This interactive Michigan Physician Ebook contains 16 hours of continuing education. To complete click the Complete Your CE button at the top right of the screen.
Michigan Continuing Medical Education
MICHIGAN MEDICAL LICENSURE PROGRAM
MANDATORY CME REQUIRED FOR MICHIGAN LICENSE RENEWAL ENCLOSED PROGRAM INCLUDES: • 3 CREDIT HOURS Implicit Bias (NEW Online Webinar) • 5 CREDIT HOURS Medical Ethics • 3 CREDIT HOURS Pain and Symptom Management/ Controlled Substances • 8 CREDIT HOURS DEA MATE Act Requirement
INCLUDES: DEA’s New One-time MATE Requirement
InforMed is Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
CME FOR:
AMA PRA CATEGORY 1 CREDITS ™ MIPS MOC STATE LICENSURE
CME DEADLINE: PRIOR TO YOUR UPCOMING LICENSE RENEWAL
AVAILABLE ONLINE AT: MI.CME.EDU
MICHIGAN PHYSICIAN
Dear Colleagues,
Michigan physicians and PAs must complete three (3) credit hours of implicit bias training each triennial renewal period. In addition, one (1) credit hour of medical ethics and three (3) credit hours of pain and symptom management must be completed each renewal period. NEW: Beginning with applications and renewals on and after May 28, 2024, licensed prescribers or dispensers of controlled substances must complete training in opioids and controlled substance awareness, every renewal period. Topics may be obtained from more than one program. (Per MI Board of Pharmacy R 338.3135 eff 5/28/2024).
Effective June 27, 2023, renewing DEA-registered practitioners must complete eight (8) credit hours of one-time training on the treatment and management of patients with opioid or substance use disorders.
Scan the QR code to complete your Implicit Bias Requirement!
The InforMed Michigan Medical Licensure Program is designed to streamline the education requirements of the Michigan Board of Medicine. Licensees who complete this program optimize their learning path while satisfying professional credentialing requirements for the new implicit bias training, five (5) credit hours on medical ethics, three (3) credit hours on pain and symptom management, and eight (8) credit hours on the DEA’s one-time MATE Act requirement. To complete the program online, visit BOOK.CME.EDU , enter the book code MDMI1625 in the box then click GO .
Thank you for choosing lnforMed as your CME provider. We strive to create a high-quality, streamlined program for our colleagues. Please contact us with any questions, concerns, or suggestions.
Best Regards,
The lnforMed CME Team
LARA - Bureau of Professional Licensing | P: (517) 241-0199 | F: (517) 241-0032 Department of Licensing and Regulatory Affairs | Bureau of Professional Licensing P.O. Box 30670 | Lansing, MI 48909
We are a nationally accredited CME provider. For all board-related inquiries please contact:
1-800-237-6999
BOOK CODE: MDMI1625
BOOK.CME.EDU
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What’s Inside
01
MEDICAL ETHICS FOR PHYSICIANS COURSE ONE | 5 CREDITS SATISFIES THE MANDATORY CME REQUIREMENT ON MEDICAL ETHICS
Medical ethics, also known as bioethics, is an amalgam of medicine, law, and religion. It is also influenced by cultural beliefs. In this course, we will define the most common ethical principles and note their relationship to the basic theories of ethics. Some of the prominent court cases that have dictated the basis of physician-patient relationships, especially in end-of-life care, are presented. Also, the Patient Self-Determination Act is outlined with explanations of advance directives—better known as physician directives and durable power of attorney for health care. Finally, a possible method of setting up a workable ethical decision-making framework is presented in some detail. Hopefully, this will be useful in the event of a conflict or when a decision involving ethical issues confronts us or our fellow physicians. This course should allow us to comprehend the basic precepts of medical ethics and afford us the general knowledge of how to apply them in our everyday practice of medicine.
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RESPONSIBLE AND EFFECTIVE OPIOID PRESCRIBING COURSE TWO | 3 CREDITS
SATISFIES THE MANDATORY CME REQUIREMENT ON PAIN AND SYMPTOM MANAGEMENT
Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat pain patients with opioids. By implementing these tools, clinicians can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge. SUBSTANCE USE DISORDERS AND PAIN MANAGEMENT: MATE ACT TRAINING COURSE THREE | 8 CREDITS SATISFIES THE DEA’S ONE-TIME MATE ACT REQUIREMENT Substance use disorders continue to be an important health issue in the United States and can lead to significant problems in all aspects of a person’s life. For DEA-registered practitioners, fulfill your DEA opioid training requirement and strengthen your expertise on appropriate assessment and management of substance use with this course. In addition, the presence of substance use disorders can complicate the treatment or management of comorbid medical conditions. Given the ongoing prescription and illicit opioid use and overdose epidemic in the United States and the widespread incidence of chronic pain, opioid prescribing and optimum safe pain management is a public health concern. All clinicians should have good knowledge of the available options for substance use disorder treatment and for safe opioid prescribing and dispensing.
