The natural history of prescription opioid abuse: A pilot study exploring change in routes of administration and motivation for changes.

OBJECTIVE: The purpose of this retrospective, observational pilot study was to explore change in route of administration (RoA) and motivation for changing RoA during the course of opioid abuse. DESIGN: This retrospective pilot study involved collecting and analyzing semistructured interview data. SETTING: Interviews were conducted with patients undergoing outpatient substance abuse treatment at a buprenorphine clinic. PARTICIPANTS: Twenty adult patients (50 percent male) participated in the interviews. MAIN OUTCOME MEASURES: Interview data were qualitatively and quantitatively analyzed to evaluate trends and motivations for changing RoA. RESULTS: In this sample, RoA varied over time. Most patients (75.0 percent) began abusing prescription opioids by swallowing intact pills, and 53.3 percent of patients eventually progressed to chewing. All patients who initiated abuse through chewing or insufflation (ie, intranasal use) progressed to injection. However, several patients (20.0 percent) did not exhibit a linear progression from RoAs with lesser to greater risk for serious adverse events. Of the eight motivations for changing RoA identified in the current study, the most frequently cited (38.2 percent) motivation was to achieve a desired effect (eg, euphoria). CONCLUSIONS: This pilot study is one of the first to investigate natural history of RoA in prescription opioid abuse and motivations for changing RoA. Results suggest that a defined pathway of RoA progression may not exist, and that achieving a desired effect is a common motivation for changing RoA. Although these findings need to be replicated in a larger sample, this research may help support the development of opioid risk mitigation strategies.

Patterns of abuse and routes of administration for immediate-release hydrocodone combination products.

PURPOSE: Prescriptions for hydrocodone immediate-release (IR) combination products have recently decreased, yet they represent the majority of opioid prescriptions dispensed and are commonly abused analgesics among both adults and adolescents. Little data exist to understand the contribution of IR products to the problem of prescription opioid abuse. This study aimed to better understand abuse patterns for hydrocodone IR combination products among adult and adolescent substance abusers. METHODS: This cross-sectional study examines abuse prevalence (including abuse adjusted for prescription volume and morphine milligram equivalents) and abuse characteristics for hydrocodone IR combination products and other prescription opioids among separate samples of adults and adolescents assessed for substance abuse problems or entering treatment from January 2012 through June 2015. RESULTS: Results indicate higher abuse for hydrocodone IR combination products than other opioid categories per 100 assessments but lower per prescriptions dispensed. Hydrocodone IR combination products had similar abuse prevalence to all extended-release and long-acting opioids when considering abuse measured per morphine milligram equivalents dispensed. An upward trend in hydrocodone IR combination product abuse was observed among adult substance abusers comparing the period prior to and after Drug Enforcement Administration rescheduling of these products in October 2014. Most individuals reported oral abuse of hydrocodone IR combination products, but snorting, reported by 23% of hydrocodone IR combination product abusers, also appears to be a route of abuse that may have public health relevance. CONCLUSIONS: Given their high prescription volume, hydrocodone IR combination products, even at a relatively low prevalence of abuse, may contribute substantially to the overall problem of prescription opioid abuse. Additional public health interventions, including development of abuse-deterrent formulations for these types of opioid products may aid in reducing their abuse.

Nonmedical Use and Diversion of ADHD Stimulants Among U.S. Adults Ages 18-49: A National Internet Survey.

OBJECTIVE: Evaluate nonmedical use (NMU) of ADHD prescription stimulants (Ritalin(®), Adderall(®), Adderall(®) XR, Concerta(®), and Vyvanse(®)) in a U.S. adult general population sample. METHOD: In all, 10,000 adults (aged 18-49) from an online, opt-in panel, proximity matched to U.S. Census demographics, were surveyed to assess NMU prevalence, routes of administration (ROA), reasons for NMU, and diversion source. RESULTS: Lifetime NMU of any prescription drug was 35.1%, pain medications (24.6%), sedatives/tranquilizers (15.6%), sleep medications (9.9%), and prescription stimulants (8.1%). Within the prescription stimulants, rates of NMU (per 100,000 prescriptions dispensed) were 1.62 for Ritalin and 1.61 for Adderall followed by Adderall XR (0.62), Concerta (0.19), and Vyvanse (0.13). Respondents used stimulants mostly for wakefulness and performance enhancement, obtained the drugs from family/friends, and used oral ROA. CONCLUSION: NMU of ADHD prescription stimulants were low compared with other prescription medications. While prevalence of NMU was higher for immediate-release than extended-release ADHD medications, absolute rates for prescription stimulants were low.

