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Sentinel Initiative

Summary

Sentinel Initiative is a set of efforts by U.S. Food and Drug Administration (FDA) that tries to improve the ability to identify and evaluate safety of medicinal products.[1][2][3]

It has several parts: Sentinel System,[4] Postmarket Rapid Immunization Safety Monitoring (PRISM) system, and Blood Safety Continuous Active Surveillance Network (BloodSCAN).[5] Part of Sentinel Initiative is a surveillance program for biologics. It is called Biologics Effectiveness and Safety (BEST) Initiative.[6]

Sentinel System edit

The Sentinel System uses pre-existing electronic healthcare data (including billing data). Part of the Sentinel System is a tool called Active Postmarket Risk Identification and Analysis (ARIA) system that was mandated in the U.S. Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007.[7]

See also edit

References edit

  1. ^ "Sentinel Initiative Website".
  2. ^ Racoosin, Judith A.; Robb, Melissa A.; Sherman, Rachel E.; Woodcock, Janet (2012-01-03). "Chapter 30: FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals". In Strom, Brian L.; Kimmel, Stephen E.; Hennessy, Sean (eds.). Pharmacoepidemiology. Wiley-Blackwell. pp. 534–554. doi:10.1002/9781119959946.ch30. ISBN 9781119959946.
  3. ^ Desai, Rishi J.; Matheny, Michael E.; Johnson, Kevin; Marsolo, Keith; Curtis, Lesley H.; Nelson, Jennifer C.; Heagerty, Patrick J.; Maro, Judith; Brown, Jeffery; Toh, Sengwee; Nguyen, Michael (2021-12-20). "Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework". npj Digital Medicine. 4 (1): 170. doi:10.1038/s41746-021-00542-0. ISSN 2398-6352. PMC 8688411. PMID 34931012. S2CID 245330913.
  4. ^ Ball, R; Robb, M; Anderson, SA; Dal Pan, G (2016). "The FDA's sentinel initiative--A comprehensive approach to medical product surveillance". Clin Pharmacol Ther. 99 (3): 265–8. doi:10.1002/cpt.320. PMID 26667601. S2CID 5129131.
  5. ^ "Sentinel Description". FDA.
  6. ^ "The Biologics Effectiveness and Safety Initiative". BEST Initiative.
  7. ^ "Background". FDA. 4 February 2022.