Perry G. Fine

An interdisciplinary expert consensus statement on assessment of pain in older persons

This paper represents an expert-based consensus statement on pain assessment among older adults. It is intended to provide recommendations that will be useful for both researchers and clinicians. Contributors were identified based on literature prominence and with the aim of achieving a broad representation of disciplines. Recommendations are provided regarding the physical examination and the assessment of pain using self-report and observational methods (suitable for seniors with dementia). In addition, recommendations are provided regarding the assessment of the physical and emotional functioning of older adults experiencing pain. The literature underlying the consensus recommendations is reviewed. Multiple revisions led to final reviews of 2 complete drafts before consensus was reached.

Opioids for Chronic Noncancer Pain: Prediction and Identification of Aberrant Drug-Related Behaviors: A Review of the Evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline

UNLABELLED Optimal methods to predict risk of aberrant drug-related behaviors before initiation of opioids for chronic noncancer pain and to identify aberrant behaviors after therapy is initiated are uncertain. We systematically reviewed published literature identified through searches of Ovid MEDLINE and the Cochrane databases through July 2008. Diagnostic test characteristics and accompanying confidence intervals were calculated with data extracted from the studies. Four prospective studies evaluated diagnostic accuracy of risk prediction instruments. Two higher-quality derivation studies found that high scores on the Screener and Opioid Assessment for Patients with Pain (SOAPP) Version 1 and the Revised SOAPP (SOAPP-R) instruments weakly increased the likelihood for future aberrant drug-related behaviors (positive likelihood ratios [PLR], 2.90 [95% CI, 1.91 to 4.39] and 2.50 [95% CI, 1.93 to 3.24], respectively). Low scores on the SOAPP Version 1 moderately decreased the likelihood for aberrant drug-related behaviors (negative likelihood ratio [NLR], 0.13 [95% CI, 0.05 to 0.34]) and low scores on the SOAPP-R weakly decreased the likelihood (NLR, 0.29 [95% CI, 0.18 to 0.46]), but estimates are too imprecise to determine if there is a difference between these instruments. One lower-quality study found that categorization as high risk using the Opioid Risk Tool strongly increased the likelihood for future aberrant drug-related behaviors (PLR, 14.3 [95% CI, 5.35 to 38.4]) and classification as low risk strongly decreased the likelihood (PLR, 0.08 [95% CI, 0.01 to 0.62]). Nine studies evaluated monitoring instruments for identification of aberrant drug-related behaviors in patients on opioid therapy. One higher-quality derivation study found higher scores on the Current Opioid Misuse Measure (COMM) weakly increased the likelihood of current aberrant drug-related behaviors (PLR, 2.77 [95% CI, 2.06 to 3.72]) and lower scores weakly decreased the likelihood (NLR, 0.35 [95% CI, 0.24 to 0.52]). In 8 studies of other monitoring instruments, diagnostic accuracy was poor, results were difficult to interpret due to methodological shortcomings, or standard diagnostic test characteristics were not reported. Definitions for aberrant drug-related behaviors were not standardized across studies and did not account for seriousness of identified behaviors. No reliable evidence exists on accuracy of urine drug screening, pill counts, or prescription drug monitoring programs; or clinical outcomes associated with different assessment or monitoring strategies. PERSPECTIVE Evidence on prediction and identification of aberrant drug-related behaviors is limited. Although several screening instruments may be useful, evidence is sparse and primarily based on derivation studies, and methodological shortcomings exist in all studies. Research that performs external validation, uses standardized definitions for clinically relevant aberrant drug-related behaviors, and evaluates clinical outcomes associated with different assessment and monitoring strategies is needed.

Research Gaps on Use of Opioids for Chronic Noncancer Pain: Findings From a Review of the Evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline

UNLABELLED Chronic noncancer pain is common and use of opioids is increasing. Previously published guidelines on use of opioids for chronic noncancer pain have been based primarily on expert consensus due to lack of strong evidence. We conducted searches on Ovid MEDLINE and the Cochrane databases through July 2008 to identify studies that addressed one or more of 37 Key Questions that a multidisciplinary expert panel identified as important to be answered to generate evidence-based recommendations on the use of opioids for chronic noncancer pain. A total of 14 systematic reviews, 38 randomized trials not included in a previously published systematic review, and 13 other studies met inclusion criteria. Almost all of the randomized trials of opioids for chronic noncancer pain were short-term efficacy studies. Critical research gaps on use of opioids for chronic noncancer pain include: lack of effectiveness studies on long-term benefits and harms of opioids (including drug abuse, addiction, and diversion); insufficient evidence to draw strong conclusions about optimal approaches to risk stratification, monitoring, or initiation and titration of opioid therapy; and lack of evidence on the utility of informed consent and opioid management plans, the utility of opioid rotation, the benefits and harms specific to methadone or higher doses of opioids, and treatment of patients with chronic noncancer pain at higher risk for drug abuse or misuse. PERSPECTIVE Currently, clinical decisions regarding the use of opioids for chronic noncancer pain need to be made based on weak evidence. Research funding priorities need to be set to address these critical research needs if the care of patients with chronic noncancer pain is to improve.

