Sentinel Initiative
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]
It has several parts: Sentinel System,[3] Postmarket Rapid Immunization Safety Monitoring (PRISM) system, and Blood Safety Continuous Active Surveillance Network (BloodSCAN).[4] Part of Sentinel Initiative is a surveillance program for biologics. It is called Biologics Effectiveness and Safety (BEST) Initiative.[5]
Sentinel System
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.[6]
See also
References
- ^ "Sentinel Initiative Website".
- ^ 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.
- ^ 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.
- ^ "Sentinel Description". FDA.
- ^ "The Biologics Effectiveness and Safety Initiative". BEST Initiative.
- ^ "Background". FDA.
 | This health-related article is a stub. You can help Wikipedia by expanding it. |