Methadone Law Blog

State police at Lehighton and the state Department of Public Welfare are looking into the recent death of 16-year-old Katherine Rice of Allentown, Pennsylvania. Rice, and her friend were staying at the KidsPeace group home for troubled youths who have substance abuse problems. On April 16, 2008 the girls stole methadone pills from a counselor at the facility and later that evening began taking the pills.

As the girls began to take the pills, but feel no immediate effect, they continued to take pills throughout the night in hopes of feeling the high associated with prescription pain medications. However, instead of getting the high they desired, they fell into comas and were taken to Lehigh Valley Hospital. Rice passed away two weeks after falling into the coma, and her friend remains in the hospital in satisfactory condition.

Investigators are looking into why the methadone pills were at a facility for substance abuse patients in the first place, and more importantly, how the obvious lack of supervision allowed the teens to steal the drugs.

This is just one more example of why we need to implement stricter guidelines for the distribution of methadone. The pills have drastically devastating results and yet continue to get into the wrong hands time and time again.

You can read more on this story here.

Posted by Edward Shensky | Permalink | Email This Post

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A hospital in California received a $25,000 fine after distributing a list of medications to the wrong patient, which resulted in the death of an 87-year-old woman in August. The Fremont, CA resident was brought to Washington Hospital and was diagnosed with heart failure, dementia and shortness of breath. Several hours later she was given methadone, Lexapro, Zestril and Desipramine which were intended to be given to another patient.

Shortly after taking the medications, the patient began experiencing hallucinations. When doctors reviewed her charts, they questioned why she had been given methadone (which is normally prescribed for pain management among other things) after never having mentioned she was in pain. That’s when the hospital realized she had been given the wrong set of medications.

The incorrect mix of medications, partnered with her already weakened state, lowered the patient’s blood pressure and caused her to become lethargic. Doctors moved the patient to the intensive care unit of the hospital, but were too late. The patient died just two days after having been admitted.

The California Department of Public Health issued 12 additional fines for similar cases throughout the state last week. The fines are intended to increase the care and attention paid towards patients in order to decrease policy and procedural errors that jeopardize the health and well-being of patients, and in some unfortunate cases, lead to their death.

Posted by Paul N. Daly | Permalink | Email This Post

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Researchers at Oregon Health & Science University have concluded that methadone is a possible cause of sudden cardiac death. The study determined that sudden cardiac death could be caused by methadone even when it was taken at therapeutic levels for relief of chronic pain or drug addiction withdrawal. The study's findings were based on an evaluation of all sudden cardiac deaths in the greater Portland, Oregon metropolitan area between 2002 and 2006 where detailed autopsies were performed.

The analysis was based on a comparison of two case groups. One group consisted of 22 sudden cardiac deaths in which toxicology screens turned up 1 mg or less of methadone which is defined as therapeutic level. The cases were then compared to a second group of 106 cases where no evidence of methadone was found. In the first case group, 17 of the 22 subjects had no significant cardiac abnormalities. On the other hand, 60% of the case group where no methadone is present had identifiable evidence of cardiac disease or structural abnormalities. "The unexpectedly high proportion of otherwise unexplained sudden deaths in the therapeutic methadone group points to a significant contribution of this drug towards the occurrence of sudden cardiac death among these patients" said Sumeet Chugh, M.D. lead investigator, Director of OHSU's Cardiac Arrhythmia Center, and Associate Professor of Cardiovascular Medicine in the OHSU School of Medicine. Individual case reports have linked methadone to a rare ventricular arrhythmia, known as torsade de pointes, which can degenerate into ventricular fibrillation leading to sudden death in the absence of medical intervention.

The researchers have proposed that a large prospective evaluation of methadone therapy be undertaken since a sizable and growing number of people are utilizing methadone for both pain management and drug addiction.

Posted by Michael G. Donahue, III | Permalink | Email This Post

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The associated press reported on December 20, 2007 that a Kansas physician, Dr. Stephen J. Schneider, and his clinic, Schneider Medical Clinic, were indicted by a Topeka grand jury on charges including unlawful distribution of a controlled substance and health care fraud. According to the indictment, the doctor and his assistants illegally issued prescriptions for narcotic painkillers, muscles relaxers, and other such medications, including Methadone. It also alleges that fraudulent claims for health care benefits were filed by the doctor’s clinic. If convicted of certain of the charges, Dr. Schneider would reportedly face 20 years to life in prison.

