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Health Care Ethics
Robert L. McCarthy
CASE SCENARIO
Leo R. is a 45-year-old patient with diabetes and is a widower with three young
children. Two of Leo’s children suffer from chronic medical conditions. His oldest
daughter, like Leo, has insulin-dependent diabetes. His only son suffers from grand
mal epilepsy, which is poorly controlled by a plethora of medications. Leo works for
a small printing business, a job he enjoys, but one that makes it difficult for him to
make ends meet. With only six employees, the company’s owner cannot afford to
offer health insurance. Leo’s annual salary of $30,000 allows him to purchase only
the most basic of health plans, one that does not include coverage for prescription
medications. Leo frequently must decide between medications and food, often
opting for cheap junk food that is neither nutritious for his young family nor
appropriate for a diabetic diet. Leo has recently applied for and been offered several
other jobs, but at a lower salary and with no health insurance coverage.
Recently, Leo’s diabetes has worsened. He has developed a serious infection that
has led to lost wages and, far worse, the loss of his right leg below the knee. Leo is
weighing his options. He has heard about a new clinical research trial open to
insulin-dependent diabetics that pays $100 a week to research subjects. He has also
been quite depressed and begun to wonder if his children might not be better off
without him. He has several life insurance policies that would pay off generously if
something were to happen to him, and he has broached the subject of assisted
suicide with his long-time physician. Is there a way, he asks his physician, to have
his death look like it was from natural causes so his children could collect on the
policy?
CHAPTER QUESTIONS
1.-What ethical responsibilities do health care professionals have to their patients?
2.-What ethical rights do patients have?
3.-What is Veatch’s framework for ethical analysis?
4.-How may ethical theories and principles, moral rules, and ethical codes be used to
guide health care practitioners?
5.-What are some contemporary ethical issues in health care?
LEARNING OBJECTIVES
Upon completion of this chapter, the student shall be able to:
• -Describe the factors responsible for the heightened attention given to ethics
instruction at health professions schools.
• -Explain how macro and micro ethical situations differ.
• -Describe what Berger believes are the basic ethical obligations of pharmacists
• -Describe how medical paternalism and medical consumerism differ.
• -Explain how moral rights and legal rights to health care differ.
• -State what rights patients possess.
• -Describe a health care practitioner’s duty to their patients.
• -Explain how legal responsibility and moral obligation differ.
• -Describe the ethical responsibilities of pharmacists practicing pharmaceutical
care.
• -List the four steps in Veatch’s framework for ethical analysis.
• -Explain how teleological theories and deontological theories differ.
• -Explain utilitarianism.
• -Explain Kantian ethical theory.
• -Define the principle of autonomy; explain its ethically justifiable exceptions.
• -Define informed consent; list its five elements.
• -Define confidentiality; explain how it differs from privacy; explain its ethically
justifiable exceptions.
• -Define beneficence and nonmaleficence; describe how they differ.
• -Define fidelity; explain how covenantal fidelity and contractual fidelity differ.
• -Define distributive justice.
• -Explain how ethical codes in health care have evolved.
• -List the codes of ethics that currently govern the conduct of various health care
professionals.
• -Describe how the APhA Code of Ethics has evolved; explain how the current
version differs from earlier versions.
• -Explain why health care law and health care ethics sometimes conflict.
• -Describe why rationing of health care services is a contemporary ethical question.
• -Define assisted suicide; describe the ethical questions that surround it.
• -Describe the purpose of an IRB.
• -Explain the ethical questions surrounding the use of placebos.
• -Explain the ethical questions surrounding the use of drug formularies.
ETHICAL DECISION MAKING IN HEALTH CARE
Medical ethics, more commonly referred to today as biomedical ethics, is not a new
area of inquiry. The first code of ethics for medicine was credited to Hippocrates in
the 5th century B.C. In many ways, his code is timeless. For example, his direction
that no physician should “give a deadly drug to anybody if asked for it, nor . . . make
a suggestion to this effect” (Edelstein, 1967, p. 6) provides one moral perspective on
the contemporary issue of assisted suicide. What has changed over the past decade
or so is the attention given to biomedical ethics in the professional and scientific
literature and by health professions schools. In pharmacy, for example, surveys were
conducted in 1963 and again in 1980 to determine the state of ethics instruction in
schools of pharmacy. The 1963 survey found that only 8 of 65 schools that
responded required a formal, separate course in ethics; 19 schools offered no
required or elective course that included ethics as an explicit part. In the 1980 study,
the numbers were still worse: only 2 of 52 schools required an ethics course, and 32
schools did not offer one (Smith and Smith, 1981).
Today, most pharmacy, nursing, and medical schools require some instruction in
biomedical ethics. Haddad and colleagues, reporting on a 1991 survey of ethics
instruction at pharmacy schools, said, “While the quantity of ethics instruction has
not increased, there are encouraging signs that the quality and depth of ethics
education is improving” (Haddad et al., 1993, p. 35S). No one factor is responsible
for the heightened attention given to the study of ethics in health care. Several
factors, however, are certainly important contributors. First is the explosion of
biotechnology. Medical professionals now have available to them an arsenal of
weapons to fight disease. The ability to sustain life, deal with premature birth, and
treat conditions that heretofore were thought to be untreatable has generated new
ethical dilemmas. When we were unable to sustain the life of a person in a persistent
vegetative state, then the question of whether or not to “pull the plug” did not arise.
