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Nicholas Reuter, an analyst for the U.S. Department of Health and Human Services, says current regulations, established in 1972, are dated and apply to a breed of clinics that is practically extinct. The government pushed for five years to come up with new regulations that are applicable, appropriate and enforceable -- especially for the private clinics that have supplanted public ones.
Under the new guidelines, clinics will have to be federally accredited, like hospitals. They will have to prove that they meet accreditation standards every three years, and they must be accredited by summer 2003. Three Atlanta-area clinics, including GPA Treatment, already have been accredited.
"We feel that the accreditation system does carry a degree of enforceability," Reuter says. "Programs that are seriously non-compliant with accreditation standards need to face sanctions. In some case, very, very severe sanctions."
The federal accreditation standards are similar in many ways to current state rules. Clinics will have to have policies in place for admitting patients, drug-testing them, increasing dosages and prescribing take-homes.
But the new standards ensure that the clinics are regularly checked, and they endorse a major philosophical switch that allows methadone to be treated more like traditionally prescribed medications. The most sweeping change is that certain patients will be able to take home 30 doses of methadone. The privilege will be reserved for those who have been on methadone at least two years and who have not failed a drug test in that time.
Reuter says that when he helped develop the new standards, he had to consider the risk that some of those 30 doses will be sold.
"We consulted with the DEA very closely on this provision and they supported it," he says. "There are many, many patients who can responsibly handle medication, who would derive a significant benefit from having a monthly take-home supply."
He says patients who have been stabilized on methadone for years ought not to have to visit the clinic once a week just to pick up medication. That doesn't contribute to their rehabilitation and may actually deter people from staying with the program.
"That was kind of a trade-off," he says of the take-home provision. "But I think it's a reasonable one and a realistic one."
Atlanta Metro director Walters says he would consider the 30-day take-homes for fewer than 10 of his 235 patients.
"I don't like it personally," Walters says. "You have somebody who's been on methadone that long, it's time for them to come off. Why give you that much medication? To me, you just open the door for a chance to make a mistake, to relapse."
Some people close to the addicts themselves are wary, to say the least, of the 30-day take-home idea.
"It's laughable," says one Atlanta drug counselor who deals with recovering heroin and methadone addicts.
Whatever the impact of federal accreditation, methadone will continue to present a danger that no set of regulations can fix: used exactly as intended, it can kill you.
Methadone is slow-acting, which is why patients only need to take it once a day. But because it stays in the body so long, it can start to accumulate after many overlapping doses. A patient can take 100 milligrams today and still be feeling the remnants of yesterday's dose or the dose from two days ago. "This effect may account for the deaths in patients that occurred when methadone was initiated at high doses in methadone maintenance programs," according to a study published in the Western Journal of Medicine.
While the industry marches on, new regulations in tow, some medical professionals are raising concerns about the way methadone is being used in clinics. A commentary in the same Western Journal issue, dated Jan. 1, 2000, asks whether methadone is a miracle cure or an evil substitute. "Simply providing a long acting synthetic opioid to patients who have ... pressures to maintain their addiction cannot be expected to prevent an overdose, the misuse of other drugs, infections and crime," wrote Dr. Robert Hoffman of the New York University School of Medicine.
Dr. Ganiat Jaiyesinmi, a psychiatrist who treats indigent drug abusers at the DeKalb Community Service Board, says methadone treatment -- regardless of regulations -- is inherently flawed.
"You become dependent on it. You become tolerant to it. You have to take a higher dose so it has the same effect. But when do you stop?" she says. "I just don't advocate it."
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