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Case Studies in Pharmacy Ethics
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Case Studies in
Pharmacy Ethics
second edition
ROBERT M. VEATCH
Professor of Medical Ethics
The Kennedy Institute
Georgetown University
AMY HADDAD
Professor of Pharmacy Sciences
School of Pharmacy and Health Professions
Center for Health Policy and Ethics
Creighton University
1
2008
1
Oxford University Press, Inc., publishes works that further
Oxford Universityâ??s objective of excellence
in research, scholarship, and education.
Oxford New York
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With offices in
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South Korea Switzerland Thailand Turkey Ukraine Vietnam
Copyright © 2008 by Oxford University Press, Inc.
Published by Oxford University Press, Inc.
198 Madison Avenue, New York, New York 10016
www.oup.com
Oxford is a registered trademark of Oxford University Press
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any
form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of
Oxford University Press.
Library of Congress Cataloging-in-Publication Data
Veatch, Robert M.
Case studies in pharmacy ethics / Robert M. Veatch and Amy M. Haddad. â?? 2nd ed.
p. cm.
Rev. ed. of: Case studies in pharmacy ethics / Robert M. Veatch, Amy Haddad. 1999.
Includes bibliographical references and index.
ISBN 978-0-19-530812-9 (pbk.)
1. Pharmaceutical ethicsâ??â??Case studies. I. Haddad, Amy Marie. II. Veatch, Robert M. Case studies in pharmacy
ethics. III. Title.
[DNLM: 1. Ethics, Pharmacy. QV 21 .V394c 2007]
RS100.5.V43 2008
174.2â??â??dc22
2007014188
9 8 7 6 5 4 3 2 1
Printed in the United States of America
on acid-free paper
Robert Veatch dedicates this book to his father, Cecil R. Veatch, R.Ph.,
1905â??1978
Amy Haddad dedicates this book to her husband, Steve Martin
This page intentionally left blank
Preface
Providing health care increasingly poses ethical choices. Over the past few decades
pharmacy has undergone dramatic changes and evolved into a highly patientoriented profession. The changing role of the pharmacist, development of pharmaceutical care as a practice standard, and complex health and drug distribution
systems make it almost impossible to avoid ethical issues. The day is gone (if, indeed,
it ever existed) when members of the health care team who are not physicians can
consider themselves to be doing their jobs adequately simply by following orders.
In the seven years since the publication of the first edition of Case Studies in
Pharmacy Ethics, important developments and changes have taken place in the
practice of pharmacy. The recent addition of a prescription benefit in Medicare
has already led to many changes within the profession. Prescription benefit plans
have begun to place limits on the choices of patients and providers. Prescriptions
intended to be used by patients to commit suicide have become a legal practice in at
least one state. The use of drugs for other morally controversial purposes, including
abortion, has forced pharmacists to confront more frequently and more systematically conscientious refusal to dispense. Research medicine also has faced new and
complex problems, including the first death of a research subject from an attempt to
intentionally manipulate the human genetic code.
Advances in biomedical ethics also have occurred. The National Bioethics
Advisory Commission (1996â??2001) and, beginning in 2001, the Presidentâ??s Council
on Bioethics advanced public discussion of bioethics. New editions of major texts
and theories have appeared. New court decisions have reshaped public policy. The
teaching of ethics in schools of pharmacy has evolved. For all of these reasons, a new
edition is needed.
viii Preface
We have reviewed each case from the first edition, replaced some cases and
added others, updated pharmacological, economic, and legal information, and
added two new chapters written for this edition. The new Chapter 1 provides our
Model for Ethical Problem Solving, a systematic method of dissecting the cases in
this volume that will be particularly useful when cases resist less formal analysis.
Chapter 13, also entirely new in this edition, acknowledges that the practice of pharmacy is rapidly coming under the influence of formal institutional formularies and
drug distribution systems. Hospital and health system formularies are restricting
the use of unproven but marginally beneficial and cost-ineffective pharmaceuticals, sometimes forcing pharmacists to cooperate in treatment decisions that are not
maximizing the patientâ??s therapeutic interests. Drug distribution systems involve
pharmacists in mail-order pharmacies, drug procurement from foreign sources,
and Medicare policies. Pharmacists employed in these new and increasingly dominant systems for dispensing as well as pharmacists who are competing with these
systems face new and challenging ethical problems, the focus of cases presented in
this chapter. While the other chapter titles remain the same, each case in them has
been reviewed. New cases replace those that have become dated.