While Dr. Schneider is not charged with murder by the indictment, U.S. Attorney Eric Melgren reportedly said that the defendant(s) “emphasized volume over quality of care” and that the doctor callously referred to patients who died from overdoses as “‘bad grapes’”. According to the indictment, fifty-six (56) of the doctor’s patients have died from overdoses of prescription drugs in the last five (5) years. The clinic reportedly operated seven (7) days a week, for eleven (11) hours a day, and scheduled patients only ten (10) minutes apart. Using this churn and burn “mill” approach to “care”, the clinic succeeded in billing more than $4.24 million to heath benefit programs, including Medicare and Medicaid.

The huge billings referenced in the indictment of the Schneider Medical Clinic may explain, in part, the tremendous surge in prescriptions of Methadone which have occurred at pain management clinics in recent years. Given the large number of medications and substances which interact negatively with Methadone, and the fact that patients must be closely and carefully monitored for life-threatening side effects associated with its use - particularly when the medication is first introduced, it is not surprising that a clinic which “emphasize[s] volume over quality care” produced so many deaths. Unfortunately, this clinic is but one example of a serious and growing problem concerning Methadone and other narcotic pain killers here in the United States.

Posted by Mark W. Davis | Permalink | Email This Post

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In December 2007 the DEA announced it was relaxing the restrictions previously placed on physician prescriptions of schedule II narcotics. In the wake of the change, prescriptions for Methadone, Oxycontin, Morphine and other such drugs can now provide patients with as much as a 90-day supply of medication. Previously, prescriptions for these medications were limited to 30-day supplies; a restriction which was reportedly put in place to curtail the potential for abuse of schedule II drugs. Given the dangers associated with these medications, as findings from organizations such as the National Institute on Drug Abuse that non-medical use/abuse of prescription drugs is a serious and growing health issue in this country, this action by the DEA seems ill-advised.

Methadone, which is among the schedule II narcotics affected by the rule change, has been linked to a steadily increasing number of deaths in recent years. According to statistics cataloged in reports issued by various agencies and governmental organizations, including the Justice Dept. and the Substance Abuse and Mental Health Administration (SAMHSA), there has been an alarming rise in Methadone-related deaths (approximately 390% between 1999 and 2004 alone) which correlate to a widening in the scope of the drug’s use. According to the DEA, the number of practitioners authorized to distribute methadone has increased more than 700% since 2001. The increase in its use as an alternative treatment for chronic pain has closely paralleled each of these statistics.

The DEA’s decision, reportedly made in response to pressure from various lobbying groups, has been denounced by activist groups such as HARMD (Helping America Reduce Methadone Deaths). The group had reportedly assembled a petition condemning the decision.

Posted by Mark W. Davis | Permalink | Email This Post

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The DEA and pharmaceutical manufacturers have reach agreement that action must be taken to reduce the increase in methadone related deaths.

As of January 1, 2008, manufacturers of methadone have agreed to restrict distribution of 40 mg tablets. Methadone was previously available in 5 mg, 10 mg and 40 mg tablet formulations. The 40 mg formulation is not FDA approved for use in pain management. Under an agreement reached with the DEA, 40 mg tablets will only be available to facilities authorized for detoxification or maintenance treatment of opiod addiction. Methadone manufacturers have instructed their distributors to discontinue supplying these tablets to other facilities such as pharmacies.

Posted by Michael G. Donahue, III | Permalink | Email This Post

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Methadone is a drug used in the treatment of chronic pain and opiate addition. While it has been used with varying degrees of success since the 1950s, a recent Justice Dept. report has documented that deaths associated with its use have been increasing at an alarming rate in recent years. You can read the Methadone Diversion, Abuse, and Misuse: Deaths Increasing at Alarming Rate assessment here.

The National Drug Intelligence Center's assessment concluded that reports of methadone related poisonings increased more than 350% between 1999 and 2004, climbing from 786 reported deaths in 1999 to nearly 4000 in 2004. The report and other similar data indicate that these increases are not limited to this time frame, but rather have continued to rise.

