The goal of the Pain Management Best Practices Inter-Agency Task Force was to identify gaps and inconsistencies in existing guidelines (see recommended updates to CDC Guidelines towards the end of post) and recommend updates and improvements intended to guide the public at large, federal agencies, and private stakeholders. This report identifies changes which I believe are relevant to the chronic pain community. This is an important document as it will shape policies at federal, state and local levels over the next three years, I encourage all CPP’s to read these excerpts and stay informed.
The most encouraging information from this publication was seeing policies makers acknowledge what many in the chronic pain community has been saying since 2015, but more than that was seeing the 2016 CDC Guidelines placed in context and the manner in which states, medical boards, pharmacies, PBMs, insurance companies, clinics, hospitals and individual prescribers, were taken to task for going far beyond what was written in those guidelines and for the damage they caused. After reading through this publication, this will be the first time I feel vindicated for the criticisms I have blog about in my posts.
These excerpts, not listed in chronological order, address elements many CPPs have argued and lobbied for. Excerpts are bold and italicized. The full report can be download by clicking Pain Management Best Practices Inter-Agency Task Force..
In the United States, the estimated number of patients with chronic daily pain is 50 million, with 19.6 million having chronic, high-impact pain. Several factors act as barriers to adequate care, including inadequate insurance coverage for pain management services, shortages of medical and behavioral pain management specialists, provider underestimation of patients’ reports of pain, poorly functioning drug supply systems, lack of research on innovative and effective pain management approaches, and more recently — widespread fear among providers of regulatory scrutiny.
The recent advent of retail pharmacies limiting the duration of prescriptions, making unrequested changes to dosages, or placing barriers to obtaining properly prescribed pain medications has had the unintended consequence of limiting access to optimal pain care. Without such access, many patients face significant medical complications, prolonged suffering, and increased risk of psychiatric conditions. Medical complications from inadequately treated acute pain may include prolonged recovery time, unanticipated hospital readmissions, and transition to chronic and persistent pain. Unremitting and inadequately treated pain is also associated with increased anxiety, depression, disability, unemployment, and lost income.
In addition to experiencing medical and psychiatric consequences, individuals who receive inadequate pain treatment may transition to illicit opioid or other substance misuse. Although the pathway to illicit substance use in pain is not well understood, a small but growing number of individuals who misuse prescription opioids without the supervision or oversight of a medical provider transition to using illicit substances, such as heroin, within a year of use. The nonmedical and illicit use of opioids may increase an individual’s risk for substance use problems, accidental or intentional overdose, or death. Heroin, fentanyl, and other illicit synthetic opioids continue to drive increasing numbers of overdose deaths. Understanding the indicators associated with inappropriate opioid use may improve the ability of health care providers to tailor treatments and surveillance without placing arbitrary limitations on all patients who are prescribed opioids. This understanding could also potentially improve access to effective care.
The Pain Management Best Practices Inter-Agency Task Force (Task Force) was convened by the U.S. Department of Health and Human Services in conjunction with the U.S. Department of Defense and the U.S. Department of Veterans Affairs with the Office of National Drug Control Policy to address acute and chronic pain in light of the ongoing opioid crisis. The Task Force mandate is to identify gaps, inconsistencies, and updates and to make recommendations for best practices for managing acute and chronic pain. The 29-member Task Force included federal agency representatives as well as non federal experts and representatives from a broad group of stakeholders. The Task Force considered relevant medical and scientific literature and information provided by government and nongovernment experts in pain management, addiction, and mental health as well as representatives from various disciplines. The Task Force also reviewed and considered patient testimonials and public meeting comments, including approximately 6,000 comments from the public submitted during a 90-day public comment period and 3,000 comments from two public meetings.
How Policy Makers View the Opiate Crisis
The field of pain management began to undergo significant changes in the 1990s, when pain experts recognized that inadequate assessment and treatment of pain had become a public health issue. Recommendations for improving the quality of pain care were followed by initiatives that recognized patients’ reported pain scores as “The 5th Vital Sign.” Hospital administrators and regulators began to focus on pain scores, encouraging and incentivizing clinicians to aggressively treat pain to lower pain scores. In addition, increasing administrative burdens (e.g., required quality measures, electronic health records [EHRs], data management, and government regulation requirements) led to less time for direct patient care. The administrative burden of using EHRs has contributed significantly to physicians’ burnout, likely affecting their capacity to manage the complexity of pain care. As the mandate for improved pain management has increased, there was and is a need for better education and training of clinicians as well as more time and resources to respond to the unmet needs of patients with painful conditions.
