Joint Commission Sentinel Alert on Vincristine Administration Errors
In 2005, the Joint Commission issued a Sentinel Alert regarding the prevention of administration errors associated with vincristine.
Several cases of wrong route administration of vincristine had been reported to the United States Pharmacopeia (USP) MEDMARX database, and to the Joint Commission, some of which culminated in “near miss” events, but one which resulted in permanent paralysis. Reporting of these errors had historically been erratic, but upon investigation the Joint Commission noted at least 37 identified cases of similar error since 1968, and mainstream media began reporting cases as well (Sentinel Event Alert, 2005). Because the errors result in such a tragic outcomes (slow, progressive, painful paralysis, usually resulting in death) the Joint Commission made the unusual decision to announce an alert to identify strategies for minimizing these errors and providing administration recommendations.
The Joint Commission identified several areas of concern in the labeling, handling, administration of vincristine. These included:
Labeling: USP standards required that vincristine syringes should be labeled stating “FATAL IF GIVEN INTRATHECALLY. FOR IV USE ONLY. DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION.” Additionally, each syringe should have an additional wrapping with the same warning printed on it. The Joint Commission identified that some practitioners may not be aware of the labeling requirements.
Early Removal of Overwrap:Error risks increased when healthcare practitioners removed the overwrap in advance of the actual injection, allowing for inadvertent administration intrathecally.
Failure to check physician orders carefully, and unfamiliarity with vincristine and its properties were also identified as sources of error.
Practitioners at the Dana Farber Cancer Institute in Boston, MA developed a safety program to address these concerns, which included many safeguards to assure accurate administration. These included:
- Specific syringe and overwrap labeling;
- Special preparation protocols: drug is prepared only at time of administration, and dispensing it only to the person who will administer it;
- Attaching a unique filter to the syringe; and
- Requiring administration to occur in a room separate from where other medications are administered.
Another proposed method for decreasing risk was to prepare and administer vincristine in minibags only, which, although requiring additional preparation time, eliminates the risk of inadvertent intrathecal administration entirely.
Subsequently, the Joint Commission took the unusual step to issue a number of recommendations for administration of vincristine. Their recommendations include dilution of vincristine in a volume (preferably in a minibag) that will avoid any potential accidental administration intrathecally; clear and specific USP labeling of the syringe and the outerwrap of any vincristine to be delivered via syringe; refraining from administration of vincristine to a location where any intrathecal medication may be being administered; and assurance that at least two qualified healthcare professionals independently verify and document the drug, dose, route at the time of preparation and of administration (Joint Commission, 2005).
After the Joint Commission Alert, the World Health Organization (WHO, 2007) published a similar recommendation, supporting the Joint Commission recommendations, and including a recommendation to develop separate and unique delivery systems for intravenous and spinal drug delivery. They recommended a unique “lock and key” system which would make it physically impossible to attached an intravenous syringe containing vincristine to a spinal needle.
View the full Joint Commission alert.
View a video from the World Health Organization (WHO).
View a video from the Food and Drug Administration (FDA).
Joint Commission. (2005). Sentinel event alert, issue 34: Preventing vincristine administration errors. At http://www.jointcommission.org/sentinel_event_alert_issue_34_preventing_vincristine_
World Health Organization. (2007). Patient safety. Vincristine sulfate. At http://www.who.int/patientsafety/activities/technical/vincristine/en/index.html.