Feature Article

Primer: Bioethics for Oncology Practitioners

Jeffrey A. Bourret, MS, RPh, FASHP

Jeffrey A. Bourret is Director of Pharmacy, University of Pennsylvania Health System, Philadelphia.


Abstract

Bioethics has been around for more than 25 years. It has evolved from a theoretical discipline to one that has played a more active bedside role, assisting clinicians and caregivers with ethical issues related to the use of medical technology, the patient's desire for autonomy in making treatment decisions, and pressures exerted by managed care to contain costs while serving the patient's best interests. Ethics committees have evolved in response to the physician's, patient's, and family's need for assistance in making difficult treatment decisions. Their multidisciplinary composition is critical to making good decisions based on past experience. Oncology practitioners can better serve the patient and family by learning about both the common ethical issues and the assistance available from ethics committees and bioethics centers at major institutions of learning.

 

History of Bioethics

Medical ethics, or bioethics, is the study of moral issues in the fields of medical treatment and research.1 Some practitioners also include issues related to the distribution of scarce medical resources under the rubric of bioethics. The disciplines typically involved with bioethics and represented on institutional ethics committees include medicine, nursing, theology, social work, law, sociology, and philosophy.

Ethics pertains to decisions that involve distinguishing right from wrong. Ethical decisions usually require the assessment of a moral act based on what will be done as well as how, when, and why it will be done. Ethical issues can sometimes be extremely complex, and often much is at stake. Ethical issues arising from the application of new medical technology have led to the recognition of bioethics as a separate discipline. Indeed, many leading universities associated with academic medical centers now offer graduate degree programs in bioethics.

Bioethics has roots in ancient ethical codes, such as the Hippocratic oath, which has remained the accepted code of ethical conduct for physicians. Hippocrates was a Greek physician who taught that diseases have natural causes, can be studied, and can often be cured. One portion of the oath reads, "I will neither give a deadly drug to anybody if asked for it, nor will I make a suggestion to this effect." Many physicians are basing their decisions on this oath and the notion that doctors, above all, should do no harm.

The increased sophistication of medical science and the rapid development of medical technology are primary reasons for the development of bioethics in the 20th century. Because of these technologies, people now live longer and experience the resulting complications. Dr David Camenga, a neurosurgeon at the Duluth Clinic, stated, "When you prolong the life of a cancer patient, the natural history of the disease advances and you see complications you did not see before." He calls these complications "diseases of medical progress." Others have referred to this as "the age of the tyranny of technology." The public is concerned with the potential misuse of technology and the possibility of being trapped by it. The most compelling example of this is the Cruzan case. Nancy Cruzan had been kept alive in a persistent vegetative state for more than 6 years. She died 11 days after a judge finally authorized her parents to order removal of her feeding tube. People want more control over their lives, and many perceive that they have lost some control because of technology. The public's increased awareness of technology's intrusiveness has resulted in the development of living wills, hospice care, and ethics committees.

Bioethical dilemmas surface in issues related to informed consent for clinical trials, end-of-life decisions for the terminally ill, experimental therapy outside of clinical trials, clinical trials in pediatrics, and more recently in economics decisions related to managed care, where the principle of minimizing costs may conflict with the patient's best interests. Controversial issues, such as euthanasia and physician-assisted suicide, have become more public, increasing the need for experienced individuals who can support patients, families, and physicians in making difficult decisions.2

Dr Ubel, from the University of Pennsylvania, states, "One of the many contributions of bioethics has been to make health care professionals aware of the importance of other people's values. At the bedside, it has forced physicians and nurses to recognize that their values alone should not determine what is done with patients but that patients' values are important too."3

Many ethical dilemmas arise for patients afflicted with cancer. Some of the ongoing challenges to clinicians and caregivers are presented by research ethics, the definition of death, the application of medical technology, economic issues related to the costs of treatment in an era of limited resources, and most recently, genetic technologies identifying genes that may predispose a person to a particular disease or trait. The application of bioethics to oncology practice is diagrammed in Figure 1.


Fig. 1--Bioethics in oncology practice. The role of oncology practitioners in bioethics requires a thorough understanding of common issues confronting cancer patients.