Converging efforts to improve pain care led to an increased use of opioids in the late 1990s through the first decade of the 21st century. These initiatives included an overall effort for lowering pain scores, the more liberal use of opioids, and the aggressive marketing of new opioid formulations coupled with the continued limited coverage of non-opioid options. These trends resulted in a liberalization of opioid prescribing.3,11 Prescription opioids can and are used to treat acute and chronic pain and are often prescribed following surgery or injury and for a subset of patients with chronic pain from medical conditions such as cancer and inflammatory, neurological, and musculoskeletal conditions. Multidisciplinary and multimodal approaches to acute and chronic pain are often not supported with time and resources, leaving clinicians with few options to treat often challenging and complex underlying conditions that contribute to pain severity and impairment. As medical and policymaking organizations began to urge caution about the use of opioids for pain, the federal government has developed a multifaceted approach to the opioid epidemic, including the U.S. Department of Health and Human Services (HHS) 5-Point Strategy to Combat the Opioid Crisis. In addition, various efforts now address this public health problem across federal, state, and local governments as well as the community, private, and academic sectors, including the “Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand,” issued in 2018 by President Donald J. Trump. A public health emergency was declared in October 2017 and subsequently renewed as a result of the continued consequences of the opioid crisis.
Significant public awareness through education and guidelines from regulatory and government agencies and other stakeholders to address the opioid crisis have in part resulted in reduced opioid prescriptions. Regulatory oversight has also led to fears of prescribing among clinicians, with some refusing to prescribe opioids even to established patients who report relief and demonstrate improved function on a stable opioid regimen. The Centers for Disease Control and Prevention published a pivotal article in the New England Journal of Medicine (NEJM) on April 24, 2019, specifically reiterating that the 2016 Guideline for Prescribing Opioids for Chronic Pain (CDC Guideline) has been, in some instances, misinterpreted or misapplied. This increased vigilance of prescription opioids and the tightening of their availability have in some situations led to unintended consequences, such as patient abandonment and forced tapering. Some established patients with pain may transition to using illicit drugs for pain control, including illicit fentanyl and heroin — a separate group of patients distinguishable from those with substance use disorders (SUDs) (as evidenced by Task Force public comments). The CDC has recently noted that the opioid crisis is quickly moving to a fentanyl crisis. This has coincided with an increase in the demand for illicit synthetic opioids as well as other substances, including a four-fold increase in the rate of death from heroin since 2010.22 Nationwide, nearly half of all opioid overdose deaths in 2017 involved illicitly manufactured fentanyl. Fentanyl is an opioid 50 times more potent than morphine. Illicit fentanyl (manufactured abroad and distinct from commercial medical fentanyl approved for pain and anesthesia in the United States) is a potent synthetic opioid. Illicit fentanyl is sometimes mixed with other drugs (prescription opioids and illicit opioids, such as heroin, and other illegal substances, including cocaine) that further increase the risk of overdose and death.
A significant number of public comments submitted to the Task Force shared growing concerns regarding suicide due to pain as well as a lack of access to treatment. According to a recent CDC report using data from the National Violent Death Reporting System, the percentage of people who died by suicide and had evidence of chronic pain increased from 7.4% in 2003 to 10.2% in 2014. Numbers from this data set beyond 2014 are not yet available. These findings are made more concerning when one considers the rising trend of health care professionals opting out of treating pain, thus exacerbating an existing shortage of pain management specialists, leaving a vulnerable population without adequate access to care.
Comprehensive pain management can be a challenge for various reasons. In the current environment, patients with chronic pain — particularly those being treated with opioids — can be stigmatized, a tendency exacerbated when their pain condition is complicated by mental health comorbidities such as anxiety and depression or by SUDs. Because opioids can produce opioid use disorder (OUD) in at-risk populations, risk assessment and periodic reevaluation and monitoring are required for all patients in these populations and should be a part of the complex care management they need, particularly when there is an intersection of chronic pain, opioids, mental health, and addiction. There is strong evidence that because of awareness of and education about these issues, prescription opioid misuse has been decreasing, from 12.8 million individuals in 2015 to 11.4 million individuals in 2017.
Clinical practice guidelines for best practices that only promote and prioritize minimizing opioid administration, run the risk of undertreating pain, especially when the cause of the pain is uncertain or cannot be reduced through non-opioid approaches
To continue improving quality of pain care in the current environment of opioid-related risks, experts have noted several key challenges associated with clinical best practices (CBPs).
