Panelists on a joint FDA advisory committee voted unanimously to modify the existing risk evaluation and mitigation strategy (REMS) for extended-release/long-acting (ER/LA) opioids.
Among the key recommendations for change was making the education mandatory, and adding immediate-release opioids to the REMS, panelists said.
"I almost voted to eliminate the REMS, because there's been very little evidence that it altered behavior much at all," said panelist , of Harvard Medical School. "Instead I voted to modify it, because it's a manual on how to prescribe opioids, when it should be a blueprint on how to treat pain."
Two advisory committees -- the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) -- met for 2 days to evaluate the effectiveness of the REMS, which was implemented in 2013.
Many echoed McCann's sentiments that the program should be expanded to focus on overall treatment of pain -- not just the use of opioids -- as physician training in pain medicine has generally been lacking, they said.
"It should focus on pain management broadly, and the role of opiates within this context, rather than being about the use of opiates," said , of Rutgers University's Ernest Mario School of Pharmacy in Piscataway, N.J. "It should focus on evidence-based use of opioids ... and emphasize their risk."
Many agreed that the REMS should emphasize the risks of opioids, which have been pointed out in several recent guidances. Many of these have come out against the use of opioids as first-line drugs in a host of conditions, including back pain and headache, as there is no evidence of their efficacy for long-term use in chronic non-cancer pain.
"We need to teach physicians to use these drugs sparingly," said , of the University of Pennsylvania in Philadelphia.
There was also wide agreement that the education include the recent CDC guidelines on prescribing opioids, which weren't available when the REMS launched in 2013, as it contains the most up-to-date and best available evidence.
Various ideas were floated as to how the REMS curriculum could be made mandatory, whether through a connection to U.S. Drug Enforcement Administration registration or some other form of licensing. And there was debate over how restrictive the program should be -- whether the strictest programs, such as TIRF for certain fentanyl products or iPLEDGE for isotretinoin (Accutane), are appropriate models.
Members also wanted to add immediate-release opioids such as Vicodin (hydrocodone/acetaminophen) to the REMS, given that these account for a large proportion of opioid prescribing in the U.S.
They also didn't want the educational programs to be funded by the opioid drugmakers. Currently, the programs are jointly funded by a coalition of more than 20 opioid drugmakers, including OxyContin (oxycodone) manufacturer Purdue, and others such as Endo Pharmaceuticals and Pfizer.
"The role of industry needs to be separated from education," said , of the University of Utah in Salt Lake City.
Panelists also aired concerns about a lack of tracking to determine whether the programs are actually having an impact on opioid prescribing. Some called for a registry to assess whether practices change following the education. They also noted that a voluntary program enables selection bias, where participants interested in the programs may already be geared toward making changes, while doctors who need the education most never get it.
Other desired changes included shortening the length of the program -- which now stands at 2 hours, longer than many other continuing education programs -- and improving patient education via the medication guide and other means.
Various stakeholders took the podium during an open public hearing. Those representing the chronic pain community mostly agreed that the REMS didn't affect access for patients who truly needed the drugs.
, executive director of the American Academy of Pain Management, agreed that the program should be mandatory, and that it should be expanded to discuss all methods for treating pain.
Representatives of addiction medicine groups called for a greater emphasis on the risks of prescribing opioids as well as inclusion of the CDC opioid prescribing guidelines.
Reading on behalf of , chief medical officer of Phoenix House and executive director of Physicians for Responsible Opioid Prescribing (PROP) -- a driving force in opioid policy reform -- a speaker said the program should be changed to emphasize the risks of prescribing opioids, and that faculty who have financial ties to opioid drugmakers shouldn't be allowed to develop or deliver the educational programs.
"Strengthening the REMS sends a clear message," said panelist , of the University of Colorado in Anschutz. "It's been a challenging process, but now [FDA] can find a new path forward, in concert with other [federal] agencies."