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Traditionally, oncology pharmacy practitioners have been highly involved with issues related to pain management and informed consent in research protocols without thinking about their roles in the context of bioethics. One of the primary reasons why terminally ill patients consider euthanasia or physician-assisted suicide is their fear of inadequate pain control. This provides a new context for the pharmacist's role in facilitating adequate pain control in concert with the physician. For many, the informed consent process is routine and may not consider whether the patient truly understands and comprehends the presented information. Practitioners should learn more about their institutional ethics committees and the impact of managed care and health care policy on patients, families, and clinicians who face bioethical decisions every day.

 

Euthanasia

Euthanasia (an ancient Greek word meaning "good death") has been one of the most debated issues in the 1990s. A recent study by Asch found that 19% of a national sample of US critical care nurses reported having been involved in euthanasia or some other act to hasten a patient's death at least once in their careers.4 This study and its results were very controversial and precipitated strong reactions in many circles. The study also highlights some of the promises and pitfalls of empirical research in bioethics.

Although euthanasia is not a new topic, it is more widely discussed as a result of individuals like Betty Rollen (author of Last Wish), Derek Humphrey (founder of the Hemlock Society), and the well-known Dr Jack Kevorkian. One oncologist and national lecturer on pain management for the terminally ill states that the lay public's interest in euthanasia stems from wanting to have more control over their lives, which they feel they have lost with the advent of medical technology. He also believes that there is a perceived and actual lack of high-quality symptom management for the terminally ill. Many ethicists and practitioners concur that pain control is a real problem, and the literature supports their belief. This leads to the thought, "If you can't relieve my pain, at least give me the right to end my life."

 

The Right to Die

The National Hemlock Society is one of the leading proponents of active euthanasia and physician-assisted suicide for those who are dying slow, painful deaths. Derek Humphrey founded the organization 5 years after the death of his first wife. In his book Jean's Way, he tells the story of how he helped his 42-year-old wife commit suicide during the last stages of her battle with breast cancer. He recounts the scene in which, after exchanging good-byes with her, he brought her a cup of coffee laced with secobarbital and codeine.

For many people, who do not understand how a physician can justify bringing about death, the issue of physician-assisted suicide is disturbing. Some present the "very slippery slope" argument as the strongest argument against legalization of this practice. They believe that in some situations, an acceptable action should not be taken because it will lead to a course of unacceptable actions. Others who argued against legalization point out that medical doctors are not trained psychiatrists, that people sometimes make miraculous recoveries, and that physician-patient trust may be eroded. Those in favor of physician-assisted suicide usually build their case around two main arguments: the mercy argument (the notion of sparing someone unnecessary suffering) and the self-determination argument (the right to determine one's own fate or level of care while dying.) The ethical dilemmas of the terminally ill will be with us for years to come, as we continue to develop technology that prolongs life.

Opinions vary on where to draw the line between acceptable and unacceptable practice. Many doctors interviewed by Newman5 seemed to place that line between passive and active euthanasia. Do-not-resuscitate (DNR) orders could be considered a form of passive euthanasia. Several physicians referred to the concept of "futile treatment," whereby a doctor is not obligated to use an extraordinary intervention if its ultimate effect will obviously be futile.

 

Living Wills, Patients' Rights, and Self-Determination

In 1991, the Federal Patients Self-Determination Act went into effect. This legislation mandates that all hospitals, nursing homes, and home health care providers are required to inform patients of their rights as patients, including their right to make, before treatment, a living will (advance directive) regarding their health care. A living will is a document that informs the health care provider or physician of what types of treatment an individual wants if he or she becomes terminally ill. It can describe the treatments one wants or does not want and can name a person (proxy) to make one's health care decisions.

People are very concerned about living wills and what they mean. The living will was developed not for use in the emergency room or the operating room, but for later, when the patient is, for example, out of intensive care and being kept alive by machinery. According to the law, a living will becomes legally enforceable when the patient can no longer make treatment decisions and is terminally ill. "Terminally ill" is defined as having an incurable disease or irreversible condition for which treatment would only prolong dying. The living will applies once the patient is on a respirator.

