Abstract
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.
Highlights
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)
In the work reported here, we are interested in examining the unadjusted relative risks of abuse of seven prescription opioid compounds and, when appropriate, their immediate release and extended release formulations, similar to the relative rankings reported by Butler et al (2008)[22]. We go beyond these analyses to determine how these relative risks change when adjusted for the number of prescriptions written for the compared compounds/formulations. This question asks: how likely is a particular prescription for an opioid analgesic to end up in the hands of an abuser? In addition, we provide descriptive information on patterns of abuse via routes of administration characteristic of the various prescription opioid compounds/formulations
Respondent characteristics Data from 69,002 patients in substance abuse treatment within the Addiction Severity Index (ASI)-MV Connect system were collected during the calendar year of 2009
Summary
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). How relative risks change when adjusted for prescription volume of the products was examined along with patterns of abuse via ROAs for the products. This article uses self-report data collected from individuals entering substance abuse treatment from a large number of treatment facilities across the country to examine the relative risks of abuse of specific prescription opioid compounds and formulations and to describe route of administration (ROAs) patterns that are characteristic of the different opioid compounds and formulations. While long-term opioid therapy for chronic noncancer pain remains controversial, such use has increased substantially over the past few decades [1], as has prescribed availability of these medications [2]. A recent national survey finds that nearly 12 million persons (4.8%) 12 years of age or older indicate nonmedical use of prescription pain relievers in the past year [3]. According to the annual national survey, 70% of nonmedically used analgesics are obtained from friends or family [3]
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