Two Food and Drug Administration advisory committees have unanimously agreed that the current risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid analgesic medications requires modification in order to better serve its purpose of addressing the ongoing epidemic of opioid abuse and addiction.
The 30 members of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee who voted during a joint meeting held May 3-4, 2016, generally agreed – based on the presentation of study data and information from various stakeholders – that the current REMS for extended-release and long-acting (ER/LA) opioid analgesics should be broadened to include immediate-release formulations, that participation in education programs should be mandatory for prescribing team members rather than voluntary for the prescribing physician as is the case currently, that the burden of educational programs should be reduced where possible (such as through a test-out option), and that the focus of the REMS should be on treating pain rather than on prescribing opioids.
Committee members also stressed the need for underscoring the urgency of the matter throughout the process of modifying the REMS. The current REMS was approved in 2012 “to address the serious adverse outcomes of overdose, addiction, and death that result from long-standing problems of inappropriate prescribing, misuse, and abuse of these products,” and the central component of the 2012 REMS is the availability of educational programs for prescribers, according to an FDA briefing document.
The members were specifically tasked with addressing a number of questions, such as whether the current REMS assures safe use of ER/LA opioid analgesics without unduly limiting patient access to medications or burdening the health care system, whether the scope of the current FDA blueprint for prescriber education for ER/LA opioid analgesics should be broadened, and whether immediate-release formulations should be included in the REMS, among other questions.
Considerable testimony was presented by physicians, educators, patient advocacy groups, pharmaceutical companies, FDA representatives, and others with respect to their experiences, interests, and findings.
“Overall, what we see is a large number of health professionals have participated in or completed the training, but the targets of risk reduction training have not been met,” Igor Cerny, Pharm.D., of the FDA, said in summarizing the findings from various prescriber and patient surveys and surveillance data.
Factors limiting the success of the training include the fact that it is voluntary, that it takes 2-3 hours, that it lacks a test-out option, and that REMS awareness is suboptimal. In addition, many who start the training do not complete it, he noted.
Temporary voting member of the Anesthetic and Analgesic Drug Products Advisory Committee, Elaine Morrato, Dr.PH., like each of the panelists, explained her reasoning for voting to modify the REMS, saying, “ I recognize the unprecedented scale of the REMS. ... and I agree with many that we should be cautious in introducing unwarranted burden or unintended consequences, but for me, the misuse of prescription opioids remains a public health crisis and we have to act accordingly like a medical emergency.”
Voting to modify and strengthen the REMS sends a very clear message, as the FDA’s actions “do have a cascading effect” said Dr. Morrato of the Colorado School of Public Health, Aurora, concluding, “I’m hopeful that today we might have the political will to actually, like others have said, challenge the process and find a new path forward in concert with other regulatory agencies.”
The FDA will now take the committees’ recommendations under advisement and usually follows such recommendations. All committee members were cleared of potential conflicts of interest related to the topic of the meeting.