Ethics and Professionalism in Pharmacy Profession Assignment

Ethics and Professionalism in Pharmacy Profession Assignment Words: 9417

CHAPTER 3 Ethics and Professionalism Michael Montagne, PhD Robert L McCarthy, PhD The quest to construct systematically an ethical framework for Western civilization was begun over 2000 years ago by Socrates. He approached ethics as a science, as being “governed by principles of universal validity, so that what was good for one was good for all, and what was my neighbor’s duty was my duty also. “1 However, acceptance of the Socratic approach has proved burdensome.

After 2000 years of effort, humankind universally adheres to not even one ethical principle. No set of ethical principles, no matter how carefully thought out or how well constructed, can provide the individual professional with guidance for each decision about clients, peers, or society. There are people who believe that because each situation is different, each decision requires separate analysis of possible outcomes from different actions and the weighing of right and wrong.

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Regardless of one’s stance or approach, however, the health professional in today’s society needs continual selfexamination of professional duties and ethical principles to be prepared for the conflicts and dilemmas they will face. “They may at least act as rules-of-thumb for handling easy cases. They may at least summarize ethical reasoning that has gone before by others who have found themselves in somewhat similar situations. They may at least serve as guidelines for formulating thinking about the problem at hand. “4 BEING PROFESSIONAL

In this discussion, professional ethics is used only to denote “the profession’s interpretation of the will of society for the conduct of the members of that profession augmented by the special knowledge that only the members of the profession possess. “2 In other contexts, the term might be used to denote those ethical principles to which society believes any individual claiming professional status should subscribe. What is to be gained by development of a set of ethical principles, or a code of ethics (Fig 31), by a profession to which it expects its members to abide?

First, a code of ethics makes the decision-making process more efficient. In opposition to situational ethicists, Veatch claims: Yet if those who must resolve the ever-increasing ethical dilemmas in medicine???including patients, family members, physicians, nurses, hospital administrators, and public policy-makers???treat every case as something entirely fresh, entirely novel, they will have lost perhaps the best way of reaching solutions: to understand the general principles of ethics and face each new situation from a systematic ethical stance. Second, individual professionals occasionally may need guidelines for directing their professional behavior. Each decision made by a professional requires calling upon a store of technological information as well as the individual’s own sense of right and wrong. Almost assuredly, all professionals will be confronted with situations that they have never considered in great detail. Where one can find no apparent theological or personal ethical principles to apply, one might turn to professional ethics for guidance.

Finally, professional ethics establish a pattern of behavior that clients come to expect from members of the profession. Once a consistent pattern of behavior is discerned by clients, they expect that behavior to remain constant, and their expectations become part of the relationship they establish with the professional. To better understand the role of and necessity for ethics in professions, one must first look at the characteristics of professions. PROFESSIONAL CHARACTERISTICS

The first characteristic of a professional is possession of a specialized body of knowledge; using this body of knowledge enables the practitioner to perform a highly useful social function. All lawful occupations provide some positive benefit to society and are based on specialized knowledge. The professions generally are more socially useful than many other occupations, but social utility alone does not make an occupation a profession. An applied body of knowledge may be composed of knowledge of a manual skill or intellectual knowledge. The latter is of primary significance as a criterion or professions. The pharmacist is not considered a professional because of good typing skills. Rather, he or she possesses the relevant professional knowledge about drugs and patients that permits the pharmacist to advise patients and prescribers concerning drug therapy, detect drug interactions, select appropriate product sources, and exercise professional judgment. The exercise of proper judgment is a key element in this first professional characteristic. Professional services traditionally are rendered to an individual rather than to a group.

Using the specialized body of knowledge of the profession and the intellectual abilities of the professional, the practitioner makes a judgment as to the best course of treatment for each individual. Clinical practice predisposes pharmacists to a situationalist approach to ethics through its emphasis on individual differences in response to therapeutic regimens. Some guidelines, however, exist for adjusting drug therapy in patients with compromised renal or hepatic function, electrolyte or hormonal imbalance, and other pathological abnormalities.

