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.

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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.

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  • Loved the article, I am an ER Nurse currently working on my DNP. I have a brother who is an ER Physician who also is passionate about this. The most frustrating part is restricted prescribing access. If it were written for pain management there are no restrictions, but for opioid use disorder, there are (as you point out).

    The title of the article, buprenorphine is missing the second r.

  • Sadly, the “opioid crisis” is now being driven by illegally made, incredibly potent, fentanyl from China and Mexico. As a 65-year-old, chronic pain patient, I chose Subutex in 2013 as an alternative to traditional opioid treatment. Even then, I could see how the “drug war” would eventually affect legitimate chronic pain patients’ ability to obtain the medications they need to function. Then Subutex came under further scrutiny by the DEA, and many pain patients were forced to go on Suboxone, unless they were pregnant or proven allergic to naloxone. Today, there are still many in the medical community who are nearly clueless about how to treat pain in the Subxone-dependent patient. I live in fear of an unexpected injury or surgery in which my pain would be inadequately treated, due to ignorance of the medical staff. There is still a great deal of stigma connected to being treated with Suboxone, regardless of the reason.

  • Drug addiction is often the result of attempting to cope with emotional distress. Many people suffer from untreated mental health issues or have a lack of healthy coping skills for managing stress. They begin taking drugs like painkillers and find that it greatly reduces their distress and they even feel a sense of euphoria. Over time, this becomes their only way of coping with distress and dependence forms as tolerance increases.

    Prescribing opioid replacement drugs has shown success in keeping people off illicit opioids. However, they are still taking a synthetic opioid so they are dependent. Suboxone and methadone are a quick fix to help keep a user from overdosing, but it’s not a complete treatment by any means. Individuals still eventually need to detox off of these drugs due to side effects or a desire to be opioid free. The problem is these powerful opioids have intense and long-lasting withdrawal symptoms which makes it extremely difficult to taper off. We need to offer different detox and mental health treatment methods based on the needs of each patient rather than standardized treatments that don’t work for most patients.

    • Waisman Method!

      That comment is the standard industry line. It sounds great, but 20 years out, there has not been much “treatment.” The US has a physician shortage, and there are few resources in the communities that need them. A lot of the money directed at opiates, went to law enforcment, and less expensive 12 step programs. At the same time the number of deaths and new addictions is increasing. The rates of infection, by HIV, Hep A-B-C, and syphilus are also increasing. Addicts alos get infections from injecting, requiring hospitlaization. These Facts are rarely reported on.

      The Only thing we can do now, is allow Bupenorphin to be distributed, it is less harmfull than injecting. The rest is nonsense propganda and lies, since nothing they have done has been effective.

  • I like your views. I would like to know if the same deregulation could be applied to methadone? It would almost be bias, from the patient’s perspective, to have buprenorphine available, and not methadone.

    • Interestingly, any physician with a DEA number can prescribe methadone for pain relief or management; though, in practice, fewer and fewer are. Likewise, a physician with said DEA number can prescribe it for management of opioid use disorder; however, there are a number of regulations covering such programs for dispensing methadone for such. Also, methadone overall does not have the same safety profile that buprenorphine has. In particular, there is a greater risk of respiratory depression either alone or with other respiratory depressants.

  • We really don’t have a choice, about this. It is really clear there is a lakc of physicians, and other practitioners. It has been 20 years of this nonsese. They not only strigmatized the addicted, the y went after pain patients too. This was due to to a Pharma misininfrmation campaign, that the media and profiteers are still engaged in. The so called opiate epidemic has been really profitable for quite a few industries.
    Americans are subject to lies and misinformation continually. The media continues to misreport what is an epidemic of despair in order to protect pharma profits, while spreading lies and misinformation. They continue to mislead with anecdotal stories about 12 step programs and prayer. At the same time the dubios “Spreading Awareness Campaigns” appear to be a marketing scheme for useless treatment centers, and introduce drug abuse to a new generation.
    It is really clear that whatever they have been doing for the past 20 years has not worked. They lied about all of it. This drug may help, but the profiteers took an old medication, relabled it and jacked the price. The market based healthcare industry failed to identify the problem or inform the public. They are still misleading the public with lurid stories of addcited infants, and misinformation. They used this scourge as a marketing campaign, to deny care to millions of Americans with pain. People are now undergoing painfull excruciating surgeries with no pain control, while cancer pateints die in agony.
    Buprenorphin is certainly better than illegal Fentanyl, or exposure to HIV, Hep C or syphillus. In the meantime the lies and denial can continue, while profitteers continue to lie to the public. The FDA failed, to regulate the marketing of opiates, just like they failed to hold treament providors accountable. We are living in post fact america, and marketing ahs replaced factual evidence. The number of deaths is climbing, and the rates of suicide are going up, indicating that something is wrong.

