Florida Death from Prescribed Methadone

Florida has passed legislation known as "tort reform" which places limits on what a person can recover in a medical malpractice case. For example, the statute sets out who can claim a loss for the death of a person, and what kinds of losses can be claimed. Funeral expenses are recoverable, as is the wage loss to the heirs of the deceased. But what if the person who died had no children and no spouse? What are the losses? His lost wages are not recoverable, as no one was depending on his income. His funeral expenses are recoverable. His parents can claim a loss for his society and companionship. But the statute caps the amount of money that can be awarded for this loss. A mother called me yesterday to tell me that she has contacted law firms who have refused her case because her son who was given a drug overdose in a hospital had no heirs or spouse and the case "just wasn't worth it." If there is no consequence to medical providers who cause the death of a patient, will the medical providers change their behavior? How can the loss of a human life be "just not worth it?"

Oxycodone Dosing Error

I got a call a couple of weeks ago from a grieving father. He found his 27 year old son dead in his bed one morning in February. His son had earlier that day been to a new doctor for his chronic back pain, and the doctor had prescribed 120mg of oxycontin /oxycodone without any information from the young man that he could tolerate this high dose. The labelling for oxycontin describes a starting dose of 10 mg. The cause of death has been ruled oxycodone toxicity.

The Label on the Pill Bottle

Terry Paul Smith, a 46-year-old roofer, suffered from a disorder of the peripheral nerves (neuropathy) in his back and legs, which kept him in chronic pain. He took Oxycontin and Neurontin, but he disliked the way it made him feel, e.g., making him sometimes "drop out" in the middle of a conversation. After he complained about the pain medications' side effects, his doctor changed the prescription to methadone. The doctor wrote a prescription for Terry to take four 10-milligram pills, twice a day. Terry filled the prescription at a local Walgreen's pharmacy in Jacksonville, Florida. The label on the pill bottle directed Terry to take four tablets "as needed for chronic pain," and did not mention any limits on the frequency. Terry took the pills for the first time on July 23-24, 2001. Within 36 hours, Terry was dead. The autopsy found toxic levels of methadone in his blood. The pharmacist's error to "take as needed" rather than take "twice a day" increased the risk of Terry's death. Now Terry's widow, Pearl Smith, is pursuing a lawsuit against Walgreen's. A company spokesman says Walgreen's has spent $1 billion over the last decade on pharmacy safety systems, safety training and technology. Walgreen's filled more than half a billion prescriptions in the last fiscal year.

This overdose death illustrates the importance to discuss the doctor's prescribing orders with her and check her prescription carefully against the label on the bottle, especially for a new medicine. Read an informed consent story, or read more from the source article by Kevin McCoy in the USA Today of Nov. 2.

Methadone Dosing

I am not a doctor. I do not treat patients with methadone. I do not prescribe methadone. But in the methadone death cases I have seen and in my discussions with physicians, pharmacologists and toxicologists, the issue of safe dosing has been front and center. The problem with dosing methadone, is that one size does not fit all. Some people can tolerate higher initial doses than others. While a low dose of methadone (2.5 mg three times of day) is thought to be well-tolerated even in opiate naive individuals, a person beginning even this protocol of methadone therapy should be carefully monitored for side effects that could indicate respiratory depression. One pain doctor I know starts patients at 2.5 mg, 3-4 times a day, unless he has solid confirmation from previous pharmacy and medical records that a person has been continuously using opiates at a determined level. This same physician increases the dose only every 7 days, and only by 2.5 mg. Sure, other pain doctors may criticize him for a dosing schedule that may not provide complete analgesia to pain patients during the initial phase of methadone treatment, but this pain doctor would rather endure that criticism than lose a patient to overdose. For more information about safe dosing of methadone in pain settings, the FDA cites Goodman F., Jones W., Glassman P., Methadone Dosing Recommendations for Treatment of Chronic Pain, Pharmacy Benefits Management Strategic Healthcare Group, United States Department of Veterans Affairs, December 2001.

