Opioid abuse has been in the news for the past few months, and it seems as though it will continue to be in the news for awhile. Late last week, on April 14, 2016, three high-level officials at the Food and Drug Administration (FDA) – Robert M. Califf, M.D.; Janet Woodcock, M.D.; and Stephen Ostroff, M.D. – published an article in the New England Journal of Medicine on what they deem to be a “Proactive Response to Prescription Opioid Abuse.” Their proactive response includes a multi-faceted approach, touching upon many different aspects of healthcare, including continuing medical education (CME).
In the article, the three FDA leaders opined that efforts to assist in the crisis of opioid misuse must be “founded on two complementary principles: that the United States must deal aggressively with opioid misuse and addiction, and at the same time, that it must protect the well-being of people experiencing the devastating effects of acute or chronic pain.” The FDA is, therefore, launching a broad national campaign.
Balancing Risk
Part of that campaign will be working in tandem with the National Academy of Medicine (NAM) to develop a regulatory framework for opioid review, approval, and monitoring, that balances the individual need for control over ones own pain with considerations of broad public health consequences of abuse and misuse. The FDA’s Science Board will consider a series of relevant issues at their next meeting, aimed at advising the FDA on the role of pharmaceuticals in pain management, development of alternative pain medications, and postmarketing surveillance activities.
Revisiting Opioid Labeling and Postmarketing Study Requirements
Through the new campaign, the FDA will also reexamine how opioids should be labeled more generally. Current labeling requirements for extended-release or long-acting (ER/LA) opioids require descriptions of associated risks, the need for monitoring, and the idea that opioids should be used only if other measures are deemed insufficient, among other things.
Manufacturers of ER/LA opioids are also currently subject to a Risk Evaluation and Mitigation Strategy (REMS) program that mandates they fund continuing medical education (CME) courses on the appropriate use of these products. These CME courses must be offered by CME providers at low or no cost, and are subject to an online FDA curriculum. Over 38,000 providers and prescribers have taken part in these opioid CME courses, and an evaluation of the courses is currently in progress.
While the FDA is happy with a voluntary CME training component, it continues to support a mandatory education course for prescribers. The article states that, “[a]long with improving prescriber education, we will assess whether broader measures should be instituted for labeling and postmarketing evaluation of the entire class of opioids.”
Other Topics Touched Upon
The FDA commentary does not stop there, however, the FDA leaders continue to discuss other plans, including: developing a better evidence base for chronic pain treatment, refining guidelines for opioid use, and prioritizing development of nonopioid alternatives for pain relief. For a more in-depth reading of the FDA’s plan, the article can be found here.