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

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Abstract

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.

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Authors and Affiliations

  1. Saint Louis County Department of Public Health, Saint Louis, MO, USA

    Jocelyn Clogston & Jenelle Leighton

  2. Bureau of Immunizations, Missouri Department of Health and Senior Services, Jefferson, MO, USA

    Lana Hudanick

  3. Immunization Safety Office, Division of Health Care Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS D-26, Atlanta, GA, 30333, USA

    Tiffany A. Suragh, Paige Lewis, Christopher Schembri & Tom T. Shimabukuro

  4. Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Chris Jankosky & Craig Zinderman

  5. Office of the Center Director, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    David Martin

  6. Division of Medication Error Prevention and Analysis, Office of Medication Error Prevention and Risk Management/Office of Surveillance and Epidemiology, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Yelena Maslov, Mishale Mistry, Sarah Vee & Jo Wyeth

  7. Division of Metabolism and Endocrinology, Office of New Drugs, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Jennifer R. Pippins

Authors
  1. Jocelyn Clogston
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  2. Lana Hudanick
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  3. Tiffany A. Suragh
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  4. Chris Jankosky
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  5. Paige Lewis
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  6. David Martin
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  7. Christopher Schembri
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  8. Craig Zinderman
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  9. Yelena Maslov
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  10. Mishale Mistry
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  11. Jennifer R. Pippins
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  12. Sarah Vee
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  13. Jo Wyeth
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  14. Tom T. Shimabukuro
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  15. Jenelle Leighton
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Corresponding author

Correspondence to Tiffany A. Suragh.

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No external sources of funding or sponsorship supported this work.

Conflict of interest statement

None of the authors have any financial or personal relationships to disclose or any conflict of interest that would bias their work.

Additional information

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Saint Louis County Department of Public Health, Missouri Department of Health and Senior Services, Centers for Disease Control and Prevention (CDC), or the US Food and Drug Administration (FDA). Mention of a product or company name does not constitute endorsement by the Saint Louis County Department of Public Health, Missouri Department of Health and Senior Services, CDC or FDA.

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Clogston, J., Hudanick, L., Suragh, T.A. et al. Unintentional administration of insulin instead of influenza vaccine: a case study and review of reports to US vaccine and drug safety monitoring systems. Drugs Ther Perspect 32, 439–446 (2016). https://doi.org/10.1007/s40267-016-0333-2

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  • DOI: https://doi.org/10.1007/s40267-016-0333-2

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