Therapeutic guidelines give us a place to begin solving a clinical problem. Rules of morality serve the same purpose: 1 2 PART 1: ORIENTATION Figure 3-1. Code of ethic (From “Code of Ethics for Pharmacists. ” Am J Health-Syst Pharm 1995; 52: 2131. ) The second characteristic of a professional is a set of specific attitudes that influence professional behavior. The basic component of this set of attitudes is altruism, an unselfish concern for the welfare of others: “The professional man, it has been said, does not work in order to be paid: he is paid in order that he may work.

Every decision he makes in the course of his career is based on his sense of what is right, not on his estimate of what is profitable. “5 One measure of social sanction is the granting of exclusive rights of practice through the licensing power of the state. Licensing not only attempts to protect the public from incompetent practitioners, but also frequently creates a relationship of trust between society and the professionals, because within the sphere of professional activities, the professional exercises an authoritative power over patients.

As explained by Greenwood, [T]he professional dictates what is good or evil for the client, who has no choice but to accede to professional judgment. Here the premise is that, because he [or she] lacks the requisite theoretical background, the client cannot diagnose his [or her] own needs or discriminate among the range of possibilities for meeting them. 6 Professionals are concerned with matters that are vital to the health or well-being of their clients. The practitioner employs highly specialized technical knowledge, which the patient or client does not possess.

Both the client’s lack of knowledge and the vital nature of professional services provide the professional with an opportunity to exploit the client. The consequences of such exploitation are severe. The smooth functioning of the professions requires that the practitioner must consider the needs of the patient as paramount, relegating his or her own material needs to an inferior position. Social sanction, the third characteristic of a professional, is a resultant effect of the two characteristics already discussed. Whether an occupation is considered to be a profession depends, to a large degree, on whether society views it as such.

The extent of the public’s trust is a measure of the degree of social sanction, and this is evident in society’s permitting the exercise of sovereign power over professional matters. Given the legal monopoly inherent in professional licensing, the failure of society to impose further controls on the profession is sanctioning, by implication, the profession’s performance and self-regulation. Thus, professions have evolved as occupations connected with high status. The functional relationship of professions to CHAPTER 3: ETHICS AND PROFESSIONALISM 3

American Association of Colleges of Pharmacy At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy. I will consider the welfare of humanity and relief of human suffering my primary concerns. I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve. I will do my best to keep abreast of developments and maintain professional competency in my profession of pharmacy. I will maintain the highest principles of moral, ethical, and legal conduct.

I will embrace and advocate change in the profession of pharmacy that improves patient care. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public. Figure 3-2. Oath of a pharmacist. (From http://www. aacp. org/site/ tertiary. asp? TRACKID & VID 2 & CID 686 & DID 4339. Accessed May 14, 2004. ) Only 2 of the 52 schools that responded to a 1980 survey required a formal, separate course in ethics; 32 schools offered no course, required or elective, of which ethics was an explicit part. 3 Today, however, most pharmacy schools require some instruction in ethics. A 1991 survey of ethics instruction at pharmacy schools found that, “while the quantity of ethics instruction has not increased, there are encouraging signs that the quality and depth of ethics education is improving. “14 Several factors appear responsible for the heightened attention given to the study of ethics in pharmacy, including the explosion of biotechnology and the rapidly rising cost of health care in the US, of which drugs are an important component.

Macro Ethical Issues versus Micro Ethical Situations Ethical situations in pharmacy can be divided into two broad categories: macro and micro. Macro ethical issues are issues that are not specific to a given pharmacist, but rather are those that must be addressed by all pharmacists and by society in general. These include abortion, assisted suicide, genetic engineering, rationing of and access to health care, organ transplantation, and in vitro fertilization. Micro situations are those issues that may confront individual pharmacists in the course of their daily practice.

They include the use of placebos, patient confidentiality (eg, revealing information about a patient’s medications to members of the family), and informed consent (eg, what and how much information about a medication should be disclosed to a patient). Sometimes, macro issues are manifested in micro situations. This is especially true with socially controversial issues. For example, a pharmacist may receive a prescription for a drug and know that it is intended for use in an assisted suicide. Not only must the pharmacist deal with the legal issues involved, but also with the ethical responsibility as a health care professional.

