Mark J. Edlund

risk factors for clinically recognized opioid abuse and dependence among veterans using opioids for chronic non-cancer pain

Abstract A central question in prescribing opioids for chronic non‐cancer pain (CNCP) is how to best balance the risk of opioid abuse and dependence with the benefits of pain relief. To achieve this balance, clinicians need an understanding of the risk factors for opioid abuse, an issue that is only partially understood. We conducted a secondary data analysis of regional VA longitudinal administrative data (years 2000–2005) for chronic users of opioids for CNCP (n = 15,160) to investigate risk factors for the development of clinically recognized (i.e., diagnosed) opioid abuse or dependence among these individuals. We analyzed four broad groups of possible risk factors: (i) non‐opioid substance abuse disorders, (ii) painful physical health disorders, (iii) mental health disorders, and (iv) socio‐demographic factors. In adjusted models, a diagnosis of non‐opioid substance abuse was the strongest predictor of opioid abuse/dependence (OR = 2.34, p < 0.001). Mental health disorders were moderately strong predictors (OR = 1.46, p = 0.005) of opioid abuse/dependence. However, the prevalence of mental health disorders was much higher than the prevalence of non‐opioid substance abuse disorders (45.3% vs. 7.6%) among users of opioids for CNCP, suggesting that mental health disorders account for more of the population attributable risk for opioid abuse than does non‐opioid substance abuse. Males, younger adults, and individuals with greater days supply of prescription opioids dispensed in 2002 were more likely to develop opioid abuse/dependence. Clinicians need to carefully screen for substance abuse and mental health disorders in candidates for opioid therapy and facilitate appropriate treatment of these disorders.

Delivery of evidence-based treatment for multiple anxiety disorders in primary care: a randomized controlled trial.

CONTEXT Improving the quality of mental health care requires moving clinical interventions from controlled research settings into real-world practice settings. Although such advances have been made for depression, little work has been performed for anxiety disorders. OBJECTIVE To determine whether a flexible treatment-delivery model for multiple primary care anxiety disorders (panic, generalized anxiety, social anxiety, and posttraumatic stress disorders) would be better than usual care (UC). DESIGN, SETTING, AND PATIENTS A randomized controlled effectiveness trial of Coordinated Anxiety Learning and Management (CALM) compared with UC in 17 primary care clinics in 4 US cities. Between June 2006 and April 2008, 1004 patients with anxiety disorders (with or without major depression), aged 18 to 75 years, English- or Spanish-speaking, were enrolled and subsequently received treatment for 3 to 12 months. Blinded follow-up assessments at 6, 12, and 18 months after baseline were completed in October 2009. INTERVENTION CALM allowed choice of cognitive behavioral therapy (CBT), medication, or both; included real-time Web-based outcomes monitoring to optimize treatment decisions; and a computer-assisted program to optimize delivery of CBT by nonexpert care managers who also assisted primary care clinicians in promoting adherence and optimizing medications. MAIN OUTCOME MEASURES Twelve-item Brief Symptom Inventory (BSI-12) anxiety and somatic symptoms score. Secondary outcomes included proportion of responders (> or = 50% reduction from pretreatment BSI-12 score) and remitters (total BSI-12 score < 6). RESULTS A significantly greater improvement for CALM vs UC in global anxiety symptoms was found (BSI-12 group mean differences of -2.49 [95% confidence interval {CI}, -3.59 to -1.40], -2.63 [95% CI, -3.73 to -1.54], and -1.63 [95% CI, -2.73 to -0.53] at 6, 12, and 18 months, respectively). At 12 months, response and remission rates (CALM vs UC) were 63.66% (95% CI, 58.95%-68.37%) vs 44.68% (95% CI, 39.76%-49.59%), and 51.49% (95% CI, 46.60%-56.38%) vs 33.28% (95% CI, 28.62%-37.93%), with a number needed to treat of 5.27 (95% CI, 4.18-7.13) for response and 5.50 (95% CI, 4.32-7.55) for remission. CONCLUSION For patients with anxiety disorders treated in primary care clinics, CALM compared with UC resulted in greater improvement in anxiety symptoms, depression symptoms, functional disability, and quality of care during 18 months of follow-up. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00347269.

