American Society of Anesthesiologists
Joint Committee on Pain Medicine and Ad Hoc Committee on Prescription Opioid Abuse
Considerations for Long-Term Opioid Use in Chronic, Non-Cancer Pain Conditions
This information statement was developed to provide an educational tool to support safe and appropriate opioid prescribing. It is the result of a review of findings from expert panels, evidence-based research and clinical practice experience. Individual providers are encouraged to develop their own approaches to appropriate opioid prescribing and conclusions after considering the information presented.
This document is provided as a guide to management of opioid use for chronic non-cancer pain. The recommendations do not apply to cancer or acute pain management including post-operative pain. Any provider who cares for patients with chronic pain is encouraged to consult with a physician pain medicine specialist, particularly regarding management of patients with complex pain conditions who may require chronic opioid therapy as part of a comprehensive multimodal approach to treating the painful symptoms.
Nearly one third of the United States population suffers with chronic pain. Pain that is severe enough to limit activity is present in approximately 25 million Americans. The societal costs of chronic pain are astronomical, estimated at over $600 billion alone in annual lost work productivity and medical expenses.1 These costs (including direct medical costs and lost wages) are higher than those for heart disease, cancer, and diabetes combined.
The management of patients with chronic, non-cancer pain is particularly challenging. Physicians who care for this patient population must balance many important considerations when initiating opioid therapy. While opioids can be effective for well-selected patients, many patients may not have sustained benefit from this class of medications and may potentially have the increased risk of inappropriate misuse or abuse due to opioid dependence and addiction.2 Opioid prescriptions increased dramatically from the 1990’s to 2004 and have remained high in subsequent years3 with nearly 220 million prescriptions written in 2011, compared to 76 million in 1991.4 Simultaneously, a dramatic increase in opioid addiction, overdose and death is occurring.5,6 It is important to recognize that the source of the medications may not be related to the current management strategy or, in some cases may be unrelated to any new prescriptions. In fact, the predominate source of opioids misused by patients is leftover or surplus prescription medication, often not in the name of the patient. A 2013 national survey reported that 53 percent of those abusing prescription painkillers received them from a friend or relative; and further, the source of the prescription was a single doctor in 84 percent of these cases.7 As important ongoing prescribing of opioids after an initial administration is common. Discontinuation of opioid therapy after the initial opioid overdose does not consistently occur in the majority of cases.8
Clinicians from all specialties have the responsibility to address this issue and also understand the inadvertent role that they have contributed to the rise in opioid prescriptions. The greatest number of opioid prescriptions are written by primary care physicians and advanced practice providers and highest dosages for opioids are prescribed by clinicians in pain management, physical medicine and rehabilitation, and anesthesiology.9 The dramatic increase in opioid prescribing has contributed to the prevalence of prescription drug abuse in the United States. It is imperative that opioid prescribers carefully weigh risks versus benefits of opioids for chronic, benign pain and contemplate important considerations in making the decision to utilize opioids based on patient selection, initiation and titration of opioids versus other medications as first line treatment, documentation of effectiveness, potential need for random drug testing, and, perhaps most significant, ensuring collaboration with specialists and other caregivers, and ensuring cessation of opioids when no longer required.
The American Society of Anesthesiology believes that a systematic, multimodal, and comprehensive approach to chronic pain is necessary to optimize outcomes for this patient population while minimizing the risk of opioid related long-term disability, morbidity, mortality, abuse and diversion. Failure to recognize the complexity of chronic pain and the need for comprehensive care may potentially lead to significant risk and ineffective treatment. Ongoing educational programs that describe best practices and universal precautions for patients, physicians and caregivers are necessary to ensure a multimodal, comprehensive, multi-disciplinary approach to chronic pain. Patients and providers must understand that the expectations from opioid therapy and most importantly those opioids alone do not provide a long-term sustained treatment plan for chronic pain.
The American Society of Anesthesiology has carefully put forth the following considerations for safe, effective, and responsible opioid prescribing in the context of chronic non-cancer pain:
Comprehensive Evaluation and Documentation Prior to Initiation of Opioid Therapy:
Patient assessment begins with a comprehensive history and physical exam to: (1) determine the diagnosis for the patient’s pain complaint including a detailed assessment and appropriate diagnostic studies, (2) evaluate how the pain is affecting the patient’s quality of life and function and ability to enjoy life, (3) characterize co-morbidities and psychosocial factors which could affect the choice of therapies, (4) assess prior approaches to pain management and their effectiveness, and (5) establish a basis for developing a treatment plan to help reduce the patient’s pain and return the patient to the desired level of functioning and quality of life and ability to enjoy life as per CDC recommendations for pain assessment, including documentation of pain intensity, aggravating and relieving factors, history of pain treatments and level of functioning.
