Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline: A Consensus Panel Report.

BACKGROUND: A national crisis of opioid-related morbidity, mortality, and misuse has led to initiatives to address the appropriate role of opioids to treat pain. Deployment of a guideline from the Centers for Disease Control and Prevention to reduce the risks of opioid therapy has raised substantial clinical and public policy challenges. The agency anticipated implementation challenges and committed to reevaluating the guideline for intended and unintended effects on clinician and patient outcomes. OBSERVATIONS: A multidisciplinary expert panel met to review the influence of the core recommendations of the guideline on pain management practices, principally regarding the estimated 5 to 8 million Americans with chronic pain currently on opioids. The panel identified implementation challenges, including application of dosage ceilings and prescription duration guidance, failure to appreciate the importance of patient involvement in decisions to taper or discontinue opioids, barriers to diagnosis and treatment of opioid use disorder, and impeded access to recommended comprehensive, multimodal pain care. Furthermore, policy-making and regulatory bodies may misapply guideline recommendations without flexibility and, sometimes, without full awareness of what the guideline contains. CONCLUSIONS AND RELEVANCE: The panel largely supported the guideline, endorsing its focal points of safety and comprehensive assessment and monitoring. To mitigate clinical and policy challenges identified with implementing the guideline, the panel discussed areas where viewpoints diverged and arrived at consensus proposals. The target audience includes the leaders and institutions that create policy and influence guideline implementation to include regulatory agencies, legislators, public and private payers, and health care systems.

Rational Urine Drug Monitoring in Patients Receiving Opioids for Chronic Pain: Consensus Recommendations.

Objective: To develop consensus recommendations on urine drug monitoring (UDM) in patients with chronic pain who are prescribed opioids. Methods: An interdisciplinary group of clinicians with expertise in pain, substance use disorders, and primary care conducted virtual meetings to review relevant literature and existing guidelines and share their clinical experience in UDM before reaching consensus recommendations. Results: Definitive (e.g., chromatography-based) testing is recommended as most clinically appropriate for UDM because of its accuracy; however, institutional or payer policies may require initial use of presumptive testing (i.e., immunoassay). The rational choice of substances to analyze for UDM involves considerations that are specific to each patient and related to illicit drug availability. Appropriate opioid risk stratification is based on patient history (especially psychiatric conditions or history of opioid or substance use disorder), prescription drug monitoring program data, results from validated risk assessment tools, and previous UDM. Urine drug monitoring is suggested to be performed at baseline for most patients prescribed opioids for chronic pain and at least annually for those at low risk, two or more times per year for those at moderate risk, and three or more times per year for those at high risk. Additional UDM should be performed as needed on the basis of clinical judgment. Conclusions: Although evidence on the efficacy of UDM in preventing opioid use disorder, overdose, and diversion is limited, UDM is recommended by the panel as part of ongoing comprehensive risk monitoring in patients prescribed opioids for chronic pain.

The ACTTION-APS-AAPM Pain Taxonomy (AAAPT) Multidimensional Approach to Classifying Acute Pain Conditions.

