ETHICS IN PAIN MANAGEMENT AND END-OF-LIFE CARE
B. Eliot Cole, MD, Executive Director, American Society of Pain Educators, and Vice President for Medical and
Scientific Services, Aventine Health Sciences, Montclair, NJ, and Consultant in Pain Management, Kaiser
Permanente Medical Group, Honolulu, HI
Ethical Implications and Legal Challenges
| External barriers to pain management: still exist; legislation and regulations restricting use of opioids; problematic
access in some communities; lack of accountability in some institutions; paucity of education in medical
schools; lack of priority for pain management, except as companion to something else (eg, parturition, surgery);
cultural resistance to idea of opioid therapy; patients’ fear that if they use opioids, they will become “sniveling drug
addicts”; fear of side effects of opioids; concern that opioid doses will escalate; physicians’ fear that they will get
arrested for excessive prescribing of opioids
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| Addiction mythology: persistent; includes physicians’ belief that lower-potency medications have less addictive potential
than higher-potency medications; also includes belief “that there’s some kind of an absolute unifying addictive
personality disorder [and] that with the right Rorschach card, we’ll be able to diagnose” people’s tendency to addiction
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| Need vs addiction: patient with pain seeks reduction in pain intensity and improvement in function; addict’s goal is
to get high; pain patients always have some pills left over, whereas addict or abuser always runs out early
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| Analgesic options: speaker prefers older medications whose efficacy and safety well established; ideal analgesic
works quickly, results in stable blood levels, has no drug interactions, does not produce high, does not lead to accumulation
of toxic metabolites, and has stable effect over time
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| What causes trouble with regulators? failure to—evaluate patients; make diagnosis before initiating treatment;
obtain outside medical records and/or contact previous therapists; establish goals for treatment; document diagnosis,
treatment plan, goals for treatment, continuing need for medication, and laboratory results; suspect misbehavior or substance
abuse; understand what drug testing can and cannot indicate; other pitfalls—deviation from drug agreement;
blind acceptance of whatever patient says; bullying law enforcement or regulatory agents; assuming arrogant or contemptuous
attitude toward law enforcement or regulatory agents
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| Staying out of trouble: always perform thorough history and physical examination; do not lump diagnoses together
but try to determine what is really wrong; screen all patients for substance abuse and other forms of psychologic
dependency; chart everything (what you see, think, hear, and feel); leave nothing for future reader’s
imagination; make chart entries sufficiently detailed to stand alone if separated from chart; explain your plan, alternatives
you and patient considered, and how you intend to follow patient over time
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 | Obtain informed consent: be certain patient understands what is being proposed; be certain patient understands
risks and benefits of opioids; insist patient use only you for prescriptions for controlled substances; discourage
patient from visiting emergency department for current pain and from “doctor shopping”
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| Use one pharmacy: call pharmacist, explain diagnosis, prognosis, and reason for use of opioids; advise pharmacist
that you never telephone prescriptions or refills for opioids and that any such phone calls are fraudulent and
should be reported to you; do not write open-ended prescriptions, but see patient at regular intervals (4-12 wk) to
evaluate need for continuing medication
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| Use long-acting medications: give controlled-release medication when pain expected to last for extended period
and patient requires continuous analgesia; prescribe medications on time-contingent basis, not “as needed”; back up
sustained-action medications with immediate-release medications; determine minimum dose required; after 6 mo to
1 yr, try to reduce dosage by 25% to 35%, working with patient to find time convenient to him or her (eg, over weekend)
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| Drug screens: order them for all patients; know limitations of methodologies used; make sure screening technique
has ability to identify prescribed medication; screen for illicit substances; do urine screens on ≥2 consecutive visits
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| Universal precautions in pain management: continue to obtain good education about pain management; make
diagnosis with appropriate differential; identify treatable causes of pain and direct therapy at those causes; in absence of
specific objective findings, treat symptoms; address comorbid disorders, including substance abuse disorders and other
psychiatric illnesses; perform complete psychiatric assessment, including risk for addictive disorders; perform urine
drug screening 1) where opioid trial to be undertaken, 2) when response to therapy inadequate, 3) periodically when patient
on opioids; patients found to be using illicit or unprescribed licit drugs should be offered further assessment for
possible substance use disorders; those who refuse such assessment should be considered unsuitable candidates for controlled
substances
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| Treatment agreement: avoid term “contract,” because it leaves practitioner vulnerable to lawsuit for breach of
contract; whether written or verbal, expectations and obligations of both parties need to be clear; carefully worded
treatment agreement helps clarify boundary limits, making possible early identification of and intervention around
aberrant behavior
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| Pain level and function: assess pain and function before beginning therapy (standardized scales available); establish
goals for pain therapy; reassess pain and function at regular intervals; if goals of therapy not met, reevaluate
treatment plan and change if necessary; assess and reassess “five A’s” of pain management, ie, analgesia, activity
(function), adverse effects, aberrant behavior, and affect
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| Periodically review pain diagnosis and comorbid conditions: underlying illnesses evolve; not uncommon
for patient to move from one disorder dominating to another dominating, so be prepared to change treatment focus;
document, document, document
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| Suggestions from Drug Enforcement Administration (DEA): when confronted by suspected drug abuser 1)
perform thorough examination; 2) document results of examination and questions you asked patient; 3) request patient’s
identification (preferably with photo) and Social Security number, and include these in patient’s chart; 4) call
previous practitioner, pharmacist, or hospital to confirm patient’s story; 5) confirm patient’s telephone number; 6)
confirm patient’s current address at each visit; 7) write prescriptions for limited quantities; 8) do not take patient’s
word for anything; 9) do not dispense drugs just to get rid of patient; 10) do not prescribe, dispense, or administer controlled