Demonstration of Empathy and Compassionate Communication:
It is critical to understand that clinicians need to (1) demonstrate empathy in accepting the patient’s report of pain (2) simultaneously determine if the magnitude and characteristics of the pain complaint is commensurate with causative factors and (3) if these factors have been adequately evaluated and treated with non-opioid therapy. Providers must bear in mind that patient’s pain and response to treatment will vary over time and according to genetic, psychosocial and cultural factors so may require reassessment on a regular basis.
Consideration of Multimodal Treatment Options:
In addition to non-opioid medication therapy, a variety of pain treatment modalities can be employed before initiating opioids, such as physical/occupational therapy, psychological approaches (e.g. cognitive behavioral therapy, biofeedback and relaxation therapy), and interventional pain treatments such as epidural steroid injections, radiofrequency denervation and spinal cord stimulation (SCS). There are other interventional pain procedures which may decrease oral opioid use for chronic non-cancer pain.
Development of Quality of Care Metrics and Standardized Opioid Protocols Integrated Into Clinical Practice:
Integration of standardized opioid protocols into clinical practice will assist physicians and their staff when discussing opioid therapy with patients and families. Practice based protocols and policies can help physicians set expectations with patients at the onset of therapy. Patients should be educated as to the risks and benefits of opioids, and the expectation that they follow the agreed upon initiation, maintenance and discontinuation plans. Opioid policies and protocols may include the development of uniform approaches to opioid use within a group and limits on amounts of opioids dispensed and refills. Individual physicians and groups should consider parameters for duration and maximum doses of opioids. The group should also define pain syndrome for which opioids might be appropriate and those for which they should generally be avoided. Non-specific pain syndromes without a clear etiology generally do not respond favorably to opioid therapy. Guidelines are available for prescribing opioids for chronic pain.14,15 A recent systematic review of chronic pain guidelines noted that most guidelines suggest max doses (in morphine equivalents) of 90 – 200 mg/day. As agreed upon by the physician and the patient, the amount of opioid prescribed should be commensurate with the opioid medication to be used. The patient should not increase the dose without discussing changes with the physician first. Physicians and their teams should include ongoing assessment of specific quality metrics in their practices, including measures like screening for substance use disorder, appropriate documentation of indications for opioids and documentation of follow-up visits, and improvement in pain scores and function.
Careful Assessment for Appropriateness of Opioid Therapy:
Additional assessment may be necessary to determine the appropriateness of opioid therapy, which may include testing for important co-morbidities such as respiratory conditions, liver dysfunction, renal insufficiency, sleep apnea (both obstructive and central), cardiac disease, and medication allergies that might be absolute or relative contraindications to opioid administration. The geriatric population is a vulnerable group that needs special attention if opioid therapy is considered. In general, lower starting dose and longer dosing intervals are advised until patient response is assessed.
Clear Communication of Realistic Goals and Documentation of Plan of Care Specific to Opioid Therapy:
Early in the process, realistic expectations should be set with the patient regarding opioid therapy, including goals for pain reduction and improved function. Ideally, a patient treatment agreement to document patient understanding and agreement with the expectations of opioid use is recommended. There is evidence that some patients do not adhere to prescribed treatment (including with an agreement); however, these agreements are necessary and are coupled with a urine drug-screening program.
Patients should be informed about what constitutes responsible use of opioids and how to interact with their physician and pharmacy in obtaining medication. A continuing discussion with the patient regarding chronic opioid therapy should include goals, expectations, potential risks, and alternatives to opioids. This plan should be signed and dated and placed in the patient’s chart, and be clearly discussed on routine follow up evaluations. Once completed, the agreement can be an effective tool for both monitoring compliance and defining how to address violations of the agreement.
Evaluate Carefully for Potential Drug Interactions, Co-Morbidities, and Other Conditions that May Predispose to Opioid Overdoses:
Benzodiazepines and other sedatives can increase the risk of side effects or adverse events when combined with opioids, particularly respiratory depression and/or aspiration. Both classes of medications have been implicated in the worsening of obstructive sleep apnea (OSA) and thus are relatively contraindicated with this condition due to suppression of the gag reflex and reduction of airway protection. Similarly, other illnesses that compromise respiratory function and oxygenation, such as COPD or pneumonia, may pose additional risks for patients taking opioids; this risk is particularly high with the addition of sedative/hypnotic medications such as benzodiazepines. All of these situations should be monitored while a patient is taking chronic opioids.