A further complication in such situations is the influence of the pharmacist’s personal beliefs in choosing the course of action. society reinforces their status position, and the status itself acts as a motivating factor in the drive of any occupation to gain recognition as a profession. Several studies have attempted to identify which occupations qualify as professions. The most prominent study was done by Carr-Saunders and Wilson in 1933. 7 Primarily because of the commercial elements inherent in modern pharmacy practice, the study reached no definitive conclusion as to pharmacy’s professional status.

More recent studies have produced similar results. Montague,8 Smith,9 Smith and Knapp,10 and Denzin and Mettlin11 consistently found pharmacy to fall short of full professional status. The key issues include a lack of autonomy (eg, pharmacists follow orders, fill prescriptions, decided by others, the prescriber) and potential or real conflicts regarding professional compensation based more so on products than on services (eg, pharmacists counsel patients on nonprescription products without charging a fee, but compensation comes through the sale of that product).

All professions, however, can be found to fall short of being a complete profession in at least a few respects. Pharmacy has a legitimate claim to a theoretical body of knowledge, to a growing degree of socially sanctioned decision-making authority, and to a commitment of service functions as articulated by a code of ethics and an oath (Fig 3-2) that is sworn by individuals entering the profession. Competence, Trustworthiness, and Caring Any examination of pharmacy ethics must begin with a discussion of the basic moral responsibilities that all health care practitioners have toward their patients.

Berger15 has attempted to describe the characteristics that a pharmacist should possess: 1. 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. 2. Pharmacists must be trustworthy. Patients must know that they can seek the confidential advice and assistance of their pharmacist and that their wishes will be carried out. 3. Pharmacists must care for and about their patients.

As the 1995 American Pharmaceutical (now Pharmacists) Association (APhA) Code of Ethics directs, “A pharmacist places concern for the wellbeing of the patient at the center of professional practice. “16 ETHICAL DECISIONMAKING Pharmacy ethics has received a great deal of recent attention, but the study of ethics, ethical questions, and codes of ethics has been an integral component of pharmacy and medical practice for centuries. The first code of ethics for medicine was credited to Hippocrates in the 4th century BC.

In many ways, the Hippocratic 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”12 provides one moral perspective on the contemporary issue of assisted suicide. Over the past decade or so, the attention given to pharmacy ethics in the professional and scientific literature, and in schools and colleges of pharmacy, has changed a great deal. Pharmacists, unfortunately, do not always effectively communicate their concern for the welfare of their patients.

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 their concerns are much more likely to be viewed as caring. Health Professional???Patient Relationship: Consumerism Versus Paternalism It was not long ago that when a patient was instructed by their physician or pharmacist to take a medication, they did so with- 4 PART 1: ORIENTATION out 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 they held, such as suffrage or due process. Today, patients have become true consumers of medical care. Patients wish, and have a right, to be informed and asked for their consent. For a health care professional to do otherwise would not only be unprofessional and unethical, but also have potential legal ramifications. Patients also expect a certain level of service.

As with sellers of other goods and services, health professionals who fail to meet the demands of medical consumers for care will quickly find themselves without customers and, sometimes, with legal problems. 17 bility 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 (American Pharmaceutical Association, now called the American Pharmacists Association), which states in part that “a pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner. 16 The Code appears to suggest 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 that “a pharmacist serves individual, community and societal needs. “16 What then is the extent of the pharmacist’s duty to his or her patients? Is it the pharmacist’s moral obligation to care for them without exception? Moral Rights Versus Legal Rights to Health Care Any discussion of pharmacy ethics must be clear about what is meant by the term right. In this society, one frequently refers to the legal rights of individuals.

