Ethical Behavior when Communicating with Patients

Ethical Behavior when Communicating with Patients

Ethical Patient Care The following cases illustrate several principles of ethical behavior discussed in this chapter. As you read the following three cases, make notes about what you would do in each situation. At the end of the chapter you will find an analysis of each case. Before reading the analyses, re-read the cases, and see if you would solve them any differently than you initially did. Then compare your analyses with those provided.

Each of these patient cases presents decisions that must be made on the basis of legal and ethical principles. Your ability to choose a proper course of action in these situations depends on your understanding of the ethical principles involved. The legal aspects of these cases are covered under state and federal law. However, many elements are not specifically addressed in laws and regulations but do involve underlying ethical principles of patient–health professional interaction. Principles related to ethical decision making in patient care include beneficence, autonomy, and honesty. This is by no means a complete list, but the principles seem to be most relevant to the communication responsibilities of pharmacists. Other issues that are derived from these principles and are particularly important in patient counseling are informed consent, confidentiality, and fidelity. These important concepts will be discussed in later sections of this chapter. A Pharmacy Code of Conduct for a Modern World Over the last few decades rapid advancements in health care and adoption of new technologies have changed the environment in which medical care is given. Despite its rapid change, the health care environment remains an exciting and complex arena offering rich opportunities for growth, professional satisfaction, and interesting intellectual challenges that affect all professionals—including pharmacists. The emerging role of pharmacists as medication therapy managers requires you to be more effective and efficient when engaging in all forms of communication as it relates to medications (Dhillon et al, 2001). As the practice of comprehensive pharmaceutical care grows, you will find yourself in the midst of a vast array of ethical and legal considerations that need resolution if you are to be guided into the more cognitive service role of “helping people get the best use of their medicine.” This phrase was adopted by the Joint Commission of Pharmacy Practitioners following their Pharmacy in the 21st Century Conference (Zellmer, 2001; Tindall and Millonig, 2003) and attempts to convey one important factor involving contemporary pharmacy practice: Pharmacists serve as repositories of sensitive and protected health information about their patients. Pharmacists are also being challenged by contemporary social issues such as being asked to dispense medications that end life (see Case Study 14.5), in physician-assisted suicide situations, or in situations that involve terminating pregnancies (see Case Study 14.4). Pharmacists can be proud of the fact that the World Health Organization (WHO) has praised their importance as communicators and health care givers (Zellmer, 2001). Thus, you must be prepared to carefully recognize and resolve ethical issues by understanding general and specific ethical principles and by applying these principles to pharmaceutical care and medication therapy management. 

THE PHARMACISTS CODE OF ETHICS

 The APhA adopted a revised Code of Ethics for Pharmacists in 1994; the American Society of Health-System Pharmacists (ASHP) endorsed the same code in 1996. This code was founded using a patient-centered approach and its eight principles are based on moral obligations and virtues intended to guide pharmacists in their professional relationships with patients and other health care professionals (APhA, 1994). This pharmacist-specific Code of Ethics addresses only ethical behavior and does not address any of the state and federal statutes and regulations governing pharmacy practice although both state and federal statutes and regulations address how pharmacists are to conduct themselves in relationships designed to respect and protect the well-being of the public. The eight principles described in the APhA Code of Ethics for Pharmacists are as follows: Principle I: A pharmacist respects the covenantal relationship between the patient and pharmacist. Principle II: A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner. Principle III: A pharmacist respects the autonomy and dignity of each patient. Principle IV: A pharmacist acts with honesty and integrity in professional relationships. Principle V: A pharmacist maintains professional competence. Principle VI: A pharmacist respects the values and abilities of colleagues and other health professionals. Principle VII: A pharmacist serves individual community and societal needs. Principle VIII: A pharmacist seeks justice in the distribution of health resources. While these principles outline the professional obligation of pharmacists to use their knowledge and skills for the benefit of others, they reflect general and ethical principles held in high esteem by all health care professionals. More importantly, the APhA Code was built on a contemporary interpretation of underlying ethical principles that address nonmaleficence, beneficence, paternalism, autonomy, honesty and truth telling, informed consent, confidentiality, and fidelity. These underlying principles are something that every pharmacist should understand. Seven Key Principles Guiding Ethical Conduct  • Nonmaleficence • Beneficence • Autonomy versus paternalism • Honesty and truth telling • Informed consent • Confidentiality • Fidelity Underlying Ethical Principles Beardsley 

