Drugs, Ethics, and Quality of Life: Cases and Materials on Ethical, Legal, and Public Policy Dilemmas in Medicine and Pharmacy Practice

333 Pages·2007·13.961 MB·English

by  Bruce David White

Drugs, Ethics,
and Quality of Life
Cases and Materials
on Ethical, Legal,
and Public Policy Dilemmas
in Medicine and Pharmacy Practice
Drugs, Ethics,
and Quality of Life
Cases and Materials
on Ethical, Legal,
and Public Policy Dilemmas
in Medicine and Pharmacy Practice
Bruce D. White
informa
healthcare
New York London
CRC Press
Taylor & Francis Group
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Boca Raton, FL 33487-2742
© 2007 by Taylor & Francis Group, LLC
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Version Date: 20130304
International Standard Book Number-13: 978-1-4822-0401-8 (eBook - PDF)
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R. Clayton McWhorter
Joseph 0. Dean Jr.
Mickey C. Smith
Pharmacists all, who as visionary leaders
set the highest ethical standard,
and thereby improved the quality of life
of countless others
CONTENTS
Foreword xiii
Kenneth V. /serson
Preface xv
Acknowledgments xxi
Introduction: Pellegrino on Professionalism:
A Human Values Basis for the Healing Arts 1
Appendix: Principles of Medical Ethics of the American
Medical Association (200 l) 5
Special Additional Introduction: Ethics and a Code
of Ethics in Pharmacy Practice 7
Joseph L. Fink III
Appendix: Code of Ethics for Pharmacists
of the American Pharmacists Association (1994) I 0
PART 1: FOUNDATIONAL BASICS
Chapter 1. Tobacco and Choices: How Values
and Definitions Impact Decision Making 15
FDA's 1996 Tobacco Regulations
and FDA v. Brown & Williamson 15
Definitions 20
Continuing Dilemmas with Tobacco 33
Chapter 2. COX-2 Inhibitors and Conflict:
How Balancing Beneficence and Nonmaleficence
Influences Decision Making 37
COX-2 Inhibitors and Their Effects 40
The FDA's Drug Approval Process and VIOXX 40
A Balancing Act: Beneficence, Nonmalcticence,
and Profit and Other Motives 44
Cost-Benefit Analysis, Stakeholders,
and Issues Management Analysis 46
Continuing Dilemmas with COX-2 Inhibitors 54
Chapter 3. Marijuana, Individual Liberty, and Police
Power: How Autonomy Drives Decision Making 61
Marijuana 63
Marijuana Control in the United States 64
Personal Freedom, Autonomy, and the California
Compassionate Use Act 69
State Police Power and Federalism: Gonzales v. Raich 73
Continuing Dilemmas with Medical Marijuana 79
Appendix: Examples of California's Criminal Statutes
Controlling Marijuana Calif. Health & Safety
Code§§ 11357 and 11.358 83
Chapter 4. The "Morning-After" Pill and Systematic
Ethics and Public Policy Analysis: How Justice Tempers
Decision Making 85
Emergency Contraceptives and Rights 88
Balancing "Rights": Ethics and Public Policy 90
Justice and Conscientious Objection 96
Conflict and Systematic Ethical Analysis 98
Continuing Dilemmas with Emergency Contraceptives 100
PART II: PAIN MEDICINES
AND END-OF-LIFE DRUGS
Chapter 5. Pain Medicines and Palliative Care Drugs 113
Bergman v. Chin 115
When Will Adequate Pain Control Be the Norm? 118
Continuing Dilemmas with Pain Medicines
and Palliative Care Drugs 129
Chapter 6. Drugs Used for Assisted Suicide 133
The Debate about Physician-Assisted Suicide
and Euthanasia 136
The Oregon Death with Dignity Act 144
Continuing Dilemmas with Assisted Suicide
and Euthanasia !52
Chapter 7. Drug Use in "Dwindling" Patients
and in Medically Futile Situations 159
"Dwindling" Patients and Quality of Life 161
Medical Futility 168
Sun·ogate Medical Decision Making 178
Continuing Dilemmas Involving Drug Use in "Dwindling·•
Patients and Medically Futile Situations 184
Appendix: Tennessee Health Care Decisions Act (2004) 190
PART III: DRUG EXPERIMENTATION
Chapter 8. Gene Therapy and Experimentation 199
The Federal Drug Research and Patient Safety Framework 203
Gelsinger v. University (d. Pennsylvania 209
Continuing Dilemmas with Gene Therapy
and Experimentation 216
Afterword 225
John Lachs
Appendix 1. Law and Decisions 227
Objectives 227
What Does Law Mean? 227
What Are the Four Primary Sources of Law
in the United States? 229
How Do the People (The Nation's Citizens) Create Law? 231
How Do Legislative Bodies Create Law? 234
How Do Federal and State Administrative Agencies
Create Law'? 236
How Do Federal and State Judges Create Law? 240
Appendix 2. Continuing Dilemmas Involving Drugs,
Ethics, and Quality of Life: An Outline for Further
Discussion 249
Topics Related to Drug Use 251
Topics Related to Professional Virtues 256
Notes 259
Index 299
ABOUT THE AUTHOR
Bruce D. White, DO, JD, is a pharmacist, a board-certified pediatri
cian, and an attorney with fellowship training in clinical medical eth
