The addiction treatment drug buprenorphine will come under closer scrutiny through a new federal initiative to track the deaths of opiate addicts taking it or methadone.
U.S. Substance Abuse and Mental Health Services Administration officials hope the new tracking system will significantly improve the safety and quality of drug treatment for more than 400,000 addicts across the country, including thousands in Baltimore.
A series of articles published in The Sun in December showed that while buprenorphine can be a highly effective addiction medicine, misuse of the drug is on the rise. Some people have died when taking buprenorphine with other drugs. But the number of deaths is unknown, because medical examiners in Maryland and most other states don't test for buprenorphine in overdose deaths.
Federal officials disclosed the data collection effort in a Jan. 2 notice in the Federal Register. Drug treatment programs will be asked to voluntarily report information about deaths.
The system will help policymakers identify "preventable causes of deaths, and ultimately take appropriate action to minimize risk and help improve the quality of care," according to the notice.
"We're doing this to get a better handle on any trends," Nick Reuter, a senior public health analyst with SAMHSA, said yesterday. "There's no central repository for that information."
Health officials stress that both methadone and buprenorphine are safe when taken properly and help ease cravings addicts feel for opiates. Using illegal drugs such as heroin or cocaine poses far greater dangers of death or injury, they say.
Methadone has been the nation's mainstay addiction therapy since the 1970s. It is dispensed by about 1,100 clinics to roughly 250,000 people nationwide. To stem abuses, methadone clinics initially require addicts to appear daily for their doses. About 60 percent of the methadone clinics also use buprenorphine for some patients, according to Reuter.
While reliable national figures are difficult to obtain, some states have tied an alarming overdose death toll to methadone. Medical examiners in Florida, for instance, reported that the drug caused 312 deaths in the first six months of 2006 alone, more than any other drug.
Many drug treatment experts believe the vast majority of patients who have died from methadone overdoses were taking the drug for pain and often took it with other drugs.
"We don't anticipate there are many deaths [in methadone clinic patients]," said Mark W. Parrino, president of the American Association for the Treatment of Opioid Dependence. "We're very happy to cooperate."
How much information the government will be able to garner about buprenorphine is less clear.
Buprenorphine, sold mainly under the brand name Suboxone, has been on the market since late 2002. It is prescribed to about 170,000 people, either through clinics or several thousand specially licensed doctors, who would not be part of the reporting system.
Federal officials consider buprenorphine much safer than methadone and are encouraging more private physicians to begin using it to treat addicts. Though it also can suppress breathing if abused, Suboxone has a ceiling effect that limits the danger of overdose as more is consumed. But that effect diminishes when the drug is taken with tranquilizers and other drugs.
Buprenorphine enjoys wide political support. That's especially true in Baltimore. Earlier this week, Mayor Sheila Dixon requested $5 million from the Maryland General Assembly to greatly expand buprenorphine treatment.
Yet Maryland authorities have paid little attention to the drug's emergence as a street commodity.
Some patients illegally sell the orange, hexagonal tablets after receiving them to take at home. Some abusers use the pills to get high or to tide them over when they can't find heroin or other opiates.
Deaths from mixing the pills with other drugs also are likely to escape scrutiny in most states, including Maryland, where medical examiners lack the lab equipment to detect the drug.
The Sun series reported that the drug's manufacturer knew of 13 deaths since the start of 2005 from taking buprenorphine in combination with other drugs. The newspaper uncovered two such deaths the company didn't know about. They occurred in Vermont, the state with the nation's highest rate of buprenorphine use.
Reuter, the SAMHSA official, conceded that the new surveillance system is not likely to capture much information from private doctors, who are not involved in the reporting system but are prescribing most of the buprenorphine used to treat addicts.
A few medical examiners around the country are considering adding tests for buprenorphine as overdose deaths related to abuse of the drug begin to surface.
Dr. Steven Shapiro, Vermont's medical examiner, began this month to test for buprenorphine in every suspected overdose death.
"We're the number one per capita prescriber of this drug and we have no clue how much is out there," he said.
Dr. Margaret Greenwald, Maine's chief medical examiner, wants to routinely test for buprenorphine. But she said the $200 cost per buprenorphine screen is prohibitive.
She said two men have died over the past two years of overdoses caused by mixing illegally obtained buprenorphine with other substances. One man, Donald Morin, died on Feb. 16, 2006, after mixing buprenorphine with the tranquilizer Xanax and cocaine. Suboxone pills were found in his pocket, which led to the test, she said. Another man died July 21, 2007, of an overdose caused by mixing buprenorphine with alcohol and two antidepressants, she said.
The Maryland Department of Health and Mental Hygiene has asked the commission that oversees the state medical examiner's office to review possible testing for buprenorphine. The state is spending $3 million to roll out the drug statewide, plus nearly $2 million to pay for prescriptions of low-income patients.
Dr. J. Ramsay Farah, president of the Maryland Society of Addiction Medicine, supports testing.
"If you don't look for something you're not going to find it," Farah said. "You need to look for it."