1. THE PRINCIPLE OF NONMALEFICENCE

 The “principle of nonmaleficence” is commonly stated as the principle of “above all else do no harm.” This is probably the most quoted principle of all moral maxims and has been used for 3,500 years, gaining prominence in the Oath of Hippocrates. The principle of nonmaleficence requires a health care provider to not act in any way that intentionally inflicts needless harm or injury to a patient, either through acts of commission or omission (Munson, 2000). The principle of nonmaleficence can be violated in two distinct ways. First, pharmacists can violate this principle if they knowingly and intentionally cause a patient harm. For example, knowingly filling a prescription to which a patient has an allergy or filling a prescription in defiance of the published literature that states it may have a drug–food interaction without telling the patient about the drug–food interaction may be seen as malfeasance. The principle of nonmaleficence may also be violated when no malice or intent to do harm is involved. For example, a pharmacist by honest mistake misreads a prescription for Zyrtec and fills it with Zyprexa. Should that patient come to harm through this error, the pharmacist may be found negligent in his or her actions even though the pharmacist had no intention to cause harm. The pharmacist may be considered as having failed to exercise due care in discharging his or her responsibilities as a professional. Thus, the pharmacist failed to meet his or her obligation of nonmaleficence and may be held accountable by the court system for his or her actions. The obligation of care imposed by the principle of nonmaleficence is not to demand that pharmacists or any health professional accomplish the impossible or to be perfect in any way. Rather, pharmacists must provide a standard of care that any reasonable professional would have done under the same circumstances and also at a level that is higher than an “ordinary” person. In essence, this expectation is reasonable because perfection in medicine is not possible since it is not a perfect or exact science. Thus, pharmacists and other health care professionals are held to “standards of due care.” It is by these standards, set by the profession, that their actions are evaluated and judged harmful or appropriate. To further protect the members of society from “malfeasance,” some dueprocess standards are met by using licensing statutes and regulations, educational requirements, standards for practical learning, and credentialing committees to set up entry barriers to a profession. This way society has some assurance that individuals trained as pharmacists have obtained and continue to maintain an acceptable level of knowledge and skills needed to take on the responsibility of providing care. Thus, the APhA Code of Ethics for Pharmacists addresses this ethical principle of nonmaleficence when it states that pharmacists must maintain professional competence and that they “have a duty to maintain knowledge and abilities as new medication, devices, and technologies become available and health information advances.” 

2. THE PRINCIPLE OF BENEFICENCE

 “As to disease, make a habit of two things—to help or at least to do no harm.” This directive from Hippocratic writings focuses on two moral principles:  nonmaleficence, as discussed above, and beneficence. Both principles require the health care provider to evaluate the potential benefits of an intervention in relation to the risk of harm to the patient. To be more specific, beneficence is the principle that health professionals should behave in the best interest of their patients. The principle of beneficence is also addressed in the APhA Code of Ethics for Pharmacists (APhA, 1994) when it states, “a pharmacist places concern for the well-being of the patient at the center of professional practice.” When considering a medical or pharmaceutical intervention that best benefits the patient, that intervention should answer some or all of the following seven questions: Does it promote health and prevent disease? Does it relieve symptoms, pain, and suffering? Does it cure the disease? Will it prevent untimely death? Will it improve functional status or maintain a compromised health state? Will its educational content and counseling help better a patient’s condition and prognosis? Will the intervention help avoid harm to the patient in the course of care? Although there are times when all or most of these questions can be answered, there are times in every professional’s life when it is really difficult to accomplish a desired therapeutic outcome due to a conflict between patient and provider expectations (i.e., what a patient wants versus what a professional wants for them) (Jonsen et al, 2002). For example, the use of combined antiretroviral therapy in the treatment of HIV infection comes with many benefits as well as risks. While the use of these drugs improves the patient’s quality of life and prolongs his survival, the side effect profiles of these drugs are extensive and the cost for such drugs is unduly burdensome. Thus, the use of these drugs for preventive purposes produces a risk-to-benefit relationship that must be carefully considered by both patient and practitioner. 

