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.{{cite web |title=Sentinel Initiative Website |url=https://www.sentinelinitiative.org}}{{cite book|title=Pharmacoepidemiology|last1=Racoosin|first1=Judith A.|last2=Robb|first2=Melissa A.|last3=Sherman|first3=Rachel E.|last4=Woodcock|first4=Janet|date=2012-01-03|publisher=Wiley-Blackwell|isbn=9781119959946|editor-last=Strom|editor-first=Brian L.|pages=534–554|language=en|chapter=Chapter 30: FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals|doi=10.1002/9781119959946.ch30|editor2-last=Kimmel|editor2-first=Stephen E.|editor3-last=Hennessy|editor3-first=Sean}}{{Cite journal|last1=Desai|first1=Rishi J.|last2=Matheny|first2=Michael E.|last3=Johnson|first3=Kevin|last4=Marsolo|first4=Keith|last5=Curtis|first5=Lesley H.|last6=Nelson|first6=Jennifer C.|last7=Heagerty|first7=Patrick J.|last8=Maro|first8=Judith|last9=Brown|first9=Jeffery|last10=Toh|first10=Sengwee|last11=Nguyen|first11=Michael|date=2021-12-20|title=Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework|journal=npj Digital Medicine|language=en|volume=4|issue=1|page=170 |doi=10.1038/s41746-021-00542-0|pmid=34931012 |pmc=8688411 |s2cid=245330913 |issn=2398-6352|doi-access=free}}
It has several parts: Sentinel System,{{cite journal |title=The FDA's sentinel initiative--A comprehensive approach to medical product surveillance |pmid=26667601 | doi=10.1002/cpt.320 | volume=99 |issue=3 |year=2016 |journal=Clin Pharmacol Ther |pages=265–8 | last1 = Ball | first1 = R | last2 = Robb | first2 = M | last3 = Anderson | first3 = SA | last4 = Dal Pan | first4 = G|s2cid=5129131 }} Postmarket Rapid Immunization Safety Monitoring (PRISM) system, and Blood Safety Continuous Active Surveillance Network (BloodSCAN).{{cite web |title=Sentinel Description |url=https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm |publisher=FDA}} Part of Sentinel Initiative is a surveillance program for biologics. It is called Biologics Effectiveness and Safety (BEST) Initiative.{{cite web |url=https://www.bestinitiative.org/ |title=The Biologics Effectiveness and Safety Initiative |website=BEST Initiative}}
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.{{cite web |title=Background |date=4 February 2022 |url=https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm149340.htm |publisher=FDA}}