Buprenorphine has the potential to be a transformative tool in health care practitioners’ fight to reduce deaths from opioid overdose. A simple medicine that dissolves under the tongue, buprenorphine satiates the opioid receptors that cause cravings and is shown to substantially reduce drug use. It is easy to take, has few adverse side effects, and minimal potential for abuse. Current policy needlessly restricts the use of buprenorphine by requiring physicians to obtain a special “X waiver” before prescribing it. This requirement is onerous, outdated, and hampers our ability to help patients manage and recover from opioid addiction.
The X waiver requirement stems from the Drug Addiction Treatment Act (DATA) of 2000, which was passed by Congress in response to the growing crisis of opioid use disorder. The DATA allows physicians who meet certain qualifications to treat opioid use disorder with buprenorphine in clinic offices. This component of the act was an attempt to reduce practitioners’ reliance on methadone, another opioid used for maintenance therapy, which is heavily regulated and can only be administered in federally approved clinics. At the time of its passage, the DATA seemed progressive: It expanded access to evidence-based treatment for people suffering from addiction. But now, 19 years into the opioid epidemic, the requirements imposed by the DATA make it unnecessarily difficult for providers to care appropriately for those who need the most help.
In the fight against the opioid epidemic, buprenorphine is as close to a miracle drug as it gets. When prescribed as part of “maintenance therapy” (the use of daily medication to fend off opioid cravings and withdrawal symptoms), buprenorphine has been shown to decrease drug use, recidivism, high-risk behaviors, health care costs, and the risk of death. In France, after policy makers deregulated buprenorphine, the increase in access to the medication was associated with a 79 percent decrease in opioid overdose. Similar deregulation could have significant impact in the United States, but the requirements imposed by the DATA handcuff doctors who want to offer office-based Suboxone therapy.
To prescribe buprenorphine as a primary care provider, I applied for the required buprenorphine DATA X waiver. After taking an eight-hour course and submitting an application to the Drug Enforcement Administration (DEA), I received a new prescriber identification number starting with the letter “X,” which allows me to offer buprenorphine in my clinic. These extra steps to prescribe medicine are not typical, particularly for common medications with minimal risk profiles. Insulin, fentanyl, and even acetaminophen have much higher side effect profiles, yet they can all be prescribed without additional training.
As a provider, I’ve had the privilege of seeing patients reclaim their lives with the help of a buprenorphine regimen. The medication allows them to focus on their jobs, their families, and their own well-being instead of fighting their addiction from the first minute of each day. And yet, many individuals in desperate need of treatment don’t receive treatment. A 2016 Surgeon General report showed that only 10 percent of individuals in need of addiction treatment receive medication. In 2011, 43 percent of counties across the country had no physicians waivered to prescribe buprenorphine. This “treatment gap” persists despite a general consensus that medications such as buprenorphine are the gold standard for patients suffering from opioid addiction.
Despite strong evidence for the effectiveness of buprenorphine therapy, only 5 percent of medical providers are licensed to prescribe it. Physicians seeking an X waiver must undergo eight hours of training modules, while advanced practitioners (physician assistants and nurse practitioners) must undergo 24 hours of training. Advanced practitioners deliver the bulk of primary care, and thus, could lead the health system’s push to address opioid overdoses. But we hamper their abilities to offer treatment with unreasonably burdensome training requirements. The costs of taking an 8- or 24-hour course are most pronounced for these front-line providers, who do not have the time and resources to take days off.
Prescribing buprenorphine is safe, guideline-driven, and not particularly complex. Moreover, buprenorphine is widely considered to be safer than pain relief opioids. Ironically, the opioids that are actually contributing to the current epidemic can be prescribed with no additional training. (I prescribed morphine in a hospital setting as an intern only weeks out of medical school).
Of the several treatments available to patients suffering from opioid addiction, buprenorphine is the most optimal in terms of safety, efficacy, and accessibility. Methadone can be used to successfully treat opioid use disorder, but it can only be dispensed by federally recognized methadone clinics. Long-acting injectable naltrexone has also recently gained favor as an intervention for preventing overdose deaths, although the evidence for its safety and efficacy is much less robust. Naltrexone is also difficult to initiate, requires a detox period, and is cost prohibitive for most patients. Naloxone (Narcan) is an emergency medicine that can save lives during an overdose, but it does not address the causative disease.
Underlying many limitations on treatment for opioid use disorder is the persistent stigma surrounding addiction. For too long, health practitioners and policy makers have treated addiction as an individual failing, rather than as a systemic public health crisis. Complex but clearly identifiable social and economic factors contribute to drug use, including unemployment and poverty, undertreated behavioral health conditions, and adverse childhood events. We must also acknowledge the role that physicians themselves played in creating the opioid epidemic: It is widely recognized that in treating pain as the “fifth vital sign,” physicians overprescribed narcotics for decades.
As health care providers and policy makers, we must re-affirm our commitment to treating all patients suffering from addiction with compassion, respect, and effective care. Obstacles such as the X waiver make it more difficult to do so. Discontinuing the buprenorphine X waiver would allow more providers to prescribe medication for opioid use disorder and would help empower individuals to overcome addiction. A recent editorial in JAMA Psychiatry highlights the strong scientific evidence supporting this policy change. Moreover, a growing body of robust medical evidence continues to support more “low threshold” treatment for patients. In short, medication helps patients overcome addiction.
Providers should not be required to spend 24 or even 8 hours on the intricacies of a relatively simple and safe medication. If we in the health care community are truly committed to addressing the opioid epidemic, regulations should not continue to tie the hands of providers capable of helping. Ending the X waiver is an easy first step. We must join the call from our colleagues to reduce barriers to treatment and “X the X waiver.”
Author’s Note
The author would like to acknowledge and thank Dr. Ben Oldfield, Dr. Ravi Gupta, Peter Martin, and Andrea Marcin for their comments in developing this post.
