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

NCT02920762 | Unknown

• 1 other identifier: Assessment 7
• Study Type: observational
• Target: 5,575,834
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (10)

• Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients

  Monthly over 54 months

• Monthly volume of opioid non-tolerant patients prescribed products indicated for use only in opioid-tolerant patients

  Monthly over 54 months

• Monthly volume of high-starting dose prescriptions in opioid-tolerant patients

  Monthly over 54 months

• Monthly volume of high starting dose prescriptions in non-opioid tolerant patients

  Monthly over 54 months

• Proportion of opioid non-tolerant patients that have high-starting dose prescriptions

  Monthly over 54 months

• Volume of early refills by monthly patient cohort

  Monthly over 54 months

• Volume of normal refills (non-early refills) by monthly patient cohort

  Monthly over 54 months

• Proportion of patients receiving early refills

  Monthly over 54 months

• Early refill rate by monthly patient cohort

  Monthly over 54 months

• Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly

  Monthly over 54 months

Study Arms (8)

Buprenorphine

Other: on-interventional study - retrospective database review

Fentanyl

Other: on-interventional study - retrospective database review

Hydromorphone HCl

Other: on-interventional study - retrospective database review

Morphine Sulfate

Other: on-interventional study - retrospective database review

Morphine Sulfate Beads

Other: on-interventional study - retrospective database review

Oxycodone HCl

Other: on-interventional study - retrospective database review

Oxymorphone HCl

Other: on-interventional study - retrospective database review

Tapentadol

Other: on-interventional study - retrospective database review

Interventions

on-interventional study - retrospective database review OTHER

Buprenorphine; Fentanyl; Hydromorphone HCl; Morphine Sulfate; Morphine Sulfate Beads; Oxycodone HCl; Oxymorphone HCl; Tapentadol

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects filling a prescription for a product of interest indicated for opioid-tolerant patients, filling prescriptions early and determining concomitant use of products as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™

You may qualify if:

• Subjects filling a prescription for a product of interest during the specified time period will be included.

You may not qualify if:

• None

Sponsors & Collaborators

• ER/LA Opioid REMS Program Companies (RPC): lead

MeSH Terms

Conditions

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 30, 2016
• Primary Completion: July 1, 2019
• Last Updated: September 30, 2016

Record last verified: 2016-09