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The National Alliance of Advocates
for Buprenorphine Treatment

Buprenorphine (Suboxone®, Subutex®3, Zubsolv®4, Bunavail™5, Probuphine®6) is an opioid medication used to treat opioid addiction in the privacy of a physician's office.1 Buprenorphine can be dispensed for take-home use, by prescription.1 This, in addition to the pharmacological and safety profile of buprenorphine, makes it an attractive treatment for patients addicted to opioids.2

Why are doctors limited as to how many people they can help with buprenorphine?


DATA-2000 was written to allow for opioid-based drugs (specially FDA approved for the treatment of opioid addiction) to be used in an office based setting by certified physicians. In 2002 Suboxone/Subutex became the first drugs that physicians could use. Since then, other brands and generic offerings have become available. As a compromise to passage of the law, arbitrary patients limits were enacted, at first limiting doctors to only helping 30 patients concurrently. Many patients and physicians have complained that the law is too restrictive because almost every physician can prescribe potentially addictive medication but once a patient becomes addicted physicians are restricted on how many they can treat for addiction. Plus, there was insufficient evidence to support any rationing of this lifesaving treatment.

The law has been amended three times. The first in August 2005 allowed every certified doctor to prescribe to up to 30 patients regardless of whether they are in a group or sole practice. Until then, a group practice had the same limit as a single practitioner, leaving large HMOs only allowed to treat 30 patients total regardless of how many doctors were certified. The second amendment was signed into law 12/29/2006 and allowed physicians who have had their DATA-2000 certification for more than one year the option of increasing their maximum to 100 patients. This change had a great impact on the number of patients that could get treatment, although the need still far outweighed the supply of providers. In 2016 a third amendment added the framework for Nurse Practitioners and Physician Assistants to become eligible to prescribe. Also in 2016 the Secretary of HHS changed the regulations so the maximum number of patients was increased to 275 for qualifying doctors. 

Despite aggressive recruitment efforts over the last decade, only about 31,000 of America's 800,000 potential physicians, have become certified and are eligible to prescribe the treatment, but only about 1/3 of them actually do. This shortage in supply of treatment has had negative consequences including high prices for office visits, limited acceptance of insurance, and limited overall access to this lifesaving care.

Reasons to end the limit

 

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The Purpose of Buprenorphine Treatment:

To suppress the debilitating symptoms of cravings and withdrawal, enabling the patient to engage in therapy, counseling and support, so they can implement positive long-term changes in their lives which develops into the new healthy patterns of behavior necessary to achieve sustained addiction remission. - explain -

The National Alliance of Advocates for Buprenorphine Treatment is a non-profit organization charged with the mission to:

  1. U.S. Food and Drug Administration, FDA Talk Paper, T0238, October 8, 2002, Subutex and Suboxone approved to treat opiate dependence.
  2. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration, 2004.
  3. Subutex Discontinued in the US market in late 2011.
  4. Zubsolv (bup/nx sublingual tablet) FDA approved 7/3/2013 see buprenorphine pipeline graphic -in pharmacies now.
  5. Bunavail (bup/nx bucal film) FDA approved 6/6/2014 see buprenorphine pipeline graphic -in pharmacies now.
  6. Probuphine FDA approved 5/26/2016 - FDA Probuphine press release