A piece published today in MeetingsNet highlighted the use of continuing medical education (CME) in combatting the emerging health crisis over prescription opioid abuse. As explained by Tom Sullivan, President of the CME provider Rockpointe, the Food and Drug Administration (FDA) has the opportunity to expand the usefulness of its Risk Evaluation and Mitigation Strategy (REMS) in fighting the epidemic by including immediate-release short-acting opioids. The current REMS has utilized the unique capabilities of CME providers for extended-release long-acting opioids, with widespread success. FDA officials plan to hold a joint meeting of the Drug and Safety and Risk Management Advisory Committee in early May to discuss the program.
The article in its entirety is below.
CME Plays Vital Role in Remedying the Opioid CrisisDramatic increases in death due to prescription opioid abuse has gained national attention. In the last month alone, the Centers for Disease Control and Prevention has issued new guidelines on prescribing opioids, the Food and Drug Administration has issued restrictive labeling guidelines on immediate release opioids, and Congress has held almost weekly hearings on the issue of opioid abuse. All major party candidates for the U.S. presidency have stated that reducing opioid abuse is a top priority. Congress is in the midst of passing several large bills designed to restrict access to prescription opioids and help those who struggle with addiction.
According to the CDC, the rate of overdose deaths involving opioids increased by 200 percent from 2000 to 2014. Additionally, in 2014 61 percent of drug overdose deaths involved some form of opioid; on average, 78 Americans die daily from overdoses of heroin or painkillers.
One of the tools in the FDA’s toolbox is to assign a Risk Evaluation and Mitigation Strategy, or REMS, for a group of products. In 2011, the FDA required manufacturers to pay for accredited continuing medical education courses for the extended-release long-acting (ER-LA) opioids.
Over the past four years, CME providers across the country have been quietly educating U.S.–based healthcare providers on the proper and safe use of ER-LA opioids as outlined in the FDA blueprint. This has been a monumental effort embracing more than 50 CME providers from every aspect of the CME enterprise, educating thousands of clinicians on how to safely use ER-LA opioids. The blueprint takes anywhere from three to six hours to effectively complete and has been a huge time commitment for American physicians. Despite this barrier, America’s clinicians have embraced this content. These activities cover how to properly access pain and the assess risk for opioid dependence, what medications and modalities are available to manage pain, and how to do that in the safest and most efficacious manner possible. This effort has been supported by the ER/LA Opioid Analgesics REMS Program Companies (RPC), which consists of 24 pharmaceutical companies.
State courts have started to pay attention to this effort. A recent settlement in New York requires a manufacturer to remind New York providers, both in writing and orally, to participate in the FDA ER-LA REMS Prescriber Education each year.
Time to Expand the Model?
This effort has had almost no mention in the media, but that is about to change. On May 3–4, the FDA will be holding a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Drug Products to review the progress of this effort by these CME providers. The goal of the hearing will be to see if this model developed for ER-LA Opioids should be expanded to immediate-release short-acting (IR-SA) opioids. CME providers have learned many lessons from these programs and their learnings will be invaluable to the FDA going forward.
One side effect of only targeting ER-LA opioids and not IR-SA opioids may be that the FDA may have inadvertently encouraged the use of short-acting opioids, which can be significantly more complex to manage than the long-acting opioids.
The FDA has the opportunity to fix this problem and to refine the opioid REMS to include immediate-release short-acting opioids. Hopefully in years to come we will look back at the opioid crisis and the work that CME providers have done and be grateful that we have helped to prevent perhaps thousands of deaths from overdose.
Thomas Sullivan is President of Rockpointe, a CME provider. His organization has participated in a grant for education from the REMS Program Committee.