3. THE PRINCIPLE OF AUTONOMY VERSUS PATERNALISM 

Another ethical issue in health care is based on finding a balance between autonomy and paternalism in order to provide the best help to the patient. Paternalism refers to those health professionals or pharmacists who see their relationships with patients as “paternalistic.” That is, they see themselves in a parental role knowing what is best for the “child” (patient). In essence, paternalism is a poor practice as it fails to take into consideration the preferences, beliefs, and practices of the patient, especially those that could be of most benefit to them. Conversely, the principle of autonomy establishes a patient’s rights to self-determination; that is, the patient’s moral right to choose one’s own life plan and action (Jonsen et al, 2002; Munson, 2000). This right is considered paramount even if health professionals judge patient decisions as being damaging to their health. According to the “Harm Principle,” constraints on an individual’s free choices are morally permissible only when an individual’s preference infringes on the rights and welfare of others (Munson, 2000). When pharmacists desire to assess situations of ethical dilemmas, they find it helpful to do this in light of a patient autonomy–paternalistic continuum. If they assess some actions as being more authoritarian than others, they would place their actions toward the “paternalistic” end of this continuum. Actions that encourage patient involvement in decision making would be placed toward the “patient autonomy” end of this continuum. In daily practice, however, there may be many forces that limit or even obstruct the appreciation of patient autonomy, such as the compromised competence of patients, the disparity between provider and patient knowledge, the psychodynamics of the patient–provider relationships, and the stress of illness (Jonsen et al, 2002). Medical ethicists often state that the danger of paternalism is that it threatens individual rights and personal liberties. Yet, in past times, medicine has used the beneficence principle as justification for “paternalistic” relationships with patients. For example, physicians made decisions by themselves (without necessarily informing patients and without patient consent) and then did what was necessary because they saw it in the patient’s best interest. Put another way, they made certain decisions based on their perceptions of what was needed, and they did not include the patient in their decision making. Similarly, pharmacists say they are using “professional judgment” when they adjust a dose or refill a certain medication while rationalizing that the patient has no need to know what has happened. Although most health care professionals embrace and find value in the principle of patient autonomy, in some situations patient autonomy may be unintentionally compromised. For example, some patients who are naturally shy, nonassertive, uneducated, or illiterate may be intimidated in the presence of anyone wearing a white coat. Thus, although the pharmacist is not deliberately attempting to infringe on the patient’s autonomy, social and psychosocial factors may be so overpowering that the patient feels he or she is powerless to make a decision. It is easy to see how autonomy is critically linked to information. Information is vital to protecting and preserving patient autonomy. In an era of consumer-driven health care, it is hard to deny well-informed patients active partnership roles in their health care. Likewise, to become well informed, patients need to be informed in language they understand, and to have explained in unbiased terms the possible treatment options as well as their risks and benefits. In today’s hurried medical environment, patient education and even informed consent are many times pushed aside. Thus, patients often feel rushed and unprepared to make important decisions about their health care and thus relinquish their right to autonomy to their provider. 

4. THE PRINCIPLE OF HONESTY AND TRUTH TELLING

 On principle, all communications between patients and their health professionals should be truthful under all instances. But what should be done when full disclosure of every detail could prove to be harmful? With the increased prominence of the principle of autonomy and with the patient’s right to informed consent in these modern times, full disclosure and truthfulness have become the more accepted ethical courses of action (Da Silva et al, 2003; Jonsen et al, 2002).  The principle of honesty states that patients have the right to truthful communication regarding their medical condition, the course of their disease, the treatments recommended, and alternative treatments available. The APhA Code of Ethics for Pharmacists (1994) states that a pharmacist “has a duty to tell the truth and to act with conviction of conscience.” A certain level of trust must develop between patients and pharmacists to strengthen these relationships. This trust is developed because pharmacists adhere to the principle of honesty. Some health care providers, when withholding information, will claim “therapeutic privilege” as their reason for doing this. This is because they perceive that full disclosure or divulging all medical information would be harmful or upsetting to the patient. In addition, “privilege makes sense in an ethics based on paternalistic patient benefit, but it is contrary to an ethic giving important place to the principle of autonomy” (Veatch, 2000, p. 69). Further, therapeutic privilege, as a paternalistic attitude, has also been criticized because “displaying such behavior is not seen as providing a service but as guarding special knowledge and who would be in control as to when and who to reveal the truth to” (Da Silva et al, 2003, p. 420). Pharmacists may find themselves in the middle of an ethical dilemma concerning truth telling and therapeutic privilege. For example, a patient who claims to have allergies and/or hypersensitivities to some medications previously taken may be prescribed a similar medication but not told of the potential for an allergy or hypersensitivity by a prescribing provider who believes the information about it is purely psychological and has no basis in pathology. In some cases, the patient’s pharmacist may be asked to withhold a patient drug information sheet. The prescribing provider may claim “professional privilege,” stating that telling the patient of possible side effects or adverse reactions may actually cause the patient undue distress or even lead to the patient not taking the medication at all. This leaves the pharmacist in a position to make his or her decision not only within the confines of the statutes and regulations, but also under his or her own interpretation of what is ethically acceptable. 