Methadone clinics are known to start their patients at higher initial doses because of their goal of addressing withdrawal symptoms and the belief that opiate-tolerant patients can safely receive higher doses. But methadone clinics must also use caution in determining the initial starting dose, and must match the dose to the level of withdrawal and the history of opiate use. Good physicians will tell you that a person in mild withdrawal from low level daily opiate use should be started at a lower dose of methadone than a patient in raging withdrawal from high level daily opiate use. SAMHSA has warned that the 40 mg a day federal limit for methadone clinic patients should not be a one-size-fits-all dose. If clinics dose all their patients at this initial dose, patients will die.

FDA Advisory: Respiratory Depression and Death

FDA Public Health Advisory: Methadone Use for Pain Control May Result in Death and Life-Threatening Changes in Breathing and Heart Beat

ADVISORY--FDA has received reports of death and life-threatening side effects in patients taking methadone. These deaths and life-threatening side effects have occurred in patients newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers. Methadone can cause slow or shallow breathing and dangerous changes in heart beat that may not be felt by the patient. Prescribing methadone is complex. Methadone should only be prescribed for patients with moderate to severe pain when their pain is not improved with other non-narcotic pain relievers. Pain relief from a dose of methadone lasts about 4 to 8 hours. However methadone stays in the body much longer—from 8 to 59 hours after it is taken. As a result, patients may feel the need for more pain relief before methadone is gone from the body. Methadone may build up in the body to a toxic level if it is taken too often, if the amount taken is too high, or if it is taken with certain other medicines or supplements.To prevent serious complications from methadone, health care professionals who prescribe methadone should read and carefully follow the methadone (Dolophine) prescribing information FDA is issuing this public health advisory to alert patients and their caregivers and health care professionals to the following important safety information:Patients should take methadone exactly as prescribed. Taking more methadone than prescribed can cause breathing to slow or stop and can cause death. A patient who does not experience good pain relief with the prescribed dose of methadone, should talk to his or her doctor. Patients taking methadone should not start or stop taking other medicines or dietary supplements without talking to their health care provider. Taking other medicines or dietary supplements may cause less pain relief. They may also cause a toxic buildup of methadone in the body leading to dangerous changes in breathing or heart beat that may cause death. Health care professionals and patients should be aware of the signs of methadone overdose. Signs of methadone overdose include trouble breathing or shallow breathing; extreme tiredness or sleepiness; blurred vision; inability to think, talk or walk normally; and feeling faint, dizzy or confused. If these signs occur, patients should get medical attention right away. FDA recently approved new prescribing information for methadone products approved for pain control. The information in the new prescribing information is based on a review of the scientific literature completed by FDA. A Medication Guide for patients is planned.

Zero Unintentional Deaths

The American Society of Anesthesiology has taken action regarding the increasing numbers of methadone deaths in the United States. And the ASA is a great organization to take such action: they count among their members people the common folk in America call "pain physicians." The ASA is engaged in an educational campaign entitled “Zero Unintentional Deaths” to reduce the number of accidental methadone deaths.
“Six Steps to Zero” highlights important rules for pain patients who are prescribed methadone:
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.

I wish they had added this rule:

"If you get sleepy while taking methadone, call 911."

Many of my clients' families reported not understanding that drowsiness was a dangerous side effect of methadone, and remembering when their loved one retired to the bedroom to "sleep it off."
You can contact the ASA at Zero Unintentional Deaths c/o Life Source, 617 East 3900 South, Salt Lake City, UT 84106.

Phyllis Lile-King

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Montana Methadone Deaths

I called up a coroner in Montana last week. I needed a document from him for a case I am investigating. When he learned I was a lawyer and looking into a methadone death, he struck up a conversation. He volunteered the following: Methadone is one of the most common drugs causing poisoning deaths in Montana. He has seen the numbers skyrocket in the last few years. I shared with him that my case involved a new prescription for methadone at 50 mg starting dose, which he remarked sounded "way too high." He shared with me he had one young man die of methadone and they learned that the prescription allowed him to take the drug as needed-- a recipe for disaster in a drug like methadone. He volunteered that, if I wanted to see patients dying from methadone, I needed to go to the VA Hospital. He said, "They are the worst." I said, "Have you called the medical board? Have you let them know that doctors need some education about this drug? "That is not my job," he said.

Phyllis Lile-King

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