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Pain: Ethical and Legal Issues

Persis Mary Hamilton, RN, CNS, MS, EdD

Wild Iris Medical Education is an approved provider for paramedic and EMT continuing education in California by the California Emergency Medical Services Agency: EMS CE Provider #49-0057.
Wild Iris Medical Education is an approved provider (#0007) of continuing education by the Continuing Education Coordinating Board for Emergency Medical Services (CECBEMS).
This course is appropriate for EMTs, paramedics, and first responders.

ETHICAL CONCERNS

Ethics, A Branch of Philosophy

Many folks roll their eyes and change the subject when they hear the word ethics, viewing it as too controversial or too complex to discuss freely. Nonetheless, ethics is a significant concern of thinking, caring persons, especially nurses who manage the care of people in pain.

Ethics is the branch of philosophy concerned with the rightness or wrongness of human behavior and the goodness or badness of its effects. Ethics assumes that people have the ability to make choices about their behavior. For that reason it has been the subject of philosophical discussion for centuries and has generated an enormous body of literature. Students of ethics have divided these writings into three general categories: descriptive (characterizing), analytical (metaethics), and prescriptive (normative). Descriptive ethics reports and describes the moral choices people make. Analytical ethics scrutinize the language people use to discuss issues of right and wrong. Prescriptive ethics offers advice about how people should decide what is good or bad behavior. It does this from two very different perspectives: teleological and deontological.

A teleological (consequential, utilitarian, situational) perspective affirms that the rightness or wrongness of an act is determined by the end results of an action. The term comes from the Greek teleos, meaning “end.” If the end result harms others, the act is considered wrong or bad. If the end result benefits others, the act is considered good or right. The central issue of this perspective is the principle of the “greatest good.” The utilitarian teachings of John Stuart Mill and the situation ethics teachings of Joseph Fletcher maintained that end results and circumstances are essential factors in considering the rightness or wrongness of any human behavior (Hamilton, 1996).

Teleological theories foster morality by developing the capacity of humans to make choices. These theories reject fixed moral rules of conduct such as the biblical command “Thou shalt not kill” (Exodus 20:13). For example, a man is suffering with intractable pain caused by an incurable disorder. He begs his physician to perform a surgical procedure that will relieve his suffering but might hasten his death. According to teleological perspective, the physician should perform the surgery because the end result (relieving pain) is a greater good than keeping the man alive with intractable pain.

The deontological (nonconsequentialist) perspective fosters morality by teaching humans to accept and obey fixed laws. The term comes from the Greek deontos, meaning “duty to obey.” Immanuel Kant is the theorist most often identified with deontological ethics. He maintained that certain acts are inherently right or wrong, regardless of the situation or the end results. In deontological ethics, there are no exceptions or mitigating circumstances. According to this perspective, preserving the life of the man with intractable pain is a greater good than relieving his pain and hastening his death. The physician’s duty is to obey the commandment “Thou shalt not kill,” regardless of the situation or end results. Thus, the deontological perspective simplifies ethical decision-making by removing the issue of mitigating circumstances.

Bioethics and Related Concepts

Bioethics is the application of ethics to matters of human life. As scientific knowledge expands and healthcare providers have greater control over pain and pain relief, life and death, it is vital that nurses address issues of right and wrong behavior.

Although some authors use the term morals to refer to human behavior and ethics to refer to formalized codes of conduct, both words mean the same thing. Ethics comes from the Greek word ethos and morals from the Latin word mores. In recent years, some politicians have substituted the word values for morality; however the word values has a much broader meaning.

Values are treasured ideals or attributes, such as creativity, achievement, adventure, power, friendship, and belief systems. Understanding one’s values brings purpose and clarity to life. The desirability of such clarity was recognized by Socrates, who is credited with saying “An unexamined life is not worth living.” To help people examine their lives and clarify their values, Louis Raths (1979) suggested a seven-step process that he called “values clarification.” Box 3-1 presents Raths’ process.

