WASHINGTON — Eighteen state public health directors, a growing group of physicians, and a prominent member of Congress are pushing a dramatic expansion of substance use treatment by posing a simple question: Why can’t doctors who prescribe opioids also prescribe drugs to treat opioid addiction?

Their push to deregulate use of buprenorphine, which is used to lessen opioid cravings and withdrawal symptoms, would represent a fundamental shift in U.S. addiction treatment. The medication — and addiction medicine in general — are highly regulated, largely due to fears that opioid-based treatment drugs like buprenorphine and methadone could be misused.

This week, the effort will gain support from Washington: Rep. Paul Tonko (D-N.Y.) will soon introduce legislation to allow any medical practitioner licensed to prescribe controlled substances to prescribe buprenorphine, he told STAT. Currently, physicians must undergo an eight-hour training to prescribe the drug — 24 hours for nurse practitioners and physician assistants.

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“These professionals can use their training and skill and ability to provide medication for treatment of pain,” Tonko said in an interview. “But when it comes to addressing the illness of addiction, they have to jump through additional hoops.”

The bill, Tonko said, “removes unnecessary obstacles and really expands the access we’ve created to provide for treatment on demand.”

Tonko’s push — though in its early stages — gives formal backing to an effort by treatment advocates who have long argued the federal government’s response to a crisis claiming 50,000 lives each year has been irresponsibly slow and at times counterproductive.

This month, top health officials in 18 states, three U.S. territories, and the District of Columbia wrote health secretary Alex Azar urging him to relax restrictions on the addiction medication.

Deregulating buprenorphine would make it far easier for Americans to get addiction care from their own doctors instead of being pushed through bureaucratic hoops and into treatment programs of varying quality, said Dr. Andrew Kolodny, the co-director of the Brandeis University Opioid Policy Research Collaborative. Currently, just 1 in 20 doctors have obtained the license necessary to prescribe it.

“For your average person who is opioid-addicted, who may have a relationship with their primary care doctor who they know and trust,” Kolodny said, “there’s a 95% chance that doctor is going to have to say: Well, let’s find a place to send you.”

The movement, however, appears to lack institutional support from major addiction medicine groups, including the American Society of Addiction Medicine. The National Council for Behavioral Health, which represents mental health and addiction providers, has no position on the proposal.

Opponents of deregulating addiction medicine say it could encourage more people to use buprenorphine illegally. In recent years, the Drug Enforcement Administration has raided the offices of numerous physicians who prescribe buprenorphine, including a leading addiction doctor in Tennessee and the past president of the American Society of Addiction Medicine, to investigate whether the high-volume treatment facilities had effectively become “pill mills.”

Those raids have come in spite of the DEA’s own acknowledgment that most diversion — or illegal sales and misuse — of buprenorphine is effectively a means of obtaining addiction-treatment drugs. Most illegal use stems from “the failure to access legitimate addiction treatment,” the agency wrote in a 2016 report, and could be curtailed by expanding legal access to the drug.

To assuage concerns of drug misuse, advocates have pointed to France’s approach in the mid-1990s, when buprenorphine was first approved for use there. With no limits on who could prescribe the drug, overdose deaths fell by nearly 80 percent between 1994 and 2002. The successes were credited in large part to aggressive buprenorphine prescribing, though the country did contend with some buprenorphine trafficking and illegal sales.

The prevalence of HIV, which is often associated with injection drug use, also dropped from one-quarter of all injection drug users to just 6% by 2010.

American advocates say their objectives are largely the same: to mainstream addiction treatment and allow patients to obtain medication from their own doctor instead of a convoluted referral process.

Patients who use nonprescribed buprenorphine could even be more likely to succeed in treatment, said Dr. Sarah Wakeman, an addiction medicine specialist at Massachusetts General Hospital.

“The vast majority of patients now that I start on buprenorphine have tried it before on the street, mostly as a means of addiction treatment,” she said, pointing to research that suggests better outcomes for patients who had tried buprenorphine in nonclinical settings (and therefore obtained it illegally).

But arguing that diversion of a controlled substance can yield positive public health outcomes, Wakeman acknowledged, can prove politically tricky.

“We want people to be getting medication from health care providers,” she said. “The question with buprenorphine diversion is how you best reduce its nonprescribed use — and the answer is probably expanding access to treatment.”

Others have questioned whether physicians prescribing the drug without training could increase rates of patient harm, particularly if some started to take dangerous combinations of opioid-based drugs and anxiety medicines or alcohol. Prescriptions for treatment drugs, they also argue, should be coupled with services like psychosocial counseling.

