Mark A Rothstein. The Journal of Law, Medicine, and Ethics. Volume 45, Issue 4, 2017.
In the next hour, eight Americans will die of a drug overdose. According to the National Center for Health Statistics, in 2016, approximately 71,600 Americans died of a drug overdose. The largest number of deaths, 20,100, were from synthetic opioids excluding methadone (primarily fentanyl and fentanyl analogs), which was more than double the 9,900 deaths the preceding year. There were also 15,400 deaths from heroin; 14,400 deaths from natural and semi-synthetic opioids (including prescription opioids); 10,600 deaths from cocaine; 7,600 deaths from psychostimulants with abuse potential (methamphetamines); and 3,300 deaths from methadone. Between 1999 and 2014, opioid deaths increased nearly fourfold.
The magnitude of the opioid abuse problem and the nature of the harms extend beyond the number of deaths from overdoses. The number of opioid prescriptions written in the United States peaked in 2012, when health care providers wrote 259 million prescriptions for opioid pain medications, the equivalent of one for every adult in the country. By 2016, “only” 215 million opioid prescriptions were dispensed by retail pharmacies. The National Institute on Drug Abuse estimates that 91.5 million Americans are taking opioids, such as OxyContin and Vicodin. At least 2 million people have an opioid use disorder (OUD) involving prescription opioids.
Although the problem of opioid abuse has increased greatly in the last decade, substance abuse is a longstanding, multi-faceted, and seemingly intractable social problem in the United States. Anne Case and Angus Deaton, economists at Princeton, have written that overdoses, suicides, and alcohol- and drug-associated diseases are actually the symptoms of a larger problem – what they call “deaths of despair.” The despair, borne of economic decline, poor health, and the absence of hope for the future, is greater in certain demographic categories, such as income groups and geographic areas. To illustrate the effects of income and geography, in 2016, the low-income states of Alabama, Arkansas, Tennessee, and Mississippi had the highest opioid prescribing rates, whereas the high-income states of Minnesota, California, New York, and Hawaii had the lowest opioid prescribing rates.
In devising long-term solutions to the opioid crisis it is essential to focus on the larger societal issues, including economic development, income distribution, educational opportunities, environmental conditions, and access to health care and social services. Only then will strategies for the prevention and treatment of substance abuse have a realistic chance of success.
This paper, however, will not consider everything that needs to be done to address the opioid crisis. It will be much narrower. I will discuss the effect of the opioid crisis on the physician-patient relationship, including the physician’s role in pain management and treatment of OUD. Unquestionably, physicians are still prescribing far too many opioids. Nevertheless, in my view, many physicians, in their efforts to reduce opioid prescribing, are now failing to provide adequate pain management for certain patients, such as those who have intermittent, debilitating, acute pain caused by serious, chronic medical conditions.12 In addition, many physicians have recently implemented policies of discontinuing any treatment of patients suspected of having OUD, leaving them without access to rehabilitation services or continuity of medical care. Left to their own devices, many of these individuals begin using heroin or illegally obtained synthetic opioids, become infected with hepatitis B or C or HIV, or suffer the catastrophic effects of an overdose.
Role of Physicians
Unlike other substance abuse problems in U.S. history, such as those involving opium or cocaine, many of today’s addicted individuals trace their addictions to opioid pain prescriptions lawfully written by physicians. For example, in one study, 80% of current heroin users reported that they began with prescription opioids. I mention this not to blame or shame physicians, but because I believe the role of physicians in contributing to addiction helps to establish their ethical responsibilities to take an active role in treating and supporting their patients as our society attempts to deal with this devastating public health challenge.
Unquestionably, physicians are still prescribing far too many opioids. Nevertheless, in my view, many physicians, in their efforts to reduce opioid prescribing, are now failing to provide adequate pain management for certain patients, such as those who have intermittent, debilitating, acute pain caused by serious, chronic medical conditions.
Several other actors in the opioid tragedy also deserve mention. These include the pharmaceutical companies that aggressively marketed opioids while understating their highly addictive nature; medical educators who failed to train their students adequately in pain management and safe opioid prescribing practices; health insurers that preferred to pay for cheaper opioids than more expensive, but safer, alternatives, such as behavioral and physical therapies; and other prescribers, such as dentists and even veterinarians, some of whom also prescribed opioids without adequately taking steps to prevent diversion.
As awareness of the problem of prescription opioid abuse heightened in the last few years, legislators, regulators, and physician practice administrators began to address it. In a growing number of institutions and in many physician practices it became acceptable for physicians to write opioid prescriptions only for post-operative patients, cancer patients, and patients at the end of life. Even among these groups of patients with obviously legitimate pain management needs, many patients are finding it more difficult to obtain essential opioids. One reason is that physicians are concerned about the possibility that state medical boards, accrediting bodies, and law enforcement agencies will conclude that their prescribing practices for opioids are improper.
