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ISMP Calls on FDA— No More Syringes for Vinca Alkaloids!

Since January 2019, ISMP has learned about 4 children who received vinCRIStine erroneously by the intrathecal route of administration, each suffering a very painful death. Three of the children were from Guyana, and one was from Norway. The child from Norway had a brain tumor and was just 6 years old when vinCRIStine was injected into the spinal fluid via an intraventricular catheter instead of methotrexate. The three children from Guyana were just 3, 6, and 7 years old.

The most effective way to prevent patient harm is to supply all vinca alkaloids in minibags, thus avoiding the risk of confusion with syringes. ISMP has strongly advocated this practice since 2001. Dispensing vinCRIStine (and other vinca alkaloids) in a minibag of compatible solution, and not in a syringe, was among the very first ISMP Targeted Medication Safety Best Practices for Hospitals released in 2014. Other accrediting and professional organizations have helped promote this practice, including The Joint Commission (TJC), National Comprehensive Cancer Network (NCCN), Oncology Nursing Society (ONS), American Society of Clinical Oncology (ASCO), and many others.

Internationally, the World Health Organization (WHO) has promoted dilution of vinca alkaloids in minibags since 2007, and in Norway, where one of the latest events happened, this practice had been widely implemented for children during treatment of leukemia, but not consistently for treatment of other cancers using vinca alkaloids. According to Andrew Seger, a pharmacist from Boston’s Brigham and Women’s Hospital who tracks vinCRIStine errors from around the world, 5 years ago the total number of fatalities and neurological devastation from intrathecal vinca alkaloid administration worldwide was 120 (44 in the US and Canada)—all involving vinca alkaloids in syringes. Today, the total is 135, and as far as we know, none of these cases involved vinca alkaloids prepared in minibags.

Most practitioners in the US dilute vinCRIStine (and other vinca alkaloids) in a minibag prior to administration. According to a 2017 ISMP survey of US hospitals, 86% of 338 hospital respondents have fully adopted this practice. This represents a steady increase in compliance since 2014, when only half of respondents reported this practice. Also, in our recent 2018 ISMP Medication Safety Self Assessment® for High-Alert Medications, 81% of almost 500 hospital respondents reported full adoption of this practice. Although the latest tragic events have occurred internationally, the error could still happen in the US given that 19% of our 2018 assessment respondents reported that they still use syringes to administer vinca alkaloids. Furthermore, even though the US official prescribing information includes directions to dilute the drug in a flexible plastic container to reduce the risk of wrong route errors, the labeling still allows for administration of vinca alkaloids via a syringe and even provides explicit directions for this alternative yet unsafe method of administration.

ISMP calls upon the US Food and Drug Administration (FDA) to lead the way internationally by requiring the removal of administration by syringe from the prescribing information for all vinca alkaloids. Administration by syringe has been at the root of all reported errors associated with vinca alkaloids given by the intrathecal route and should NOT be an approved method of preparation for administration. The cost in human lives has been high—it is an error for which death is almost certain. It is time for FDA regulatory action, which we hope will lead to similar global changes. If FDA commits to taking regulatory action, ISMP and the International Medication Safety Network (IMSN) will have the support needed to continue vigorously advocating for other countries to do the same.

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