Likewise, when no treatment existed for dealing with prematurity, cancer, or
cardiovascular disease, the ethical questions associated with those treatments did not
need to be answered. The second factor is the rapidly rising cost of health care in the
United States. The United States spends a greater proportion of its gross domestic
product on health care than any other nation, yet leaves many of its citizens without
adequate access to care, as in the case of Leo and his family. As Howard Hiatt
(1975) has described, we have only limited resources to spend on health care; how
much we spend, and how we allocate it within health care, is a vital question we
must answer as a society. These financial concerns give rise to questions of limiting
access, rationing, and denial of care.
Biotechnology and costs are not the only factors that have led to this increased
emphasis on ethics instruction and research, but they are clearly major contributors.
Whatever the reason, ethical considerations play a very significant role in health
care delivery as we begin the new millennium. This chapter discusses health care
ethics from a practical perspective by introducing ethical “tools” that health care
professionals can use in their daily practice. These tools include ethical theories and
principles, moral rules, and codes of ethics. Special emphasis is given to the ethical
aspects of pharmacy practice.
“MACRO” VERSUS “MICRO” ETHICAL SITUATIONS
Ethical situations in health care can be divided into two broad categories: “macro”
and “micro.” Macro situations involve issues that are not specific to a given health
care practitioner (such as the pharmacist); these situations involve issues that must
be addressed by all health care practitioners and society in general (such as abortion,
assisted suicide, genomics, rationing of and access to health care, organ
transplantation, and in vitro fertilization). Micro situations are those that may
confront individual practitioners in the course of their daily practice. In the case of
pharmacists, they include the use of placebos, patient confidentiality (for example,
revealing information about a patient’s medications to members of his or her
family), informed consent (such as what and how much information about a
medication should be disclosed to a patient), and as illustrated in Leo’s situation,
providing necessary medications to those who are uninsured and unable to pay.
Sometimes, macro issues are manifested in micro situations. This is especially true
with socially controversial issues like abortion and assisted suicide. For example, a
pharmacist may receive a prescription for a drug that is known to be intended for use
in an assisted suicide. The pharmacist must deal not only with the legal issues
involved but also with his or her ethical responsibility as a health care professional.
A further complication in this and similar situations is what—if any—influence the
pharmacist’s (or other health care professional’s) personal beliefs should have on his
or her course of action.
COMPETENCE, TRUSTWORTHINESS, AND CARING
Any discussion of health care ethics must begin by describing the basic moral
responsibilities health care practitioners have toward their patients. Berger (1993)
has attempted to describe the characteristics that a pharmacist should possess. First,
pharmacists must be competent. They must possess a knowledge base that at least
minimally allows them to carry out their functions as reliable therapeutic experts.
However, competency is more than simply having an adequate base of knowledge.
Skills that allow the pharmacist to appropriately time and organize patient
counseling information, or that include the patient as a partner in his or her own
care, are of equal importance in evaluating a pharmacist’s competence.
Second, pharmacists must be trustworthy. Patients must know that they can
confidentially seek the advice and assistance of their pharmacist and that their
wishes will be carried out. As Berger notes, “Being seen as trustworthy by the
patient is connected to the ethical covenant made between the pharmacist and the
patient. Once the pharmacist and patient identify what each is responsible for, trust
becomes a measure of the patient’s perception of how well and how consistently the
pharmacist upholds his or her end of the covenant” (Berger, 1993, p. 2401).
Third, pharmacists must care for and about their patients. The American Pharmacists
(formerly Pharmaceutical) Association (APhA) code of ethics (1995) directs, “A
pharmacist places concern for the wellbeing of the patient at the center of
professional practice.” Unfortunately, pharmacists do not always effectively
communicate that they care about their patients’ welfare. All too often, patients
perceive just the opposite. Busy practitioners who fail to spend adequate time
interacting with their patients do little to alter this perception. Conversely,
pharmacists who do spend time with their patients and attempt to understand
patients’ concerns are much more likely to be viewed as caring. As Berger points
out, “Probably nothing is more powerful in communicating caring than
understanding, and thus legitimizing, the concerns of the patient” (Berger, 1993, p.
2401).
These characteristics of pharmacists described by Berger also hold true for all health
professionals. Physicians, nurses, physical therapists, and others should—within the
moral and professional parameters of their own profession—strive to be competent,
trustworthy, and caring (McCarthy, 1996c).
THE HEALTH PROFESSIONAL–PATIENT RELATIONSHIP: CONSUMERISM
VERSUS PATERNALISM
Not long ago, when patients were instructed by their physician or pharmacist to have
an operation, go for a laboratory test, or take a medication, they did so without
question. 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
(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 to be asked for their consent. To do otherwise
would be both unprofessional and unethical—not to mention the potential legal
ramifications. Patients expect a certain level of service. As with sellers of other
goods and services, health professionals who fail to meet the demands of health care
consumers may lose customers or experience legal problems (McCarthy, 1996c).
MORAL RIGHTS VERSUS LEGAL RIGHTS TO HEALTH CARE
It is important in any discussion of health care ethics to be clear about what is meant
by the term rights. In contemporary U.S. society, one frequently refers to the legal
rights of individuals. These are rights that are guaranteed fundamentally in the U.S.
Constitution (such as the right of free speech and the right of assembly) or are
provided by laws and regulations promulgated at the federal, state, or local level. We
sometimes confuse what is really a legal duty (such as providing free elementary
and secondary school education) with our moral obligation to do something (such as
our responsibility to ensure that the next generation of Americans is provided with
an adequate education).