Co-Prescription of Naloxone with Opioid Therapy:
Physicians are encouraged to consider co-prescribing naloxone with an opioid for patients at high risk of overdose. Those at high risk of overdose include individuals who are prescribed a daily dose equivalent to 100 milligrams of morphine or more, have an underlying respiratory condition such as sleep apnea, have a history of a non-opioid substance use disorder or a mental health disorder, or are currently prescribed a benzodiazepine or other sedative/hypnotic. Prior to receiving access to naloxone, laypersons (relatives, close friends) that might witness an opioid overdose should be trained on how to recognize an opioid overdose, and on effective resuscitation and post-resuscitation care, which includes administering naloxone and calling emergency services.
Opioid Therapy Should be Considered as a Trial and Plan For Taper Should be Completed Prior to Initiation of Opioid Therapy:
Prioritizing patient safety is paramount throughout opioid therapy, and clinicians should prescribe the lowest possible dose that is effective for the patient.10 The initial use of opioids for the treatment of chronic non-cancer pain should be considered as a trial, and not a commitment to long-term therapy. Further, it should be communicated to the patient that treatment with opioids will be discontinued if the trial is considered unsuccessful. Treatment success will be determined based on a balance between the benefits (e.g. improvements in function, pain, quality of life, ability to enjoy life, return to work) and adverse effects. A plan for tapering off opioids should be in place prior to initiation of opioid therapy if it is determined to be ineffective. This should be discussed with the patient at the time of opioid therapy initiation and is a part of expectation setting. Physicians who are not skilled in safely down-titrating opioid medications should avoid up-titrating opioids and should seek subspecialty consultation for guidance.
Careful Assessment for Risk of Opioid Dependence and Addiction:
Assessment must be made in a non-judgmental, compassionate manner that acknowledges that chronic pain may affect any and all individuals. It is of critical importance that consultation with mental health professionals be provided for high-risk individuals, including an addiction specialist, prior to initiating opioid therapy.
If opioid therapy is considered, patients at risk for abuse and opioid related complications should be carefully and meticulously identified based on a number of criteria, including, but not limited to a history of current or former substance abuse, misuse, or under-treated mental health disorders (e.g. depression, anxiety, post-traumatic stress disorder). Additionally, a comprehensive assessment should be completed of all social factors that may impact pain management and compliance including: employment, job satisfaction, marital history, social network, and history of legal problems. Patients with multiple co-morbidities and concurrent use of medications likely to interact with opioids may also be poor candidates. In particular, central nervous system depressants such as benzodiazepines can act synergistically with opioids and place the patient at risk for adverse respiratory outcomes.
Consideration of Opioid Maintenance Therapy:
Extended-release opioids should only be considered after detailed evaluation over an extended period of time. It is reasonable to refer chronic non-cancer pain patients to a pain physician for assessment of a broadened treatment plan, possibly including extended-release opioids. Per the CDC guidelines, it is important to assess pain, functionality, and quality of life on every visit if opioid therapy is maintained for an extended period of time. Some guidelines recommend that patients achieve at least 30% reduction in pain scores and 30% increase in function to justify continuing opioid therapy.12 Ongoing evaluation of benefit versus harm of opioid therapy should be carried out every 3 months or more frequently if needed. Because there is a lack of data that clearly supports long-term (> 1 year) benefit of opioids for the treatment of chronic non-cancer pain,11 patients must be evaluated on a case-by-case basis to determine the appropriateness of continuing opioid therapy.
Routine Check in PDMPs and Documentation of PDMP Assessment:
Prescription drug monitoring programs (PDMPs) are present in most states (except Missouri). They collect data in near real time on all dispensed opioids and most other controlled substances. The utility of the program is that any prescriber can check on all sources of dispensed controlled substances if obtained legally, even if the prescription is self-paid. Before and after initiating opioid therapy, physicians should use state prescription drug monitoring programs. PDMPs are valuable tools for physicians to identify medications their patients are receiving from other providers, and can increase patient safety and reduce overdose risk. However, there is little interstate operability with PDMPs at this time, so reviewing the prescription pattern in a single state may not account for individuals obtaining treatment from multiple neighboring states.
