Current Diagnosis & Treatment of Pain, 1st Edition

22. Legal & Regulatory Issues in Pain Management

Perry G. Fine MD

Scott Fishman MD

Clinicians worry about appropriate use and iatrogenic consequences of long-term opioid therapy in patients with persistent pain syndromes. Legal and regulatory concerns often focus on indications for, and legitimate use of, opioid analgesics for pain syndromes that are poorly responsive to other pain-relieving modalities. Uncertainty arises because principles of practice, clinical consequences, standards of monitoring, and outcomes for long-term opioid therapy are still evolving. Meanwhile, in day-to-day clinical practice, great tension exists between traditional ethical duties-and more recently, legal imperatives-to relieve suffering and optimize health status, and real or perceived legal and regulatory constraints. The situations that confront most clinicians are not easily reduced to “black and white,” even when there is apparent clarity or consensus around some of the associated ethical and legal issues.

Recognizing that there are innumerable variations on the many clinical themes and scenarios that confront practitioners, and countless case examples involving possible legal and ethical issues pursuant to opioid prescribing, the intent of this chapter is to outline and clarify the contemporary legal, regulatory, and related ethical issues that pertain to this class of drugs in commonly encountered medical contexts. Prescribing clinicians must understand the regulations and laws that govern the use of controlled prescription drugs and must be able to structure a prescription regimen that is consistent with the perceived risk of abuse or addiction and includes the monitoring necessary to identify problems early if they occur.

Armed with this information, clinicians should be better prepared to address the issues that arise in their practices, protecting themselves and their patients in a world where no equally efficacious alternatives to the opioid analgesics for many pain conditions yet exist. To set the stage for this discussion, several cases are presented that typify the types of quandaries experienced in typical practice.

Common Issues Clinicians Face

The ambiguities and difficulties encountered in practice can be illustrated in the following five cases. We invite you to compare your thoughts with the notes the authors provide to address the issues raised by each case.

Case 1: Long-Term Prescribing of a Controlled Substance

An otherwise healthy young man underwent lumbosacral spine fusion surgery for a work-related injury. He has completed an intensive rehabilitation program focused on “work hardening” and pain control, due to persistent postinjury and postoperative pain. He has returned to work and he is referred back to his primary care physician for long-term management. His discharge disposition included recommendations for continuing use of sustained-release morphine for ongoing pain control. His physician feels wary about his obligation to write monthly prescriptions for controlled substances for, perhaps, many years to come.

Discussion

Persistent debilitating pain is too prevalent, indications for opioid analgesic therapy too common, and pain specialists are too few for primary care physicians to defer these cases. When no other therapies exist that provide similar efficacy and positive therapeutic outcomes, physicians need to overcome their reluctance and learn how to manage these case skillfully and with confidence. Using the analogy of other chronic conditions and the importance of having structured disease management strategies (eg, diabetes, heart failure, obstructive airways disease), expertise is gained both through formal and self-directed continuing education and practice. Associating informally with a physician who has expertise in long-term opioid therapy, in order to discuss issues when they arise, may be a helpful strategy. However, the primary care

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physician should also recognize when referral to a pain treatment center, mental health professional, or chemical dependency program is indicated-knowledge and skill developed through continuing education.

Case 2: Balancing Therapeutic & Potentially Adverse Outcomes

A middle-aged man with chronic daily headaches has undergone thorough evaluation as well as multiple nonpharmacologic and nonopioid pharmacologic treatment approaches in several specialty headache clinics for his debilitating pain syndrome. After an exhaustive array of treatments, he reports that he can only maintain a functional life with several doses of a short-acting opioid each week. He has acknowledged suicidal ideation due to the severity of his headaches, but when his pain is controlled, he has no signs or symptoms of depression. He has no prior history of chemical dependency. However, he has demonstrated a tendency to dose-escalate over time, requiring opioid rotation every few months and “drug holidays” every year or so. He requires testosterone supplementation due to opioid-induced hormone suppression. His physician feels “caught between a rock and a hard place.” She asks herself, “In the long run, by continuing to prescribe opioids, am I helping him or causing harm? If there is a bad outcome such as a suicide attempt, in what ways am I most-or least-culpable”?