Moral rights may be reinforced by laws, but their basis lies not in the law, but in
ethical principles. Such rights might include the right to live without fear of harm
and the right to food and adequate shelter. More recently, Americans have grappled
with the question of health care as a moral right. Do Leo and his children, for
example, have a moral right to adequate health care? As one might expect, moral
rights and legal rights may be in conflict. There is disagreement over whether issues
like abortion involve moral rights or legal rights. The question of the right to die has
been played out in the media across the country. Dr. Jack Kevorkian and his socalled suicide machine have forced this society to deal with a moral question in legal
terms.
PATIENTS’ RIGHTS
When patients seek the care of health care providers, what rights do they have?
What can they reasonably expect from health care providers? Patients can expect
that clinicians will employ their knowledge and experience in caring for them. As
autonomous individuals, patients can expect that health care providers will respond
to their wishes about their treatment.
At first glance, the American health care system seems fundamentally based upon
ensuring the rights of patients. Patients generally choose their own physician,
pharmacy, and hospital. Patients are allowed to choose from multiple options for
treatment when they exist (such as surgery versus drug therapy). Patients must give
their approval, through the process of informed consent, prior to the initiation of
care. All of the preceding presupposes that treatment is available and that the patient
has the economic wherewithal to pay for that treatment. For patients who are
uninsured or lack the ability to pay (like Leo), the right to choose the nature of their
health care is meaningless. As Mappes and Zembaty argue, the United Nations (UN)
Declaration of Human Rights may state “that all persons have a right to medical
treatment” (1991, p. 36), but “A citizen of the United States . . . cannot walk into a
hospital, demand and receive treatment simply on the basis of the claim that the UN
Declaration proclaims his or her right to such care” (1991, p. 37). Patients also have
a right to treatment that is both safe and effective within given parameters. The
fundamental question that must be posed prior to considering any medical or
surgical treatment for a patient is, “Is the treatment safe and effective?” Such a legal
standard for drugs has been in effect since the early part of last century (Musto,
1987). Not only must a drug be shown to be effective—that is, able to produce the
effect for which it was administered—but it must do so with a certain degree of
safety.
HEALTH CARE PRACTITIONERS’ DUTY TO THEIR PATIENTS
What is the responsibility of health care practitioners? As Mappes and Zembaty
point out, “The [Hippocratic] oath requires physicians to act so as to ‘benefit’ the
sick and ‘keep them from harm’” (1991, p. 45). 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.
This view is supported by the Code of Ethics of the APhA, which states, “A
pharmacist promotes the good of every patient in a caring, compassionate, and
confidential manner” (APhA, 1995, p. 2131). The code suggests that pharmacists
have a moral obligation to do whatever they deem necessary in the interest of their
patients. But the code goes on to state, “A pharmacist serves individual, community
and societal needs.” Therefore, how far does a pharmacist’s or another health care
professional’s duty to his or her patients go? Is it the health care professional’s
moral obligation to care for patients without exception?
LEGAL RESPONSIBILITY VERSUS MORAL OBLIGATION
Rem Edwards provides an example of a radical interpretation of the Hippocratic
Oath when he asserts that medical professionals have an obligation to do whatever is
necessary to relieve the pain and suffering of their patients (Edwards, 1984).
Edwards’ contention, although seemingly laudatory, has serious flaws when applied
to medical practitioners. All health care professionals practice under the constraints
of law, which may limit their doing “whatever is necessary.”
As a result, the patient’s rights and the practitioner’s responsibilities may sometimes
be in conflict not on ethical grounds but on legal ones. To direct that health care
professionals should assume an individualistic approach and take an illegal, yet
ethical, action for their patients despite the legal consequences is asking them to
unrealistically subjugate their own interests to those of their patients.
ETHICAL RESPONSIBILITY IN PHARMACY: PHARMACEUTICAL CARE
In their landmark paper, the members of the Commission to Implement Change in
Pharmaceutical Education stated their belief “that the mission of pharmacy practice
is to render pharmaceutical care. Pharmaceutical care focuses pharmacists’ attitudes,
behaviors, commitments, concerns, ethics, functions, knowledge, responsibilities
and skills on the provision of drug therapy with the goal of achieving definite
outcomes toward the improvement of a patient’s quality of life” (Commission to
Implement Change in Pharmaceutical Education, 1993, p. 376).
Pharmaceutical care, therefore, changes the focus of pharmacy practice and
broadens the professional responsibility of pharmacy practitioners. 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. Physicians, and not pharmacists, were the health care
professionals who held ultimate responsibility for monitoring the patient’s progress
and ensuring that the desired outcome was achieved. Pharmaceutical care directs
that this responsibility is to be a shared obligation between the prescriber and the
pharmacist (McCarthy, 1996c; for further reading, see Chapter 3).
VEATCH’S FRAMEWORK FOR ETHICAL ANALYSIS
Robert Veatch (1989) has suggested a framework for ethical analysis that health care
professionals can use to determine the ethical course of action to follow in a given
situation. His four-step approach involves ensuring adequate knowledge of all the
pertinent facts involved in a given situation (step 1), and the application of moral
rules (step 2), ethical principles (step 3), and ethical theories (step 4). When faced
with a situation involving ethical decision making, health care practitioners should
begin with step 1 and continue along Veatch’s continuum, through steps 2, 3, and 4,
if needed, until a decision is made
Veatch contends that ethical situations can sometimes be solved without the
application of moral rules, ethical principles, or ethical theories. Sometimes an
ethical dilemma can be solved by simply ensuring that all the facts are known about
a case (step 1). For example, a question of whether to break patient confidentiality
might be moot if it is determined that the patient has agreed to allow the health
professional to divulge such information.
