Nearly 100 million people in the United States, or roughly one-third of the population, experience some form of chronic pain. Meanwhile, prescription opiate abuse and addiction have reached epidemic proportions in the United States, including the widespread illegal diversion of prescription opioids for street use, which in turn can increase the rates of abuse of illegal narcotics. Some clinicians have also prescribed opioids without adequate training surrounding their abuse potential. Many primary-care providers have recently become reluctant to prescribe opioid pain relievers in the context of current public health concerns surrounding addiction, which leads to some chronic pain patients now going without any appropriate treatment.
On May 3 and 4, 2017, the Food and Drug Administration (FDA) convened a public workshop (agenda) examining “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics.” Andy Rosenberg presented testimony on behalf of the CME Coalition, in which he spoke to the role of CME in opioid prescriber education. Among the key points made in Andy’s remarks, "FDA should continue to rely on accredited CME as a vital tool in prescriber education in the opioid space. The strength of CME is that it can produce myriad educational activities that are targeted to physicians based on their professional practice gaps, individualized needs, and stages of learning and change. Added flexibility will allow prescriber education to better address individual prescribers’ educational and practice needs... Finally, as an incentive for prescribers to participate in opioid REMS, we recommend that the FDA encourage CMS to include opioid REMS as an improvement activity in the Quality Payment Program MIPS.”
On May 3-4, 2016, the Food and Drug Administration (FDA) hosted 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 CME Coalition submitted public comments following the meeting, emphasizing that FDA should consider standardizing the REMS process, while allowing more flexibility in content. The Coalition also suggested that REMS should be expanded to include short acting opioids.
On May 3-4, 2016, the Food and Drug Administration (FDA) hosted 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 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.
In a letter to the Food and Drug Administration (FDA), the CME Coalition applauds the agency’s recognition—as noted in its September 2014 report—that continuing medical education (CME) plays an essential role in improving knowledge of drug-related risks. The Coalition highlights their support for the FDA’s intention to evaluate the feasibility of drug-specific REMS CME training. As detailed in the letter, “preliminary research suggests that REMS-related CME can reach substantial numbers of providers who do not otherwise choose to engage with standard REMS communication, such as a Dear Healthcare Provider letter… As noted in the FDA’s September 2014 report, REMS CME activities could be developed both for approved drugs as well as for pending drugs prior to FDA approval, with the REMS CME published or presented upon drug launch.” The Coalition goes on to suggest that plans to develop CME should include provision of resources to measure and evaluate the effect of the activities, and expresses a willingness to work with the FDA regarding priorities for REMS education, resolution of priorities and barriers, and best practices for adult learning in the CME environment as it relates to REMS.