Discussion

The ongoing evaluation and reevaluation of benefit versus burden of potentially harmful therapies attends most medical decisions when treating chronic conditions, including cancer, heart disease, and psychiatric conditions. This should be an iterative process. A well-structured plan of care that includes regularly scheduled follow-up visits, a treatment agreement (eg, one prescribing clinician, one pharmacy, no early refills, keeping appointments, and urine drug screens), and ongoing evidence of therapeutic benefit that is well documented will satisfy the physician's ethical obligations to her patient while protecting herself.

Case 3: Possible Drug Diversion

A young woman with multiple sclerosis is being treated with a sustained-release opioid analgesic for control of pain that is refractory to other therapies. She also requires one or two doses of an immediate-release opioid formulation every few days for severe, debilitating pain exacerbations that are unpredictable (breakthrough pain). Her physician receives a note from the patient's mother, with whom she lives, stating that she is worried that her daughter is “hoarding” her medications and that she is “running with a crowd” that may be taking advantage of her, using her medications for “recreational purposes.” The doctor does not know what to do.

Discussion

The receipt of information from third parties must be handled with great care, both from ethical and legal standpoints. Since this patient is a competent adult, her permission is required to communicate with her mother about her medical condition and related matters. This is probably a good idea since her mother is (and likely will increasingly be) an important ally in her ongoing care. This is an important opportunity to deepen the therapeutic alliance with the patient, not weaken it, by compassionate but direct and clear communication about her responsibilities. An appointment needs to be scheduled wherein there is unhurried and ample time to let her know the serious legal risks and consequences to her and you as her physician if there is ever any diversion of her prescriptions. As in the previous cases, a structured treatment plan needs to be implemented and documented. These types of cases present a timely opportunity to initiate counseling as part of the renegotiated treatment plan since there is no criminal intent but rather maladaptive psychosocial issues.

Case 4: Rekindling Substance Abuse

A young man with HIV-related pain is not responding adequately to nonopioid therapies. His pain is unrelenting, severe, and contributing to sleep deprivation, anorexia, anxiety, and depression. The patient's physician suspects that the pain can be appreciably reduced with around-the-clock opioid analgesia. However, both the patient and his physician are afraid to initiate a trial of opioid therapy because the patient is an acknowledged opioid addict in drug-free recovery.

Discussion

There is no right answer in these cases. The patient's fears are quite justified, and they need to be fully heard and appreciated (validated). In the absence of other effective pain-mitigating therapies, and in collaboration with both an addiction disorder and pain management specialist, it is feasible to have successful therapeutic intervention with opioids in patients with a history of substance abuse. With little empiric evidence to rely upon, anecdotal experience suggests that successful outcomes require agreement on distinct goals (eg, sleep, mood, functional improvement) and contingencies (treatment agreement), coupled to a time-limited trial of medication (ie, an “exit strategy” if the plan is not working).

Daily prescription of methadone, or every-third-day prescription of a fentanyl patch, seems to be most effective, allowing for close monitoring of medication use

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and effects, and direct contact with the patient to provide psychological support. With adherence and positive therapeutic outcomes, duration between visits can increase. However, because this is a very time-intensive process, few practices may be able to sustain such attention.

Case 5: Hastening Death

A widowed older woman with metastatic colon cancer and severe abdominal pain has been well managed on oral opioid therapy for several months. She has become quite frail and was recently admitted to a nursing home. A hospice program has been called in to help manage terminal care. Her abdominal pain and nausea have dramatically increased, requiring change to a continuous subcutaneous infusion of opioids. Her mental status has declined, making patient self-report difficult. Some of the nurses express concern that the patient is exhibiting distress that they think is due to unrelieved pain. The medical director at the long-term care facility is hesitant to increase her opioid dose, fearing that this will be interpreted as intentionally hastening her death.

Discussion

Clinicians who care for patients at the end of life have an ethical obligation to become adept at evaluating and treating pain in cognitively impaired patients, or to be able to make timely and appropriate referrals. Pain is such a common concomitant symptom of life-limiting illnesses, and its adverse effects on well-being are so clear, that it is not tenable to actively or passively allow undertreatment. In all institutional settings, patients should be assessed frequently, and conferences between family members and clinical care providers should be held to review the morbid effects of pain, behaviors that signal pain, the indications for analgesics, and the ethical principles involved, so that everyone understands the plan of care.