The increase in documented adverse events parallel an increased use of the medication to treat conditions other than opiate addition, most notably chronic pain. In the wake of this disturbing trend, the FDA issued a public health advisory concerning methadone in November 2006 which noted that a dose of methadone can remain active in the body for as much as 59 hours and thus, may build up in the body and reach toxic levels. This fact, as well as the number of medications and substances which can negatively interact with methadone, and other similar factors can produce dire consequences if the medication is not administered properly and under close supervision.

Methadone and other opioid deaths, 1999-2004

Posted by Mark W. Davis | Permalink | Email This Post

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Today, methadone is killing more Americans than heroin. In 2004, there were 3,849 reported deaths involving methadone in the United States. This astounding death toll could be significantly reduced according to Rick Sponaugle, Medical Director of Florida Detox, by using a version of the drug currently available in Germany.

The fatal and therapeutic methadone doses are almost the same for many methadone patients. In fact, methadone patients are 7 times more likely to die from a methadone overdose during the first two weeks of methadone treatment. It is during this period that their individual response to methadone is determined.

Eliminating S methadone from the mixture of R and S methadone used in the United States could reduce deadly cardiac arrhythmias and decrease the dangerous, unpredictable variations in methadone therapeutic dose between individuals. The most common route of administration at a methadone clinic is in a racemic oral solution, though in Germany, only the (R)-methadone enantiomer has traditionally been used, as it is responsible for most of the desired opioid effects.

Dr. Sponaugle, a physician Board Certified in Addiction Medicine and Anesthesiology, observed that "replacing R/S methadone with safer R methadone would reduce methadone cardiotoxicity and dangerous methadone half life variations{.}" He encourages the FDA to expedite any approvals required for R methadone to be prescribed in the United States. Dr. Sponaugle also favors measures such as requiring physicians to obtain additional training and certification before they are allowed to prescribe methadone.

Posted by Michael G. Donahue, III | Permalink | Email This Post

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The American Society of Anesthesiology has recently expressed concern regarding the high number of methadone-related deaths. A campaign entitled “Zero Unintentional Deaths” was begun to try to lesson the likelihood of death when methadone is prescribed for pain relief. It was developed to educate physicians, chronic pain sufferers and other interested individuals about the increasingly serious issue of unintentional overdose deaths relating to methadone as well as other prescription medications. The goal of the campaign was to remedy unintentional deaths without compromising access to treatment of pain.

A program entitled “Six Steps to Zero,” six specific hazards were addressed. They are as follows:

1. Never take a prescription painkiller unless it is prescribed to you.
2. Do not take pain medicine with alcohol.
3. Do not take more doses than prescribed.
4. Use of other sedative or anti-anxiety medications can be dangerous.
5. Avoid using narcotic medications to facilitate sleep.
6. Lock up prescription painkillers.

It is hoped that if these six steps are followed the rate of unintentional methadone related deaths could be reduced.

The Zero Unintentional Death campaign appears here and can be reached through Zero Unintentional Deaths c/o Life Source, 617 East 3900 South, Salt Lake City, UT 84106.

Posted by Michael G. Donahue, III | Permalink | Email This Post

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In an article prescribing methadone safely, Dr. Lynn R. Webster discusses the fact that methadone has been implicated to a disproportionate degree in many overdose deaths recorded across the country. He noted that physicians don’t have all the answers as to why these deaths are occurring, but some tie to the fact that methadone is prescribed for pain. The United States Substance Abuse and Mental Health Services Administration (SAMHSA) has reached a similar conclusion.

One or two causes are usually to blame when pain treatment goes wrong. The medications are either being prescribed incorrectly or are being consumed inappropriately. While it is recognized that patient noncompliance is common and almost all clinicians should be familiar with it. With painkillers, patients often over-consume their pain medication to try to counteract the stress they are experiencing in their lives. They want their pain to be eliminated rather than just controlled. Many patients believe that if two tablets are good, a third must be better. While this may not be dangerous with some medication, it can have a deadly result with methadone. Further, patients mix methadone with other medications and/or with alcohol. This is a cocktail which could easily lead to death. Patients must be instructed to follow all medical directions to the letter when consuming methadone or any other opiate.

Physicians also make errors when prescribing opiates, particularly methadone. This may be attributable to widely available conversion tables. The starting dose is critical and tolerance by a patient cannot be assumed.

