While the safest possible course of treatment is to avoid initiating chronic opioid analgesic therapy (COAT) for chronic pain, patients receiving COAT must be carefully managed to mitigate the potential for opioid-related adverse effects. The risks and harms associated with chronic opioid use are well known. These include increased rate of falls, fractures, traffic accidents, constipation, delirium, pneumonia, sleep disordered breathing, endocrine dysfunction, opioid misuse, OUD, non-fatal overdose and overdose deaths. However, in the existing pain management environment, patients receive opioids for chronic pain and some clinicians will continue to use opioids as a component of pain management. In this context, it must be recognized that abrupt cessation of opioid therapy is also a risk, and may cause significant patient harm. Clinicians must recognize that the decision to prescribe opioids for chronic pain requires: ongoing, active risk assessment; frequent monitoring; responsibility for the patient’s safety and management of the conditions that contribute to the patient’s pain experience.
The Opioid Prescribing Work Group recommends that patient safety is a paramount treatment consideration when prescribing opioids for chronic pain. Improving functional status and reducing pain intensity also remain important treatment goals. Develop a multi-modal, active pain management plan with the patient to achieve these goals. Titration of opioids only to pain or self-reported functional status is not recommended. This often leads to accelerating doses based on a perception that higher doses will effectively ameliorate pain or improve function.
The following recommendations promote careful monitoring of patients receiving COAT. The recommendations are divided into three sections:
Section V. Tapering Opioid Analgesic Therapy addresses tapering COAT when the risk of opioid-related harm outweighs the benefit of continuing therapy at the current dose.
Assessment of pain intensity alone for patients experiencing chronic pain is insufficient. Research demonstrates that pain intensity scores of chronic pain patients are not predicted by etiology of the pain (Hashmi, 2013). Therefore, assessment tools are more likely to be useful when function and quality of life are included in the assessment.
Diagnose or confirm the origin of the pain at the time of assessment. Former injuries and diagnoses should be considered in the differential diagnosis, however it is possible that they are no longer the pain generator. Consider opioid-induced hyperalgesia in the differential diagnosis when the patient has long-term opioid exposure. The correct diagnosis of the etiology of the pain is necessary to guide effective selection of patient-specific treatment modalities. Diagnostic evaluation should be complete, but should avoid exhaustive testing that has no reasonable expectation of providing a nociceptive etiology.
Not all patients have the resources needed to use health care services, engage in healthy behaviors and participate in treatment plans. Socioeconomic factors clinicians need to consider include, but are not limited to: geographic location; housing; employment; transportation; social support; education. Health care systems or practices with access to a social worker should include the social worker in the health care team. Social workers can help patients address resource/socioeconomic barriers that hinder patient engagement in the treatment plan.
Clinicians should carefully discuss goals with patients experiencing chronic pain. Explain to patients that while a reduction in pain intensity is an important treatment goal, the goals should also include engagement in valued life activities through improved social function and social interaction. Elimination of pain is never a realistic goal. Treatment goals should be tailored to the individual. Clinicians should encourage the patient to drive the goal-setting process and provide input on improvement that is objective, attainable and measurable.
Patient Provider Agreements (PPAs) are typically written treatment plans that identify the clinician and patient’s roles and responsibilities related to initiating long-term opioid therapy. Clinicians should approach initiating the PPA as a means to educate the patient about best practices for opioid use. In addition, the PPA may serve as a diagnostic tool to identify concerns as the patient continues his or her opioid therapy. Review the agreement with the patient at regular intervals determined by the patient’s risk profile. In general, review the agreement with the patient at least annually.
Components of an effective PPA include:
It is not demonstrated that PPAs improve clinical outcomes related to opioid therapy, however the PPA can serve as an important educational, communications and diagnostic tool. (CDC, 2016a; Starrel, 2006). Clinicians should consider the multiplicity of objectives that a PPA serves and stress the importance of the PPA to set expectations about both the clinician’s and patient’s responsibilities during opioid therapy. When used appropriately, a PPA can help prevent patient provider disagreement and allow the clinic to insist on consistent and universal practices for opioid-receiving patients (ICSI, 2017).
