Opioid-Related Disorders Clinical Trial
Official title:
Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction
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.
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