ACCME to Participate in FDA’s Public Advisory Committee Meeting on REMS

May 2, 2016
Posted by: 
Tamar Hosansky

The ACCME is honored to be participating in the FDA public advisory committee meeting on the Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS, scheduled for May 3–4. In the comments submitted for the meeting, Graham McMahon, MD, MMSc, President and CEO, ACCME, writes: “We appreciate the FDA’s recognition of the value of accredited continuing education (CE) in carrying out this critical public health initiative. We believe that accredited CE has made — and can continue to make — significant contributions to addressing the patient safety issues identified in the ER/LA Opioid Analgesics REMS. We value our engagement with the FDA and look forward to continuing to work together to make a difference to patients, families, and communities across the country.”

Dr. McMahon presents data from March 2013 through April 2016, showing that that 96 CME providers, accredited within the ACCME system, reported 647 ER/LA Opioid Analgesics REMS-compliant activities, educating close to 168,000 healthcare professionals.

He says that the ACCME fully supports the ongoing use of accredited CE as a delivery mechanism for prescriber training for the ER/LA Opioid Analgesics REMS. “By applying the lessons learned and incorporating a continuous improvement process, we are confident that accredited CE can continue to make an important contribution to reducing opioid misuse and promoting safe prescribing practice,” Dr. McMahon writes.

In addition, the ACCME believes that accredited CE can play a significant role in addressing the patient safety issues identified in REMS. “We fully support using accredited CE as a delivery mechanism for prescriber education for other REMS, including pre-and post-approval REMS, and single product REMS, provided the proper controls are in place to ensure independence from commercial influence. The collaboration between the FDA and the accredited CE community in support of the ER/LA Opioid Analgesics REMS has laid the groundwork for our continued work together in support of patient safety,” Dr. McMahon writes.

Read the ACCME’s comments.

Read all the comments on the FDA website.

Read more about CME in Support of REMS.