Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction

2016-01-31 17:27:31 | BioPortfolio


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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Opioid-Related Disorders


DB review for Doctor/Pharmacy Shopping Behavior


Active, not recruiting


Member Companies of the Opioid PMR Consortium

Results (where available)

View Results


Published on BioPortfolio: 2016-01-31T17:27:31-0500

Clinical Trials [1850 Associated Clinical Trials listed on BioPortfolio]

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

A Survey to Eval the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion

To evaluate the reasons patients go to more than one prescriber or more than one pharmacy to obtain prescriptions opioids and assess whether the percentage of patients reporting misuse, ab...

Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers

A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids

Monitoring prEscriptiondruG Abuse Using DOctor Shopping bEhavior

Prescription drug abuse is a major challenge in public health, in particular in countries such as France, one of the main consumers of medication in Europe. A single source of information ...

Incidence and Predictors of Opioid Overdose and Death in ER/LA Opioid Users as Measured by Diagnoses and Death Records

Retrospective study to assess incidence and predictors of opioid abuse, addiction, overdose & death among patients prescribed ER/LA opioid products

PubMed Articles [29150 Associated PubMed Articles listed on BioPortfolio]

The effect of state laws designed to prevent nonmedical prescription opioid use on overdose deaths and treatment.

Nonmedical use of prescription opioids has reached epidemic levels in the United States and globally. In response, federal, state, and local governments are taking actions to address substantial incre...

Using Eye Tracking to Explore Consumers' Visual Behavior According to Their Shopping Motivation in Mobile Environments.

Despite a strong shift to mobile shopping trends, many in-depth questions about mobile shoppers' visual behaviors in mobile shopping environments remain unaddressed. This study aims to answer two chal...

Utilization of buprenorphine and methadone among opioid users who inject drugs.

There has been a rise in opioid abuse and related injection drug use in the United States and treatment for opioid use disorders may be underutilized. The study aim was to describe utilization of opio...

Racial and ethnic differences in opioid agonist treatment for opioid use disorder in a U.S. national sample.

Opioid Agonist Treatment (OAT) is the standard of care for the treatment of opioid use disorders. However, most people in treatment do not receive OAT. This study evaluated whether there are racial an...

Access to treatment for opioid use disorders: Medical student preparation.

The current opioid epidemic requires new approaches to increasing access to treatment for patients with opioid use disorders and to improve availability of medication assisted treatment. We propose a ...

Medical and Biotech [MESH] Definitions

Educational programs for pharmacists who have a bachelor's degree or a Doctor of Pharmacy degree entering a specific field of pharmacy. They may lead to an advanced degree.

Disorders related or resulting from abuse or mis-use of opioids.

These disorders are related to both SCHIZOPHRENIA SPECTRUM AND RELATED DISORDERS and DEPRESSIVE DISORDERS in terms of symptomatology, family history, and genetics. (DSM-V) .

Individuals enrolled in a school of pharmacy or a formal educational program leading to a degree in pharmacy.

Boxes in which physicians kept their drugs and other medications, medical instruments and supplies, manuals, etc. As a carrying case or convenient storage receptacle, or a kind of portable pharmacy, the medicine chest was indispensable to the itinerant physician. The chest was usually larger and sturdier than a doctor's kit or bag.

More From BioPortfolio on "Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction"

Quick Search

Searches Linking to this Trial