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FINAL EXAMINATION ANSWER SHEET REQUIRED TO RECEIVE CREDIT
Go online to complete this package PLUS your 3-credit hour Implicit Bias requirement InforMed offers a convenient package of courses to fulfill your Michigan CME requirements, including all your mandatory subjects. Scan the QR code to review and purchase the online package that meet your mandatory CME requirements.
Mandatory CME requirements package (including implicit bias requirement)
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MOC/MIPS CREDIT INFORMATION
Table 1. MOC Recognition Statements Successful completion of certain enclosed CME activities, which includes participation in the evaluation component, enables the participant to earn up to the amounts and credit types shown in Table 2 below. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit. Board Programs Participants can earn MOC points equivalent to the amount of CME credits claimed for designated activities. InforMed currently reports to the following specialty boards: ABA, ABIM, ABS, ABPath and ABP. To be awarded MOC points, you must obtain a passing score, complete the corresponding activity evaluation, and provide required information necessary for reporting.
American Board of Anesthesiology’s redesigned Maintenance of Certification in Anesthesiology TM (MOCA®) program, known as MOCA 2.0®
ABA
ABIM
American Board of Internal Medicine’s Maintenance of Certification (MOC) program
ABS
American Board of Surgery’s Continuous Certification program
ABPath
American Board of Pathology’s Continuing Certification program
ABP
American Board of Pediatrics’ Maintenance of Certification (MOC) program
Table 2. Credits and Type Awarded
AMA PRA Category 1 Credits T M
ABA ABIM ABS
ABPath
ABP
Activity Title
5 Credits LL
5 Credits MK
5 Credits SA + AC
5 Credits LL
5 Credits LL+SA
5 AMA PRA Category 1 Credits TM
Medical Ethics for Physicians
Responsible and Effective Opioid Prescribing
3 Credits LL
3 Credits MK
3 Credits SA + AC
3 Credits LL
3 Credits LL
3 AMA PRA Category 1 Credits TM
Substance Use Disorders and Pain Management: MATE Act Training
8 Credits LL
8 Credits MK
8 Credits SA + AC
8 Credits LL
8 Credits LL+SA
8 AMA PRA Category 1 Credits TM
Legend: LL = Lifelong Learning, MK = Medical Knowledge, SA = Self-Assessment, LL+SA = Lifelong Learning & Self-Assessment, AC = Accredited CME
DATA REPORTING: Federal, State, and Regulatory Agencies require disclosure of data reporting to all course participants. InforMed abides by each entity’s requirements for data reporting to attest compliance on your behalf. Reported data is governed by each entity’s confidentiality policy. To report compliance on your behalf, it’s mandatory that you must achieve a passing score and accurately fill out the learner information, activity and program evaluation, and the 90-day follow up survey. Failure to accurately provide this information may result in your data being non-reportable and subject to actions by these entities.
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How to complete
Please read these instructions before proceeding. Read and study the enclosed courses and answer the final examination questions. To receive credit for your courses, you must provide your customer information and complete the mandatory evaluation. We offer two ways for you to complete. Choose an option below to receive credit and your certificate of completion.
ONLINE
FASTEST AND EASIEST!
• Go to BOOK.CME.EDU and enter code MDMI1625 in the book code box, then click GO. • Proceed to your exam. If you already have an account, sign in with your username and password. If you do not have an account, you’ll be able to create one now. • Follow the online instructions to complete your final examination. Complete the purchase process to receive course credit and your certificate of completion. Please remember to complete the online evaluation.
Enter book code
MDMI1625
GO
IF YOU’RE ONLY COMPLETING CERTAIN COURSES IN THIS BOOK: • Go to BOOK.CME.EDU and enter the code that corresponds to the course below, then click GO. Each course will need to be completed individually, and the specified course price will apply.
Complete the answer sheet and evaluation found in the back of this book. Include your payment information and email address. Mail to: InforMed, PO Box 997432, Sacramento, CA 95899
BY MAIL
Mailed completions will be processed within 2 business days of receipt, and certificates emailed to the address provided. Submissions without a valid email address will be mailed to the postal address provided.
Program Options Price
Option
Code
Credits
ONLINE PACKAGE • Hospice and Palliative Care For Healthcare Professionals • Substance Use Disorders: A DEA Requirement • Understanding, Recognizing and Mitigating Implicit Biases in Healthcare - Physicians ENTIRE PROGRAM • Medical Ethics for Physicians • Responsible and Effective Opioid Prescribing • Substance Use Disorders and Pain Management: MATE Act Training
$112
12 Credits
$95
MDMI1625 16 Credits
$35
Medical Ethics for Physicians
MDMI05ME 5 Credits
$21
Responsible and Effective Opioid Prescribing
MDMI03OP 3 Credits
$69
Substance Use Disorders and Pain Management: MATE Act Training
MDMI08SU 8 Credits
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__________________________________________________________________ Medical Ethics for Physicians MDMI05ME — 5 CREDITS R elease D ate : 02/01/23 E xpiration D ate : 01/31/26
Medical Ethics for Physicians
In addition to receiving AMA PRA Category 1 Credit TM , physicians participating in Maintenance of Certification will receive the following points appropriate to their certifying board: 5 ABIM MOC Points, 5 ABS MOC Points, 5 ABA MOCA Points, 5 ABP MOC Points, 5 ABPath CC Points.
