Simon H. Budman

Development and validation of the Current Opioid Misuse Measure

Abstract Clinicians recognize the importance of monitoring aberrant medication‐related behaviors of chronic pain patients while being prescribed opioid therapy. The purpose of this study was to develop and validate the Current Opioid Misuse Measure (COMM) for those pain patients already on long‐term opioid therapy. An initial pool of 177 items was developed with input from 26 pain management and addiction specialists. Concept mapping identified six primary concepts underlying medication misuse, which were used to develop an initial item pool. Twenty‐two pain and addiction specialists rated the items on importance and relevance, resulting in selection of a 40‐item alpha COMM. Final item selection was based on empirical evaluation of items with patients taking opioids for chronic, noncancer pain (N = 227). One‐week test–retest reliability was examined with 55 participants. All participants were administered the alpha version of the COMM, the Prescription Drug Use Questionnaire (PDUQ) interview, and submitted a urine sample for toxicology screening. Physician ratings of patient aberrant behaviors were also obtained. Of the 40 items, 17 items appeared to adequately measure aberrant behavior, demonstrating excellent internal consistency and test–retest reliability. Cutoff scores were examined using ROC curve analysis and reasonable sensitivity and specificity were established. To evaluate the COMM’s ability to capture change in patient status, it was tested on a subset of patients (N = 86) that were followed and reassessed three months later. The COMM was found to have promise as a brief, self‐report measure of current aberrant drug‐related behavior. Further cross‐validation and replication of these preliminary results is pending.

Validation of a screener and opioid assessment measure for patients with chronic pain

Abstract There has been a need for a brief assessment tool for providers who treat chronic pain patients to determine potential risk of abuse when prescribed opioids for pain. The purpose of this study was to develop and begin the validation of a self‐administered screening tool (Screener and Opioid Assessment for Patients with Pain, SOAPP) for chronic pain patients considered for long‐term opioid therapy. A consensus of 26 pain and addiction experts was obtained on important characteristics of chronic pain patients that predict future medication misuse using concept mapping. A 24‐item SOAPP (version 1.0) was developed based on this consensus and was administered to 175 patients who were taking opioids for chronic pain. After 6 months, 95 of these patients were re‐evaluated. Validation of the SOAPP was conducted by identifying those patients exhibiting aberrant drug‐related behavior as determined by any of the following: a positive score on the Prescription Drug Use Questionnaire (PDUQ) interview, positive urine toxicology screen, and/or ratings by staff as to whether patients had a serious drug problem. Of the original 24 items, 14 SOAPP items appeared to predict subsequent aberrant behaviors. Coefficient α for these 14 items was acceptable for a short scale (0.74). Receiver operating characteristics curve analysis yielded an area under the curve of 0.881 (P<0.001), suggesting adequate sensitivity and specificity for a screening device. These reliability and predictive validity results suggest that the SOAPP is a promising step toward screening risk potential for substance misuse among persons with chronic pain.

Validation of the Revised Screener and Opioid Assessment for Patients With Pain (SOAPP-R)

UNLABELLED The original Screener and Opioid Assessment for Patients with Pain (SOAPP) is a conceptually derived self-report questionnaire designed to predict aberrant medication-related behaviors among chronic pain patients considered for long-term opioid therapy. The purpose of this study was to develop and validate an empirically derived version of the SOAPP (SOAPP-R) that addresses some limitations of the original SOAPP. In successive steps, items were reduced from an initial pool of 142 to a 97-item beta version. The beta version was administered to 283 chronic pain patients receiving long-term opioid therapy. Items were evaluated based on data collected at follow-up, including correlation with the Aberrant Drug Behavior Index (ADBI), derived from interview data, physician ratings, and urine toxicology screens. Twenty-four items were retained and comprise the final SOAPP-R. Coefficient alpha was .88, and receiver operating characteristics curve analysis yielded an area under the curve of .81 (P < .001). A cutoff score of 18 showed adequate sensitivity (.81) and specificity (.68). The obtained psychometrics, along with the use of a predictive criterion that goes beyond self-report, suggest that the SOAPP-R is an improvement over the original version in screening risk potential for aberrant medication-related behavior among persons with chronic pain. PERSPECTIVE There is a need for a screener for abuse risk in patients prescribed opioids for pain. This study presents a revised version of the SOAPP-R that is empirically derived with good reliability and validity but is less susceptible to overt deception than the original SOAPP version 1.