Clinicians should avoid dismissing patients from care when the patient is unable to comply with the terms provided in the PPA. This may be an indicator that the patient is developing dependence or OUD and the patient should be referred to the appropriate care.
Clinicians should consider opioid-induced pain, a newly onset OUD and/or the potential for drug diversion prior to increasing the daily dose. Tolerance at high doses is not a sufficient reason to increase dosage to ≥ 90 MME/day. Dosages greater than 90 MME/day should be considered temporary (e.g., acute on chronic pain for verifiable new condition) and every effort should be made to reduce the dosage as soon as possible.
Several studies have examined the relationship between the total daily dose of oral opioids—expressed as total MME per day—and opioid related harm. Evidence supports a dose-response relationship, with risk of overdose-related death increasing significantly at 100 MME/day. Studies examining other opioid-related harms demonstrate increasing risk of harm between 50 and 100 MME/day (Han, 2015; Gomes, 2011; Dunn, 2010). It is the belief of the work group that as the dose-response relationship is further studied, the evidence may support even lower daily doses of opioids to avoid opioid-related harm. Clinicians are encouraged to keep daily doses under 50 MME/day and continually offer to reduce doses for those patients whose daily dose exceeds the 50 MME/day limit.
Opioids incur greater risk of overdose in certain populations, including patients with substance use disorder (CDC, 2016a; Han, 2015; Turner, 2015). Given the inherent risk of prescribing opioids to a patient with untreated substance use disorder, clinicians should use non-opioid and non-pharmacologic therapies when treating the patient’s pain.
Extended release/long acting (ER/LA) opioids include extended-release versions of oxycodone, oxymorphone, hydrocodone and morphine. There is limited evidence on the increased efficacy or safety of ER/LA opioids versus intermittent use of immediate-release opioids (CDC, 2016a). One clinical study found a higher risk for overdose among patients initiated on treatment with ER/LA than among those initiated on treatment with immediate release opioids (Miller, 2015).
The FDA notes that “because of the greater risks of overdose and death with extended-release opioid formulations, reserve ER/LA opioids 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 to provide sufficient management of pain.” (FDA, 2014). FDA has also noted that some ER/LA opioids are only appropriate for opioid-tolerant patients, defined as patients who have received certain dosages of opioids (e.g., 60 mg daily of oral morphine, 30 mg daily of oral oxycodone, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid) (FDA, 2014).
Contraindications to ER/LA opioids listed in the FDA safety information include, but are not limited to:
Routine rotation or substitution of opioids should be avoided, however there may be circumstances in which it is appropriate to change to a different opioid. These circumstance include, but are not limited to:
Opioid conversion tables do not account for incomplete cross-tolerance in opioid-tolerant patients (AMDG, 2015, Webster, 2012). Therefore, doses of the new opioid should be reduced by 30-50% of the previous daily MME dose to avoid any harm related to incomplete cross-tolerance.
Methadone has unique pharmacokinetic and pharmacodynamics properties, including a long and variable half-life that is not consistent among patients. It is highly lipophilic and the respiratory depressant effect lasts longer than the analgesic effect (Chou, 2009). Clinicians trained in prescribing methadone are better prepared to educate patients on methadone’s unique risk profile, dose appropriately and provide the ongoing monitoring and assessment necessary to manage risk appropriately.
Methadone treatment for chronic pain may be indicated for a small, sub-set of patients, including patients with incurable, chronic neuropathic pain that has not responded to other opioid formulations.
Transdermal fentanyl is a long-acting, renal-safe synthetic opioid. Clinicians who prescribe fentanyl for chronic pain should consider the following:
Sublingual fentanyl should be reserved for only those in need of palliative care for extreme pain and unable to take any alternatives.
All patients receiving COAT should be monitored for opioid-related harms and misuse, however there is not a specific monitoring protocol indicated in the scientific literature. Clinicians should monitor use using the following risk management strategies, depending on the patient’s risk:
Query the PMP each time opioids are prescribed to patients on COAT.
