KEYWORDS:
Vaccine Safety
Post Licensure monitoring
BACKGROUND:
With the dramatic decrease in infectious diseases, in large part due to the success of effective vaccines, there has been a shift in public health focus from disease prevention to vaccine safety concerns. Generally, the risk is quite small, and therefore data from large populations is required in order to make such assessments with any statistical assurity.
The Vaccine Adverse Event Reporting System (VAERS) voluntary, and therefore not expected to record all possible adverse events. Several computerized Immunization Registries are currently developing interactive reporting to VAERS, which should improve its sensitivity, accuracy, timeliness and acceptability. However, additional data is needed to carry out large-scale safety studies of vaccines. Several large registries use their data for vaccine safety studies.
OBJECTIVE:
To describe the necessity for using data from large registries, and discuss attributes necessary for vaccine safety studies.
METHOD:
Use of regisry data is important to record immunizations given and adverse events, and to eliminate duplication of patient records in the epidemiological analysis. Registries must have good de-duplication methodology, and quality assurance measures answering the questions "Are all immunizations recorded?" and "Are they recorded accurately?" Duplication and quality assurance data was collected before and after application of algoruthms and quality assurance programs to KITS.
RESULT:
Southern California Kaiser Permanente's Immunization Tracking System (KITS), which has been a part of the Vaccine Safety Datalink Study is an example of a large registry successfully contributing to vaccine safety analysis. Covering all ages of present and past Southern California Kaiser Permanente members, the registry contains over 23 million entries. De-duplication methodology results in a 95% automated process (up from 80% without de-duplication algorithms). Comparison of KITS with clincal charts now shows less than 1% discrpancy.
CONCLUSION:
Application of algorithms developed for KITS de-duplication and quality assurance has improved the quality and usefulness of KITS for Vaccine Safety studies.
LEARNING OBJECTIVES:
To be able to define quality measures and content which make registries valuable in Vaccine Safety Studies.
Back to Connecting the Vaccine Safety Efforts and Immunization Information Systems: A Health Partnership
Back to The 2003 Immunization Registry Conference (October 27-29, 2003)