The cost of buprenorphine treatment and the 30-patient limit on physicians
who offer the in-office opioid addiction treatment were identified as the
leading barriers to broader physician use of this intervention, a recent study
The study was required by the Drug Addiction Treatment Act of 2000, the
legislation that legalized the office-based treatment for addiction to heroin
and opioid painkillers.
The findings also undercut concerns that led to the inclusion of the law's
requirement that physicians can provide buprenorphine treatment to no more
than 30 patients at a time. Despite concerns by federal drug officials, little
evidence has emerged that the only available office-based treatment for opioid
addiction has spurred further illegal drug use.
In 2005 the law was amended to eliminate the 30-patient limit on group
practices and entire clinics.
The study reported on the results of surveys conducted by the Substance
Abuse and Mental Health Services Administration's (SAMHSA) Center for
Substance Abuse Treatment. About 1,800 physicians who have received waivers to
prescribe the drug were interviewed, as were nearly 400 drug abusers under
treatment with buprenorphine. The data represented responses received through
The surveys found consistently high treatment continuation or treatment
completion rates among all treatment groups, and 74 percent of prescribing
physicians reported the drug was effective by one month into treatment.
The study found evidence that the 30-patient limit has, however, had a
major impact. More than 25 percent of physicians reported that the limit led
to reduced prescribing of buprenorphine.
A separate postmarketing survey required by the Food and Drug
Administration and conducted by researchers at Wayne State University
similarly found that in the first quarter of 2006, among surveyed physicians
who prescribe buprenorphine, 29 percent had turned away at least one patient
because of the limit. On average, physicians turned away 9.3 patients, with a
total of 2,009 patients turned away by the survey respondents.
"I was surprised how high this number was, and it speaks to the need
to raise the limit and increase the number of physicians who provide this
service," said Charles Schuster, Ph.D., the postmarketing study author
and director of the Clinical Research Division on Substance Abuse at Wayne
State University. Schuster made his remarks during a Senate symposium on
buprenorphine in August.
The postmarketing study, which included surveys of physicians and drug
abusers and Internet searches to gauge the level of abuse of the drug, found
little illegal diversion. The three-year study found buprenorphine treatment
is clinically effective and well accepted by patients and has increased the
availability of medication-assisted treatment well beyond the estimated
240,000 methadone treatment slots available.
Although federal drug-enforcement officials expressed fears that
buprenorphine would work its way onto the illicit drug market, the
postmarketing study was unable to identify a single case of a drug-addicted
patient who began his or her drug "career" with buprenorphine.
Herbert Kleber, M.D., director of the Division on Substance Abuse at the
New york State Psychiatric Institute and a former deputy director in the
Office of National Drug Control Policy, said at the Senate forum that
office-based buprenorphine treatment has brought into treatment many patients
who were reluctant to seek care when the only option was frequent attendance
at a methadone clinic. The treatment of an estimated 200,000 patients by more
than 7,800 physicians authorized to prescribe buprenorphine has not had the
negative outcomes feared by some drug enforcement officials.
Kleber and others at the symposium said that blame for the lack of access
to treatment for the estimated 1 million heroin addicts and 4.4 million
nonmedical users of prescription opioid analgesics also lies with insurance
programs that do not adequately cover buprenorphine's cost or the costs to the
prescribing physician who provides this intervention. Many unemployed people
and low-income working people, for example, lack access to medical care, and
many addicts are unaware that the medication is an option available to
The SAMHSA surveys found that nearly half of the prescribing physicians
surveyed reported that the cost of the drug was among the top challenges to
Another limit repeatedly cited by physicians at the symposium was the
reluctance of many physicians to deal with "both the stigma attached to
addicts and the extensive oversight exercised by federal and state law
enforcement agencies," Kleber said.
Congressional supporters of buprenorphine treatment promised they would
push for removal of the 30-patient limit on physicians authorized to prescribe
"We need to remove this limit and frankly, I don't know how anyone
could oppose that at this point," said Sen. Orrin Hatch (R-Utah), in an
interview with Psychiatric News. He said he plans to push for removal
of the limit before the end of the current session of Congress as a
crime-control measure. The measure is included in legislation to reauthorize
the Office of National Drug Control Policy (S 2560), which the full Senate is
slated to consider in September. There is no House bill aimed at removing the
Sen. Carl Levin (D-Mich.), who described the buprenorphine treatment option
as a "landmark" in addiction treatment, said more effort is needed
to expand the treatment's use beyond the less than 2 percent of primary care
physicians authorized to use it. He noted that only 2,910 general
practitioners out of 242,924 have been certified to prescribe the drug. The
evidence of the treatment's benefits and lack of adverse impact, Levin said,
show the need to remove legislative limits that have resulted in long waiting
lists and lack of access for many addicts.
"This [SAMHSA] study confirms our hopes about the effectiveness of
buprenorphine and also helps to illuminate the things that need to be done to
help more patients reach this powerful medicine," Levin said.
Supporters of buprenorphine treatment hope to increase physician
participation by expanding the required eight-hour training sessions to
include an online alternative. Elinore McCanceKatz, M.D., Ph.D.,
president-elect of the American Academy of Addiction Psychiatry, said her
organization—like APA— developed a Web-based course that leads to
waiver eligibility. The alternative will make it easier and less costly for
physicians to receive training in office-based opioid addiction care.
"Going forward, we plan to continue to try to train as many
physicians as possible to provide these services to patients," she
Further information on buprenorphine treatment is posted at<http://buprenorphine.samhsa.gov>.
APA's online buprenorphine course is posted at<www.psych.org/edu/bup_training.cfm>.▪