It's nearly impossible to tell whether the risk evaluation and mitigation strategy (REMS) for extended-release/long-acting opioids (ER/LA) has had an impact on falling rates of abuse, overdose, and death from prescription painkillers, presenters said here.
Both company representatives and FDA officials agreed, during the first day of a 2-day advisory committee meeting, that it's difficult to discern the program's effect on these trends.
The FDA's Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) were convened to evaluate the effectiveness of the REMS, which was implemented in 2013.
"Is REMS making any progress? That's a difficult question to answer," said , of the epidemiology division of the Center for Drug Evaluation and Research (CDER) at FDA. "Evaluating the effectiveness of an intervention using only observational data is inherently challenging."
Although Wednesday's discussion will bring recommendations from the panel members, Tuesday's agenda involved presentations from the REMS Program Companies (RPC), FDA staff reviewers, and the continuing education (CE) companies that produce the educational programs.
, director of medical affairs at Purdue Pharma who led the discussion for the REMS Program Companies, delivered program stats through Feb. 29, 2016.
In total, a "Dear Reader" letter went out to 3 million prescribers for whom the education would be relevant, and surveys revealed that about a third actually read it, he said.
A total of 839 CE courses were conducted in the 3 years since the program started. They involved a total of 438,461 participants, of whom 157,493 ended up completing the courses -- and 66,219 of them were ER/LA prescribers, the target group for the program.
, the REMS assessment analyst for FDA, said that latter figure accounted for only 41% of the 160,000 ER/LA prescribers targeted for education by the third year of the program.
The provider knowledge survey, which assessed whether the education was getting through, found that 83% of prescribers understood the material well, as did 86% of their patients.
But whether that is translating into improved outcomes is more difficult to decipher, participants agreed.
REMS Program Companies presented data from observational studies that showed rates of abuse, overdose, and death have been on the decline.
, director of the Rocky Mountain Poison and Drug Center in Denver, said RADARS data -- a surveillance system he operates with funding from the drug industry -- show these rates declining, but noted there's no way to determine whether REMS is the main reason for the decline.
And , of Albany Medical College in New York, reported new results from the PriMed study, which relied on data from Amazing Charts -- a company that captures deidentified electronic health record (EHR) data -- totaling 441 healthcare providers who had the REMS training and 4,669 providers who were not trained.
It found those who had REMS training had a 10% drop in ER/LA prescribing compared with a 4% increase in the untrained population, Argoff said.
McAninch, who delivered the FDA's epidemiological review, echoed that reductions in abuse, overdose, and death began before the REMS came out, as several policy changes -- including the White House's strategy against prescription opioid abuse -- to fix the nation's painkiller crisis had also been implemented.
She noted that there were also declines in the prescribing of immediate-release opioids and benzodiazepines, which are two drug classes not covered by the ER/LA REMS.
Cerny noted some improvements for future monitoring, including improving the "Dear prescriber" letter and better aligning the competing CE courses, particularly those given at the state versus federal level.
, of the FDA's office of surveillance and epidemiology, noted that there is no national registry tracking which providers have completed the REMS training. Having a complete registry in which the prescribing patterns of all completers could be compared with those of non-completers would offer a clearer picture of the program's impact, she said.