5. THE PRINCIPLE OF INFORMED CONSENT

 “Informed consent is a critical element of any theory that gives weight to autonomy” (Veatch, 2000). Thus, “informed consent” is the way in which patient preferences become expressed and are applied out of respect for that patient’s autonomy (Jonsen et al, 2002). Both honesty and autonomy serve as foundations to the right of the patient to give informed consent to treatment. The informed consent principle states that patients have the right to full disclosure of all relevant aspects of care and must give deliberate consent to treatment based on “usable” information and a clear understanding of that information (Munson, 2000; Quallich, 2005). In general, consent is not required when a procedure is simple and the risks are commonly understood (Cady, 2000). However, any provider who recommends treatment for a patient, especially if it is invasive, must obtain informed consent. Informed consent forms the ethical basis for the patient–provider relationship as it “consists of an encounter characterized by mutual participation, good communication, mutual respect, and shared decision  making” (Jonsen et al, 2002). For informed consent to successfully take place, it requires a dialogue between patient and provider that consists of five distinct components (Quallich, 2005): • Diagnosis or nature of the specific condition that requires treatment(s), • The purpose and distinct nature of the treatment(s), • Risks and potential complications associated with the proposed treatment(s), • All reasonable alternative treatment(s) or procedures and a discussion of their relative risks and benefits including the option of taking no action, and • The probability of success of the proposed treatment(s). Thus, it is understood that informed consent has occurred and treatment can be implemented if all relevant information is provided, if consent is freely given and is without coercion, and if the patient is capable of understanding the salient information provided. Even under the very best of circumstances it is not always easy to determine who is competent to consent to treatment and who is not (Munson, 2000; Wingfield, 2003). Health care providers must consider how “vulnerable populations,” such as children, the mentally retarded, and those suffering from psychiatric illnesses, are to be considered with respect to consent. The law often uses the terms “competence” and “incompetence” to indicate whether individuals have the legal authority to make health care decisions for themselves. Judges alone have the authority to rule that an individual is legally incompetent. However, medical providers may encounter legally competent patients who appear to have their mental capacity compromised by illness, anxiety, pain, or even hospitalization (Jonsen et al, 2002; Wingfield, 2003). This clinical situation is referred to as “decisional capacity” rather than the legal term of “determination of competency.” Many times in actual practice, health care professionals focus more on “disclosure” than on patient understanding of information. This point can be summarized by the phrase, “the central problem about informed consent are issues of communication rather than the disembodied and abstract issues about proper legal standards of disclosure” (Beauchamp, 1989). Thus, the message that is implicitly being given is that a pharmacist’s success in interpersonal communication is related to his or her willingness to invite patients to engage in open and honest dialogue based on questioning and the exchange of information and full disclosure of it. The pharmacist must create an atmosphere that encourages patients to seek answers to questions. Unfortunately, this style of dialogue is often inhibited by limitations in communication skills and styles, patient comprehension, the inability of pharmacists to listen carefully to their patient’s words and the emotions underlying them, and the time constraints imposed by reimbursement policies that reward procedures rather than education (Jonsen et al, 2002). A meaningful dialogue or consent process is unlikely to be initiated by patients themselves for a variety of reasons. This is true in part because of patient reticence to question providers. In addition, patients often do not know when there is important information about treatment that they have not yet acquired. The burden is on providers to make sure that patients understand all they need to know both to make a reasoned decision about therapy and to implement therapeutic plans appropriately. While drug therapy is the most common type of therapy in health care, informed consent issues surrounding drug therapy are largely ignored compared with issues involving other types of treatment, such as surgery. In addition, patients have much more control over adhering to their medication therapy. Earlier assumptions by society that risks associated with drug therapy are minimal have been challenged by recent research and government reports, such as the Institute of Medicine’s Crossing the Quality Chasm (IOM, 2001). The estimated number of deaths and adverse health events caused by inappropriate therapy is staggering. In the future, pharmacists will be expected to assume their share of responsibility in ensuring that informed consent has occurred before drug treatment is initiated. What are the roles of pharmacists in informed consent? Many pharmacists assume that when patients bring in prescriptions, (a) their physicians have provided all relevant information, (b) patients understand the information, and (c) they have consented to treatment. In fact, many patients lack information on crucial aspects of drug treatment. In addition, physicians frequently do not explicitly discuss key aspects of drug therapy and often fail to obtain meaningful consent from patients. In certain situations, it may become clear that informed consent has really not occurred. Patients may not fully understand important aspects of treatment, may have unanswered questions, or may not be aware of significant side effects. In addition, patients may indicate reluctance to begin taking medications but feel that they have no choice but to follow their physicians’ directions. Many may feel coerced into their decision based on the hierarchical relationship between patient and provider, where power is largely vested in the health professionals on whom patients feel dependent. It is difficult to determine whether consent to treatment has been freely given. When patients express reservations about initiating drug treatment, pharmacists may need to consult not only with patients but also with prescribing physicians to inform them of the lack of freely given consent to treatment. 