Belief systems are organized patterns of thought regarding the origin, purpose, and place of humans in the universe. These systems seek to explain the mysteries of life and death, good and evil, health and illness. Typically, belief systems include an ethical code of conduct about how people should relate to the world and its inhabitants.

Religions are patterns of thought and action that typically include belief systems, devotional rituals, organizational structures, and faith in a mystical power. Often, however, people develop their own belief systems, independent of organized religions.

Ethical Principles

Ethical principles are fundamental concepts by which people judge behavior. These principles help individuals make decisions and serve as criteria against which they measure behavior. Laws, on the other hand, are rules made by an authority with the power to enforce them. Although laws flow from ethical principles, they are limited to specific situations. Ethical principles are guiding ideals of conduct that speak to the spirit of a law, not necessarily to its letter.

Throughout recorded history, leaders of world religions have taught an overarching ethical principle commonly called the Golden Rule: “Do unto others as you would they do unto you.” Other teachers have proposed different choices: Kant held that duty was the central issue; Mills, the interest of all; Fletcher, love; Thiroux, human dignity; Nodding, care; and Gilligan, care and justice. A single, global principle for ethical behavior is an attractive approach, but when people face real-life situations they seek more precise guidance. Over the years, five ethical principles have emerged as especially applicable to nursing. They include: respect for human life and dignity, beneficence, autonomy, honesty, and justice. These principles take on special significance as we consider the management of pain.

HUMAN LIFE AND DIGNITY

Respect for human life and dignity is one of the most basic of ethical principles. It requires that “individuals be treated as unique and equal to every other individual and that special justification is required for interference with an individual’s own purposes, privacy, and behavior” (Rawls 1971). This ethical principle elevates respect for the life, freedom, and privacy of all humans. Thiroux says this principle is necessary for any moral system because “there can be no human being, moral or immoral, if there is no human life” (1990). When applied to pain management, respect for human life and dignity means nurses:

• Attend to every report of pain by clients or their families.
• Regard the personal privacy of clients as they deal with pain.
• Respect the lifestyle, personhood and belief systems of clients.
• Strive to sustain human life and dignity while relieving pain and suffering.

BENEFICENCE

Beneficence means doing good to benefit others. Although some writers separate beneficence (doing good) from nonmalfeasance (not doing harm), Frankena (1973) suggested the ethical principle of beneficence represents a continuum from not harming to doing good, specifically: (1) not inflicting harm, (2) preventing harm, (3) removing harm, and (4) promoting and doing good.

For nurses, beneficence means more than providing technically competent client care. It means acting in ways that demonstrate genuine and accurate empathy with nonpossessive warmth, including listening, empathizing, supporting, and nurturing. In fact, the central task of nursing—its very essence—is doing good for others. When applied to pain management, beneficence means nurses:

• Attend to the needs and complaints of clients, carefully assessing their level of pain.
• Believe clients when they report pain.
• Provide timely, appropriate interventions to relieve pain.
• Accurately evaluate the effectiveness of an intervention.
• Communicate the effectiveness of interventions to other healthcare members.
• Give clients nonpossessive warmth, accurate empathy, and unconditional positive regard.

AUTONOMY

Autonomy is the right of self-determination, independence, and freedom. It is the personal right of individuals to absorb information, comprehend it, make a choice, and carry out that choice. Nurses carry out the principle of autonomy by providing information to clients, assisting them to understand the information, and helping them make decisions based on knowledge they have gained. When applied to pain management, autonomy means nurses:

• Inform clients about available options for pain management.
• Make sure clients fully understand the actions and risks of pain relieving options.
• Allow clients enough time to consider pain-relieving alternatives.
• Accept decisions clients make regarding management of their pain.
• Implement and evaluate pain-relieving interventions chosen by clients.