8. Describe elements of setting up a workable ethical decision-making framewor Faculty John M. Leonard, MD , Professor of Medicine Emeritus, Vanderbilt University School of Medicine, completed his post-graduate clinical training at the Yale and Vanderbilt University Medical Centers before joining the Vanderbilt faculty in 1974. He is a clinician-educator and for many years served as director of residency training and student educa- tional programs for the Vanderbilt University Department of Medicine. Over a career span of 40 years, Dr. Leonard conducted an active practice of general internal medicine and an inpatient consulting practice of infectious diseases. Michele Nichols, RN, BSN, MA , received her Associates Degree in Nursing in 1977, her Bachelor of Science Degree in Nursing in 1981 and obtained her Master of Arts Degree in Ethics and Policy Studies in 1990 through the University of Nevada, Las Vegas. She was Chief Nurse Executive at Valley Hospital Medical Center in Las Vegas, Nevada, and retired as the System Director for the Valley Health System University, a five hospital system in Las Vegas, Nevada. She is currently a volunteer nurse for Volunteers in Medicine of
HOW TO RECEIVE CREDIT
• Read the enclosed course. • Complete the final examination questions at the end. A score of 70% is required. • Return your customer information/answer sheet, evaluation, and payment to InforMed by mail or complete online at BOOK.CME.EDU.
Audience This course is designed for physicians and interested health-
care professionals. Course Objective
The purpose of this course is to briefly review the history, theory, and practical application of ethical principles to issues that arise in clinical practice. The goals of the course are to heighten awareness and promote self-reflection, address knowledge gaps, improve communication and decision- making skills, and promote reasonable, humane care for
patients and families. Learning Outcomes
Southern Nevada. Faculty Disclosure
Upon completion of this course, you should be able to: 1. Outline the history of bioethics, including the evolution of the physician-patient relationship. 2. Discuss the Karen Ann Quinlan and Nancy Cruzan cases as they influenced national and state healthcare policies. 3. State the purpose of the Patient Self-Determination Act (PSDA) of 1990 and the role of healthcare profes- sionals. 4. Differentiate between the types of advance directives. 5. Discuss the national ethical standards frameworks and their relationship to ethical decision making for patients. 6. Define terminology regarding bioethics, including the principles guiding medical ethical decision making. 7. Compare and contrast various ethical theories as they relate to health care.
Contributing faculty, John M. Leonard, MD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned. Contributing faculty, Michele Nichols, RN, BSN, MA, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned. Division Planner John V. Jurica, MD, MPH Senior Director of Development and Academic Affairs Sarah Campbell
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Division Planner/Director Disclosure The division planner and director have disclosed no relevant financial relationship with any product manufacturer or
It is the CME activity provider’s responsibility to submit par- ticipant completion information to ACCME for the pur- pose of granting ABP MOC credit. This activity has been designated for 5 Lifelong Learning (Part II) credits for the American Board of Pathology Con- tinuing Certification Program. Successful completion of this CME activity, which includes participation in the evaluation component, earns credit toward the Lifelong Learning requirement(s) for the Ameri- can Board of Ophthalmology’s Continuing Certification program. It is the CME activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting credit. Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitio- ners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “CME in Support of MOC” program in Sec- tion 3 of the Royal College’s MOC Program. About the Sponsor The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare. Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice. Disclosure Statement It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.
service provider mentioned. Accreditations & Approvals
In support of improving patient care, NetCE is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy
Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Designations of Credit NetCE designates this enduring material for a maximum of 5 AMA PRA Category 1 Credit(s) ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Successful completion of this CME activity, which includes participation in the evaluation component, enables the par- ticipant to earn up to 5 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certifica- tion (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Completion of this course constitutes permission to share the completion data with ACCME. Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and Self-Assessment requirements of the American Board of Surgery’s Continu- ous Certification program. It is the CME activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit. This activity has been approved for the American Board of Anesthesiology’s ® (ABA) requirements for Part II: Lifelong Learning and Self-Assessment of the American Board of Anesthesiology’s (ABA) redesigned Maintenance of Cer- tification in Anesthesiology Program ® (MOCA ® ), known as MOCA 2.0 ® . Please consult the ABA website, www. theABA.org, for a list of all MOCA 2.0 requirements. Main- tenance of Certification in Anesthesiology Program ® and MOCA ® are registered certification marks of the American Board of Anesthesiology ® . MOCA 2.0 ® is a trademark of the American Board of Anesthesiology ® . Successful completion of this CME activity, which includes participation in the activity with individual assessments of the participant and feedback to the participant, enables the participant to earn 5 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program.