“I’m not saying to you, let people die rather than let them get access,” said Mark Parrino, a longtime advocate and president of the American Association for the Treatment of Opioid Dependence, a group representing providers of methadone, an addiction-treatment and pain drug regulated even more tightly than buprenorphine. “My view is, if they get access, make sure you’re building in systemic responses that they will at some point get more than the medication.”

The division between groups like ASAM and a newer wave of addiction doctors like Wakeman has led to fears that the buprenorphine-expansion effort could resurface long-simmering tensions between providers of the few treatment drugs.

Recently, the Massachusetts drug maker Alkermes has aggressively marketed its addiction-treatment medication Vivitrol — which is not an opioid — as a “non-addictive” medication, attempting to draw a contrast with its two competitor, opioid-based medications.

And in the early 2000s, when buprenorphine was first approved, some treatment advocates, including AATOD and other methadone providers, lobbied to keep buprenorphine tightly restricted. Initially, physicians waivered to prescribe the drug could only treat 30 patients — a cap later relaxed to 100, then 275.

Tim Condon, who worked as the associate director for science policy at the National Institute on Drug Abuse, said it took substantial advocacy to prevent the DEA from classifying buprenorphine as a Schedule II drug, which would have prevented doctors from prescribing it in office-based settings.

But the limited risk associated with buprenorphine, some experts argue, does not justify an aggressive law-enforcement response or maintaining tighter regulations than for potentially addictive pain drugs.

“There are two things we should worry about,” Kolodny said. “Whether a diverted opioid is going to increase the incidence of opioid addiction, and whether or not the diverted opioid is killing people. And in the case of buprenorphine, the answer for both is no.”

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  • I am on Medicare. I searched for a doctor in my home state of Montana. There was just 2 providers within 150 miles of me. Both were full and neither accepted medicare. I was prescribed oxycodone so I ended up trading my oxy 30 for strips of Suboxone.
    There is a chain clinic came to town later on. After the .gov made doctors stop Rx’ing pain meds I was able to use the Suboxone clinic since the chain store clinic is credentialed to accept Medicare. It would be to rural states advantage to have any doctor able to prescribe suboxone. The kicker is these doctors and clinics do not want drug addicts in the waiting room with mainstream patients.

  • I absolutely agree that the regulations on the prescribing of buprenorphine-based medications should relaxed. I also agree that buprenorphine-based medications can save lives. If a regulated medication keeps one with a severe addiction from using dangerous street substances – even for just a 24 hour period – then it should be used! If a recovering addict requires a buprenorphine-based medication for the rest of their lives and that continues to reduce their cravings, then it should be used! The government needs to keep their noses out of our health care.

    Having said all that, I want to know why Andrew Kolodny and the other anti-opioid zealots advocate for the prescribing of a synthetic opioid that is roughly 40 times stronger than morphine (when compared mg per mg and in those who metabolize these medications “normally”) to those with recent histories of purposely misusing and abusing opioid-based substances WHILE – at the same time – deny the prescribing of the same class of medication (opioids, which were originally approved to reduce physical pain) to those suffering from severe physical pain.

    Again, if a regulated medication can make one’s life worth living (whether that quality of life is severely affected by addiction or constant physical pain), then it should be prescribed. Currently, the anti-opioid zealots advocate THEIR opioid of choice (buprenorphine) ONLY when used to treat patients burdened with addiction while DENYING that same class of medication to patients suffering from severe pain.

    America, you’d better wake up and get your heads out of the sand. Government bureaucrats and law enforcement agencies should have NO SAY in health care, setting quotas for the production of medication, dictating who “deserves” relief and who doesn’t, etc. Currently, the opioid-hysteria is making it near impossible for even cancer patients to receive adequate pain relief.

    Doctors are now too afraid to prescribe the ONLY class of medication known to reduced severe intractable pain and chronic pain patients are the ones suffering. Many have been forcibly tapered and even cut cold turkey from medication that allowed them to have some quality of life, dignity and independence for many years. Some of these victims of the government’s war on prescription opioids have taken their own lives simply because they could no longer access medication that allowed them to live their lives.

