Global Targeted Medication Safety Best Practice 2

Prepare and dispense vinca alkaloids in a minibag, never in a syringe

Andrew C. Seger, PharmD, provided an update of this Global Targeted Medication Safety Best Practice, with editorial guidance by Alem Zekarias, Ghita Benabdallah and Houda Sefiani. The most recent cases are taken in account, as well as the requirement from the US FDA asking the product labeling of vinCRIStine to indicate that it should be administered ONLY in minibags, NOT syringes.

Click on the left panel to read Andrew Seger’s Update on the Prevention Of Fatal VinCRIstine (And Other Vinca Alkaloids) Administration
December 2020

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Background:

Vinca alkaloids (vinBLAStine, vinorelbine, vinCRIStine) are chemotherapy drugs that should only be administered intravenously (IV) and never by any other route (1). Deaths have been reported throughout the world when a vinca alkaloid was dispensed in a syringe but administered into the spinal fluid instead of IV.

The inadvertent intrathecal administration of vinca alkaloids leads to the destruction of the central nervous system radiating from the injection site. Most of the time, the outcome is fatal. Even for the few who might survive with immediate spinal fluid washout, devastating neurological damage will likely occur (2). VinCRIStine is particularly problematic and the most frequently reported vinca alkaloid associated with inadvertent intrathecal administration, because it is often ordered in conjunction with medications that are administered intrathecally (e.g., methotrexate, cytarabine, and/or hydrocortisone) (2).

The WHO indicated that, between 1968 and 2007, inadvertent intrathecal administration of vinCRIStine has been reported 55 times in a variety of international settings (3). More recently, ISMP reported 135 fatalities worldwide due to inadvertent intrathecal administration of vinCRIStine, all dispensed in a syringe (4). Despite warnings (“For Intravenous Use Only—Fatal If Given by Other Routes”) and extensive labeling requirements in some countries, inadvertent intrathecal administration of vinCRIStine still occurs today (2,3).

Goal

The goal of this medication safety practice is to ensure that vinCRIStine and other vinca alkaloids (vinBLAStine, vinorelbine) are only administered by the IV route .

Best Practice Description

IMSN strongly advocates the dilution of vinca alkaloids in a minibag containing a volume too large for intrathecal administration (e.g., 25 mL for pediatric patients and 50 mL for adults), instead of preparation and administration in a syringe.

Rationale

Administration via minibag serves as a strong forcing function to prevent inadvertent intrathecal administration. A minibag is also less likely to be confused with other drugs in syringes intended for intrathecal use. There have been no reported cases of inadvertent
intrathecal administration of a vinca alkaloid when dispensed in a minibag (2). Although patient safety might be improved by the use of neuraxial connectors, such devices are not readily available throughout the world and have not been tested as a preventive measure against the inadvertent intrathecal administration of vinca alkaloids.

Globally, many organizations have switched to preparing vinca alkaloids in minibags, overcoming concerns about extravasation (4-7) and other complications (2). However, some organizations still administer vinCRIStine via syringe, risking inadvertent intrathecal administration (1). For example, results from the 2012 International Medication Safety Self Assessment® for Oncology indicated that 39% of participants still prepare and administer vinCRIStine in syringes (8), and more recent surveys in the United States (2017) and Shanghai (2015) indicate that approximately 20% of participants still prepare and administer vinCRIStine and/or other vinca alkaloids in syringes (9,10).

Indisputably, the best practice to alleviate the risk of inadvertent intrathecal administration is to globally adopt the preparation and administration of vinca alkaloids in minibags. This is fully supported by the WHO (3); in the United States by The Joint Commission (1), ISMP (2), Oncology Nurses Society (11), and National Comprehensive Cancer Network (12); and in other countries by the UK National Health Service (NHS) (13), ISMP Canada (14), Australia Commission on Safety and Quality in Health Care (15), French Medicines Agency (16), ISMPEspaña (17), ISMP Brasil, and others.

References:

  1. The Joint Commission. Eliminating vincristine administration events. Quick Safety. 2017;37:1-3. Access
  2. ISMP 2018-2019 Targeted Medication Safety Best Practices for Hospital. Best Practice 1. December 12, 2017. Access
  3. World Health Organization. Vincristine (and other vinca alkaloids) should only be given intravenously via a minibag. Information Exchange System, Alert No. 115. July 18, 2007. Download
  4. ISMP. ISMP calls on FDA-No more syringes for vinca alkaloids! ISMP Medication Safety Alert! 2019;24(5): 1-2.
  5. Gilbar P, et al. Medication safety and the administration of intravenous vincristine: international survey of oncology pharmacists. J Oncol Pharm Pract 2015; 21: 10-18.
  6.  Gilbar PJ, Carrington CV The incidence of extravasation of vinca alkaloids supplied in syringes or mini-bags. J Oncol Pharm Pract 2006; 12: 113-118.
  7.  Nurgat ZA, et al. Introduction of vincristine mini-bags and an assessment of the subsequent risk of extravasation. J Oncol Pharm Pract 2015; 21: 339-347
  8. Greenall J, Shastay A, Vaida A, et al. Establishing an international baseline for medication safety in oncology: Findings from the 2012 ISMP international medication safety self assessment for oncology. J Oncol Pharm Pract. 2015;21(1):26-35.
  9. ISMP 2016-2017 Targeted Medication Safety Best Practices for Hospitals Survey Results. Best Practice 1. July 2017. Download
  10. Yan M, Shen C, Zhang L, et al Vincristine drug safety administration survey: results from hospitals in Shanghai, China Eur J Hosp Pharm 2015; 22: 255-259.
  11. Prischel C. New recommendations call for bagged vinca alkaloids. Oncology Nursing Society Voice November 16, 2016. Access
  12. National Comprehensive Cancer Network (US) Just bag it! NCCN campaign for safe vincristine handling. Access
  13. National Health Services (NHS) National Patient Safety Agency (NPSA). Using Vinca Alkaloid Minibags (Adult/Adolescent Units). Rapid Response Report - NPSA/2008/RRR04 . August 11, 2008. Download
  14. Institute for Safe Medication Practices Canada. Published data supports dispensing vincristine in minibags as a system safeguard. ISMP Canada Safety Bulletin 2001 ; 1(1):1. Download
  15. Australia Commission on Safety and Quality in Healthcare. Vincristine can be fatal if administered by the intrathecal route. Australian Council for Safety and Quality in Health Care Medication Alert! Alert 2. December 2005. Download
  16. French Medicine Agency (Afssaps) Recommendations destinées à prévenir les risques d’erreur d’administration intrathécale de vinca-alcaloïdes 21 May 2007. Access
  17. ISMP-España and GEDEFO. Alerta especial. Errores asociados a la administración de vincristina. ISMP-España and Gedefo. July 2006. Download

May 2023