The FDA has provided the following description of the REMS Long-Term Evaluations in its ER/LA Opioid Analgesics REMS Supporting Document:
“A subset of CE providers capable of conducting evaluations of long-term performance outcomes of prescribers who completed their REMS-compliant CE courses, or organizations that specialize in CE outcomes will be engaged to conduct such long-term assessments. CE providers or organizations that specialize in CE outcomes will be selected to conduct assessments of prescribers’ knowledge retention and practice change 6 months to 1 year after the CE courses have been completed. The long-term performance outcomes assessments of prescribers will be in addition to the post-tests conducted by CE providers immediately after all REMS-compliant CE courses. Where possible under the Standards of Commercial Support, the survey questionnaire used for the CE providers’ long-term performance outcomes assessments of prescribers who completed REMS-compliant CE courses will be similar to the survey questionnaire used in the REMS surveys of prescribers.
Survey results will be analyzed to understand what the gaps in understanding are and in which prescribers (e.g., those who have taken the training vs. not; specialists vs. primary care providers; high or low prescribers; by geographic region; by age; etc.).”