Sections marked with this symbol include evidence-based practice recommendations. The level of evidence and/or strength of recommendation, as provided by the evidence-based source, are also included
so you may determine the validity or relevance of the information. These sections may be used in conjunction with the course material for better application to your daily practice.
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In order to better understand contemporary medical ethics, it is helpful to look back at how ethical principles, frameworks, and/or codes have evolved over centuries. More specifically, it is important to recall several 20th century events in research and medicine that solidified the need for the study and application of ethics and lead to the emergence of the field of bioethics. The following pages present a brief discussion of some of the information regarding ethical issues in medicine as it pertains to the role of physicians in the 21st century. BRIEF HISTORY OF BIOETHICS Bioethics is a relatively new field that emerged in the 1960s, prompted in part by rapid technologic advances in medicine and the subspecialization of clinical care. The advent of antimicrobial and cancer chemotherapy, valve and joint replacement surgeries, and organ transplantation provided the means to greatly improve outcomes and prolong life but added new complexities to the clinical decision-making process. The convergence of modern means and rising healthcare costs created the need to talk about how medical and healthcare regulations should be made, who should make them, and what their implications might be for the long term. In the late 1960s, philosophers, theologians, physicians, lawyers, policy makers, and legislators began to write about these questions, hold conferences, establish institutes, and publish journals for the study of bioethics. In 1969, the Institute of Society, Ethics, and the Life Sciences was established at Hastings-on-the-Hudson, New York. Two years later, the Kennedy Institute of Ethics was established at Georgetown University, in Washington, DC. Prior to the 1960s, medical care decisions were part of the paternalistic role of physicians in our society. Patients readily acquiesced care decisions to their physicians because they were regarded almost as family. What drove this resolve of patients to acquiesce their medical care and treatment decisions to their physicians? David Rothman, as discussed in his book, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making , believes physicians were given such latitude by their patients because they were well- known and trusted by their patients and the community in which they practiced [1]. There were essentially no specialists. One physician took care of a patient and family for a lifetime. The frontier physician often knew the patient from birth to adulthood, made house calls, and was a family friend who knew best what the patient should do with a healthcare concern. Since the 1960s, physicians have generally become strangers to their patients.
INTRODUCTION In today’s ever-changing societal and healthcare environments, physicians are confronted with choices concerning what is best for their patients, their practice, their institution, or themselves; such choices often impose ethical considerations that challenge the physician to render a decision in accordance with the principles and values of the profession. These choices can become enmeshed in ethical dilemmas that emerge from conflicting values or administrative rules and legalities. Ethics issues range from the extraordinary, such as end-of-life decisions, to the mundane, such as whether to accept certain gifts from a pharmaceutical company, but all require some understanding of the ethical principles that govern best professional practice and test one’s resolve to act in accordance with these values. When ethical dilemmas or conflicts of interest do arise, it is useful to be well informed as to how similar issues have been adjudicated in the past and what tools are at hand to assist in the decision-making process. The precepts and principles contained within various ethical systems can assist in conceptualizing a problem-solving approach allied in resolving an ethical dilemma. Whether decision-making involves an individual facing end-of-life choices or an institution setting administrative policies, these systems and principles can help the healthcare professional clear the blurred lines that may develop in difficult ethical situations. For example, if a known use of illicit drugs demands opioid pain management, how then should appropriate treatment choices be made by those responsible for care? Other examples of potential management dilemmas might be an individual with alcohol use disorder needing a liver transplant, a patient with diabetes who seemingly refuses to adhere to a diet protocol, a sedentary businessman who resists lifestyle changes necessary for cardiovascular risk reduction, or a physician whose stress level is beyond the coping stage. Oftentimes, the patient’s aspirations or goals may not correspond with what the family or physician believes would be best. Even between seemingly alike individuals, with similar education and background, value systems may prove to be radically different. Consider the patient who refuses life support while the family insists they want every lifesaving measure taken, or conversely, the comatose patient whose family members want life support and other interventions stopped, even as the physician refuses to discontinue therapy. Until fairly recently, the majority of clinical and ethical decisions in medicine were made by physicians acting in a paternalistic manner toward their patients. Questions regarding many issues, such as organ transplantation, assisted life support, patient self-determination, appropriation of dialysis, in-vitro fertilization, cloning, and even the use of generic drugs, did not arise. The reason is simple: these techniques and procedures were not available.
