Below are NAMEC Board Member Matthew Horn's comments to the FDA’s DSaRM/AADPAC Joint Meeting.
My name is Matthew Horn, I am a licensed physician, board certified in obstetrics and gynecology, with many years of experience in managing pain in clinical practice, including the prescribing of opioids. For the last ten years, I have been focused on developing continuing medical education, including many activities on improving pain management. I am currently employed as a Senior Medical Director at Rockpointe Corporation, a medical education company. We are currently working with several partners to implement an ER/LA opioid REMS educational series, supported by a grant from the RPC committee. This initiative involves a series of live educational sessions at regional pain management conferences throughout the United States. For the last 6 years, I have also served on the board of directors of the National Association of Medical Education Companies (NAMEC), where I’ve had discussions with others developing opioid REMS education. I mention this so that the committee understands that my opinions, while solely my own, have been shaped by input received from many colleagues involved in pain management and others in general clinical practice, key opinion leaders and faculty in pain management, attendees of pain management conferences, and other professionals involved in the development of education on pain management, as well as, from patients in pain.
I would also like to mention that I have received no compensation to cover my time and travel to speak here today.
First, I would like to thank the FDA for seeing CME as a valuable tool in the fight against the opioid crisis, while still remaining cognizant of the needs of pain patients, for therapies that help them overcome and live with their pain. I would also like to state my general agreement with the FDA that pain management education is both necessary and effective in improving pain management and reducing the risks of abuse and addiction. Preliminary outcomes from our ongoing series revealed that 99% of participants rated the education as “most valuable” or “valuable” in terms of improving their practice and over 95% of participants stated that they were better able to meet each individual goal of the educational blueprint as a result of participation.
Yet despite the success of such programs, there are several areas where the REMS program could be improved upon. For one, the program is considerably behind stated goals for the number of prescribing clinicians receiving this education. One reason for this is that there simply aren’t enough opportunities, with the RPC having difficulty keeping up with demand. My company, alone, applied for seven different grants over the course of 4 years before receiving a grant for our current series. Another provider we work with created an activity based on the blueprint that resulted in over 32,000 completions by physicians with schedule II and III DEA licenses and over 10,000 self-reported ER-LA opioid prescribers, but those completions will not be counted towards the FDA’s goals because the education was not funded/approved by the RPC. In fact, there are a great number of activities that are not being counted towards the FDA’s goals. Several federal, state, and local government agencies are promoting education on the safe prescribing of opioids, which causes confusion for the physicians, as many believe they have received ER-LA REMS education but yet are counted in separate programs. A wider acceptance of education that covers the material should be considered, rather than only considering education funded through the RPC, as is the case in the current REMS program.
The program being voluntary for clinicians also plays a part in the low participation rates thus far. In our current activities we see a significant drop off between the number of physicians with DEA licenses and the number or physicians who report that they are ER-LA opioid prescribers. And this number of self-reporting prescribers is highly discrepant from the number of prescriptions currently being written. I believe that a better measure of the program should be prescribers with DEA licenses. This change could easily be done within the current program. Clinicians are very familiar with continuing education credits being required for state licensure, hospital privileges, and, even, for obtaining in-network status with insurance providers.
I recommend that the DEA-issued license, required for prescribing controlled substances, be linked to a certain number of hours per year or relicensing period. This would be seen more as a sensible approach to safe prescribing rather than a potential regulatory burden or punitive measure. This approach would also insure that all opioid prescribers receive continuing updates rather than a single certificate for completing a single activity by a subset of opioid prescribers, who take the education voluntarily.
Requiring all elements of the blueprint on each activity results in far too much information to be learned at once, lessening the skills gained. Our own activity takes over 3 hours to complete in person or online. A completion of hours approach would allow a broader range of pain education to count towards the goals, while also allowing for more in depth coverage of individual topics, permitting learners to increase abilities according to their specific needs. This approach would also be better at overcoming the lack of adequate education that clinicians received when initially trained, especially those in primary care, where most pain is managed and most opioid prescriptions are written.
A single REMS program covering all opioids should be strongly considered. The implementation of the current program that only applies to extended release and long acting opioids is likely leading to increased use of immediate acting opioids over long acting forms. This is not necessarily in the best interest of patients nor efforts to curb the risks of opioid abuse and addiction. A single REMS program that encompasses all opioids would prevent any other unintended consequences.
Finally, I would be remiss if I did not address the fact that continuing education alone, is unlikely to be enough to fully impact our pain management and opioid abuse problems. Several system changes are needed, including more comprehensive pain and pain management education in medical, nursing, and pharmacy schools, increased government and private insurance coverage of other treatment modalities, including physical therapy, acupuncture, chiropractic, and other complimentary treatments, and a less stigmatic and punitive approach towards pain sufferers and prescribing clinicians than is currently seen in other government agencies’ approaches toward managing these issues.
In summary, I would recommend that the panel consider a single REMS program for all forms of opioids, that continues to include continuing education on safe and effective pain management as a critical component, but that ties this ongoing education to DEA licensure, making it mandatory, as opposed to just being available to self-reported prescribers on a voluntary basis.
This improved REMS program should also allow for a wider range of educational activities on pain management to count towards fulfilling the educational mandate, including those that cover individual elements of the blueprint, without the need to cover all of the blueprint at once, and not requiring that the education come solely through RPC funding/approval.
The FDA committee should also lead the call for other government agencies to work together to implement some of the other solution oriented recommendations that I have made, such as promoting greater insurance coverage of other treatment modalities and a more collaborative approach towards pain sufferers and their prescribing clinicians.
Thank you for your consideration.
Matthew D. Horn, MD
Senior Medical Director, Rockpointe Corporation/Potomac Center for Medical Education
Director, Executive Board, National Association of Medical Education Companies (NAMEC)