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15 The principle of double effect in palliative care: euthanasia by another name?
The Case
Mrs. Ryan was a 58-year-old woman with widely metastatic breast cancer. She entered a hospice a month prior to this hospital admission. A Do Not Attempt Resuscitation (DNAR) order had been written 2 months ago at her request. Per her living will, she was willing to forgo artificial nutrition and hydration when she was no longer able to take food and water by mouth. Her pain and symptoms were well controlled on an outpatient regimen of celecoxib, amitriptyline, lorazepam, oxycodone hydrochloride, and morphine sulfate. After 2 weeks on this regimen, she was admitted to the hospital due to unbearable pain in her back, pelvis, and shoulders (presumed due to bone metastases). In order to relieve pain and symptoms, intravenous fentanyl and lorazepam were administered and titrated up when Mrs. Ryan exhibited verbal or physical signs of distress or pain. She was receiving 700 mcg/h of fentanyl with 100 mcg boluses every hour for breakthrough pain. In keeping with Mrs. Ryan’s wishes, her physicians achieved their therapeutic goal of relieving her pain and symptoms, but they knew there may be a “double effect.” The medications could suppress respiration and hasten her death.
What is the ethical rationale for allowing physicians to take this risk?
The principle of double effect (DE)
St. Thomas Aquinas first used the term “double effect” to refer to “the duality of results of a single human action” in discussing killing in self-defense.1 If one attempts to defend oneself, and the assailant is killed, it does not mean that death was the defender’s intention. Catholic moral theology distinguishes what someone intends and the side effect (“foreseen but unintended consequences”), suggesting that people remain responsible for, but are less culpable for, such double effects.
A modern formulation of DE is:
(T)he traditional rule of double effect specifies that an action with two possible effects, one good and one bad, is morally permitted if the action: (1) is not in itself immoral; (2) is undertaken only with the intention of achieving the possible good effect, without intending the possible bad effect even though it may be foreseen; (3) does not bring about the possible good effect by means of the possible bad effect; and (4) is undertaken for a proportionately grave reason.2
In the context of caring for a terminally ill patient, DE allows healthcare providers to: (1) provide adequate pharmacological pain and symptom management (a good action) knowing that (2) the foreseen but unintended consequence is that the medications may suppress respirations and hasten death. The provider must intend only good pain management. She may not hope to save the patient from suffering by causing the patient’s death, as this would constitute euthanasia which is illicit in this moral framework. (3) Death (the bad effect) is not a means to alleviate suffering (the good effect). (4) Pain and suffering at the end of life is a “proportionately grave reason” to justify the use of opioids, but the risk of hastening death is only ethically justified if the patient is terminally ill.
Preconditions and components of DE
Certain virtues and prohibitions are taken for granted in the employment of DE. For example, alleviating pain at the end of life is morally virtuous, and intentionally killing or assisting in the death of another person is always prohibited. Physicians need not hold these beliefs. There are a myriad of other ethical frameworks that may inform moral behavior, such as maximizing benefit and minimizing harm (utility) or acting according to duty (deontology). For example, if a competent, terminally ill patient requested euthanasia by means of high doses of opioids, one could argue this is morally permissible because it is consistent with the patient’s wishes, the patient is dying, and euthanasia will mercifully end her suffering in the manner she chooses. This is a legitimate ethical argument, but it is not an argument based in DE. Ultimately, each physician must decide if he finds DE reasoning persuasive, and to do so he should understand both the preconditions necessary for an appeal to DE and its specific components.
Proportionality
Prior to invoking DE, the patient must be dying and there must be evidence that the patient’s pain and suffering cannot be managed using less risky means, which always include non-pharmacological management such as spiritual and social support. The expert management of pharmacological and non-pharmacological treatments is essential to the concept of proportionality. Jansen and Sulmasy describe proportionality: “A physician’s therapeutic response to terminal suffering is justified, even if it imposes a high risk of hastening the patient’s death, if and only if (1) the measures implemented are directly proportionate to the intensity of the patient’s suffering; [and] (2) the measures implemented are appropriate for the type of suffering the patient is experiencing …”3 In addition, we must exhaust all “equally efficacious alternatives with fewer side-effects.”4 For example, if Mrs. Ryan was receiving moderate doses of narcotics and anxiolytics but was still in pain and her doctor chose to suddenly administer an extremely high dose of fentanyl, DE could not legitimately be invoked. There is no medical or ethical justification to leap to such a high dose of fentanyl without first testing accelerated but intermediate doses, and therefore no “proportionately grave reason” (e.g., unremitting pain despite carefully titrated analgesia). An appeal to DE can only be made after the patient is receiving expert pain and symptom management. One cannot rely on DE to justify poor clinical care.
The principle of DE does not address the issue of consent
In cultures where respect for autonomy is a legal and ethical priority, the patient or legal surrogate should understand and accept the risks of pain management. Patients and surrogates consent to all medical interventions, so palliative care should be no exception. However, we respect patient autonomy due to obligations that are independent of DE. DE is silent on consent. Instead, DE revolves around intention.
Intention
Doctors who want to appeal to or better understand DE should be able to distinguish between the intention of the act and the intention of the actor. The intention of the act is the goal of an action and should be discernible by looking at the drugs and dosage increments as well as the way pain and symptoms are assessed. For example, lorazepam, oxycodone hydrochloride, morphine sulfate, and fentanyl effectively alleviate pain and anxiety. However, the administration of potassium chloride, under the auspices of analgesia, would be impermissible because, under the principle of DE, therapy must still be governed by the standard of care, and potassium chloride cannot alleviate pain.
In the interest of good palliative care, pain and symptoms should be assessed frequently so that the patient can receive additional medication if she needs it and so that the dosage can be maintained if pain relief has been achieved. When physicians use appropriate analgesics and write orders to titrate medication based on evidence of pain and suffering, such as groaning, agitation, verbal complaints, diaphoresis, hypertension, or unexplained tachycardia, they demonstrate that the intention of the act is geared toward alleviating pain. Unmonitored continuous infusions or orders to titrate up irrespective of signs of pain, anxiety, or dyspnea may suggest poor clinical management or a covert intention to hasten death. Neither is acceptable under DE. Expert clinical management and exhaustive efforts to avoid risks of respiratory depression are preconditions of DE. Pre-emptive dosing in anticipation of signs and symptoms of suffering is not forbidden under DE, provided it meets all DE criteria, is proportional, incremental, and in keeping with expert clinical management and monitoring.
Related posts:
Informed consent and the pediatric patient
The use of ethics consultation regarding consent and refusal
Ethical considerations in interventional pain management
Conflicts of interest in research funding
Physician conscientious objection in anesthesiology practice
Opioid therapy in addicted patients: background and perspective from the US
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