  • Where do we draw the line for the doctor’s responsibility? I went to the yellow pages about 13 to 14 years ago because of a Norco habit turning into an oxycontin. Low enough dosages to take me down and lesson the withdraw. It should have been a week or two detox. The doctors from 2 clinics (oakland) (Sacramento) were my clinics but if you are not at a pain clinic you will never get off the med per my experience. I could ask for any dose, with-in reason. When talking to them about getting off they leave it up to you the addict. They don’t promote it because the money it brings in. When discussing with 2 different doctors was given the same answer ” If you were diabetic would you take insulin”? The clinic started me on 2x a week to come in but then went to once a month. The fee’s are how they make the money and don’t have any desire to lose them. My counseling at $250 per visit plus the doctor visit was $125 the money wasted makes me sick. I spend well in excess of 100k because of the time period being so long. Now trying to get work had been a stable worker never any problems. I get to the second interview and they run a background and even though you should not be disqualified they took me out of the running. Here is my complaint I went to see them with my wife to support me to get off the medication. Getting 1 8mg per day or 4 8 mg per day was easy to always get them to raise the dosage. Little did I know the hole I had dug. Sorry had to write this quickly. But if you primary could write the perscription it would help. But the clinics also need to hold part of the blame for letting this go on and not helping the person get off the drug. Email me if you want to know how I cut back. I am at 1/4 of a 2mg pill. Sure I want a little more but stay busy and tomorrow will be better.

    • I am trying to find a way to help increase the number of Suboxone providers in my state. Just yesterday I was told where to find a much more accurate list of Suboxone providers. It’s written down at home. I’ll come back in and leave it in a comment later. What state are you in?

  • I wonder if Dr. Tonko gets campaign contributions from the makers of Suboxone. I would be very careful allowing all docs to prescribe this drug. It has been associated with abuse in other countries.

  • The interesting and primary use of buprenorphine in the opiate addicted population is to help alleviate opiate withdrawal symptoms during an unexpected lull in the availability of their opiate of choice, and it is effective. However, an opiate dependent person will always choose their opiate of choice over buprenorphine products, if both are available. The only silver lining would be in the chance that an opiate addicted person would see the light, and realize that buprenorphine is a much safer alternative for life.

    • Addiction treatment research shows that some addicts do finally get off their merry-go-round of MAT in-n-out. However, few leave addiction via MAT. They realize that abstinence is a healthier path. Nobody knows what decades on opioids does to the aging brain. One odd finding, Yih-Ing Hser at UCLA who has been tracking an addict group of vets for many decades found that a) half are dead by now, but b) of the half still alive, half of them – many in their 60-70s were still shooting up – geriatric addicts! [Smyth Hoffman, Fan, Hser (2007). Preventive Medicine 44 (2007) 369–374.]

  • Seriously, this is a development that is only in baby-shoes stage? Are regulators and politicians only NOW waking up to the uber-logic of real solutions? Some 20 years after other western civilizations ????
    Oh my, America the Great is in deep trouble, it is in fact not so great all.

  • The picture at the very beginning of this article showed Suboxone (a combination of naloxone and buprenorphine that has been very successful in treating addicts who want to stop using opiates.) So why was the entire article about buprenorphine alone? That’s old school.

    • It’s talking about all forms of buprenorphine. Suboxone is one of them, but not the only one that is prescribed.

  • Did cold turkey on a 20 year nicotene addiction…NOT the way to go… Give doctors something to work with for patients and definitely do not stop everything and punish pain patients! Drug abusers and addicts who don’t care cannot be helped. Sorry.

  • Please stop using suboxone and buprenorphine interchangeably. Buprenorphine is one part of suboxone, which also contains nalaxone. When I see this at the beginning of an article, I don’t take the rest very seriously because they haven’t done their homework.

    I am one of those people with chronic pain syndrome and I use buprenorphine for pain. I get crazy when I go to the ER and an uninformed physician thinks I’m a drug seeker!

    • Hi Beth,
      I’m in the same boat but not by choice. In this new era of post opiod excess and attendant paranoia for opioid prescribing, I too am using Buprenorphine for pain management.
      Have a couple of questions, hope you don’t mind.
      1. Were you using another opiod medication prior to Buprenorphine?
      2. do you find this medication effective?
      3. Does this medication leave your mind cloudy?
      I’m a Scientist now retired that puts a lot of value on being able to think clearly. I used oxycodone for about 20 years without any significant brain fog as a side effect.
      With this med, the pain relief is not as effective and the mental fog would’ve kept me from doing my job. I’m now retired but still I like to be able to think straight.
      Given that this is my only option I ask just out of curiosity
      Everyone is different with how each medication affects their cognitive function so please don’t let my complaint ruin your effective Medical treatment
      Thanks,

      James

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