6. THE PRINCIPLE OF CONFIDENTIALITY 

The Hippocratic Oath states, “what I may see or hear in or outside the course of treatment . . . which on no account must be spread abroad, I will keep to myself, holding such things shameful to speak about.” The principle of confidentiality serves to ensure that health care providers are obligated to refrain from divulging information that is obtained from patients during the course of medical treatment and to take reasonable precautions to protect that information. In another approach to confidentiality “modern medical ethics bases this duty on respect for the autonomy of the patient, on the loyalty owed by the physician, and on the possibility that disregard of confidentiality would discourage patients from revealing useful diagnostic information and encourage others to use medical information to exploit patients” (Jonsen et al, 2002). As pharmacists become more involved with direct patient care, they gain access to a wide range of sensitive and private patient information, which is necessary for appropriately managing therapy. With the advent of the new regulations set by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pharmacists must know the working of this statute and be able to address the issues relating to its principles of confidentiality and consent, and the regulations concerning “protected health information.” This new layer of professional responsibility is made all the more important because the greatest challenges today to confidentiality result from technological developments in information storage, retrieval, and access (Jonsen et al, 2002; Wingfield and Foster, 2002). While computerization of pharmacy and medical records enhances patient care, it also enhances statistical information and administrative tasks allowing the availability of such records to third parties such as employers, government agencies, payers, and family members. This increased availability threatens patient and professional control over sensitive information. HIPAA took effect on April 14, 2003, and is one of the most significant pieces of federal legislation to affect pharmacy practice since the Omnibus Budget Reconciliation Act of 1990 (OBRA) (Spies and Van Dusen, 2003). HIPAA is also considered to be the first comprehensive federal regulation designed to safeguard the privacy and security of protected health information. Thus, every pharmacy that conducts certain financial and administrative transactions electronically, such as billing, must be in compliance with its regulations. HIPAA prescribes a framework for the use and disclosure of health information for treatment, payment, and health care operations at all health care institutions, including pharmacies (Giacalone and Cacciatore, 2003; Spies and Van Dusen, 2003). HIPAA was written to “enhance the efficiency and effectiveness of data exchange for administrative and financial transactions while improving the security and privacy of healthcare information” (Mackowiak, 2003). Confidentiality has always played a key role in pharmacy practice and therefore the new HIPAA guidelines do not necessarily replace state pharmacy statutes and regulations. However, HIPAA provides strict guidelines as to what a pharmacy can do with patient health information. It also provides important rights to patients, such as “the right to access the information, the right to seek details of the disclosure of the information, and the right to view the pharmacy’s policies and procedures regarding the confidential information” (Spies and Van Dusen, 2003). Compliance with HIPAA is mandatory. The Privacy Rule (the Rule) of HIPAA provides pharmacies some flexibility to create their own privacy rules and procedures. “The Privacy Rule requires each pharmacy to take reasonable steps to limit the use or disclosure of, and requests for, protected health information (PHI) . . . defined as individually identifiable health information transmitted or maintained in any form and via any medium” (Spies and Van Dusen, 2003). Examples of PHI include prescriptions and patient record systems. To accomplish this, pharmacies must employ reasonable policies and procedures that limit how PHI is used, disclosed, and requested. Further, pharmacies must also post their complete Notice of Privacy Practices within the facility as well as on their website, if one exists. It has been stated that “although privacy is an important issue, efforts to protect it may conflict with social needs, including the ability of health professionals  to exchange information when caring for a patient, the right of parents to sensitive health information concerning their children, and the use of data for research, public health, or audit purposes” (Jonsen et al, 2002). Therefore, it is the responsibility of the health care provider to become an advocate for the patient by being familiar with the regulations and policies and being an advocate for better control of information and for improved policies and laws to safeguard it. 