- First, there is the need to increase the use of clinical practice guidelines, (CPGs), as indicated in specific patient groups delineated by their underlying diagnosis or cause of pain (e.g., arthritis, postoperative, neuropathic), comorbidities, psychosocial characteristics (e.g., social support, stress), demographics, and settings (e.g., hospital, perioperative, primary care, emergency department [ED]).
- Second, access to effective pain management treatments must be improved through adoption of clinical best practices in medical and dental practice and clinical health systems.
- Third, clinical best practices for pain management should be better incorporated into the routine training of clinicians, with special attention to residency training to meet the needs of patients treated in each specialty.
- Finally, quality care must be adequately reimbursed.
Pain management experts have also identified specific research gaps that are impeding the improvement of pain management best practices, including synthesizing and tailoring recommendations across guidelines, diagnoses, and populations. In addition, gaps and inconsistencies exist within and between pain management and opioid prescribing guidelines. This finding is also the result of demographic and other variances, because CBPs are developed in different regions of the country. A recent review of clinical opioid prescribing guidelines by Barth et al. notes several needs — including the development of postoperative pain management guidelines for different surgical procedures, with the understanding of patient variability in physiology, drug metabolism, and underlying disease processes. This research further emphasizes the need for an individualized, patient-centered approach focused on achieving improved function, activities of daily living (ADLs), and QOL as well as pain control. In light of these gaps, pain management providers should consider potential limitations to evidence-based clinical recommendations.
A systematic review of CPGs for neuropathic pain identified shortcomings across four evaluation domains:
- (1) stakeholder involvement (i.e., the extent to which the guideline was developed by the appropriate stakeholders and represents the views of its intended users);
- (2) the rigor of development (i.e., the process used to gather and synthesize the evidence and the methods used to formulate the recommendations);
- (3) applicability (i.e., likely barriers and facilitators to implementation of the guideline, strategies to improve its uptake, and resource implications of applying it); and
- (4) editorial independence (i.e., bias in the formulation of the recommendations), not to mention the knowledge and skill set of the clinician.
Identified inconsistencies across guidelines for some painful conditions, such as fibromyalgia, have demonstrated a need for consensus in guideline development. A review of state-level guidelines for opioid prescriptions found that a minority of states had guidelines specific to EDs. Pain guidelines from the World Health Organization (WHO) are facing a lack of adoption, potentially because they lack incorporation of contemporary pain management practices.
GAPS AND RECOMMENDATIONS
GAP 1: Current inconsistencies and fragmentation of pain care limit best practices and patient outcomes. A coherent policy for pain management for all relevant stakeholders is needed.
- RECOMMENDATION 1A: Encourage coordinated and collaborative care that allows for best practices and improved patient outcomes, when clinically indicated.
- RECOMMENDATION 1B: Encourage the use of guidelines that are informed by evidence and created by specialty organizations and associations that are experts in the treatment of certain pain conditions that result from a variety of medical conditions or in different special populations
Perioperative Management of Chronic Pain Patients
GAPS AND RECOMMENDATIONS
GAP 1: Patients with chronic pain who undergo a surgical procedure often have complex issues that go unaddressed and may lead to suboptimal care.
- RECOMMENDATION 1A: The perioperative team should be consulted to form a treatment plan that addresses the various aspects that would be necessary for best outcomes in this patient population.
The idea of a ceiling dose of opioids has been recommended, but establishing such a ceiling is difficult, and the precise level for such a ceiling has not been established. The risk of overdose increases with the dose, but the therapeutic window varies considerably from patient to patient. For example, the CDC Guideline identified a dose limit of 90 morphine milligram equivalents (MMEs) per day.
A more recent study evaluated the risk of death related to opioid dose in 2.2 million North Carolinians and found that the overall death rate was 0.022% per year.129 The researchers noted that:
“Dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold. Much of the risk at higher doses appears to be associated with co-prescribed benzodiazepines. It is critical to account for overlapping prescriptions, and justifies taking a person-time approach to MME calculation with intent-to-treat principles.”
Synthetic opioids other than methadone (a category that includes prescribed and illicit fentanyl and fentanyl analogues) are now the leading opioids involved in overdose deaths in the United States. The source of illicit fentanyl and its analogues has been identified as international and rarely from diverted fentanyl pharmaceuticals in the United States. These sources currently come through the U.S. Postal Service, borders, ports of entry, and other means. The illicit fentanyl analogues used are not necessarily the same product that is legally prescribed and used during surgeries or in the transdermal and mucosal fentanyl preparations provided for moderate to severe pain. One illicit analogue that has been seen is called carfentanil, which is 100 times more potent than fentanyl. The availability of naloxone as well as patient and family education about naloxone can mitigate the risks of fentanyl-related overdose.
