Voluntary ER/LA Opioids REMS Education to Be Available in San Diego, Online

September 11, 2013 05:47 pm Matt Brown

Participants at the 2012 AAFP Scientific Assembly attend a CME session.

The AAFP will offer voluntary CME for members on extended-release/long-acting (ER/LA) opioid analgesics during the upcoming 2013 Scientific Assembly in San Diego.

Focused on the criteria set out in the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics(www.fda.gov), which is associated with the agency's risk evaluation and mitigation strategy (REMS) covering ER/LA opioids, the two-part session will be presented on Sept. 27 at 8:15 and 9:30 a.m. and again on Sept. 28 at 9:30 and 10:45 a.m.

According to Kathy Marian, M.Ed., AAFP senior manager of CME educational design and technology, the live REMS-specific CME sessions will feature two hours of faculty-led presentations and include an AAFP CME Bulletin. Physicians also are required to take the post-assessment test to officially complete this voluntary CME program. All components of the program must be completed to fully satisfy the educational criteria outlined in the FDA blueprint associated with the agency's ER/LA REMS.

Story Highlights
  • The AAFP is offering voluntary CME on extended-release/long-acting (ER/LA) opioid analgesics at the upcoming 2013 Scientific Assembly in San Diego.
  • The live CME sessions will feature two hours of faculty-led presentations along with an AAFP CME Bulletin, all of which must be completed to fully satisfy the educational criteria outlined in the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics.
  • The AAFP will offer other live and online course options to address this voluntary educational component of the ER/LA opioids REMS in October and beyond.

The goal of the ER/LA REMS, Marian said, is to reduce the number of serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse of these drugs, while also maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose and death.

"This voluntary education is designed to help mitigate the national crisis on ER/LA opioid drugs," Marian told AAFP News Now.

Goals and Process

According to Marian, the FDA has established clear benchmarks for the ER/LA Opioid Analgesics REMS Program Companies (RPC), the group of 17 ER/LA opioid manufacturers responsible for providing grant support for this education.

Specifically, the FDA goal is that within two years from the time the first REMS-compliant training becomes available, 80,000 prescribers (based on 25 percent of the 320,000 active prescribers in 2011) will have been trained. At the three- and four-year marks, respectively, the FDA anticipates 160,000 (50 percent of 2011 active prescribers) and 192,000 prescribers (60 percent) will have completed the voluntary training.

Should the voluntary approach fail, Marian said, there's a possibility that the DEA could institute a specific statutory requirement for physicians to complete CME to prescribe these drugs.

The AAFP worked as an "In Cooperation With Organization" with the Collaborative for REMS Education(www.core-rems.org) (CO*RE), which spearheaded development of this CME activity through grant funding. CO*RE, in turn, received its grant support for the entire program from the RPC.

Free Chronic Pain Webinar Available

The free AAFP webinar "Chronic Pain: Management and Safe Treatment" is now available online.

According to Kathy Marian, M.Ed., AAFP senior manager of CME educational design and technology, this CME chronic pain course -- funded by an educational grant to the AAFP from Purdue Pharma L.P. -- focuses on educating family physicians about chronic, nonmalignant pain and encourages them to talk with patients about past or present risk factors.

Using outcomes data gleaned from the "Mission: Pain Management -- The Efficient First Visit" session held during the 2012 AAFP Scientific Assembly in Philadelphia, Marian said the webinar addressed gaps identified in the outcome measures and barriers identified by members who attended the session.

A patient brochure addressing several topics, including the elements of pain, how opioids work, the safe use of opioids and how to recognize signs of opioid overdose, also is offered.

"CO*RE is a collaboration that includes 11 partners and three in-cooperation-with organizations that have created a curriculum that meets the needs of all targeted learners," Marian explained. "The Academy's CME educational design staff included an AAFP physician-member expert to further coordinate our efforts, providing suggestions regarding the CME content to support and improve the education delivered to members. The Academy is actively engaged in the planning and continuous improvement of the curriculum."

Other Opportunities

Marian said the live ER/LA REMS course also will be offered on the following days during these national courses:

  • Oct. 3 and 4 during the Emergency and Urgent Care live course at the Westin Hilton Head Island Resort and Spa in Hilton Head, S.C.;
  • March 6 and 7, 2014, during the Women's Health CME live course at the Caribe Royale All Suite Hotel and Convention Center in Orlando; and
  • April 9-12, 2014 (exact dates TBD), during the Emergency and Urgent Care live course at the Westin Chicago North Shore in Wheeling, Ill.

In addition, an online version of the course is scheduled for release soon, according to Marian. The AAFP plans to include supplemental tools in the online CME activity to further reinforce the learning experience.

"The interactive online format will be released at the end of October," she said. "Learners can participate in that online CME at their own pace, and once they've completed the program and post-assessment, they'll have met the objectives outlined in the FDA REMS blueprint. Physicians will also be able to share this education with members of their team."

Related ANN Coverage
FDA Proposes Label Changes, Other Controls on ER/LA Opioids
Agency's Actions Serve as Reminder to Prescribe Judiciously, Says FP Expert
(9/11/2013)

AAFP, NIDA Offer Non-CME Educational Program on Addiction

(6/11/2013)


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