Legal rights are either guaranteed fundamentally in the US Constitution (eg, the rights of free speech and assembly) or are provided by laws and regulations promulgated at the federal, state, or local level. We sometimes confuse what are really legal rights with our moral obligations. Moral rights are quite different from legal rights. Granted, these rights may be reinforced by laws, but their basis lies not in law but in ethical principles. 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. As one might expect, moral rights and legal rights may conflict. There is disagreement, for example, over whether issues such as abortion involve moral rights or legal rights. Legal Responsibility Versus Moral Obligation Rem Edwards provides an example of a radical interpretation of the Hippocratic oath insofar as he asserts that medical professionals have an obligation to do whatever is necessary to relieve the pain and suffering of their patients. 19 Edward’s contention, however laudatory, has serious flaws when applied to pharmacists.

All pharmacists practice under the practical constraints of law that may limit their doing whatever is necessary. Consequently, although they have a moral obligation to care for their patients, this obligation is constrained by law. Thus, patient rights and practitioner responsibility may sometimes be in conflict, not on ethical grounds but on legal ones. Directing a pharmacist to assume an individualistic approach and take an illegal, yet ethical, action for a patient despite legal consequences is asking the pharmacist to subjugate his or her own interests to that of the patient.

ETHICAL RESPONSIBILITY Patient’s Rights When a patient seeks the care of a pharmacist, what rights do they have? What can they reasonably expect from pharmacists? Patients can expect that pharmacists will employ their knowledge and experience in caring for them. They can expect that, as autonomous individuals, pharmacists will respond to their wishes about their treatment. 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 of treatment when they exist. 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, the right to choose the nature of their health care is meaningless. 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 passage of federal legislation in the early part of the 20th century. 18 Not only must a drug be shown to be effective???that is, able to produce the effect for which it was administered???it must work with a certain degree of safety. 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, not pharmacists, were the health care professionals who held ultimate responsibility for monitoring the progress of a patient and ensuring that the desired outcome was achieved. The concept of “pharmaceutical care,” however, directs that this responsibility is to be a shared obligation between the prescriber and the pharmacist. 17 According to the Commission to Implement Change in Pharmaceutical Care, 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 the quality of life of the patient. 20 Pharmaceutical care forces pharmacy practitioners to change their focus, broaden their professional responsibility. VEATCH’S FRAMEWORK FOR ETHICAL ANALYSIS Robert Veatch21 has suggested a framework for ethical analysis that can be used by pharmacists to determine the ethical course of action to follow in a given situation.

His four-step approach involves (1) ensuring adequate knowledge of all the pertinent facts involved in a given situation, and the application of (2) moral rules, (3) ethical principles, and (4) ethical theories. Veatch contends that some ethical situations can be solved without the application of moral rules, ethical principles, or ethical theories. Sometimes an ethical dilemma can be solved by simply ensuring all the facts are known about a case (step 1). Medical Practitioners’ Duty to Their Patients What is the responsibility of medical practitioners?

Some might argue that health care providers have a Hippocratic responsi- CHAPTER 3: ETHICS AND PROFESSIONALISM 5 For example, a question of whether to break patient confidentiality might be moot if the patient has already agreed to allow the health professional to divulge such information. If step 1 does not provide an answer, the professional may proceed to step 2, the application of moral rules. The rules of confidentiality and/or consent (informed consent) may offer some guidance. If a dilemma still exists, ethical principles may be employed (step 3).

These include autonomy, beneficence, nonmaleficence, veracity, fidelity, and justice. Ethical theories, Veatch suggests, are the ultimate arbiter of ethical dilemmas (step 4). ETHICAL THEORIES Although many approaches to ethics (such as virtue-based and feminist theories) have applicability to the biomedical field, the majority of contemporary biomedical texts focus on two prominent types: teleological (consequentialist) theories and deontological (nonconsequentialist) theories. Teleological theories, such as utilitarianism, state that the rightness or wrongness of an action depends on the consequences produced. As

Beauchamp and Childress suggest, “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. “22 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 action 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 actions produced.

As Beauchamp and Childress point out, “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. “23 Deontologists maintain that factors such as integrity and truth must be included when determining the ethical acceptability of a given action. their education and training???know what is best for their patients. As a result, health care professionals believe they are justified in overriding the autonomy of a patient.