GAPS AND RECOMMENDATIONS
GAP 1: Clinical policies tend to treat the large population of patients with multiple conditions that cause chronic pain with simple medication rules. Guidelines for medication use for specific populations of patients (e.g., different ages, genders, medical conditions, comorbidities) with chronic pain need to be developed for each specialty group and setting.
- RECOMMENDATION 1A: Develop condition-specific treatment guidelines that guide physicians to have a more individualized approach to common pain syndromes and conditions. A multidisciplinary approach that integrates the biopsychosocial model is recommended when clinically indicated.
- RECOMMENDATION 1B: Primary care and non-pain specialists should have timely, early consultation with pain specialists and other members of the pain management team for the assessment of patients with complex pain to prevent complications and loss of function and to improve QOL, as clinically indicated.
- RECOMMENDATION 1C: Develop a collaborative, multimodal treatment plan as clinically indicated among the referring physician, the pain medicine team, and the patient.
- RECOMMENDATION 1D: Pharmacies should collaborate with area health care providers to develop more effective and patient-friendly delivery systems to meet the needs of their patients.
GAP 2: Opioids are often used early in pain treatment. There has been minimal pain education in medical school and residency programs, and little guidance for PCPs on appropriate pain treatment approaches (see Section 3.3.3: Provider Education; see Section 3.4: Access to Pain Care).
- RECOMMENDATION 2A: Non-opioids should be used as first-line therapy whenever clinically appropriate in the inpatient and outpatient settings.
- RECOMMENDATION 2B: If an opioid is being considered, clinicians should use evidence-informed guidelines.
- RECOMMENDATION 2C: The type, dose, and duration of opioid therapy should be determined by treating clinicians according to the individual patient’s pain condition while using the opioid medication at the lowest effective dosage and shortest duration appropriate to achieve adequate pain control for improved function and QOL.
- RECOMMENDATION 2D: Opioid therapy should be initiated only when the benefits outweigh the risks; the patient is experiencing significant acute or chronic pain that interferes with function and QOL; and the patient is willing to continue to engage with the team on a comprehensive multidisciplinary treatment plan, as clinically indicated, with established clear and measurable treatment goals, along with close follow-up and regular risk assessment and reevaluation.
- RECOMMENDATION 2E: CMS and private payers should provide reimbursement that aligns with the medication guidelines the Task Force has described. Private payers and CMS should provide more flexibility in designing reimbursement models.
- RECOMMENDATION 2F: Pharmacy Benefit Managers (PBM) and payers should be more transparent about non-opioid pharmacologic options in their formulary, and the Task Force encourages state and federal regulators to review payer and PBM formularies to ensure that non-opioid options are on low-cost tiers.
GAP 3: There is often a lack of understanding and education regarding the clinical indication and effective use of non-opioid medications for acute and chronic pain management. Chronic pain is often ineffectively managed for a variety of reasons, including clinician training, patient access, and other barriers to care (see Section 3.3: Education):
GAP 3: There is often a lack of understanding and education regarding the clinical indication and effective use of non-opioid medications for acute and chronic pain management. Chronic pain is often ineffectively managed for a variety of reasons, including clinician training, patient access, and other barriers to care (see Section 3.3: Education):
- RECOMMENDATION 3A: Clinicians who treat chronic pain should understand the full complement of options, including the use of non-opioid medications and their mechanism-based pharmacology for managing different components of pain syndromes. (See Section 2.3: Restorative Therapies, Section 2.4: Interventional Procedures; Section 2.5: Behavioral Health Approaches; and Section 2.6: Complementary and Integrative Health.)
- RECOMMENDATION 3B: For neuropathic pain, as a first-line therapy, consider anticonvulsants (e.g., gabapentin, pregabalin, carbamazepine, oxcarbazepine), SNRIs (e.g., duloxetine, venlafaxine), TCAs (e.g., nortriptyline, amitriptyline), and topical analgesics (e.g., lidocaine, capsaicin). Regardless of the route of medication, education regarding the side effects as well as risks and benefits is vital in terms of understanding clinical indications and patient outcomes.
- RECOMMENDATION 3C: For non-neuropathic, noncancer pain, use NSAIDs and acetaminophen as first-line classes of medications, following standard dosing schedules when clinically appropriate. Other classes of medication can be used depending on the patient’s response and may include (depending on specific pain syndromes) antispasticity medications (e.g., tizanidine, baclofen) and topical preparations of various classes of medication in addition to other multimodal approaches. Additional consideration may be given to SNRIs or TCAs.
