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| Buprenorphine Control Outlined |
| News Briefs - News Briefs | |
| Written by Jenna Bensoussan | |
| Thursday, 28 February 2008 | |
|
WASHINGTON - Amid growing illegal sales and abuse of buprenorphine, top
federal officials outlined yesterday action they might take to curb
problems with the addiction-treatment drug, including more precise
detection methods, improved training of doctors and stronger warning
labels for patients. "The issue of diversion has been out there since 2004," said Dr. H. Westley Clark, director of the Center for Substance Abuse Treatment, which oversees the federal government's buprenorphine initiative. "We've been concerned about that, and we will continue to be concerned about that." Clark spoke to reporters after a two-day, closed-door summit of experts on buprenorphine, which the government sees as the best medical treatment for hundreds of thousands of people addicted to heroin or painkillers. Introduced in 2003, the drug known as "bupe" has been subject to increasing misuse and illegal sales as more of it is prescribed by physicians, The Sun reported in a series of articles beginning in December. Some patients sell it on the street; buyers use it to get high or hold off withdrawal symptoms until they can get their next heroin or painkiller hit. With tens of thousands of opiate addicts in Maryland, Baltimore and state officials are investing millions of dollars in bupe treatment. Experts say it's safer than methadone - the traditional heroin treatment, normally given out under close supervision - and more likely to appeal to addicts because they can get bupe from their doctors. Though Clark and other officials said they are encouraged that bupe has expanded access to drug treatment, they acknowledged publicly for the first time a need to tighten safeguards over use of the drug, sold mainly under the name Suboxone. Suboxone was developed as a joint project by the National Institute on Drug Abuse and Reckitt Benckiser Pharmaceuticals Inc. of Richmond, Va. An estimated 170,000 addicts are taking it. Many patients and doctors say that bupe pills are extremely effective in curbing withdrawal sickness and help ease cravings for heroin or prescription opiates. The Sun's articles identified a variety of problems the government hadn't acknowledged when it approved buprenorphine. Some users crush and inject the drug, a dangerous practice because it can spread diseases. Many experts told the newspaper that an eight-hour training course required for doctors who prescribe bupe is not adequate and that some physicians are contributing to illegal sales of the narcotic substitute by prescribing it too generously. Dr. David Fiellin, a Yale University professor who directs the Physician Clinical Support System, said that "there are physicians who are practicing outside" the standards of care. Fiellin said the support system, funded by the government, will work with private medical societies to teach doctors how to properly store the medication and to identify patients who might be misusing or selling the drug. "There is not an active surveillance system in place to identify physicians who are practicing outside the guidelines," Fiellin said. When they are found, he said, his group will work to report them. Dr. Charles R. Schuster, a former director of the National Institute on Drug Abuse who tracks abuse of the drug for the manufacturer, agreed. "We have reports from physicians that they know of other physicians not practicing within the standards of care," Schuster said. The biggest problem, according to Schuster, is that some doctors are prescribing 30-day supplies of the pills to addicts after only a single visit. While that's legal, Schuster said, doctors should become comfortable that a patient is not abusing the drug before prescribing large amounts. "A small minority of doctors are not practicing good medicine," he said. "That's a problem we need to be concerned with." Experts and officials identified other problems, including doctors who provide little counseling. An official with the NIDA said studies are showing that buprenorphine works better with pain-pill addicts, not heroin abusers. Schuster also said he learned at the two-day conference that federal government drug-abuse warning systems were considering ways to add new medications to their watch lists. "Currently they are designed for detecting the use and abuse of drugs that have been around for quite a while," he said. Dr. Celia Winchell, a medical officer for the U.S. Food and Drug Administration, which approved Suboxone in late 2002, acknowledged that some abusers are able to crush the pills and inject the drug despite the presence of a chemical intended to deter that. "Certainly, we're concerned about diversion and abuse," she said. Winchell said the FDA is evaluating whether to strengthen warnings on the drug labels to "prevent diversion" and alert doctors and patients to adverse effects that accompany misusing it. "We're exploring if there's anything left unsaid in packaging," Winchell said. But the government can do little to alter doctors' practices. The Drug Addiction Treatment Act of 2000, which authorized buprenorphine treatment, forbids the government from interfering in private medicine. Federal regulations allow doctors to prescribe a 30-day supply of buprenorphine and up to five refills, a practice that is far more lenient than in most countries. Canada, for instance, requires that a patient be in treatment for two months before receiving Suboxone to take unsupervised.
--The Baltimore Sun
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