Associations between public health indicators and injecting prescription opioids by prescription opioid abusers in substance abuse treatment.

OBJECTIVE: To determine what, if any, public health and societal impacts are associated specifically with injection of prescription opioids. DESIGN: Cross-sectional observational study. SETTING: Five hundred forty treatment facilities in 35 states across the United States performing Addiction Severity Index-Multimedia Version (ASI-MV) assessments. PARTICIPANTS: Adult patients (29,459) who reported past 30-day abuse of any prescription opioid on the ASI-MV assessment between January 2007 and January 2011. MAIN OUTCOME MEASURES: The public health indicators selected for this study were liver disease, HIV/AIDS status, recent visit to an emergency room, treatment for pain, treatment for overdosing, homelessness, residence with alcohol/substance abuser, and unemployment. RESULTS: Prescription opioid injection was significantly associated with health problems, psychosocial problems, and utilization of medical services. CONCLUSIONS: This study demonstrates an approach to measure the potential impact of injecting prescription opioids on public health indicators. Findings indicate a positive association between injection of prescription opioids and public health indicators suggesting a need for prescription opioid formulations that may inhibit injection of these medications.

Spanish translation and linguistic validation of the screener and opioid assessment for patients with pain-revised (SOAPP-R).

INTRODUCTION: Given the increase in misuse and abuse of prescription opioids, clinicians clearly benefit from a standardized tool to screen patients being considered for chronic opioid therapy. The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a widely used opioid risk assessment tool in clinical practice. As one third of the US population experiences chronic noncancer pain at any given time, and the Hispanic population now accounts for about 16% of the nation's population, the availability of a Spanish-language SOAPP-R fills an important clinical need. OBJECTIVE: To derive a linguistically validated Spanish-language version of the SOAPP®-R. METHOD: Each step of Spanish translation and linguistic validation of the SOAPP-R was based on the US Food and Drug Administration and the International Society for Pharmacoeconomics and Outcomes Research translation process. RESULT: A linguistically validated Spanish-language version of the SOAPP-R. CONCLUSION: The Spanish SOAPP-R may be useful as a risk assessment tool, considered along with other clinical information, by clinicians who prescribe opioid therapy for patients whose preferred language is Spanish.

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.

Measuring online endorsement of prescription opioids abuse: an integrative methodology.

PURPOSE: The ability to track prescription opioid abusers' endorsement of compounds may be valuable in forecasting abuser's preferences. We developed a metric, referred to as the Endorsement Ratio (ERo), to explore the feasibility of quantifying the sentiment expressed by opioid abusers who post online about prescription opioid products. METHODS: Internet posts written between April 1, 2010 and March 31, 2011 and related to six prescription opioid compounds (oxycodone ER, hydrocodone, hydromorphone, oxymorphone, morphine ER, and tramadol) were identified and qualitatively coded. A mixed effects multinomial logistic regression was employed to model the probability of observing endorsing, discouraging, mixed, or unclear messages per compound. Endorsement-to-discouragement ratio (ERo) and ratio of endorsement-to-discouragement ratios (RERo) were estimated for each compound. RESULTS: In the study sample of 12 838 Internet posts, a ranking of endorsement could be established, with oxymorphone as most endorsed (ERo = 7.39), followed by hydromorphone (ERo = 5.02), hydrocodone (ERo = 3.53), oxycodone ER (ERo = 3.23), morphine ER (ERo = 2.71), and tramadol (ERo = 1.76). Relative rankings of products required that route of administration be considered. CONCLUSIONS: This study expands existing Internet monitoring approaches by developing a metric to estimate the endorsement of specific prescription opioid compounds as viewed through the lens of Internet communities. Route of administration must be taken into account when examining preferences of drug abusers for various products. This study did not assess whether the novel metric is valid with respect to classification of abuse rates of different drugs. Further studies examining external validation studies are warranted.