GAP 4: Barriers include lack of coverage and reimbursement for buprenorphine as well as the lack of education and training on the proper usage of buprenorphine. There has been a lack of access to buprenorphine treatment for chronic pain.
- RECOMMENDATION 4A: Make buprenorphine treatment for chronic pain available for specific groups of patients, and include buprenorphine in third-party payer and hospital formularies.
- RECOMMENDATION 4B: Encourage CMS and private payers to provide coverage and reimbursement for buprenorphine treatment, both for OUD and for chronic pain. Encourage primary use of buprenorphine rather than use only after failure of standard mu agonist opioids such as hydrocodone or fentanyl, if clinically indicated.
- RECOMMENDATION 4C: Encourage clinical trials using buprenorphine for chronic pain to better understand indication, usage, and dosage.
GAP 5: Education is currently inadequate for patients and clinicians regarding safe medication storage and appropriate disposal of excess medications targeted at reducing outstanding supplies of opioids that others can misuse or that children and other vulnerable members of the household can inadvertently access.
- RECOMMENDATION 5A: Increase public awareness of poison control center services as a resource that provides educational outreach programs and materials; referral to treatment facilities; links to take-back facilities; and resources for safe drug storage, labeling, and disposal.
- RECOMMENDATION 5B: HHS, in partnership with DEA and other federal and state agencies, should increase opportunities for safe drug disposal and drug disposal sites (e.g., pharmacies, police departments).
- RECOMMENDATION 5C: Adopt neutralization technologies and methods that may make safe disposal more readily available for opioids and other relevant medications.
- RECOMMENDATION 5D: Educate all providers, including veterinarians, on the importance of safe storage and disposal of opioid medications in their practice. In addition, educate patients and pet owners about the importance of safe storage and disposal of opioid pain medication prescribed for their pets.
Starting on page 53 is a discussion of Cross-Cutting Clinical and Policy Best Practices. The first section discuss risk assessment and I was not surprised to read how the NARX report generated by state PDMP programs was being misused. Pharmacist refusing to fill scripts because multiple prescribers are found on this report even though all prescribers work in the same clinic, or doctors who taper medications based on a NARX score, or impose other restrictions on patients which are inconsistent with clinical findings.
McAllister et al. found that all prescribers who were surveyed indicated that accessing PDMP data altered their prescribing patterns. Caution is needed when using PDMPs as a tool to aid in the proper dispensing of medications. However, PDMPs are not to be used as tools to stop dispensing medications appropriately to those in need. For example, it is important for pharmacists to know that doctors often work as teams and to ensure that the conclusion of inappropriate multiple provider use is made only after the pharmacist has communicated directly with the prescribing clinician. Concerns that physicians, nurses, dentists, and pharmacies may have should be communicated among one another or to the relevant state regulatory agencies, including state medical boards, nursing boards, dental boards, and pharmacy boards, when appropriate.
Baehren et al. found that when PDMP data were used in an Emergency Departments, 41% of cases had altered prescribing after the clinician reviewed PDMP data, with 61% of the patients receiving fewer or no opioid pain medications than the physician had originally planned prior to reviewing the PDMP data and 39% receiving more opioid medication than previously planned because the physician was able to confirm that the patient did not have a recent history of controlled substance use. The effective use of PDMP data is beneficial to both health care professionals and patients.
Stigma associated with having chronic pain, especially when opioid therapy is used as a treatment modality, is a major concern and has far-reaching effects on patients and all those involved in their care. The different facets of stigma — at the patient, provider, and social levels — collectively serve as a significant barrier to effective treatment of chronic pain. There is a growing body of empirical research into stigmatization and the resulting barriers to care. Studies suggest that patients who are receiving or who have previously received long-term opioid therapy for nonmalignant pain face both subtle and overt stigma from their family, friends, coworkers, the health care system, and society at large for their opioid treatment modality. Compassionate, empathetic care in a provider-patient partnership is best for countering the stigma, isolation, and psychosocial challenges of living with pain.
Feelings of guilt, shame, judgement, and embarrassment resulting from such stigma can increase the risk for behavioral health issues, such as anxiety and depression, which can further contribute to symptom chronicity. Reducing barriers to care that exist as a consequence of stigmatization is crucial for patient engagement and treatment effectiveness.