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The trend away from the family doctor making all the healthcare decisions toward a healthcare system replete with specialists, policy makers, ethical codes, administrative codes, and informed consent was brought about largely by three events in U.S. History. First, World War II research and experimentation (e.g., experimentation on concentration camp prisoners by the Nazis, research on atomic bomb survivors) brought attention to people as test subjects and what rights should be recognized on their behalf. Second, the modern structuring and organization in healthcare delivery moved patients from their familiar surroundings of home and neighborhood clinics to the often intimidating, large hospital. Third, the medical technologic boom brought life-saving interventions; people now live longer due to major advances, such as improved diagnostic procedures, antibiotics, new surgical techniques, and vaccines. Extensive publicity about three research projects resulted in the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The first project involved elderly patients with chronic illness who were injected with live cancer cells in an effort to discover whether the cells would survive in a person who was ill but did not previously have cancer. No consent was obtained from patients or family members before proceeding. The second project began in 1932, when the Public Health Service initiated a syphilis study on 399 black men from Tuskegee, Alabama. The goal of the study was to observe the men over a period of time to examine how the disease progressed in individuals of African descent. When the study began, there was no cure for the disease; however, fifteen years into the study, penicillin was discovered to be a cure for syphilis. The research participants were never informed, and treatment was withheld in spite of the fact that by the end of the experiment in 1972, 128 men had died either from the disease or related complications [2]. Finally, in 1967, children with mental retardation at the Willowbrook State School, New York, were given hepatitis by injection in a study that hoped to find a way to reduce the damage done by this disease. Although consent was obtained in this study, the consent sometimes had an element of coercion. Gaining admission to the school was difficult and parents were given a guarantee their child would be admitted if they consented to the participation of their child in the study. In response to these events, the National Commission for the Protection of Human Subjects was created in 1974 by public law. Finally, in 1979, the commission published The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research [3]. This commission recommended that all institutions receiving federal research funding should establish institutional review boards (IRBs). These boards, made up of researchers and lay people, were to review biomedical and behavioral research proposals to ensure that they met ethical standards for protecting the rights of the potential subjects. For many, this was an initial entry into what would later be called bioethics.
In 1973, the first edition of the Hastings Center Studies pointed out the problems they felt were most important to consider when developing healthcare research projects [4]. Remarkable advances were projected in the areas of organ transplantation, human experimentation, prenatal diagnosis of genetic disease, the prolongation of life, and control of human behavior. All of these had the potential to produce difficult problems, thus requiring that scientific knowledge be matched by ethical insight. Soon, the federal government, private philanthropists and foundations, universities, medical schools, and committed professionals moved quickly to address these questions. The federal government supported programs through the National Science Foundation’s Ethics and Values in Science and Technology (EVIST) and the National Endowment for the Humanities, which developed applied medical ethics courses for medical students and college undergraduates. Universities established departments, institutes, and programs in bioethics, including some in which graduate studies could be pursued. Professional organizations (including local bar and medical associations) began to establish committees to look at ethical issues in healthcare. In addition, such interdisciplinary organizations as the Society for Health and Human Values came into existence, including among their members physicians, nurses, social workers, attorneys, theologians, and philosophers. Hospitals also began to consider how bioethical concerns affected the care they provided patients. In 1976, the Massachusetts General Hospital Critical Care Committee published its recommendations for treating hopelessly ill patients and for using critical care facilities. In Catholic hospitals, committees were formed not only to discuss such specific care issues as sterilization, but also to consider the more general question of how Catholic values should be implemented in their hospitals. In November 1978, The President’s Commission for the Study of Ethical Problems in Medicine and Medical and Biobehavioral Research was created [5]. Its members began work in January 1980. The United States Congress charged them with conducting studies and reporting on a number of topics, including the definition of death, informed consent, and access to healthcare. By spring 1984, the commission had published nine reports addressing many of the problems facing the healthcare system. These reports stand as a foundation for the organized and socially sanctioned study of the ethical implications of high-technology medical care and ethical regulation of the healthcare industry. The remainder of the 1980s and early 1990s saw continued emphasis on the protection of individual rights. However, more attention began to be paid to the allocation of resources and the effectiveness of complex treatments, especially in terms of the quality of life associated with the prolonging of lives.
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The President’s Commission, like the National Commission for the Protection of Human Subjects before it, established a model for finding consensus and for articulating ethical conflicts when consensus could not be found. They did for the nation what each ethics committee does for its own hospital or individual health agency. It was during these transitional years that ethics, law, and medicine began to form an alliance. The legal and medical professions were often on opposite sides of an issue. However, they found themselves increasingly working toward the same goals. It was the New Jersey Supreme Court Decision in the Karen Ann Quinlan case that brought bioethics to the level of the individual through the media and transformed physician paternalistic authority into patient-physician shared decision making [6]. Patient autonomy issues came into public focus in the 1970s when the legal community set a precedent for deciding withdrawal/withholding of life-sustaining treatment. Although there were many related cases with decisions on medical treatment and decision making for competent and incompetent patients, two cases are recognized as landmark cases and were the most important in influencing the medical and legal community. These two cases were most responsible for moving the primary healthcare decision making into the hands of the individual. These court cases are the previously mentioned New Jersey Supreme Court Decision in the Matter of Karen Ann Quinlan (1976) and the U.S. Supreme Court Decision in the Matter of Nancy Cruzan (1990) [7]. From these two cases, and more specifically from the Nancy Cruzan case, the Patient Self-Determination Act (PSDA) of 1990 was enacted [8].