Objective: With the increasing societal awareness of the prevalence and impact of acute pain, there is a need to develop an acute pain classification system that both reflects contemporary mechanistic insights and helps guide future research and treatment. Existing classifications of acute pain conditions are limiting, with a predominant focus on the sensory experience (e.g., pain intensity) and pharmacologic consumption. Consequently, there is a need to more broadly characterize and classify the multidimensional experience of acute pain. Setting: Consensus report following expert panel involving the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), American Pain Society (APS), and American Academy of Pain Medicine (AAPM). Methods: As a complement to a taxonomy recently developed for chronic pain, the ACTTION public-private partnership with the US Food and Drug Administration, the APS, and the AAPM convened a consensus meeting of experts to develop an acute pain taxonomy using prevailing evidence. Key issues pertaining to the distinct nature of acute pain are presented followed by the agreed-upon taxonomy. The ACTTION-APS-AAPM Acute Pain Taxonomy will include the following dimensions: 1) core criteria, 2) common features, 3) modulating factors, 4) impact/functional consequences, and 5) putative pathophysiologic pain mechanisms. Future efforts will consist of working groups utilizing this taxonomy to develop diagnostic criteria for a comprehensive set of acute pain conditions. Perspective: The ACTTION-APS-AAPM Acute Pain Taxonomy (AAAPT) is a multidimensional acute pain classification system designed to classify acute pain along the following dimensions: 1) core criteria, 2) common features, 3) modulating factors, 4) impact/functional consequences, and 5) putative pathophysiologic pain mechanisms. Conclusions: Significant numbers of patients still suffer from significant acute pain, despite the advent of modern multimodal analgesic strategies. Mismanaged acute pain has a broad societal impact as significant numbers of patients may progress to suffer from chronic pain. An acute pain taxonomy provides a much-needed standardization of clinical diagnostic criteria, which benefits clinical care, research, education, and public policy. For the purposes of the present taxonomy, acute pain is considered to last up to seven days, with prolongation to 30 days being common. The current understanding of acute pain mechanisms poorly differentiates between acute and chronic pain and is often insufficient to distinguish among many types of acute pain conditions. Given the usefulness of the AAPT multidimensional framework, the AAAPT undertook a similar approach to organizing various acute pain conditions.

Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation.

OBJECTIVE: Aims of this consensus panel were to determine (1) an optimal symptom-based method for assessing opioid-induced constipation in clinical practice and (2) a threshold of symptom severity to prompt consideration of prescription therapy. METHODS: A multidisciplinary panel of 10 experts with extensive knowledge/experience with opioid-associated adverse events convened to discuss the literature on assessment methods used for opioid-induced constipation and reach consensus on each objective using the nominal group technique. RESULTS: Five validated assessment tools were evaluated: the Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL), Stool Symptom Screener (SSS), Bowel Function Index (BFI), and Bowel Function Diary (BF-Diary). The 3-item BFI and 4-item SSS, both clinician administered, are the shortest tools. In published trials, the BFI and 12-item PAC-SYM are most commonly used. The 11-item BF-Diary is highly relevant in opioid-induced constipation and was developed and validated in accordance with US Food and Drug Administration guidelines. However, the panel believes that the complex scoring for this tool and the SSS, PAC-SYM, and 28-item PAC-QOL may be unfeasible for clinical practice. The BFI is psychometrically validated and responsive to changes in symptom severity; scores range from 0 to 100, with higher scores indicating greater severity and scores >28.8 points indicating constipation. CONCLUSIONS: The BFI is a simple assessment tool with a validated threshold of clinically significant constipation. Prescription treatments for opioid-induced constipation should be considered for patients who have a BFI score of ≥30 points and an inadequate response to first-line interventions.

Short-Term Functional, Emotional, and Pain Outcomes of Patients with Complex Regional Pain Syndrome Treated in a Comprehensive Interdisciplinary Pain Management Program.

BACKGROUND: Complex regional pain syndrome (CRPS) is difficult to effectively treat with unimodal approaches. OBJECTIVE: To investigate whether CRPS can be effectively treated in a comprehensive interdisciplinary pain management program. DESIGN: Observational cohort study of 49 patients aged 18-89 who fulfilled 'Budapest Criteria' for CRPS and completed an interdisciplinary pain management program. Preprogram to postprogram changes in physical functioning, perceived disability, emotional functioning, acceptance, coping, and pain were assessed. The measures used included: Pain Disability Index, Six minute walk test, 2-minute sit-to-stand, Numerical Rating Scale, Center for Epidemiologic Studies Depression Scale, Pain Anxiety Symptoms Scale, Chronic Pain Acceptance Questionnaire, Coping Strategies Questionnaire-Revised, RIC- Multidimensional Patient Global Impression of Change (RIC-MPGIC), and Medication Quantification Scale. For worker's compensation patients, the rate of successful release to work at the end of the program was calculated. RESULTS: Results indicated significant improvements in physical functioning and perceived disability (P's<0.001). Patients reported increased usage of an adaptive coping strategy, distraction (P = 0.010), and decreased usage of maladaptive and passive strategies (P's < 0.001). Patients showed greater chronic pain acceptance (P's ≤ 0.010) and reductions in emotional distress (P's < 0.001). Medication usage at 1-month follow-up was significantly reduced compared to program start (P < 0.001) and discharge (P = 0.004). Patients reported "much improvement" in overall functioning, physical functioning, mood, and their ability to cope with pain and flare-ups (RIC-MPGIC). Patient report of pain was not significantly reduced at discharge (P =0.078). Fourteen (88%) of 16 total worker's compensation patients were successfully released to work at the end of the program. CONCLUSIONS: This study demonstrates short-term improvements in physical and emotional functioning, pain coping, and medication usage. These findings are consistent with the rehabilitation philosophy of improving functioning and sense of well-being as of equal value and relevance to pain reduction.