Like all professions, pharmacy imposes ethical standards and obligations on its
practitioners. Although pharmacists practice in a variety of settings, such as community pharmacies, hospitals, ambulatory clinics, and home care, there are many
problems that all pharmacists share. To begin with, virtually any pharmacist may
be asked by a physician, other health care provider, or patient to engage in actions
that are not consistent with the pharmacistâ??s conscience. Unless it is supposed that
it is best for pharmacists simply to accommodate any and all requests, instances of
legitimate moral conflict are bound to occur between the preferences of pharmacists and those of all the other individuals constituting the practice of health care.
Pharmacists may be held accountable for their actions when their professional
association has a code, such as the Code of Ethics for Pharmacists of the American
Pharmacists Association (APhA). The APhA Code of Ethics calls for certain kinds of
conduct. It places the profession (or at least those who are members of the association) on record as viewing the work of its members as people responsible for their
actions. The Code of Ethics may conflict, however, with the instruction of the physician, the wishes of the patient, the demands of a third-party payer, or the conscience
of an individual caregiver. Codes of various health professions, as we shall see, may
actually come into conflict with one another.
Every pharmacist, whether aware of it or not, is constantly making ethical
choices. Sometimes these choices are dramatic, life-and-death decisions, but often
they are more subtle, less-conspicuous choices that are nonetheless important. One
way of seeing the implications of these issues and the moral choices inherent in
them is to look at the experiences of oneâ??s colleagues, to listen to their stories and
the kinds of choices they have had to make in situations like the ones typically faced
by pharmacists. This volume is a collection of those situations. It is, we believe,
the best way to study the biomedical ethics of the pharmacy profession. Since
some teachers of pharmacy ethics may want to use these cases to survey the full
range of issues involved in health professional ethics, and given that some courses
Preface
ix
include practitioners and students from other health professions, we have made
an effort to include as many topics in health care as possible, including some that
pharmacists face only occasionally (such as genetics and birth technologies), and
to include examples of pharmacists interacting with representatives of other health
professions.
Pharmacists constitute a significant force in the health care system. Taken
together with the many other members of the health care team who daily face difficult
moral situations, the instances wherein pharmacists collectively have involvement
in the value-based and ethical dimensions of health care are of such magnitude that
the exploration of issues contained in this volume is particularly timely.
This collection of cases is based on real situations experienced by practicing
pharmacists. Many of the original cases in the first edition were obtained from a
national random survey of pharmacists wherein over 400 respondents described
ethical problems common to their pharmacy practice.1 Additional cases were solicited from pharmacy alumni and faculty members as well as clinicians locally and
nationally. We have modified details to protect anonymity and to provide clarity in
presenting the ethical issues, but in each case some pharmacist has had to face the
actual problem presented here. We are grateful to all of the pharmacists who helped
us by providing cases.
The writing of this volume has been a truly collaborative effort. Each of
the authors has been involved in every case and commentary. In general, Amy
Haddad, who is a professor in the Department of Pharmacy Sciences of the School
of Pharmacy and Health Professions of Creighton University, drew on her more
than 20 years of teaching ethics in the pharmacy program and clinical interactions
with pharmacy colleagues as well as the responses of the pharmacists to the abovementioned survey to prepare first drafts of most of the cases. Robert Veatch, who
is a pharmacist and served as a lecturer in pharmacology before pursuing a career
in health care ethics, prepared the first draft of much of the introductory material
and commentaries, but both participated extensively in all aspects of each chapter
and each case.
In addition to the pharmacists who helped by providing case material, we also
want to acknowledge the assistance of many others who provided insights about the
structure of the book, drug information, research or clinical clarification, including
Lee Handke, Pharm.D., Vice President of Pharmacy and Wellness, Blue Cross and
Blue Shield of Nebraska; Gary Yee, Pharm.D., University of Nebraska College of
Pharmacy; Jennifer Upward, Pharm.D., 2005 graduate, Creighton University School
of Pharmacy and Health Professions; Amy Wilson, Pharm.D., and Morgan Sperry,
Pharm.D., both faculty members of the School of Pharmacy and Health Professions
at Creighton University; and the following Doctor of Pharmacy students from
Creighton University: Dua Anderson, Nicole Dunn, Thythu Luu, Katie Normile,
Amy Schroeder, Jaclyn Waters, and Erika Zender-Weber. Rebecca Crowell and Justin
Herrick of the Center for Health Policy and Ethics at Creighton University also were
of particular assistance in the organization of the manuscript.
Robert Veatch also acknowledges the continuing career-long cooperation
of the dedicated professional library staff of the National Reference Center for
x
Preface
Bioethics Literature at the Kennedy Institute of Ethics, Georgetown University.
