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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  • I am taking Suboxone for Opioid Use Disorder. It took me years to find a Dr. that could prescribe Suboxone and be able to except my insurance. Even now that I have a prescription l still hide it from people because of the stigma. Suboxone saved my life and could save many others if they had the opportunity to get it. Suboxone is so expensive on the streets, that’s it’s still cheaper for people to be addicted to opioids. The only way some people can afford to go to the Dr. and get their Prescription is by selling them. I had to leave a very well paying job just to go to a job with insurance so I could stop buying Suboxone off the street and could afford to go to a Dr. and Insurance pay for my Suboxone, but I’m now “legally” able to take Suboxone and not face any legal issues if I was ever caught with Suboxone. Which has also been a problem for me. I’m trying to do right and work 2 jobs to take care of my Family and I get arrested for a Felony and spend 4 days in jail and awaiting trial all because I had something that saved my life. Which would they rather? It’s a never ending circle! If the Government made it easier for people to get Suboxone then they would lose money. It’s a conspiracy! People would get off drugs there for not as many people going to jail and having to pay fines that is gonna put them back in jail because they can’t afford it therefore ending back up on drugs because they are so stressed and so worried because they have now lost their jobs, home, family, friends and themselves! We end up losing our license then having to keep living, work, kids, school, legal things that the courts ask of you, etc… etc… etc… then we get pulled over, another ticket, car towed, go back to court, jail time, lost job again, lost home again, lost kids again, more fines, back on drugs. “The never ending circle” It literally NEVER stops! There is no hope for the end, for a lot of us! Most of us are just asking for a second chance to do right. They call it a second chance when they let you out of jail or prison or some other legal issues we have, but it’s a trap! They sat you up for failure and then want to punish you even more when you don’t meet their expectations, which are impossible to meet. I got out of rehab about 5 years ago for alcohol etc… which I lost my license before that, the reason I needed rehab. You would think after all these years I would have the chance to get my license back, but No! Yet, I still have to live life. I’m a single Mom with the added stress of fighting Addiction and I have to work, take my kids to School and go to the store to shop, take them to Dr. Apts and all the things that most parents take for granted, like taking my kids to their School functions, practices etc… Then I have to go to court dates and urine samples when my color is called because I was helping an abandoned Woman get home and got pulled over and searched and they found the one thing that was saving my life, Suboxone. I’m now facing a Felony charge, which I will lose my job if I’m found Guilty, and jail time for Driving with No License not to mention more “Fines”! Now with all that said, if I would have had an opportunity to have Suboxone in my life 10 years ago, none of this would have happened! The sad thing is, 10 years ago, I had no idea Suboxone even existed! Instead my Dr. fed me Opiates until he wasn’t allowed to anymore and where did that leave me after 5 surgery’s? Addiction is not always the Addicts fault, but yet we pay all the prices for it! This World has become so Heartless. All we can do is Pray!!!

  • I retired from a very successful and rewarding family practice last year primarily due to government and burocratic interference .
    I treated many elderly patients with opioids and found them far safer than NSAIDS and Tylenol ,tramadol etc that doctors are pushed to use.
    The sigma of well managed opioid use esp in the elderly and in significant pain has gone way overboard.Patients are struggling to get pain meds now.
    With computerization the provider abusers can very easily be identified and routed out.Let decent doctors do what they trained to do.
    Good luck with getting your pain managed.

  • Kathy clearly has had a very bad time using Suboxone for chronic pain.
    In 2013, I switched from traditional opiates to buprenorphine to help me cope with long-term chronic pain.
    Now I am terrified of the withdrawals if I choose to quit Suboxone (note I am forced to take Suboxone instead of the original Subutex because I must either be pregnant or have a life-threatening reaction to naloxone). In addition, I am more terrified of the need for adequate pain control in the event of an accident or unplanned surgery (by not having time to get off Suboxone and clear my brain’s opiate receptors).
    I trust my pain management doctor, but these situations were never discussed with me initially. Today, when I voice these concerns, my doctor says, “but what can you do about controlling your pain if you stop Suboxone?”
    Daily Tylenol or ibuprofen are out of the question. The amount I’d have to take would be extremely dangerous. It seems that traditional opiates may have been the better choice, but then I would have to deal with the fallout of the “opioid crisis.”
    Chronic pain patients need help!

    • I agree with this %100. All doctors that do prescribe it in my area will not take new patients and the only doctor that will is cash only $175 each visit. I feel like im.being ripped off and taken advantage of because of my condition. They know I’ll pay that money because I’ll get sick if I dont. They went from not taking my insurance, to $100, then $125, and now $175. They won’t do refills either so I have to come every month. I just dont know what to do. Its wrong. They’re just a legal drug dealer if you ask me

  • I totally agree with everything said. My Rheumatologist wants me to get off Oxycontin and gave me a referral to look into this Dr. who is promoting his business in 3 or 4 different area’s around where I live. Him and his wife (an RN) will be working with opioid addiction. And also those with chronic pain wanting to get off of Oxycontin, Vicodin, or morphine. He will be using Suboxone. I really want to do this, I’ve been on Oxycontin for almost 10 years and it’s so hard because they really do help my pain, but my doctor thinks they will eventually be fading out. Plus I was told at CVS when asking about Belbuca that they were going to be doing away with opioids. How can they do that. I’m pretty sure she was referring to that when I mentioned the Belbuca. I’m trying to do as much research on this as I can. I think I will give this Dr. (doing the detoxing) a call real soon because I don’t want to be stuck going through withdraw without help or a backup. I was going to ask him about the Belbuca also. I read some really good reviews on that. I don’t know maybe Suboxone works better.
    Thank you.

