ISMP Releases Bi-Annual Report on Vaccination Errors that Reveals Mistakes with Newer Vaccines

As this year’s cold and flu season is underway and new COVID variants continue to emerge, the Institute for Safe Medication Practices (ISMP) is raising awareness that more needs to be done to reduce the risk of vaccination-related errors. Though immunization is one of the greatest public health achievements, the continued success of immunization programs relies on proper prescribing, dispensing, storage and administration of vaccines. The recently released 2022-2023 Bi-Annual Report from the ISMP National Vaccine Errors Reporting Program shows that errors continue to be an issue, with newer vaccines adding new opportunities for confusion and mistakes.  

In 2023, the U.S. Food and Drug Administration (FDA) approved two vaccines for respiratory syncytial virus (RSV) infection in adults, one targeted for adults 60 years and over (AREXVY), and the other for pregnant individuals at 32 through 36 weeks gestational age as well as adults 60 years and older (ABRYSVO). Since the time period covered by ISMP's latest vaccine report, AREXVY gained an additional indication for patients 50 through 59 who are at increased risk and the FDA approved a third RSV vaccine, MRESVIA, to protect adults aged 60 years and older. In addition, each year updated formulas for COVID-19 and influenza vaccines made by a variety of manufacturers enter the market. 

“The wide range of available vaccines that vary in indications, intended patient ages, and preparation before administration can present unique risks for errors, especially in outpatient settings where barcode scanning prior to vaccine administration is often lacking,” says Michael J. Gaunt, PharmD, senior manager, error reporting programs for ISMP. “Healthcare organizations should strive to identify system-based causes of errors involving vaccines, and layer multiple high-leverage risk-reduction strategies to attain reliable outcomes. Healthcare practitioners should engage patients and caregivers, discuss with them the health benefits of vaccines, and involve them in error prevention efforts.”

Analysis of nearly 2,000 events reported from January 1, 2022, through December 31, 2023, showed that the most frequent types of errors were:

• Wrong vaccine (25%)
• Expired vaccine or contamination/deterioration (20%)
• Wrong dose--overdosage and underdosage events (12%)
• Wrong age (10%)
• Extra dose (9%)
• Wrong time or interval (7%)
• Vaccine/component omission where only the diluent or single component of two-component vaccine was administered (4%)
• Wrong route (2%)
• Wrong patient (1%)

Since most vaccines were administered in the outpatient setting, most reported events occurred in those settings: medical clinics (43%), public health immunization clinics (18%), doctors’ offices (17%), or community pharmacies (9%). Forty-eight percent of the events involved medical assistants, 27% involved registered nurses, 19% involved licensed vocational nurses or licensed practical nurses, and 13% involved pharmacists. In some cases, more than one practitioner, including physicians, nurse practitioners, physician assistants, and students were involved in reported events.

ISMP’s most recent sets of best practices for hospitals and community pharmacy provide strategies that  healthcare organizations can use to safeguard against errors with vaccines. Additional ISMP safe practice recommendations include:

• Maximize technology
• Ensure safe storage
• Verify identity, age, and vaccine(s) requested.
• Prepare and label syringes.
• Engage the patient
• Document the vaccine(s)
• Educate practitioners
• Report vaccine-related errors

“Immunization is one of the most effective ways to prevent disease and improve health outcomes,” says ISMP President Rita K. Jew, PharmD, MBA, BCPPS, FASHP. “ISMP and ECRI remain committed to reducing the risk of preventable errors with vaccines that can lead to inadequate immunity, increased cost and reduced confidence in the healthcare delivery system.”

For a copy of the latest bi-annual report from the ISMP National Vaccine Errors Reporting Program (VERP) with more detailed analysis of data, discussion of contributing factors, and explanation of risk reduction strategies, visit: https://home.ecri.org/blogs/ismp-resources/vaccine-bi-annual-report. To report an error, near miss, or hazard involving a vaccine to the VERP, visit: https://home.ecri.org/pages/ecri-ismp-error-reporting-system.  

Contact
Renee Brehio, Medication Safety Analyst and Editor, rbrehio@ismp.org

About the Institute for Safe Medication Practices
The Institute for Safe Medication Practices (ISMP) is the nation’s first 501c (3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected for its medication safety information. For more than 30 years, it also has served as a vital force for progress. ISMP’s advocacy work alone has resulted in numerous necessary changes in clinical practice, public policy, and drug labeling and packaging. Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting program, publishes newsletters with real-time error information read and trusted throughout the global healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In 2020, ISMP formally affiliated with ECRI to create one of the largest healthcare quality and safety entities in the world, and ECRI and the ISMP PSO is a federally certified patient safety organization by the U.S. Department of Health and Human Services. As an independent watchdog organization, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its life-saving work. Visit www.ismp.org and follow @ismp_org to learn more.