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    Propofol Scheduling Debate Reignited after Jackson Death

    By Jennifer Huddleston, staff writer     

    Reports that Diprivan was found at Michael Jackson’s home after his sudden death June 25, 2009, has rekindled the debate over whether the drug, also known by its generic name propofol, should be scheduled as a controlled substance. Propofol is the most widely used intravenous drug for inducing general anesthesia.

    What role, if any, propofol played in Jackson’s death is yet unknown, but its mere presence in the Jackson home is enough to raise questions, given that the drug is intended to induce general anesthesia for surgical and diagnostic procedures. According to a statement by the American Society of Anesthesiologists (ASA), the drug should be used only in a medical setting by professionals trained in the provision of general anesthesia. The U.S. Food and Drug Administration (FDA) lists similar guidelines on the drug’s product labeling.

    Media reports have suggested that Jackson used the drug to combat severe insomnia, but how he may have obtained it is uncertain.

    “The use of propofol at home without proper monitors would be clear malpractice and if anyone actually prescribed it, their license should be suspended immediately,” said Clifford Gevirtz, M.D., M.P.H., medical director of Somnia Pain Management Services. “It has no indication for insomnia. This episode is yet another reason it should be a scheduled drug.”

    Opponents to scheduling the drug argue that doing so will not necessarily prevent people from abusing it. However, according to Paul E. Wischmeyer, M.D., an anesthesiologist at the University of Colorado Health Sciences Center in Denver, Colorado, and a professor of anesthesiology at the University of Colorado, propofol should be scheduled as a controlled substance simply because of how deadly it can be.

    Propofol abuse is rather rare outside the medical community but has increased fivefold over the past 10 years. Such abuse is more commonly seen among healthcare professionals who have easy access to the often unmonitored drug.

    Wischmeyer’s 2007 study, published by the International Anesthesia Research Society in Anesthesia & Analgesia, found that in 18 percent of the 126 academic anesthesia programs in the U.S., one or more individuals had abused propofol in the last 10 years. Of the seven deaths reported in the study, six of the individuals were residents and one was an anesthesia technician. Wischmeyer began researching propofol abuse after one of his classmates in residency died from taking the drug.

    Even trained medical professionals with knowledge of the drug can end up in deadly situations, as Wischmeyer’s study shows. There is not only the risk of overdose, but also the chance that propofol can become contaminated after sitting out of proper storage for too long. In addition, the use of propofol outside the parameters recommended by the ASA and FDA is particularly dangerous given the drug’s small therapeutic window.

    “The difference between being high and being dead,” Wischmeyer said, “is a cc [cubic centimeter] or two.”

    Wischmeyer’s study also revealed that 71 percent of the academic anesthesia programs in the U.S. do not regulate propofol and that there is a statistically significant correlation between a lack of monitoring and the prevalence of abuse.

    The study noted that applying stricter pharmacy controls over propofol would require increased funding and supervision and that opioids and benzodiazepines, which are strictly controlled by federal laws and pharmacy regulations, are abused much more frequently than propofol.

    While the debate continues among those in the anesthesia field, it seems that for now propofol will remain unscheduled. A statement from the U.S. Drug Enforcement Agency indicated that it has no plans to revisit its position on the drug because the agency does not currently see it as being abused.

    [1] “Jackson Death Renews Debate Over Propofol Status.” Anesthesiology News Web exclusive. July 1, 2009.
    [2] Landau, Elizabeth. “Should Diprivan (Propofol) Be a Controlled Substance?” Paging Dr. Gupta Blog. July 6, 2009.

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