Chronic pain treatment agreements that outline the responsibilities of the patient and the provider are indicated for long-term treatment with opioids or other medications with the potential for substance abuse disorder. The U.S. Department of Health and Human Services, Division of Indian Health Services, recommends that treatment agreements include the following tenets. 102 • Treatment goals are defined in terms of pain management, restoration of function, and safety. • The patient is responsible for safe medication use (i.e., not taking more than prescribed; understanding the dangers of using in combination with alcohol, cannabis, benzodiazepines, or other CNS depressants unless closely monitored by the prescriber). • The patient will ensure secure storage and safe disposal. • The patient will obtain opioids from only one clinician or practice. • The patient will fill the opioids at only one pharmacy. • The patient will agree to periodic drug testing (i.e., urine drug screening). • The clinician is responsible for making themselves available or having a covering clinician available to care for unforeseen problems and to prescribe scheduled refills. Complete pain relief is often not achieved; a 30% reduction in pain is considered a good clinical response and a reasonable goal when managing patient expectations. 103 In a function-based treatment strategy for chronic pain, treatment efficacy is measured by the patient’s ability to achieve improved function rather than complete pain relief. These goals may include going to work, walking, achieving enhanced sleep, or improving social interactions. It may be beneficial to begin with more easily achievable goals and progress to more challenging ones after initial successes. This approach can be much more motivating than a plan resulting in early treatment failure. 104 Initiating Opioid Therapy for Chronic Noncancer Pain When initiating opioid therapy for chronic pain, clinicians should start with immediate-release opioids and avoid extended-release formulations or long-acting opioids. Begin with the lowest effective dosage. Evaluate patients within 1 to 4 weeks of starting opioid therapy or dose escalation. Clinicians should evaluate patients every 3 months to assess the continued benefit and the development of any adverse effects once the opioid dose is stabilized. If the patient no longer benefits from the opioid therapy, the clinician should optimize the treatment regimen, including adding other treatment modalities or tapering off the opioid regimen. 105 Some patient populations and patients with certain conditions require closer monitoring and counseling before initiation and during chronic pain treatment. For example, patients receiving other central nervous system depressants, especially benzodiazepines, require special attention because
of an increased risk of adverse events, including increased sedation, confusion, difficulty driving or performing other tasks requiring high concentration levels, respiratory depression, and overdose. It is also necessary to assess how the patient uses work equipment that requires precise motor control, heavy machinery, or chemical or biohazardous materials. Pregnant women also require an enhanced level of caution because chronic opioid use during pregnancy increases the risk of harm to the newborn, specifically neonatal opioid withdrawal syndrome. Further, these medications must be used cautiously in breastfeeding women because some opioids can be transferred to breast milk and may cause sedation or respiratory depression in the nursing infant. In elderly patients, clinicians should consider employing a lower starting dose, a slower titration period, and a longer dosing interval with more frequent monitoring. Patients with psychiatric disorders are at increased risk of adverse events associated with chronic opioid therapy. Untreated depression and other mental health disorders place patients at increased risk for misuse and abuse of opioid analgesics, including addiction and overdose. In addition, untreated depression may interfere with pain resolution. In cases where the opioid dosage increases, the prescriber should educate the patient on the risk of cognitive impairment that can negatively impact their ability to drive or perform other activities. Special Considerations for Extended-Release and Long-Acting (ER/LA) Opioids The FDA advises that extended-release and long-acting (ER/LA) opioid analgesics be reserved for patients when alternative treatment options are ineffective, not tolerated, or inadequate to provide sufficient pain relief. Before prescribing these products, review FDA-approved risk evaluation and mitigation strategies (REMS) programs, medication guides, and black box warnings. 106 These products, listed in Table 11 on the next page, are not for acute pain, pain that is mild or not expected to persist for an extended period, or use on an as-needed basis. In addition, the FDA-approved black-box warnings (BBWs) on these products advise clinicians of the following. • ER/LA opioid analgesics expose users to addiction, abuse, and misuse risks, leading to overdose and death. Assess each patient’s risk before prescribing and regularly monitor for the development of these behaviors and conditions. • Life-threatening severe or fatal respiratory depression may occur. Monitor closely, primarily upon initiation or following a dose increase. Instruct patients to swallow ER/ LA opioid analgesics to avoid exposure to/ ingestion of a potentially fatal dose. • Accidental ingestion of ER/LA opioid analgesics can result in a fatal overdose, especially in children. ( Note: Accidental pet ingestion has also led to deadly consequences.)
Prolonged ER/LA opioid analgesics use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life- threatening if not recognized and treated. In prolonged opioid use in pregnant women, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available. • Initiation of CYP 3A4 inhibitors (or discontinuation of medications that induce CYP 3A4) can result in a fatal overdose. Opioid Patient Education and Safety Patient education about the effects of these medications is critical and necessary when prescribing opioids to treat acute or chronic pain. Advise both patient and family about the common side effects and best practices related to dosing. Planning should include provision of prescriptions or distribution of naloxone to use in the event of overdose or respiratory depression. In addition, whenever an opioid is prescribed, the patient and family should be educated about the safe use and storage of the medications. Safe use refers to adherence to clinician instructions about dosing, avoiding potentially dangerous drug interactions, and preventing diversion. Remind patients that opioid pain medications are frequently diverted, and opioids should be stored in a locked cabinet or other secure storage unit. If a locked unit is not available, patients should be advised to not keep opioids in an open place that is easily accessed by others, since theft by friends, relatives, and guests is a known route by which opioids become diverted. 115 Discuss the effects that opioids might have on ability to operate a vehicle, particularly when opioids are first started, when dosages are increased, or when other central nervous system depressants, such as benzodiazepines or alcohol, are used concurrently. Proper disposal methods should be explained. Common instructions include the recommendation to not flush medications down the sink or toilet unless the prescribing information specifically instructs to do so. Many pharmacies, health centers, police stations and other organizations have take-back programs, including tamper-proof drop-off containers. Mixing the medicine with an undesirable substance such as coffee grounds or kitty litter for disposal in the trash is another option. 116 Commercial disposal systems such as DisposeRX have been developed and represent a safe way to dispose of these medications. Managing Opioid-Induced Adverse Effects An essential component of any chronic opioid therapy follow-up evaluation is assessment for opioid-related adverse effects. Tolerance to acute opioid-induced side effects (e.g., sedation, nausea/vomiting, itching) will develop; however, other adverse effects may continue to be an issue. Additionally, clinicians must be aware of long-term side effects.
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