Typologies of prescription opioid use in a large sample of adults assessed for substance abuse treatment.

BACKGROUND: As a population, non-medical prescription opioid users are not well-defined. We aimed to derive and describe typologies of prescription opioid use and nonmedical use using latent class analysis in an adult population being assessed for substance abuse treatment. METHODS: Latent class analysis was applied to data from 26,314 unique respondents, aged 18-70, self-reporting past month use of a prescription opioid out of a total of 138,928 cases (18.9%) collected by the Addiction Severity Index-Multimedia Version (ASI-MV®), a national database for near real-time prescription opioid abuse surveillance. Data were obtained from November 2005 through December 2009. Substance abuse treatment, criminal justice, and public assistance programs in the United States submitted data to the ASI-MV database (n = 538). Six indicators of the latent classes derived from responses to the ASI-MV, a version of the ASI modified to collect prescription opioid abuse and chronic pain experience. The latent class analysis included respondent home ZIP code random effects to account for nesting of respondents within ZIP code. RESULTS: A four-class adjusted latent class model fit best and defined clinically interpretable and relevant subgroups: Use as prescribed, Prescribed misusers, Medically healthy abusers, and Illicit users. Classes varied on key variables, including race/ethnicity, gender, concurrent substance abuse, duration of prescription opioid abuse, mental health problems, and ASI composite scores. Three of the four classes (81% of respondents) exhibited high potential risk for fatal opioid overdose; 18.4% exhibited risk factors for blood-borne infections. CONCLUSIONS: Multiple and distinct profiles of prescription opioid use were detected, suggesting a range of use typologies at differing risk for adverse events. Results may help clinicians and policy makers better focus overdose and blood-borne infection prevention efforts and intervention strategies for prescription opioid abuse reduction.

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

BACKGROUND: Evaluation 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. METHODS: Using 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. RESULTS: Unadjusted 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. CONCLUSIONS: Unadjusted 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.

Illustration of a statistical process control approach to regional prescription opioid abuse surveillance.

OBJECTIVE: To investigate and illustrate the use of statistical process control (SPC) for prospective monitoring and detection of regional changes in prescription opioid abuse rates. METHODS: A demonstration project was conducted by applying several types of SPC charts to Louisiana TANF (Temporary Assistance for Needy Families) applicant self-reported opioid illicit use data collected during 21 months. These charts were constructed and examined for signals of abuse rate changes both at the aggregate statewide level and for each state region (parish) separately. RESULTS: SPC identified increases in opioid illicit use in 2 parishes and subsequent decreases in both regions. These fluctuations were not as apparent when the data were examined using traditional bar graphs and summary tables. The remaining parishes exhibited stable abuse rates with no statistically significant changes over time. CONCLUSIONS: These results illustrate proof of concept for monitoring prescription drug abuse regionally via statistical control charts and the potential of this approach for real-time prospective surveillance for abuse rate changes.

Cross validation of the current opioid misuse measure to monitor chronic pain patients on opioid therapy.

OBJECTIVES: The Current Opioid Misuse Measure (COMM) is a self-report measure of risk for aberrant medication-related behavior among persons with chronic pain who are prescribed opioids for pain. It was developed to complement predictive screeners of opioid misuse potential and improve a clinician's ability to periodically assess a patient's risk for opioid misuse. The aim of this study was to cross-validate the COMM with a sample of chronic noncancer pain patients. METHODS: Two hundred and twenty-six participants prescribed opioids for pain were recruited from 5 pain management centers in the United States. Participants completed the 17-item COMM and a series of self-report measures. Patients were rated by their treating physician, had a urine toxicology screen, and were classified on the Aberrant Drug Behavior index. RESULTS: The reliability and predictive validity in this cross validation as measured by the area under the curve (AUC) were found to be highly significant (AUC=0.79) and not significantly different from the AUC obtained in the original validation study (AUC=0.81). Reliability (coefficient α) was 0.83, which is comparable to the 0.86 obtained in the original sample. DISCUSSION: Results of the cross validation suggest that the psychometric parameters of the COMM are not based solely on unique characteristics of the initial validation sample. The COMM seems to be a reliable and valid screening tool to help detect current aberrant drug-related behavior among chronic pain patients.