Medical paternalism dominated Western medical practice until the last several decades, when the primacy of patient rights and the concept of medical consumerism became recognized. A form of medical paternalism, weak paternalism, still allows the autonomy of an individual 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. Some have argued that weak paternalism isn’t paternalism: if one lacks the ability to make an autonomous decision, then how can his or her autonomy be overridden?

Weak paternalism has remained generally accepted as a justifiable exception to the principle of autonomy. Strong paternalism???the violation of the autonomy of another person because you believe they are either 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. However, under the harm principle, one is justified in overriding the autonomy of another if, in the exercise of that autonomy, harm may come to others. 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 the right of that individual to make an autonomous decision. The rule of informed consent directs that patients must be fully informed about the benefits and risks of their participation in a clinical trial, taking a medication, or electing to have surgery, and this disclosure must be followed by their autonomous consent. For legal and ethical reasons, informed consent is always obtained formally in situations such as clinical research and surgery through an informed consent form.

In the case of clinical research, these documents are usually drafted by the investigator or pharmaceutical manufacturer and subsequently are approved by the institutional review board (IRB) where the research will take place. The role of the IRB will be discussed later in this chapter. 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 occurs. The patient is informed about the benefits and any risks of the drug, and then decides whether to take it.

Informed consent is composed of five elements: disclosure, understanding, voluntariness, competence, and consent. 25 Disclosure directs that all the pertinent information that is necessary for an informed decision must be made available to the patient. Understanding requires that patients fully understand what they are consenting to, including any benefits or hazards. Voluntariness instructs that patients who choose to enroll in a research endeavor or be compliant in taking medication must be free from coercion. Competence requires that patients be autonomous individuals, who have the functioning ability to make decisions for themselves.

Consent provides the patient with a point of decision, and is the final legal and moral criterion to be met in ensuring that informed consent has been obtained. ETHICAL PRINCIPLES AND MORAL RULES Pharmacists have an ethical obligation to care for their patients. Moral rules and ethical principles, rather than ethical theories, are more likely to be the tools used by pharmacists on a daily basis as they face ethical situations. Ethical principles and moral rules provide guidance for practitioners about what the commitments of patient care entail. 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 self-governance, liberty rights, privacy, individual choice, liberty to follow one’s will, causing one’s own behavior, and being one’s own person. “24 In health care, we think of autonomy as the right of individuals to make decisions about what will happen to their bodies, what choices will be made among competing options, and what they choose to take, or not take, into their bodies.

We also allude to questions of autonomy when we refer to choice among health care providers, and the choice of refusing medical treatment. 25 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 autonomy. Medical paternalism suggests that pharmacists and other health care professionals???because of Confidentiality The rule of confidentiality, like informed consent, is an application of the principle of patient autonomy.

When pharmacists keep information private from others, unless the patient gives permission to release it, they respect the autonomous decision of the individual. Medical confidentiality need not be requested explicitly by patients; all medical information, by nature, is 6 PART 1: ORIENTATION generally considered to be confidential, unless the patient grants approval for its release. Confidentiality and privacy have received a great deal of attention recently with the passage and implementation of the Health Insurance Portability and Accountability (HIPAA) Act. Though often used interchangeably, the terms confidentiality and privacy do differ.

A violation of privacy occurs in situations where personal information is obtained/revealed by an individual who has not been granted access to such information. A computer hacker would be an example. Conversely, a violation of confidentiality results from the inappropriate release of personal information to others by a person, such as a health care professional, who has been granted access to such information. In health care, it is sometimes unclear which members of the health care team may have access to confidential medical records without the express consent of the patient.

Should a pharmacist or physical therapist caring for a patient have the same access to medical records that is afforded the patient’s physician or hospital nurse? 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 tell a pharmacist of her decision to alter her prescribed therapeutic regimen, but request that the pharmacist not disclose this information to her 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 pharmacist may be ethically justified in violating the confidentiality of a patient when keeping information private may harm others (harm principle) or when the patient lacks autonomy (weak paternalism). plumber or electrician. What remains in dispute is where the pharmacist???patient relationship lies along the continuum between covenant and contract. Veracity Veracity is the ethical principle that instructs pharmacists to be honest in their dealings with patients.

