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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 Leos 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 companys owner cannot afford to offer health insurance. Leos 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, Leos 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 Veatchs 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 practitioners 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 Veatchs 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 patients 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 Leos 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 whatif anyinfluence the pharmacists (or other health care professionals) 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 pharmacists 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 patients 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 shouldwithin the moral and professional parameters of their own professionstrive to be competent, trustworthy, and caring (McCarthy, 1996c). THE HEALTH PROFESSIONALPATIENT 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 paternalismthe belief that the health care professional knew bestwas 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 wishand have a rightto be informed and to be asked for their consent. To do otherwise would be both unprofessional and unethicalnot 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 effectivethat is, able to produce the effect for which it was administeredbut 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 pharmacists or another health care professionals duty to his or her patients go? Is it the health care professionals 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 patients rights and the practitioners 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 patients 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 patients 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).

VEATCHS 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 Veatchs 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 71). 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 professionals 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 individuals 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 ones will, causing ones own behavior, and being ones own person (1989, pp. 6768). 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 professionalsbecause of their education and trainingknow what is best for their patients. As a result, health care professionals believe they are justified in overriding a patients 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 individuals 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 individuals autonomy be overidden? Strong paternalismthe violation of anothers autonomy because they are making the wrong decision or a decision that will cause harm to themselvesis not considered an ethically justifiable reason to override a patients autonomy. Consequently, to override Leos decision to end his life based on strong paternalism would be unethical. Under the harm principle, one is justified in overriding anothers autonomy if, in the exercise of that autonomy, harm may come to others. In Leos 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 individuals 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 individuals 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 patients 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 patients physician or hospital nurse? Generally, these individuals do have access to such records, absent specific instructions from the patient or patients 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 patients 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 professionals 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 patients 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 contractbetween 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 patients needs and desires are met? In Leos 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 societys 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 patients 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 professionalthat 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 researchsuch as autonomy, beneficence, and justicehave 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 Patients 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 Patients 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 notin fact should notbe 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 72; 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 patients 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 patientsubjects rights and welfare are protected (Gallelli, Hiranaka, and Grimes, 1986, p. 487). The IRBs 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), placebosby definitionare 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 patients 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

patients knowledge. Today, such use of placebos with-out patient knowledge and consent might be judged to be un-ethicala 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 drugs absence from the formulary was not usually a great barrier to a prescribers obtaining it for a patient. The prescriber could make a special request to a member of the hospitals 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 advancescombined with the ever-increasing cost of health carewill 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 professionals ethical obligations to his or her patients and a patients rights to health care in the future? 2.-How does embracing the concept of pharmaceutical care as the mission of pharmacy affect a pharmacists 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 References APhA. (1865). Code of ethics of the American Pharmaceutical Association. In

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