CME for REMS an education sea change

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At a July FDA advisory hearing on ways to increase the safety of extended-release and long-acting opioid drugs, the agency opened the door to using continuing medical education (CME) to help reach the goal.

Dr. Bob Rappaport, director of FDA's division of anesthetic and analgesic products, while reviewing elements of a REMS (risk evaluation and mitigation strategy) for this category, said the FDA would be responsible for approving the content of prescriber training developed by sponsors.

That comment marked “a real milestone,” said Dr. Murray Kopelow, chief executive of the Accreditation Council for CME. “If control of the content remains in the hands of organizations outside of industry, then it's independent and accredited CME can deliver it.”

It means that professional practice gaps, hypothetically, can be reflected by a commercial supporter in an RFP. Then the education could be created specific to a single product. Kopelow stressed, though, that the initiative has to come from the FDA and the content has to be controlled or approved by the FDA.

The FDA advisory committee rejected the agency's proposed REMS.

Once a class-wide REMS is finalized, it could create more opportunity for those CME providers that understand the rules and regulations, and could also come as welcome news to companies that market long-acting and extended-release opioids.

“We're all looking for ways to effectively educate our prescribers and patients and to make sense of our products,” said Dr. Eric Carter, chief science office for King Pharmaceuticals, marketer of Embeda and Avinza, two forms of extended-release morphine.

According to a government report, substance abuse treatment admissions aged 12 or older involving pain reliever abuse more than quadrupled between 1998 and 2008.
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