On March 19th, the federal government loosened regulations around methadone and buprenorphine, two medications used to treat opioid addiction. The change was triggered by the novel coronavirus and concerns that current practices would either contribute to its spread or restrict critical opioid addiction treatment. For all the havoc the coronavirus is undoubtedly causing, it is also compelling us to examine our approach to these medications with a fresh lens. Though not specifically addressed in the recent regulatory adjustment, one such opportunity exists in a reconsideration of the related “X-waiver.” What is the X-waiver? The X-waiver is a Drug Enforcement Administration (DEA) requirement for outpatient providers who wish to prescribe buprenorphine – again, a medication FDA-approved to treat opioid addiction. By contrast, no special training is necessary to prescribe opioids like Oxycontin, Vicodin, and even fentanyl – medications now well-understood to be addictive and major contributors to the devastating overdose death rates of our nation’s opioid epidemic. As a third-year psychiatry resident, I arranged for my colleagues to participate in X-waiver training. Doing so required jumping through a number of logistical hoops, including working with administration to block off time for the 8-hour training, securing the trainers, finding an appropriate meeting space, and advertising the training. At the time, I thought (naively) that after the training, we would simply begin prescribing buprenorphine to our patients. Instead, I came to appreciate that key, practical steps had been left unaddressed – things like developing clinic protocols, curating patient and provider educational materials, defining our referral sources, and generally building buy-in among providers. It was hard not to view the X-waiver as a distracting hurdle, siphoning off the finite time I had as a resident to impact our clinic. Even more frustrating was confronting all these obstacles for a medication that maintains such an impressive resume. Buprenorphine has been shown to be safe and effective, keeping people in treatment longer and decreasing their risk of death. It also has evidence it helps to improve social functioning, decrease infectious disease transmission, reduce criminal engagement, and lower health care costs. The X-waiver requirement was admittedly well-intended, aiming to reduce potential diversion (or non-prescribed use), but it has outlived the data, and better alternatives exist. Multiple studies have shown that the grave majority of people (75 to 90 percent) who use non-prescribed buprenorphine do so with the purpose of self-treating opioid withdrawal and/or cravings – likely a reflection of the present barriers to treatment rather than a consequence of buprenorphine. In fact, the most commonly prescribed formulation, Suboxone, combines buprenorphine with naloxone, an abuse deterrent. When taken under the tongue as prescribed, the naloxone is inactive; however, if crushed and injected, the naloxone becomes active, counteracting the buprenorphine and preventing a euphoric high. The Suboxone formulation notably came out in 2002, two years after the X-waiver was introduced, a natural but missed opportunity for a reevaluation of its utility. Moreover, medications like Xanax and Adderall (medications without abuse-deterring formulations, but significant risks of addiction) continue to be freely prescribed without a waiver. Thus, buprenorphine lingers on a relative island off the coast of the mainland of other controlled substances. Despite its benefits and safety profile, we tolerate an “a la carte” and “opt-in” system, enabling some providers to use their lack of an X-waiver as a reason for not offering this form of treatment to their patients. Though any physician is eligible to apply for an X-waiver, less than 4 percent of licensed U.S. physicians currently have one, and nearly half of counties have no waivered providers. These grim numbers live in the context of the just as discouraging reality that less than 40 percent of the 2.3 million Americans with an opioid use disorder get evidence-based treatment for it. And the U.S. is not the only nation to grapple with this issue. For example, France’s opioid overdose death rates decreased by almost 80 percent in the four years after they opted to deregulate buprenorphine in 1995. Of course, and sadly, I recognize that even if we evolved to a post-X-waiver world, barriers would remain. Beyond the implementation details mentioned, these include things like stigma, which many argue the X-waiver propagates by the differential treatment of buprenorphine, as well as provider discomfort with prescribing it due to lack of exposure. Yet there are opportunities to redirect our worthwhile efforts to educate providers about buprenorphine and opioid use disorder through X-waiver training into a space better suited for it – one that is both more comprehensive and mandatory. Doing away with the X-waiver would not hinder our capacity to support general addiction education in medical schools, residency programs, and continuing education – programming which could go beyond one medication and one type of addiction. This may include required curricula and clinical experience with useful supervision or consultation, approaches more consistent with the ways in which physicians grow confident in identifying and treating basically all other disorders. Indeed, removing the X-waiver buffer may even embolden these endeavors and accelerate our investments in them, eliminating the argument that such training simply already exists in the, by nature, narrow and voluntary X-waiver training. If one was automatically eligible to prescribe buprenorphine when granted a DEA license, as is the case with other controlled substances, then physicians may suddenly experience an impetus to learn more about it. Fortunately, my stance is not particularly novel or fringe. An entire social media movement has formed around the hashtag #XtheXwaiver. And in the past year, major physician organizations have published position statements in support of abolishing the X-waiver, including the American Society of Addiction Medicine and the American College of Medical Toxicology. Each organization has importantly also commented on steps we can take to fill any potential void left by removal of the X-waiver. They make viable suggestions, like channeling our resources into incorporating addiction education into various stages of schooling and practice, tying critical trainings to licensure, and/or strengthening our addiction-trained workforce. Congress is getting on board as well with bipartisan bills introduced in the House and Senate in July 2019 that would lift the X-waiver requirement. Coronavirus has required us to overhaul daily life. Why not also reimagine the outdated X-waiver requirement? Doing so would be a simple, cost-effective, and lifesaving move, freeing us up to focus on the workable barriers that persist. Sara K. Schenk is a psychiatry resident. Source