To combat the problem of opioid abuse, virtually every state has adopted a prescription drug monitoring program (PDMP) to prevent “doctor shopping,” “pill mills,” and other abusive behaviors by drug-seeking individuals or rogue prescribers. These programs were advanced by two federal statutes. The first law, the Controlled Substances Act of 1970 (CSA), required physicians prescribing controlled substances to register with the Drug Enforcement Administration and to maintain records of scheduled drugs they prescribed. The CSA also endorsed triplicate prescription forms for controlled substances. In 1977, the Supreme Court case of Whelan v. Roe considered whether the records generated and stored by these programs violated the Fourth Amendment prohibition on unreasonable searches and seizures. Whelan involved a challenge to a New York law requiring the collection in a centralized database of the names and addresses of all persons who obtained, pursuant to a doctor’s prescription, Schedule II drugs, such as oxycodone and hydromorphone. The Supreme Court upheld the law as a reasonable measure designed to prevent the unlawful diversion of controlled substances.
The second important federal law in this area is the National All Schedules Prescription Electronic Reporting Act of 2005, which authorized the Department of Health and Human Services to award grants to states for the creation of PDMPs or enhancement of existing programs. Every state except Missouri has enacted a PDMP law. There is general agreement that the adoption of PDMPs has caused a sharp reduction in the prescribing of Schedule II opioids. One study of prescribing practices in 24 states from 2001-2010 found more than a 30% reduction. Another study of Medicaid data suggested that mandatory prescriber registration with state PDMPs led to decreased prescribing of Schedule II opioids, “although whether this resulted in safer prescribing or limited access to legitimate pain relief could not be assessed.”
About half the states with PDMPs mandate that prescribers query the system before writing prescriptions for controlled substances. “These requirements face pushback from prescribers, many of whom consider them to be burdensome incursions into clinical practice.” Prescribers also are concerned about possible punitive consequences for themselves, including loss of licensure and even imprisonment. As mentioned earlier, one effect of increased administrative requirements and closer scrutiny of opioid prescribing may be the underutilization of opioid analgesics for the treatment of multiple types of severe pain.
Pain Management
Pain management became an important part of health care policy in the mid-1990s. During this time there was a greater emphasis on pain control, including efforts to designate pain as the “fifth vital sign.” Also, the degree of pain control was added to surveys of patient satisfaction with health care providers and institutions, thereby encouraging providers to write more opioid prescriptions. At the same time, the Food and Drug Administration approved extended release oxycodone, in the form of OxyContin. Purdue Pharma, manufacturer of OxyContin, saw sales skyrocket from $45 million in 1996 to $1.1 billion in 2001. Physicians were expected to address pain, patients demanded pain relief, and pharmaceutical companies spent tens of millions of dollars promoting their opioid products to fill this need. Opioids became the preferred method of addressing patient pain complaints.
Unfortunately, the reaction of many physicians goes beyond weaning to immediate and total nonrenewal policies, sometimes adopted and implemented literally overnight. Such policies go too far and jeopardize the health of patients in two ways. First, sudden withdrawal from opioids followed by a relapse greatly increases the risk of a fatal overdose. Second, withdrawal of opioids eliminates the patient’s primary source of pain control.
Within the last few years the pendulum has swung back and physicians have been advised to severely restrict the use of opioids for pain control. In 2016, the Centers for Disease Control and Prevention (CDC) published its Guideline for Prescribing Opioids for Chronic Pain. The first provision in the Guideline states that “Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain.” Other provisions in the CDC Guideline call for establishing treatment goals with patients; discussing known risks and benefits with patients; reviewing the patient’s history of controlled substance prescriptions; limiting the quantity of medication prescribed to, at most, three to seven days; and using urine drug testing before starting therapy and at least annually thereafter.
The intensive oversight attached to opioid prescribing might be justified for some new patients, but it is less compelling for established patients. Writing in JAMA earlier this year, Kurt Kroenke and Andrea Cheville stated: “Many patients currently receiving long-term opioids were started when opioids were still considered a viable treatment option and if satisfied with their pain control and using their medications appropriately should not be unilaterally compelled to wean off opioids.” Unfortunately, the reaction of many physicians goes beyond weaning to immediate and total nonrenewal policies, sometimes adopted and implemented literally overnight. Such policies go too far and jeopardize the health of patients in two ways. First, sudden withdrawal from opioids followed by a relapse greatly increases the risk of a fatal overdose. Second, withdrawal of opioids eliminates the patient’s primary source of pain control. The National Academy of Medicine report on the opioid epidemic addressed this second point: “From the perspective of those suffering chronic pain, any remedy, even one that may simply remit the pain for a few hours or days, may be a welcome relief despite risks or side effects.”
A foundational principle of medical ethics is that physicians have an obligation to relieve suffering. According to the AMA Code of Medical Ethics: “The practice of medicine, and its embodiment in the clinical encounter between a patient and a physician, is fundamentally a moral activity that arises from the imperative to care for patients and to alleviate suffering.” This obligation is not lessened during a public health crisis caused, at least in part, by prior, inappropriate prescribing practices. Furthermore, access to pain management has been recognized as a fundamental human right by the United Nations and other international bodies.
