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PAQ—PA QUANDARIES

Ethics in everyday practice

F. J. Gianola, PA
department editor

A practical, case-based approach to health care ethics—and the case of Mr. T.

What is bioethics, and why is JAAPA launching a department on the subject? Bioethics is simply truth telling and advocating for your patients, even when you don't agree with their choices. Ethical decisions rarely involve options that are clearly right or wrong—instead, they are the complicated choices that appear to pit one right against another. When we are presented with value conflicts between the provider as an individual and as a medical professional, or between the patient's values and wishes and those of the clinician, bioethical dilemmas are born.

Four years into the 21st century, medical providers are dealing with issues never before contemplated, such as those associated with human fetal tissue transplantation, cloning, and genomic medicine. We face the patient who requests a prescription after seeing an advertisement for a drug on television, or the one who wants a whole body CT scan after reading about this technology on the Internet. And what about the patient with a recent history of substance abuse who may be in pain after an injury but whose pain medications could exacerbate his addiction? These cases, too, have a notable ethical impact on the way we practice medicine.

In every clinical encounter with a patient that gives rise to an ethical issue, the problem will be unique to the patient. How can PAs learn to recognize ethical dilemmas for what they are, and how can we address them in the short time we have to interact with our patients? In her last editorial in July 2003, JAAPA's founding editor, Leslie Kole, stated: "PAs want practical clinical information they can put to immediate use." In keeping with that mission, I, as the department editor, along with the editors of JAAPA, hope that this new column will initiate a dialogue and provide tools for PAs who are looking for a consistent, practical approach to clinical ethics.

Our practical approach to clinical ethics

In 1970, Beauchamp and Childress provided a framework that clinicians can use to recognize and apply ethical principles. They defined the basic principles as

• Autonomy: respecting the decision-making capacities of autonomous individuals

• Nonmaleficence: avoiding the creation of intentional, needless harm or injury to the patient, either through acts of commission or omission

• Beneficence: being of benefit to the patient, taking positive steps to prevent harm to and remove harm from the patient

• Justice: allocating benefits, risks, and costs fairly.¹

Our challenge is how to move from these broad principles to applied clinical ethics—a realistic, planned approach to recognizing, evaluating, and making judgments on the ethical issues we see in clinical medicine.

Jonsen and colleagues created a clinical approach to ethical issues that is practical and accessible to all clinicians.² Their paradigm consists of four topics that are fundamental in every clinical encounter where an ethical issue may be identified.

• Medical indications: What is the clinical presentation, including diagnosis, treatment, and prognosis?

• Patient preferences: What are the patient's goals? What would the patient like done in this situation? With all clinical encounters, the patient's values are integral to ethical decision making.

• Quality of life: What signs and symptoms will affect the patient's quality of life? The objective of all clinical encounters is to improve, or at least address, quality of life for the patient.

• Contextual features: What is the context for this clinical encounter? We must consider such things as the patient's family, insurance coverage, hospital policy, and legal constraints.

We can approach ethical issues by using this paradigm similarly to the way we undertake a history and physical examination to collect data. In so doing, we will find that the paradigm becomes a valuable clinical tool. First, we identify the ethical question. What is the dilemma or disagreement? Then we can ask ourselves whether our case is similar to other cases we have encountered, and how. Can we identify a comparable case where there has been community and professional agreement? This may help us, but our decision will of course depend on the facts of our specific case.

The decision-making process when addressing ethical dilemmas requires consistent and thoughtful behavior. Ethical issues in clinical medicine are not simple. But if we first collect all the information we need to make a decision and then approach the decision in a standard manner, the process can become both less complicated and more dependable.

In "PAQ—PA Quandaries," JAAPA's new department, we will use the four-topic paradigm to analyze the decision-making process we apply to cases. As we develop this department, we invite you to share cases that can contribute to our better understanding of how to approach clinical ethics.

THE CASE OF MR. T.

Mr. T. is a 50-year-old Vietnam veteran who receives his health care outside of Veterans Administration (VA) facilities. Seven years ago, he received a diagnosis of hepatitis C virus (HCV) infection, which was assumed to be secondary to past IV drug use. He has also been treated for bipolar disorder and posttraumatic stress disorder (PTSD). He has had three major depressive episodes in the past 25 years, with suicidal ideation (but no suicide gestures or attempts) in two of the three episodes. His last major episode was 3 years ago and was without suicidal ideation.