Psychiatric History and Psychologic Adjustment as Risk Factors for Aberrant Drug-related Behavior Among Patients With Chronic Pain

ObjectiveTo investigate the role of psychiatric history and psychologic adjustment on aberrant drug-related behavior among patients prescribed opioids for noncancer pain. MethodsTwo hundred twenty-eight patients prescribed opioids for chronic pain were classified as either high or low on psychiatric morbidity on the basis of their responses on the psychiatric subscale of the Prescription Drug Use Questionnaire (PDUQ). They also completed the Brief Pain Inventory (BPI), Screener and Opioid Assessment for Pain Patients (SOAPP), and the Current Medication Misuse Measure (COMM). Patients were followed for 5 months and submitted a urine toxicology screen, and their treating physician completed the Prescription Opioid Therapy Questionnaire (POTQ). On the basis of the results from the SOAPP, COMM, POTQ, and urine screens, patients were classified as positive or negative on the Drug Misuse Index (DMI). ResultsOne hundred and three (N=103) of the patients (45%) were classified in the low psychiatric group (Low Psych) whereas 55% (N=125) were classified in the high psychiatric morbidity group (High Psych). High Psych patients were significantly younger than Low Psych patients and had been taking opioids longer (P<0.05). The High Psych group showed significantly higher SOAPP and COMM scores than the Low Psych patients (P<0.001), had a greater frequency of abnormal urine toxicology screens (P<0.01), and significantly higher scores on the DMI (P<0.001). A consistent association was found between psychiatric morbidity and prescription opioid misuse in chronic pain patients. DiscussionPsychiatric factors, such as a history of mood disorder, psychologic problems, and psychosocial stressors, may place patients at risk for misuse of prescription opioids. Future studies to elucidate the risk of medication misuse and aberrant drug behavior among this patient population are needed.

Abuse Rates and Routes of Administration of Reformulated Extended-Release Oxycodone: Initial Findings From a Sentinel Surveillance Sample of Individuals Assessed for Substance Abuse Treatment

UNLABELLED Oxycodone hydrochloride controlled-release, also known as extended-release oxycodone (ER oxycodone), was reformulated with physicochemical barriers to crushing and dissolving intended to reduce abuse through nonoral routes of administration (ROAs) that require tampering (eg, injecting and snorting). Manufacturer shipments of original ER oxycodone (OC) stopped on August 5, 2010, and reformulated ER oxycodone (ORF) shipments started August 9, 2010. A sentinel surveillance sample of 140,496 individuals assessed for substance abuse treatment at 357 U.S. centers between June 1, 2009, and March 31, 2012, was examined for prevalence and prescription-adjusted prevalence rates of past-30-day abuse via any route, as well as abuse through oral, nonoral, and specific ROAs for ER oxycodone and comparators (ER morphine and ER oxymorphone) before and after ORF introduction. Significant reductions occurred for 8 outcome measures of ORF versus OC historically. Abuse of ORF was 41% lower (95% CI: -44 to -37) than historical abuse for OC, with oral abuse 17% lower (95% CI: -23 to -10) and nonoral abuse 66% lower (95% CI: -69 to -63). Significant reductions were not observed for comparators. Observations were consistent with the goals of a tamper resistant formulation for an opioid. Further research is needed to determine the persistence and generalizability of these findings. PERSPECTIVE This article presents preliminary findings indicating that 8 outcome measures of abuse of a reformulated ER oxycodone were lower than that for original ER oxycodone historically, particularly through nonoral ROAs that require tampering (ie, injection, snorting, smoking), in a sentinel sample of individuals assessed for substance use problems for treatment planning.

Foundations of Opioid Risk Management

Increased abuse and diversion of prescription opioids has been a consequence of the increased availability of opioids to address the widespread problem of undertreated pain. Opioid risk management refers to the effort to minimize harms associated with opioid therapy while maintaining appropriate access to therapy. Management of these linked public health issues requires a coordinated and balanced effort among a disparate group of stakeholders at the federal, state, industry, practitioner, and patient levels. This paper reviews the principles of opioid risk management by examining the epidemiology of prescription opioid abuse in the United States; identifying key stakeholders involved in opioid risk management and their responsibilities for managing or monitoring opioid abuse and diversion; and summarizing the mechanisms currently used to monitor and address prescription opioid abuse. Limitations of current approaches, and emerging directions in opioid risk management, are also presented.

A Short Form of the Inventory of Interpersonal Problems Circumples Scales

The 127-item Inventory of Interpersonal Problems (IIP) has proven useful in capturing clinically important aspects of clients interpersonal functioning. Alden, Wiggins, and Pincus constructed a 64-item circumplex form of the IIP (IIP-C). We found that an even shorter form was needed for situations involving the screening of patients in a brief time. We, therefore, constructed a 32-item short circumplex form (IIP-SC). This form was found to exhibit excellent internal consistency reliability and strong test-retest correlations in three outpatient samples. It was found to correlate highly with the longer forms of the IIP and to show similar treatment responsiveness to them. The IIP-SC has also been demonstrated to correspond closely to the circumplex model of interpersonal behavior. The IIP-SC is, thus, an adequate substitute for the complete IIP in settings where brevity is important.