Characteristics of prescription opioid abusers in treatment: prescription opioid use history, age, use patterns, and functional severity.

Research has raised the possibility that the length of time one engages in nonmedical use of prescription opioids may be associated with abuse of other drugs, more risky drug-related behavior, and more severe functional problems. This study drew on data from the Addiction Severity Index-Multimedia Version Connect system. A total of 55,341 client assessments at substance abuse treatment centers were analyzed to help understand the impact of length of time one has abused opioids on the patterns of abuse and functional problems. From this larger sample, 5686 individuals who had abused a prescription opioid within the past 30 days were studied. Multiple logistic regression analyses were run to examine the impact of length of time abusing any opioid, after adjusting for several demographic variables, on route of administration (injection or injection/snorting), other drugs abused, and functioning in the areas of medical status, employment, drug and alcohol use, legal status, family and social problems, and psychiatric status. Overall findings supported the hypothesis that length of opioid abuse is associated with higher risk of drug use patterns as well as functional problems.

Gender differences in risk factors for aberrant prescription opioid use.

UNLABELLED: This is a longitudinal predictive study to examine gender differences in the clinical correlates of risk for opioid misuse among chronic pain patients prescribed opioids for pain. Two hundred seventy-five male and 335 female patients prescribed opioids for chronic noncancer pain were asked to complete a series of baseline questionnaires, including the revised Screener and Opioid Assessment for Pain Patients (SOAPP-R). After 5 months, the subjects were administered a structured prescription drug use interview (Prescription Drug Use Questionnaire; PDUQ) and submitted a urine sample for toxicology assessment. Their treating physicians also completed a substance misuse behavior checklist (Prescription Opioid Therapy Questionnaire; POTQ). At 5-month follow-up, women showed higher scores on the PDUQ (P < .05), whereas men had a higher incidence of physician-rated aberrant drug behavior on the POTQ (P < .05). An item analysis of the SOAPP-R, PDUQ, and POTQ showed that women tended to score higher on items relating to psychological distress, whereas the male patients tended to report having more legal and behavioral problems. These results suggest that risk factors associated with prescription opioid misuse may differ between men and women. PERSPECTIVE: Understanding gender differences in substance abuse risk among chronic pain patients is important for clinical assessment and treatment. This study suggests that women are at greater risk to misuse opioids because of emotional issues and affective distress, whereas men tend to misuse opioids because of legal and problematic behavioral issues.

Can abuse deterrent formulations make a difference? Expectation and speculation.

It is critical that issues surrounding the abuse and misuse of prescription opioids be balanced with the need for these medications for the treatment of pain. One way to decrease the abuse of prescription opioid medications is to develop abuse deterrent formulations (or ADFs) that in some way prevent drug abusers from extracting out the active ingredient in order to employ alternate routes of administration, such as injection, snorting, and smoking. Several factors including the pharmacokinetic profile of the drug, the features of the drug formulation that make it attractive or unattractive for abuse, the type of drug abuser, the progression of one's addiction pathway, and one's social environment may all play a role in the abuse of prescription opioids and what methods are used to abuse these drugs. This paper will examine these factors in order to understand how they affect the abuse of prescription opioids and routes of administration, and how the development of ADFs may alter these patterns.

Women who abuse prescription opioids: findings from the Addiction Severity Index-Multimedia Version Connect prescription opioid database.

