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Follow-up study of medication errors reported to the vaccine adverse event reporting system (VAERS)
Frederick Varricchio1, John Reed,
1Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville MD, USA. Varricchio@comcast.net
Background:
A study was done to determine if the apparent medication errors found in the Vaccine Adverse Event Reporting System (VAERS) database are true errors, and if true errors are found, to determine what corrective action was taken. Furthermore, if a true error did not occur, we wanted to determine at what point the misinformation was entered into the system.
Methods:
The VAERS database was searched for reports received between July 1, 2001 and June 30, 2002 which had either been classified as "error" or the word "error" appeared in the text of the report. The database was also searched for reports which indicated that the measles-mumps-rubella (MMR), diphtheria-tetanus-pertussis (DTP), diphtheria-tetanus-acellular pertussis (DTaP) or diphtheria-tetanus-pertussis-haemophilus (DTPH) vaccinations had been administered at an age outside of the usual recommendation.
Results:
A total of 119 reports of possible errors were found. Follow-up was successful in 102 (86%) cases. Additional information obtained showed that 26 cases were actual medication errors. Seventy-six cases were not actual medication errors; 9 cases were physician decisions, 37 cases were data entry errors and 30 cases were reporter errors.
Conclusion:
The nature of the actual errors was similar to those reported previously; wrong inoculum, improper interval, wrong route of administration, and overdose. Many errors could have been prevented by more attention to detail. Remedial action usually consisted of retraining. The new requirement that all medications be barcoded, purchasing products from different manufacturers and segregation of vials may help prevent vial confusion.
Insights
Medication errors reported in the Vaccine Adverse Event Reporting System (VAERS) were investigated. Most were not true errors, but data or reporter mistakes, though actual errors like wrong dosage were found.
Area of Science:
- Pharmacovigilance
- Medication Safety
- Vaccine Reporting Systems
Background:
- Apparent medication errors in the Vaccine Adverse Event Reporting System (VAERS) require investigation to determine their validity.
- Understanding the source of misinformation in VAERS is crucial for improving data accuracy.
Purpose of the Study:
- To ascertain if reported medication errors in VAERS are genuine.
- To identify corrective actions for true errors and pinpoint the origin of misinformation for non-errors.
Main Methods:
- Searched VAERS database for reports classified as 'error' or containing the word 'error' (July 2001-June 2002).
- Investigated reports of vaccinations (MMR, DTP, DTaP, DTPH) administered outside recommended ages.
Main Results:
- 119 potential errors identified; 102 (86%) were followed up.
- 26 cases confirmed as actual medication errors.
- 76 cases were not actual errors: 9 physician decisions, 37 data entry errors, 30 reporter errors.
Conclusions:
- Actual medication errors included wrong inoculum, improper interval, wrong route, and overdose.
- Many errors are preventable with increased attention to detail.
- Preventive measures include barcoding, diverse manufacturers, and vial segregation to avoid confusion.
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