Clinton
Administration
Proposes
Changes
to
Methadone
Regulations
7/30/99
The US Department of Health and Human Services (DHHS) this week proposed new regulations for methadone treatment, including a federally supervised accreditation system for all methadone clinics that is intended to improve standards of care nationwide. Currently, some 800 methadone clinics, serving 180,000 patients, operate around the country under widely varying state regulations. Since 1972, federal oversight for methadone programs has been the responsibility of the Food and Drug Administration (FDA), which focused more on making sure methadone was not diverted from clinics to the street than upon the quality of care patients received. Under the new proposal, that responsibility would shift to the Department of Health and Human Services' Substance Abuse and Mental Health Administration (SAMHSA), which would manage the accreditation process. Methadone, widely acknowledged to be the most effective medical treatment for heroin addiction, has long been the most regulated drug in the US pharmacopoeia. Even patients who have remained successfully in treatment for years are required to submit to frequent drug tests, and are allowed no more than a six day supply of the drug without a special dispensation from the FDA. The proposal suggests options that could offer clinics and users greater flexibility, based upon individual circumstances, and opens the door to physicians being allowed to prescribe methadone in private practice. The proposed changes were hailed as "a major step forward" by White House drug policy chief General Barry McCaffrey, who said they represent "a fundamental shift in the way we approach drug abuse treatment in our nation." McCaffrey, who has vociferously opposed HIV-prevention measures such as needle exchange, has nevertheless been an outspoken supporter of methadone maintenance. Last year, he went to bat on the issue against New York City mayor Rudolph Giuliani, who wanted to shut down that city's methadone programs. But not all methadone advocates are as enthusiastic about the proposed changes as McCaffrey. DRCNet spoke with Dr. Robert Newman, president of Continuum Health Partners, which operates the country's largest and oldest methadone program at Beth Israel Medical Center in New York. "To the extent that the goal is to expand treatment capacity, it's not clear to me how this proposal will be effective," Newman said. "It basically replaces one regulatory process with another, and the new process seems more complicated, and is certainly, according to DHHS, twice as expensive. I don't see any way that general practicing physicians will be able to accommodate the requirements, especially such unprecedented requirements as developing a plan to prevent diversion of the medication." DHHS estimates that once the new regulations are in place, reporting requirements for an accredited clinic or practitioner will take at least 1,300 hours per year -- fewer than under the current rules, but still a terrific burden for a general practitioner. Still another obstacle to greater access to methadone is state regulations, which in many cases are more restrictive than the current federal laws. Eight states ban methadone altogether, forcing some addicts who want treatment to drive long distances as often as several times a week. While states will have to cede their certification powers to the federal accreditation program, the new federal regulations would not prevent states from imposing further restrictions, including banning the drug. Nevertheless, many methadone advocates are hopeful that the proposal is a step in the right direction. "I'm hoping that one of the main things this will do is bring methadone into mainstream medicine," said Joycelyn Woods, executive vice president of the National Alliance of Methadone Advocates. Woods said she was encouraged that patients were included in the process of developing the new regulations, and that SAMHSA was better equipped to address patient concerns than the FDA. "They've put a lot of thought into inviting everybody into this, and trying to make it work by creating a system that is more open and responsive than what it was. And I think if you've got that, you've taken your first baby steps," she said. The proposed regulations will be open to public comment until November 19, 1999, after which they will undergo a formal review by DHHS. The final rules are expected next year. The full text of the proposal is online via the SAMHSA web site, at http://www.samhsa.gov/990722link.htm. (To learn more about methadone maintenance, visit the web site of the National Alliance of Methadone Advocates at http://www.methadone.org, and the Lindesmith Center methadone "focal point" at http://www.lindesmith.org/library/focal3.html. Also see http://www.drcnet.org/methadone/ for "Prescribing Methadone, Pursuing Abstinence" by Dr. Robert Newman, as well as DRCNet's interview with Dr. Newman from issue #51 of the Week Online, http://www.drcnet.org/wol/051.html#newman.)
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