substances outside scope of your professional practice or in absence of formal patient-practitioner relationship
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| Legal perils: “patients with decision-making capacity get to make decisions”; failure to provide adequate pain control
not only clinical failure, but ethical and legal failure as well
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Pain Management and Western Ethical Tradition
| Common aspects of pain: patient often blames self for illness; patient’s loved ones suffer with him or her; loved ones
may feel frustrated and helpless; pain experience always multifactorial (eg, physical, psychologic, sociologic, spiritual);
pain is soul-stealing; patient’s greatest fear is loss of control
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| History of ethical imperative to try to relieve pain: Socrates—aim of civil disobedience is to reform state,
not to overturn it, and those who are civilly disobedient are among heroes of society, since they are willing to sacrifice
their own well-being for good of state; speaker posits that much of modern pain management borders on civil
disobedience because our society still holds outdated notions about use of controlled substances; Plato—living
ethically should be primary goal of human life; moral failing likely to arise from lack of humility in otherwise
praiseworthy persons; Aristotle—humans have specialized function or purpose; those who perform this function
excellently are virtuous; virtuous persons flourish in life; flourishing life is lived in mean between extremes; St. Thomas
Aquinas—suicide is wrong because it violates natural law of self-preservation; not permissible to achieve
good end, no matter how great, by evil means, no matter how minor; Immanuel Kant—some actions are morally
wrong, regardless of their consequences; humans’ capacity for reason gives them freedom and responsibility
(which inspired idea of “informed consent”); John Stuart Mill and Jeremy Bentham—actions that cause good consequences
are ethically good and those that cause bad consequences are ethically bad; human suffering is bad wherever
it is found; society ought to be arranged so that suffering is minimized
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| Principles of biomedical ethics: beneficence; nonmaleficence; respect for autonomy; justice
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| Making ethical behavior less intuitive: better reasons must be given in favor of overriding principle; moral objective
in disregarding principle must have realistic chance of being achieved; infringement of principle must be
least infringement possible commensurate with achieving primary goal; negative effects of infringement should be
minimized; decisions must be made in impartial manner
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| Beneficence: practitioner’s actions ought to benefit his or her patients; preventing or removing harm; promoting
good; specifying goals of therapy; “I will use treatment to help the sick according to my ability and judgment, but I
will never use it to injure or wrong them”
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| Nonmaleficence: practitioner’s actions ought not to harm patients; duty to refrain from certain actions; “primum
non nocere”; nonmaleficence must be balanced with beneficence; intent to benefit primary
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| Autonomy: practitioner ought to respect patient’s right to make decisions about his or her health care; respect patient’s
personal wishes; do not interfere with patient’s choices; amount of autonomy given to patient depends on his or her decision-making
capacity; provide informed consent; patients have right to—information necessary to make decisions;
treatments necessary to resolve pain; refuse therapy they consider burdensome; consideration for time-limited trials
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| Justice: practitioner ought to balance fairly interests of all parties affected by patient’s decisions; distributive justice
involves resolving problems of scarcity of resources, competition, and trade-offs; principle of formal justice asks,
“what is equality?”
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| Ethics of informed consent: patients must have access to enough information to make informed consent; they
must be informed of alternatives (including doing nothing); consent must be voluntary; get patient to ask question
and document both question and answer; communicate decisions to patient’s family or significant others
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| Discuss treatment preferences: involve all members of care team; be familiar with policies and statutes; select
appropriate setting for discussion; ask patient and family what they understand; discuss general goals of care
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| Aspects of informed consent: identify problem to be addressed by treatment; explain what is involved in that
treatment; discuss what is likely to happen if patient declines treatment; describe benefits and burdens of treatment
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| Principle of double effect: an action that causes bad effect is permissible if and only if 1) only good effect is intended
(bad effect may be foreseen, as long as not intended); 2) action is not intrinsically wrong; 3) causal chain
that leads to good effect must not contain bad effect; 4) there are no ways to achieve good effect without causing
bad effect; 5) good effects of action outweigh bad effects
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| Physician-assisted suicide: ancient problem (going back at least to Hippocrates’ time); most physicians probably
receive request to assist in suicide, but it may be veiled (eg, “this hospice care is not for everyone” or “how much
longer is this going to go on?”); such requests are signs of patient crises; patients often request help with dying because
of fear (eg, fear of becoming embarrassing to family, draining family finances), depression, physical suffering;
current legal status—United States Supreme Court ruled that people have no constitutional right to die, that
physician-assisted suicide is state’s rights issue; Oregon only state that allows physician-assisted suicide at this
time; however, Supreme Court also said patients do have right to palliative care
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| New legal theory: failure to treat pain in elderly patients is form of elder abuse and as such is felony in some states
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| Changing philosophy about pain management: patient may actually know what helps and what does not; locus
of control given to patient may provide best level of pain management; patient can best determine endpoints of
therapy; patient part of pain-management team; opioids play increasingly important role in long-term pain management
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| Last words: “we must continue to improve education about pain treatments that have clear benefits, while also acknowledging
risks; there is still a lack of access to pain-management services for too many people”
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Educational Objectives
| The goal of this program is to educate the listener about ethical and legal implications of pain management and end-
of-life care. After hearing and assimilating this program, the clinician will be better able to:
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| 1. Describe some of the external barriers to pain management that still exist in American society.