Their commitment to careful, systemic mastery of the bioethics literature makes
research in the field a joy. He also thanks Moheba Hanif, Sally Schofield, and Linda
Powell at the Kennedy Institute of Ethics as well as all the faculty of the Kennedy
Institute, many of whom helped provide documentation and clarity for the cases
presented here.
In the early stages of this project that resulted in the first edition of this book,
Lou Vottero, the former Associate Dean of the Raabe College of Pharmacy at Ohio
Northern University, was a full participant. While other responsibilities did not
permit him to continue with the writing, we are grateful to him for the role he played
in the design of the first edition. While we appreciate the help of all these people, we
are, of course, solely responsible for judgments contained in the volume.
In the years since the publication of the first edition, our friend and editor,
Jeffrey House, has retired. We are pleased to now be working with Peter Ohlin as
editor for this second edition. He has made the transition seamless and resolved
many publication problems involved in generating this new edition of the pharmacy
case collection as well as developing the companion medical ethics volume.
At the same time that we have prepared this second edition, we have launched
preparation of the manuscript of a companion volume, Case Studies in Medical
Ethics. We have adapted the introductory and theoretical material of this volume
for a new collection of cases covering more broadly ethical problems in the various
health professions. That volume will provide a much-needed update of the original
case study volume in what has now become a series of books presenting cases in the
health professions, including nursing, dentistry, and allied health, as well as the more
general practice of medicine by physicians and other health professionals. Working
with physician and bioethicist Dan English, we expect this companion collection
of cases to prove useful for courses in medical ethics that involve students of other
health professions in addition to pharmacy as well as undergraduate students of
medical ethics.
Note
1. Haddad, A. M. â??Ethical Problems in Pharmacy Practice: A Survey of Difficulty and
Incidence.â? American Journal of Pharmaceutical Education 55, no. 1 (1991): 1â??6.
Contents
List of Cases
xv
Introduction: Four Questions of Ethics
3
What Are the Source, Meaning, and Justification of Ethical Claims?
4
1. Distinguish Between Evaluative Statements and Statements Presenting
Nonevaluative Facts
4
2. Distinguish Between Moral and Nonmoral Evaluations
5
3. Determine Who Ought to Decide
7
What Kinds of Acts Are Right?
9
Consequentialism
9
Deontological or â??Duty-Basedâ? Ethics
10
Other Issues of Normative Ethics
12
How Do Rules Apply to Specific Situations?
13
What Ought to Be Done in Specific Cases?
15
Notes
17
PART I Ethics and Values in Pharmacy
Chapter 1: A Model for Ethical Problem Solving
The Five-Step Model
21
Application of the Model
22
1. Respond to the Sense That Something Is Wrong
2. Gather Information
24
3. Identify the Ethical Problem/Moral Diagnosis
21
23
25
xii
Contents
4. Seek a Resolution
26
5. Work with Others to Choose a Course of Action
Notes
28
Chapter 2: Values in Health and Illness
Identifying Value Judgments in Pharmacy
Separating Ethical and Other Evaluations
27
29
30
35
Chapter 3: What Is the Source of Moral Judgments?
41
Grounding Ethics in the Professional Code
42
Grounding Ethics in the Physicianâ??s Orders
46
Grounding Ethics in Hospital Policy
49
Grounding Ethics in the Patientâ??s Values
51
Grounding Ethics in Religious or Philosophical Perspectives
Notes
54
52
PART II Ethical Principles in Pharmacy Ethics
Chapter 4: Benefiting the Patient and Others: The Duty to Do Good and
Avoid Harm
57
Benefiting the Patient
58
Health in Conflict with Other Goods
58
Relating Benefits and Harms
61
Benefits of Rules and Benefits in Specific Cases
63
Benefiting Society and Individuals Who Are Not Patients
Benefits to Society
65
Benefits to Specific Nonpatients
68
Benefits to the Profession
69
Benefits to the Pharmacist and the Pharmacistâ??s Family
Notes
72
65
Chapter 5: Justice: The Allocation of Health Resources
Justice Among Patients
74
Justice Between Patients and Others
Justice in Public Policy
79
Justice and Other Ethical Principles
Notes
85
Chapter 6: Autonomy
73
77
83
