Sentinel Initiative Explained

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

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

Notes and References

  1. Web site: Sentinel Initiative Website .
  2. Book: Pharmacoepidemiology. Racoosin. Judith A.. Robb. Melissa A.. Sherman. Rachel E.. Woodcock. Janet. 2012-01-03. Wiley-Blackwell. 9781119959946. Strom. Brian L.. 534–554. en. Chapter 30: FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals. 10.1002/9781119959946.ch30. Kimmel. Stephen E.. Hennessy. Sean.
  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. en. 4. 1. 170 . 10.1038/s41746-021-00542-0. 34931012 . 8688411 . 245330913 . 2398-6352. free.
  4. The FDA's sentinel initiative--A comprehensive approach to medical product surveillance . 26667601 . 10.1002/cpt.320 . 99 . 3 . 2016 . Clin Pharmacol Ther . 265–8 . Ball . R . Robb . M . Anderson . SA . Dal Pan . G. 5129131 .
  5. Web site: Sentinel Description . FDA.
  6. Web site: The Biologics Effectiveness and Safety Initiative . BEST Initiative.
  7. Web site: Background . 4 February 2022 . FDA.

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