Ethnicity and interdisciplinary pain treatment.

OBJECTIVE: The purpose of this study was to identify ethnic differences in interdisciplinary pain treatment outcome and whether these differences occur while controlling for the effects of demographics, psychosocial, and secondary gain. METHODS: We assessed a sample of 116 (Caucasian, African American, and Latino/a) chronic pain patients who participated a 4-week interdisciplinary pain treatment program. Outcome measure included pretreatment, post-treatment, and change scores on the Multidimensional Pain Inventory, Pain Anxiety Symptom Scale 20, Chronic Pain Acceptance Questionnaire, Coping Strategies Questionnaire-revised, and the Center for Epidemiologic Studies Depression Scale-short form. RESULTS: Analysis of covariances revealed that after accounting for educational and sex differences, ethnic minorities differed from Caucasians on a number of treatment outcome measures at pre- and post-treatment [F's ≥ 5.38; P's < 0.01]. At pretreatment, Latino/a's endorsed greater levels of pain-related anxiety, pain severity, and pain catastrophizing than Caucasians. Both Latino/a's and African Americans reported greater use of prayer at pre- and post-treatment, with Caucasians showing the greatest decrease in the use of prayer in response to treatment. At post-treatment, African Americans had higher level of depression and lower levels of reported activity than Caucasians. CONCLUSIONS: Results support the notion that ethnic differences in pain treatment outcome exist. Further, ethnic minority groups appear to have greater levels of distress compared to Caucasians. However, African Americans, Latino/a's and Caucasians demonstrated similar improvements on all outcome measures, with exception of the use of prayer. Future studies should begin to explore the mechanisms to explain why ethnic group differences in pain treatment outcome occur.

Treatment outcomes for workers compensation patients in a U.S.-based interdisciplinary pain management program.

OBJECTIVES: Assess the efficacy of an outpatient-based interdisciplinary pain rehabilitation program for patients with active workers compensation claims. PATIENTS: Data were available for 101 patients, primarily with chronic low back pain (75%), who participated in the program. METHODS: Treatment included a 4-week (Monday to Friday), 8-hours/day graded progressive program that included individual and group therapies (pain psychology, physical therapy, occupational therapy, relaxation training/biofeedback, aerobic conditioning, pool therapy, vocational counseling, patient education and medical management). Outcome measures included program completion status, release-to-work status, return-to-work status, total scores on the Beck depression inventory, state-trait anxiety inventory, pain catastrophizing scale, and the McGill pain questionnaire visual analogue scale (MPQ VAS). The majority of the patients (65%) graduated from the program. Pre-postoutcome data were available for those who graduated from the program. For noncompleters, last obtained MPQ VAS was compared with their initial MPQ VAS scores. RESULTS: Of those completing the program, most patients (91%)were released to return to work; with 80% released to full-time status and 11% released to gradual return. Approximately half (49%) of the program completers returned to work. Paired-samples t-tests showed that program completers had significant reductions in depression (P = 0.000), pain-related catastrophizing (P = 0.033), and pain intensity (P = 0.000), but not in anxiety (P = 0.098). Interestingly, the last obtained (at early discharge/withdrawal) pain intensity scores (M = 70.33) were higher than at baseline (M = 61.20) in the noncompleters. This difference was not statistically significant (P = 0.127) but may be clinically meaningful. DISCUSSION: Our results support the efficacy of an outpatient-based 4-week interdisciplinary pain rehabilitation program in decreasing emotional distress, reducing pain intensity, and improving return-to-work status in the majority of completers in this challenging population. Patients reporting increased pain at discharge or those discharged early may have been due to operant factors.