Mr. Quinlan asserted that his daughter’s right of privacy was justification for the request to terminate life support, and the court accepted the relevance of this right both to the treatment termination decision and to Mr. Quinlan’s right to assert his daughter’s right to privacy. In this way the court eliminated the issue of criminal homicide. Despite the court’s acknowledgment of autonomy, it did not permit that right as the basis for a decision to terminate the treatment. However, the court did decree that if an ethics committee agreed with Quinlan’s physicians that there was “no reasonable possibility of Karen’s ever emerging from her present comatose condition,” and if the family and Ms. Quinlan’s guardian agreed, the ventilator could be withdrawn [6]. The expectation was that Karen would die following the weaning off the ventilator. In fact, Ms. Quinlan was successfully weaned off the ventilator and lived until June 1985. However, she never regained consciousness in that time. The Karen Ann Quinlan case is significant because it was the first case to deal specifically with the question of withdrawing ventilator support from a permanently unconscious patient. It is often cited as a source for the importance of the “privacy right” in life and death decisions. NANCY CRUZAN CASE In 1983, Nancy Cruzan presented to the local hospital in a comatose state, a result of an automobile accident that left her in a persistent vegetative state (PVS). What links Ms. Cruzan’s case to the principle of the patient’s autonomy (and subsequently to issues of right to die) and to the Karen Ann Quinlan case is the fact that neither individual could speak for herself once the actual situation requiring a decision presented itself. Therefore, the two cases are linked by the fact that family members went forward to speak for the individuals. The difference between this and the Quinlan case is that a feeding tube, and therefore continuation of artificial feeding and hydration, was the central focus and seemed to be viewed differently than other life-sustaining treatment measures. The Cruzan parents fought to have the artificial feeding tube removed from their daughter. Nancy was not comatose in the common sense, yet not able to function on her own. To many, PVS was not seen as synchronous with terminal illness. As a result, the court determined that only if there was proof by clear and convincing evidence that she (Nancy Cruzan) authorized such treatment (or rejection of it) prior to losing her decision-making capacity would they rule to discontinue the tube feeding. Through other case decisions, it had been determined that competent and incompetent patients alike had the same rights of decision making under specific circumstances. As long as the now incompetent individual had provided evidence at an earlier time of her life, while competent, of what healthcare decisions she would make under specific conditions, her voice could be heard as if she was competent and making the decision during the present time.
LANDMARK COURT CASES
KAREN ANN QUINLAN CASE In the case of Karen Ann Quinlan, the concept of acknowledging a patient’s right and, in this case, the family’s right to speak for an individual came to the public via the televised and printed news media. The plight of Karen and her parents began in 1975 when she presented at the local hospital, unconscious, possibly from ingestion of a mixture of alcohol and barbiturates. Placed on a ventilator and with little hope of regaining consciousness, her physicians related this grim prognosis to Karen’s parents. Karen’s father went to the New Jersey court requesting he be made his daughter’s guardian and in so doing would be permitted to consent (for her) to discontinue ventilator support. The New Jersey Attorney General and the County Prosecutor stood firmly embedded in their advisement that to remove the ventilator from Ms. Quinlan constituted criminal homicide. Medical experts testified that under the current “medical standards, practice, and ethics,” the ventilator must be continued [6].
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The first ruling came on July 27, 1988 from Judge Charles Teel of the Missouri court who agreed with the parents and, acting for Nancy Cruzan, now a ward of the court, gave permission to have the feeding tube removed. However, in a 4-3 decision by the Missouri Supreme Court on November 16, 1988, that ruling was overturned and upheld in the U.S. Supreme Court on June 25, 1990. Their reason for overturning Judge Teel’s decision was there had been no clear, convincing evidence that Nancy Cruzan had indicated verbally or in writing what her prior wishes would have been in the situation she now experienced. On December 14, Judge Teel once again sustained his decision to allow the discontinuance of the artificial feeding and hydration tube. The difference between his first and final judgments was the new “clear and convincing evidence,” required by the State, which was brought forward on November 1 by three new witnesses. These witnesses were friends of Nancy Cruzan who testified for the first time that she had told them many years before that she would have wanted to terminate the tube feeding if she was in a situation like the present one. The “clear evidence” was presented in three points made by Judge Teel [7]: • “That the intent of our ward, if mentally able, would be to terminate her nutrition and hydration.” • “That there was no evidence of substance to cause belief that our ward would continue her present existence, hopeless as it is, and slowly progressively worsening.” • “That the co-guardians, Lester L. and Joyce Cruzan, are authorized to cause the removal of nutrition and hydration from our ward, Nancy Beth Cruzan.” It is important to emphasize that the U.S. Supreme Court’s ruling does not require all states to mandate clear and convincing evidence of anything before life support may be terminated. Each state remains free to set its own standard of proof. Each state may decide to require or not to require clear and convincing evidence of the incompetent individual’s previously determined wishes. Over the years, from the Quinlan and Cruzan cases to the many others (including the more recent Schiavo case) that address patients’ rights to refuse treatment and the idea of who can speak for incompetent patients, state courts began to address the issues explicitly. Multiple states reached substantial agreement that: • Competent patients have a constitutional and common- law right to refuse treatment. • Incompetent patients have the same rights as competent patients. • The interests of the state opposing this right are virtually nonexistent in the case of competent patients and very weak in the case of incompetent patients whose prognosis for recovery is dim.
