FDA Letter Encourages Prescribers of ER/LA Opioids to Pursue Training

March 05, 2013 02:25 pm Matt Brown

Coinciding with the arrival of the FDA's March 1 deadline for the release of the first manufacturer-funded CME activities on prescribing extended-release/long-acting (ER/LA) opioid analgesics, the agency has sent an open letter(www.fda.gov) to prescribers of these drugs, encouraging them to seek out and take advantage of the available training options.

"FDA remains committed to making sure that patients in need have continued access to appropriate pain medications, while also ensuring that all opioid products are used as safely and effectively as possible under the supervision of prescribers armed with sound information and training," says the letter. "Prescribers are critical to successfully curtailing this national problem."

Delivery of CME funded by the manufacturers of ER/LA opioid analgesics is a major part of the risk evaluation and mitigation strategy (REMS) for these drugs that the FDA approved in July 2012. The process has required the development of an appropriate grant-making process and standardized reporting fields for CME/CE accreditors of education about ER/LA opioid analgesics. Collaboration between multiple stakeholders is essential to ensure the CME aligns with the guidelines of multiple credit systems and the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support to ensure reporting is consistent.

story highlights

  • A March 1 letter from the FDA encourages prescribers of extended-release and long-acting (ER/LA) opioids to seek out and take advantage of opioid-specific training funded by ER/LA opioid manufacturers.
  • The training is part of an FDA risk evaluation and mitigation strategy for ER/LA opioids that aims to combat misuse and abuse of these medications.
  • The AAFP expects to have appropriate CME products available this summer.

As a national CME accreditor, the AAFP has been actively involved in conversations with the FDA, the REMS program committee, other credit systems and CME provider organizations for the past three years. The development and design of certification standards for REMS CME for ER/LA opioids began last year and has not yet been finalized.

As an ACCME-accredited CME provider, the AAFP was notified in mid-February that it would receive grant funding to support CME that addresses the educational goals identified in an FDA CME/CE blueprint, says Kathy Marian, M.Ed., AAFP manager of CME standards and outcomes. That blueprint, developed with input from stakeholders, including the AAFP, lays out the core messages to be covered in educational offerings for prescribers of ER/LA opioids.

"The Academy is currently working to develop live, online and self-study CME activities that align with the educational goals set forth by the FDA blueprint(www.fda.gov) and will ensure the CME developed is in compliance with relevant CME accreditation guidelines to ensure validity and independence," says Marian. "Because the grant funding came well behind the timeline, the AAFP expects to make its live and online CME activities available this summer."

Marian says it also is important to point out that although the FDA requires ER/LA opioid analgesic manufacturers to make this CME available for prescribers, the agency cannot mandate that physicians complete the CME.

"The goal is that voluntary participation in this CME will help to address the growing problem of prescription drug abuse and misuse," says Marian. "The REMS introduces new safety measures to reduce risks and improve safe use of ER/LA opioids while continuing to provide access to these medications for patients in pain.

"The FDA metric for success is that 60 percent of the 320,000 prescribers of these drugs in 2011 will have participated in REMS CME for ER/LA opioids during the next three years."

Marian says that if a voluntary approach to reach prescribers fails, the DEA, which has the power to regulate physicians, could mandate a specific statutory requirement for physicians to complete CME to prescribe these drugs. Individual states, on the other hand, may require the completion of certain types of CME as a condition of licensure.

In addition to the CME offerings cited above, the AAFP webinar "Chronic Pain and Safe Use of Opioids" is in the works and is expected to come online in late summer, according to Marian.

The chronic pain course will focus on educating family physicians about chronic, nonmalignant pain and encouraging them to talk with patients about past or present risk factors. The curriculum will use outcomes data gleaned from the "Mission: Pain Management -- The Efficient First Visit" session held during the 2012 AAFP Scientific Assembly in Philadelphia.

Marian says the Academy plans to address gaps identified in the outcome measures and barriers identified by members who attended the October session. A patient brochure also will be offered that will address several topics, including the elements of pain, how opioids work, the safe use of opioids and how to recognize signs of opioid overdose.