BACKGROUND: Evidence suggests gender differences in abuse of prescription opioids. This study aimed to describe characteristics of women who abuse prescription opioids in a treatment-seeking sample and to contrast gender differences among prescription opioid abusers. METHODS: Data collected November 2005 to April 2008 derived from the Addiction Severity Index Multimedia Version Connect (ASI-MV Connect) database. Bivariate and multivariable logistic regression examined correlates of prescription opioid abuse stratified by gender. RESULTS: 29,906 assessments from 220 treatment centers were included, of which 12.8% (N=3821) reported past month prescription opioid abuse. Women were more likely than men to report use of any prescription opioid (29.8% females vs. 21.1% males, p<0.001) and abuse of any prescription opioid (15.4% females vs. 11.1% males, p<0.001) in the past month. Route of administration and source of prescription opioids displayed gender-specific tendencies. Women-specific correlates of recent prescription opioid abuse were problem drinking, age <54, inhalant use, residence outside of West US Census region, and history of drug overdose. Men-specific correlates were age <34, currently living with their children, residence in the South and Midwest, hallucinogen use, and recent depression. Women prescription opioid abusers were less likely to report a pain problem although they were more likely to report medical problems than women who abused other drugs. CONCLUSIONS: Gender-specific factors should be taken into account in efforts to screen and identify those at highest risk of prescription opioid abuse. Prevention and intervention efforts with a gender-specific approach are warranted.

Does report of craving opioid medication predict aberrant drug behavior among chronic pain patients?

OBJECTIVE: To examine the relationship between the self-report of craving prescription medication and subsequent opioid misuse among chronic pain patients prescribed opioids for pain. METHODS: Six 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). RESULTS: Three 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). DISCUSSION: These results suggest that self-reported craving is a potential marker for identification of those at risk for opioid medication misuse.

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 clinician's ability to assess a patient's risk for opioid misuse. The aim of this study was to cross-validate the SOAPP-R with a new sample of chronic, non-cancer pain patients. METHODS: Three hundred and two participants (N=302) prescribed opioids for pain were recruited from five pain management centers in the U.S. Subjects completed a series of self-report measures and were followed for five 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 one 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 = .91; coefficient alpha = .86; AUC = .74) and were sufficiently similar to values found with the initial sample. A cut-off score of 18 revealed a sensitivity of .80 and specificity of .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.

National addictions vigilance intervention and prevention program (NAVIPPRO): a real-time, product-specific, public health surveillance system for monitoring prescription drug abuse.

PURPOSE: The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a scientific, comprehensive risk management program for scheduled therapeutics. NAVIPPRO provides post-marketing surveillance, signal detection, signal verification and prevention and intervention programs. Here we focus on one component of NAVIPPRO surveillance, the Addiction Severity Index-Multimedia Version (ASI-MV) Connect, a continuous, real-time, national data stream that assesses pharmaceutical abuse by patients entering substance abuse treatment by collecting product-specific, geographically-detailed information. METHODS: We evaluate population characteristics for data collected through the ASI-MV Connect in 2007 and 2008 and assess the representativeness, geographic coverage, and timeliness of report of the data. Analyses based on 41,923 admissions to 265 treatment centers in 29 states were conducted on product-specific opioid abuse rates, source of drug, and route of administration. RESULTS: ASI-MV Connect data revealed that 11.5% of patients reported abuse of at least one opioid analgesic product in the 30 days prior to entering substance abuse treatment; differences were observed among sub-populations of prescription opioid abusers, among products, and also within various geographic locations. CONCLUSIONS: The ASI-MV Connect component of NAVIPPRO represents a potentially valuable data stream for post-marketing surveillance of prescription drugs. Analyses conducted with data obtained from the ASI-MV Connect allow for the characterization of product-specific and geospatial differences for drug abuse and can serve as a tool to monitor responses of the abuse population to newly developed "abuse deterrent" drug formulations. Additional data, evaluation, and comparison to other systems are important next steps in establishing NAVIPPRO as a comprehensive, post-marketing surveillance system for prescription drugs.

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.

Development and validation of the Current Opioid Misuse Measure.

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.