Pain, paralysis, and knowledge of impending death marks intrathecal vincristine

PROBLEM:We received a newspaper report last week about a former police chief with Burkitt's lymphoma who received vincristine (ONCOVIN and others) intrathecally instead of methotrexate. As a result, he suffered paralysis, agonizing pain, and awareness of his own impending death, which occurred on Christmas day, 10 weeks after a neurologist administered the drug. The vincristine was intended for IV use. The potential for this tragic mix-up is well known. Warnings appear in the product labeling, drug monographs, and numerous articles in this newsletter and professional journals. Why do such needless tragedies continue to happen when they are so readily preventable?

While we have no specific information other than news reports about the above-cited error, most often, errors result when medication syringes are mixed up during the injection process. USP requires specific cautionary labeling when dispensing vincristine. A label that states, "FATAL IF GIVEN INTRATHECALLY. FOR IV USE ONLY. DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION," must be applied to all syringes by dispensers. Each syringe must be placed into an overwrap which also must have this labeling. However, some may not be aware of the labeling standard or may not know that each drug carton contains the cautionary labels and overwrap. These may be missed if staff is not specifically looking for them. Even if vincristine is properly labeled and packaged, clinical personnel may dangerously remove the drug from its overwrap in advance of IV injection. If vincristine is near an intrathecal medication during the drug administration process, the physician, focused on performing a lumbar puncture, maintaining sterility, and preventing patient movement, may overlook the syringe label and accidentally pick up the intrathecal medication. A neurologist, who may not be familiar with cancer drugs or protocols, may administer the drug. If both syringes are present, the neurologist may erroneously believe that each is to be given intrathecally.

SAFE PRACTICE RECOMMENDATION: ISMP and FDA will be increasing efforts to alert the healthcare industry about this problem and suggest solutions. We both urge you to take the following steps today to prevent accidental intrathecal administration of IV medications:

• The list of intrathecal drugs that are administered for any disease is very small. Cytarabine, methotrexate, thiotepa, gentamicin, vancomycin, and hydrocortisone are among those used for cancer patients. Establish a list of drugs that can be administered intrathecally (or epidurally) and ban all other injectable drugs from rooms where lumbar punctures are performed.
• Require at least two health professionals to independently verify and document the accuracy of all intrathecal doses before administration. In some cases, a family member might help in the checking process.
• Wrap intrathecal drugs within a sterile bag which is then wrapped again in a sterile towel or another bag labeled for intrathecal use. Do not unwrap the package until immediately prior to injection.
• Accrediting and regulatory bodies should provide oversight to assure that facilities where chemotherapy is given have policies and procedures in place that are being followed to prevent accidental intrathecal injection of IV drugs.