Treating Patients with Opioid Use Disorder
Besides refusing to prescribe opioids for pain relief to new patients and tapering or discontinuing opioids for established patients, many physicians have imposed strict conditions when they prescribe opioids. Often, these provisions are included in so-called “opioid contracts,” documents that patients must sign as a condition of obtaining a prescription for opioids. Opioid contracts vary, but they generally provide that the patient pledges to follow certain terms, such as agreeing to take the drugs only as prescribed, consenting to urine drug testing, promising not to seek opioids from other prescribers, and vowing not to divert the drugs. A patient’s failure to comply with the agreement will result in the patient not being prescribed additional opioids and also may result in the physician terminating treatment altogether.
There is little evidence that opioid contracts have any benefit for patients, such as by promoting more responsible use of opioids. Make no mistake. These are not contracts in the legal sense, which typically involve mutual obligations and a bargained-for exchange between parties with comparable bargaining power. By contrast, opioid contracts are documents prepared by health care facilities for the sole benefit of physicians and presented to powerless patients in a “take it or leave it” manner. These documents are one-sided, and they rarely contain any responsibilities on the part of physicians. An opioid contract I recently reviewed contained 31 obligations for the patient, but not a single one for the physician.
One way of characterizing the value of opioid contracts to physicians is that “[doctors] need a way to ‘just say no’ to patients. Opioid contracts may represent one way that, although unproven, sets explicit and rigid limits that give clinicians a way out of supporting some patients’ drug abuse.” It is a way of seemingly limiting their professional or legal liability and an easy way to end a physician-patient relationship without arguments merely by invoking the supposedly mutually agreed upon conditions.
There are no published data on the frequency of patients failing to adhere to their responsibilities in opioid contracts, but the fact that 2 million individuals have OUD suggests that it is common for patients to violate one or more provisions of an opioid contract. An important ethical question is whether terminating the physician-patient relationship for breaching an opioid contract constitutes abandonment of the patient. According to the AMA Code of Medical Ethics: “While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured.” The summary termination of patients would seem to violate this provision.
Context is especially important here. Patients frequently disappoint their physicians, such as by being noncompliant with their medication regimens, failing to keep an appointment for an agreed upon consultation with a specialist, and failing to improve unhealthy habits, including diet, exercise, smoking, and drinking. If physicians fired all of their non-compliant patients, many physicians would simply run out of patients. This raises the issue of whether there is something special about opioid dependence that excuses physicians from their traditional obligation to provide continuity of care. Put another way, “[a]t some point, it became culturally acceptable to treat all conditions in a patient except addiction.”
From the perspective of some physicians, it is intolerable to continue treating patients who have not only violated their agreements, but who are engaging in illegal activity. Many physicians also justify not treating patients with addictions because they lack the training or experience in dealing with patients with OUD. They do not feel any responsibility to continue caring for these patients, and they believe it is best simply to terminate the relationship.
I strongly disagree with this position. I believe that a lack of expertise is an insufficient reason for not providing essential medical services to this extremely vulnerable group of patients. Because of the widespread nature of opioid addiction there is an ethical obligation for physicians, especially those who prescribe opioids, to become knowledgeable about addiction medicine and to continue treating their patients with OUD, except in the following three situations: (1) the patient is dealing drugs and diverting prescribed opioids; (2) the patient is simultaneously obtaining opioid prescriptions from multiple prescribers; or (3) the patient is acting in ways that are dangerous to the medical staff or other patients. In general, however, physicians and their institutions, especially large health care institutions, have a responsibility to establish or support substance abuse treatment programs because many existing programs have been overwhelmed by the demand and have unacceptably long waiting lists for entry into treatment.
In my view, this obligation is based on the role of prescribers in the development of opioid addiction, the magnitude of the public health problem of opioid abuse, the unwillingness of many other health care providers to assume care for individuals with addictions, and the significant risk of tragic consequences from terminating the relationship. As Alison Rapo-port and Christopher Rowley wrote recently in the New England Journal of Medicine: “Under the watchful eyes of physicians, many people survive their acute illness only to die in public restrooms, in private homes, or on the street.”
Conclusion
The practice of medicine is a noble profession built on the ethical principle of beneficence. Historically, physicians have considered it their professional duty to treat even loathsome patients—from prisoners of war to mass murderers. They have treated patients who had highly stigmatized diseases—from leprosy to AIDS. They have treated patients in the midst of deadly epidemics—from influenza pandemics to Ebola—even when doing so placed their own lives at risk. Viewed in this light, surely physicians can and ought to treat patients with OUD.
The United States is in the midst of a crisis of opioid abuse, started in many cases by the improper prescribing of highly addictive painkillers and fostered by the despair of individuals who have fallen out of the mainstream of the American economy and society. Physicians are required to comply with the legal and ethical demands of public health, but they should never forget that they owe a duty of loyalty to their patients, which means placing the welfare of their patients above their own interests. Their primary professional obligations are to promote the health and relieve the suffering of their patients. Physicians have an ethical imperative to manage the pain of their patients with skill and compassion, and not abandon them in their darkest hour of dependence.