Physicians are still ultimately responsible for the decisions made about a patient's treatment. In fact, under some living will statutes, the patient's health care provider may choose not to follow all or part of a patient's living will. The medical provider may be required to tell the patient about this option immediately on receiving a copy of the living will. The patient then has two choices: to stay with that medical provider or to find a different one. One ethicist clarifies the reason for this by recounting the history of physician-patient relationships. According to the theocratic model, physicians were viewed as if they were God and had all the answers. The more gentle paternal model established the physician as a "father" who knew what was best for his patients, and the engineering model, which appeared as medical care became more technical, likened the physician to an engineer, who had more knowledge than the patients and was trusted to take over and do what was correct.

Doctors now realize that health care consumers are more sophisticated and aware because of the accessibility of knowledge. According to the current ideal model, the cooperative model, the physician and patient work as a team, contributing input about the course of treatment. This model establishes rights for both the patients and physicians. Patients know what they want done to their own bodies, yet physicians know what is possible or advisable, based on both their personal morality and their medical knowledge. The point is that sometimes the physician cannot in good conscience fulfill the directives in a living will and is not obligated to do so. Most people have living wills because they do not want to place a tremendous burden of responsibility and decision making on a loved one. They either identify a proxy decision maker who is not a relative or family member, or they prepare living wills without a proxy decision maker.

One can make a living will by various means. Some states have a legally approved living will form obtainable from the physician. The form asks questions to help clarify what an individual does and does not want in terminal health care. A living will does not have to be complicated. It may consist of a simple statement, such as, "If in the opinion of two physicians I am brain dead, I do not want to be kept alive." The living will is simply a tool to help ensure that patients get the health care they want; it is not required. If a patient does not have one, the next of kin will be consulted in making decisions.

 

Pain Management

For years, inadequate pain management has been a concern in the treatment of the terminally ill. The inappropriate prescribing of pain medication (eg, inadequate dosage, selection of an inappropriate drug, or overestimation of the dosing interval) has led to patients' experiencing unnecessary pain and the development of a pain cycle that causes discomfort and the need for even higher doses. This problem stems from a lack of understanding about narcotic analgesics and a stigma associated with their use. Inadequate pain management has been an ongoing problem with terminally ill patients, specifically patients with cancer. It has been repeatedly discussed in the literature and academic institutions and was the focus of guidelines developed by the Agency for Health Care Policy and Research of the Federal Government. Pain control is a key quality measure of the Joint Commission on the Accreditation of Health Care Organizations and many managed care organizations.

Inadequate pain management is one of the greatest fears of those afflicted with terminal illnesses and has been at the heart of the controversies related to euthanasia and physician-assisted suicide. It is the core issue in the mercy argument for euthanasia, which states that the immense pain and indignity of prolonged suffering cannot be ignored and that it would be inhumane to force an individual to continue such suffering. Practitioners could make a meaningful contribution by improving pain control and the quality of symptom management.

 

Research Ethics

An account of abuses of human subjects in medical research at major US universities and medical centers was published in 1966 by Dr Henry Beecher, a physician at the Harvard Medical School. He cited a number of ethical violations, including the use of subjects who did not give their consent and of subjects who were not offered the option of standard treatment. Beecher's article sparked intense discussion of the importance and practicality of obtaining consent from research subjects or from surrogates when the subjects could not provide consent for themselves. The Tuskegee Study, conducted by the US Public Health Service between 1932 and 1972 to assess the clinical course of syphilis, withheld diagnostic information and effective treatment from black men enrolled in the study in order to ensure their continued participation. The abuses of the Tuskegee Study resulted in the assembly of a national commission to examine ethical issues in research and led Congress to enact regulations requiring the informed consent of participants and the review of federally funded health research by appointed review boards.

 

Informed Consent

The importance of informed consent is unquestioned. Respect for patients requires that they have, to the degree to which they are capable, the opportunity to decide what will happen to them. They have this opportunity when adequate standards for informed consent are satisfied. However, people still debate the effectiveness of current methods of obtaining informed consent. Questions are still raised about what information patients require to make good decisions, whether they comprehend the information, and whether their decisions are voluntary.

