The Food and Drug Administration plans to release new guidance for opioid prescribing, which it intends to use as the basis of new digital training tools for providers aimed at addressing the addiction epidemic.
Commissioner Scott Gottlieb, M.D., said staffers from the FDA will be meeting with the National Academy of Medicine in mid-November to start building a centralized hub of evidence-based guidelines for providers.
It would allow the FDA to use a digital tool to require physicians to undergo training before they could prescribe opioids in large amounts.
Physicians considering a 30-day supply of opioids, for example, would be obligated to undergo safety training for these drugs to do so, he said. Most doctors wouldn’t need to do this and could instead be directed to a more appropriate option—based on the guidelines—such as a recommending a five-day supply of opioids post-surgery.
The FDA considers such a program a “reasonable hurdle” to overprescribing,” Gottlieb said. More broadly, the FDA wants to see more providers using electronic prescribing and prescription drug monitoring programs, Gottlieb said, which can be upgraded to include tools like the planned mandatory education program.
“[E-prescribing] will allow doctors to have better visibility,” he said.
Gottlieb was one of several speakers on ways to harness technology to address the opioid epidemic and better manage diabetes hosted by the news organization Politico. Gottlieb said that although the FDA has this plan in place, there are barriers to expanding the use of such tools.
PDMPs are regulated at the state level and the FDA cannot simply mandate that providers nationwide participate in one. Gottlieb said that the agency is exploring regulations that could encourage greater adoption.
It's not just about the number of prescriptions dispensed, but also the potency. FDA will be more focused on the potency and that's information that could be made available through e-prescribing. @SGottliebFDA #POLITICOHealth https://t.co/YvvwrJTDq6— POLITICO Live (@POLITICOLive) October 18, 2018
Even in states with strong PDMPs, many providers lag behind on the tech capabilities needed to use a mandatory education program like the one the FDA envisions, Gottlieb said. And for those that do, different tools may not be integrated into the electronic health record and may not be interoperable with other providers.
As the system’s tech capabilities improve, FDA can scale up its plans for the education and e-prescribing tools. Meanwhile, having evidence-based guidelines can facilitate other useful changes, Gottlieb said.
The guidelines, for example, could lead to greater adoption and use of blister packs that make it easy to offer patients a short supply of opioids. Physicians often reach for supplies of 30-days by default, so offering unit-based dosing more widely could change that behavior.
“We think if there are more one- or two-day packs on the market, more physicians will default to that,” Gottlieb said.
The guidelines could also allow for clearer labels that can offer more detailed warnings and instructions to patients, he said. It could also provide more explanation about the potency of certain medications and dosages to both prescribers and patients, he said.