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Drug safety experts stunned by vincristine-related death

For the second time in less than four years, a New Jersey patient who was undergoing chemotherapy at a hospital died because a drug was given via the wrong route of administration. Instead of being given intravenously, vincristine, a chemotherapy agent used to treat certain types of leukemia, was delivered intrathecally.

In the most recent incident, the family of Richard Fulton filed a wrongful death medical malpractice claim against Randall Siegel, M.D., and Saint Peter's University Hospital in New Brunswick, N.J. Fulton was battling Burkitt's lymphoma when he died in July of 2002.

In an earlier incident—in 1999—Mt. Olive, N.J., police chief Charles Brown died when a physician at Morristown Memorial Hospital injected vincristine into Brown's spine instead of his veins. Brown was also being treated for Burkitt's. A malpractice lawsuit was recently settled in that case.

The Fulton case, said Michael Cohen, president of the Institute for Safe Medication Practices, "was a shocker." ISMP has issued no fewer than 10 warnings in the past several years regarding the grave risks associated with intrathecal injection of vincristine. The Fulton tragedy has left many medication safety experts scratching their heads. The U.S. Pharmacopeia requires manufacturers of vincristine to provide special package warning labels indicating that vincristine, if given intrathecally, is fatal.

As an extra-added precaution, manufacturers are also required to provide plastic overwrap bags for syringes and vials. In addition, most hospitals administer intrathecal medications in areas physically separated from rooms where IV medications are given.

What has medication safety experts perplexed about the Fulton case in particular is that some of the standard protocols associated with intrathecal administration were followed. According to Ronald Goldfaden, an attorney representing Fulton's family, the patient's drug regimen included four agents, one that was being administered intrathecally. Goldfaden said that, based on information obtained from the hospital, Fulton was taken to a special procedures room to receive his intrathecal medication. But when he arrived, there were no medications present. Three IV medications and one intrathecal agent were brought to the special procedures room where he was given the fatal dose of vincristine intrathecally.

ISMP's Cohen said that drugs such as vincristine that are designed for intravenous administration should never be sent to the same area where intrathecal medications are being administered. "Never send vincristine from the pharmacy if a patient is simultaneously getting intrathecal medications, such as methotrexate or cytarabine, until you get a call from the clinical staff that says they've completed the intrathecal therapy, redressed the lumbar puncture site, and are ready for the IV drug," he said.

The Fulton tragedy underscores the need for more oversight when it comes to vincristine administration, noted Larry Trissel, director of clinical pharmaceutics research program, M. D. Anderson Cancer Center in Houston.

Trissel asserted that many of the errors involving vincristine occur because it is usually a part of a multidrug regimen that includes agents that are supposed to be administered intrathecally. This confusion happens frequently with methotrexate and cytarabine, both of which are given intrathecally, he said.

Even when safety protocols are followed, such as in the Fulton case where separate rooms were designated for intrathecal drug administration, tragic errors can still occur. "As you can see, there's still a way around that, and that was simply carrying the drug up to the wrong place," said Trissel.

Medication safety experts assert that there are several ways to avoid administration problems associated with vincristine. One way would be to dilute it. Vincristine doses should be prepared only in infusion volumes. That would make them unsuitable for intrathecal injection. Packaging vincristine doses in minibags is a good idea too because minibags are incompatible with intrathecal drug delivery, thereby providing a physical barrier to accidental intrathecal injection.

ISMP has been pressuring syringe and catheter manufacturers to install special catheters and syringes designed only for intrathecal injections so that IV drugs like vincristine simply cannot be connected. Cohen noted that some hospitals have built custom-made catheters and syringes designed for intrathecal injections. However, the major commercial vendors have not marketed such systems. "They have balked at development saying that the business case doesn't support it," said Cohen. He added that standard setting and regulatory requirements might be necessary to ensure patient safety.

Cohen contends that the errors linked to vincristine are "100% preventable. We ought to be able to take steps to prevent this from even being a problem in a hospital."

Anthony Vecchione

 

Tony Vecchione. Drug safety experts stunned by vincristine-related death. Drug Topics May 19, 2003;147:HSE31.