In the flurry of activity that Congress undertook before its December
recess, it increased the maximum number of patients for whom individual
physicians can provide outpatient opioid addiction treatment with
buprenorphine from 30 to 100.
Buprenorphine is the only FDA-approved, controlled medication indicated for
treatment of opioid dependence that government-certified physicians may
prescribe in private medical offices.
Since office-based buprenorphine treatment was first legalized in 2000, APA
has lobbied hard not just to increase but to lift the limit on the number of
patients that individual physicians are permitted to treat. The 30-patient
limit resulted in patients being kept on waiting lists for weeks or months for
The new limit was passed in legislation (HR 6344) reauthorizing the Office
of National Drug Control Policy and amends the Controlled Substances Act. It
applies to Suboxone (buprenorphine HCl/naloxone HCl dihydrate) and Subutex
Physicians must have prescribed the drug for a year before they are allowed
to treat up to 100-patients at a time.
Eric C. Strain, M.D., chair of the APA Council on Addiction Psychiatry,
noted, "This increase in the limit is an important step forward in
expanding treatment capacity for opioid addiction and should be especially
valuable for underserved areas where there are few physicians available to
A May 2006 survey of buprenorphine-prescribing physicians conducted by the
Substance Abuse and Mental Health Services Administration (SAMHSA) and the
Center for Substance Abuse Treatment found that the 30-patient cap led more
than 25 percent of physicians surveyed to limit their buprenorphine
prescribing to the point that they could not meet the demand for it
(Psychiatric News, September 1). The survey was conducted to evaluate
the prescribing program as required by the Drug Addiction Treatment Act of
2000 (DATA 2000), which first authorized office-based buprenorphine
Herbert Kleber, M.D., a member of the APA Council on Addiction Psychiatry,
told Psychiatric News that buprenorphine is a critical tool to combat
addiction to heroin, which afflicts about 1 million Americans, and the growth
of prescription opioid addiction, estimated to afflict more than 2 million
The number of physicians certified to prescribe buprenorphine was 9,626 by
mid-December 2006, and was expected to top 10,000 by early 2007, according to
SAMHSA officials. However, the agency believes that only half of the
physicians certified to prescribe the medication are doing so.
The number of certified physicians exceeds initial estimates of federal
officials, who thought before the program was approved that about 6,000
clinicians, or 1 percent of U.S. physicians, would participate.
Supporters of the new limit said it may encourage more physicians to offer
the treatment because the higher limit would increase their experience with it
and make them more comfortable treating addictions.
Kleber, director of the Division on Substance Abuse at Columbia University
Medical Center and a former deputy director in the Office of National Drug
Control Policy, helped to launch an opioid-addiction treatment program with
the Columbia University Department of Psychiatry at New York Presbyterian
Hospital, which treats about 90 patients at any given time. Large
opiate-addiction treatment programs—unlike individual
physicians—have not been subject to the 30-patient limit. Federal
drug-enforcement officials argued for the limit because of fears that
office-based treatment for opioid addiction would spur further illegal drug
use. In July 2006 Congress lifted a provision of DATA 2000 that had also
imposed the 30-patient limit on group treatment practices.
Patients are most successfully treated when they have realigned their
entire lives to support detoxification, and physicians generally"
maintain" such patients on buprenorphine while that realignment
is taking place. Because that process is time consuming, said Elinore
McCance-Katz, M.D., Ph.D., president-elect of the American Academy of
Addiction Psychiatry, some physicians faced with patient waiting lists were
tempted to hurry the detoxification process, which can endanger patients'
"People with addictions have serious psychosocial problems that
require extensive counseling, as well as medical treatment,"
McCance-Katz told Psychiatric News.
Edwin Salsitz, M.D., director of the addiction program at Beth Israel
Medical Center in New York City, described opioid dependence and addiction as
a national public health crisis.
"Office-based treatment with Suboxone is one option in the
physician's arsenal, and removing restrictions around its use surely will be
beneficial to patients across the country," Salsitz said in a written
statement. "And, of course, the corollary to removing unnecessary
restrictions on prescribing is that more doctors need to become active in
treating this under-treated and often unrecognized but life-threatening
Information on APA's online buprenorphine training course is posted
SAMHSA provides a physician locator and other information on buprenorphine