Furthermore, the sub-population of patients with painful conditions and comorbid SUD face additional barriers to treatment because of stigmatization of both chronic pain and addiction. Chronic pain is common among individuals with SUD, including opioid misuse, yet stigma remains a significant barrier to implementation of programs and treatments for OUD, such as medication-assisted treatment and naloxone. Patients with comorbid problematic opioid use and chronic noncancerous pain report significant perceived stigma associated with methadone and buprenorphine treatment. Clinicians who treat acute and chronic pain, particularly with opioids, may experience stigma from colleagues and society in general that — in addition to fear of scrutiny from state medical boards and the DEA — may also dissuade them from using opioids appropriately. Clinicians are overburdened with time constraints, EHR demands, and other administrative tasks, which has led to unprecedented levels of burnout among physicians. Stigma, combined with the enhanced time required to effectively evaluate and treat pain, leads to over-referral and patient abandonment.432 According to one study, only 12.2% of individuals who require treatment for a SUD actually seek treatment. In addition, stigma is found to be a significant barrier, with 20.5% not seeking treatment because of negative consequences associated with their work and around 17% being concerned about negative judgements by friends or community.
REVIEW OF THE CDC GUIDELINE
In 2016, in response to growing concerns about overprescribing opioids for pain management and opioid-related overdose, CDC published a widely read guideline on opioid therapy for chronic pain. Their recommendations focus on the use of opioids in treating chronic pain in patients 18 years or age or older. The “CDC Guideline for Prescribing Opioids for Chronic Pain” is not intended for patients who are in active cancer treatment, palliative care, or end-of-life care.
It is important to note that CDC reports that the recent acceleration in deaths from opioid overdose is largely driven by illicit opioids as opposed to prescribed opioids. Illicit fentanyl has been found in a growing number of toxicology studies of overdose decedents. Furthermore, given the current state of the overdose crisis, further drastic reduction of clinician prescribing alone may not have a large effect on decreasing opioid overdose deaths in the short term.
The CDC Guideline provides useful general guidance for prescribing opioids that is primarily intended for primary care providers. Various organizations, such as the American College of Physicians, supported the guideline when it was initially released, but clinicians, patients, professional organizations, and other stakeholders have highlighted important limitations since its publication. A commentary by Busse et al. identified several limitations related to expert selection, evidence inclusion criteria, method of evidence quality grading, selective support of some recommendations with low-quality evidence, and instances of vague recommendations. CDC cited the lack of clinical trials with a duration of one year or longer as lack of evidence for sustained clinical effectiveness of opioids in chronic pain. The Task Force respectfully points out that there is little clinical trial evidence showing that opioids lack clinical efficacy for such patients. Furthermore, Tayeb et al. found that lack of long-term efficacy is true for all common medication and behavioral therapy studies. Long-term studies of therapies for chronic, moderate, or severe pain are difficult to conduct because of patient drop-out for ineffective treatment. One long-term study from VA assessed patients on opioids versus non-opioid medications over a 12-month study evaluation period. Both groups showed similar changes in pain severity and pain-related function over 12 months. The authors conclude that the results of this study do not support initiation of opioid therapy alone for moderate to severe chronic back pain or hip or knee osteoarthritis pain. Noting that the CDC Guideline focused primarily on patients initiating opioid treatment, Gordon and Connoly discussed application of the guideline to patients who are already receiving opioid maintenance therapy for chronic pain. Given that chronic pain is associated with many different underlying conditions, with great patient variability in analgesic drug metabolism, risk for abuse, and underlying comorbid medical condition, further studies are needed to assess the value of long-term opioids alone and in combination with other therapies, coupled with risk assessment and periodic reevaluation (see Section 3.1: Risk Assessment).
The Task Force recognizes the utility of the 2016 CDC Guideline for many aspects of pain management and its value in mitigating adverse outcomes of opioid exposure. Unfortunately, misinterpretation, in addition to gaps in the guideline, has led to unintended adverse consequences. Our report documented widespread misinterpretation of the CDC Guideline — specifically, the recommendation regarding the 90 morphine milligram equivalents (MME) dose. In November 2018, the American Medical Association issued a statement advocating against the misapplication of the CDC Guideline. Educating stakeholders about the intent and optimal application of this guideline and re-emphasis of its core beneficial aspects are essential. Instances have been reported where the CDC Guideline was misapplied to the palliative care and cancer populations with pain and to providers who care for these patient populations. It is important to recognize the need for an individualized approach to palliative care and cancer patients with pain, a population that typically requires higher doses of opioids for pain relief and function, often for long periods. The American Society of Clinical Oncology, the American Society of Hematology, and the National Comprehensive Cancer Network recently received a key clarification letter from the CDC (February 2019) that the guideline was developed to provide recommendations for primary care clinicians who prescribe opioids for patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care, and the guideline is not intended to deny clinically appropriate opioid therapy to any patients who suffer acute or chronic pain from conditions such as cancer and sickle cell disease.