If step 1 does not provide an answer, step 2 involves 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. Sometimes there may be a conflict among two or more moral rules or ethical
principles. In such cases, one should determine whether one rule or principle or
combination of rules or principles has precedence in the given situation; if not, an
ethical theory should be employed. According to Veatch, ethical theories (step 4) are
the ultimate arbiter of ethical dilemmas (see Exhibit 7–1).
ETHICAL THEORIES
A number of ethical theories have been described. The two most prominent types in
the modern period are teleological (consequentialist) theories and deontological
(nonconsequentialist) theories. There are other approaches to ethics that have
applicability to the biomedical field, such as virtue-based and feminist theories.
However, most contemporary biomedical texts focus on teleological and
deontological theories.
Teleological theories, such as utilitarianism, state that the rightness or wrongness of
an action depends on the consequences produced. According to Beauchamp and
Childress: “Consequentialism is the moral theory that actions are right or wrong
according to their consequences rather than any intrinsic features they may have,
such as truthfulness or fidelity” (1989, p. 25). Utilitarianism, as a consequentialist
theory, directs that the most appropriate course of action is that which will produce
the “greatest good for the greatest number” when the consequences of all
alternatives in a given situation are weighed.
Conversely, deontological theories, such as Kantian ethical theory, argue that the
rightness or wrongness of an action is independent of the consequences produced.
According to Beauchamp and Childress, “Deontologists maintain that the concepts
of obligation and right are independent of the concept of good and the right actions
are not determined exclusively by the production of good consequences” (1989, p.
26). Deontologists maintain that factors other than consequences, such as integrity
and truth telling, should be included when determining the ethical acceptability of a
given action (Beauchamp and Childress, 1989).
For example, consider the question of whether a health care professional ought to
tell an elderly patient she is terminally ill despite pleas from her children that she not
be told. A utilitarian would consider the consequences of the available options (tell
or not tell), while the Kantian would consider factors including the health care
professional’s obligation to be truthful with the patient.
A more detailed discussion of ethical theories is beyond the scope of this chapter,
especially given that ethical principles and moral rules are more likely to be the
“tools” used by health care practitioners on a daily basis as they face ethical
situations.
ETHICAL PRINCIPLES AND MORAL RULES
Medical practitioners have an ethical obligation to care for their patients. Ethical
principles and moral rules provide guidance for practitioners about what this
obligation entails. When faced with an ethical dilemma, health care professionals
should first consider whether or not moral rules are applicable and helpful in
determining an acceptable course of action (step 2). If not, they should move to the
level of ethical principles (step 3) for guidance.
Autonomy
The principle of autonomy states that an individual’s liberty of choice, action, and
thought is not to be interfered with. As Beauchamp and Childress have noted,
“Autonomy has . . . been used to refer to a set of diverse notions including selfgovernance, liberty rights, privacy, individual choice, liberty to follow one’s will,
causing one’s own behavior, and being one’s own person” (1989, pp. 67–68). In
health care, we think of autonomy as the right of individuals to make decisions
about what will happen to their bodies (for example, whether or not to have
surgery), what choice will be made among competing options (such as surgery
versus medical management), and what they choose to take or not take into their
bodies (for example, compliance versus noncompliance with prescribed
medications). We also allude to questions of autonomy when we refer to choice
among health care providers (such as physicians, hospitals, and pharmacies) and the
choice to refuse medical treatment (such as decisions about the right to die and
assisted suicide) (McCarthy, 1996b).
There are two ethically justifiable exceptions to the principle of autonomy: weak
paternalism and the harm principle. The concept of medical paternalism is in direct
conflict with the principle of patient autonomy. Medical paternalism suggests that
physicians and other health care professionals—because of their education and
training—know what is best for their patients. As a result, health care professionals
believe they are justified in overriding a patient’s autonomy. Medical paternalism
dominated Western medical practice until the last several decades, when the primacy
of patients’ rights and the concept of medical consumerism became recognized.
Nevertheless, a form of medical paternalism, “weak paternalism,” has remained
generally ac-accepted as a justifiable exception to the principle of autonomy. Weak
paternalism allows an individual’s autonomy to be violated 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. It might be argued that given the stress
caused by his current situation, Leo is not an autonomous individual and is thus
unable to make a rational decision whether to enter a clinical trial or end his life.
Some have argued that weak paternalism is not paternalism. If a person cannot make
an autonomous decision because he or she lacks the capacity to do so, then how can
that individual’s autonomy be overidden? Strong paternalism—the violation of
another’s autonomy because they are making the wrong decision or a decision that
will cause harm to themselves—is not considered an ethically justifiable reason to
override a patient’s autonomy. Consequently, to override Leo’s decision to end his
life based on strong paternalism would be unethical.
Under the harm principle, one is justified in overriding another’s autonomy if, in the
exercise of that autonomy, harm may come to others. In Leo’s situation, one could
argue that he should be prevented from ending his life (i.e., his autonomy should be
overridden) because of the emotional harm such an act would inflict upon his
children.
Informed Consent
The principle of autonomy is a vital component of informed consent. For example,
when one provides informed consent to an individual contemplating participation in
a clinical research trial, one respects that individual’s right to make an autonomous
decision. The rule of informed consent directs that patients must be fully informed
about the benefits and risks of participating in a clinical trial, taking a medication, or
electing to have surgery; this disclosure is followed by their autonomous consent.