Focused review of interdisciplinary pain rehabilitation programs for chronic pain management.

Interdisciplinary pain rehabilitation programs (IPRPs) are based on a functional restoration approach to treating complex chronic pain conditions. With a greater appreciation for a biopsychosocial approach to more effectively manage patients with chronic pain has come the development of more comprehensive treatment programs with less of a biomedical emphasis (i.e., interventional therapy, unimodal physical therapy, and passive modalities) and more of a biopsychosocial one. Interdisciplinary programs involve the use of multiple disciplines such as physical and occupational therapy, pain psychology, medical pain management, vocational rehabilitation, relaxation training, and nursing educations. Multiple psychometric tools are used in the assessment process and along treatment to better assess outcomes. This article will examine components of IPRPs, discuss desirable features of successful programs and teams, and more closely review four established outpatient pain programs in the United States. A greater understanding of the unique features and shared values of successful programs will help one better understand how these programs can be more widely used and available. The review will also highlight common psychometric outcomes tools used in assessing patients and monitoring outcomes. Most importantly, the review will help to answer a common question, even among pain physicians: "What goes on in those chronic pain programs?"

Evolution of opioid risk management and review of the classwide REMS for extended-release/long-acting opioids.

In 2007, the Food and Drug Administration Amendments Act (FDAAA) afforded the US Food and Drug Administration (FDA) the ability to enforce postmarketing risk management strategies for prescription medicines. Under this policy, certain medications with known or potential risks could be required to have a Risk Evaluation and Mitigation Strategy (REMS), a risk management program designed to ensure that a product's therapeutic benefit outweighs its risks. Prescription opioid analgesics, particularly extended-release (ER)/long-acting (LA) formulations, have undergone scrutiny in recent years due to the serious risks associated with their use, especially when they are prescribed improperly, misused, or abused. In July 2012, the FDA approved a classwide REMS for ER and LA opioids. This ER/LA opioid REMS program is designed to improve prescriber education and patient awareness about safe opioid use to minimize the risks of addiction, unintentional overdose, and death. Because clinicians often encounter patients with moderate-to-severe chronic, noncancer pain who are in need of around-the-clock opioid analgesia, knowledge of the conditions of this classwide REMS may become essential to continue prescribing ER/LA opioids. This article briefly describes the changes in US risk management policies that have shaped today's regulatory environment and provides an overview of the requirements for the classwide ER/LA opioid REMS.

Topical Analgesics.

Topical analgesics are a growing area of clinical interest, given improvements in formulation drug delivery and local delivery of medicine, limiting risk for potential adverse systemic effects. Topical analgesics include medications for acute and chronic pain, such as musculoskeletal pain disorders, including sprains and strains; neuropathic pain; and muscle pain related to trauma. This review covers an update on formulations for acute and chronic pain, a discussion on advancements in drug delivery, and an update on recent treatment guidelines related to topical medications for osteoarthritis and neuropathic pain conditions.

Ensuring Patient Protections When Tapering Opioids: Consensus Panel Recommendations.

Long-term opioid therapy has the potential for serious adverse outcomes and is often used in a vulnerable population. Because adverse effects or failure to maintain benefits is common with long-term use, opioid taper or discontinuation may be indicated in certain patients. Concerns about the adverse individual and population effects of opioids have led to numerous strategies aimed at reductions in prescribing. Although opioid reduction efforts have had generally beneficial effects, there have been unintended consequences. Abrupt reduction or discontinuation has been associated with harms that include serious withdrawal symptoms, psychological distress, self-medicating with illicit substances, uncontrolled pain, and suicide. Key questions remain about when and how to safely reduce or discontinue opioids in different patient populations. Thus, health care professionals who reduce or discontinue long-term opioid therapy require a clear understanding of the associated benefits and risks as well as guidance on the best practices for safe and effective opioid reduction. An interdisciplinary panel of pain clinicians and one patient advocate formulated recommendations on tapering methods and ongoing pain management in primary care with emphasis on patient-centered, integrated, comprehensive treatment models employing a biopsychosocial perspective.