Opioid Continuing Education Rules Hamper REMS Assessments

04 May 2016

Sponsors do not have access to list of who completed the courses, so they can't tell if those prescribers changed their behavior.

Industry's ability to assess the reach of prescriber education under the REMS for extended-release/long-acting opioids has been handicapped by the need to straddle the line between a regulatory risk management program and continuing education courses.

At a May 3 FDA advisory committee review of the Risk Evaluation and Mitigation Strategy for ER/LA opioids, industry representatives...