To make sure it's having its intended reach, Hamburg said there will be regular audits of the programs to assess whether enough clinicians are completing the courses. According to the FDA, there are about 320,000 prescribers of long-acting opioid analgesics in the U.S., and the agency expects 25% of them to be trained at the end of the program's first year. The goal is to have 60% of prescribers trained by year three.
The FDA also will audit how well the participants understood the educational material, and these assessments will also check on whether the REMS is impacting patient access to necessary pain meds.
Kerlikowske said the REMS is part of a national strategy to curb the prescription painkiller epidemic, which was responsible for about 15,600 deaths in 2009, the latest year for which there are data.
About 23 million prescriptions for extended-release and long-acting opioids were written in 2011, FDA said.