• The decision-making process should generally occur in the clinical setting without resort to the courts, which are available to assist in decision making when an impasse is reached. • In making decisions for incompetent patients, surrogate decision makers should effectuate the patient’s own preferences expressed before the patient lost decision- making capacity (the subjective standard); however, if these references are not known, the surrogate, based on whatever evidence is available, should approximate what the patient would have wanted (the substituted judgment standard). If there is no information about the patient’s preferences, the surrogate should make a decision that is in the patient’s best interests (the best interests standard). • In ascertaining an incompetent patient’s preferences, the attending physician and surrogate may rely on the patient’s “advance directive,” which may be written or oral. • Artificial nutrition and hydration are medical treatments and may be withheld or withdrawn under the same conditions as any form of medical treatment. The Nancy Cruzan case was the ultimate landmark decision that led to legislation that would give legal rights to individuals to make healthcare decisions for themselves. Those decisions could then be written down as directives for use in the future should the individual not be able to speak for him or herself and found to be in a healthcare situation requiring decisions regarding further treatment choices (or refusal of such) in the life of that individual. This legislative act became known as the Patient Self-Determination Act of 1990. PATIENT SELF-DETERMINATION ACT (PSDA) OF 1990 Although this multi-state consensus was not without exception, these were the precursor principles to the PSDA of 1990, a federal law given over to the states to implement as of December 1, 1991 [8]. This new legislation applied to hospitals, nursing homes, hospice, HMOs/PPOs, and any other facilities that received funds from Medicare or Medicaid programs. It mandated that each of the affected facilities must advise their patients of their legal rights and options for accepting or refusing treatment if they (the patients) should become unable to speak for themselves. The primary provisions of the PSDA are: • Providers must offer written information and summaries of pertinent institutional policies to all adult patients regarding their rights under state laws to accept or refuse treatment and to make advance directives. • The patient’s record must be documented to indicate whether the patient has an advance directive.
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__________________________________________________________________ Medical Ethics for Physicians
To this statement or its facsimile, this form does have a clause exempting any pregnant mother from having this advance directive honored while she remains in a pregnant state. Another clause may be added regarding the individual’s agreement or non-agreement to the discontinuance of artificial feeding and hydration through a feeding tube (adopted from the Nancy Cruzan case decision). The directive is signed by the individual and is honored only if the patient meets the criteria set forth in the advance directive. It is the clear and convincing evidence required by some states that the individual initiates and signs this form while competent, and his or her signature (usually required to be notarized or witnessed by two witnesses) affirms this. DURABLE POWER OF ATTORNEY FOR HEALTH CARE (DPAHC) The second type of form is known as a durable power of attorney for health care (DPAHC) and allows the individual to choose another person to act on his or her behalf should the individual become incapacitated and unable to do so, at any future time. This document offers more comprehensive choices for the individual by giving more scenarios and noting the patient’s wishes in those situations in the future. The DPAHC states the individual’s wishes in writing, as does the physician directive, but goes further into the circumstances under which future healthcare decisions may need to be made. It also allows another (a surrogate, also called an attorney-in- fact) to act on the patient’s behalf. The named person becomes equal to the patient in terms of his or her right to receive the same information required for decision making. This form also must be signed by the individual and notarized or witnessed. In both cases, the physician directive and the DPAHC are legal documents in all states and require all healthcare institutions to honor them if the patient meets the criteria. Healthcare agencies must have policies and procedures that allow the process for patient self-determination rights to be honored. The purpose of the Act is to communicate and protect patients’ rights to self-determination in health care. The underlying assumptions of the PSDA are that [8]: • Patients who are informed of their rights are more likely to take advantage of them. • If patients are more actively involved in decisions about their medical care, then that care will be more responsive to their needs. • Patients may choose care that is less costly.
• Institutions may not discriminate against or refuse care to a patient based upon whether the patient has executed an advance directive. • Institutions have an affirmative obligation to comply with requirements of state law regarding advance directives. • Institutions must provide (individually or with others) education to staff and community regarding issues associated with advance directives. • State Medicaid laws must be amended to require participating healthcare institutions to furnish the written information mentioned above. • With the Department of Health and Human Services’ assistance, state Medicaid agencies must develop written descriptions of state laws on advance directives, and these materials are to be distributed by participating healthcare institutions. Finally, legislation was created to keep end-of-life medical decision-making issues out of the courts and in the appropriate arena, with the appropriate players: the patient/family and the healthcare professionals. The central focus of the law is the provision of patient education. The means or the tool for the individual to document his or her wishes for future healthcare decisions is called an advance directive. There are two types of advance directives available. Although both are not required to be completed together, most people are encouraged to do so.
