Methadone overdoses are causing opioid treatment programs to make changes in their operations: fewer take-homes, 7-day clinics, closer scrutiny of other drugs like benzodiazepines, and individualized dosing especially during the induction phase. Even if most of the methadone overdoses are linked to pain prescriptions, even one OTP-related death is too much, advocacy groups, federal regulators, and OTPs themselves agree.

Methadone overdoses: Take-homes, benzodiazepines, induction phase debated
Alcoholism & Drug Abuse Weekly, November 19, 2007

      Opioid treatment programs (OTPs) and their patients have been blamed for the rising swell of methadone-related overdoses, creating public relations problems that have lead to siting and other problems. A vocal grassroots group, HARMD (Helping America Reduce Methadone Deaths), is calling for changes in the way OTPs operate; in addition, a new report from the National Association of State Alcohol and Drug Abuse Directors (NASADAD) focuses on state responses to the problem, with the perspective of keeping OTPs distinct from methadone prescribed for pain. And finally, OTPs are also facing the threat of lawsuits.

      Although the methadone causing most increases is more likely methadone prescribed for pain, not the liquid form of the drug that is dispensed in OTPs, there are two main areas of concern that do apply to OTP patients: receiving too high a dose during the induction phase, and using other respiratory depressants such as benzodiazepines while also getting methadone. A third area of concern — take-home doses — could be linked to diversion and is leading to a call for eliminating take-homes, and keeping clinics open 7 days a week.

      These concerns — induction, take-homes, and diversion — are at the heart of a comprehensive new report from NASADAD. The report, released this month and written by NASADAD’s Marcia Trick, M.S., details state responses to methadone overdoses. Trick notes that while research shows most methadone over- doses have been linked to increases in pain prescriptions of the drug, the public hasn’t understood the distinc- tion, and “OTPs have been consid- ered guilty by association.” Even though OPTs are not re- sponsible for most of the overdoses, they are “being painted with the same broad brush,” agreed Tom Brady, M.D., chief medical officer for CRC Health Group, based in Cu- pertino, Calif.

      Underlying the clinical concerns is a barrage of negative publicity from HARMD, which has been growing in political clout. The group is a membership organization staffed by volunteers who have lost loved ones to methadone. One, Martha Hottenstein, whose son died from methadone purchased on the street, went to personal injury lawyer Ed Shemsky, who is featured on the HARMD web site. Along with HARMD founder Melissa Zuppardi, whose fiancé, Ron, died during the induction phase of methadone treat- ment, Hottenstein is keeping track of cases — filed and in progress — against OTPs and physicians. Armed with data about methadone over- dose deaths, HARMD has been able to take its message to the press and to politicians.

      Some of the more serious conse- quences of methadone overdose publicity include the push to ban take-homes and more closely supervising the induction phase, especially with today’s clients who may be younger and addicted to prescription drugs instead of heroin. HARMD is calling for these and more restrictions. Treatment providers — and the federal government — are paying attention, and agree that there are problems that need to be solved.


      “These are issues that should legitimately be debated,” said CRC’s Brady, of the take-homes and the induction issues. “But we need to look at them from all sides, to look at the health cost-benefit ratio,” Brady told ADAW. For example, he said, banning take-homes would have a deleterious effect on treatment because it would discourage people who need methadone from getting it. “If you prohibit take-homes, the likely result will be the large hassle factor of a patient being required to visit a clinic daily,” he said, adding that this will discourage some people from staying in treatment. “Every one of these quick fix solutions will have unintended consequences.”

      Zuppardi doesn’t think all take-homes should be eliminated, just those for people who are not stabilized in treatment. “If they’re stable and they’ve shown a stable record of a year and a half or two years, then by all means, I have no problem with those people getting a 30-day supply,” she told ADAW. “Those people deserve more rights as patient.” But, she said, new patients shouldn’t be getting their take-home doses right away — not even for the single day a week — Sunday — that many clinics are closed.

      There already is a requirement that a physician decide when a patient should be eligible for a take-home, said Robert Lubran, M.S., director of the division of pharmacology therapies at the Substance Abuse and Mental Health Services Administration (SAMHSA).

      “You have to look at a reasonable balance between the needs of the patient and the needs of the community,” Lubran told ADAW. “Is it reasonable to make everyone come in every day? No. But could the programs do a better job of evaluating the people who get take homes? Yes.”

