Changes in the Drug Enforcement Agency’s policy regarding treatment of patients with opiate and other substance abuse disorders shines a light on ever-evolving perceptions of best practices in healthcare and the importance of professional development to stay abreast of them.
All physician leaders should be aware of two major policy changes from the Drug Enforcement Agency (DEA). First, on January 12, 2023, the DEA eliminated the buprenorphine waiver. Buprenorphine, a medication used to treat opiate use disorders (OUDs), required a special DEA “waiver” registration for prescribers in addition to their regular DEA registration. The waiver program effectively restricted the prescribing of buprenorphine to those with this DEA credential.
With the continued and increasing morbidity and mortality of OUDs, the DEA identified the elimination of the waiver as one step toward improving access to OUD treatment.(1) Now, any DEA-registered practitioner can prescribe buprenorphine for OUDs.(1)
In addition, the DEA implemented a policy change for DEA-registered practitioners that imposes a one-time continuing medical education requirement of eight hours for the treatment and management of patients with opioid and other substance use disorders (SUDs).(2) The requirement became effective June 27, 2023 and is necessary for continued registration at the provider’s next DEA renewal date.(2) The focus of this conversation is on this second policy change.
Opioid Use Disorder Training
In preparing to renew my own DEA registration, I performed a quick online search and was pleasantly surprised to see a range of available options to fulfill the DEA’s new training requirement, including both online and in-person formats. Offerings range in price from free to several hundred dollars. Many national organizations and state medical societies have already implemented programs to help their members comply with the training requirement, and some include the training in their membership fee. Nurse practitioners and physician assistants can also enroll in many of the same programs or gain access through their own professional societies.
I chose to enroll in an online continuing medical education program that provided eight hours of training in a series of modules in case-based presentations. In addition to fulfilling the DEA requirement, I earned AMA credits and was also granted Maintenance of Certification credit. I found the cases to be authentic in terms of situations that might be encountered in daily clinical practice. Quizzes were standard multiple-choice formatted questions with an option to retake mis-answered questions as learning progressed.
The program provided a thorough review of basics such as narcotic receptors and pharmacology, but also offered practical and improved methods to assess patients’ pain, identify the type and character of their pain, and prescribe a plan of treatment. Sensible alternatives to narcotics and combinations of adjunctive medications that could be used to effectively manage patients’ pain were described. Tools were available to alert physicians to which patients were most at risk for an OUD, how to manage the patient, and when to obtain consultation. In-line references augmented the program and provided opportunities to print and save for future reference.
At no time was there a suggestion that pain control should be withheld, even in those patients who required higher doses of medications. There was enough attention to pain control during cancer care to make me feel comfortable with increasing dosage management for my patients with cancer and pain.
The Water Cooler Conversation
I was enthusiastic about my newly acquired knowledge, and one morning as my team was preparing to see patients, I shared the training link and background on the DEA’s new requirement with them. Many of my colleagues are recent graduates, and my excitement was clearly overwhelming them. For many of them, their careers had started within the era when SUDs and OUDs were identified as being real entities. These conditions have real morbidity and real mortality associated with them. There is an epidemiology associated with it and disparities in care disproportionately affect certain socioeconomic and racial demographics.
My colleagues stood in disbelief as I shared with them that throughout my specialty training in the intensive care unit (ICU), the standard of care was to use liberal doses of narcotics and benzodiazepines to facilitate the performance of invasive procedures like mechanical ventilation and central venous catheterization. For our youngest patients, critically ill children, these medications were delivered with continuous intravenous infusions to reduce pain and induce amnesia often from the point of ICU admission. When they left the ICU, it became commonplace to order detoxification regimens of standing methadone and benzodiazepines to avoid withdrawal and to educate parents and caregivers on the signs of acute withdrawal in these patients.
How Did We Get Here?
How have we arrived here today, with OUD and SUD accounting for adverse effects to so many patients when liberal narcotic dosing was standard practice not so long ago? As I set out to answer this question, I learned that by some reports, nearly 80% of patients with an OUD received their first dose of narcotics with a legitimate prescription from a provider who was trying to alleviate their pain. In the late 1990s, pain became identified by many national organizations as the fifth vital sign to ensure diligence in assessing a patient’s pain level, intervening appropriately, and following up with an evaluation to assure that the pain management plan was effective. Standards and regulations were established to ensure that a patient’s pain would be managed routinely and effectively by the care team. Today, some of those same organizations are offering training to meet the intent of the DEA’s new requirement.
What Physician Leaders Should Consider
I asked myself, “What changed?” How did we move during the past 25 years from a liberal stance to a conservative stance on narcotic use for pain? Of the several reasons some are easier to accept than others.
First, the simplest explanation is that we learned. One of the most exciting aspects of the practice of medicine is that it is dynamic; as new knowledge is acquired, it is implemented to improve our care of patients. I was personally feeling a bit let down by this explanation. Why does it take an entire generation to figure out that we were on a track that might cause harm?
Second, we have better methods of treating illness and disease than we did even one or two decades ago. Why, then, does it take so long for us to implement evidence-based guidelines and protocols that might benefit our patients? The delay in implementation is often cited as 7 to 10 years.
Third, we have become better at measurement. We have better tools than ever to assess our patients objectively and monitor their outcomes across specialties and illness categories. It took time for these tools to be developed and validated, but now that they are here, we should encourage their use.
Fourth, while we have always had methods like journals, annual meetings, continuing medical education, and board recertification, to share information among and between professionals, we now have a new problem with information overload. New sources like social media provide medical information that is anecdotal and unvetted.
Fifth, once again a mandated requirement has become necessary because as physician leaders, we did an inadequate job of raising patient awareness of a real problem. This one seems heavy handed but I encourage you to think about it.
Finally, and most importantly, OUD and SUD are only one example of care paradigms that change with time. What are the current standards of care that we accept and encourage our teams to use today that in 10 or 20 years will be associated with harm for those that they were meant to protect? This is the ultimate question for all physician leaders as we care for our patients.
Conclusion
In this example, the DEA is doing good work by enhancing access to much needed evidence-based therapies like buprenorphine while helping us keep pace with changes in care that are essential for our patients. How do we, as physician leaders, consider commonplace occurrences that may be harmful to patients and proactively assert our expertise on topics that are in the best interests of those patients we serve? Sometimes, only time will tell.
References
U.S. Department of Justice. Letter to DEA Registrants Regarding the DATA Waiver Program for Buprenorphine. January 12, 2023. https://www.deadiversion.usdoj.gov/pubs/docs/A-23-0020-Dear-Registrant-Letter-Signed.pdf .
U.S. Department of Justice. Letter to DEA Registrants regarding the new Continuing Medical Education Requirements for Opiates and Substance Use Disorders. https://www.deadiversion.usdoj.gov/pubs/docs/MATE_Training_Letter_Final.pdf