Trends in use of opioids for non-cancer pain conditions 2000-2005 in commercial and Medicaid insurance plans: The TROUP Study

&NA; Opioids are widely prescribed for non‐cancer pain conditions (NCPC), but there have been no large observational studies in actual clinical practice assessing patterns of opioid use over extended periods of time. The TROUP (Trends and Risks of Opioid Use for Pain) study reports on trends in opioid therapy for NCPC in two disparate populations, one national and commercially insured population (HealthCore plan data) and one state‐based and publicly‐insured (Arkansas Medicaid) population over a six year period (2000–2005). We track enrollees with the four most common NCPC conditions: arthritis/joint pain, back pain, neck pain, headaches, as well as HIV/AIDS. Rates of NCPC diagnosis and opioid use increased linearly during this period in both groups, with the Medicaid group starting at higher rates and the HealthCore group increasing more rapidly. The proportion of enrollees receiving NCPC diagnoses increased (HealthCore 33%, Medicaid 9%), as did the proportion of enrollees with NCPC diagnoses who received opioids (HealthCore 58%, Medicaid 29%). Cumulative yearly opioid dose (in mg. morphine equivalents) received by NCPC patients treated with opioids increased (HealthCore 38%, Medicaid 37%) due to increases in number of days supplied rather than dose per day supplied. Use of short‐acting Drug Enforcement Administration Schedule II opioids increased most rapidly, both in proportion of NCPC patients treated (HealthCore 54%, Medicaid 38%) and in cumulative yearly dose (HealthCore 95%, Medicaid 191%). These trends have occurred without any significant change in the underlying population prevalence of NCPC or new evidence of the efficacy of long‐term opioid therapy and thus likely represent a broad‐based shift in opioid treatment philosophy.

Risks for opioid abuse and dependence among recipients of chronic opioid therapy: Results from the TROUP Study

OBJECTIVE To estimate the prevalence of and risk factors for opioid abuse/dependence in long-term users of opioids for chronic pain, including risk factors for opioid abuse/dependence that can potentially be modified to decrease the likelihood of opioid abuse/dependence, and non-modifiable risk factors for opioid abuse/dependence that may be useful for risk stratification when considering prescribing opioids. METHODS We used claims data from two disparate populations, one national, commercially insured population (HealthCore) and one state-based, publicly insured (Arkansas Medicaid). Among users of chronic opioid therapy, we regressed claims-based diagnoses of opioid abuse/dependence on patient characteristics, including physical health, mental health and substance abuse diagnoses, sociodemographic factors, and pharmacological risk factors. RESULTS Among users of chronic opioid therapy, 3% of both the HealthCore and Arkansas Medicaid samples had a claims-based opioid abuse/dependence diagnosis. There was a strong inverse relationship between age and a diagnosis of opioid abuse/dependence. Mental health and substance use disorders were associated with an increased risk of opioid abuse/dependence. Effects of substance use disorders were especially strong, although mental health disorders were more common. Concerning opioid exposure; lower days supply, lower average doses, and use of Schedule III-IV opioids only, were all associated with lower likelihood of a diagnosis of opioid abuse/dependence. CONCLUSION Opioid abuse and dependence are diagnosed in a small minority of patients receiving chronic opioid therapy, but this may under-estimate actual misuse. Characteristics of the patients and of the opioid therapy itself are associated with the risk of abuse and dependence.

Regular use of prescribed opioids: association with common psychiatric disorders.