The 2016 CDC Guideline, which provided a comprehensive synthesis of scientific evidence on opioid prescribing, was intended as a tool primarily for PCPs to help inform their decisions about managing pain with opioids and to encourage dialogue and discussion of risks between providers and patients (shared decision making). Although the CDC Guideline was not intended to be model legislation, at least 28 states have gone beyond the guidelines and enacted legislation related to opioid prescription limits. As a result, such unintended consequences have led health care providers to limit or not provide pain treatment due in part to concerns and undue burdens of investigation and prosecution by drug enforcement. Furthermore, many states and organizations have implemented the guideline without recognizing that the intended audience was PCPs; have used legislation to override what should be medical decision making by health care professionals; and have applied them to all physicians, dentists, NPs, and PAs, including pain specialists. Some stakeholders have interpreted the guideline as intended to broadly reduce the amount of opioids prescribed for treating pain; some experts have noted that the guideline emphasizes the risk of opioids while minimizing the benefit of this medication class when properly managed.
A major problematic unintended consequence of the guideline is the forced tapering, medication discontinuation, or abandonment that many patients with chronic pain on stable long-term doses of opioids have experienced. CDC published a pivotal article in New England Journal of Medicine on April 24, 2019, specifically reiterating that the CDC Guideline has been, in some instances, misinterpreted or misapplied. The authors highlight that the dose recommendations in the CDC Guideline do not address or suggest discontinuation of opioids prescribed at higher dosages. They note “policies invoking the opioid-prescribing guideline that do not actually reflect its content and nuances can be used to justify actions contrary to the guideline’s intent.” This conclusion is supported by the comments the Task Force has received indicating that many patients have experienced access issues related to provider fears and concerns with how the guideline would be interpreted and have caused some to consider obtaining opioids from illicit sources or suicide (see Section 3.2: Stigma).
The FDA recently issued a safety announcement recognizing harm reported from sudden discontinuation of opioid pain medicines, including serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide. They are requiring label changes to guide prescribers on gradual, individualized tapering. PCPs should be encouraged to refer to or seek input from pain specialists and (potentially) addiction specialists in complex or high-risk patient scenarios (see Section 2.5: Behavioral Health Approaches). In the expert opinion of the Task Force members, the CDC Guideline does not sufficiently emphasize that optimal pain management begins with identification of the cause of the pain and the biopsychosocial mechanisms that contribute to its severity and associated disability.
The CDC Guideline recommends that opioids prescribed for acute pain be limited to three or fewer days and that more than a seven-day supply is rarely necessary. Various health insurance plans, retail pharmacies, and local and state governments are implementing the CDC Guideline as policy, limiting the number of days a patient can receive prescription opioids even when the seriousness of the injury or surgery may require opioids for adequate pain management for a longer period. A more even-handed approach would balance addressing opioid overuse with the need to protect the patient-provider relationship by preserving access to medically necessary drug regimens and reducing the potential for unintended consequences. The vast majority of medical organizations, in response to the 90-day public comment period to the Task Force draft report, supported this balanced approach. Policies should help ensure safe prescribing practices, minimize workflow disruption, and ensure that beneficiaries have access to their medications in a timely manner, without additional, cumbersome documentation requirements. In essence, clinicians should be able to use their clinical judgement to determine opioid duration for their patients while considering risk assessment recommendations as discussed in Section 3.1: Risk Assessment. Safe opioid stewardship involves a proper history and examination, periodic reevaluation, and risk assessment, with a focus on measurable outcomes, including function, QOL, and ADLs.
1: There is an absence of high-quality data on the duration of opioid effectiveness for chronic pain, which has been interpreted as a lack of benefit.
- RECOMMENDATION 1A: Support studies to determine the long-term efficacy of opioids in the treatment of chronic pain syndromes (primary and secondary) in different populations as determined by clinical context, clinical conditions, and comorbidities.
- RECOMMENDATION 1B: Conduct clinical trials on specific disease entities, with a focus on patient variability and response to tissue injury and on the effectiveness of opioid analgesics. Design trials to be applicable in real-world settings (e.g., patients receiving trialed opioid medications while maintaining the usual multimodal therapy).
2: There is an absence of criteria for identifying the sub-population of patients for whom opioids may contribute significantly to improve their pain management and therefore their QOL and functionality.
- RECOMMENDATION 2: Conduct clinical studies or complete systematic reviews to identify which chronic pain conditions and patient characteristics are appropriate for long-term opioid treatment in conjunction with the various non-opioid modalities.
EMPHASIZE OR EXPANDED RECOMMENDATIONS
3: There is wide variation in patient and disease factors that determine the dose of opioids that is optimal for pain relief and minimizes risk.
