The Food and Drug Administration has released the final form of its Risk Evaluation and Mitigation Strategies, or REMS, for extended-release and long-acting opioids. The 20 companies that manufacture these drugs, whose misuse and abuse of ER/LA opioids has become so widespread that related overdoses, addiction, and deaths now constitute a public health crisis, are now required to educate prescribers on their appropriate use.
The final “Blueprint for Prescriber Continuing Education Program,” which continuing medical education providers will use to develop educational materials for the manufacturers’ training related to these pain medications for physicians, nurse practitioners, and physician assistants. The blueprint was developed in collaboration with stakeholders, including the CME community, pharma, patients, and the FDA.includes the
Making the announcement during a press briefing, FDA Commissioner Margaret Hamburg said, “The FDA’s goal is to ensure that healthcare professionals have the education they need to prescribe ER/LA opioids and that patients know how to safely use these drugs.” The FDA expects that the first REMS educational activities will launch in March 2013. The agency also plans to audit the programs to ensure that they are reaching enough clinicians to improve the situation with these drugs. While the training isn’t required, the goal is to train 25 percent of the 320,000 current ER/LA opioid prescribers by the end of the first year, half by year two, and 60 percent within three years.
In 2007, the FDA acquired the ability to compel drug manufacturers to develop a REMS to make sure a product’s benefits outweigh its risks. Because the ER/LA opioids REMS includes an educational component, some in the CME community consider this REMS to be a door-opener to more opportunity as companies provide educational grants to accredited CME providers to develop REMS-related activities that will be offered free or for a nominal expense to prescribers.
The FDA expects the training to last two to three hours, but it is leaving it up to the CME providers to determine how many credits trainees can earn. Trainees will learn the risks and benefits of ER/LA opioids, how to ensure they prescribe the drugs only to the most appropriate patients, how to ensure patients understand how to use the drugs safely, and how to monitor patients to ensure use doesn’t become misuse or abuse. CME providers also may survey the prescriber trainees to ensure they are retaining and using the information, and that patients who need the drugs still are getting them.
CME providers who work with REMS do not have to worry that they will be out of compliance with the Accreditation Council for CME’s Standards for Commercial Support, which says that commercial supporters cannot control the content of the activity. The meeting earlier in 2012 that “The accreditors have looked at all the elements, and we haven’t found anything you shouldn’t be part of.”’s chief executive, Murray Kopelow, said at a
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REMS and ACCME Standards