There may be times when the violation of veracity may be ethically justifiable (as with the use of placebos), but the violation of this principle for non-patient-centered reasons would appear to be unethical. In a professional relationship based upon professional fidelity, patients have a right to expect that their pharmacist will be forthright in dealings with them. 17 Distributive Justice Distributive justice refers to the equal distribution of the benefits and burdens of society among all members of this society. 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. Even though justice instructs that pharmacists demonstrate an equivalent amount of care, pharmacists do not always provide care with equal fervor to all patients. Sadly, issues such as the patient’s socioeconomic status often impact the level and intensity of care provided by health care professionals. Medicaid patients are sometimes provided a much lower quality of care than a patient who is a cash-paying customer or who has a fullcoverage drug benefits plan.

All too often, the care provided by a health care professional is viewed in terms of the personal reward for the professional, such as the level of reimbursement the care is likely to reap. Justice demands that the focus be on patients and their medical needs, not on the financial impact on the health care professional. 17 Beneficence/Nonmaleficence Beneficence and nonmaleficence are ethical principles that are, in a sense, complimentary to one another. Beneficence indicates that you act in a manner to do good. Nonmaleficence refers to taking due care or avoiding harm.

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. 26 ETHICAL CODES Ethical principles and rules 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 attributed to the Greek philosopher Hippocrates, 5th century BC Medicine (American Medical Association) and pharmacy (Philadelphia College of Pharmacy) developed codes of conduct for their respective practitioners in 1848. As Montagne notes, “the guiding principles of these codes were a respect for human life and service to humanity. “27 The Holocaust during World War II, and the subsequent Nuremberg trials, would prompt the first major development of a code dealing specifically with experimentation on human subjects.

Subsequent to 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. In 1964, the Declaration of Helsinki was adopted based upon the Nuremberg principles, and it was further revised in 1975. 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. 7 Ethical codes provide health care professionals with ethical principles and standards by which to guide their practice. However, ethical principles and codes cannot hope to 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 Fidelity Fidelity requires that pharmacists 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 pharmacist the burden of acting in the best interest of the patient. Pharmacists have an obligation of fidelity 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 have for a regular customer. 17 The depth of the fidelity relationship between the pharmacist and patient is a topic of ongoing discussion among pharmacy ethicists.

Two forms of fidelity are frequently alluded to: covenantal and contractual. Covenantal fidelity is often described as an intimate and spiritual commitment between individuals. Examples would include the fidelity of marriage and the fidelity between a member of the clergy and his or her congregation. Conversely, contractual fidelity does not involve a level of commitment beyond that owed another as the result of a binding agreement. An example of this form of fidelity would be the relationship one might have with a contractor such as a

CHAPTER 3: ETHICS AND PROFESSIONALISM 7 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 in each situation and the alternative actions or decisions that can be made. “28 cerns. In a way, these activities might represent the most important type of emerging conflicts for society and for pharmacy, which is viewed as the profession responsible for monitoring and controlling drug use. APhA Code of Ethics

The Code of Ethics of the APhA is the only code of ethics 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 in 1852 seemed to reflect the wide acceptance of medical paternalism, the attitude that the physician knows best. Amazingly, the code seems to suggest that errors by physicians or pharmacists, unless done with malice, need not???in fact should not???be revealed to patients!

The 1952 version of the Code clearly outlined the duties of a pharmacist, and these were quite in conflict with what is accepted practice today. The 1952 Code instructs, seemingly in direct conflict with what we see as pharmaceutical care today, that “the pharmacist does not discuss the therapeutic effects or composition of a prescription with a patient. “29 The 1994 Code (see Fig 3-1), 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. 16 The elements of pharmaceutical care appear throughout, and the Code is consistent with the new mission of pharmacy. Law and Ethics Many of the laws, regulations, and other rules that govern our daily life are an outgrowth of our morality and ethics. Those laws that prevent homicide, robbery, and other offenses are simply a codification of the values we share as members of society. Unfortunately, laws and regulations cannot be promulgated to cover every eventuality, nuance, condition, or situation. They are created in such a way as to provide legal guidelines for the usual or most common situation.