Mr. T.'s liver enzymes are elevated up to two times the upper limits of normal. His renal function and glucose levels are normal. The HCV viral load is 480,000 eq/mL of genotype 3 HCV. A liver biopsy shows mild chronic hepatitis without bridging fibrosis or cirrhosis. HIV test results are negative.

His medical history includes the abuse of multiple drugs and alcohol and 20 pack-years of smoking. He stopped smoking 20 years ago and has not used hard drugs for the past 12 years or alcohol for 5 years.

After discussion of treatment options and side effects, Mr. T. agrees to see a gastroenterologist to discuss combination ribavirin and pegylated interferon treatment for hepatitis C. However, the gastroenterologist refuses to treat Mr. T., citing his past history of depression, suicidal ideation, and alcohol abuse.

The ethical question

The primary care provider asks, "How can I carry out my ethical duty to provide the best care for the patient [beneficence] by initiating interferon therapy when the gastroenterologist favors no treatment because it may cause severe depression and because he is concerned about the patient's ability to adhere to therapy [nonmaleficence]?"

Discussion

Clinicians should approach ethical dilemmas consistently, just as we routinely obtain histories and perform physical examinations. The Jonsen paradigm provides an effective guide.²In this case we will focus on the medical-indications portion of the paradigm. Future cases will explore the other portions in greater detail than we do here.

Medical indications (beneficence and nonmaleficence) The first section of the paradigm includes the diagnosis, prognosis, and treatment of the patient's medical problem as well as the goals of treatment. In Mr. T.'s case, the treatment is combination therapy with ribavirin and pegylated interferon and the goal is to eliminate measurable levels of HCV, decreasing the need for liver transplant. The treatment also decreases the risk of hepatocellular carcinoma. The side effects include influenza-like symptoms, hematologic abnormalities, and neuropsychiatric symptoms. Depression is common in patients with hepatitis C, and severe depression is a common side effect of interferon therapy.

Mr. T.'s viral genotype, low viral load, favorable liver biopsy, and HIV-negative status are factors that make him a good candidate for combination therapy. However, he has a history of significant previous drug and alcohol abuse, bipolar disorder, and PTSD. This may worsen his prognosis, increase his risk for severe side effects, and influence his ability to adhere to treatment.

The consulting gastroenterologist cites the National Institutes of Health (NIH) 1997 consensus statement on the management of hepatitis C,³ which says that the "treatment of patients who are drinking significant amounts of alcohol or . . . actively using illicit drugs should be delayed until these habits are discontinued for at least 6 months." The consensus statement also says that "such patients are at risk for the potential toxic effects" of treatment and also may not be compliant. Depression is one contraindication to treatment with interferon that must be considered.

In response, the primary care team presents updated recommendations from the 2002 NIH consensus statement on the management of hepatitis C,⁴ which states that "many patients" with chronic HCV infection "have been ineligible for trials because of injection drug use, significant alcohol use, age, and . . . comorbid medical and neuropsychiatric conditions. Efforts should be made to increase the availability of the best current treatments to these patients."

According to the 2002 consensus statement, therapy for hepatitis C "has been successful even when . . . patients have not abstained" from drugs and alcohol or are taking methadone. "However, few data are available on . . . treatment" for hepatitis C in "active [injection drug users] who are not in drug treatment programs. Thus, it is recommended that treatment of such patients be considered on a case-by-case basis, and that . . . drug use in and of itself not be used to exclude [them] from receiving antiviral therapy."

The gastroenterologist and primary care provider discuss both sets of NIH recommendations. The gastroenterologist maintains that he cannot in good conscience recommend treatment for Mr. T.

Patient preference (autonomy) The second section of the paradigm includes information that supports the patient's right to choose within ethics and law. What is the patient's preference for treatment? Has he been informed of benefits and risks? Does he comprehend the information, and has he given consent? Mr. T. has repeatedly expressed his wish for combination therapy for his hepatitis C. He is aware of the risk of interferon-induced severe depression and is willing to take an antidepressant if needed for this side effect.