- RECOMMENDATION 3A: Consider patient variables that may affect opioid dose in patients prior to initiation of opioid therapy, including respiratory compromise, individual patient metabolic variables, or differences between opioid medications that could affect plasma opioid concentrations.
- RECOMMENDATION 3B: Perform comprehensive initial assessments for patient management, with an understanding of the need for periodic comprehensive reevaluation to adjust the medication dose.
- RECOMMENDATION 3C: Careful consideration should be given to patients on an opioid pain regimen who have additional risk factors for OUD (see Section 3.1: Risk Assessment).
- RECOMMENDATION 3D: The CDC Guideline, meant for primary care clinicians, should explicitly reemphasize that the 90 MME/day maximum dose recommendation is not mandatory but is a target that may be exceeded if clinically appropriate when benefits outweigh risks.
4: Specific guidelines addressing opioid tapering and escalation need further elucidation.
- RECOMMENDATION 4A: Undertake opioid tapering or escalation only after a thorough assessment of the risk-benefit ratio. This assessment should be conducted in collaboration with the patient.
- RECOMMENDATION 4B: Develop guidelines for tapering and dose escalation for the sub-populations of patients who have chronic pain conditions that includes consideration of their comorbidities.
- RECOMMENDATION 4C: Consider maintaining therapy for patients who are stable on long-term opioid therapy and for whom the benefits outweigh the risks.
5: Multiple potential causes of worsening pain are often not recognized or considered. Non Tolerance-related factors include iatrogenic causes such as surgery, flares of the underlying disease or injury, and increased ergonomic demands or emotional distress.
- RECOMMENDATION 5A: When a stable dose has been established for at least two months, avoid increases in the dose until the patient has been reevaluated for the underlying causes of elevated pain or possible OUD risk.
6: Although the risk of overdose by benzodiazepine co-prescription with opioids is well established, this combination may still have clinical value in patients who have chronic pain and comorbid anxiety, which commonly accompanies pain, and in patients who have chronic pain and spasticity. However, initiating regular long-term use of benzodiazepines with opioids should be done with caution, because SSRIs, SNRIS, and psychotherapies are preferred treatments for anxiety disorders.
- RECOMMENDATION 6A: If clinically indicated, co-prescription should be managed and coordinated by physicians and clinician specialists who have knowledge, training, and experience in co-prescribing benzodiazepines with opioids. For those patients who have anxiety disorders or SUD who have been prescribed benzodiazepines, risk mitigation strategies and counseling, collaboration with experts in mental health, and the use of psychological modalities should be considered.
- RECOMMENDATION 6B: Develop CPGs that focus on tapering for co-prescription of benzodiazepines and opioids.
7: The variability in effectiveness and safety (respiratory depression and abuse liability) at any given dose of an opioid is not clearly defined and may vary between different opioids and different patients. Consequently, the risk-benefit balance for opioid management of pain may vary for individual patients. Similarly, the balance of benefit and risk for doses above 90 MME/day may be acceptable in some patients. Failure to closely monitor patients when opioid dose is adjusted puts them at risk for either inadequate pain control or overdose toxicity.
- RECOMMENDATION 7A: Use the lowest effective opioid dose and shortest duration appropriate for the pain condition that balances benefits, risks, and adverse reactions. Clinicians should individualize dose based on a carefully monitored medication trial. With each dose adjustment patients should be assessed at expected peak drug concentration for analgesic effectiveness and adverse effects, such as respiratory compromise and sedation.
- RECOMMENDATION 7B: Additional factors influence risk and benefit that should be considered; therefore, guidance regarding dose should not be applied as strict limits. Providers should use established and measurable goals such as functionality, ADLs, and QOL measures.
8: The duration of pain following an acute, severely painful event such as trauma, surgery, or burn is widely variable. For clarity, the CDC Guideline recommendation #6 refers to acute pain that is non-surgical, non-traumatic pain.
- RECOMMENDATION 8A: Appropriate duration of therapy is best considered within guidelines, and then ultimately determined by the treating clinician. The CDC recommendation for duration of treatment should be emphasized as guidance only for a general approach, with individualized patient care as the primary goal, and the clinician then considering all modalities for best outcomes.
- RECOMMENDATION 8B: Develop and/or update acute pain management guidelines for common surgical procedures and trauma management, as noted in Section 2.1.1: Acute and Chronic Pain, Recommendation 2a.
- RECOMMENDATION 8C: To address this variability and provide an easy solution to the challenges of medication duration, consideration should be given to a partial refill system.