What should be done, therefore, when such a situation (eg, committing homicide in self-defense) arises, especially if the legal course of action is inconsistent with the ethical course of action? Conflicts can and will emerge with changes in the laws relating to the practice of pharmacy, in the evolution of new problems and developments in both the profession and the population it serves, and in the roles and functions of drug use in our society. The conflict often might be between a certain law or regulation and an ethical principle held by the profession.

Many pharmacists have faced dispensing decisions in which the act of providing the drug would be in the best interests of the patient, but it also would violate a specific law or regulation related to the practice of pharmacy, or it would be contrary to his or her own beliefs and ethical stances. These conflicts occur fairly routinely in pharmacy. 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 such patients with a few doses to hold them over until a new prescription can be obtained, even though this course of action is illegal. To follow the example a bit farther, what if the medication is a controlled substance used for pain control in a terminally ill patient? The potential for legal action from drug enforcement authorities might make a pharmacist reluctant to dispense extra doses, even though the patient might be in just as much need. ETHICAL CONFLICTS AND ISSUES IN HEALTH CARE

The conflict between the personal interests of the professional and the duty to subordinate these interests to the benefit of the patient presents one of the major unresolved problems of the professions. In addition, changing patterns in pharmacy and health care delivery present additional ethical conflicts. The traditional focus of professional service has been on the individual. Professional services have not been mass-produced, but rather each rendering of a service is specifically tailored to the individual needs of a specific patient.

In general, the ethics of professions have evolved on the basis of primacy of the individual. Within the health professions, the impairment of physical or mental functioning as a result of drug use or other factors has become a very important issue. While some studies have indicated that the level of social/recreational drug use among physicians and pharmacists does not differ much from that of general society, the extent of drug-use problems in the health professions is great enough to warrant the development of prevention programs and referral groups. 0 Regardless of the appropriateness or inappropriateness of such drug-taking in general, the professional ethics of the pharmacist should dictate that any degree of impairment while practicing pharmacy is unacceptable. The impact of such impairment on the ability to perform one’s professional duties, especially the delivery of patient care, is considerable. Such cases affect the image of pharmacy, the trust of the patient, and impact many other ethical and interpersonal aspects of professional practice.

Innovative uses for old and new drug products have created a number of ethical dilemmas. 31???33 Conflicts continue to occur for many pharmacists when they find themselves faced with dispensing placebogenic agents, oral contraceptives, drugs for lethal injections, and drugs for controlling certain types of behavior (see the bibliography for some representative references in this area). The whole process of modern drug development probably will continue to generate a wide variety of ethical con-

Rationing of Health Care Services As the cost of providing health care services continues to grow, some have suggested and even attempted to implement a system that would ration the availability of health care. American health care policy makers have tried to avoid this approach because it represents a contradiction with a long-standing implicit belief that all that can be done for each patient ought to be done. Medical insurance, both publicly and privately funded, has attempted to support this ideal.

But, in the absence of costcontainment, rising insurance rates have resulted, thereby driving individuals out of the health insurance system and threatening the viability of governmental programs. The consequence of this policy is seen in both increasing numbers of individuals who are unable to afford health insurance and increasing restrictions on who qualifies for public programs. Therefore, fewer people have access to health care, or at the very least many have decreased choices of where they can receive health care (eg, 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. “34 8 PART 1: ORIENTATION 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 present crisis, current facts not withstanding. 5???37 At the same time, there is a shared determination by the government and the public at large that reform is essential and, further, that whatever changes are made, they must ensure universal access to health care while controlling costs and reducing fraud. 38,39 As Friedman notes, “high health care costs breed medical indigence; if one is to be fixed, so must the other. “40 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 assisted suicide advocate Dr Jack Kevorkian spurred a great deal of public and professional discussion of this issue. 41???44 Several states have considered the legality of assisted suicide; some have rejected it, while others have accepted it within strict guidelines. 45 The US Supreme Court decided that there is no constitutionally guaranteed right to assisted suicide. This decision has not ended the legal debate, but rather has shifted it to the states, who must decide the legality of assisted suicide on their own.

