FDA Announces Draft Blueprint for Opioid REMS Prescriber Education

On November 7, FDA announced the availability of a draft document entitled Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS (Blueprint). According to the announcement, the draft Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended-release opioids under the required REMS for these products (Opioid REMS).  

FDA is requiring manufacturers to develop prescriber educational materials but it is voluntary for prescribers to complete. Manufacturers will have to report back to FDA on prescriber utilization/completion of the material. The draft Blueprint suggests that the CE should be part of a basic 2-3 hour educational module.

While this particular education material is being developed for prescribers (physicians, physician assistants, and nurse practitioners), there is still reason for pharmacy to be interested as there may be pharmacies who wish to have their pharmacists complete the education material, or there may be pharmacists who voluntarily wish to review/complete the material. In addition, the Blueprint sets the stage for future REMS that may include a pharmacist-specific requirement to complete educational materials through CE. 

Pharmacists are encouraged to participate in FDA’s request for provider input into the document. After comments have been received, FDA will update the document as appropriate and post it on its website for use by CE providers. Comments are due to FDA on December 7, 2011.

November 16, 2011