The Accreditation Council for Continuing Medical Education (ACCME®) recently applauded the federal government’s 2011 Prescription Drug Abuse Prevention Plan and the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid medications, announced last week.
The new REMS plan focuses primarily on educating doctors about proper pain management, patient selection, and other requirements and improving patient awareness about how to use these drugs safely. As part of the plan, FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.
FDA wants drug makers to work together to develop a single system for implementing the REMS strategies. Toward that goal, FDA is now notifying opioid makers that they must propose a REMS plan within 120 days.
The collaborative, multiagency Prescription Drug Abuse Prevention Plan, released by the White House Office of National Drug Control Policy on April 19, includes four major action areas. The first action area is education, including continuing education for health care professionals. The plan states: “Educating prescribers on substance abuse is critically important, because even brief interventions by primary care providers have proven effective in reducing or eliminating substance abuse in people who abuse drugs but are not yet addicted to them.”
In its notification to manufacturers, FDA said it “expects that the training will be conducted by accredited, independent continuing medical education providers, to the extent practicable.”
ACCME Chief Executive Murray Kopelow, MD, asserted that the ACCME is “honored that the government views accredited CME as a strategic asset to public health and safety initiatives.” In a press release from ACCME, Dr. Kopelow recognized that, “the overuse, underuse, and misuse of opioid analgesics are a major public health issue.” Accordingly, he asserted ACCME’s belief that “accredited CME can have a demonstrable impact on improving physician expertise and patient safety in this area.”
As a result, he noted that ACCME “will continue to work with FDA, drug manufacturers, and accredited providers, to ensure that accredited CME about REMS meets the ACCME’s standards for independence and FDA expectations.”
Consequently, Dr. Kopelow emphasized that as this initiative moves forward, ACCME will be guided by their first priority — to promote public health and safety.” In addition, he noted that as the “REMS plan evolves, the ACCME will develop guidance for the CME provider community to assist with their understanding and application of the process.
FDA information about the opioid REMS, including links to the FDA letter to manufacturers and frequently asked questions, is available here.
A replay of the April 20 FDA teleconference briefing is available by dialing (866) 463-4969. An archived video of the April 19 news briefing about the action plan is available here.
ACCME Interactions with Government
Through its interactions with government, the ACCME aims to fulfill its responsibilities of transparency and accountability, inform public officials about the value of accredited CME, and support national health care quality and safety initiatives.
As we noted back in July 2010, Dr. Kopelow made a presentation to an Advisory Committee of the Food and Drug Administration’s Center for Drug Evaluation and Research during a meeting on REMS for extended-release and long-acting opioid analgesics. The ACCME was one of two organizations invited to present about continuing education; the Accreditation Council for Pharmacy Education also made a presentation.
Dr. Kopelow served as special advisor to the ONDCP from June through December 2009. He was one of several experts appointed by the ONDCP to help the office formulate long-term drug control policies that improve public health and safety. Dr. Kopelow’s role was to encourage medical organizations, physicians and health care teams to integrate Screening and Brief Intervention (SBI) into health care practice. The ACCME has a long-standing, ongoing collaboration with the ONDCP.