemma

One final issue should be addressed relative to cultural
considerations
The legal requirements of the society within which an
ethical dilemma occurs are part of the culture and must be
identified
A specific ethical decision will not always exactly
conform to the existing legal requirements of the society
The ultimate nature of ethical deliberations may result
in decisions that are more demanding than the legal
requirements, and unfortunately, may even occasionally
involve perceived or true conflict with specific legal
requirements
a. A decision not to divulge confidential
communications between a professional and a
client
b. An ethical decision may not provide information
related to abortion or infliction of euthanasia,
even though these activities are acceptable
within the law
The process of full ethical deliberation can begin once the
three preliminary steps have been completed

VEATCHS STAGES OF ANALYSIS
One can begin this analysis by looking at moral
rules that should apply to specific groups of cases
Moral rules between biomedical ethics
Confidential rule that dictates that patient-
entrusted information not be disclosed or an
informed consent rule that addresses the
individuals right to information before agreeing
to a specific medical procedure
In general ethics inquiries there are moral rules that
dictate that one should not inflict suffering or murder.
There is no definite list of such rules and sometimes
multiple pertinent rules can be in conflict. There are
acceptable exceptions to most moral rules.
Disregarding the informed consent rule might be
justifiable to acutely protect the life of the client,
suffering may be necessary in order to achieve
cure of serious disease, and may not be a specific
rule that resolves a particular ethical dilemma.
The involved parties can reach an acceptable
resolution to an ethical dilemma, the professional may
decide that the primary principle is to respect the
autonomy of the client and that this requires providing
complete information that enables the client to make an
informed decision.
If security of life is considered the most fundamental
ethical principle, decisions or acts that deny this principle
would be considered unethical
Parenthetically, it should be noted that specific
action-guides may be considered a rule within one
ethical theory and a principle within another
Veracity(truth telling) may be considered a
specific moral rule by some and a general
principle by others, depending upon which ethical
theory is followed
For the practitioner immediately involved in
analyzing a specific ethical dilemma, defining the
relevant action-guides as rules or principles is
important only to the extent that it helps in
assessing which are more fundamental to the
issue at hand
When confronted with conflicting ethical principles,
the professional will need to examine the ethical theories
that describe how these conflicting principles might be
prioritized or balanced
This can lead to more rational and honest decision
making or action taking
Those dilemmas that cannot be fully resolved can at least
be viewed with greater clarity
These ultimate deliberations at the level of ethical
theory will be affected by our most basic religious
and/or philosophical commitments.
The TWO broad ethical theories
1. Consequentialist
Focuses on one feature of an act its consequences
The informed consent rule can be of value within
consequentialist theory because consent generally
results in improved compliance and outcome
good consequences
If informed consent were likely to result in a bad
outcome, it would not be justifiable within
consequentialist theory
2. Deontological theory (Deon = duty)
Looks more to intrinsic qualities of an act or decision to
assert its moral rightness or wrongness.
Considers inherent features of an act besides
consequences as also relevant and often of greater
importance
An act is considered wrong if it involves
dishonesty, or the primary principle is considered
respect for autonomy of the patient.
The components of a complete theory will answer such
questions as what rules apply to specific ethical cases, what
ethical principles stand behind the rules, how seriously the
rules should be taken, and what constitutes the fundamental
meaning and justification of the ethical principles

CONTRACY THEORY OF MEDICAL ETHICS
Describes an implicit (unwritten) contract
between professionals and patients
Addresses the application of a process of ethical
analysis in identifying, analyzing, and resolving ethical
dilemmas that may arise during the provision of drug
information by pharmacists
a) Identification of background facts relevant to the
ethical issue at hand
b) Identification of who is affected by the issue
c) Determination of the cultural perspectives and
legal requirements for those affected by the
dilemma
d) Identification and justification of the relevant
moral rules and principles pertinent to the case
e) Deliberation on how to rank/ balance the rules
and principles pertinent to the case through the
use of moral intuition and application of theory in
order to resolve the ethical dilemma