7. THE PRINCIPLE OF FIDELITY AND THE PATIENT–PROVIDER RELATIONSHIP 

The principle of fidelity, as it relates to the patient–provider relationship, is based on the concept of loyalty. It is understood that a special type of relationship is created between patient and provider, one that is based on all the ethical principles previously discussed. The ethics of medicine have traditionally directed providers to attend exclusively to the needs of the patient and to act in ways that best benefit the patient. However, it is also recognized that providers, in some sense, have certain responsibilities beyond their patients. Thus, ethical problems brought on by multiple responsibilities can arise when it is unclear which responsibilities have priority or when it appears that duty to one’s patient is in direct conflict with other duties (Jonsen et al, 2002). Fidelity or loyalty is then even more clearly defined as “a sustained commitment to the welfare of persons or to the success of an endeavor, requiring an investment of effort and sometimes even a subordination of self-interest” (Jonsen et al, 2002). Pharmacists, like other health care providers, have multiple loyalties—to family, to friends, to a religious faith, to a community, and to other personal, professional, and financial obligations. Thus, pharmacists, at times, may experience differing loyalties that will pull them in opposing directions, which is difficult when one choice must be made. For example, pharmacists who promote the use of vitamins by patients who do not need them may be enhancing their financial well-being at the expense of their patients. Pharmacists who refuse to confront physicians about inappropriate prescribing because they want to ensure that physicians will continue to direct patients to their pharmacies are displaying a misplaced sense of their professional responsibility. Pharmacists who are more attentive to the desires of the parties signing their paychecks than to the health care needs of their patients are in a conflict-of-interest situation. Ethically, the responsibilities of pharmacists should be directed toward the welfare of patients. The focus on the rights of patients and the obligations of providers can make the relationships between them seem mechanistic and legalistic. It would be easy to create a list of dos and don’ts for each party to follow. However, the situations encountered within patient–provider relationships are often complicated. Thus, the principles discussed above must be considered when working with patients. In addition, the ability to effectively work through sensitive issues depends on trusting, caring relationships between patients and providers. Each patient is a unique individual and, in an illness situation, is particularly vulnerable. Thus, patients have the right to be treated with compassion. Patients need humane, sensitive care from providers, care that will assist them in making the best decisions they are able to make. This is the essence of the “helping” role of the  health care professional. There is a caveat to this helping role: it is influenced by the vulnerability of the patient, especially the status accorded to physicians and other helping professionals that sets up a power difference between the patient and provider. In fact, “if one shares power with the person having the greatest danger of being victimized, the potential for self-correction of

error seems greatest” (Brody, 1992). So, once again, the need for mutual participation through an active patient role in health care decision-making becomes essential if one wants to reduce health care errors and mishaps. Empowering patients to be active participants in treatment decisions, with decisions being made in the context of a respectful, trusting relationship then becomes a large part of the work pharmacists must take on as part of their professional responsibility to patients.