Urine drug screens can play an important role in monitoring patients on COAT. Although there is limited evidence that routine use of UDS improves patient outcomes, current opioid prescribing guidelines recommend routine use of UDS in chronic pain patients (CDC, 2016a; ICSI, 2017). Urine drug screens can identify other substances used by the patient and/or when the patient is not adherent to his or her treatment regimen. Clinicians should use the results of a UDS to guide treatment decisions and referral to the appropriate level of care. The results of UDS cannot be used to diagnose substance use disorder or confirm diversion.
Interpreting urine drug screens is highly complex. In order for UDS to be an effective component of clinical management of chronic pain patients, clinicians must develop knowledge regarding proper specimen collection and validation, interpretation of positive and negative results and the role and need for confirmatory testing. Clinicians and health systems are encouraged to take an active role in the design and development of their UDS processes. An “on-call” toxicologist or addictionologist is a useful resource for assistance with inconsistent drug screens.
Although the medical literature has shown no well-established benefit of callbacks, it is the opinion of the Opioid Prescribing Work Group that pill count callbacks are useful for certain patient populations. These patient populations include those with demonstrated difficulty taking their medicine as prescribed and those for whom there is suspicion of diversion (ICSI, 2017).
Pill count callbacks are often a burden to patients. Include pill count callbacks in the patient-provider agreement and risk monitoring discussions, if appropriate. Patients should be aware that pill counts are possible as part of their COAT and contact information should be kept updated. If the pill count results in fewer or greater pills than expected, schedule a visit with the patient to discuss the results. Possible reasons for a discrepancy in the number of pills include diversion and misuse, but may also be a result of misunderstood directions, overprescribing, opioid-induced hyperalgesia, or an attempt to cope with an emerging mental health condition.
Patients who receive COAT should be managed by a multi-disciplinary care team, including, but not limited to, medical providers, mental health providers and other providers such as physical therapists. In addition, health care providers who prescribe opioids should develop a referral network of specialists for patients at higher risk of opioid related harm. The network should include mental health providers, addiction specialists, pain medicine specialists and medication-assisted treatment providers. These services can also be provided in the clinic, especially in situations where an office based medication-assisted treatment program exists.
Clinicians, especially those who practice in rural settings, are encouraged to develop referral networks using existing and developing technology, such as telemedicine and Project ECHO.
Clinicians are encouraged to complete the DATA 2000 Qualifying Buprenorphine training in order to be able to treat OUD in emergency department, primary care, obstetric, or pain medicine settings. Clinicians, especially those who practice in rural settings, are encouraged to develop referral networks or obtain support for their medication-assisted treatment (MAT) practice using existing and developing technology, such as telemedicine and Project ECHO.
The guidance below provides an overview of when referral to a specialist or a substance use disorder evaluation program may be appropriate. The guidance is not intended to be all-inclusive.
a. Addiction specialists and medication-assisted treatment (MAT) providers
b. Pain medicine specialists physicians are certified as specialists in the treatment of pain through the American Board of Medical Specialties and the American Board of Pain Medicine.
Pain medicine specialists provide a broad range of services and not all specialists treat pain with the same modalities. Referring clinicians should become familiar with the pain specialists in their geographical area and the types of treatment modalities provided. When a referral is appropriate, refer the patient to a pain medicine specialist with experience in the appropriate treatment modality and who is able to engage in multi-disciplinary patient care.
c. Mental health providers
All patients receiving opioids, regardless of the patient’s risk profile, should receive care from a multi-disciplinary team, including mental health screening and monitoring. It is the opinion of this work group that most chronic pain patients with functional limitations will benefit from treatment by a pain psychologist.
Coping with limitations caused by pain is a major reason to refer a patient to a pain psychologist, even if no mental health disorder or no behavioral issues are present.