 

Information

The information most often provided in obtaining consent to participate in clinical trial includes the research procedure; the purposes, risks, and anticipated benefits; alternative procedures (where therapy is involved); and a statement offering the opportunity to ask questions and to withdraw from the research at any time. Some have proposed informing subjects of the selection process and the person responsible for the research. Even when some direct benefit to the subjects is anticipated, they should fully understand the risks and the voluntary nature of participation. Information about risks should never be withheld to elicit the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from those in which disclosure would simply inconvenience the investigator.

 

Comprehension

Comprehension, the manner and context in which information is received, is as important as the information itself. Information presented in a disorganized and rapid fashion, with too little time for consideration, or curtailed opportunities for questioning may adversely affect a patient's ability to make an informed choice. An individual's ability to comprehend is directly related to intelligence, rationality, maturity, and language, and one must adapt the presentation of information accordingly. It is the investigator's responsibility to assess the subject's comprehension of the information presented, a responsibility that increases commensurately with the degree of serious risk to which the subject might be exposed. It may be appropriate to provide subjects with oral or written tests of comprehension. Special steps may need to be taken when comprehension is severely limited, as in the case of immature or mentally disabled individuals, infants and young children, the terminally ill, and the comatose. Any third party given the authority to provide informed consent should be one who is most likely to understand the incompetent subject's situation and to act in that person's best interest. The authorized third party should be given an opportunity to observe the research and to withdraw the subject from the research if that is in the subject's best interest.

 

Voluntariness

An agreement to participate in research constitutes valid consent only if voluntarily given. This component of informed consent requires freedom from coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented to obtain compliance. Undue influence, in comparison, is the offer of an excessive, unwarranted, inappropriate, or improper reward or other overture to obtain the subject's participation. Ordinarily acceptable inducements may become undue influences if the subject is especially vulnerable. It is difficult, if not impossible, to state exactly where justifiable persuasion ends and undue influence begins. Justifiable persuasion may include explaining how experimental treatment of a patient might be the best chance they have for prolonged life or survival based on the available data or lack of effective nonexperimental treatments. Undue influence would include manipulating a subject through the influence of a close relative and threatening to withdraw health service to which an individual would otherwise be entitled.

 

Ethical Debates in Oncology

Several ongoing ethical debates in oncology are relevant to situations clinicians, patients, and their families face every day. For example, the question "Should transplantation therapy occur outside of the clinical trial setting?" was the subject of a mock congressional hearing sponsored by the Center for Bioethics of the University of Pennsylvania. Peripheral stem cell transplantation and bone marrow transplantation are being used more often as therapy for cancer, frequently outside the clinical trial setting. Some clinicians prefer that transplantation be associated with ongoing clinical studies to allow the evaluation of their effectiveness versus that of standard chemotherapy regimens. The question of whether women with breast cancer should be candidates for bone marrow transplants has also presented an ethical dilemma: opponents believe that they are too risky, too costly, and of unproven benefit and should not be used in any setting; supporters think that if they work even some of the time, they should be available to patients who desire them. Clinicians often find themselves facing these questions, frequently without the data to answer them fully.

The past debate on the ethics of the Breast Cancer Prevention Trial sponsored by the National Surgical Adjuvant Breast and Bowel Project is another one that clinicians have had to discuss repeatedly with patients and their families. The question raised is "Should tamoxifen be used to prevent breast cancer?" Some believe that the trial is inappropriate because current methods are unable to predict accurately whether a woman is at high risk of developing breast cancer and that the trial of a drug with the defined toxicity of tamoxifen (possible increased risks of endometrial cancer and thromboembolic disease, hot flashes, vaginal discharge, irregular menses, and unintended pregnancy) for primary prevention of a rare event should not be continued. Those supporting the use of tamoxifen cite the limited options for women at high risk of breast cancer: increased surveillance and prophylactic mastectomy, with no studies completed to assess their efficacy. They also state that the drug is not experimental and has been used as an effective adjuvant therapy for the treatment of breast cancer for more than 10 years. They further state that the trial could affect the treatment of the estimated 200,000 American women who carry the BRCA1 gene and who could benefit from proven preventive approaches to breast cancer. Supporters feel that an appropriate review system for the trial is in place, allowing for external review to weigh the relative risks and ethical considerations. This is a prime example of the critical role of ethics in the evaluation and conduct of medical research, in trial design, and in rigorously obtaining informed consent from study subjects.