86
Determining Whether a Patient Is Autonomous
External Constraints on Autonomy
93
Overriding the Choices of Autonomous Persons
Notes
100
89
95
Chapter 7: Veracity: Dealing Honestly with Patients
The Condition of Doubt
Lying in Order to Benefit
71
104
106
102
Contents xiii
Protecting the Patient by Lying
106
Protecting the Welfare of Others
108
Special Cases of Truth Telling
111
Patients Who Donâ??t Want to Be Told
111
Family Members Who Insist That the Patient Not Be Told
The Right of Access to Medical Records
114
Notes
116
113
Chapter 8: Fidelity: Promise-Keeping and Confidentiality
118
The Ethics of Promises: Explicit and Implicit
119
The Limits on the Promise of Confidentiality
122
Breaking Confidence to Benefit the Patient
123
Breaking Confidence to Benefit Others
126
Incompetent, Impaired, and Dishonest Colleagues
128
Notes
133
Chapter 9: Avoidance of Killing
134
Active Killing Versus Letting One Die
137
Withholding Versus Withdrawing Treatment
Direct Versus Indirect Killing
144
Justifiable Omissions
148
Voluntary and Involuntary Killing
150
Killing as Punishment
152
Notes
155
142
Part III Special Problem Areas
Chapter 10: Abortion, Sterilization, and Contraception
159
Abortion
159
Abortion for Medical Problems of the Fetus
161
Abortion Following Sexual Assault
164
Abortion to Save the Life of the Pregnant Woman
167
Abortion and the Mentally Incapacitated Woman
169
Abortion for Socioeconomic Reasons
171
Sterilization
172
Contraception
174
Notes
179
Chapter 11: Genetics, Birth, and the Biological Revolution
Genetic Counseling
183
Genetic Screening
187
In Vitro Fertilization
189
Surrogate Motherhood
192
Genetic Engineering
194
Notes
196
181
xiv Contents
Chapter 12: Mental Health and Behavior Control
199
The Concept of Mental Health
200
Mental Illness and Autonomous Behavior
203
Mental Illness and Third-Party Interests
207
Other Behavior-Controlling Therapies
209
Notes
213
Chapter 13: Formularies and Drug Distribution Systems
215
Formularies
216
Eliminating Unproven Therapies
217
Eliminating Proven but Marginally Beneficial Therapies
220
Eliminating Proven but Cost-Ineffective Therapies
222
Appeals to Override Formularies
224
Physician Behavior with Drug Company Influence
226
Drug Distribution Systems
229
Mail-Order Pharmacies
229
Drugs from Canada
231
Notes
234
Chapter 14: Experimentation on Human Subjects
236
Calculating Risks and Benefits
239
Privacy and Confidentiality
242
Equity in Research
245
Conflicts of Interest in Research
248
Informed Consent in Research
250
Notes
253
Chapter 15: Consent and the Right to Refuse Treatment
The Elements of a Consent
256
The Standards for Consent
259
Comprehension and Voluntariness
Notes
272
Chapter 16: Death and Dying
263
274
The Definition of Death
275
Competent and Formerly Competent Patients
Never-Competent Patients
281
Limits Based on Interests of Others
285
Notes
289
Appendix
293
The Hippocratic Oath
293
Code of Ethics for Pharmacists
Index
297
294
278
255
Cases
Case 1-1: Reporting a Possibly Lethal Error: Who Needs to Know?
Case 2-1: Over-the-Counter Diet Pills
Case 2-2: Managing Dental Pain
Case 2-3: Use of Generic Drugs
22
30
33
34
Case 2-4: Nonprescription Access to Legend Drugs
Case 2-5: What Should Be Behind the Counter?
36
39
Case 3-1: What Is â??In the Best Interest of the Patientâ??
43
Case 3-2: Professional and Public Views on Closing a Pharmacy
Case 3-3: Whether to Dispense a Potentially Lethal Drug
Case 3-4: Respecting the Wishes of the Terminally Ill
44
46
47
Case 3-5: A Medication Error on the Oncology Unit: Who Has the Final
Word?
49
Case 3-6: Is the Patient Always Right?
51
Case 3-7: Oral Contraceptives: The Pharmacistâ??s Refusal to
Dispense
52
xv
xvi Cases
Case 4-1: A Matter of Priorities: A Patient Who Chooses to Reduce
Antihypertensive Medication
59
Case 4-2: Aesthetics Versus Health
59
Case 4-3: The Benefits and Harms of High-Risk Chemotherapy
62
Case 4-4: When the Exception Breaks the Rule: Charitable Use of Outdated
Drugs
64
Case 4-5: The Benefit of Cost Savings in a Health Maintenance
Organization
66
Case 4-6: The Interests of the Patient Versus His Family: Burdens on the
Caregiver
68
Case 4-7: For the Welfare of the Profession: Should Pharmacists
Strike?
69
Case 4-8: Choosing Between Patients and Pharmacistâ??s Family
71
Case 5-1: The Hypochondriac and the Patient in Crisis: Whose …
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