ics. He came to St. Joseph's Hospital and Medical Center in Phoenix,
Arizona, from Nashville, Tennessee, in March 2004 to serve as a
member of the general pediatrics residency faculty; he currently is
academic chair of the pediatrics department. He also directs the clini
cal ethics fellowship program for the hospital. He holds faculty ap
pointments as Clinical Professor of Pediatrics in the University of
Arizona College of Medicine: Clinical Professor of Pharmacy Prac
tice and Science in the College of Pharmacy, Tucson, Arizona; and
Clinical Professor of Pediatrics in the Creighton University School of
Medicine, Omaha, Nebraska. He also serves as Professor and Direc
tor of the campus-wide, interdisciplinary Healthcare Ethics and Law
(HEaL) Institute at Samford University in Birmingham, Alabama. He
directs an interactive Web site-www.ethicsconsultant.com-which
offers online clinical ethics coaching, mentoring, and educational ser
vices to a pilot group of hospitals and ethics committee members na
tionwide.
CONTRIBUTORS
Gretchen A. Fair, .JD, MA, holds law and bioethics degrees from
the University of Virginia. She was an associate with the Venable law
firm in Washington, DC, for three years before serving as the 2005-
2006 fellow in clinical ethics at St. Joseph's Hospital and Medical
Center, Phoenix, Arizona.
Joseph L. Fink III, BS Pharm, .JD, is Professor of Pharmacy at the
University of Kentucky College of Pharmacy in Lexington, where he
focuses on pharmaceutical public policy and pharmacy law, and
is Professor of Public Health in the College of Public Health. He
chaired the committee for the latest revision of the American Phar
macists Association Code of Ethics for Pharmacists. For more than
twenty years he has been an editor of Pharmacy Law Digest. the most
widely used pharmacy law text and reference in the United States.
Kenneth V. Iserson, MD, MBA, is Professor of Emergency Medi
cine in the College of Medicine and Director of the Arizona Bioethics
Center at the University of Arizona, Tucson, where he also chairs the
ethics committee of the University Medical Center. He is the author
of over 300 scientific articles and nine books, including Getting into
a Residency: A Guide for Medical Students (6th eel., 2003), Grave
Words: Not(fying Survivors of' Stu/den, Unexpected Death ( 1999),
and Ethics in Emergency Medicine (2nd eel., 1995).
Jan M. Kovarik is a freelance copyeditor and proofreader (a.k.a.
Jan K., The Proofer), and has been serving the publications industry
at large since 1996. Her principal focus is academic-level research
journals (in the accounting and computer technology fields). Jan also
provides primary freelance editing services for postgraduates who
are in their dissertation stage. Prior to becoming a freelancer, Jan
worked for more than twenty years in the corporate accounting arena.
XI
XI! l>RU;s, ETHICS, AMJ QUAU7T OF UFE
.John Lachs, PhD, is Centennial Professor of Philosophy at
Vanderbilt University, Nashville, Tennessee. His philosophical in
terests center on human nature, which takes him into metaphysics,
philosophy of mind, political philosophy, and ethics. He is general
editor of the Enc.vclopedia of'American Philosophy and the author of
seven books.
Edmund D. Pellegrino, MD, is the John Carroll Professor Emeritus
of Medicine and Medical Ethics at Georgetown University, and
Chairman of the President's Council on Bioethics, Washington DC.
He is a Master of the American College of Physicians, Fellow of the
American Association for the Advancement of Science, and Member
of the Institute of Medicine of the National Academy of Sciences.
Dr. Pellegrino formerly directed the Kennedy Institute of Ethics, Cen
ter for the Advanced Study of Ethics, and Center for Clinical Bioethics
at Georgetown. He is the author of over 500 published items in medi
cal science, philosophy, and ethics, and is a member of numerous
editorial boards.
Somlynn Rorie is a freelance journalist residing in Phoenix, Arizona.
She obtained her bachelor's degree in English from Arizona State
University. She has written extensively on the topics oflnternet tech
nology, current events, fashion and beauty, natural health and healing,
herbal supplements, pharmaceuticals, food ingredients, and organic
food. Her articles have been featured in many publications, and she
has served as editor for several magazines such as Organic and Natu
ral News, Natural Products Insider, and Health Supplement Retailer.
Currently, she provides marketing and public relations for a global
digital media company that provides access controls and management
for digital entertainment products.