An Analysis of the Root Causes for Opioid-Related Overdose Deaths in the United States

OBJECTIVE A panel of experts in pain medicine and public policy convened to examine root causes and risk factors for opioid-related poisoning deaths and to propose recommendations to reduce death rates. METHODS Panelists reviewed results from a search of PubMed and state and federal government sources to assess frequency, demographics, and risk factors for opioid-related overdose deaths over the past decade. They also reviewed results from a Utah Department of Health study and a summary of malpractice lawsuits involving opioid-related deaths. RESULTS National data demonstrate a pattern of increasing opioid-related overdose deaths beginning in the early 2000s. A high proportion of methadone-related deaths was noted. Although methadone represented less than 5% of opioid prescriptions dispensed, one third of opioid-related deaths nationwide implicated methadone. Root causes identified by the panel were physician error due to knowledge deficits, patient non-adherence to the prescribed medication regimen, unanticipated medical and mental health comorbidities, including substance use disorders, and payer policies that mandate methadone as first-line therapy. Other likely contributors to all opioid-related deaths were the presence of additional central nervous system-depressant drugs (e.g., alcohol, benzodiazepines, and antidepressants) and sleep-disordered breathing. CONCLUSIONS Causes of opioid-related deaths are multifactorial, so solutions must address prescriber behaviors, patient contributory factors, nonmedical use patterns, and systemic failures. Clinical strategies to reduce opioid-related mortality should be empirically tested, should not reduce access to needed therapies, should address risk from methadone as well as other opioids, and should be incorporated into any risk evaluation and mitigation strategies enacted by regulators.

Clinical application of opioid equianalgesic data

Physicians and other healthcare professionals may often be faced with the need to change opioids during the course of a patients opioid analgesic care due to a number of clinical reasons. The act of converting opioid analgesics, for many physicians, nurses, and pharmacists, who do not receive adequate training, remains a challenging and often uncomfortable aspect of pain treatment. Part of the challenge clinicians face is secondary to the relatively weak literature evidence base that exists to support the equianalgesic ratios provided in textbooks, journals, and other medical resources. Another aspect involves the lack of a widely recognized treatment algorithm or guideline to assist clinicians with opioid conversion. The final decision on which opioid dose to prescribe must involve a thorough clinical assessment to minimize the risk of prescribing inappropriate opioid doses over or under the patients actual need. The purpose of this paper is to provide the clinician with an approach for dealing with the conversion between opioid analgesics that is standardized, yet allows for individualized results to meet unique patient needs. We present a 5-step process as a guide for clinicians faced with the need to change a patients opioid regimen. This approach may help to build a comfort level when dealing with the clinical challenges of converting from one opioid to another.

Opioid Pharmacotherapy for Chronic Non-Cancer Pain in the United States: A Research Guideline for Developing an Evidence-Base

UNLABELLED This document reports the consensus of an interdisciplinary panel of research and clinical experts charged with reviewing the use of opioids for chronic noncancer pain (CNCP) and formulating guidelines for future research. Prescribing opioids for chronic noncancer pain has recently escalated in the United States. Contrasting with increasing opioid use are: 1) The lack of evidence supporting long-term effectiveness; 2) Escalating misuse of prescription opioids including abuse and diversion; and 3) Uncertainty about the incidence and clinical salience of multiple, poorly characterized adverse drug events (ADEs) including endocrine dysfunction, immunosuppression and infectious disease, opioid-induced hyperalgesia and xerostomia, overdose, falls and fractures, and psychosocial complications. Chief among the limitations of current evidence are: 1) Sparse evidence on long-term opioid effectiveness in chronic pain patients due to the short-term time frame of clinical trials; 2) Insufficiently comprehensive outcome assessment; and 3) Incomplete identification and quantification of ADEs. The panel called for a strategic interdisciplinary approach to the problem domain in which basic scientists and clinicians cooperate to resolve urgent issues and generate a comprehensive evidence base. It offered 4 recommendations in 3 areas: 1) A research strategy for studying the effectiveness of long-term opioid pharmacotherapy; 2) Improvements in evidence-generation methodology; and 3) Potential research topics for generating new evidence. PERSPECTIVE Prescribing opioids for CNCP has outpaced the growth of scientific evidence bearing on the benefits and harms of these interventions. The need for a strong evidence base is urgent. This guideline offers a strategic approach to creating a comprehensive evidence base to guide safe and effective management of CNCP.

