K. Fernandez

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.

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.

Does Report of Craving Opioid Medication Predict Aberrant Drug Behavior Among Chronic Pain Patients

ObjectiveTo examine the relationship between the self-report of craving prescription medication and subsequent opioid misuse among chronic pain patients prescribed opioids for pain. MethodsSix hundred thirteen patients taking opioid medication for chronic noncancer pain were asked how often they have felt a craving for their medication on a scale from 0=never to 4=very often. All participants completed a series of baseline questionnaires. After 6 months the participants were administered a structured prescription drug use interview (Prescription Drug Use Questionnaire), and submitted a urine sample for toxicology assessment. Their treating physicians also completed a substance misuse behavior checklist (Prescription Opioid Therapy Questionnaire). ResultsThree hundred thirty-seven participants (55.0%) reported that they never felt a craving for their medication, whereas 276 (45.0%) reported some degree of craving their medication (seldom to very often). Those who reported craving their medication were significantly more often male (P<0.01), unmarried (P<0.05), had lower scores on social desirability (P<0.001), and had been prescribed opioids for a longer time (P<0.05) than those who did not report craving medication. At 6-month follow-up, those who reported craving their medication showed higher scores on the Prescription Drug Use Questionnaire (P<0.001), had a higher incidence of physician-rated aberrant drug behavior on the Prescription Opioid Therapy Questionnaire (P<0.05), showed a higher frequency of abnormal urine toxicology screens (P<0.001), and more often had a positive Aberrant Drug Behavior Index (P<0.001). DiscussionThese results suggest that self-reported craving is a potential marker for identification of those at risk for opioid medication misuse.

Internet-based Survey of Nonmedical Prescription Opioid Use in the United States

IntroductionPrescription opioid misuse is a growing problem in the United States. There are limited data to illuminate the nature of this issue. The Internet seems to be a novel approach in surveying populations of opioid users. An Internet-based survey of nonmedical opioid users visiting informational drug websites was used to measure rates of nonmedical use and characterize users. MethodsThe prescription opioid module of the Addiction Severity Index Multimedia Version Connect was adapted to include variables such as favorite opioid. Links to the survey were posted on an informational drug website. Nonmedical use rates for KADIAN (morphine sulfate extended-release tablets), OxyContin (oxycodone HCl controlled-release tablets), Vicodin (hydrocodone bitartrate and acetaminophen tablets), and product-classes (morphine ER, oxycodone ER, and hydrocodone) were calculated. Descriptive statistics were calculated for remaining questions. ResultsDuring a 1-month recruitment period, 896 valid individuals completed the survey. Majority were white (78.3%) and male (72.4%). Participants were less likely to have used KADIAN in the past 30 days compared with OxyContin (P<0.0001) and Vicodin (P=0.0021). Additionally, participants were less likely to have used morphine ER in the previous 30 days than either oxycodone ER (P<0.0001) or hydrocodone (P<0.0001). Among OxyContin, Vicodin, and KADIAN users, OxyContin (43.8%), Dilaudid (15.6%), and fentanyl (9.4%) were the top 3 favorite opioids. DiscussionThis project demonstrates the feasibility of conducting product-specific, online surveys with rapid recruitment of participants from websites. This approach differentiates rates of nonmedical use of specific prescription opioids and provides other insights into individuals who nonmedically use opioids.

Update on Prescription Monitoring in Clinical Practice: A Survey Study of Prescription Monitoring Program Administrators

OBJECTIVE Prescription drug abuse and undertreatment of pain are public health priorities in the United States. Few options to manage these problems are balanced, in simultaneously supporting pain relief and deterring prescription drug abuse. Prescription monitoring programs (PMPs) potentially offer a balanced approach; however, the medical/scientific communities are not well informed about their current status and potential risks/benefits. The purpose of this study was to provide a benchmark of the current status of PMPs for healthcare providers upon which to engage PMP administrators. DESIGN A Web survey of current PMP directors with a telephone follow-up conducted in June-July 2006 regarding goals, data captured, data sharing procedures, healthcare provider training, and evaluation efforts. RESULTS Eighteen of 23 states with operating PMPs at that time participated. Eleven programs allowed physician access to PMP data. Data were delivered by mail (N = 6), fax (N = 8), e-mail (N = 1), and Websites (N = 8). Eight programs provided data to providers within 1 hour. Three states have developed provider PMP usage guidelines. Eight states developed or are developing educational programs. Two states completed or are conducting evaluations of the public health impact of PMP implementation. Five states have begun utilizing PMP data as an epidemiological tool. CONCLUSIONS Initial public safety orientation of PMPs is evolving to include improving public health and patient care. Beginning with efforts to engage healthcare providers through data sharing and education, and progressively including program evaluation on public health and patient care, our results suggest a rapid movement in the direction of utilization of PMPs to improve health care.

Development and preliminary experience with an ease of extractability rating system for prescription opioids.

Abstract One important factor in the abuse potential of an opioid product is the ease with which active drug can be extracted. There are currently no standards for testing or reporting extractability. This article describes the development of an Extractability Rating System for use by the pharmaceutical industry and regulators. Despite several limitations, this effort serves as a call for standardized testing and reporting so that products can be accurately rated, and should help establish goals for drug developers who wish to develop “abuse-resistant” opioid products.

Validation of the Spanish Addiction Severity Index Multimedia Version (S-ASI-MV).

This study aimed to develop and test the reliability and validity of a Spanish adaptation of the ASI-MV, a computer administered version of the Addiction Severity Index, called the S-ASI-MV. Participants were 185 native Spanish-speaking adult clients from substance abuse treatment facilities serving Spanish-speaking clients in Florida, New Mexico, California, and Puerto Rico. Participants were administered the S-ASI-MV as well as Spanish versions of the general health subscale of the SF-36, the work and family unit subscales of the Social Adjustment Scale Self-Report, the Michigan Alcohol Screening Test, the alcohol and drug subscales of the Personality Assessment Inventory, and the Hopkins Symptom Checklist-90. Three-to-five-day test-retest reliability was examined along with criterion validity, convergent/discriminant validity, and factorial validity. Measurement invariance between the English and Spanish versions of the ASI-MV was also examined. The S-ASI-MV demonstrated good test-retest reliability (ICCs for composite scores between .59 and .93), criterion validity (rs for composite scores between .66 and .87), and convergent/discriminant validity. Factorial validity and measurement invariance were demonstrated. These results compared favorably with those reported for the original interviewer version of the ASI and the English version of the ASI-MV.