SAN DIEGO — Despite the recent potential easing of the federal limit on the number of opiate-addicted patients a physician can treat, substance abuse experts continue to see a pressing need for more buprenorphine slots.
At a recent meeting of the American Society of Addiction Medicine, those experts complained that there were still more potential patients than they can legally treat. These experts are lobbying government officials for a further easing of the limit.
A bill recently introduced in the U.S. Senate by Sen. Arlen Specter (R-Pa.) would in essence relax the limits further. The revision would allow those who have had their buprenorphine waiver for 1 year to apply for more patients.
The Drug Addiction Treatment Act of 2000 created the office buprenorphine prescribing program. Initially, the 30-patient limit established by the act was interpreted to mean 30 patients could be treated per site. However, in August 2005, that provision was amended to mean 30 patients could be treated per physician, regardless of the number of physicians with a waiver who were based at a particular site.
Those attending the meeting cheered and applauded when Mark L. Kraus, cochair of the society's public policy committee, said in a statement from the society that the law “makes absolutely no sense” and “constitutes rationing of care.”
“No other FDA-approved medication has an arbitrary limit as to the number of patients a physician is allowed to treat,” Dr. Kraus said. “If government's major purpose is to prevent diversion, rationing of care is not reasonably related to that goal.”
Currently, about 7,000 physicians have received the training and a waiver for office treatment of addiction with buprenorphine.
No one ventures to estimate the number of potential opiate-addicted individuals who are prevented from getting treatment because of the 30-patient limit. However, it has been reported that clinics in some cities have hundreds on their waiting lists.
And some physicians are known to be openly flouting the limit and exceeding it, with one physician in Massachusetts treating some 600 patients, government officials said at the meeting.
On the other hand, only 20% of 1,059 waivered physicians reported being at the 30-patient limit in a 2005 survey, said Arlene Stanton, Ph.D., of the Center for Substance Abuse Treatment, of the Substance Abuse and Mental Health Services Administration (SAMHSA).
The caveat to interpreting that number, however, is that only 67% of the waivered physicians reported having prescribed buprenorphine and, of those who had prescribed it, 38% used it only to detoxify patients, not for maintenance.
Regarding safety and effectiveness, the buprenorphine program appears to be going well, according to Dr. Stanton's report. In a survey of about 400 patients, 59% were free of all illicit drug use; 81% were free of all opioid use. At the same time, the Drug Abuse Warning Network recorded only 108 emergency department visits related to buprenorphine use in 2004.
By March 2005, 104,640 patients had been started on buprenorphine, with about 65,000 of those patients on maintenance treatment.
Diversion of buprenorphine may be occurring, but it is not considered a problem by federal authorities, said Denise Curry, deputy director of the Office of Diversion Control at the Drug Enforcement Agency (DEA), who spoke at the meeting.
She said there are reports that Suboxone is available on the streets and goes for about $45 a dose in Virginia, but the agency has not found any evidence of abuse and has no confirmed cases of diversion.
The DEA is much more concerned with other problems, particularly methamphetamine, Ms. Curry said.
“We have bigger fish to fry,” she said.
The other, equally important, solution to the lack of availability of buprenorphine for all those who need it is to encourage more physicians to get a waiver, said Dr. H. Westley Clark, the director of SAMHSA's Center for Substance Abuse Treatment.
There are about 500,000 ambulatory-care physicians in this country, but only 7,000 have a waiver. Getting a waiver takes only 8 hours of training, and most states require physicians to have 25 hours of continuing medical education a year, he said.
“We need to convince our colleagues in primary care that they, too, have a responsibility in this,” he said. “We have a large number of physicians who are not willing to deal with this.”
But while increasing the number of prescribers might be a solution in the cities, it may not be in rural areas, according to one person at the meeting who got up to speak.
Rural America has a big problem with illicit opioid use in general and OxyContin in particular. But most primary care physicians in rural areas are too busy already to take on treating substance abusers, said Dr. James W. Berry, of Bangor, Maine.