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| 2. Explain the difference between medical need for controlled substances and addiction.
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| 3. Discuss behaviors that get physicians into trouble with drug regulators.
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| 4. Briefly describe the influence of the Western ethical tradition on pain management.
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| 5. Explore the current legal approach to pain management.
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Suggested Reading
Alpers A: Criminal act or palliative care? Prosecutions involving the care of the dying. J Law Med Ethics 26:308,
1998; Beauchamp TL, Childress JF: Principles of Biomedical Ethics 5th ed. New York, NY: Oxford University
Press, 2001; Benton TJ: Pain management is part of advance directives discussion. Am Fam Physician 73:1331,
2006; Boswell MV, Cole BE, eds: Weiner’s Pain Management: A Practical Guide for Clinicians. Boca Raton:
CRC Press, 2000; Brett C: Challenges and conflicts in pain management. Camb Q Healthc Ethics 10:88, 2001;
Cantor NL. On Kamisar, killing, and the future of physician-assisted death. Mich Law Rev 102:1793, 2004;
Cleeland CS: Undertreatment of cancer pain in elderly patients. JAMA 279:1914, 1998; Cornelison AH: Cultural
barriers to compassionate care—patients’ and health professionals’ perspectives. Bioethics Forum 17:7, 2001;
Dubois MY et al: Pain management at the end of life: often a difficult call. Pain Med 4:81, 2003; Emanuel L:
Ethics and pain management: an introductory overview. Pain Med 2:112, 2001; Fins JJ: Commentary: Professionalism
and pain management. J Pain Symptom Manage 19:156, 2000; Flamm A: Legal trends in bioethics. J Clin
Ethics 13:168, 2003; Gallagher RM: Physician variability in pain management: are the JCAHO standards enough?
Pain Med 4:1, 2003; Gilbert HC, Rich BA, Fine P: Quality of care, teaching responsibilities, and patients’ preferences.
Pain Med 5:206, 2004; Gourlay DL, Heit HA, Almahrezi A: Universal precautions in pain medicine: a
rational approach to the treatment of chronic pain. Pain Med 6:107, 2005; Kaldjian LC et al: Internists’ attitudes
towards terminal sedation in end-of-life care. J Med Ethics 30:499, 2004; Lewis T: Pain management for the elderly.
William Mitchell Law Rev 29:223, 2002; Martino AM: In search of a new ethic for treating patients with
chronic pain: what can medical boards do? J Law Med Ethics 26:332, 1998; Rich BA: An ethical analysis of the barriers
to effective pain management. Camb Q Healthc Ethics 9:54, 2000; Rich BA: Physicians’ legal duty to relieve
suffering. West J Med 175:151, 2001; Rosenfeld B et al: Measuring desire for death among patients with HIV/
AIDS: the schedule of attitudes toward hastened death. Am J Psychiatry 156:94, 1999; Sial VA, Moss AH: Pain
management for end-of-life care. W V Med J 96:556, 2000; Sullivan M: Ethical principles in pain management.
Pain Med 1:274, 2000; Tucker KL: The debate on elder abuse for undertreated pain. Pain Med 5:214, 2004;
Tucker KL: Treatment of pain in dying patients. N Engl J Med 338:1231, 1998.
Faculty Disclosure
In adherence to ACCME guidelines, the Audio-Digest Foundation requests all lecturers to disclose any significant financial
relationship with the manufacturer or provider of any commercial product or service discussed. For this issue,
Dr. Cole disclosed that he is a consultant to, on the advisory board of, or on the Speakers’ Bureau of Purdue, Endo,
Pfizer, Ligand, Eli Lilly & Co; and he is a full-time employee of Aventine Health Sciences.
Dr. Cole was recorded at Pain Management and the Care and Treatment of the Terminally Ill, held February 16-19,
2006, in Las Vegas, NV, and sponsored by the American Psychiatric Association and the Nevada Psychiatric Association.
The Audio-Digest Foundation thanks Dr. Cole and the sponsors for their cooperation in the production of this
program.
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