Abstract:
BACKGROUND:The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program is the immunization safety monitoring component of FDA's Mini-Sentinel project, a program to actively monitor the safety of medical products using electronic health information. FDA sought to assess the surveillance capabilities of this large claims-based distributed database for vaccine safety surveillance by characterizing the underlying data. METHODS:We characterized data available on vaccine exposures in PRISM, estimated how much additional data was gained by matching with select state and local immunization registries, and compared vaccination coverage estimates based on PRISM data with other available data sources. We generated rates of computerized codes representing potential health outcomes relevant to vaccine safety monitoring. Standardized algorithms including ICD-9 codes, number of codes required, exclusion criteria and location of the encounter were used to obtain the background rates. RESULTS:The majority of the vaccines routinely administered to infants, children, adolescents and adults were well captured by claims data. Immunization registry data in up to seven states comprised between 5% and 9% of data for all vaccine categories with the exception of 10% for hepatitis B and 3% and 4% for rotavirus and zoster respectively. Vaccination coverage estimates based on PRISM's computerized data were similar to but lower than coverage estimates from the National Immunization Survey and Healthcare Effectiveness Data and Information Set. For the 25 health outcomes of interest studied, the rates of potential outcomes based on ICD-9 codes were generally higher than rates described in the literature, which are typically clinically confirmed cases. CONCLUSION:PRISM program's data on vaccine exposures and health outcomes appear complete enough to support robust safety monitoring.
journal_name
Vaccinejournal_title
Vaccineauthors
Baker MA,Nguyen M,Cole DV,Lee GM,Lieu TAdoi
10.1016/j.vaccine.2013.04.088subject
Has Abstractpub_date
2013-12-30 00:00:00pages
K98-112eissn
0264-410Xissn
1873-2518pii
S0264-410X(13)00682-8journal_volume
31 Suppl 10pub_type
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