HONESTY (TRUTHFULNESS)

Honesty means communicating the truth in word and deed. Even when nurses must convey unwelcome information to clients about an illness, injury, or treatment option, they do so truthfully. Withholding information from a client is appropriate only when the client is a minor child or an adult under the care of a legal guardian. When applied to pain management, the ethical principle of honesty means nurses:

• Provide factual information about treatment options, including benefits and risks.
• Use language that is clear and appropriate to the age and capacity of the client.
• Encourage client participation in pain management decisions.
• Convey genuine concern when giving unwelcome information.
• Accurately report and record critical data, regardless of personal consequences.

JUSTICE

Justice implies fairness and equality. It requires impartial treatment of clients. Like other ethical principles, justice is based on respect for human life and dignity. The traditional image of justice is a blindfolded woman with a scale, weighing an issue on the basis of objective evidence and judicial precepts. Justice means that scarce resources are to be distributed equally, using the same criteria for everyone. When applied to pain management, the ethical principle of justice means nurses:

• Attend to complaints of pain by clients, no matter how difficult they may be.
• Assess pain and intervene to relieve pain with equal diligence for all clients.
• Evaluate and communicate information about pain with fairness and lack of bias.

Ethical Dilemmas

A dilemma is a perplexing problem that requires a choice between conflicting alternatives. An ethical dilemma is a moral problem that requires a choice between two or more opposite actions, each of which is based on an ethical principle. For example, a nurse weighs whether to fully disclose the risks of a proposed treatment for pain, honoring the ethical principle of autonomy, or to withhold information about the risk of a treatment to reduce the client’s anxiety, honoring the ethical principle of beneficence. (See the preceding section titled Honesty.) Healthcare professionals are faced with many such dilemmas.

Resolution of ethical dilemmas requires careful evaluation of all the facts of the case, consultation with all concerned parties, and honest appraisal of the decision makers’ ethical stance (whether it is teleological, considering end-results, or deontological, obeying fixed laws of behavior).

Nowadays, ethical dilemmas in healthcare facilities arise more frequently because modern medicine can keep hearts and lungs functioning much longer than thinking brains. To help resolve these perplexing issues, many institutions appoint ethics committees made up of healthcare professionals, ethicists, lawyers, and clergy. The task of ethics committees is to help decision makers resolve ethical dilemmas. They often use an ethical decision-making process such as the following:

1. Gather relevant facts about the client’s age, diagnosis, circumstances and the ethical stance of the decision maker (deontological or teleological).
2. Identify and clearly state the problem.
3. List alternative actions, together with ethical principles that support each action.
4. Determine who can make the decision and assist that person to make it.
5. Provide emotional support to all the involved parties.

In support of the ethical principle of autonomy and to reduce ethical dilemmas, the Joint Commission on Accreditation of Healthcare Organization recommends that all adults discuss their wishes regarding artificial life support and sign a legal document, called an Advance Healthcare Directive, appointing someone to make healthcare decisions in their stead if they should become incapacitated (JCAHO, 2003).

Codes of Ethics

Codes of ethics are formal statements that set standards of ethical behavior for groups of people. In fact, one of the hallmarks of a profession is a code of ethics to which its members subscribe. Box 3-2, American Nurses Association’s Code of Ethics for Nurses with Interpretive Statements and Box 3-3, International Council of Nurses’ Code of Ethics for Nurses, make explicit the goals and values of the profession and provide guidance for carrying out nursing responsibilities.

LEGAL ISSUES

Federal Pharmaceutical Legislation

Although there are many modalities in the pain management arsenal, drugs constitute one of its most effective and often-used weapons. Until the beginning of the twentieth century, no federal rules or regulations protected consumers from ineffective or harmful drugs. After several drug-induced tragedies, the U.S. Congress passed the Pure Food and Drug Act of 1906. This act recognized the United States Pharmacopeia, a publication that lists drugs that met certain standards for dosage, therapeutic use, client safety, quality, purity strength, and packaging. These drugs were called “official” and were permitted to print “USP” after the name of the drug. This act also empowered the federal government to take legal action against manufacturers of drugs that did not comply with standards. Since then, many laws have been passed to further ensure the safety and effectiveness of drugs. Table 3-1 lists some of the most important legislation.