The National Comprehensive Cancer Network recommends asking patients if they have a living will, medical power of attorney, health care proxy, or patient surrogate for health care. If not, patients should be encouraged to prepare one.
(https://www.nccn.org/professionals/physician_gls/ pdf/palliative.pdf. Last accessed January 13, 2023.) Level of Evidence : Expert Opinion/Consensus Statement
PHYSICIAN DIRECTIVE The first type of advance directive is called a physician directive, sometimes called directive to physician. The precedent form is the living will, an earlier, legally non-binding form. The living will allowed an individual to state his/her treatment choices should he or she be found in a terminal state, comatose, and/ or in another condition leading to imminent death for which the physician saw no cure. The patient stated that he/she be allowed to die naturally without medical intervention, with only comfort measures employed.
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Medical Ethics for Physicians __________________________________________________________________
From 1991, when the PSDA was first implemented, to today, most individuals have not completed advance directives and/ or do not have them when they enter healthcare agencies that fall under the umbrella of the PSDA. What does this mean for those working in the healthcare field? A method of making an easier end-of-life decision is available, but not often used by the patient. Conflict between patient autonomy and physician paternalism, poor communication, institution or physician fear of litigation, and/or family disagreement with the patient or healthcare professionals continues to be an issue. More policies or guidelines are being adopted to assist the process so that, even when advance directives are unavailable, dialogue can be initiated with family members who can legally act for their loved ones. It does not address the cases where the DPAHC surrogate is a non-relative and relatives disagree with the surrogate, and therefore, the patient’s wishes. It does not settle satisfactorily the right of the significant other, the named surrogate vs. his sibling, or the present wife vs. the ex-wife, who wishes to make decisions for the patient without an advance directive. Those cases make for interesting studies but hopefully can be decided by directives from hospital policy regarding who can speak for the individual without an advance directive.
presents to a hospital in a coma? The hospital must work with the advance directive provided. Some states allow surrogate decision makers for patients under certain conditions, such as terminal illness or vegetative state. Those laws usually require the physician to certify that the patient meets the medical conditions before allowing a surrogate decision maker to step in. When there is no advance directive, some states allow the patient’s spouse or adult children (or other direct relatives listed in a specified order of preference) to decide for the patient. DEFINITIONS OF ETHICAL PRINCIPLES The major ethical principles of significance to physicians and other healthcare personnel are respect for persons, autonomy, veracity, beneficence, non-maleficence, justice, fidelity, and right-to-know [10]. These terms are used widely in bioethics and should be briefly defined: • Respect for persons requires that each individual be treated as unique and be entitled to treatment that is respectful of their human dignity. • Autonomy refers to the right of the patient to determine what will be done with his or her own person. It also involves the patient’s right to have confidentiality of their own medical history and records, and for the medical personnel to safeguard that right. • Veracity involves truthfulness. Physicians are obligated to be truthful with patients and/or their families and should avoid withholding information. This allows them to make informed choices. • Beneficence refers to the ethical principle of doing or promoting good. • Non-maleficence correlates to Hippocrates’ principle of doing no harm. • Justice is broadly understood as fairness; however, it pertains to what someone or a group is owed. It also relates to the distribution or allocation of a scarce resource or treatment. The principle of justice can also be applied in decisions about end-of-life care, such as the right of the patient to receive adequate palliative treatment. • Fidelity means remaining faithful to promises made. • Right-to-know is the principle of informed consent.
STANDARDS OF ETHICS, RIGHTS, AND RESPONSIBILITIES
Many situations require only listening and someone to support the patient and family through the process of decision making. The Joint Commission has established standards on patient rights, including ethical decision making. Very clearly, the Joint Commission has outlined that hospitals should have defined policies and procedures allowing patients to create and modify advance directives. The 2000 Joint Commission Standards regarding patients’ rights to formulate an advance directive, to have a mechanism in place to deal with ethical issues, and for their rights to accept or refuse care, is found in Figure 1 . Because the information in Figure 1 presents so many useful concepts in a single page, it remains a part of this course although it is no longer contained in the current Joint Commission manual [9]. This form has since been replaced with an entire section titled “Rights and Responsibilities of the Patient,” which appears in the 2022 revision of the Comprehensive Accreditation Manual for Hospitals published by the Joint Commission [9]. This section outlines the standards that healthcare organizations must follow in order to obtain or maintain accreditation. The expanded standards section makes it easier for healthcare organizations to test their compliance and for reviewers to rate them. The Joint Commission requires healthcare organizations to follow their state laws. If a person is from out of state, they may have an advance directive that does not comply with the state laws where the patient is hospitalized. Some attorneys advise hospitals treating patients who bring advance directives from out-of-state to ask them to complete an advance directive for the state in which they are being treated. What if the patient
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