History of Opioids as a Regulated Class of Drugs

Creation of a Regulatory Environment

Early in the twentieth century, increasingly common use of opioids and other drugs with abuse potential led to public clamor for legislative action. The Pure Food and Drug Act was passed in 1906, giving the federal government authority and responsibility to regulate drugs, including the obligation to establish safety and efficacy for drugs being sold in the United States. Shortly thereafter, the most enduring and influential law affecting opioid prescribing was passed: the Harrison Narcotics Act of 1914. It applied strict controls to opioid analgesics and included prohibitions against prescribing this class of drugs to known addicts. Importantly, and problematically, “addiction” was not clearly defined as a psychophysiologic condition distinct from pharmacologic properties such as dependence upon or tolerance to opioids for medical indications related to pain control. This absence of clarity has led to a century of confusion and conflict.

In 1919, the Supreme Court upheld the Harrison Act, with opinions stating that physicians could not legally provide narcotics (opioids) for maintenance of an addict. As a result, opioid maintenance centers were closed, driving procurement underground. Addicts-and all those who required daily dosing of opioids, lest they experience abstinence-were considered to be criminals, since their ability to obtain opioids became dependent on illegal means. Drug use subsequently became the purview of the criminal justice system, rather than a health care-related issue. The Marijuana Tax Act of 1937, outlawing cannabis and heroin (diacetyl morphine), added to the criminal code and further blurred distinctions among pharmacologic classes of drugs, lumping them under the legal/regulatory rubric of narcotics.

Efforts to curb opioid use mounted over the proceeding decades with little differentiation between illicit use and medical need. In 1970, the Federal Controlled Substances Act (CSA) increased governmental oversight of manufacturing, prescribing, and dispensing of opioids. Currently, the framework of laws and regulations governing the use of opioids and other controlled substances has three tiers: (1) international laws and treaties, (2) federal laws and regulations, and (3) state laws and regulations.

National governments are encouraged to ensure the availability of opioid drugs for legitimate medical and scientific purposes. International treaties have been designed to achieve a balance between ensuring the availability of controlled substances for medical purposes and preventing illegal diversion. The International Narcotics Control Board was established in 1968 as an independent and quasi-judicial body empowered to implement the United Nations drug conventions. It attempts to ensure that adequate supplies are available for medical and scientific uses, and that diversion from licit sources to illicit traffic does not occur. To accomplish this, it administers an “estimates system” for opioid drugs and monitors international trade in drugs. It also monitors government control over chemicals used in the illicit manufacture of drugs, and assists governments in preventing diversion of these chemicals into illicit traffic. Finally, the Board also attempts to identify where weaknesses in the national and international control systems exist.

At the federal level, the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) work together to regulate drugs and thereby prevent drug diversion and abuse. The DEA enforces the CSA and laws regulating the manufacture, distribution, dispensing, and record-keeping requirements for controlled

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substances. The DEA also sets production quotas for controlled drugs, which are intended to accommodate all legitimate medical and scientific uses of scheduled drugs. Each state works with the federal government to oversee the movement of controlled prescription drugs and minimize abuse and diversion. Individual states also have sole responsibility for maintaining standards of health care practice through licensure of professionals. Medical practice and licensure is governed through state medical boards, whose members are appointed by the executive branch. Law enforcement occurs at the local and the state level through numerous agencies.

Before a pain medication can reach patients, the FDA must determine its efficacy and safety, including its potential for abuse. If a product does not receive marketing approval (or an exemption) from the agency, then it cannot be legally produced or prescribed. The CSA empowers the DEA to classify drugs into different groups, called schedules, based on the risk of abuse and diversion, medical use, and safety. It requires registration of all prescribers of controlled substances and categorizes potentially abusable drugs into one of five schedules, each with progressively more stringent regulatory mandates, from schedule V (low abuse potential) up to schedule I (for which there are no approved medical indications in the United States; heroin resides in this group).

Schedule II opioids include morphine, methadone, fentanyl, oxycodone, hydromorphone, levorphanol, and oxymorphone. The law stipulates that drugs in schedule II cannot be prescribed by telephone nor can they be refilled without a new, written prescription. Schedule III includes those opioids that are either combined with other dose-limiting coanalgesic agents (ie, hydrocodone with acetaminophen) or considered to be less subject to abuse, such as tramadol. Whereas federal regulations apply throughout all states, individual states have created an array of their own complex laws and regulations that vary from one jurisdiction to another.

