PopMedNet in Mini-Sentinel Tiffany Siu Woodworth PopMedNet User Group Conference July 27, 2015

Mini-Sentinel  An FDA-funded pilot project, operating under FDA’s public health authority  Scientific operations for an active medical product safety surveillance  Continuous access to electronic healthcare databases

Mini-Sentinel Partner Organizations Institute for Health Lead – HPHC Institute Data and scientific partners Scientific partners

Mini-Sentinel Distributed Database  178 million individuals* 358 million person-years of observation time  36 million individuals have over 3 years of data  31 million individuals with at least 1 laboratory results  4 billion dispensings  4.1 billion unique encounters, including 42 million inpatient stays  48 million currently accumulating data *As of July Potential for double-counting exists if individuals moved between data partner health plans

Early Use of PopMedNet in Mini-Sentinel  Major goal of Mini-Sentinel – rapid response Summary Tables –simple and rapid menu-driven querying of pre-populated summary tables “Modular Programs” –Reusable, modular SAS programs Distributed via PopMedNet Programs upload to Secure Portal & s sent to Data Partners with file location

Current Use of PopMedNet  Query fulfillment and distribution of requests All data requests sent via PopMedNet, including: –Summary Table Requests –SAS Program Packages  “Modular Programs”  Custom SAS programs  Quality assurance programs –Data Partner Surveys  Tracking data requests Data Partner response time Number of requests

Future Enhancements  To date, distributed over 750 data requests  Hundreds of users at Operations Center and Data Partner sites  Multiple ongoing projects and assessments with various funding sources Many, many more requests to come! Soon to add more users, including FDA and Scientific Partners Focus on improving tracking and accounting capabilities

Future Enhancements: Workflow Full Query Fulfillment Standard Operating Procedure

Prepare Specifications Prepare Request Package Run Request Package Draft Report Future Enhancements: Workflow (2) Finalize and Send Report Query Fulfillment Process (Simplified) Distribute package to Data Partners Receiving data from Data Partners Receive final program specifications Send final report / complete request Web-based request form

Future Enhancements: Meta-data  Increasing the amount of meta-data associated with each request to track and record: Dates associated with all parts of the request process FDA division Funding source Level of effort Transparent system with FDAImproved communications with Data PartnersClearer auditing system

Future Enhancements: Reporting  Queriable database of request meta-data Ability to create custom reports of requests by any combination of meta-data fields Examples, reports by: –Data Partner –Request type –Funding source –Requesting division  Future goal: Common reports automatically generated (e.g., monthly reports)

Recap  Sentinel will continue to expand More collaborators (scientific, data, FDA) Increased number of requests  PopMedNet will be instrumental in the organization of Sentinel’s network activity

Thank you!