Tapering and Dose Adjustments of Opioid Therapy Should Be Under Close Supervision:
If opioid therapy is determined to be ineffective, tapering of the opioid should be performed. Tapering opioids should be done slowly under close physician supervision. Consultation with physicians with expertise in pain or addiction medicine should be considered when tapering of opioids is initiated. Some clinicians will rotate opioids to take advantage of incomplete cross-tolerance between drugs when weaning a patient from opioid medications. Opioid rotation must be done carefully. While the use of morphine equivalent tables can provide some initial guidance, caution is advised on relying entirely on such calculators due to incomplete cross-tolerance and inter-individual variability.13
Dosing Adjustments and Follow Up Assessment Should Follow FDA and CDC Guidance:
Follow-up in 1-4 weeks of initiation of opioid therapy is reasonable to assess benefits versus any harm related to this class of medication. Rationale for changes in opioid doses should always be documented, especially when high dose opioid therapy is used, as the need for up-titration may be a sign that further therapy may prove ineffective or incur additional risk. Patients should be counseled on how to monitor and manage common side effects of opioids include nausea and vomiting, ileus, sedation, pruritus and constipation. Multimodal therapy should be initiated before up-titration of opioids occurs. Life threating events result from respiratory depression. Long-term opioid use may also result in decreased libido, testicular atrophy, menstrual dysfunction, osteopenia and increased risk for heart attack.11 Recent CDC guidelines suggest careful risk versus benefit assessments before increasing the dose of opioids ≥ 50 morphine milligram equivalents/day (MME/day), and avoidance of doses ≥ 90 MME/day without careful justification of that decision. 10 There is no clear opioid dosage threshold below which adverse events – including catastrophic respiratory depression – can be guaranteed not to occur. There is a dose-dependent increase in adverse events; increasing the dose should be managed carefully with increased vigilance. The FDA has approved black box warnings for the safe use opioid medications and recommends increasing risk mitigation strategies to limit the potential for opioid abuse,
Urine Drug Testing Should Be Completed at Baseline and Every 3 Months:
Urine drug testing should be carried out before initiating opioids and considered every 3 months as determined utilizing a risk assessment tool. It is also reasonable to carry out more frequent urine drug testing when high morphine equivalent therapy is being prescribed or the physician determines that the patient is at higher risk for opioid misuse. Providers should have a plan in place to address urine testing results including when to obtain confirmatory testing and how to discuss the findings and their implications with the patient.
Acute Pain Must Be Evaluated Closely in Patients with History of Chronic Opioid Use:
If patients reach an effective, stable dose of opioids but then suffer an exacerbation of their pain, they should be evaluated for a new pain source or progression of underlying pathology and treated as an acute problem. Alternative management strategies, including multi-modal therapies may be more helpful than increasing opioid use in these clinical situations. If the clinician chooses to increase the opioid dose, it should be titrated back to the initial dose as soon as possible after resolution of the acute exacerbation of pain.
Development of a Support Network of Professionals and Family for Patient Recovery and Treatment:
In order to address the prescription drug epidemic while simultaneously effectively treating patients with pain, collaboration is needed among physicians, hospitals, pharmacies, pharmacy boards, insurance companies and law enforcement. As important for the individual patient is the need for family and friends to be included in educational efforts and how to most effectively provide physical and emotional support for the chronic pain sufferer.
Continued Education for Physicians on Opioids:
It is vital that physicians understand the pharmacology, risks and indications for opioids, in addition to indicators of abuse and aberrant drug related behaviors. Continuing medical education regarding opioids and pain management options should be provided, since they will contribute to safe prescribing and improved patient outcomes.
Treatment of Pain with the Biopsychosocial Model and Understanding the Opioid Culture Change:
Appropriately and with the best of intentions, regulatory agencies and physicians have made pain control a focus of medical practice. However, the use of opioids for difficult to manage pain can produce consequences that elevate risk for both patients and their families, including adverse health outcomes like myocardial infarction, hormonal changes, bone density loss, addiction and death. Patients and clinicians alike view opioid use as sole therapy for acute and chronic pain as a cultural expectation in the United States, further contributing to the opioid epidemic. To change this cultural expectation, a multimodal, individualized approach to pain management that focuses on the biological, social and psychological components of pain is necessary. In addition, there is a critical need for onboard-based education of the public, health care workers and clinicians on pain etiology, the value and risks associated with opioid use and treatment alternatives to chronic opioid therapy.
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- Okie S: A flood of opioids, a rising tide of deaths. The New England journal of medicine 2010; 363: 1981-5
- Case A, Deaton A: Rising morbidity and mortality in midlife among white non-Hispanic Americans in the 21st century. Proc Natl Acad Sci U S A 2015; 112: 15078-83
- Larochelle MR, Liebschutz JM, Zhang F, Ross-Degnan D, Wharam JF: Opioid Prescribing After Nonfatal Overdose and Association With Repeated Overdose: A Cohort Study. Ann Intern Med 2016; 164: 1-9
- Chen JH, Humphreys K, Shah NH, Lembke A: Distribution of Opioids by Different Types of Medicare Prescribers. JAMA Intern Med 2016; 176: 259-61
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- Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA: The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med 2015; 162: 276-86
- Furlan AD, Reardon R, Weppler C: Opioids for chronic noncancer pain: a new Canadian practice guideline. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 2010; 182: 923-30
- Nuckols TK, Anderson L, Popescu I, Diamant AL, Doyle B, Di Capua P, Chou R: Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Annals of internal medicine 2014; 160: 38-47