The “Law” of Unintended Effects

A consequence of the unique regulatory milieu surrounding this aspect of medical practice has led clinicians to fear investigation, stigmatization, sanctions, and criminal prosecution. In particular, under-utilization of opioids in situations where their use is medically indicated, and especially where no other sufficient means of pain control is possible, has been attributed to the emotionally charged regulatory environment. In recognition of this, and the increasingly evident need to manage debilitating pain in a demographically and medically very different world than that of prior generations (eg, a rapidly growing population of aging individuals living for many years with multiple, and very often pain-producing, chronic, progressive conditions), significant changes among regulatory agencies-both in knowledge and attitude-are evolving.

Specifically, indications for long-term opioid analgesic therapy are openly acknowledged and increasingly accepted. In parallel, though, increased therapeutic use comes with greater demands for vigilance and monitoring for the ever-present risk of medication misuse and abuse, adverse effects, and iatrogenic addiction: conditions that are fundamentally medical rather than legal.

Toward Improved Public Policy

The ethics and laws applying to pain management have greatly evolved over the past few decades, especially with regard to the use of opioid analgesics. Before this rather dramatic shift in social thought and policy, neither the ethical imperatives of the health profession (formalized in normative bioethics) nor health care jurisprudence (formalized in statutes and codes) played a positive role in pain management. In many cases, their influences created barriers to adequate pain relief for many patients. Historically, definitive statements on pain management centered on the admonition to avoid fostering addiction in patients by over prescribing opioid analgesics. Disciplinary actions were taken against physicians who were perceived as having failed to follow this injunction.

Only recently has there been due attention paid to the positive duty to relieve pain and mitigate the suffering caused by it, and a convergence of this ethical imperative with regulatory policies and the law. Legal precedents are being set in court cases at both ends of the pain management spectrum. In rare cases, physicians have been convicted of criminal charges for opioid prescribing that is believed to be excessive and outside the scope of medical practice. At the opposite extreme, there have been two cases where physicians have been found guilty of elder abuse for insufficient pain control. This creates a pressing need for clinicians to attend to pain as a humanistic, medical, and forensic issue. Clinicians must become sufficiently knowledgeable to recognize the indications for opioid therapy without erring on one side (undertreatment) or the other (iatrogenic harm from opioids).

Current policy redirection is founded upon the view that adverse public health and criminal consequences of drug abuse, addiction, drug diversion, and trafficking of prescription opioids can be anticipated, recognized, and prevented by prescribers. Presumably, these policies are implemented to the extent that licit practice is not significantly curtailed. However, there is growing debate over the unintended but highly consequential role of law enforcement in the practice of medicine, particularly in relation to use of opioids. The “principle of balance” has been invoked as an appropriate response to competing needs and challenges surrounding prescription opioids (Table 22-1). Representatives from public policy,

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regulatory, and scientific and clinical bodies have joined to address the need to ensure sufficient access to appropriate therapeutic use of opioids while addressing the potential for harm. Exactly where this balance point sits remains in question, particularly in light of ongoing serious disagreements between the DEA and many pain experts around interpretation of the CSA. Among several points of contention, there is heated debate around the therapeutic value versus putative harm of high-dose opioid therapy in nonterminally ill chronic pain patients.

Table 22-1. The Principle of Balance.

Medical Availability

· While opioid analgesics are controlled drugs, they
are also essential drugs and are absolutely
necessary for the relief of pain.

· Opioid analgesics should be accessible to all
patients who need them for relief of pain.

· Governments must take steps to ensure the
adequate availability of opioids for medical and
scientific purposes, including:
     - Empowering medical practitioners to provide
   opioids in the course of professional practice.
     - Allowing them to prescribe, dispense, and
   administer according to the individual medical
   needs of patients.
     - Ensuring that a sufficient supply of opioids is
   available to meet medical demand.

Drug Control

· When misused, opioids pose a threat to society.

· Clinicians must recognize that a system of controls
is necessary to prevent abuse and diversion.
Although the system of controls is not intended to
interfere with legitimate medical uses, they are
necessary to protect the public health and should
be understood and supported by the clinical
community.

· Minimizing risk of abuse and diversion during the
treatment of individual patients is part of the
essential skill set needed for the safe and effective
clinical use of opioid drugs.

Adapted from http://www.medsch.wisc.edu/painpolicy/index.htm Pain and Policy Studies Group at the University of Wisconsin Comprehensive Cancer Center. Accessed October 13, 2005.