For legal and ethical reasons, informed consent is always obtained through a written
form in situations such as clinical research and surgery. In the case of clinical
research, these documents are usually drafted by the investigator or research sponsor
(e.g., pharmaceutical manufacturer) and subsequently approved by the institutional
review board (IRB) at the institution where the research will take place.
Informed consent is also obtained informally in some instances. For example,
whenever a pharmacist counsels a patient and dispenses a medication to a patient, a
type of informal informed consent is occurring. The patient is informed about the
benefits and risks of the drug and then decides whether or not to take it.
Informed consent is composed of five elements: disclosure, understanding,
voluntariness, competence, and consent (McCarthy, 1996b). Disclosure directs that
all the pertinent information necessary for an informed decision be made available to
the patient. Understanding requires that the patient fully understand what he or she is
consenting to, including any benefits or hazards. Voluntariness instructs that patients
must choose to enroll in a research endeavor or be compliant with a medication free
from coercion. (It might be argued that Leo would not be making a voluntary
decision to enroll in the clinical trial given his financial circumstances.) Competence
requires that patients be autonomous individuals, who functionally have the ability
to make decisions for themselves. Consent is the final legal and moral criterion that
must be met in order to ensure that informed consent has been obtained. It provides
the patient with a point of decision.
Confidentiality
The rule of confidentiality, much like informed consent, is an application of the
principle of autonomy. When a health care professional keeps information private
from others, unless given permission to do so by the patient, the professional
respects the individual’s autonomous decision. Medical confidentiality need not be
expressed explicitly by the patient. All medical information, by nature, is generally
considered to be confidential unless released with the patient’s approval.
The terms confidentiality and privacy are often used interchangeably, yet, in
actuality, they are not the same. Confidentiality is the act, by a health care
professional, of keeping information private from others, unless given the
permission to reveal such information by the patient. In contrast, privacy is the act of
keeping information from others who do not have our consent, or even the right, to
access such information. A violation of confidentiality occurs when a health care
professional inappropriately discloses patient information, either purposefully or
accidentally, to others after being given access to such information. A violation of
privacy occurs when an individual (e.g., a computer hacker) gains inappropriate
access to private information. Given this distinction, the primary focus of
biomedical ethicists is on confidentiality.
In health care, it is sometimes unclear which members of the health care team
should have access to confidential medical records without express consent of the
patient. Should a pharmacist or physical therapist caring for a patient have the same
access to medical records afforded the patient’s physician or hospital nurse?
Generally, these individuals do have access to such records, absent specific
instructions from the patient or patient’s family that they should not.
Another difficult ethical situation involves a patient who explicitly expresses a
desire not to have information divulged to a member of the health care team. For
example, a patient may divulge to a pharmacist his or her decision to alter a
prescribed therapeutic regimen but request that the pharmacist not disclose this
information to the physician.
Confidentiality has the same two ethically justifiable exceptions as does the
principle of autonomy: the harm principle and weak paternalism. As with autonomy,
a health care professional may be ethically justified in violating a patient’s
confidentiality if, by keeping information private, harm may come to others (harm
principle) or if the patient lacks autonomy (weak paternalism).
Confidentiality is an example of an ethical precept that has found its way into our
legal system. The Health Insurance Portability and Accountability Act (HIPAA) of
1996, though primarily focused on the portability of employer-based health
insurance, codified health care professionals’ responsibility to maintain patient
confidentiality. The provision of this law relating to the security and privacy of
health information was only fully effective in early 2003 (Giacalone and Cacciatore,
2003). Consequently, the impact of the HIPAA on health care delivery in the United
States is still to be determined. Nevertheless, it is already clear that HIPAA will
dramatically change the way health care professionals handle patient-sensitive
information. The concern is whether HIPPA, while protecting patient
confidentiality, may result in new ethical problems involving limiting access to
patient information that may impair a health care professional’s ability to care for
their patient.
Beneficence/Nonmaleficence
Beneficence and nonmaleficence are ethical principles that, in a sense, are
complementary. To act in a beneficent manner indicates that one will act to “do
good” for another. Nonmaleficence refers to “avoiding harm” or “taking due care.”
Beauchamp and Childress compare these related principles:
The word nonmaleficence is sometimes used more broadly to include the prevention
of harm and the removal of harmful conditions. However, because prevention and
removal require positive acts to assist others, we include them under beneficence
along with the provision of benefit. Nonmaleficence is restricted . . . to the
noninfliction of harm. (1989, p. 194)
A practical example of the difference between beneficence and nonmaleficence
might be as follows: While driving down the street one day, you notice an elderly
woman crossing the street. Stopping your car to allow her to cross safely is an
example of practicing nonmaleficence, while getting out of your car to assist her
across the street exemplifies beneficence. Similarly, in health care, a pharmacist who
refuses to fill a prescription because of a drug interaction is practicing
nonmaleficence. The same pharmacist contacting the prescriber for an alternative
medication is demonstrating beneficence.
Fidelity
The principle of fidelity requires that health care professionals act in such a way as
to demonstrate loyalty to their patients. A type of bond or promise is established
between the practitioner and the patient. This professional relationship places on the
health professional the burden of acting in the patient’s best interest. Health care
professionals have a fidelity obligation to all their patients, regardless of the length
of the professional relationship. In community pharmacy, for example, practitioners
have the same obligation to show fidelity to an occasional patient as they do to a
“regular” customer (McCarthy, 1996c).
