Guiding Ethical Principles in Patient Care

In pain management and end of life care, there are four guiding ethical principles which govern our decision making and care of patients. These are the same principles that guide us in the conduct of medicine in general:

• Nonmaleficence: minimize harm (Hippocratic oath)

• Beneficence: do good if you can (St. Thomas Aquinas, 13th century)

• Patient autonomy: respect for the patient as a person, informed consent (Nuremberg trial of Nazi physicians who performed experiments on humans without consent is an example of violation of patient autonomy)

• Justice: fair use of available resources (not everyone is entitled to everything that medicine has to offer when resources are limited)

In implementing the above principles the physician has to balance three dichotomies:

• The potential benefits of treatment must be balanced against the potential burdens.

• Striving to preserve life but, when biologically futile, providing comfort in dying.

• Individual needs are balanced against those of society.

Eric J. Casssel, in his article regarding nature of suffering and the goals of medicine published in the New England Journal of Medicine, stated ".. .The relief of suffering and the cure of disease must be seen as twin obligations of a medical profession that is truly dedicated to care of the sick. Physicians' failure to understand the nature of suffering can result in medical intervention that (though technically adequate) not only fails to relieve suffering but also becomes a source of suffering itself."

In pain management as well as end of life care, providing pain relief can present a dilemma for physicians who operate under misconceptions of both the law and ethics. The Rule of Double Effect, which is the moral doctrine taken from the teachings of St. Thomas Aquinas of the 13th century, gives physicians the duty and obligation to relieve pain and suffering. Yet these philosophical arguments do not provide insight into the ambivalence that practitioners feel when they legitimately engage in these practices. Why should a physician feel ambivalent about doing the "right thing?"

The Rule of Double Effect states that an action having two effects, one good and one bad, is permissible if five conditions are fulfilled:

1. The act itself is good or at least morally neutral, e.g., giving morphine to relieve pain.

2. Only the good effect is intended (relieving pain) and not the bad effect (killing the patient).

3. The good effect is not achieved through the bad effect (pain relief does not depend on hastening death).

4. There is no alternative way to attain the good effect (pain relief).

5. There is a proportionately grave reason for running the risk, e.g., relief of intolerable pain.

Clearly, to justify use of this rule, the patient or surrogate decision maker would need to be informed of the risks and give valid consent. It is clear that any patient coming for surgery is expecting that his/her physician will attend to the pain which results from the surgery including the use of opioids. If other forms of pain relief are to be used such as epidural analgesia or peripheral nerve blockade, then additional consent discussions should be undertaken so that patients can make informed decisions about their pain management care.

According to the Rule of Double Effect it is clear in end of life care that there is ethical and legal sanctions for the use of whatever doses of opioids that are necessary so long as death is not directly intended. If the doses of the opioids necessary to relieve pain are large enough to produce deep sedation, this too would be permissible, if suffering can be relieved in no other way.

Thorn and Sykes (2000) studied 238 consecutive dying patients. In a retrospective study, they found that there was no difference in survival between those patients requiring escalating doses of opioids vs. those patients that were on stable doses of opioids. Because of this finding they concluded that the Rule of Double Effect was not even needed to justify the use of opioids for the control of pain at the end of life.

Much of inadequate pain management, particularly in end of life care, can be traced to lack of knowledge on the part of physicians. In a typical example, a physician stated, "We must wean off the morphine. We're killing him." This statement was in regard to an endstage acquired immunodeficiency syndrome (AIDS) patient who had a do not resuscitate (DNR) status, documented pain scores of 5/10 and 6/10, and was currently receiving 3 mg/h IV morphine infusion. The physician wanted to give naloxone to reverse the effects of the morphine and then remedicate the patient with 25 mg meperidine IV q4h PRN for pain control. What is wrong with this scenario?

• 72 mg morphine = 720 mg meperidine

• The patient was already in moderate to severe pain at the current dosage which was already inadequate, and the physician was reducing the dose by 80%. Further, by writing a PRN order, the physician was insuring that the patient would not even get the 25 mg of meperidine q4h.

This is a classic case of "opiophobia" - the unreasonable fear of opioid use, based on an inaccurate assessment of its dangers. It affects patients as well as physicians and may be one of the greatest barriers to the provision of effective pain medication. The 1993 California Medical Board Statement on the Prescribing of Controlled Substances stated that concerns about regulatory scrutiny should not make physicians who follow appropriate guidelines reluctant to prescribe or administer controlled substances, including schedule II drugs, for patients with a legitimate medical need for them.

Likewise, the Federal Controlled Substances Act (CSA) does not address medical treatment issues such as the selection or quantity of prescribed drugs. The CSA regulates drugs, not the practice of medicine. According to a Drug Enforcement Administration (DEA) policy, the practitioner's judgment, based upon training, medical specialty, and practice guidelines, determines what may be considered legitimate medical purpose. According to the Federal CSA, in order for a prescription to be valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. A dentist, for example, cannot prescribe opioids for gynecological pain even though he/she has a DEA number.

