The day each of us received our licenses from the Drug Enforcement Administration, we were able to write prescriptions for oxycodone and fentanyl, two drugs that have fueled the opioid overdose epidemic. But we couldn’t prescribe buprenorphine, a far safer partial opioid that is an effective treatment for opioid use disorder, without getting additional training, a special license with a number that begins with “X,” and agreeing to allow DEA agents to inspect our patient records.
That doesn’t make sense to us, especially as our country is in the midst of an overdose epidemic.
Opioid use disorder can cause tremendous suffering for people with it and their families. As physicians who specialize in addiction medicine, we have seen the transformative effects of treatment with medications such as buprenorphine. When combined with naloxone, it’s sold as Suboxone. People who take it report that they no longer feel compelled to use illicit opioids. They can focus on their recovery and on restoring their relationships.
Yet in spite of the fact that buprenorphine has been available as an effective treatment for opioid use disorder for 17 years, opioid overdose deaths are now the number one cause of accidental death in the U.S. Nearly 50,000 people in the U.S. died from opioid overdoses in 2017, the last year for which there are complete statistics. That’s equivalent to the number of Americans who died in combat during the Vietnam War. Since 1999, nearly a half-million Americans have succumbed to opioid overdoses.
As we and a colleague argued in a Viewpoint in JAMA Psychiatry, one possible solution to this terrible epidemic is hidden in plain sight: remove governmental restrictions on prescribing buprenorphine to treat addiction.
Before the turn of the 21st century, the only way people suffering from opioid use disorder could get effective medical treatment was through tightly regulated opioid treatment programs that administered methadone. Methadone is an extremely effective treatment and the structure of supervised dosing can be helpful for some patients. Yet the requirement to attend a clinic every day and wait in dosing lines, along with the stigma associated with receiving addiction care outside of the traditional medical system, prevented many from getting this lifesaving treatment. People want the option to receive care for opioid use disorder in the same place and by the same trusted providers who manage their diabetes, depression, or hypertension.
When Congress passed the Drug Addiction Treatment Act of 2000, it opened the door to allow the secretary of Health and Human Services to give waivers to qualified clinicians — physicians, nurse practitioners, and physician assistants — that allowed them to treat opioid addiction in settings other than traditional methadone clinics. Buprenorphine, which was approved for treating opioid use disorder in 2002, made office-based treatment even easier.
Clinicians who qualify for this waiver receive DEA licenses that begin with the letter “X.”
Many experts hoped that most clinicians would apply for the wavier and begin treating opioid use disorder like they treat any other health problem. Sadly, that never happened. Under 7 percent of U.S. physicians currently have DEA waivers. Even among newly trained doctors, few complete the necessary steps to get this license. As a result, more than half of the counties in the U.S. lack even one buprenorphine prescriber.
There are several reasons why so few doctors and other prescribers get the waiver. Lack of training in how to diagnose and effectively treat opioid use disorder is one hurdle. Obtaining the waiver requires extra training (eight hours for physicians and 24 hours for nurse practitioners and physician assistants) and then submitting an application for a waiver license. Agreeing to inspections of office records by DEA agents is a deterrent, as physicians fear this kind of scrutiny. Then there are practical matters, like finding colleagues who also have the waiver who can cover a practice, that discourage doctors who obtained the waiver from ever actually using it.
Stigma is another barrier, from both the physician and patient perspectives.
The media has long demonized people living with opioid use disorder. Even clinicians use stigmatizing language like “addict” or “drug abuser” or refer to recovery as “getting clean” or call a urine drug test that shows evidence of ongoing opioid use “dirty urine.” This is language that would be unacceptable for any other medical condition. Imagine a physician telling a patient with high cholesterol and obesity that she is a food abuser and her blood was dirty with cholesterol.
Misunderstandings about the role of medication in treating opioid use disorder also continue to influence treatment decisions. Despite decades of research showing how effective buprenorphine is at increasing remission rates and preventing overdose deaths, the myth persists that people who take buprenorphine are simply replacing one drug with another and are still “addicted.”
