Unintentional administration of insulin instead of influenza vaccine: a case study and review of reports to US vaccine and drug safety monitoring systems

• Published in: Drugs & therapy perspectives : for rational drug selection and use 2016-10, Vol.32 (10), p.439-446
• Main Authors: Clogston, Jocelyn, Hudanick, Lana, Suragh, Tiffany A., Jankosky, Chris, Lewis, Paige, Martin, David, Schembri, Christopher, Zinderman, Craig, Maslov, Yelena, Mistry, Mishale, Pippins, Jennifer R., Vee, Sarah, Wyeth, Jo, Shimabukuro, Tom T., Leighton, Jenelle
• Format: Article
• Language: English
• Subjects: Medicine; Pharmacotherapy; Pharmacy; Short Communication
• ISSN: 1172-0360; 1179-1977
• DOI: 10.1007/s40267-016-0333-2

Introduction There have been isolated case reports of medication product mix-ups involving insulin unintentionally given to patients when the intent was to administer vaccines. Information on how and why these types of errors occur is limited. Objective To describe incidents of unintentional administration of insulin instead of influenza vaccine and identify possible causes for errors. Methods We describe a 2014 investigation of an apparent mix-up where a cluster of five adult patients unintentionally received insulin instead of influenza vaccine. We also searched Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) vaccine and drug safety monitoring databases from January 2005 to April 2015 in order to identify other incidents. We classified cases as either ‘highly suggestive’ or ‘suggestive’ of insulin and influenza vaccine mix-ups. Results Investigation of the primary cluster incident revealed deviations from recommended practices for storage, handling, preparation, and administration of drugs and vaccines; the five cases were classified as highly suggestive of insulin and influenza vaccine mix-ups. Our search of CDC and FDA vaccine and drug safety monitoring databases identified an additional two highly suggestive and 15 suggestive cases, for a total of 22 cases (7 highly suggestive and 15 suggestive) during the 10-year study period. Conclusion Insulin and vaccine mix-ups have the potential to cause serious harm to patients, and are preventable with proper training and application of standards. Our investigation indicated that improper storage—including inadequate segregation of insulin and influenza vaccine products in clearly labeled containers or bins—lack of standardized procedures for confirming the contents of vials, and decreased vigilance in preparation and administration likely contributed to the primary cluster incident.