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 used suboxone to get off opioids.Took it for 4 months,never more than two mg at a time,once a day.I tapered off the suboxone over a 45 day period.I was sick for almost 4 months with suboxone withdrawal and would tell anyone that thinks that this will help them get off opioids to just face the withdrawal and get through it.Suboxone is just substituting one opioid addiction for another that is worse than heroin withdrawal

  • Luke: Thank you for the response. I see you are in the NYC area.
    You mention my son’s to cooperation a treatment option. I agree.
    He is in self denial and has detoxed several times always referring to his conception drugs are not the problem; an underlying undiagnosed stomach ailment is to blame. UCLA Reagan center and several gastroenterologists will disagree in the fact nothing has been found for years except a common use of prescribed opioids and little coordination and follow up since 12 years of age.
    I look forward to a talk with you.

  • The two statements concerning the existing methadone cartel’s lobbyist efforts and the French efforts bring up two points.
    One effort is to protect marketing territory, financial interest, and a growing industry of remedial expensive treatment. The French model seems to strive to solve a problem of addiction.
    As a father with a son in prison awaiting a treatment avenue to return him to society in a progressive capacity and investigating the treatment scene; I can only come to the conclusion the social support system of a healthy America is not the priority.
    Financial gain is the instituted program.
    Let’s be honest here.

  • There is a need for for prescribers however the fact that medical professionals with typically no formal education in addiction during medical school and only an 8 hour on line course is greatly concerning. Lack of knowledge about addiction has the potential to make the issues worse. There are individuals who are opiate dependent and those who meet criteria for opiate use disorder. Very different needs. The system wants to treat them the same. Individuals with OUD are often very complex with many other issues and treatment needs that may go undiagnosed. Prescribers need more than an 8 hour on line course.

  • Buprenorphine daily has great data, big difference in relapse rates in 6 wk or 12 wk, but, most of it is industry sponsored and short term. Often, the control group has 100% relapse in a couple weeks, which suggests that it isn’t a fully committed control group (not even 1 in 100 or 1 in 250 is abstinent in 4 weeks?? Really?) There isn’t such great data known yet for 2- or 5-year outcomes with Rx assisted management.

  • Yes, we need to open up access. I took the Nurse Practitioner training and worked in a Methadone clinic where I had to confront my own ignorance.
    I had had no REAL understanding of how addiction destroyed peoples lives and ripped their families apart. I have come to acknowledging my negative prejudices and am learning all that I can from colleagues who have open and accepting attitudes. It is not easy to change beliefs about others is it? Thank you for the article. Melanie ARNP

    • Yes. It seems to be a good, common sensical approach they are taking now. The right people are taking command. Dr. Kolodny! I wish you would please step back and stop meddling in this process! I will never come to grips with why he always seemed to want to make trouble for others.

  • Allowing Buprenorphine to become more widely and more easily available is probably the stupidest thing I ever heard! Firstly, having a patient get off of Suboxone is almost as difficult as Opioids . Secondly, what these people will do is take Suboxone until they can get more opioids so they don’t go into withdrawal. Therefore allowing these
    patients to stay addicted to opioids for ever !

  • This policy proposal may have terrible unintended consequences. Physicians and even nonphysicians may be allowed to write scrips for opioids (suboxone) to people who are either not addicted (but then soon will be) or who need more than just pills to stay off illegal drugs. Opioid agonist drugs do not cure addiction – just the symptoms. Stop medicating and patients go into opioid withdrawal just like with heroin or other opioids.

    The relapse rate for suboxone and methadone is not much different from abstinence treatments – very very high. So, relaxing who can prescribe opioid agonist meds, and to how many patients, might make the public feel good, but it definitely risks kicking the epidemic can down the road to an even worse epidemic in the near future. If I was Big Pharma, I would be doing a happy dance about now.

  • I would just like to thank the pharmaceutical companies for developing opioids for the many of us who suffer in pain. We realize that there may be some greed in your business, but the benefits of your pain medications far outweighs the detriment for us.

  • Follow the money. More medications for a problem worsened by medications in this “new epidemic”. What is your answer doctors for the rapidly growing methamphetamine “problem”? Whatever happened to sobriety and recovery

    • I have the benefit of over half a century of experience in the treatment of opioid addiction. When private medical practitioners were permitted to treat the addicted the result was widespread diversion of methadone, overdose deaths, and the creation of experimenters who often became full-blown dependents. Subsequently, methadone clinics were born and doctors were no longer able to prescribe legally. My question is ,”What has changed that assures this policy will not have the same devastating outcomes?” People dependent on drug misuse LOVE doctors. They are easily manipulated and do not have the time necessary to adequately provide comprehensive treatment for each patient. Substitution drug treatment MUST have an intensive counseling component for the masses to be stabilized and hope for a full recovery. This policy will fail on a grand scale miserably.

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