The Food and Drug Administration (FDA) is hosting a two-day long Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The FDA is seeking comments from the committees as to whether this REMS with Elements to Assure State Use (ETASU): actually assures safe use, does not unduly burden patient access to drugs, and somewhat minimizes the overall burden to the healthcare delivery system.
The day started out with introductory remarks from Janet Woodcock, MD, the Director of the Center for Drug Evaluation and Research (CDER) at the FDA where she outlined the goals of the REMS program and the importance of educating prescribers on safe opioid use.
Next, there were presentations focused on the ER/LA REMS background, history, authority, and a general overview, presented by Terry Toigo, MBA, RPh, and Cynthia LaCivita, PharmD, both of the CDER. Dr. LaCivita noted that there is no national registry tracking which providers have completed the REMS training and which ones have not. Having such a registry where prescribing patterns of all completers could be compared with those of physicians who do not complete the training may offer a clearer picture of the program’s total impact.
Wilson Compton, MD, MPE, the Deputy Director of the National Institute on Drug Abuse at the National Institutes of Health, presented on state and federal efforts. Heroin and prescription painkiller abuse tends to be more common in particular areas, such as the Southwest, the Northeast, and rural areas. Additionally, there is a bit of overlap between people who are on Medicaid and those who abuse opioids. As such, Medicaid and individual state budgets tends to shoulder the burden of treating those patients when they are sick. However, as more people become eligible for Medicaid through the federal health law, that burden will likely grow. As such, it will be important in the future for states to create individual plans for combating this epidemic, but also fit their plans in with a larger, federal plan, for all providers.
The morning concluded with presentations by representatives of various REMS Programs Companies (RPC), including Pernix Therapeutics, Albany Medical Center, and Purdue Pharma. Paul Coplan, ScD, delivered program statistics through February 29, 2016, stating a total of 839 CE courses were conducted in the three years of the program, involving a total of 438,461 participants. Of those participants, 66,219 of them who completed the courses were ER/LA prescribers, the target group.
The provider knowledge survey, which assessed whether the education was actually getting through to physicians and prescribers, found that 83% of prescribers understood the material well, as did 86% of their patients.
Discussion ensued as to whether the rate of success is translating into improved outcomes. The discussion seemed as though it was positive for CE and REMS, and that some industry leaders recognize that working with CE providers to help educate providers is beneficial to patients and the healthcare system overall.
The meeting continues Wednesday, May 4, 2016, with discussions that are expected to elicit recommendations from the panel members.