It seems the clinicians who prescribe methadone for pain as well as the patients that are taking methadone may be underestimating the risk of respiratory or depression that is associated with the drug. Methadone is eliminated from the body at a slower rate than other medications and has a half life which averages around 48 hours. Because it lasts so long, methadone is particularly prone to dangerous drug interactions. The pharmacologic properties of methadone require a conservative approach to even the most opiate-tolerant patients. Careful monitoring of the patients response is key.

Posted by Michael G. Donahue, III | Permalink | Email This Post

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Methadone replacement therapy has been utilized as a treatment for opiate addiction for more than thirty (30) years. In recent years, however, the use of methadone as a treatment for chronic pain has been increasing, as has the number of practitioners prescribing the medication. Against this backdrop, both Federal and State agencies, including the Center for Disease Control (CDC) and the National Center for Heath Statistics (NCHS), have documented striking increases in the number of methadone-related deaths. For example, according to data from the NCHS, the number of poisoning deaths involving methadone increased 390 percent between 1999-2004; that’s 336 percent higher than the increase in the number of poisoning deaths involving all sources. Coincidence? The data would suggest otherwise. Of all narcotics mentioned in these poisoning deaths, not one demonstrated a larger relative increase than methadone.

The data suggest multiple causes for this alarming trend. For instance, for many methadone patients, the fatal and therapeutic dosages are almost the same. Further, responses to the medication and the rate at which it is eliminated from the body’s tissues varies tremendously from person to person. Methadone has also been shown to interact negatively with an alarming number of medications and substances which, if used in conjunction with methadone, can produce a lethal cocktail resulting in arrhythmia, respiratory depression and/or death. As such, it is not surprising that methadone patients are 7 times more likely to die from a methadone overdose during the first two weeks of treatment, while their individual response to methadone is still being determined.

At least 2 alternatives to methadone, “Subutex" and “Suboxone”, exist and are currently approved by the FDA to treat opiate dependence in the United States. Others, such as “Pure R” methadone, have been used with success overseas. Given that the data suggest that these alternatives carry a lower risk of the fatal cardiac disturbances and respiratory depression than are associated with the “R/S” methadone utilized in the United States, one can only wonder why methadone remains so widely prescribed and whether the health care community in the U.S. is sufficiently attuned to the serious risks its use presents. The data discussed above demonstrates that placing any patient on methadone can truly represent a “life and death” decision. As such, one would hope that doctors and clinics are not motivated by profit to prescribe methadone over the alternatives. But methadone is big business. And, for the pharmaceutical companies which manufacture it and certain of the clinics which dispense it, a source of big profits. Coincidence? You be the judge.

Posted by Mark W. Davis | Permalink | Email This Post

Posted In: Pain Management

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When a person takes medication there is always a risk to how they new medication will interact with other drugs. In the case of methadone, there are more than 100 substances that can interact in some fashion to affect a patient’s response. These substances include prescription medications, illicit drugs, and even “over the counter” (OTC) products which would seem to be benign. This is a significant issue, because many individuals in methadone maintenance treatment (MMT) have co-occurring physical and/or mental disorders requiring multiple medications.

Drugs are broken down, or metabolized, by chemical reactions into molecules that can more easily be eliminated. One of the primary ways in which the body metabolizes drugs involves proteins. Proteins facilitate these chemical reactions, allowing the medication to accomplish its purpose. These proteins are known as CYP450 enzymes, and there are more than 28 CYP enzymes encoded to 57 different human genes.

There are 3 different, primary ways in which substances interact with the enzyme system:

• 1) by acting as a substrate


• 2) through inhibition


• 3) through induction

A substrate is any drug metabolized by one or more CYP enzymes, an inhibitor slows the metabolism of substrate drugs, and an inducer boosts the metabolism of substrate drugs. Inhibitors may cause an excessively high drug level and related toxic effects, while and inducer may cause a lower than expected level of the substrate drug.

For a detailed list of medications, illicit drugs and other substances that may cause a drug interaction with methadone, see Addiction Treatment Forum, 3rd Edition, November 2005 Revision/Update by Stewart B. Leavitt, Ph.D. (PDF)

Posted by John A. Sakson | Permalink | Email This Post

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