Notwithstanding these unresolved issues, the compelling need to implement the principle of balance motivated the Federation of State Medical Boards of the United States to create Model Policy for the Use of Controlled Substances for the Treatment of Pain (2004). This model policy is meant to serve as a guideline for states and has been endorsed by several federal and state regulatory bodies, professional organizations, and patient advocacy groups. A report card on how each of the states is faring with regard to policies that positively and negatively impact pain management is available through the University of Wisconsin's Pain and Policy Studies Group (Achieving Balance in State Policy: A Progress Report Card) at http://www.medsch.wisc.edu/painpolicy. It is recommended that clinicians access this information so that they can understand what is occurring within their own practice jurisdictions.

Opioid Analgesics & State Licensing Boards

Only within the last decade have state medical boards offered policy statements or guidelines on pain relief, including aggressive symptom control in the treatment of dying patients. Typically, disciplinary actions admonished or sanctioned physicians for excessive use of opioids, in contrast to minimal attention to undertreatment of pain, signaling that “abuse of prescribing privileges” was a one-way street. In retrospect (and still today in too many cases), medical board members lack sufficient knowledge about pain medicine, opioid pharmacology, and addiction medicine to make informed decisions.

In response to what has been acknowledged as an epidemic of uncontrolled pain, several states have enacted “intractable pain” (or similarly titled) statutes. Such statutes are a response to the perceptions of many clinicians that their licensing boards are hostile to the use of opioids for the management of chronic noncancer pain, and uncomfortable about the high doses of opioids that may be required to mitigate against unnecessary pain in patients with progressive, fatal diseases, such as cancer—especially during the terminal phase of the disease. Intractable pain statutes are well intentioned, but they may also have some limitations. In many cases, they single out physicians, leaving out other clinicians (eg, nurse practitioners) with prescribing authority who may be involved in patient care.

Legal protections are not necessarily guaranteed for clinicians who adhere to the statutes. To date, there has been no all-inclusive remedy to these limitations that include ambiguities of language. For instance, New York law defines an addict as “a person who uses a controlled substance for nonlegitimate or unlawful use; and who by reason of such use is dependent thereon.” That would seem reasonable were it not for the fact that it goes on to strictly limit the clinical conditions for which controlled substances can be administered or dispensed to “addicts” or “habitual users,” precluding patients with severe noncancer chronic pain or cancer pain prior to the

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determination that it is “incurable and fatal”.1 Similarly, Texas law governing the prescribing of controlled substances uses the maltropisms “narcotic drugs” and “dangerous drugs” instead of pharmacologic classifications of FDA-approved medications. These examples point to the necessity for prescribing clinicians to be knowledgeable about the regulations and statutes that govern controlled substances in the states in which they hold licensure.

Fine PG, Portenoy RK. A Clinical Guide to Opioid Analgesia. Minneapolis: McGraw Hill; 2004:1-8.

Fishman SM. The debate on elder abuse for undertreatment of pain. Pain Med. 2004;5:212.

Fishman SM et al. Regulating opioid prescribing through balanced prescription monitoring programs. Pain Med. 2004;5:255..

Gilson AM et al. A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002. J Pain Symptom Manage. 2004;28:176..

Mendelson D. Aspects of legal liability in pain management involving opioid medications. J Law Med. 2001;9:145..

Pain and Policy Studies Group: Achieving balance in federal and state pain policy: a guide to evaluation. 2nd ed. Madison, WI: University of Wisconsin Comprehensive Cancer Center, 2003. Available at http://www.mesch.wisc.edu/painpolicy/2003_balance/.

Risks of Opioid Misuse, Abuse, & Addiction

Treatment of severe pain in cancer patients over the course of many years has suggested that long-term opioid therapy in populations with no prior history of substance abuse is rarely associated with de novo development of abuse or addiction. Similarly, very large surveys of patients who receive opioids to treat acute pain indicate that this therapy has a very low risk of precipitating addiction. In persons with acute pain or pain due to cancer, there are considerable challenges in treating persons with a known history of drug abuse, but the risk of iatrogenic addiction among those without this history appears to be very low.

Notwithstanding the reassuring data concerning the de novo development of addiction in the nonabusing cancer pain and acute pain populations, the incidence and prevalence, or impact, of various aberrant drug-related behaviors are not known in the oncologic setting, no less noncancer chronic pain patients. The reasons for, and rates of, all types of aberrant drug-related behavior within these diverse populations remain an important topic of current and future research.