Efficacy of a brief psychosocial intervention for symptoms of stress and distress among patients in primary care.

Psychosocial problems and symptoms of emotional distress play a prominent role in patients reporting to primary care settings. Interpersonal counseling (IPC) was developed as a brief psychosocial intervention for patients with stress and distress to be administered by nurse practitioners in a primary care setting. The results of a pilot study indicate more rapid reduction of symptoms and improvement in emotional sysmptoms and psychosocial functioning in the IPC group than in a comparison group with initially elevated scores on the General Health Questionnaire. The priorities for further testing are discussed, and possible implications for service delivery are explored.

Abuse risks and routes of administration of different prescription opioid compounds and formulations

BackgroundEvaluation of tamper resistant formulations (TRFs) and classwide Risk Evaluation and Mitigation Strategies (REMS) for prescription opioid analgesics will require baseline descriptions of abuse patterns of existing opioid analgesics, including the relative risk of abuse of existing prescription opioids and characteristic patterns of abuse by alternate routes of administration (ROAs). This article presents, for one population at high risk for abuse of prescription opioids, the unadjusted relative risk of abuse of hydrocodone, immediate release (IR) and extended release (ER) oxycodone, methadone, IR and ER morphine, hydromorphone, IR and ER fentanyl, IR and ER oxymorphone. How relative risks change when adjusted for prescription volume of the products was examined along with patterns of abuse via ROAs for the products.MethodsUsing data on prescription opioid abuse and ROAs used from 2009 Addiction Severity Index-Multimedia Version (ASI-MV®) Connect assessments of 59,792 patients entering treatment for substance use disorders at 464 treatment facilities in 34 states and prescription volume data from SDI Health LLC, unadjusted and adjusted risk for abuse were estimated using log-binomial regression models. A random effects binary logistic regression model estimated the predicted probabilities of abusing a product by one of five ROAs, intended ROA (i.e., swallowing whole), snorting, injection, chewing, and other.ResultsUnadjusted relative risk of abuse for the 11 compound/formulations determined hydrocodone and IR oxycodone to be most highly abused while IR oxymorphone and IR fentanyl were least often abused. Adjusting for prescription volume suggested hydrocodone and IR oxycodone were least often abused on a prescription-by-prescription basis. Methadone and morphine, especially IR morphine, showed increases in relative risk of abuse. Examination of the data without methadone revealed ER oxycodone as the drug with greatest risk after adjusting for prescription volume. Specific ROA patterns were identified for the compounds/formulations, with morphine and hydromorphone most likely to be injected.ConclusionsUnadjusted risks observed here were consistent with rankings of prescription opioid abuse obtained by others using different populations/methods. Adjusted risk estimates suggest that some, less widely prescribed analgesics are more often abused than prescription volume would predict. The compounds/formulations investigated evidenced unique ROA patterns. Baseline abuse patterns will be important for future evaluations of TRFs and REMS.

Cross-Validation of a Screener to Predict Opioid Misuse in Chronic Pain Patients (SOAPP-R)

Objectives:The Screener and Opioid Assessment for Patients with Pain—Revised (SOAPP-R) is a self-report questionnaire designed to predict aberrant medication-related behaviors among persons with chronic pain. This measure was developed to complement current risk assessment practices and to improve a clinicians ability to assess a patients risk for opioid misuse. The aim of this study was to cross-validate the SOAPP-R with a new sample of chronic, noncancer pain patients. Methods:Three hundred two participants (N = 302) prescribed opioids for pain were recruited from 5 pain management centers in the U.S. Subjects completed a series of self-report measures and were followed for 5 months. Patients were rated by their treating physician, had a urine toxicology screen, and were classified on the Aberrant Drug Behavior index. Results:Seventy-three percent (73.2%) of the subjects (N= 221) were followed and 66 participants repeated the SOAPP-R after 1 week for test-retest reliability. The reliability and predictive validity, as measured by the area under the curve (AUC), were found to be highly significant (test-retest reliability = 0.91; coefficient α = 0.86; AUC = 0.74) and were sufficiently similar to values found with the initial sample. A cut-off score of 18 revealed a sensitivity of 0.80 and specificity of 0.52. Conclusions:Results of this cross-validation study suggest that the psychometric parameters of the SOAPP-R are not based solely on the unique characteristics of the initial validation sample. The SOAPP-R is found to be a reliable and valid screening tool for risk of aberrant drug-related behavior among chronic pain patients.