Opiophobia (literally, a fear of opioids or their side effects, especially respiratory suppression) has been around for a long time. Nowadays it’s primarily prompted by the opioid epidemic that has caused a five-fold increase in overdose deaths over the past two decades. With opioids implicated in over 40,000 deaths in the United States each year, interventions such as daily milligram limits, short-term prescribing, and “risk evaluation and mitigation strategies” are important public health measures.
In addition to responding to the epidemic, we also need to identify what caused it. One contributing factor was the short-sighted extrapolation of the well-documented benefits of opioids in end-of-life care to chronic, non-malignant conditions. Opioids represent an invaluable (and largely irreplaceable) treatment for extreme pain at the end of life, whereas long-term prescribing can often lead to addiction, diversion, and long-term side effects.
But just as it was wrong to assume that opioids would benefit chronically ill patients in the same fashion as dying patients, it is equally misguided to attribute the risks of opioids for non-malignant conditions to end-of-life situations. While limiting opioid prescribing for chronic conditions makes good sense, blanket restrictions on opioid prescribing could lead to inadequate treatment of pain and dyspnea at life’s end.
Even before the epidemic, opiophobia was a profound concern for physicians. Studies showed that concern for opioids causing a patient to stop breathing (especially at high doses) led many patients to endure significant pain at the end of life. In response, the Rule of Double Effect (RDE) was used to reassure physicians that judicious pain management at the end of life did not constitute euthanasia. Based on the writings of St. Thomas Aquinas, the RDE helps to determine whether an action that has two effects—one good and one bad—is morally permissible. The RDE has four basic components:
1. The act itself must be, at worst, morally neutral.
2. The bad effect cannot be the means to the good effect.
3. The good effect must outweigh the bad effect (principle of proportionality).
4. The agent must only intend the good effect, although the bad effect may be foreseen.
Opioids that are used to relieve severe pain (the good effect) but end up suppressing a patient’s respiratory drive (the bad effect) meet all four conditions:
1. Administering an FDA-approved medication for a condition it is indicated for is not morally bad.
2. Pain is relieved through direct action of the medication, not through the patient’s death.
3. In cases where the pain is severe and the patient’s prognosis is poor, the benefit of analgesia can outweigh the harm of hastened death.
4. In appropriately titrating the opioids, the physician’s intention is to treat pain, with the foreknowledge—though not the intention—that death might be hastened.
While providing reassurance to some, the RDE has been criticized by others. Specific criticisms include its historical roots within a particular religious tradition, the complexity of physician intention, the responsibility for what occurs as a foreseeable result of someone’s actions (and not just what someone intended to happen), and the potential overemphasis on a physician’s intention (as opposed to the patient’s welfare).
While some have attempted to defend the RDE, others have questioned whether the RDE is really necessary to justify intensive opioid treatment at the end of life. The RDE, after all, is designed to justify actions that have two inevitable effects, one good and one bad. In the case of opioid treatment, however, respiratory suppression is far from inevitable. In point of fact, this side effect is actually rather rare when opioids are used appropriately.
In this respect, symptomatic treatment at the end of life is no different than nearly every other medical treatment, which involves a balancing of the hoped-for benefit with the possible complications or side effects. And while the bad effect in this case is indeed serious, death is also a risk of many other medical procedures. Far from necessarily hastening death, opioids often extend life in a patient who is dying. Opioids have been shown to prolong survival after ventilator withdrawal, likely by decreasing oxygen demand. Indeed, a large study of hospice patients found that opioid use was directly—rather than inversely—correlated with duration of life for terminally ill patients. Thus Fohr concludes: “In the case of medication to relieve pain in the dying patient, the RDE should be rejected not on ethical grounds, but for a lack of medical reality.”
Far from necessarily hastening death, opioids often extend life in a patient who is dying
Not only is the RDE unnecessary and often misapplied, appealing to it can actually be counterproductive as this risks perpetuating the misperception that opioids will certainly (or even likely) hasten death. Ironically, what was intended to empower physicians to optimally treat suffering—by assuaging concerns about euthanasia—could ultimately discourage them from achieving this goal by inextricably linking two effects: one noble, intended, and inevitable; the other frightening, unintended, and unlikely.
By attempting to reassure those who fear stepping over the line into euthanasia that they are not doing anything wrong, a great many others may be led to believe that hastened death is inevitable, rather than rare. Ethicists may bear some responsibility for this perception. A recent study of medical school ethics educators found that one-third believed that opioids were “likely to cause significant respiratory depression that could hasten death.” Understandably, these educators routinely appealed to the RDE as justification for such intensive pain management.
Given the uncertain—or even unlikely—correlation between opioid treatment at the end of life and hastened death, the RDE should not provide the sole justification of the former. Of course, some of the elements of the RDE would naturally factor into one’s analysis, such as whether the benefits of the treatment outweigh the risks. And to those with heightened concern about the ethicality of potentially hastened death, the RDE could provide valuable reassurance, especially given its roots in a religious tradition that might have prompted that very concern.
But for most physicians, all four components of the RDE need not necessarily be satisfied to justify a treatment with only potential complications. Otherwise, overreliance on the RDE could actually perpetuate the very injustice it was designed to prevent. As Angell notes, “I can’t think of any other area in medicine in which such an extravagant concern for side effects so drastically limits treatment.”
Featured Image Credit: “Focus on the hand of a patient in hospital ward” by Thaiview. Via Shutterstock.