Ethicists sometimes describe two types of fidelity obligations: contractual and
covenantal. Contractual fidelity is that which occurs as the result of an agreement—
a contract—between two parties. It refers to the obligations that might exist
between, for example, a building contractor and a client or an employer and an
employee. Covenantal fidelity, on the other hand, implies a much deeper or spiritual
commitment such as that which exists between a husband and wife or a member of
the clergy and his congregation. Contractual and covenantal fidelity lie on opposites
end of a continuum. Fidelity obligations may be contractual or covenantal in nature
or may lie some where between the two on the continuum. Where the relationship
between pharmacist and patient falls along the continuum is a point of much
discourse. This is important from a practical perspective when one considers the
level of obligation health care professionals have to their patients. How far should
medical practitioners go to ensure that their patient’s needs and desires are met? In
Leo’s case, what level of fidelity do his physician and other health care professional
have?
Veracity is the ethical principle that instructs practitioners to be honest in their
dealings with patients. There may be times when the violation of veracity is ethically
justifiable (for example, the use of placebos to benefit a patient), but the violation of
this principle for non-patient-centered reasons would appear to be unethical. In a
professional relationship based upon professional fidelity, patients have a right to
expect that health care professionals will be forthright in dealing with them
(McCarthy, 1996c).
Distributive Justice
Distributive justice refers to the equal distribution of the benefits and burdens of
society among all of society’s members. We often think of distributive justice in
terms of our health care delivery system. This principle is frequently used as a
justification for providing health care as a right to all Americans.
Health professionals do not always provide care with equal fervor to all patients.
Justice instructs health care providers to demonstrate an equivalent amount of care
toward all their patients. Unfortunately, issues such as the patient’s socioeconomic
status often affect the level and intensity of care provided by health care
professionals. Medicaid patients are sometimes provided a much lower quality of
care than cash paying customers or patients who have a “Cadillac” drug benefit plan.
All too often, the care provided by a health care professional is viewed in terms of
the personal reward for the professional—that is, the level of reimbursement that the
care is likely to reap. Justice demands that the health care professional focus on the
patient and his or her medical needs, not on the financial impact on the health care
professional.
As the United States examines the possibility of significantly reforming its health
care system, equal access to quality care for those like Leo and his family must be
the cornerstone of any reform effort (McCarthy, 1996c).
ETHICAL CODES
Ethical principles that apply to medical practice and research—such as autonomy,
beneficence, and justice—have long served as the basis for a system or code of
ethical conduct. Western medical ethics is primarily based on the Hippocratic code
established by the Greek philosopher Hippocrates in the 5th century B.C. Medicine
(American Medical Association) and pharmacy (Philadelphia College of Pharmacy)
developed codes of conduct for their practitioners in 1847 (American Medical
Association, 2000) and 1848, respectively. As Montagne notes, “The guiding
principles of these codes were a respect for human life and service to humanity”
(1992, p. 303).
The Holocaust during World War II, and the subsequent Nuremberg trials, prompted
the first major development of a code dealing specifically with experimentation on
human subjects. After Nuremberg, several other codes of medical ethics were
established. In 1949, the World Medical Association drafted the Geneva Convention
Code of Medical Ethics, a contemporary version of the Hippocratic Oath. In the
1960s, the same organization established an ethical code on clinical research. The
Declaration of Helsinki was adopted in 1964 (and revised in 1975); this was based
upon the Nuremberg principles (Montagne, 1992). In 1972, the American Hospital
Association issued a “Statement on a Patient’s Bill of Rights.” In 1977, the
Declaration of Hawaii provided ethical guidelines for clinical research in psychiatry
(Montagne, 1992). Nurses are guided by the “Code of Ethics for Nurses,” most
recently revised by the American Nurses Association in 2001. Physicians follow the
“Principles of Medical Ethics,” revised by the American Medical Association in
2001. In 1992, the National Association of Boards of Pharmacy issued a revised
“Pharmacy Patient’s Bill of Rights” (Buerki and Vottero, 2002).
These codes provide health care professionals with standards to guide their practice.
However, ethical principles and codes cannot provide health care professionals with
answers to every moral question that may arise in the course of their practice.
Ethical questions in health care involve decision making that is usually situationspecific. The purpose of such principles and codes is not to provide practitioners
with right and wrong answers but to offer them a framework to use when faced with
ethical questions. As Montagne points out, “The formulation of an oath or ethical
code does not remove the moral choices and the need to carefully consider each
individual situation and the alternative actions or decisions that can be made” (1992,
p. 304).
APhA Code of Ethics
The code of ethics of the American Pharmacists (formerly Pharmaceutical)
Association (APhA) is the only one that specifically guides the practice of
pharmacy. A careful examination of the evolution of the code since its inception in
1852 shows both a greater degree of responsibility to the patient expected of the
pharmacist and a greater respect for the autonomy of patients.
The first APhA code reflected the wide acceptance of medical paternalism or the
attitude that the “physician knows best.” In Article 5 of the 1852 code, for example,
is the following:
As physicians are liable to commit errors in writing their prescriptions . . . the
apothecary should always, when he deems an error has been made, consult the
physician before proceeding. . . . It is his duty, when possible to accomplish the
interview without compromising the reputation of the physician. . . . When
apothecaries commit errors . . . the physician . . . should feel bound to screen them
from undue censure, unless the result of a culpable negligence (APhA, 1865, p. 25).
Amazingly, the 1852 code suggests that errors by physicians or pharmacists, unless
made negligently, need not—in fact should not—be revealed to patients.