TABLE 3-1

FEDERAL PHARMACEUTICAL LEGISLATION

Year	Title of Law	Major Provisions
1906	Pure Food and Drug Act	Designated official standards for drugs and their labeling in the USP and National Formulary
1912	Sherley Amendment	Prohibited manufacturers from making fraudulent claims about drug efficacy and therapeutic effects
1914	Harrison Narcotic Act	Legally classified habit-forming drugs as narcotics: regulated the importation, manufacture, sale, and use of narcotic substances
1938	Federal Food, Drug, and Cosmetic Act	Added the Homeopathic Pharmacopeia as a third drug standard; required that drugs be approved as safe by the FDA before marketing; further outlined criteria for drug labeling
1945	Amendment to the Food and Drug Act	Provided for certification of biological products used as drugs (antibiotics, insulin, etc.) on batch basis; allowed for direct supervision and inspection of drug manufacture
1952	Durham-Humphrey Amendment	Distinguished between prescription and nonprescription drugs
1962	Kefauver-Harris Amendment	Authorized FDA to supervise drug manufacture to ensure safety and efficacy and to establish official drug names; specified greater controls on experimental drugs
1971	Comprehensive Drug Abuse, Prevention, and Control Act, also known as the Controlled Substances Act	Set strict controls on manufacture and distribution of controlled substances (possession unlawful without a prescription); established government programs to promote prevention and treatment of dependence
1997	Food and Drug Administration Modernization Act	Tightened regulation of food, drug, devices, and biological products
1998	Drug Regulation Reform Act	Shortened drug investigation process to hasten release of drugs to the public

Controlled Substance Act

In 1971, in response to the growing misuse and abuse of drugs in the 1960s, Congress passed the Comprehensive Drug Abuse, Prevention, and Control Act. Known as the Controlled Substance Act, the legislation is of particular concern to healthcare professionals concerned with the management of pain. The act created a schedule of controlled substances, ranking them according to their potential for abuse. Specifically, it identified five categories or schedules of drugs, from those with the highest abuse potential (C-I) to those with the lowest abuse potential (C-V) as shown in Table 3-2.

TABLE 3-2

CONTROLLED SUBSTANCES AND DISPENSING RESTRICTIONS

Category/ schedule	Abuse potential	Dispensing restrictions	Examples
C-I	High: possible severe physical and psychological dependency; no approved medical use	Only with approved protocol	Heroin, marijuana, LSD, mescaline, peyote, psilocybin, methaqualone
C-II	High; possible severe physical and psychological dependency	Written prescription only (if phoned in, written prescription required within 24 hours) no prescription refills, container warning label required	Codeine, cocaine, hydromorphone, morphine meperidine, methadone, oxycodone, secobarbital, pentobarbital, amphetamine, methylphenidate
C-III	Less than C-II drugs; moderate to low physical or high psychological dependency	Written or oral prescription that expires in 6 months; Maximum refills: 5 in 6 months; container warning label required	Combination drugs containing hydrocodone, codeine, dihydrocodeine, oxycodone, paregoric, morphine; non-narcotic compounds of pentazocine, propoxyphene
C-IV	Less than C-III; limited physical or psychological dependency	Written or oral prescription that expires in 6 months; no more than 5 refills in 6 months; container warning label required	Barbital, phenobarbital, chloral hydrate, meprobamate, fenfluramine, benzodiazepines, dextropropoxyphene, pentazocine etc.
C-V	Less than C-IV; limited physical or psychological dependency	Written prescription or over-the-counter; varies with state law	Medications used for relief of coughs or diarrhea containing limited amounts of opioids

State Legislation

In addition to federal laws, legislative bodies of the states and territories pass laws regulating the manufacture and distribution of food, drugs, and medical devices. This authority is derived from the Tenth Amendment to the U.S. Constitution, which says “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” Of special concern to nurses are laws that affect the management of pain, and, specifically, laws that authorize the medicinal use of marijuana.