The ethics of phase I clinical trials has also been of interest in the literature. The ethical issues include the following: phase I trials as an example of the sacrifice of the individual for the good of society, and the vulnerability of patients with far-advanced cancer and their need for special protection.6 Special ethical considerations also come into play in the conduct of clinical trials in pediatric oncology.7 The concurrent controlled clinical trial is still believed to be the best way to address clinical questions among children.

 

Economic Issues

Bioethics has been useful in addressing many economic issues associated with the practice of medicine. In the 1960s, patient selection for the use of scarce life-saving dialysis machines resulted in the creation of committees to assist in the selection process. In the 1980s, the inadequate supply of transplant organs and criticism about their availability based on the patient's ability to pay prompted the establishment of national systems for organ distribution based on such criteria as the patient's place on a waiting list, the recipient-donor organ match, and the severity of the patient's illness.

The 1990s have been associated with increasing pressures to decrease health care costs, with managed care organizations playing a large role. Many bioethicists and practitioners are concerned about potential conflicts between the needs to reduce costs and to act in the patient's best interests. Gag orders preventing physicians from revealing limitations on treatment options imposed by managed care organizations have provoked serious discussion. The potential impact of capitated reimbursement that increases the physician's financial gain for providing less care has been seen in areas of the country with high managed care penetration. For example, the dramatic reduction in frequency of cardiac catheterization following capitated reimbursement for cardiologists was larger than that explainable by overutilization, prompting questions about whether patients were being denied needed treatment. As managed care focuses increasingly on the acutely and chronically ill, the elderly, and the disabled, continued pressure to contain costs will create additional ethical dilemmas related to the rationing of health care. The dramatic increase in health care costs has made it impossible to provide every appropriate health care service to all who might benefit.

 

Resources for Clinicians, Patients, and Families Seeking Assistance With Ethical Decisions

Ethics Committees

Physicians, nurses, pharmacists, patients, and families face many ethical dilemmas as a result of the advances in health care. We have witnessed the development of living will legislation, the hospice movement, and a greater understanding of cancer and pain management. The creation of ethics committees has also assisted ethical decision making by physicians, patients, and families. More than half of the hospitals in this country have established ethics committees to increase understanding and to address a variety of ethical dilemmas faced by health care personnel in today's increasingly complex environment. Nursing homes are establishing ethics committees for the same reasons.

Although each institution has its own way of structuring its ethics committee, in general ethics committees have three basic functions. The first is educating the institution's staff, the patients, and the community about the ethical dimensions of health care. The second is reviewing policies to make sure that they meet ethical standards. The third is reviewing specific cases and care provided by the staff at an institution and working as a consultant in difficult cases. The individuals who serve on ethics committees represent a multitude of backgrounds and usually consist of physicians, nurses, pastoral care staff, lawyers, social workers, ethicists, and in some cases a representative family member and an administrator. This composition is a good mix for evaluating cases from important and varied perspectives.

Ethics committees provide a forum for the exchange of information and ideas. Committee members follow the literature on ethics from their own disciplines and meet regularly to discuss the current issues. The resulting information is then disseminated by various means to the community of physicians and caregivers. Information may be disseminated through simple discussions or through specific presentations made to the entire medical or institutional staff on an ethical issue routinely confronting them.

Ethics committee members are also available as formal or informal consultants to physicians dealing with very difficult cases. When an ethics consultation is requested, members of the committee may meet with the physician, nurse, patient, family, and other involved individuals to try to solve the ethical dilemma. In some institutions, an ethics consultation can be requested by the patient or anyone involved with the patient. A key ethics committee member may then meet to review the case and call for a formal committee case review if necessary. The committee's role is really educational and facilitative, rather than decision-making. The attending physician is ultimately responsible for the medical treatment provided, always acting as an advocate of the patient's best interests. The consultation helps the physician, patient, and family clarify a course of treatment by helping people to see an issue from different viewpoints. Ethics committees have also helped health care institutions keep abreast of national health care issues, such as the Patients Self-Determination Act of 1991, which swept the nation and captured the attention of all caregivers and of legal and administrative institutional staff.

