Similar to treatments that carry substantial risks and must be used with great care, the drug group collectively known as opioid analgesics can be therapeutically desirable for treating severe acute pain, pain at the end of life, and other pain conditions in which the benefits of use outweigh the potential risks. Despite the need for cautious use of opioids, prescribing has become pervasive and excessive. Although opioids are one of many legitimate and diverse options for treating pain, they represent a large share of risk.

Chronic pain is a common reason patients seek medical care. A significant challenge in treating patients with chronic pain is that no perfect method exists to assess the existence or intensity of pain that a patient experiences. It remains impossible to prove that a patient does or does not have pain or pain relief. Prescribers with limited background in pain management and scarce resources may feel pressured to lean too heavily on opioids as the first or only option for chronic pain management. For many prescribers, pain management and opioids have become synonymous, as if prescribing opioids is equivalent to adequate pain management or withholding them were equivalent to undertreatment.

Over the past decade, interrelated public health trends have developed as a result of the prevalence of and difficulty in treating patients with pain syndromes. First, increased clinical attention was directed across all medical specialties to the undertreatment of pain. This was followed by more frequent and escalating prescribing of opioids. The improved comfort and quality of life seen with aggressive opioid therapy for patients with terminal cancer was extrapolated to patients with chronic pain. Moreover, predictions of safety with chronic use of opioids were founded on low-quality data. The increased availability of opioid medications was followed by a shift in patterns of drug abuse from illicit to prescription drugs—most notably a dramatic increase in diversion and nonmedical use of opioid pain medications within the United States. A paradigm shift is under way that emphasizes safety and a more limited role for opioids in overall chronic pain care. Major policy changes have also emerged that every prescriber should be well aware of.

Addiction and abuse are pivotal concerns associated with using opioids. However, opioids have a wide range of adverse effects that can result in serious morbidity and mortality. Additionally, opioid medications are not universally effective for all types of chronic pain or all patients.¹ A major risk associated with opioids is respiratory depression resulting from unintended overdose. The risk for respiratory depression is heightened in older persons, those with mental illness, those with impaired renal or hepatic function, and individuals with cardiopulmonary disorders such as chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and sleep apnea. Patients who combine opioids with other respiratory depressants such as alcohol, benzodiazepines, barbiturates, or sedative-hypnotics are also at increased risk for respiratory depression. Chronic opioid use also has a negative impact on endocrine function and possibly heightened fracture risk related to effects on bone metabolism,^2,3 potential birth defects in unborn children,⁴ and potential facilitation of tumor growth in cancer.^5,6,7

Prescriptions for opiates increased from 76 million in 1991 to 207 million in 2013; the United States was the largest consumer of opioid medications.⁸ Hydrocodone is the most prescribed drug in the United States, which consumes 99% of the world’s supply.⁸ Factors that contribute to the increase in opioid prescribing include the introduction of long-acting formulations and novel delivery systems, as well as prescriber concerns about the dangers of non-opioid analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDS) and acetaminophen. These factors are seen in a much different light as the United States confronts an epidemic of opioid prescription abuse:

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  Between 1998 and 2008, the rate of opioid abuse increased 400%.⁹

  
  
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  More than 6 million Americans abuse prescription drugs—more than the number estimated to abuse cocaine, heroin, hallucinogens, and inhalants combined.¹⁰

  
  
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  Emergency-department visits related to pharmaceutical opioids doubled between 2004 and 2008.¹¹

  
  
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  Between 1998 and 2012, a tenfold increase was noted in drug treatment admissions for prescription opioids.¹²

  
  
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  The number of deaths nationwide attributable to prescription opioid analgesics nearly quadrupled between 1999 and 2012.¹³

  
  
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  From 1999 to 2005, the number of poisoning deaths mentioning methadone increased 468%.¹⁴

  
  
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  Drug abuse is now a leading cause of accidental death in America, exceeded only by car crashes; in many states opioid overdose is the leading cause of accidental death.¹⁵

These alarming statistics have led some to propose extreme measures to curb opioid misuse. A number of physicians have chosen to stop treating chronic pain in patients altogether even though the problem of unrelieved pain is significant. In the United States, the incidence of chronic pain is estimated at 100 million people,¹⁶ greater than that of diabetes, heart disease, and cancer combined.^17,18 The cost of treating patients with chronic pain is estimated to be up to $635 billion.¹⁶

Regardless of the need for comfort, prescribers must weigh the benefits versus the risks of pain management. Clinical guidelines, policy statements, and organizational goals generally accept the following principles of pain treatment:¹⁹

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  Pain management is integral to good medical practice for all patients.