Relationship Between Fibromyalgia and Obesity in Pain, Function, Mood, and Sleep

UNLABELLED Fibromyalgia syndrome (FMS) is a prevalent and disabling chronic pain disorder. Past research suggests that obesity is a common comorbidity and may be related to the severity of FMS. The main objective of the present study was to evaluate the relationships between FMS and obesity in the multiple FMS-related domains: hyperalgesia, symptoms, physical abilities, and sleep. A total of 215 FMS patients completed a set of self-report inventories to assess FMS-related symptoms and underwent the tender point (TP) examination, physical performance testing, and 7-day home sleep assessment. Forty-seven percent of our sample was obese and an additional 30% was overweight. Obesity was related significantly to greater pain sensitivity to TP palpation particularly in the lower body areas, reduced physical strength and lower-body flexibility, shorter sleep duration, and greater restlessness during sleep. The results confirmed that obesity is a prevalent comorbidity of FMS that may contribute to the severity of the problem. Potential mechanisms underlying the relationship are discussed. PERSPECTIVE This report presents how obesity may be interrelated to fibromyalgia pain, disability, and sleep. We found that obesity is common in FMS. Approximately half of our patients were obese and an additional 30% were overweight. We also found that obesity in FMS was associated with greater pain sensitivity, poorer sleep quality, and reduced physical strength and flexibility. The results suggest that obesity may aggregate FMS and weight management may need to be incorporated into treatments.

An open label study of oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough cancer pain

Ten patients with advanced cancer and breakthrough pain between the ages of 39 and 78 received oral transmucosal fentanyl citrate (10-15 micrograms/kg) 4 or 5 times each over 2 days (42 total administrations) in an open study. Baseline vital sign and rating scale results did not vary over administrations, except for heart rate which showed an 8 beats/min decrease over 4 administrations. Heart rate and oxygen saturation did not vary significantly over 120 min of evaluation, and minimal changes in blood pressure and respiration rate were found. Significant reduction in pain scores as measured by a pain descriptive scale, the McGill-Melzack scale, and a numeric (VAS) scale were seen at all evaluations from 5 to 120 min. Average time to onset of pain relief was 9.5 min after administration. Wellbeing was significantly increased at all evaluations. Activity level as recorded by the investigator was significantly reduced from 10 to 30 min after administration, however, activity level as reported by the patient was significantly increased at 5 min and from 60 to 120 min after OTFC administration. There were no significant adverse effects.

Long-term consequences of chronic pain: mounting evidence for pain as a neurological disease and parallels with other chronic disease states.

OBJECTIVE This article reviews the potential physical and psychological consequences of chronic pain and the importance of implementing effective therapeutic strategies to mitigate the harms associated with inadequate treatment. RESULTS A review of recent literature examining the neurobiology and pathophysiology of chronic pain reveals that this highly prevalent condition negatively impacts multiple aspects of patient health, including sleep, cognitive processes and brain function, mood/mental health, cardiovascular health, sexual function, and overall quality of life. Furthermore, chronic pain has the capacity to become increasingly complex in its pathophysiology, and thus potentially more difficult to treat over time. The various health complications related to chronic pain can also incur significant economic consequences for patients. CONCLUSIONS Like other chronic conditions, it is important that chronic pain is managed with the objective of minimizing or avoiding its associated long-term sequelae. In line with this approach, early and effective multimodal treatment strategies, including analgesic therapy that controls pain intensity, are essential to improving outcomes and returning patients to normal levels of function.

Pharmacological Management of Persistent Pain in Older Persons

Drugs without a strong evidence base and outside of recommendations are too often pre- scribed for older adults. Established guidelines such as Beers criteria have identified both specific medications and certain drug classes as inappropriate for older adults, primarily due to adverse effects. Age-related physiological changes in distribution, metabolism, and elimination often alter the effects of pharmacotherapies in older adults. When designing a therapeutic program, all elements contributing to the pathophysiology of painful conditions should be considered, as well as the mechanisms of action of analgesic drug classes. Both appropriate and inappropriate medica- tions for older adults are detailed herein, as well as their contraindications and potential drug- drug or drug-disease interactions. The number needed to treat (NNT) can be useful in considering efficacy, while the safety of a pharmacotherapy is indicated by the calculated number needed to harm (NNH). The NNT is a measure describing the number of patients who require treatment for every 1 who reaches the therapeutic goal, and the NNH describes the number of participants who manifest side effects; these can further be segregated into numbers who withdraw from studies due to intol- erable side effects. These parameters, along with a patients comorbidities and concomitant medica- tions, should be considered when selecting an analgesic and dose regimen. In addition, practitioners should avoid prescribing multiple-drug therapies that have overlapping pharmacodynamics or that may have an adverse pharmacokinetic interaction. Perspective: The pharmacotherapeutic armamentarium for treating pain has continued to grow. Both opioids and adjuvants are important options for treating persistent pain in older adults, a pop- ulation prone to individualistic differences requiring greater treatment tailoring and optimization. a 2011 by the American Pain Society