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The PRISM Network

The PRISM Network. Daniel A. Salmon, PhD, MPH Director of Vaccine Safety National Vaccine Program Office U.S. Department of Health and Human Services. H1N1 Vaccine Safety: Microcosm of the Vaccine Safety Challenge. Response to H1N1 is the largest mass vaccination program in recent history

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The PRISM Network

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  1. The PRISM Network Daniel A. Salmon, PhD, MPH Director of Vaccine Safety National Vaccine Program Office U.S. Department of Health and Human Services

  2. H1N1 Vaccine Safety: Microcosm of the Vaccine Safety Challenge Response to H1N1 is the largest mass vaccination program in recent history Public concern regarding vaccine safety Reported safety concerns include Vaccine production was “rushed” Vaccine “inadequately tested” 1976 experience with Guillain-Barré Syndrome

  3. National Vaccine Advisory Committee (NVAC) Recommendation for H1N1 Safety Monitoring Enhance active surveillance for signal confirmation and evaluation of possible associations between vaccines and adverse events

  4. http://www.flu.gov/professional/federal/fed-plan-to-mon-h1n1-imm-safety.pdfhttp://www.flu.gov/professional/federal/fed-plan-to-mon-h1n1-imm-safety.pdf Advisory Committees in Red

  5. Collaborators – Partial List National Vaccine Program Office Daniel Salmon Kirsten Vannice Centers for Disease Control and Prevention Frank deStefano Food and Drug Administration Robert Ball America's Health Insurance Plans Kevin Fahey Barbara Lardy Victor Rhee Public Health Informatics Institute Ellen Wild Bill Brand Elaine Lowery Therese Hoyle Alan Hinman David Ross Harvard Pilgrim Health Care Institute Richard Platt Tracy Lieu Grace Lee Jeff Brown Melisa Rett Charlene Gay Katherine Yih Yury Vilk Health Information Systems Consulting Robert Rosofsky EpiPatterns Yinong Young-Xu Computer Sciences Corporation Daniel Foltz Jim Van Dyke Aurelia Ford Jim Roddy John Manson Vic Tandon Cigna Therese Conner Anthony Sumner Daniel Carmody Ha Nguyen Mark Regine Aetna Claire Spettell Cheryl Walraven Joaquim Fernandes Yihai Liu Healthcore (Wellpoint, BC/BS) Peter Wahl Alex Cannon Lori Meyers Greg Daniel Chris Hetrick Humana David Nau Yihau Xu Amy Ball Arizona State Immunization Information System Lisa Rasmussen         Roger Volp Richard Bradley Florida Shots Susan Lincicome Pete Garner • Georgia Registry of Immunization Transactions and Services • Tracy Culbreath • Elizabeth Sullivan • Michelle Conner • Archie Banks • Andre Wilson • Michigan Care Improvement Registry • Therese Hoyle • Ian Hancke • Minnesota Immunization Information Connection • Emily Peterson • Diana Jaeger • New York State Immunization Information System • Loretta Santilli • New York City, Citywide Immunization Registry • Vikki Papadouka • Rezaul Kabir • Luiz Homem de Mello • Pennsylvania Statewide Immunization Information System • Frank Caniglia • Mike Jamula • Wisconsin Immunization Registry • Dan Hopfensperger

  6. PRISM Aims Link health plan data and state immunization registry data in new H1N1 vaccine safety surveillance network Conduct continuous active surveillance for pre-specified outcomes Provide timely information on unanticipated potential adverse events

  7. Building on Past Experience • Vaccine Safety Datalink (VSD) • Active surveillance through 8 MCOs • 3% of US population • MCV4 and GBS Signal • Distributed data network • captures @25% of US adolescent population • Vaccine exposure (MCV4) typically captured by health plan databases through billing (CPT4) codes

  8. Assessment of Immunization Information Systems (IIS) • Rapid survey of state immunization programs through Association of Immunization Managers (AIM) • Intention to use IIS for H1N1 • % of public and privately delivered vaccine anticipated to be captured by IIS • Anticipated timeliness of IIS • History of linking to health plan databases on individual level (HEDIS reporting) • In depth interviews with selected states

  9. State immunization registries Participating states MI, FL, GA, PA, AZ, WI, MN, NY, NYC Total ~14 million persons in the participating health plans

  10. Health plans Selection criteria Ability to rapidly assemble data Ability to update data every 1-2 weeks Participating health plans Aetna, CIGNA, Humana, HealthCore (WellPoint plans in CA, NY, CO; BCBS in MI) Total ~26 million persons

  11. Organizations in PRISM HHS America’s Health Insurance Plans(Administration) Harvard Dept of Population Medicine(Scientific coordination) Computer Sciences Corporation(Technical support) StateImmunization Registries Health plans Public Health Informatics Institute

  12. Outcomes being monitored Guillain-Barré Syndrome (GBS) Demyelinating disease Neuropathies Seizures Encephalitis Bell’s palsy Other cranial nerve disorders Myocarditis Ataxia Anaphylaxis Other allergic reactions Spontaneous abortion Stillbirth Pre-eclampsia

  13. Weekly monitoring of counts Risk (exposure) windows Periods after H1N1 vaccination 2, 14, 21, or 42 days, depending on outcome

  14. Statistical analyses Compare the observed number of AEs in the current season to the expected number based on historical data Use a self-controlled case series (SCCS) design to compare the number of AEs in risk window to number in unexposed comparison window

  15. Data Sharing and Confidentiality Classified as not research Many health plans and states used the HIPAA public health exemption for exchange of Protected Health Information All person-level data remains at the health plans after transformation to standard format Distributed programs create counts that are shared with scientific coordinating center

  16. PRISM H1N1 Vaccine Doses ** Live H1N1 vaccine is not distinguishable from inactivated in claims data, nor in data from all state registries * LAMV is not distinguishable from MIV in claims data nor in data from all state registries. 17

  17. Contribution of state immunization registry data to influenza vaccine data in PRISM

  18. PRISM Outcomes for H1N1 inactivated vaccine Chart review and adjudication of GBS cases is being initiated. * Not statistically significant. Historical comparison. 19

  19. PRISM Outcomes for H1N1 inactivated vaccine * None are statistically significant. ** Self-controlled case series method; others are historical comparisons. 20

  20. PRISM Outcomes for H1N1 inactivated vaccine * None are statistically significant. ** Self-controlled case series method; others are historical comparisons. 21

  21. The PRISM Network Daniel A. Salmon, PhD, MPH Director of Vaccine Safety National Vaccine Program Office U.S. Department of Health and Human Services

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