  
  
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  Opioid therapy to relieve pain and improve function is a legitimate medical practice for acute and chronic pain of both cancer and noncancer origin.

  
  
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  The use of opioids for other than legitimate medical purpose poses a threat to the individual and to society.

  
  
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  Prescribers have a responsibility to minimize the potential for the abuse and diversion of controlled substances.

The Food and Drug Administration (FDA) announced in September 2013 that it would require more specific language regarding patient risks in the labeling of extended-release/long-acting opioid medications.²⁰ Manufacturers are now required to include language to emphasize potential for misuse and abuse, neonatal opioid withdrawal syndrome (NOWS), addiction, overdose, and death.²¹ In addition to new labeling requirements, the FDA released strong recommendations advising prescribing physicians to carefully weigh the risks and benefits of opioid medications for the treatment of chronic pain, stopping short of recommending that opioid medications not be used for chronic pain.

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  “Indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

  
  
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  LA/ER opioids are not intended for use as an “as-needed” pain reliever.

  
  
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  Other, less potentially addictive, treatment options should be considered first [“Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, LA/ER opioids should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate”].

  
  
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  Patients in pain should be assessed not only by rating on a pain intensity scale but also based on a more thoughtful determination that their pain—however it may be defined—is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.

  
  
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  The new labeling will provide increased detail and elevate the risk of neonatal opioid withdrawal syndrome (NOWS) to the most prominent position in labeling—a boxed warning. It will emphasize the symptoms of NOWS, including poor feeding, rapid breathing, trembling, and excessive or high-pitched crying [FDA-approved labeling previously described the effects on newborns of exposure to these drugs while in the mother’s womb and warned against use by women during pregnancy and labor and nursing.].

  
  
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  Manufacturers of LA/ER opioids will be required to fund and conduct longer-term post-market studies and trials of LA/ER opioid pain relievers that evaluate long-term use and assess known serious risks, including misuse, abuse, addiction, overdose, death, and increasing sensitivity to pain.

  
  
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  Patient/consumer education will be required that will target risk reduction. Educational materials for patients and health care professionals (HCPs) will be modified to reflect new labeling for ER/LA opioids and LA/ER opioid manufacturers will revise a paper handout that patients will receive with their prescription.

  
  
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  The ER/LA Opioid Risk Evaluation and Mitigation Strategies program for LA/ER opioids, which offers voluntary education on risks and risk management associated with opioid use that is funded by manufacturers, will be updated to reflect the new labeling.

The FDA is not alone among regulatory agencies and medical organizations in publishing policy and regulation changes regarding the use of opioid medications. Other organizations such as the Centers for Disease Control (CDC), the Office of National Drug Control Policy (ONDCP), the Federation of State Medical Boards, the American Society for Interventional Pain Physicians (ASIPP), the American Pain Society (APS) and the American Academy of Pain Medicine have recently published new or updated previous versions of guidelines in response to reports of increases in opioid-related deaths with concomitant increases in the rate of opioid prescribing.^22,23,24

REVISED MODEL POLICY FOR THE USE OF OPIOID ANALGESICS IN THE TREATMENT OF CHRONIC PAIN

The Model Policy for the Use of Opioid Analgesics in the Treatment of Chronic Pain, published by the Federation of State Medical Boards (FSMB), was revised in August 2013.²⁵ The policy assists state medical boards in advising and regulating physicians with regard to medically appropriate prescribing practices when using opioid medications for the treatment of chronic pain. It was updated to address dramatic increases in rates of abuse, misuse, and diversion of opioid medications with increased morbidity and mortality in the United States.²² The updated policy emphasizes the need to assess and treat chronic pain as well as promote access to substance abuse and addiction treatment for high-risk patients. It recommends that physicians screen patients for history of abuse, misuse, or opioid addiction prior to and subsequent to prescribing opioid medications.