The indications for referral listed below—with exception—address circumstances in which the patient is at high-risk for opioid-related harm. DSM-5 Axis One disorders confer mortality risk and predict development of OUD in patients who are prescribed opioids for chronic pain. Any patient receiving chronic opioids for pain who has such a mental health disorder should be evaluated and optimally treated for their mental health. This may require a psychology or psychiatric referral. Determine whether referral to a psychologist or a psychiatrist is appropriate based on the patient’s risk factors and medical history.
Indications for referral:
A psychiatry referral is appropriate at any time a patient has a major mental illness that cannot be satisfactorily managed by the primary care provider. The patient should be seen by a psychiatrist as a condition of being on opioids. A psychiatry referral is also appropriate when seeking a diagnosis or for suicidal/homicidal/psychotic thoughts or emotional instability.
A systematic review of 38 studies by Vowles et al. (2015) found that the rates of opioid misuse averaged between 21 and 29% among adult patients with chronic non-cancer pain. Misuse in this review was defined as opioid use contrary to the directed or prescribed pattern of use, regardless of the presence or absence of harm or adverse effects (Vowles, 2015). Opioid misuse and OUD are adverse events that can occur in all patients and clinicians should monitor all patients and provide universal screening (Volkow, 2016b; Kirschner, 2014; Dowell, 2013).
Patients with OUD receiving opioid analgesia for pain are at high risk for opioid-related harm, including fatal overdose. Clinicians who prescribe COAT are responsible for being able to recognize the symptoms of OUD in their patients and provide referrals to treatment, or offer medication-assisted treatment with behavioral therapies. The State recognizes that while many clinicians are largely untrained to recognize OUD, there are a growing number of resources available to clinicians to enhance their training and knowledge about this disease.
Consider the current OUD diagnostic criteria when monitoring patients for signs of opioid misuse (APA, 2013). Clinicians who are unable to provide a diagnostic assessment for OUD should screen patients using the Tobacco, Alcohol, Prescription medication and other Substance abuse (TAPS) tool. The TAPS tool consists of a 4-item screening for tobacco use, alcohol use, prescription medication misuse and illicit substance use in the past year and can detect clinically relevant problem substance use in a primary care setting (McNeely, 2016). Refer patients who screen positive for substance use disorder for treatment.
Clinicians should be knowledgeable about evidence-based OUD treatment options (see below) and consider offering MAT to their patients with OUD. Clinicians who choose not to directly offer MAT should work within their group to provide treatment capacity or develop a strong referral network for MAT and behavioral therapies.
MAT offers stabilization of OUD through buprenorphine-containing products or opioid antagonists integrated with behavioral health interventions and recovery-based supports. MAT has been shown to be safe and effective in suppressing illicit use, improving physical and mental well-being and reducing all cause and overdose mortality (Mattick, 2014; Department of Veterans Affairs, 2015). MAT has also been shown to be successful among patients who experience chronic pain (Weiss, 2011; Dennis, 2015).
Clinicians may refer to the Department of Human Services Health Services Advisory Council Recommendations for Medication-Assisted Recovery.
The following evidence-based treatment [modalities] should be delivered in conjunction with behavioral health interventions and recovery-based supports:
Patients receiving COAT can develop an OUD. Patients with OUD may continue to have chronic pain (Neumann, 2013; Alford, 2006). Patients who have developed OUD as a result of COAT tend to be more sensitive to pain and develop painful conditions (Compton, 2012; Doverty, 2001).
In some instances, the pain provider may discover that there is an OUD and in fact, no pain generator, or the pain generator has resolved but the OUD persists. In these cases, OUD may masquerade as pain and the pain treatment can be discontinued.
When OUD is diagnosed, pain management should continue in conjunction with addiction treatment when there is ongoing chronic pain. Address ongoing chronic pain with a selection of non-opioid and non-pharmacologic therapies, concurrent with initiation of an evidence-based addiction treatment modality. Clinicians who are unable to directly provide addiction treatment in an office-based setting should work closely with the addiction treatment provider to address ongoing pain. This requires ongoing consultation including a specific patient release to consult with the addiction treatment provider.