Some doctors worry, needlessly, that people with opioid use disorder will be unusually difficult patients. Others worry about the impact of addiction treatment on their other patients.
Stigma is also a barrier to patients. Our patients often tell us they feel stigmatized by doctors, nurses, pharmacists, and even friends and family. Outside of cost, stigma is the single largest barrier to opioid treatment. “X” waivers perpetuate this stigma and marginalize patients, making them feel less worthy. Patients often experience barriers trying to fill prescriptions for buprenorphine — told they cannot fill it if the “X” is missing from the prescriber’s license number — or feel shamed when filling buprenorphine prescriptions. Some feel embarrassed telling other doctors they are taking buprenorphine.
Deregulation of buprenorphine could help in three main ways.
First, deregulation would eliminate the extra steps needed for clinicians to prescribe this medication. It would likely encourage training programs to ensure that clinicians were better prepared to prescribe it.
Second, it would reduce barriers that patients face in finding prescribers, since any clinician with a DEA license could prescribe buprenorphine. Deregulation would help normalize prescribing and ensure that clinicians working in emergency departments or hospitals could prescribe it.
Third, and probably most important, deregulation would help remove the stigma from treatment. Taking the “X” off prescribers’ licenses would send a powerful signal to the medical community and patients that opioid use disorder is no different than diabetes or other chronic health problems.
Would deregulation work? After France instituted this approach in 1995, deaths from opioid overdoses dropped nearly 80 percent. A similar drop in the U.S. would mean 37,000 fewer deaths from opioid overdoses in 2017. It’s true that the U.S. is not France. All French citizens have health insurance and Americans with insurance pay much more out of pocket. But even if deregulation of buprenorphine prescribing led to “just” a 50 percent decrease, that would mean 20,000 fewer deaths.
Skeptics worry that some patients will sell their buprenorphine, much like some sell their oxycodone. That could happen. The current shortage of prescribers creates a black market for the illicit sale of buprenorphine. But if buprenorphine were more widely prescribed, the black market might begin to dry up and fewer people would try to sell it. Although there is limited research about the illicit use of buprenorphine, several studies suggest that the main reasons people buy illicit buprenorphine are to self-manage withdrawal from opioids or to self-treat their opioid use disorder. If that’s the case, greater access to buprenorphine via legitimate channels would be a positive intervention.
Within the medical and behavioral health communities, some practitioners worry that increasing access to buprenorphine without requiring participation in counseling will not be effective. However, studies comparing adding psychological interventions like cognitive behavioral therapy to buprenorphine therapy with medication management alone (meaning counseling from the prescriber during the visit, much like primary care providers do for other health conditions where treatment involves behavior change, such as diabetes, high blood pressure, or obesity) have found these two approaches to be equivalent.
To be clear, this does not mean that psychological care and substance use counseling aren’t important. Behavioral therapies should be readily available to patients with opioid use disorder and integrated whenever possible into their care. But given the clear evidence that medication management with buprenorphine in primary care settings is effective with or without adjunctive counseling, deregulation of buprenorphine is an important step to expand access.
What about safety? Buprenorphine has a much better safety record than opioids like oxycodone or fentanyl that are commonly prescribed for pain. Between 2002 and 2013, 464 deaths in the U.S. were attributed to buprenorphine, or one-thousandth the number of deaths attributable to opioids during that period. Most buprenorphine-related deaths occur when the drug is mixed with alcohol or sedatives.
We strongly believe that deregulating buprenorphine and making it easier for clinicians to prescribe this medication will on balance save many lives. We also believe that Congress should take additional steps, such as requiring basic training in how to appropriately prescribe buprenorphine for opioid use disorder and providing incentives for doctors and other prescribers to prescribe buprenorphine for opioid use disorder and to encourage individuals with opioid use disorder to seek counseling for it.
We are puzzled why Congress has yet to take these simple steps to help end the opioid overdose epidemic.
Kevin Fiscella, M.D., is professor of family medicine, public health sciences, and community health at the University of Rochester and co-director of its Center for Communication and Disparities Research. Sarah E. Wakeman, M.D., is the medical director of the Substance Use Disorders Initiative at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School.