Joint Commission issues alert on vincristine administration
Tragic errors’ continue to occur, the organization says
Saying "tragic errors" related to vincristine administration continue to occur, the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, issued a Sentinel Event Alert in July.
The errors take place when vincristine is administered intrathecally rather than intravenously. There have been 49 documented cases of this error, reports Michael R. Cohen, RPh, MS, ScD, president of Institute for Safe Medication Practices in Huntingdon Valley, PA. Cohen says he provided assistance to Andrew Seger, PharmD, senior research pharmacist at Partners HealthCare Systems and the Division of General Medicine and Primary Care at Brigham and Women’s Hospital in Boston, in documenting the cases. Most of the patients involved in those errors have died.
Plenty more cases of the erroneous vincristine administration don’t get reported, Cohen says. The Joint Commission suggests that health care organizations may choose not to report the error because of concerns over legal discoverability of the information. "It doesn’t happen all that often, but when it does, it is one of the most devastating medication errors," he says.
Once the drug is injected intrathecally, little can be done to reverse the painful process. The patient slowly deteriorates and progressively loses function as the drug affects the nervous system. "It is so horrible to see someone become slowly paralyzed and lose organ function," Cohen says.
The United States Pharmacopeia (USP) has a dispensing standard and requirements for vincristine labeling. Some health care workers may not be aware of these requirements, the Joint Commission says. USP requires that a label stating, "FATAL IF GIVEN INTRATHECALLY. FOR IV USE ONLY. DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION," be applied to each syringe by the person doing the dispensing. Each syringe also should be placed in an overwrap that carries the same label warning. A health care worker can remove the overwrap, however, making it easier for a physician to overlook the labeling on the syringe.
In addition, catheters used for lumbar punctures may have fittings that are identical to those that are used for intravenous injections, Cohen says. This can increase the possibility that the vincristine will be mistaken for a drug to be injected intrathecally.
Recommendations for handling vincristine
In its alert, the Joint Commission offered recommendations for preparing, dispensing, and administering intravenous vincristine (and other vinca alkaloids):
Dilute intravenous vincristine in a volume — ideally for IV infusion in a minibag — that precludes administration via the intrathecal route. The Joint Commission says that a report has shown that the use of vincristine sulfate doses diluted in 0.9% sodium chloride for injection and packaged in minibags or in 30 mL syringes showed no evidence of physical or chemical instability.
If vincristine is to be administered via syringe, clearly label each vincristine syringe: "FATAL IF GIVEN INTRATHECALLY. FOR IV USE ONLY. DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION." Each syringe also must be placed in an overwrap carrying the same label warning.
Do not dispense intravenous vincristine (or any intravenous medication) in a manner that would permit it to be administered at a time and location where intrathecal medications are administered. If a dedicated location for intrathecal administration is not possible, the pharmacy should not dispense intravenous vincristine to a location where intrathecal medications are administered until it receives confirmation that intrathecal drug administration is not imminent or has been completed.
Conduct a "timeout" with at least two qualified health care professionals to independently verify and document the drug, dose, and route at the time of pharmacy preparation of intravenous vincristine and before each administration of intravenous vincristine.
The Joint Commission also made recommendations for drugs that are intended for intrathecal administration:
- Prepare intrathecal medications in the pharmacy as close as possible to the time of administration, label them with an appropriate short expiration time (such as eight hours), and then deliver them to and administer them in a designated (ideally separate) location, at a regular, specified time of the day or week.
- Establish a list of drugs that can be administered intrathecally, designate specific locations where intrathecal administration may be done, and ban all other injectable drugs from those physical locations during times when intrathecal injections are administered.
- Conduct a "timeout" with at least two qualified health care professionals to independently verify and document the drug, dose, and route at the time of pharmacy preparation of drugs for intrathecal administration and before each intrathecal administration of such drugs.
Wrap intrathecal drugs within a sterile bag, which is then wrapped again in a sterile towel or another bag labeled: "FOR INTRATHECAL USE ONLY." Wraps or packages must be removed immediately prior to injection only by the person administering the medication.