    The medical industry lied about the effectiveness of surgeries, the number of elderly people they subjected to intrusive painfull surgeries requiring pain medications. They lied about injured workers and the rising rates of chronic pain in Americans. The Facts have been withheld by a complicit media. The lies and propaganda have been repated for so long that they have replaced the facts.
    Last year more Americans died from Alcohol Abuse than opiods or otehr random drugs, but that is not a problem. The alcohol industry and the big box stores, incluing the pharmacies that sell it could lose profits. It is kind of ironic that the same corporations that make billions selling alcohol and prescription drugs are also involved in opiate education for teens. This is a merely a marketing gimmick, that uses kids. This kind of thing should be against the law, but not in the US. It is really no wonder the US is in an Epidemic of Despair!

    • Mavis Johnson,

      Give us solutions. You complain a lot, but with no concrete solution. Let’s fix it. Tell us how.

    • Hey T. Trust!

      My first “Solution” woule be to limit or ban people peddling nonsense and psuedo scince on these sites. There are solutions, but first everyone has to be on the same page with the facts. As long as magical cures like accupuncture or prayer are being promoted, more people will die.

      The solutions are right in front of us! Other countries have done it.

  • Accolades to Dr. Kevin Fiscella ! The US is disastrously “behind” in removing paranoia about buprenorphine, and Congress is wearing blinders of ignorance to the significant opioid-crisis-reducing successes through buprenorphine prescription, combined with assistance programs, like in France. In The Netherlands “Methadon busses” (mobile sites with staff that also gained trust and directed users to support programs) were an enormous success – already 40 years ago ! Really, in DEA matters, the USA is decennia behind. The US government needs to open up to the proven succesful methods of opioid crisis reduction – and grow out of its antiquated stigmas that do not serve its population. That happens in third-world countries, and should definitely not occur in “the greatest country in the world”.

  • Suboxone has been a life saving treatment for me, my husband, and my in-laws! A few injuries, and ailments- in the early 2000’s sent all of us down the “this will help with your pain”- hydrocodone-trail. Needless to say, several agonizing years later we had perfected “doctor shopping”, or buying from the street. I even caught a felony drug charge, due to 5 oxycodone in my console during a routine traffic stop! Our lives were in ruin for many years, 12 step programs and ‘detox facilities’ became revolving doors. Many accused us of ‘not wanting to quit’– ‘don’t you care about your careers’-your children?!’- when in fact, we cared more than they would of ever believed, feared the consequences, and desired nothing more than to live again! Suboxone was introduced to my husband and I by my Mother in-law (who had lost everything from buying hydrocodone off the street, and was living in a laundry mat). It has truly been a miracle-for 5 years! Some doctors taper their patients after a year or two, ours is 5–which in all honesty, is the only amount of time I actually feel comfortable about tapering! I recently had oral surgery, prior to surgery I came off of my suboxone, because is pain is pain and I did not want to experience that!! I was able to successfully take prescription opioid pain medicine only when I needed them for pain, my urge to abuse them did not surface! I am not insinuating that everyone would have the same results, however with ample treatment time (years) it is my opinion that far less opiate addicts would relapse. Thank you for this article, it envelopes each emotion of the patient and those in the medical field. I hope in the future we can change the stigmas, and hurdles of opioid dependency and treatment! C.F.- Medical Systems Management

    • I’m delighted to hear about your successful recovery via Buprenorphine.
      I’d also guess that your encounters with the forces of drug Prohibition (aka Drug War) caused as much devastation to your life as your addiction. Please correct me if I’m wrong.
      I’m still trying to get a clear picture of the number of overdose deaths that occure directly after a few days or weeks in jail or rehab. The issue is that officials don’t bother informing users that their tolerance for opiates is substantially lowered after a week or two of being clean. So the user decides to get high and naturally thinks it is fine to use the same dose he/she did before getting clean…
      AND DROPS DEAD.
      Prisons and abstinence rehab clinics don’t want to tell users this because they fear it encourages relapse. Personally I think those officials should be held criminally liable for negligence for this.
      Subutex has reduced the overdose rate post rehab/jail because tolerance remains high with Subutex treatment.
      I can tell you one thing that Subutex isn’t worth a darn for.
      Pain management. Because it blocks the effects of other Opioid Meds, the one option that would be rational isn’t even possible. After neck surgery a couple decades ago I’m just so grateful that prescription Opioids were available for about 15 of those years so I could lead a normal productive life. Now things are even worse than in the mid 1990s. Nobody mentions that there was a darn good reason that Congress passed a resolution to encourage pain management. It wasn’t all the Drug companies, it was that pain was being ignored just like it is now.
      Funny how nobody mentions that. Or the fact that the harder they restrict the meds the more people die. Predictable as the sunrise.
      If you or anyone here has access to the real numbers regarding post rehab/jail overdose deaths I’d sure like to see them
      Thanks,
      James

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