Opioid-Related Disorders Clinical Trial
Official title:
Retrospective Cohort Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Diversion, Abuse and/or Addiction by Medical Record Review
To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories of increasing doctor/pharmacy shopping behavior.
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, diversion, abuse and/or addiction.
Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current
study (#2065-4 sub-study, Study 4C), the association of doctor/pharmacy shopping behavior
with misuse, diversion, abuse and/or addiction will be assessed by reviewing medical charts
in a sample of patients within specific categories of a priori defined doctor/pharmacy
shopping. The four categories of doctor/pharmacy shopping behaviors identified and defined in
Study 4A and will be applied to Study 4C. The medical chart is a rich source of information
about the patient's medical conditions and behaviors suggestive of misuse and abuse. Medical
record review for behaviors suggestive of misuse and abuse in patients with chronic pain
discriminates between patients with and without opioid use disorders. Therefore, Study 4C was
designed to utilize an insurance/health plan database (HealthCore Integrated Research
Database [HIRD]) with access to medical records, to evaluate the association of a priori
defined categories of doctor/pharmacy shopping and behaviors suggestive of misuse, diversion,
abuse and/or addiction.
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