 

Information Resources

Other resources for practitioners include a variety of sites on the Internet's World Wide Web. Sites like the one established by the Center for Bioethics at the University of Pennsylvania (www.med.upenn.edu/~bioethic/) can be extremely valuable for obtaining information on current issues and for accessing sites at other bioethics centers throughout the United States as well as information on upcoming seminars and events. For a listing of some bioethics-related websites, see Table 1. Numerous associations (Table 2), journals (Table 3), and networks relevant to bioethics in the United States and Canada have evolved over the years. The American Association of Bioethics was established to promote the exchange of ideas among bioethics scholars, clinicians, and policy makers; to enhance the clinical activities of bioethicists; to encourage discussion and research in the field of bioethics; and to encourage teaching and the education of new scholars in bioethics. An excellent website that has received great reviews from the public is the University of Pennsylvania's Oncolink (www.oncolink.upenn.edu/), where patients or caregivers can access relevant information on various topics related to cancer diagnosis, treatment, and research, including the ability to search information related to bioethics and cancer.

 


Table 1.--Selected Bioethics-Related Websites*

Biomedical Ethics: Readings on the Internet www.uwc.edu/fonddulac/faculty/rrigteri/biomed.HTM
Bioethics Discussion Pages www-hsc.usc.edu/~mbernste/#CurrentComments
Bioethics Online Service (at the Medical College of Wisconsin) www.mcw.edu/bioethics/
Centre for Applied Ethics (at the University of British Columbia, Canada) www.ethics.ubc.ca/
Ethics Updates (edited by Lawrence Hinman) ethics.acusd.edu/index.html
The Center for Bioethics (at the University of Pennsylvania School of Medicine) www.med.upenn.edu/~bioethic/
The Joseph and Rose Kennedy Institute of Ethics (at Georgetown University) guweb.georgetown.edu/kennedy/
MacLean Center for Clinical Medical Ethics (at the University of Chicago) ccme-mac4.bsd.uchicago.edu/CCME.html
MedWeb: Bioethics (at Emory University Health Sciences Center Library) www.gen.emory.edu/medweb/medweb.bioethics.html
UB Center for Clinial Ethics and Humanities in Health Care (at the University of New York at Buffalo) wings.buffalo.edu/faculty/research/bioethics
University of Toronto Joint Centre for Bioethics www.utoronto.ca/jb/
*Note that most of these sites contain numerous links to other bioethics-related websites.

 


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Table 2.--Major Associations in Bioethics

American Association of Bioethics
Kim Segal, Executive Director
University of Utah
FHPF Center for Health Care Studies
2127 Annex Bldg
Salt Lake City, UT 84112
American Society of Law, Medicine, and Ethics
765 Commonwealth Ave, 16th Floor
Boston, MA 02215
Bioethics Consultation Group
2322 Sixth St, Suite 193
Berkeley, CA 94710
European Society for the Philosophy of
Medicine and Health Care
Department of Ethics, Philosophy, and
History of Medicine
Catholic University of Nijmegen
PO Box 9101
6500 HB
Nijmegen
The Netherlands
International Association of Bioethics
Centre for Human Bioethics
Monash University
Clayton, Victoria 3168
Australia
Society for Bioethics Consultation
Department of Bioethics, P-31
Cleveland Clinic Foundation
9500 Euclid Avenue
Cleveland, OH 44195

Society for Health and Human Values
6728 Old Mclean Village Dr
Maclean, VA 22101


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Table 3--Bioethics Reference Journals

 

American Journal of Law & Medicine

Bioethics

Cambridge Quarterly of Healthcare Ethics

Clinical Ethics Report

Hastings Center Report

Healthcare Ethics Committee Forum

IRB

Journal of Clinical Ethics

Journal of Legal Medicine

Journal of Medical Ethics

Journal of Medicine and Philosophy

Kennedy Institute of Ethics Journal

Last Rights

Medical Ethics Advisor

Medical Humanities Report

Nursing Ethics

Second Opinion

Trends in Health Care, Law and Ethics


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Opportunities for Pharmacists in Bioethics

Like all health care providers, pharmacists should strive to assist their patients and families in understanding bioethical issues related to their care and decision making. They should be familiar with the appropriate process of obtaining informed consent, continuing problems with inadequate pain control, and assistance obtainable from ethics committees to help patients, families, and clinicians in making ethical decisions about care and treatment. They should be aware of developments in the field related to advance directives, public awareness, questions about euthanasia and assisted suicide, and potential conflicts that arise from managed care and limited health care resources.

