title: Post-licensure rapid immunization safety monitoring program (PRISM) data characterization.
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.
  
  
  CONCLUSIONS
  PRISM program's data on vaccine exposures and health outcomes appear complete enough to support robust safety monitoring.
authors: Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, United States; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States. Electronic address: meghan_baker@harvardpilgrim.org.
authors: Meghan A
authors: MA
authors: Baker
authors: US Food and Drug Administration Center for Biologics Evaluation and Research, Rockville, MD, United States. Electronic address: Michael.Nguyen@fda.hhs.gov.
authors: Michael
authors: M
authors: Nguyen
authors: Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, United States. Electronic address: david_cole@harvardpilgrim.org.
authors: David V
authors: DV
authors: Cole
authors: Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, United States; Division of Infectious Diseases, Department of Medicine, Boston Children's Hospital, Boston, MA, United States. Electronic address: Grace.Lee@childrens.harvard.edu.
authors: Grace M
authors: GM
authors: Lee
authors: Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, United States. Electronic address: tracy.lieu@kp.org.
authors: Tracy A
authors: TA
authors: Lieu
mesh_terms: D003625:Data Collection / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology; D001330:Electronic Data Processing / Q000379:methods; D006801:Humans; D007345:Insurance Claim Review; D038801:International Classification of Diseases; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018571:Sentinel Surveillance; D014481:United States; D014486:United States Food and Drug Administration; D014611:Vaccination / Q000009:adverse effects* / Q000706:statistics & numerical data; D014612:Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: CDC; CPT; CVX; Centers for Disease Control and Prevention; Codes for Vaccine Administered; Common Procedural Terminology; DTaP; Data characterization; ED; FDA; Food and Drug Administration; HEDIS; HPV; Health outcome; Healthcare Effectiveness Data and Information Set; Hib; ICD; IPV; International Classification of Diseases; MCV4; MMR; Mini-Sentinel; NIS; National Immunization Survey; PCV; PPV; PRISM; Post-Licensure Rapid Immunization Safety Monitoring; Surveillance; Td; Tdap; Vaccine; combined tetanus, diphtheria and pertussis; diphtheria, tetanus and pertussis; emergency department; haemophilus influenzae type B; human papillomavirus (HPV); inactivated polio vaccine; measles, mumps and rubella; meningococcal conjugate vaccine; pneumococcal conjugate vaccine; pneumococcal polysaccharide vaccine; tetanus and diphtheria