An observational study in Opioid-Related Disorders, Opiate Addiction and Narcotic Abuse, sponsored by Member Companies of the Opioid PMR Consortium. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by Member Companies of the Opioid PMR Consortium · Observational
The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction
Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The four observational post-marketing requirement (PMR) studies are labeled Study #2065-1, Study #2065-2, Study #2065-3, and Study #2065-4.
The objective of PMR Study #2065-4 is to define and validate "doctor/pharmacy shopping" as outcomes suggestive of misuse, abuse and/or addiction.
Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current study (#2065 sub-study, Study 4A), the IMS® LRx database, a longitudinal pharmacy database that captures both third-party and self-pay transactions, will be linked to the PharMetrics Plus™ database, which contains provider, facility and pharmacy claims. From these databases, patients with shopping behavior will be identified and evaluated against an algorithm for abuse/addiction that will be developed and validated in PMR Study #2065-3B. Study #2065-3B will review the literature for health information suggestive of abuse/addiction in medical charts and medical claims. Then, through iterative processes that involve experts reviewing claims profiles and medical charts, text searches of medical records using natural language processing and supervised machine learning will identify and create a compilation of codes and health information with the best specificity and sensitivity to identify patients with opioid abuse/addiction. The compilation of codes and health information will be used to develop the algorithm that Study 4A will apply to define abuse/addiction. Restricting the validation of shopping behavior to only patients with diagnoses related to abuse would ignore the population with undiagnosed abuse. By supplementing ICD-9 codes with other information available on claims (e.g., addiction treatments, emergency visits) to define abuse/addiction, the measurement bias will be decreased and the estimates of the association of shopping behavior with abuse/addiction will be more valid. Categories of doctor shopping will be derived from the population distributions of the multiple variables analyzed for opioid users. The 4 categories will range from no shopping behavior (lowest level) to extensive shopping behavior (most extreme). The specifics of how the categories will be defined will be driven by the data.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 164,923 is above the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Member Companies of the Opioid PMR Consortium is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (18 years of age or older) with data in both IMS LRx and PharMetrics Plus, who also have a minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first. Dispensings will be determined from the IMS LRx database.
Exclusion Criteria:
N/A
Patients receiving two or more opioid dispensings within 18 months
Other: DB review for Doctor/Pharmacy Shopping Behavior
Patients receiving two or more Diuretics dispensings within 18 months will serve as negative control
Other: DB review for Doctor/Pharmacy Shopping Behavior
Database review to evaluate of doctor/pharmacy shopping behaviors
Numbers and proportions of patients with shopping behavior
Time frame: Retrospective review over 18 month period starting with first dispensing in 2012
Sensitivity and predictive value of different levels of shopping behavior in relation with Algorithmically Identified Abuse and Addiction (AIAA)
Time frame: Retrospective review over 18 month period starting with first dispensing in 2012
No study locations are listed for this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Member Companies of the Opioid PMR Consortium