The 1952 code clearly outlined the duties of a pharmacist, which were quite in
conflict with what is accepted practice today. The preamble begins: “The primary
obligation of pharmacy is the service it can render to the public in safeguarding the
preparation, compounding, and dispensing of drugs and the storage and handling of
drugs and medical supplies” (APhA, 1952, p. 721).
The 1952 code went on to instruct, seemingly in direct conflict with what we today
refer to as pharmaceutical care, that
The pharmacist refuses to prescribe or diagnose; he refers those needing such
service to a properly licensed practitioner. . . . The pharmacist does not discuss the
therapeutic effects or composition of a prescription with a patient. When such
questions are asked, he suggests that the qualified practitioner is the proper person
with whom such matters should be discussed (APhA, 1952, p. 722).
By the 1969 revision, the code was significantly shorter, enabling it to be placed on
a placard suitable for display in pharmacies. The 1981 code was gender neutral; “he”
was replaced by “a pharmacist.”
The 1994 code, much less prescriptive than earlier versions, speaks to the
“covenantal relationship between the patient and the pharmacist” and the obligation
of pharmacists to promote “the good of every patient in a caring . . . manner”
(APhA, 1995, p. 2131). The elements of pharmaceutical care appear throughout and
are consistent with the new mission of pharmacy (see Exhibit 7–2; see Chapter 3).
ETHICAL ISSUES IN HEALTH CARE
Law and Ethics
Many of the laws, regulations, and other rules that govern our daily life are an
outgrowth of our morality and ethics. Laws that prohibit homicide, robbery, and
similar 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. They are created in such a way as to
provide legal guidelines for the “usual” or “most common” situation. What should
be done, then, when the legal course of action is inconsistent with the ethical course
of action (for example, when a person commits homicide in self-defense)?
Conflicts of this kind occur routinely in medicine. For example, what should a
pharmacist do when a patient’s prescription for heart medicine has been depleted, no
refills remain, and the prescriber is unavailable? Clearly, most pharmacists would do
the ethical thing and provide the patient with a few doses to hold the patient over
until a new prescription can be obtained, even though this course of action is illegal.
To follow the example a bit further, what if the medication is a controlled substance
used for pain control in a terminally ill patient? A pharmacist might be more
reluctant to dispense a few doses, even though the patient might be in just as much
need, due to potential legal ramifications from drug enforcement authorities.
Rationing
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 (for example, the Oregon Plan). American health care
policy makers have tried to avoid this approach because it contradicts a longstanding implicit belief that all that can be done for each patient ought to be done.
Medical insurance providers, both publicly and privately funded, have attempted to
support this traditional ideal. But the lack of cost containment has resulted in rising
insurance rates, thereby driving individuals out of the health insurance system and
threatening the viability of governmental programs.
The consequence of this policy is seen in increasing numbers of individuals who are
unable to afford health insurance. Fewer people have access to health care and
others have decreased choices of where they can receive health care (such as
municipal hospitals, free clinics). As McDermott points out:
Approximately 15% of our people [Americans] have no health insurance coverage at
any one time, and at least 57 million nonelderly Americans lack health insurance for
some part of the year. This does not even include the underinsured and those on
Medicaid whose coverage cannot begin to provide them with access that is
consistent with good health care (1994, p. 782).
As a result, the United States may not in theory ration health care, but in practice it
certainly does. As Light argues in reference to the arbitrary way private insurance
companies often make coverage decisions:
Surely, criteria for rationing should be developed openly and with fairness to all. So
far, the American health care system has relied on myriad private companies to
make not only these decisions but also related ones on the use of resources, using
hundreds of proprietary systems with different forms and different, unsubstantiated
methods (1994, p. 498).
For at least the present, most American health care planners have determined that
rationing of care, in any manner, is not a viable alternative for dealing with our
current crisis. At the same time, however, there is a shared determination by the
government and the public at large that reform is essential and that whatever
changes are made must ensure universal access to health care while controlling costs
and reducing fraud (you will recall the discussion of distributive justice and equal
access to health care earlier in this chapter). As Friedman notes, “High health care
costs breed medical indigence; if one is to be fixed, so must the other” (1993, p.
2438).
Assisted Suicide
Although medical euthanasia (“mercy killing”) has long been an ethical issue, it has
only been in recent years that the question of assisted suicide has been examined.
The activities of Dr. Jack Kevorkian (frequently referred to as “Dr. Death” for his
activities assisting terminally and chronically ill patients to end their life) have
spurred a great deal of public and professional discussion of this issue. Several states
have considered the legality of assisted suicide. Some have rejected it (Washington),
while others have accepted it within strict guidelines (Oregon). In 1997, the U.S.
Supreme Court ruled that assisted suicide is nota constitutionally granted right,
while upholding state laws in New York and Washington banning the practice.
However, the Court left to individual states the option of legalizing assisted suicide.
From an ethical perspective, the key issue remains whether assisted suicide violates
the Hippocratic responsibilities of health care practitioners to “do no harm.” Those
who advocate its availability to patients suggest that allowing a patient to continue
to experience unrelenting pain is to do harm. They suggest that patients have the
right to make an autonomous decision to end their life; opponents worry that legal
assisted suicide would be abused (such as might be the case with Leo).
Human Drug Experimentation
As discussed earlier, a number of ethical codes have been established by the medical
community since 1945. Several of these codes deal with research on human subjects,
including the testing of drugs. Two important ethical aspects of human drug
experimentation are the role of the institutional review board (IRB) and the use of
placebos.