Abstract Use of opioids for chronic non‐cancer pain is increasing, but the clinical epidemiology and standards of care for this practice are poorly defined. Psychiatric disorders are associated with increased physical symptoms and may be associated with opioid use. We performed a secondary analysis of cross‐sectional data from the Health Care for Communities (HCC) survey conducted in 1997–1998 (N=9279) to determine the association of psychiatric disorders and self‐reported regular use of prescribed opioids within the past year. Regular prescription opioid use was reported by 282 (3%) respondents. In unadjusted logistic regression models, respondents with common mental disorders in the past year (major depression, dysthymia, generalized anxiety disorder, or panic disorder) were more likely to report regular prescription opioid use than those without any of these disorders (OR=6.15, 95% CI=4.13, 9.14, P< 0.001). Respondents reporting problem drug use (OR=4.75, 95% CI=2.52, 8.94, P<0.001), or problem alcohol use (OR=1.89, 95% CI=1.03, 3.40, P=.041) reported higher rates of prescribed opioid use than those without problem use. In multivariate logistic regression models controlling for demographic and clinical variables, the presence of a common mental disorder remained a significant predictor of prescription opioid use (OR=3.15, 95% CI=1.69, 5.88, P<0.001), among individuals reporting low pain interference (N=8307); but not (OR=1.27, n.s.) among those reporting high pain interference (N=972). Depressive, anxiety and drug abuse disorders are associated with increased use of regular opioids in the general population. Depressive and anxiety disorders are more common and more strongly associated with prescribed opioid use than drug abuse disorders.

Risks for possible and probable opioid misuse among recipients of chronic opioid therapy in commercial and medicaid insurance plans: The TROUP Study.

&NA; The use of chronic opioid therapy (COT) for chronic non‐cancer pain (CNCP) has increased dramatically in the past two decades. There has also been a marked increase in the abuse of prescribed opioids and in accidental opioid overdose. Misuse of prescribed opioids may link these trends, but has thus far only been studied in small clinical samples. We therefore sought to validate an administrative indicator of opioid misuse among large samples of recipients of COT and determine the demographic, clinical, and pharmacological risks associated with possible and probable opioid misuse. A total of 21,685 enrollees in commercial insurance plans and 10,159 in Arkansas Medicaid who had at least 90 days of continuous opioid use 2000–2005 were studied for one year. Criteria were developed for possible and probable opioid misuse using administrative claims data concerning excess days supplied of short‐acting and long‐acting opioids, opioid prescribers and opioid pharmacies. We estimated possible misuse at 24% of COT recipients in the commercially insured sample and 20% in the Medicaid sample and probable misuse at 6% in commercially insured and at 3% in Medicaid. Among non‐modifiable factors, younger age, back pain, multiple pain complaints and substance abuse disorders identify patients at high risk for misuse. Among modifiable factors, treatment with high daily dose opioids (especially >120 mg MED per day) and short‐acting Schedule II opioids appears to increase the risk of misuse. The consistency of the findings across diverse patient populations and the varying levels of misuse suggest that these results will generalize broadly, but await confirmation in other studies.

Racial and ethnic differences in the mental health problems and use of mental health care

Objectives:We compared rates of mental health problems and use of mental health care across multiple racial and ethnic groups using secondary data from a large, nationally representative survey. Methods:We pooled cross-sectional data from the 2001–2003 National Surveys on Drug Use and Health. Our sample included 134,875 adults classified as white, African American, American Indian/Alaskan Native, Asian, Mexican, Central and South American, Puerto Rican, other Hispanic-Latino, or those with multiple race and ethnicities. For each group, we estimate the past year probability of: (1) having 1 or more mental health symptoms in the past year, (2) having serious mental illness in the past year, (3) using mental health care, (4) using mental health care conditional on having mental health problems, (5) reporting unmet need for mental health care, and (6) reporting unmet need for mental health care conditional on having mental health problems. Results:We found significantly higher rates of mental health problems and higher self-reported unmet need relative to whites among American Indian/Alaskan Natives and lower rates of mental health problems and use of mental health care among African American, Asian, Mexican, Central and South American, and other Hispanic-Latino groups. These differences generally were robust to the inclusion of clinical and socio demographic covariates. Conclusions:Overall, our study shows wide variation in mental health morbidity and use of mental health care across racial and ethnic groups in the United States. These results can help to focus efforts aimed at understanding the underlying causes of the differences we observe.

