Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics

• Conditions: Opioid Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse
• Interventions: Other: Non-interventional study - retrospective database review

• Registration Number: NCT02920775
• Lead Sponsor: ER/LA Opioid REMS Program Companies (RPC)

Brief Summary

Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could have greater impact on prescribing (e.g., dentists). Trends and changes in monthly prescription volume and average monthly prescription volume will be evaluated by prescriber specialty.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-28
• Last Update Submitted: 2016-09-28
• Study First Posted: 2016-09-30
• Last Update Posted: 2016-09-30
• Primary Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360000

Inclusion Criteria

• Changes in number of prescriptions for prescriber types with less or more compelling reasons to prescriber ER/LA opioid analgesics

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Emergency Medicine	Non-interventional study - retrospective database review	-
All Other Specialties	Non-interventional study - retrospective database review	-
Nurse Practitioners	Non-interventional study - retrospective database review	-
Hospice and Palliative Medicine	Non-interventional study - retrospective database review	-
PCP	Non-interventional study - retrospective database review	-
Surgery	Non-interventional study - retrospective database review	-
Pain	Non-interventional study - retrospective database review	-
Neurology	Non-interventional study - retrospective database review	-
Rheumatology	Non-interventional study - retrospective database review	-
Dentist	Non-interventional study - retrospective database review	-
Oncology	Non-interventional study - retrospective database review	-
Anesthesiology	Non-interventional study - retrospective database review	-
Pediatrics	Non-interventional study - retrospective database review	-
Physical Medicine & Rehabilitation	Non-interventional study - retrospective database review	-
Physician Assistant	Non-interventional study - retrospective database review	-

Primary Outcome Measures

Name	Time	Method
Monthly volume of prescriptions by specialty	July 2010-December 2014