Pharmacists have several opportunities to promote bioethics (Table 4). The first is to investigate the current membership of the ethics committees in their institutions. They should speak to the chairperson and committee members who represent oncology to learn more about the issues and the process used to resolve them. Second, pharmacists should inform committee members of their willingness to assist in making decisions related to pharmaceutical care. Third, and perhaps most important, pharmacists should do all that they can to mount an aggressive plan to improve symptom control for oncology patients, specifically pain management and control. This can be done through work with the pain management team, implementation of the pain management guidelines developed by the Agency for Health Care Policy and Research through the Pharmacy and Therapeutics Committee, and increased efforts in the ambulatory care setting. Ongoing, focused educational efforts should be pursued at all levels to improve pharmacists', nurses', and physicians' effectiveness in managing pain. Lastly, pharmacists should be involved in improving the informed consent process, especially its effectiveness in conveying often complex information to patients.


Table 4--Opportunities for Pharmacists in Bioethics


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Ethics in pharmacy practice has been a topic in the literature for some time (Table 5), and pharmacists have promoted their own code of ethics for many years. Pharmacists have experienced some difficult ethical dilemmas. Executions by lethal injection, the dispensing of products that lead to abortion, and a host of ethical issues related to formulary management and decisions, patient confidentiality, pharmaceutical industry guidelines for ethical conduct, pharmacist-patient relations, and research issues have been well documented in the literature. The newest wave of issues is related to assisted suicide and advances in genetics that will continue to challenge pharmacists as well as all health care providers for years to come.

 


Table 5--Selected Readings in Bioethics of Possible Interest to Pharmacists

 

Pharmacy Code of Ethics

Code of ethics for pharmacists. Am J Health Syst Pharm. 1995;52:2131.

Erlen JA, Erlen J, Dickstein E. Professional oaths--pharmacy can lead the way. J Clin Pharm Ther. 1991;16:301-303.

Hutchinson RA, Schumock GT. Need to develop a legal and ethical base for pharmaceutical care. Ann Pharmacother. 1994;28:954-956.

Manolakis ML. Why APhA should reject its code of ethics. Am Pharm. 1991;NS31:46-48.

Pellegrino ED. Ethics. JAMA. 1996;275:1807-1809.

Redman BK. The ethics of leadership in pharmacy. Am J Health Syst Pharm. 1995;52:2099-2104.

Snyder K. Ethical hot spots: what should you do? Drug Top. January 20, 1997:41-62.

Vottero LD. The code of ethics for pharmacists. Am J Health Syst Pharm. 1995;52:2096. Editorial.

Weinstein BD. Ethical decision making in pharmacy. Am Pharm. 1993;NS33:48-50.

Pharmacy Practice

DuChane J, Hsu I, Veatch R. Ethical opinion in a formulary recommendation. Am J Health Syst Pharm. 1995;52:1564-1568.

Ethical decision making in pharmacy practice. Am Pharm. 1993;NS33:70-80.

Kaatz B. Ethics and formulary choices. S D J Med. 1994;47:433.

Kelly WN, Krause EC, Krowinski WJ, et al. National survey of ethical issues presented to drug information centers. Am J Hosp Pharm. 1990;47:2245-2250.

Talbert RL. Ethics in clinical pharmacy practice and research: an introduction. Pharmacotherapy. 1993;13:521.

Research and Authorship

American College of Clinical Pharmacy. Ethical issues related to clinical pharmacy research. Pharmacotherapy. 1993;13:523-530.

Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA. 1996;276:67-72.

Peterson AM, Lowenthal W. Authorship on a manuscript intended for publication. Am J Hosp Pharm. 1993;50:2082-2085.