Induction phase

      Overdose deaths during the induction phase particularly concern Shemsky, the personal injury lawyer. “Our biggest problem is that there are a lot of younger people in methadone treatment now whose problem is prescription painkillers, not heroin,” he told ADAW. “For some reason, these people don’t have the same tolerance for methadone as the heroin abusers have.” How does he know? “Because they are dying,” he said.

      The lawyer is partly right, medical experts said. When heroin addicts come into methadone treatment, they have typically been on heroin for many years, and have developed a tolerance as a result, said Brady. “The prescription opiate population tends to be younger, and to have been on opiates for a shorter period of time.” There have been no data to support the conclusion that prescription opiate users need different treatment then heroin users, according to federal officials. But the data to dismiss this conclusion is lacking, as well, they told ADAW.


      The role of benzodiazepines in methadone overdoses is also under examination, and of keen interest to Shensky because he questions whether the benzodiazepine-methadone combination is itself unsafe. “I know of case after case of people going into these clinics and dying within the first seven days,” he told ADAW. “And they fall into two main categories — people who are legitimately taking multiple medications, or people who are abusing some other medication.” Methadone patients are attracted to benzodiazepines because they “mimic the heroin buzz,” said Brady. However, another reason for prescribing benzodiazepines to methadone patients is to treat their panic or anxiety.

      Zuppardi criticized OTPs for keeping patients for the long-term if they are abusing benzodi-azepines. “It’s not recovery if they’re using benzodiazepines to get high,” she told ADAW. “They’re putting their own lives at risk. Also, they’re still abusing drugs, and that is putting the integrity of the program at risk.” OTPs should be treating the whole patient, not just the opioid addiction, said Zuppardi. “As a tax- payer, you have to say, what is the purpose of this treatment if they are still abusing drugs? I don’t think methadone treatment is a right. It’s a privilege to be in the program.” Zuppardi also said that if meth- adone patients are abusing other drugs, that makes it likely that they are selling their take-home doses. At CRC, OPTs perform random urine toxicology screens, said Brady. “When we identify benzodi- azepines, we run it down and find out whether it’s legitimate, and if so, we push for safer alternatives,” Brady said.

"OTPs have been considered guilty by association."
-- Stat Issue Brief, NASADAD

Responses in the states

      Nevertheless, when there are methadone overdose deaths, OPTs are suspected. This happened in North Carolina, and OPTs were ex- onerated, but only after an exten- sive investigation by the Centers for Disease Control (CDC).

      North Carolina responded to a spike in overdose deaths in 2002 by working with the CDC to look at 1,096 medical examiner reports. As part of their investigation, the re- searchers looked at the OTPs and found that of the 198 people who died from methadone overdoses for 1997-2001, only 4 percent were cur- rent or former patients of OTPs. Be- cause of this, and because North Carolina has strict take-home poli- cies, investigators felt that OTPs were not a significant source of di- version.

      “Only that small percentage of methadone deaths can be associat- ed with addiction treatment,” said Spencer Clark, ACSW, assistant chief of community policy management in the North Carolina Division of Mental Health, Developmental Disabilities and Substance Abuse Services. “But for this small number, we are evaluating the deaths in terms of limiting take-homes, looking at patient risk factors, and patient education,” he told ADAW.

      “Our biggest concern is making sure that with the public, and with providers, we’re not mixing up the deaths that are related to the pain clinics,” said Clark, who is functioning as the state methadone authority. “Methadone already suffers from being stigmatized, and our consumers are highly stigmatized.”

      But Clark cautions that the treatment field can’t establish the distinction between pain- and addiction-related overdoses on its own. “There’s a larger obligation of the entire public health community to help sort this out,” he said.

      Meanwhile, the lawyers are also considering lawsuits against the pharmaceutical companies that distribute methadone. “We think we are going to find that they have the information about mixing the drugs, the half life, the danger in the induction phase,” Shemsky told ADAW. “I don’t think the clinics have been properly warned.”

      And although Shemsky and other personal injury lawyers are raising concerns for OPTs, HARMD is not anti-methadone, according to Zuppardi. “I’m anti-methadone death,” she told ADAW. And she would still be in favor of methadone for her fiancé, if it would have helped him. “Being with Ron, and knowing he was addicted, I would have supported him in a program if it would have made a difference.”

      Soon, OPTs will report deaths to SAMHSA, said Lubran. “We will begin collecting data from treatment programs on every death.” Once the reporting form has gone through federal clearances, voluntary reporting will provide some good data, he said. “We think the numbers are small, but we don’t have the data.” •