MARIJUANA

Marijuana is made from the chopped leaves and flowers of the Cannabis sativa plant, a native of East India. It is grown for its fiber (hemp) and resin, which contains the active ingredient cannabinol. Since ancient times the plant has been chewed, smoked, and drunk by people everywhere in the world for its psychic effects. The drug produces a calm, mildly euphoric state with slowed reaction time, heightened sensations, and distorted time perception. Long-term use does not seem to cause physiologic dependence, but may cause psychological dependence and lung damage from smoke inhalation. The chemical, tetrahydrocannabinol (THC), is synthesized and marketed as the drug dronabinol (Marinol). Its two approved uses are to treat: (1) anorexia associated with weight loss in clients with HIV-AIDS, and (2) nausea and vomiting associated with cancer chemotherapy (Unimed Pharmaceuticals, 2005).

MEDICAL MARIJUANA LAWS

Because of vigorous enforcement of the Controlled Substance Act by the federal Drug Enforcement Administration (DEA), and harsh penalties imposed on individuals who use marijuana, many states, including Oregon, California, Washington, Nevada, Hawaii, Maine, and Alaska, have passed laws asserting their right to regulate drugs within their borders. These laws remove state-level criminal penalties on the use, possession, and cultivation of marijuana for medicinal purposes. Although the laws differ, most require a physician’s diagnosis and recommendation, registration of the user, and limitation of the amount of marijuana a person may grow or possess (Drug Policy Research Center, 2005).

MEDICAL MARIJUANA LAW OF OREGON

Oregon provides an example of the evolving laws about marijuana use for medical purposes. In 1998 Oregon voters approved Measure 67, a measure that removed state-level criminal penalties on the use, possession, and cultivation of marijuana by individuals who possess a signed recommendation from their physician stating that marijuana ”may mitigate” debilitating symptoms. Under the act, a diagnosis of one of the following illnesses affords legal protection:

• Cachexia
• Cancer
• Chronic Pain
• Epilepsy and Other Disorders Characterized by Seizures
• Glaucoma
• HIV/AIDS
• Multiple sclerosis and other disorders characterized by muscle spasticity and nausea

Other conditions are subject to approval by the Heath Division of the Oregon Department of Human Resources. Clients or their primary caregivers may legally possess no more than three ounces of usable marijuana, and may cultivate no more than seven marijuana plants, of which no more than three may be mature. The law establishes a confidential state-run client registry that issues identification cards to qualifying clients. Clients who do not join the registry or possess greater amounts of marijuana than allowed by law may argue the “affirmative defense of medical necessity” if they are arrested on marijuana charges. To date, nearly 5000 cards have been issued.

In July 1999 the Oregon legislature passes a law mandating that patients or their caregivers may only cultivate marijuana in one location and requires that patients must be diagnosed by their physician at least 12 months prior to an arrest in order to present an affirmative defense. This bill also states that law enforcement officials who seize marijuana from a client pending trial do not have to keep those plants alive. In 2004 the Oregon Board of Health added “agitation due to Alzheimer’s disease” to the list of debilitating conditions qualifying for legal protection.

In 2001 program administrators established temporary procedures further defining the relationship between physicians and patients. The new rule defines the attending physician as a “physician who has established a physician/patient relationship with the patient, is primarily responsible for the care and treatment of the patient, has reviewed a patient’s medical record at the patient’s request, has conducted a thorough physical examination of the patient, has provided a treatment plan and/or follow-up care, and has documented these activities in a patient file” (National Organization for the Reform of Marijuana Laws, Oregon, 2005).

Posted November 18, 2005

Expires November 1, 2009

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