The 2013 FSMB revised model policy describes expectations for prescribing of opioids and stresses areas where opioid prescribing would be departures from accepted best clinical practices:

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  Inadequate assessment to determine that opioids are clinically indicated.

  
  
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  Inadequate determination of risks associated with opioid use.

  
  
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  Inadequate monitoring of outcomes during the use of potentially abusable medications.

  
  
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  Inadequate education of patients.

  
  
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  Failure to obtain substantive informed consent.

  
  
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  Escalation of dose without adequate attention to risks or alternative treatments.

  
  
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  Excessive reliance on opioids, particularly high-dose opioids, for chronic pain management.

  
  
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  Failure to make use of available tools for risk mitigation.

The revised FSMB model policy emphasizes that competent physicians must be capable of managing patients with chronic pain with appropriate assistance from specialists when necessary. Although opioid medications may be used to provide pain relief, the use of such medications for purposes other than prescribed puts the patient, physician, and society at risk for harm. The policy indicates that physicians are responsible for minimizing risks of abuse and diversion of prescription opioids by prescribing to carefully selected patients only for whom opioid therapies will provide benefit and by reevaluating periodically the benefits versus the risks of their continued use.

Although it is intended to support the work of state medical boards, the FSMB model policy can be a tool to educate physicians in appropriate use of opioid medications as part of a comprehensive chronic pain treatment plan for their patients. The model policy is not intended for use as a rigid algorithm from which deviation will be penalized by state medical boards. However, deviations from the general recommendations contained within the model policy should be supported with documentation of sound medical justification. Additionally, it is expected that assessment of the benefits versus risks of the treatment plan for a specific patient be recorded in the medical record.

The FSMB model policy is divided into the following categories:

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  Patient evaluation and selection.

  
  
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  Development and documentation of a treatment plan.

  
  
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  Informed patient consent, agreement, and initiation of treatment.

  
  
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  Periodic review of the treatment plan and monitoring.

  
  
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  Consultation and referral.

  
  
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  Discontinuation of opioid therapy.

  
  
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  Maintenance of the medical record.

FSMB MODEL POLICY: PATIENT EVALUATION AND SELECTION

Accurate assessment, diagnosis of pain generators, and effective treatment of pain are essential for the patient with chronic pain. Evaluation is key to identification of patients with chronic pain who may need and benefit from opioid therapy for pain. An in-depth evaluation will explore the risks and benefits of a proposed therapy, including treatment with opioid medications. Such an evaluation should include a medical history and systems review, physical examination, review of pertinent imaging studies, and review of laboratory results as dictated by symptomatology and patient history.

The physician should assess the nature and intensity of pain and the effect that pain has on the patient’s daily life (functional impact). Issues such as sleep, mood, relationships, and ability to participate in recreational activities should be reviewed and documented. Validated brief assessment tools such as the three-question “Pain, Enjoyment and General Activity Score” (PEG)²⁶ may be helpful in determining the global effect of chronic pain on a patient’s life. Particular attention should be paid to evidence of untreated preexisting or onset of mental health illness, such as depression. This is important because patients with mental health comorbidities are at increased risk for abuse, misuse, and overdose of controlled medications.

As use of prescription opioid medications for illicit purposes such as recreation, diversion, or related to chemical dependency is higher than previously thought, the FSMB model policy emphasizes that opioid prescribers must protect the patient and the community at large from harm related to opioid misuse or abuse. Patients may not be forthright about their motivations for seeking opioid therapies for pain relief for various reasons. A detailed history of present and past alcohol, illicit and prescription drug abuse as well as history of physical, emotional, and sexual abuse should be obtained. Such information can be helpful, though not conclusive, to identify a particular patient’s risk for misuse of opioid-based medications and chemical dependency. It may be helpful to corroborate a patient’s health and behavior history with close friends or family members. Screening tools such as the Screener and Opioid Assessment for Patients with Pain (SOAPP-R)²⁷ and the Opioid Risk Tool (ORT)²⁸ can assist the physician in assessing a patient’s potential risk for opioid misuse. The use of prescription drug monitoring programs (PDMPs) and confirmatory tests such as urine drug screening are also expected to be useful when available.