The patient with severe pain who is no longer actively abusing drugs raises a special challenge that is similar to other dual diagnoses where a needed treatment for one disease may worsen the other. Since pain relief is a fundamental human right as well as good clinical and ethical practice, the disease of addiction does not eliminate this right or relinquish the physician's responsibility to respond to suffering. In these cases, physicians are therefore required to become risk managers (not dissimilar to the judicious use of treatments that are known to cause metaplasia in cancer treatment or disimmune effects in transplant medicine). Unfortunately, when it comes to treating pain, physicians may feel they accept excessive risk whether they treat or not. This inconsistent attribution of blame for “iatrogenic” harm in pain treatment is only beginning to be openly recognized, evaluated, and discussed.

Questionable Drug-Related Behaviors

Surveys have shown that the occurrence of aberrant drug-related behavior during opioid therapy is common among those patients referred to pain specialists. For example, studies of urine drug screens suggest that as many as 1 of every 3 patients referred to specialized multidisciplinary pain clinics who are prescribed opioid drugs and are not subsequently suspected of abuse may be using other drugs without clinician knowledge. Because patients referred to pain specialists are far more likely than the general population with chronic pain to have comorbid psychiatric disease, including prior substance abuse, it is reasonable to maintain heightened vigilance for the possibility of addiction.

It must be recognized that the base rate of addictive disease in the general population is relatively high (estimated at about 15% for alcoholism and about 5% for cocaine or heroin addiction). On this basis, it has been estimated that at least 10% of adults (and probably higher) have a genetic susceptibility to addiction. With this level of genetic vulnerability, and with other factors (psychological and social) also potentially driving aberrant drug-related behavior, it is prudent to acknowledge the risk of problematic behavior, and even addiction, whenever opioids (or other abusable drugs) are prescribed. Although the risk may be small in some subpopulations, it can never be considered to be zero, and clinicians who prescribe opioids must incorporate risk assessment (and management if needed) at the start of therapy and repeatedly during its course.

It is not surprising that patients with a past history of substance abuse or addiction are at higher risk for a similar problem developing with prescribed opioids. These

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obvious cases establish the need for close monitoring, vigilance, well-established rules and, perhaps, specialist consultation at the outset when opioids may be indicated for pain control. Recent studies have attempted to go beyond this characterization and identify other patient characteristics that can be useful in predicting aberrant drug-related behavior or addiction during opioid therapy for chronic pain. Several screening tools have recently been developed, but they all require additional validation in large prospective studies before they can be relied upon in routine practice.

Table 22-2. Strategies to Minimize Risk of Abuse and Enhance Monitoring.

 

· Written agreement following detailed consent
discussion.

· Prescribe long-acting drug without rescue dose.

· Frequent visits and small quantities prescribed.

· Urine drug screen at baseline and expressed
intention to request occasional screens in the
future.

· Requirement that only one pharmacy be used (with
permission to contact).

· Instruction to bring pill bottle to appointment (for
count).

· Instruction that there will be no early refills and no
replacement of lost prescription without police
report documenting loss.

· Requirement for nonopioid therapies, including
psychotherapy.

· Requirement for all prior records and permission to
contact all other health care providers.

· Required referral to addiction medicine specialist.

· Requirement that others (eg, spouse) be allowed to
give feedback to the physician.

· In states with electronic prescription reporting and
tracking, intention to query the database on a
regular basis.

Although there is no standard approach yet to the prediction of risk, clinicians should ensure that the assessment of the patient receiving long-term opioid therapy for pain include a variety of items related to the risk of abuse and addiction (Table 22-2). In this way, patients may be classified as relatively low risk versus high risk for future problems, and this classification, in turn, can determine the approach used to administer and monitor therapy over time. Risk assessment that supplements comprehensive evaluation, timely and regular follow-up, and documentation of salient clinical issues serve as the best protection for the patient and prescriber alike (Figure 22-1).

High-Risk Patients

Physicians are ethically bound to act in the best interest of the patient and within the law. In many cases, the risk that a patient may deteriorate due to pain may grossly outweigh the risk of relapse into addiction. In such a situation, the physician is confronted with a common dilemma over whether to use a treatment that has risk of adverse effects. For example, in the treatment of serious infectious disease, drugs that are potentially harmful to normal tissues and organs are routinely administered. Clinicians accept these risks and monitor for adverse outcomes, since the risk of not using such a treatment is even more grim. The common application of this principle, known as “double effect,” in all areas of medical practice provides the ethical foundation for almost all modern medical and surgical interventions. This is the perspective that must be considered in patients with severe pain who also have a history of opioid addiction that is in remission.

