Emerging Prescribing Guidelines

Prescribers of opioids need awareness of multiple federal and state laws, regulations, and guidelines surrounding the use of controlled substances to treat pain. Some of these parameters have evolved rapidly in recent years, as policymakers move to reduce overdose mortality, the spread of nonmedical use, and the illicit diversion of pharmaceuticals. State strategies include the increasing use of prescription drug monitoring programs (PDMPs), leveraging state-run health plans to address inappropriate prescribing, widening access to naloxone to reverse opioid overdose, more access to substance-abuse treatment, and the promotion of state-published opioid prescribing guidelines.

In addition, medical boards regulate practice within states to assure professional standards are met. Practice requirements are frequently listed on the website of each state’s medical board or professional licensing agency. Many states have adopted—in whole or in part—the criteria set by the Federation of State Medical Boards (FSMB) for the use of opioids to treat chronic pain ( Table 44.1 ). In 2016, the Centers for Disease Control and Prevention (CDC) released a “Guideline for Prescribing Opioids for Chronic Pain,” discouraging the use of opioids in treating chronic pain, excluding cancer and end of life ( Table 44.2 ). Unfortunately, insurance benefits are lacking for interdisciplinary pain treatments and alternatives to opioids, and dose limits fail to acknowledge individual analgesic response; these are matters the CDC does not adequately address in its guideline. It should be noted that strong recommendations are backed by low-quality evidence, a feature common to many opioid-prescribing guidelines.

Common elements are found in practice guidelines developed by professional medical societies, states, or federal agencies. The CDC, in partnership with other federal agencies, reviewed eight guidelines developed before 2013. These guidelines, which were intended for general practitioners, failed to address specific conditions or subpopulations and excluded guidelines intended for specialists. In addition, a systematic review of 13 opioid-prescribing guidelines gave high marks to the joint guideline of the American Pain Society (APS) and American Academy of Pain Medicine (AAPM) and the guideline from the Canadian National Opioid Use Guideline Group ; the same review rated 7 other guidelines to be of intermediate quality and determined that 4 additional guidelines could not be recommended. Taken together, the two reviews found commonly endorsed recommendations in the guidelines that include the following :

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  Conducting and documenting a physical exam, pain history, past medical history, and family and social history

  
  
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  Assessing for abuse and addiction, perhaps using an opioid-specific tool

  
  
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  Conducting urine drug testing (UDT), when appropriate

  
  
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  Checking the state prescription drug monitoring database where available for past or present patterns of unauthorized prescriptions

  
  
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  Considering all treatment options, weighing the benefits and risks of opioid therapy, and using opioids when alternative treatments are ineffective

  
  
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  Initiating opioids with the lowest effective dose

  
  
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  Implementing pain treatment agreements to set parameters and expectations of therapy

  
  
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  Monitoring pain and treatment progress with documentation

  
  
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  Using greater vigilance at high doses and/or greater abuse risk

  
  
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  Possessing special knowledge to prescribe methadone

  
  
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  Recognizing risks of fentanyl patches

  
  
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  Considering opioid rotation with adverse effects or ineffective analgesia

  
  
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  Reducing doses by ≥25% to 50% when rotating to a different opioid

  
  
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  Treating high-risk patients with more frequent and stringent monitoring and comanagement with mental health and addiction specialists

  
  
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  Considering reasons for repeated escalations in opioid dose

  
  
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  Discontinuing opioid therapy when repeated aberrant drug-related behaviors are observed

  
  
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  Using safe and effective methods for discontinuing opioids, such as tapering and making appropriate referrals to medication-assisted treatment or substance-abuse specialists

Newer or updated guidelines, particularly those developed to assist recovery from occupational injuries, emphasize dose-dependent risks of opioids, functional improvement of the patient, opioid-sparing techniques, and exhaustion of nonopioid pain modalities.

In addition to numerous practice guidelines, a number of initiatives to reduce harm and regulate prescribing have been enacted at the federal level. The US Food and Drug Administration (FDA) has made changes to labeling for ER/LA opioids to clarify indication and to add warnings regarding misuse and addiction, life-threatening respiratory depression, accidental ingestion, consumption during pregnancy, and coingestion with alcohol. Furthermore, the FDA has issued a risk evaluation and mitigation strategy (REMS), including patient medication guides and a blueprint for provider education programs, to help ensure that the benefits of opioids outweigh the risks. The US Substance Abuse and Mental Health Services Administration (SAMHSA) has published a toolkit to help communities and local governments prevent opioid overdose with information for patients, prescribers, first responders, community members, and family members.

A synthesis of these sources underscores that the administration of opioids for pain requires significant risk management in key domains through careful assessment of benefits to risks, candidate selection, stratifying by risk category, monitoring for adherence to the regimen, periodic reassessment of progress toward treatment goals, and thorough documentation in the patient record. These fundamentals of practice are discussed along with some additional, often underappreciated, risks of opioid therapy.

Patient Evaluation and Risk Stratification

Most guides specify a new patient evaluation beginning with a physical exam to include health and pain-specific information, a review of medical history, and a personal history to collect psychiatric, social, and substance-use data. Who has been caring for the patient in the past, plus the medications that have been prescribed and for what indications, should be determined; and the patient’s substance history, including their use of alcohol, prescription and over-the-counter medications, and illicit drugs should be assessed.

Problematic opioid use by the patient is behavior that threatens the integrity of pain management. Definitions related to problematic opioid use include the following :

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  Misuse: Use of a medication for a medical purpose other than that directed or indicated, regardless of the patient’s intention

  
  
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  Abuse: The intentional self-administration of a medication for a nonmedical purpose

  
  
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  Diversion: The act of removing a prescription medication from its intended and lawful use

  
  
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  Addiction: A disease state with genetic, psychosocial, environmental factors, and behavioral characteristics that include impaired control over drug use, compulsive use, continued use despite harm, and/or craving

The motive underlying problematic opioid use is not always clinically apparent and may have various causes, including addiction, uncontrolled pain, fear of withdrawal symptoms, recreational use, or an untreated mental disorder. This is why a thorough evaluation of risk for substance abuse and of psychiatric history should take place before opioids are initiated or continued.

Clinicians need knowledge of factors that may contribute to an opioid-use disorder in a patient with pain. These include, but are not limited to, family and personal history of substance abuse, a history of legal problems, a craving for prescription medication, mood swings, nicotine dependence, and a younger age. Patient risk factors for overdose death include middle age, high opioid dose, history of substance abuse, comorbid mental disorders, methadone use, benzodiazepine coprescribing, unemployment, polysubstance abuse, and sleep apnea.

Tools to assess risk for problematic opioid use may be predictive or diagnostic, but should be brief enough to include in regular clinical practice. Validated opioid-specific tools include the Opioid Risk Tool, the revised 24-item Screener and Opioid Assessment for Patients with Pain, and the Diagnosis, Intractability, Risk, Efficacy inventory. A baseline UDT and initial check of the state PDMP are common recommendations. The state PDMP can help a clinician determine whether a patient is filling prescriptions appropriately, and whether the patient is obtaining unauthorized prescriptions from other providers. Within limits, UDT may confirm the presence or absence of a specific drug or its metabolites. Many initial assessment strategies will also form part of the ongoing monitoring process.