Poikonen J, Rosenberg JS, Veatch RM. Pursuing publication of an unethical investigation. Am J Hosp Pharm. 1994;51:2412-2416.

Pharmacists and the Pharmaceutical Industry

American College of Clinical Pharmacy. Pharmacists and the pharmaceutical industry: guidelines for ethical interactions. Pharmacotherapy. 1993;13:531-533.

Griffenhagen G: Advertising and the law: ten years later. Am Pharm. 1991;NS31:43-44.

Hazlet TK, Sullivan SD. Professional organizations and healthcare industry support: ethical conflict? Camb Q Healthc Ethics. 1994;3:236-44; discussion 244-256.

Lexchin J. Canadian marketing codes: how well are they controlling pharmaceutical promotion. Int J Health Serv. 1994;24:91-104.

Poirier TI, Giannetti V, Giudici RA. Pharmacists' and physicians' attitudes toward pharmaceutical marketing practices. Am J Hosp Pharm. 1994;51:378-381.

Robb N. Sale of prescribing data by pharmacists causes growing concern among physicians. Can Med Assoc J. 1996;154:1747-1749.

Zoloth AM. The need for ethical guidelines for relationships between pharmacists and the pharmaceutical industry. Am J Hosp Pharm. 1991;48:551-552.

Pharmacist-Patient Relations

Knowlton CH. Honoring our responsibilities to our patients. J Am Pharm Assoc. 1996;NS36(10):578.

Manolakis ML, Uretsky SD. Sedation of an unruly patient. Am J Hosp Pharm. 1994;51:205-209.

Redman BK. Drug misadventuring as an issue in the ethics of leadership. Am J Health Syst Pharm. 1995;52:404-405.

Rothman DJ. The rising cost of pharmaceuticals: an ethicist's perspective. Am J Hosp Pharm. 1993;50(suppl 4):S10-12.

Soares MS, Warnock AC, Barham B. Pharmacist's obligation to hold confidential patient's intent to commit suicide. Am J Hosp Pharm. 1992;49:864-869.

Zagaria MA. Quality of life: issues for the pharmacist. Am Pharm. 1995;NS35:52-57.

Assisted Suicide

Brushwood DB, Allen WL. Constitutional right to pharmaceutically assisted death. Am J Health Syst Pharm. 1996;53:1797-1799.

Mullan K, Allen WL, Brushwood DB. Conscientious objection to assisted death: can pharmacy address this in a systematic fashion? Ann Pharmacother. 1996;30:1185-1191.

Rupp MT. Physician-assisted suicide and the issues it raises for pharmacists. Am J Health Syst Pharm. 1995;52:1455-1460. Commentary.

Rupp MT, Isenhower HL. Pharmacists' attitudes toward physician-assisted suicide. Am J Hosp Pharm. 1994;51:69-74.

Advances in Genetics

Holtzman NA. Testing for genetic susceptibility for common cancers: clinical and ethical issues. Adv Oncol. 1997;13:9-15.

Smith JE. Ethical issues raised by the human genome project. Am J Hosp Pharm. 1993;50:1945-1950.

 

*From MEDLINE® searches.


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Conclusions

Medical ethics has been important to humanity since the writing of the Hippocratic oath, which physicians and other professionals have followed for many years. Professional codes of ethics continue to be critical guides for those who care for patients. Bioethics has rapidly evolved as a distinct field, valuable in facilitating ethical decision making that has become increasingly difficult in an era of advanced medical technology and a more educated public. Physicians, caregivers, patients, and families are constantly faced with difficult choices. This is particularly so in cases of cancer. Much of the serious debate on euthanasia, physician-assisted suicide, and the right to die has been investigated by those who have had to watch patients live with insufferable pain or be kept alive by medical technology when they desired to end life with dignity. Bioethics is also relevant to research ethics and the importance of proper informed consent. We must ensure that patients are provided clear information about the benefits and risks of treatment, so that they can make an informed decision. We will see new and difficult challenges as we enter the age of genetic research, specifically regarding the use of such research to predict one's predisposition to development of cancer or other diseases. These advancements will provide pharmacists with a number of opportunities to increase their involvement in bioethical decision making.


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