Based on the severity of problematic behavior, past history, and the findings of the reassessment, the clinician must decide about continuation of treatment and referral. Pain treatment may be continued with opioids (using a different structure for prescribing) or continued without opioids, or the patient may be discharged from the practice. The decision to continue treatment with the opioid is based on the severity of the problematic behavior and evidence of functional improvement with opioid treatment from structured reassessment. Treatment should not be continued unless favorable outcomes (ie, pain relief and maintained or improved function) are manifest, ample resources are available and implemented for detecting any further signs or symptoms of addiction, there is a high likelihood that control over the therapy can be reacquired, and restructuring will allow better monitoring of drug-related behavior.

Since the manifestation of drug addiction focuses on the dysfunction or harm derived from compulsive use of a drug, and the objective outcome of effective analgesia (pain relief) is improved function, the safe use of opioids in a patient with a history of opioid addiction relies on distinguishing these opposing potential outcomes. Physicians are often confronted with helping a patient manage one risk against another. Patients often have more than one illness where treating one disease may harm another. Patients who have chronic pain as well as addiction in remission are in this situation, and physicians must manage the relative risks associated with each. To ignore one problem out of fear of protecting the other may not be in the best interest of either one as the patient must be viewed and treated as a whole person. Similarly, the social context within which the patient lives, with the relative support or risks that are there, may determine the course and choices of treatment.

 

Figure 22-1. Pain Assessment and Documentation Tool (PADTTM). (Copyright Janssen Pharmaceutica, 2003. Used with permission.)

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Should the decision to discontinue opioids be indicated, a plan should have already been put in place, and agreed upon, in order to manage expectations and smooth the transition. Discharge from the practice may be warranted if the possibility of therapeutic progress has been severely undermined by mistrust or the assessment reveals that the patient lacks interest in any nonopioid treatments. Ethical and legal protection is gained by clear documentation that the patient was provided with reasonable and available alternative options for care.

When aberrant drug-related behavior occurs, the clinician must also decide about the need for referral for consultation beyond the clinician's expertise. If a diagnosis of addiction is tenable, referral to a specialist in addiction medicine or an addiction program should be strongly considered, although this may be highly problematic in areas where there are insufficient referral centers. Addiction is a serious illness; once it is suspected, it is ill-advised to neglect treatment, as with any other complex, potentially life-threatening disease.

If the decision is made to continue prescribing, strategies should be implemented to reduce the risk of further problems and enhance the opportunity to monitor therapy. For patients who have a proclivity toward substance abuse or addiction, a more rigid structure for therapy, such as frequent visits, small quantities prescribed, the use of urine drug screens, single designated pharmacy use, and collateral information from individuals in daily close contact with the patient who can comment on function and dysfunction, may be helpful in maintaining control. This structure also provides the clinician with the reassurance necessary to continue to act in the patient's best interest. Patients who are taught that a new structure for prescribing is not punitive, but rather, fundamentally therapeutic, are more likely to accept the new restrictions without difficulty. Indeed, patients may express gratitude that the clinician is willing to continue a helpful therapy and assist them in maintaining control. When therapy is restructured, it is important that documentation be comprehensive and complete. The medical record should reflect all aspects of the thoughtful reassessment and the written plan should be explicit. It may be useful to provide the patient with a letter that clarifies the next steps, the patient's obligations, and consequences should problems recur.

Role of Opioid Agreements

A formal written agreement between the patient and physician at the start of opioid therapy is becoming a common tool for defining expectations and documenting informed consent. These agreements are often called “contracts” and are probably enforceable against clinicians who break their own terms irrespective of the title given (eg, contract, agreement, or consent) (Figure 22-2).

There may be good reasons either to implement or not implement an agreement. On the “pro” side, these agreements outline the clinician's policy for providing controlled prescription drugs, and describe the consequences of problematic drug-related behavior. They can reinforce that these medications must be used responsibly and also assure patients that medication will be prescribed, as long as there is adherence to the plan of care. Lastly, they can be used as educational tools.

