Monitoring medication safety is the key mission of the FDA’s Sentinel System. The Sentinel System includes all routinely available mortality data from health plans’ claims data. However, like all claims-based data sources, the Sentinel Distributed Database (SDD) has incomplete mortality data, particularly cause of death (e.g., in 2019, only 4.5% of patients who died had a cause of death documented in the SDD). In-hospital death data are more timely than out of hospital death. Patients who die outside of a medical setting (i.e., hospital, hospice, long-term care) may not be consistently represented in the claims and electronic health record (EHR) data that comprises the SDD.
The CDC National Center for Health Statistics (NCHS) established the National Death Index (NDI). The NDI includes mortality data from all jurisdictions across the country and is considered the “gold standard” in death data collection for the United States. It includes consistently highly complete demographic information and cause of death for each state and has been used extensively in public health research, though it is not a “real-time” data source as it is generally lagged by 2 years. Linkage between the SDD and NDI would be beneficial to any future Sentinel analyses that assess mortality.
The overarching goal of this project is to improve the capture of out of hospital death and cause of death in the SDD. This project will implement a linkage between two Sentinel data partners’ (national health insurance plans) SDD and NDI data.
The main objectives of this activity are:
Demonstrate reusability of technical process for linking NDI and SDD data
Demonstrate how more complete mortality data capture may support Sentinel queries
Sarah Dutcher, PhD, MS; Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Judy C. Maro, PhD, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Andrew Petrone, MPH; Jennifer Lyons, PhD, MPH; Laura Shockro, BA; Jolene Mosley, MS; Alexander Peters, MPH; Sarah Alam; Dan Kiernan, BS; Sampada Nandyala, MPH; Katie Shapiro, BA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Cheryl N. Walraven, PhD, MSW; Carla M. Brannan, BS; Michael Kretzler, MBA; Audrey Djibo, PhD; Aetna, a CVS Health company, Blue Bell, PA
Todd Sponholtz, PhD; Lauren E. Parlett, PhD; Grace Stockbower, MPH; Daniel, Beachler; PhD, MHS; Carelon Research/Elevance Health, Wilmington, DE