Quality of life (beneficence, nonmaleficence, and autonomy) The third section of the paradigm includes information that describes the restoration, maintenance, or improvement of the quality of life for Mr. T. Are there any deficits (physical, mental, or social) that the patient may experience if treatment succeeds? Are there any preconceived notions that may prejudice the provider's assessment of the patient's quality of life? With successful treatment, Mr. T. could return to a normal life with continued evaluation and close monitoring. Without treatment, his liver disease will likely continue to progress.

Contextual features (justice) The fourth section of the paradigm includes information about social, legal, economic, or institutional circumstances specific to this case. Are there family issues that might influence decisions on treatment? Religious or cultural factors? Problems with allocation of resources? Are there provider issues that could influence treatment decisions? Is there any conflict of interest on the part of the providers or institution? A significant contextual issue in assessing Mr. T.'s ability to participate in the HCV treatment is his history of bipolar disease, PTSD, and alcohol and drug abuse.

Recommendations

The primary care provider's opinion is that treatment is necessary for this patient (beneficence). The gastroenterologist has significant apprehension and does not want to cause harm (nonmaleficence). How does the clinician use the consultant's data to make decisions when there is a conflict regarding recommended treatment?

Generally, the primary care provider is responsible for directing and coordinating care of the patient. The ethical principle of beneficence obligates the clinician to act in the patient's best interest, weighing the risks and benefits of therapies within the patient's circumstances. In the clinician's judgment, the treatment benefits in this case outweigh the risks. The clinician trusts the patient not to abuse drugs and alcohol since Mr. T. has been abstinent for years. Their relationship has developed to the point where the clinician believes that Mr. T. is willing to take an antidepressant if needed to control any depression that may ensue with treatment.

The primary care provider's responsibility is to provide to the patient accessible, comprehensive, coordinated, continuous, accountable care. Part of this is managing consultative care. In this case, the gastroenterologist has failed to use the most recent guidelines for care, a decision that is inconsistent with ethical practices. At this point, the primary care provider should refer Mr. T. to a VA facility for consultation and care or send him to another consultant.

Many ethical dilemmas do not have a clean and satisfying end, but following the paradigm offers a method of reaching a conclusion. The paradigm covers a majority of the issues that PAs should consider when confronted with an ethical dilemma; used routinely, the process will become familiar. By definition, ethical dilemmas pit different values against each other, and the challenge for providers is to arrive at recommendations that are true to the most important values at stake while remaining sensitive to all the others.

Resources on clinical ethics

• Ethics in Medicine
http://eduserv.hscer.washington.edu/bioethics An electronic resource developed as part of the Bioethics Education Project, a collaborative effort within the University of Washington School of Medicine
• The American Journal of Bioethics
www.bioethics.net
• Sugarman J. Ethics in Primary Care. New York, NY: McGraw-Hill; 2000.

Acknowledgement

I would like to thank my students for sharing with me many of their clinical ethical dilemmas. Thank you also to Sean Rossiter, who presented this case to me.

REFERENCES

1. Beauchamp T, Childress J. Principles of Biomedical Ethics. 5th ed. New York, NY: Oxford University Pr; 2001.

2. Jonsen AR, Siegler M, Winslade WJ. Clinical Ethics. 5th ed. New York, NY: McGraw-Hill/Appleton & Lange; 2002.

3. Consensus Statements. NIH Consensus Development Program. Management of Hepatitis C. March 24-26, 1997;15(3). Available at: http://consensus.nih.gov/cons/105/105_intro.htm . Accessed May 14, 2004.

4. Consensus Statements. NIH Consensus Development Program. Management of Hepatitis C: 2002. June 10-12, 2002;19(1). Available at: http://consensus.nih.gov/cons/116/116cdc_intro.htm . Accessed May 14, 2004.

Mr. Gianola is on the faculty of the medex Northwest Physician Assistant Program, School of Medicine and Center for Health Sciences Interprofessional Education and Research, University of Washington, Seattle. He is on the board of trustees of the Physician Assistant Foundation. The author has indicated no relationships to disclose relating to the content of this article.