On the “con” side, these agreements can contribute to the stigmatization of opioid therapy and possibly reduce the likelihood of success. If they are framed in a manner that the patient perceives as threatening, they may contribute to assessment difficulties as the patient withholds or skews information in an effort to meet expectations. If they make insupportable demands (like no driving, even after dose equilibration and habituation to sedating effects) that are inconsistent with the literature and compromise function and quality of life, they could undermine the goals of therapy or encourage the patient to lie. If they give a clinician a false sense of security, and thereby reduce the vigilance, monitoring, and use of appropriate ongoing strategies that are essential to risk management, they could paradoxically increase risk. Finally, if they implicitly hold a clinician to a certain level of clinical performance, they could ultimately be used adversely in a medicolegal dispute. Given these potential negatives, and the lack of consensus about the role of this approach, each clinician must decide whether the use of an agreement is appropriate and likely to be beneficial.

Adams LL et al. Development of a self-report screening instrument for assessing potential opioid medication misuse in chronic pain patients. J Pain Symptom Manage. 2004;27:440..

Fishman SM et al. The opioid contract. Clin J Pain. 2002;18:S70..

Friedman R et al. Treating pain patients at risk: evaluation of a screening tool in opioid-treated pain patients with and without addiction. Pain Med.2003;4:182..

Michna E et al. Predicting aberrant drug behavior in patients treated for chronic pain: Importance of abuse history. J Pain Symptom Manage. 2004;28:250..

Opioids & Terminal Illness

The obligation to relieve suffering is an ethical imperative of the medical profession and is especially important in the care of persons who are dying. Among the greatest harm to dying patients, and their loved ones, is to abandon them in their need for comfort, of which relief from pain is paramount. Patients and family members expect that physicians will honor this need by effectively treating pain.

 

Figure 22-2. Sample Medication Management Agreement.

Table 22-3. Principles of Prescribing Opioids in Terminally Ill Patients.

 

· Choose the least invasive, most readily available and
acceptable route. Provide around-the-clock analgesic
coverage and a plan for breakthrough pain if the pain
pattern warrants it.

· Be prepared for an alternative route if the patient
loses the ability to swallow or absorb medications via
the oral route.

· Educate caregivers about the approach to pain
management and ensure that professional and
nonprofessional caregivers and family members
understand the principles involved (eg, recognition
of nonverbal signs of pain; titration to comfort).

· Distinguish pain from anxiety, delirium, or “terminal
restlessness,” if possible. This may require an opioid
trial in the nonverbal or cognitively impaired patient.
Distressed behaviors that do not respond to
anxiolytics or antipsychotics suggest a pain etiology.

· Pain crises that respond poorly to basic analgesic
approaches merit consultation with a specialist as
soon as possible. More aggressive therapeutic
methods may be warranted. Interventional
techniques, such as epidural or intrathecal
catheterization, certain types of nerve blocks or neurolytic
procedures, or use of drugs such as
ketamine, may be appropriate in selected patients.

· Escalating doses of opioids in patients who are not
demonstrating pain behaviors may be interpreted as
hastening death. Physician assisted suicide is only
permissible under state law (and highly
circumscribed conditions) in Oregon.

P.332

 

P.333

 

When providing opioid therapy to patients near death, the ethical principle of double effect must be understood and clearly communicated. This principle is particularly important in addressing the fear that aggressive opioid therapy at the end of life could potentially hasten death. According to the principle of double effect, a foreseeable “bad” outcome of an action (such as a potentially hastened death) is ethically acceptable if the intention is beneficent (the relief of suffering), and the need to accomplish the good is more important than the need to avoid potentially negative consequences. At the end of life, this principle guides the aggressive use of opioids and other interventions. Physicians must defend the ethical nature of aggressive pain control and clearly distinguish pain treatment from euthanasia.

Although clinicians should understand and invoke the principle of double effect when using opioids in dying patients, it is nonetheless reassuring to know that there is no convincing scientific evidence that demonstrates a significant risk of hastened death if the opioid dose is appropriately titrated at the end of life. Indeed, there is more anecdotal evidence to the contrary. Given these reassuring observations, and the well-recognized adverse physiologic and psychological effects from unrelieved pain, aggressive titration of the opioid dose to maintain relief of pain is warranted until the very end of life (Table 22-3).

Bercovitch M et al. Patterns of high-dose morphine use in a home-care hospice service: should we be afraid of it? Cancer. 2004; 101:1473..

Fine PG. The ethical imperative to relieve pain at life's end. J Pain Symptom Manage. 2002;23:273..

Fine PG. The evolving and important role of anesthesiology in palliative care. Anesth Analg. 2005;100:183..


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