DESCRIPTION OF SPECIFIC ETHICAL RULES AND
PRINCIPLES FREQUENTLY APPLIED IN MEDICAL
ETHICS INQUIRY
1. Respect for autonomy a principle prescribed
within deontological theory, this principle is
founded on a belief in the right of the individual to
self-rule and also speak to the individual right to
decide on issues that primarily affect self
2. Consent a moral rule related to the principle of
autonomy which states that the client has the right
to be informed and to freely choose a course of
action; for example, informed consent to receive a
therapy or procedure
3. Confidentiality a moral rule also related to the
principle of autonomy that specifically addresses
the clients right to give or refuse consent relative
to release of privileged information
4. Privacy another rule within the principle of
autonomy, more generally relating to the right of
the individual to control his or her own affairs,
without interference from or knowledge of
outside parties; this rule has been addresses in
deliberations on the rights of women considering
abortion or of individuals with AIDS versus their
potential contacts
5. Respect for persons a principle expressing duty
to the welfare of the individual particularly
described within religion-based deontological
theories; this principle may also be partially
expressed within dignity of life or sanctity of
human life principles; it has common elements
with the respect for autonomy principle but
addresses more directly a belief in the inherent
value of human life, independent of characteristics
or abilities of the specific human being
6. Veracity this term has been described as either
a rule or a principle; it addresses the obligation to
truth telling or honesty; veracity is considered an
ethical principle within deontological theory;
however, it is considered as useful rule within
consequentialist theory to the extent that it
promotes good
7. Fidelity another principle of moral duty in
deontological theory that addresses the
responsibility to be trustworthy and keep
promises; this principle also relates to a duty of
reciprocity consideration of the others point of
view; recent descriptions of pharmaceutical care
have spoken of the need to develop and ethical
covenant between pharmacist and client; this
covenant details the characteristics f a
relationship requiring fidelity and reciprocity, in
which each party takes on certain responsibilities
and gives up certain rights in order to achieve
specific good outcomes (consequentialist
theory): success of this contract depends in good
measure on consideration by each party of the
others point of view
8. Nonmaleficence a basic principle of
consequentialist theory; encompasses the duty to
do no harm this tenet also has a long history as
part of the Hippocratic tradition, there this
principle has often been described relative to the
health care providers duty to the individual
patient: the principle is also used as justification
for actions benefitting all, sometimes application
of the principle requires addressing conflicts
between the needs of one and all
9. Beneficence another basic principle of
consequentialist theory that expresses the duty to
promote good; again, conflict can arise between
what constitutes good for one individual versus
the larger societal group
10. Justice this principle relates to the concept of
fairness and tendering what is duel providing that
to which the individual is entitled
11. Respect the patient-professional relationship
another moral rule, generally referring to respect
for the physician-patient relationship; but also
applicable to other professional-patient
relationships, as well; this rule has been
mentioned in published reports of ethical
dilemmas arising during the provision of drug
information. It is expressed in the Hippocratic
tradition, which usually indicates that the
physicians primary duty is to the patient;
traditional interpretations of this rule have tended
to give the physician rather than the patient,
control in the relationship

DEMONSTRATION OF THIS PROCESS FOR ANALYZING
ETHICAL DILEMMAS
Brief discussion of possible learning methods
To sensitize the practitioner or student to
awareness of opportunities for ethical deliberation
The pharmacy educator and his students will
benefit from preliminary or conjoint teaching by an
individual with formal education in the field of medical
ethics
The pharmacist educator can focus more attention
on specific case discussions pertinent to the target subject
area of pharmacy practice
Formal coursework, inservices, or continuing
education opportunities can teach skills that will aid
pharmacists in handling ethical dilemmas related to work
responsibilities
Describes examples of educational methods
including case presentation and debate; scenario building
with identification and discussion of potential ethical
issues; and role playing activities.
Ethics laboratory and role playing assignments
for undergraduate pharmacy students, also lists case
scenarios that can be used in continuing education
programs for practitioners exploring ways to resolve
ethical dilemmas arising in pharmacy practice



SPECIFIC EXAMPLES OF ETHICAL DILEMMAS ARISING
DURING THE PROVISION OF DRUG INFORMATION
Examples
1. A client asks the dispensing pharmacist about the
appropriateness of a medication just prescribed
for her by a physician (who practices in the same
building where the pharmacy is located)
a. Variation: the client calls a drug
information service with this question
rather than asking his or her own
pharmacist
b. Note: consider addressing this dilemma
both where the therapy appears to be
obviously inappropriate and where it is
questionably appropriate
2. A pharmacist working for a managed care
organization is asked to review and strongly
encouraged to deny coverage for an expensive
drug therapy that is not FDA approved for the
condition being treated
a. Variations
i. There is fairly strong literature
support for the products efficacy
and safety
ii. The literature support is more
limited or preliminary in nature
iii. Efficacy appears well
documented, but possible
adverse effects may add
substantially to costs of use
iv. The therapy is for a life-
threatening condition that has
few other treatments