  • I’m so sick and tired of being treated like a drug addict. 3 different in patient 5-6 day long “detox” attempts after over 8 years of “Pain Management” (720 mgs of opiates per day). Now a slave to Suboxone (which does very little at all for my chronic pain). The more “help” I seek, the more I’m treated like a drug addict.

  • I didn’t put myself on oxycodone. I trusted the doctors. I’m tired of being labeled an addict. Doctors aren’t called drug dealers, so what’s the difference?

  • Thank you for this ive had an idea like this for a while now you made great points for the opiod community and it would help us tremendously thank you again or taking the time to wright this and get this message out there something we ant do cause no one will listen because they dont care or know the feeling

  • Newsflash! Suboxone IS an opioid. It’s an opioid that’s about FORTY TIMES STRONGER THAN MORPHINE. It also has a DANGEROUSLY LONG HALF LIFE of up to 2.5-3.0 DAYS compared to regular strength IR opioid medications’ four hour half life. For this reason, the withdrawals from Suboxone/Methadone can be exceptionally brutal and last as long as THIRTY DAYS as opposed to the 0-7 day withdrawals of regular IR opioid meds, depending on strength, proper usage, and duration of treatment with the latter.

    Author, you wrote, “Most buprenorphine-related deaths occur when the drug is mixed with alcohol or sedatives.”

    Newsflash 2! That’s because…..drum roll…..bupe is AN OPIOID! Which is why the EXACT SAME RULE applies with ALL opioid medications. Taken as directed, they are 100% safe, especially among legacy patients who, after many years on the medication, are protected from the dangers of overdose by the physiological process of tolerance. After a period of time, it literally becomes impossible for the legacy patient to overdose unless it’s intentional. Prescribed opioids are nontoxic – can’t say that about Tylenol or Advil/Motrin! – and almost NEVER cause death or injury to the patient who takes them as prescribed without the presence of other substances or an undiagnosed, underlying condition.

    The REAL, STATISTICALLY PROVEN FACT is that prescription opioids are the SAFEST and MOST EFFECTIVE analgesics available today.

    The media have promoted and perpetuated a worldwide hysteria and pandemic of opiophobia that is based entirely on a completely FALSE narrative which was floated by politicians and Suboxone investors who are all foaming at the mouth to (A) get the public scared and (B) get all chronic pain and SUD patients on buprenorphine so that the former can boast about having resolved a fake crisis that never existed among prescribed opioids, because they’re unable to resolve the real crisis which is ILLICIT opiates – heroin and “IMF” Fentanyl – and so the latter can line their pockets with the billions in profits made from the mass prescribing of Bupe.

    Media is a powerful tool. Perhaps the most powerful, most influential tool we have. So be careful. Don’t be a lemming. Don’t believe everything you are spoonfed by media, just like you don’t believe everything politicians say. Be smarter than that. Be discriminating. The real truth and statistics are out here for anyone’s perusal, published in black and white on the WWW, often by the very same entities who are misleading you. The CDC is one of them. Find their charts. Read the numbers. DO THE MATH. Then ask your govt why they’ve been lying to you, and ask yourself why you’ve been believing them. Or, in the case of this article’s author, why you’ve been perpetuating the false narrative. Because it’s truly a damn shame what’s happening in America right now, and across the globe. Chronically ill people are out here dying by suicide every day because of the lies. And you or someone you love WILL eventually be affected by this unjustified War On Prescription Opioids.

    #thereneverwasaprescriptionopioidcrisis
    #fakenews #thecrisisisheroin #takingawaypillsforcespatientsontoheroin
    #populationcontroltheory #googleCIAmethlabexplosion #USgovtwasincontrolthewholetime #DOJreportsandstatistics #sleightofhand #smokeandmirrors

    • JPA, do you have an Addiction Disease?… There is a Crisis! A BIG ONE!!! I think it’s sad for the ones who can’t see it. I have to many Friends and Loved Ones to this Crisis to say there has never been a Crisis! I do however think it’s a Conspiracy for the Government to make Money.

  • I have been on buprenorphine for over 12 yrs for pain. I take a very small dosage but it helps to just take the edge off and keep me going. I would rather eat glass then go to these insurance scamming opioid management doctors to get this prescription. I completely agree with this article and would love to get involved somehow to deregulate this drug that would benefit so many.

    • Todd, I’m right there with you. I take 8 mg twice a week. Sometimes I forget.
      My pricey spine specialist (Read: Dopeman) told me Suboxone was illegal for chronic pain, but then Prince died, and I read about a treatment center in California he was supposed to attend, and Suboxone was tentatively in his treatment plan. Then I read how you can titrate down to lower and lower doses, and less side effects, (OIC) less kidney toxicity (this is what physicians have written) and then…..the articles about Suboxone and chronic pain Completely VANISHED!

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