The IRB is the body responsible for overseeing all clinical research conducted
within a given institution. Traditionally, most clinical drug research was conducted
in hospital settings. However, with the shift in the locus of health care delivery from
the inpatient to the ambulatory setting, IRBs are now found in managed care
organizations and other ambulatory facilities. The IRB has two primary
responsibilities. The first is to ensure the integrity and scientific rigor of the
proposed research study. The IRB evaluates risks versus benefits to study
participants. If the risks outweigh benefits, the IRB would likely reject the proposal.
The board acts as somewhat of a “subject advocate” to ensure that the patientsubject’s rights and welfare are protected (Gallelli, Hiranaka, and Grimes, 1986, p.
487). The IRB’s second major responsibility is to evaluate and approve informed
consent forms used in conjunction with the research. Such forms should be drafted
in a manner consistent with the elements of informed consent discussed previously.
IRBs vary in their size and representation. Their membership may include
physicians, nurses, other allied health professionals (including pharmacists),
institutional administrators, attorneys, clergy, medical ethicists, and community
members (McCarthy, 1996b).
Placebos have generally had two roles in medicine: (1) in clinical drug research, and
(2) as a means of decreasing the dose of or weaning a patient off a drug to which a
patient has become dependent. The use of placebos has long been an integral
component of clinical drug research. Whether the drug being tested is a new drug
compound or an existing drug under study for a new indication, placebos have
served as a point of comparison for determining therapeutic efficacy. Although the
use of placebos in some instances has been shown to provide therapeutic usefulness
(such as for pain control), placebos—by definition—are agents devoid of
pharmacologic activity. Patient-subjects who receive placebos as a component of
their participation in a clinical drug study can generally not hope to derive any
benefit (beneficence) from these substances. This raises the question of whether the
use of placebos in drug research, despite the obvious scientific advantages, is
ethical. This question is further complicated by the expectation that placebos will be
employed in clinical research. A Food and Drug Administration regulator has stated:
“It is desirable to include some placebo controlled studies unless it is considered
unethical to do so” (Freedman, 1990, p. 2). This suggests that the use of placebos is
ethical in certain instances but unethical in others (McCarthy, 1996b). In a meeting
in the fall of 2000, representatives of the World Medical Association approved a
change in the 1964 Declaration of Helsinki stating “that the use of placebos in
medical experiments is unethical when treatments are available for the diseases that
are under study” (McMillen, 2000). Though this action does not have legal force in
the United States, it does carry considerable ethical weight worldwide.
The use of placebos to address genuine or perceived dependence is even more
ethically problematic. The belief that the health care practitioner knows best and,
therefore, is justified in practicing medical paternalism has been a long-standing
component of the “medical authority” model of practice. Under this model, the
patient’s perceptions and desires are subjugated to the judgment of the health care
professional. This type of thinking would be used, for example, as justification for a
practitioner to shift a patient judged to be drug dependent to a placebo without the
patient’s knowledge. Today, such use of placebos with-out patient knowledge and
consent might be judged to be un-ethical—a direct violation of patient autonomy
and informed consent.
Drug Formularies
A drug formulary is a list of drugs that are approved for use either within an
institution (such as a hospital) or for reimbursement by a third-party payer. Its
purpose is to eliminate therapeutic duplication and provide patients with the best
drug at the lowest cost (see Chapter 22). In their early days, formularies were used
by hospitals to control drug inventories and provide prescribers with a list of “drugs
of choice” for various conditions. However, a drug’s absence from the formulary
was not usually a great barrier to a prescriber’s obtaining it for a patient. The
prescriber could make a special request to a member of the hospital’s pharmacy and
therapeutics committee and, usually, the drug would be obtained.
When managed care organizations and pharmacy benefit management companies
began to employ formularies, circumventing them became much more difficult. This
restrictive nature of formularies has led to a number of important ethical questions.
For example, does the use of generics or therapeutic substitution violate the
autonomy of the patient 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”) (McCarthy, 1996a)?
However, one could argue that the use of formularies and the resultant constraint on
drug costs helps to ensure affordable access to quality health care for more people
(distributive justice).
CONCLUSIONS
The availability of biotechnological advances—combined with the ever-increasing
cost of health care—will continue to present health care professionals with new
ethical challenges. As a result, a knowledge and understanding of the ethical tools to
assist practitioners when confronted with ethical situations will be as important in
the future as it is today, if not more so. Ethical theories and principles, moral rules,
and ethical codes may not always provide a clear direction for health care
professionals, but they can provide a framework within which a decision can be
made.
QUESTIONS FOR FURTHER DISCUSSION
1.-How might the consumer-oriented model of medical practice affect both a health
care professional’s ethical obligations to his or her patients and a patient’s rights to
health care in the future?
2.-How does embracing the concept of pharmaceutical care as the mission of
pharmacy affect a pharmacist’s ethical responsibility to his or her patients?
3.-What new ethical questions might health care professionals face in the future?
KEY TOPICS AND TERMS
Macro ethical situations
Micro ethical situations
Consumerism
Paternalism
Moral rights
Legal rights
Legal responsibility
Moral obligation
Ethical theories
Ethical principles
Moral rules
Confidentiality
Informed consent
Autonomy
Beneficence
Nonmaleficence
Fidelity
Distributive justice
Veracity
Teleological (consequentialist) theories
Deontological (nonconsequentialist) theories
Utilitarianism
Kantian ethical theory
APhA code of ethics
Rationing
Assisted suicide
Human drug experimentation
Drug formularies
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