Model Guidelines for the Use of Controlled Substances for the Treatment of Pain were developed jointly by the DEA and Federation of State Medical Boards of the United States and adopted on May 2, 1998. The purpose was (to) protect legitimate medical uses of controlled substances while preventing drug diversion and eliminating inappropriate prescribing practices. Simply put, you have a license to drive your car but you have to recognize stop signs and traffic lights.

Prescribing good faith requires an equally good faith history, physical examination, and documentation [of benefit]. One can always be sued by a patient claiming injury or becoming addicted to opioids. One can always be manipulated or deceived by individual patients seeking to abuse opioid medications. But careful monitoring, and particularly documentation of benefit, will reduce these risks to both the physician and the patient to a minimum.

The issue of the benefit of opioids in the treatment of chronic pain remains controversial. It is beyond this chapter to discuss the data supporting and not supporting opioids in chronic pain, but one issue should be considered. That is the issue of opioid contracts. Many pain management physicians feel that they should have a signed contract between them and their patients in which patients are required to agree to certain stipulations in order to continue treatment with opioids. However, contracts are legal documents which imply distrust between the parties; therefore, rules must be stipulated.

Therefore, a "contract" requirement establishes an "I don't trust you" relationship between the patient and the physician. Other physicians therefore call the "contract" an

"agreement." This is a better term but it really does not convey the true intention of the document. The document is really an "informed consent agreement for treatment." The treatment of course is chronic opioid therapy, which carries with it certain risks, such as addiction, dependence, constipation, sedation, and confusion. It can also provide the benefit of pain relief.

These documents usually also contain conditions of treatment such as the patients can only obtain their prescriptions from one physician, they have a responsibility to keep track of their prescriptions such that they do not run out on weekends or holidays, and that they must refrain from using illicit drugs. The consequences of abnormal behavior are usually specified in the informed consent as well. But the document should be written in such a way that it is not threatening to the relationship between the doctor and the patient and to provide true informed consent to proceed with a treatment that does have risks as well as benefits associated with it, just like an invasive pain management procedure or a surgical procedure. The patient is also given information about the risks and benefits of alternatives to the opioid therapy to complete the process.

In providing symptom management and palliative care at the end of life, difficult decisions have to be made with respect to initiating therapeutic interventions or discontinuing interventions. It is interesting that there appears to be a great deal of discrepancy between what physicians state as to their biases for withdrawing life support measures and what they actually practice in real life. Asthenia, malnutrition, cachexia are common in dying patients with advanced cancer. They may in fact be adaptive mechanisms which do not require intervention.

Enteral feedings can lead to pneumonia from aspiration or diarrhea from poor absorption. Parenteral feeding requires intravenous access, and there is no evidence for improved survival, no evidence for improved tumor response to chemotherapy, and no evidence of decreased chemotherapy toxicity. The idea of decreased surgical complications with the use of total parenteral nutrition (TPN) is debatable. In animal studies there is evidence of actual enhanced tumor growth, but there is no evidence for enhanced quality of life or satisfaction of hunger.

In their study related to biases in how physicians choose to withdraw life support, Christakis and Asch (1993) reported that in order of preference, physicians find it easier to withdraw or withhold treatments in the following order: blood products, hemodialysis, intravenous vasopressors, total parenteral nutrition, antibiotics, mechanical ventilation, tube feedings, and finally intravenous fluids.

These therapies correlate with the preferences to withdraw forms of therapy supporting organs that failed for natural rather than iatrogenic reasons, to withdraw recently instituted rather than longstanding interventions, to withdraw forms of therapy resulting in immediate death rather than delayed death, and to withdraw forms of therapy resulting in delayed death when confronted with diagnostic uncertainty.

In their report on cancer patients receiving home TPN in 1997, Cozzaglio et al. (1997) retrospectively studied patients with metastatic cancer who were treated with home TPN. They note that the use of TPN in end-stage cancer patients varies from country to country. In the United States, Japan, and Italy, 40-60% of all patients getting home TPN have cancer, compared to only 18% in France and 5% in the UK. They further noted that the variance reflects a difference in cultural, ethical, social, and economic approaches to the problem, with a lack of a scientific basis resulting from the scarcity of specific literature.

They concluded that home TPN does not benefit cancer patients with a Karnofsky score of <50. In those patients who were treated for less than 3 months (Karnofsky < 50), there was no benefit in quality of life improvement.

Since dyspnea is a subjective experience similar to pain, it has a complicated pathophysiology that is affected by physical, psychological, social, and spiritual factors. The involvement of the entire interdisciplinary team is essential for treating dyspnea effectively, particularly in the terminal stages of disease.

Hydration is another area that presents ethical problems for physicians in the dying patient. Too much hydration in a patient who is unable to eliminate the fluid can lead to pulmonary congestion and dyspnea and edema around encapsulated tumors leading to pain.

In dealing with pain or end of life care, we must make every effort to control pain, being mindful of the risks of our interventions, but at the same time not be afraid to take action.

The late Primo Levi, an Italian journalist, said, "If we know that pain and suffering can be alleviated, and we do nothing about it, then we ourselves become the tormentors." However, according to another, unknown, author, "When men lack goals, they tend to engage in activity." Therefore, to reiterate the opening statement of this chapter, it is our job as compassionate and professional physicians to, "Do the right thing, and do it first" according to William Osler.

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