Only 35% of physicians are aware of the FDA's class-wide safety plan for extended-release and long-acting opioids, a survey showed, suggesting an awareness challenge as the plan gets under way.
Approved in July, the risk evaluation and mitigation strategy (REMS) has at its core a prescriber education program on risks and safe use. Education is to be funded by a consortium of opioid manufacturers—the REMS program companies (RPC)—through grants to accredited providers, so that it is available at no-to-nominal cost to prescribers.
The REMS doesn't require physicians to take courses, and that was already expected to make it difficult for FDA to achieve its goal of getting at least 60% of the estimated 320,000 prescribers of the drugs to receive training by year three of the program.
The opt-in nature of the training, combined with the awareness problem, could present something of a double whammy for those seeking to implement the program.
Even after physicians were presented with a summary of the REMS, their awareness only rose an additional 5% to 40% overall, found dtw Marketing Research Group, which fielded the survey in August among 103 doctors (50 PCPs, 53 specialists).
Asked for their opinions on the necessity of continuing educational training, some respondents to dtw's survey said “it was an opportunity to become more informed on issues and provide strategies for safer and more effective [opioid] use for their patients,” said David Rittenhouse, dtw manager of analytical services.
The survey firm found a “slightly higher weighting” when asking doctors about their likelihood to participate in the CE, Rittenhouse noted.
The findings follow the August posting of the first of two RFPs for RPC-supported REMS education. An online system to process grants was slated to go live by mid-September, and decisions are set to follow.
As the education program enters the implementation phase, it's being closely watched, not only because it's a partial response to the prescription drug abuse epidemic raging in the country. “This is the first time accredited education has been used as a centerpiece of a REMS, as part of the solution,” said Cynthia Kear, an SVP with the California Academy of Family Physicians. “This is new territory for all stakeholders involved.”
Kear works with a consortium of 10 membership organizations called CO*RE that represents the full continuum of targeted prescribers—MDs, DOs, NPs and PAs—who are being asked to engage in the voluntary education. The collaboration is but one of many entities expected to apply for funding.
Lots of data show the need for improvement in terms of knowledge, competence and performance, she said. Getting learners across the continuum to improve in these areas is another matter.
Acknowledging the awareness levels, Kear said, “The very real challenge is how to take this body of learners, reach them, and make them aware of the REMS.” Asked how CO*RE will do that, she said, “It's a little premature to say and, candidly, that's part of our grant [proposal].”
Rittenhouse said he doesn't see a direct correlation between the lack of awareness and a potential negative impact on the implementation of the CE portion of the REMS program. “When the FDA made it official back in July, they indicated that the first CE offerings will be offered to physicians by March 1, 2013,” he noted. “We're in mid-September now, so that still leaves five to six months for the word to get out to prescribers. It will be interesting to see what happens as we get closer to that date.”