Study to Eval Relation Btw Doctor/Pharmacy Shopping & Outcomes of Misuse, Diversion, Abuse, Addiction by Med Rec Review

NCT ID: NCT02667210

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 590 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-06
• Study Completion Date: 2017-06-21

Brief Summary

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.

Detailed Description

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.

Conditions

Opioid-Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

No shopping behavior

Medical Record Review

Intervention Type: OTHER

Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction

Minimal shopping behavior

Medical Record Review

Intervention Type: OTHER

Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction

Marked shopping behavior

Medical Record Review

Intervention Type: OTHER

Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction

Extensive shopping behavior

Medical Record Review

Intervention Type: OTHER

Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction

Interventions

Medical Record Review

Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients 18 years or older on the date of first IR or ER/LA opioid dispensing in 2012

2. Patients with at least two dispensings of any IR or ER/LA opioid. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first.

3. Continuous, fully insured enrollment with medical and pharmacy eligibility in a health plan included in the HealthCore Integrated Research Database (HIRD) for at least six months prior to the start of the follow-up period.

4. Patients with continuous enrollment during the follow-up period of 18 months

Exclusion Criteria

1. Patients who cannot be classified into one of the four a priori defined doctor/pharmacy shopping categories

2. Patients for whom no medical records can be accessed

3. Patients with a known history of abuse identified through the administrative claims data will be excluded because HealthCore is not permitted to request their medical records.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthCore, Inc.

INDUSTRY

Sponsor Role: collaborator

Member Companies of the Opioid PMR Consortium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soledad Cepeda, MD, PhD

Role: STUDY_CHAIR

Janssen Research & Development, LLC

Other Identifiers

Study 3033-10

Identifier Type: OTHER

Identifier Source: secondary_id

Observational Study 3033-10

Identifier Type: -

Identifier Source: org_study_id