Emergency department visits among recipients of chronic opioid therapy

BACKGROUND There has been an increase in overdose deaths and emergency department visits (EDVs) involving use of prescription opioids, but the association between opioid prescribing and adverse outcomes is unclear. METHODS Data were obtained from administrative claim records from Arkansas Medicaid and HealthCore commercially insured enrollees, 18 years and older, who used prescription opioids for at least 90 continuous days within a 6-month period between 2000 and 2005 and had no cancer diagnoses. Regression analysis was used to examine risk factors for EDVs and alcohol- or drug-related encounters (ADEs) in the 12 months following 90 days or more of prescribed opioids. RESULTS Headache, back pain, and preexisting substance use disorders were significantly associated with EDVs and ADEs. Mental health disorders were associated with EDVs in HealthCore enrollees and with ADEs in both samples. Opioid dose per day was not consistently associated with EDVs but doubled the risk of ADEs at morphine-equivalent doses over 120 mg/d. Use of short-acting Drug Enforcement Agency Schedule II opioids was associated with EDVs compared with use of non-Schedule II opioids alone (relative risk range, 1.09-1.74). Use of Schedule II long-acting opioids was strongly associated with ADEs (relative risk range, 1.64-4.00). CONCLUSIONS Use of Schedule II opioids, headache, back pain, and substance use disorders are associated with EDVs and ADEs among adults prescribed opioids for 90 days or more. It may be possible to increase the safety of chronic opioid therapy by minimizing the prescription of Schedule II opioids in these higher-risk recipients.

Trends in use of opioids for chronic noncancer pain among individuals with mental health and substance use disorders: the TROUP study.

ObjectivesUse of prescription opioids for chronic pain is increasing, as is abuse of these medications, though the nature of the link between these trends is unclear. These increases may be most marked in patients with mental health (MH) and substance use disorders (SUDs). We analyzed trends between 2000 and 2005 in opioid prescribing among individuals with noncancer pain conditions (NCPC), with and without MH and SUDs. MethodsSecondary data analysis of longitudinal administrative data from 2 dissimilar populations: a national, commercially insured population and Arkansas Medicaid enrollees. We examined these opioid outcomes: (1) rates of any prescription opioid use in the past year, (2) rates of chronic use of prescription opioids (greater than 90 d in the past year), (3) mean days supply of opioids, (4) mean daily opioid dose in morphine equivalents, and (5) percentage of total opioid dose that was Schedule II opioids. ResultsIn 2000, among individuals with NCPC, chronic opioid use was more common among those with a MH or SUD than among those without in commercially insured (8% vs. 3%, P<0.001) and Arkansas Medicaid (20% vs. 13%, P<0.001) populations. Between 2000 and 2005, in commercially insured, rates of chronic opioid use increased by 34.9% among individuals with an MH or SUD and 27.8% among individuals without these disorders. In Arkansas Medicaid chronic, opioid use increased by 55.4% among individuals with an MH or SUD and 39.8% among those without. DiscussionChronic use of prescription opioids for NCPC is much higher and growing faster in patients with MH and SUDs than in those without these diagnoses. Clinicians should monitor the use of prescription opioids in these vulnerable groups to determine whether opioids are substituting for or interfering with appropriate MH and substance abuse treatment.

Racial and gender variation in use of diagnostic colonic procedures in the Michigan Medicare population.

BACKGROUND There is accumulating evidence that screening programs can alter the natural history of colorectal cancer, a significant cause of mortality and morbidity in the US. Understanding how the technology to diagnose colonic diseases is utilized in the population provides insight into both the access and processes of care. METHOD Using Medicare Part B billing files from the state of Michigan from 1986 to 1989 we identified all procedures used to diagnose colorectal disease. We utilized the Medicare Beneficiary File and the Area Resource File to identify beneficiary-specific and community-sociodemographic characteristics. The beneficiary and sociodemographic characteristics were, then, used in multiple regression analyses to identify their association with procedure utilization. RESULTS Sigmoidoscopic use declined dramatically with the increasing age cohorts of Medicare beneficiaries. Urban areas and communities with higher education levels had more sigmoidoscopic use. Among procedures used to examine the entire colon, isolated barium enema was used more frequently in African Americans, the elderly, and females. The combination of barium enema and sigmoidoscopy was used more frequently among females and the newest technology, colonoscopy, was used most frequently among White males. CONCLUSION The existence of race, gender, and socioeconomic disparities in the use of colorectal technologies in a group of patients with near-universal insurance coverage demonstrates the necessity of understanding the reason(s) for these observed differences to improve access to appropriate technologies to all segments in our society.