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 doing harm. 46,47 They suggest that patients have the right to make an autonomous decision to end their life; their opponents worry that legal assisted suicide would be abused. therapeutic usefulness (eg, 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 generally cannot 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. The question is further complicated by the expectation that placebos will be employed in clinical research. An FDA regulator has stated, “it is desirable to include some placebo controlled studies unless it is considered unethical to do so. 56 This suggests that the use of placebos is ethical in certain instances, but unethical in others. 25 The use of placebos to address genuine or perceived therapeutic outcomes 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 longstanding component of the so-called medical authority model of practice. Under this model, the perceptions/desires of the patient are subjugated to the judgment of the health care professional.

It would be used, for example, as justification for a practitioner to place a patient on a placebo without the knowledge of the patient. In current medical ethic, however, this use of placebos in the absence of the patient’s knowledge and consent might be judged to be unethical???a direct violation of patient autonomy and informed consent. Drug Formularies Drug formularies are a list of drugs that are approved for use either within an institution or for reimbursement by a thirdparty payer.

Their purpose is to eliminate therapeutic duplication and provide patients with the best drug at the lowest cost. In the early days of formularies, they were used by hospitals to control drug inventories and provide prescribers with a list of drugs of choice for various conditions. However, the absence of a drug from the formulary was not usually a great barrier to a prescriber obtaining it for the patient. A special request could be made by the prescriber to a member of the pharmacy and therapeutics committee of the hospital, and usually the drug would be obtained.

When managed-care organizations (MCOs) and pharmacy benefit management companies (PBMs) began to employ formularies, circumventing them became much more difficult. This restrictive use of formularies has led to a number of important ethical questions. For example, does the use of generic and/or therapeutic substitution violate the autonomy of the patient and/or prescriber? Is the use of such substitution a violation of informed consent? Does the use of formularies violate the ethical principles of beneficence (do good) and nonmaleficence (avoid harm)? 57 Human Drug Experimentation

Several ethical codes deal with research on human subjects, including the testing of drugs. 48???50 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. 51 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 risk versus benefit ratio for the study’s participants is evaluated. Should the risks outweigh the benefits, the IRB would likely reject the research. The board acts as somewhat of a subject advocate, making sure that the rights and welfare of the patient-subject are protected. 52 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 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. 25 Placebos have generally had two roles in medicine: (1) in clinical drug research, as part of the research methodology; and (2) as a means for providing a therapeutic response in selected patient situations. 3???55 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 CONCLUSION The ethics of pharmacy in the US has experienced a continuous evolution as the profession itself has changed.

Pharmacy practice is far different today than it was when APhA issued its first code of ethics in 1852. The current changes that pharmacy (and indeed all of health care) is experiencing makes the existence of an ethical framework and personal ethic even more vital today than it was in the past. The pharmacists of the mid-19th century could not imagine the medical innovations and technological wonders that have occurred, and the financial questions that have been raised and debated in the last quarter of the 20th century.

As the concept of pharmaceutical care expands to an evergrowing number of practice sites, pharmacists must be schooled not only in their expanding ethical responsibilities as independent practitioners, but also in their traditional moral obligations CHAPTER 3: ETHICS AND PROFESSIONALISM 9 to patients. The APhA Code of Ethics and the profession at large must remain responsive to an ever-changing environment. In spite of the deficiencies of self-regulation, there remains much that can be done within pharmacy to increase the service contribution of pharmacists through ethics.

The situation was summarized by Dean LaWall when, 85 years ago, he described pharmacy as “[a] highly specialized calling, which may rise to the dignity of a true profession or sink to the level of the lowest commercialism, according to the ideals, the ability, and the training of the one who practices it. “58 REFERENCES 1. Tomlin EWF. The Western Philosophers: An Introduction. New York: Harper & Row, 1963, p 26. 2. Smith MC. In Wertheimer AI, Smith MC, eds. Pharmacy Practice: Social and Behavioral Aspects, 2nd ed. Baltimore: University Park Press, 1981, p 305. 3. Veatch RM. Case Studies in Medical Ethics.

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