The FDA Sentinel Initiative — An Evolving National Resource

Platt, Richard; Brown, Jeffrey S.; Robb, Melissa A.; McClellan, Mark; Ball, Robert; Nguyen, Michael; Sherman, Rachel E.

doi:10.1056/nejmp1809643

Cited by 154 publications

(127 citation statements)

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“…Continual monitoring of drugs and therapeutic biologics after approval for use is essential for patient and consumer safety for many years after approval . Administrative claims and electronic health record data are often used for epidemiological studies postlicensure . Analysis of safety data from spontaneous reporting systems (SRS), such as the FDA Adverse Event Reporting System (FAERS), remains a mainstay for monitoring the safety of these products and identification of safety signals .…”

Section: Introductionmentioning

confidence: 99%

“…7 Administrative claims and electronic health record data are often used for epidemiological studies postlicensure. [8][9][10][11] Analysis of safety data from spontaneous reporting systems (SRS), such as the FDA Adverse Event Reporting System (FAERS), remains a mainstay for monitoring the safety of these products and identification of safety signals. 12,13 Individual case safety reports (ICSRs) contained in such systems provide first alerts for emerging drug and therapeutic biologic product safety concerns and help to generate hypotheses that can be evaluated using other data sources and methods.…”

Section: Introductionmentioning

confidence: 99%

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An evaluation of statistical approaches to postmarketing surveillance

Ding

Markatou

Ball

2020

Statistics in Medicine

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Safety of medical products presents a serious concern worldwide. Surveillance systems of postmarket medical products have been established for continual monitoring of adverse events (AEs) in many countries, and the proliferation of electronic health record systems further facilitates continual monitoring for AEs. We review existing statistical methods for signal detection that are mostly in use in postmarketing safety surveillance of spontaneously reported AEs and we study their performance characteristics by simulation. We compare those with the likelihood ratio test (LRT) method (appropriately modified for use in pharmacovigilance) and use three different methods to generate data (AE based, drug based, and a modification of the method of Ahmed et al). Performance metrics include type I error, power, sensitivity, and false discovery rate, among others. The results show superior performance of the LRT method in almost all simulation experiments. An application to the FDA Adverse Event Reporting System database is illustrated using rhabdomyolysis‐related preferred terms reported to FDA during the third‐quarter of 2014 to the first‐quarter of 2017 for statin drugs. We present a critical discussion and recommendations for use of these methods.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An evaluation of statistical approaches to postmarketing surveillance

Ding

Markatou

Ball

2020

Statistics in Medicine

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“…The FDA's Sentinel System is a national active surveillance system for medical product safety with data from 18 sources that include national health insurers, integrated healthcare systems, and Medicare. 5 Early efforts during the Mini-Sentinel pilot examined the impact of FDA regulatory actions on drug utilization trends in long-acting beta2-agonists. 6,7 This work illustrated the potential for leveraging the Sentinel's large database of quality checked data to rigorously address drug utilization questions with sophisticated methods.…”

Section: Introductionmentioning

confidence: 99%

A new analytic tool developed to assess safe use recommendations

Cocoros

Wagner

Haynes

et al. 2019

Pharmacoepidemiology and Drug

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Purpose Develop a flexible analytic tool for the Food and Drug Administration's (FDA's) Sentinel System to assess adherence to safe use recommendations with two capabilities: characterize adherence to patient monitoring recommendations for a drug, and characterize concomitant medication use before, during, and/or after drug therapy. Methods We applied the tool in the Sentinel Distributed Database to assess adherence to the labeled recommendation that patients treated with dronedarone undergo electrocardiogram (ECG) testing no less often than every 3 months. Measures of length of treatment, time to first ECG, number of ECGs, and time between ECGs were assessed. We also assessed concomitant use of contraception among female users of mycophenolate per label recommendations (concomitancy 4 weeks before through 6 weeks after discontinuation of mycophenolate). Unadjusted results were stratified by age, month‐year, and sex. Results We identified 21 457 new episodes of dronedarone use of greater than or equal to 90 days (July 2009 to September 2015); 86% had greater than or equal to one ECG, and 22% met the recommendation of an ECG no less often than every 3 months. We identified 21 942 new episodes of mycophenolate use among females 12 to 55 years (January 2016 to September 2015); 16% had greater than or equal to 1 day of concomitant contraception dispensed, 12% had concomitant contraception use for greater than or equal to 50% of the 4 weeks before initiation through 6 weeks after mycophenolate; younger females had more concomitancy. These results may be underestimates as the analyses are limited to claims data. Conclusions We developed a tool for use in databases formatted to the Sentinel Common Data Model that can assess adherence to safe use recommendations involving patient monitoring and concomitant drug use over time.

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“…Through the Sentinel Initiative, the FDA has partnered with over 200 experts from 31 health plans and organizations to establish a distributed data network containing curated electronic health data on over 100 million people in the United States, which enables the FDA to harness more efficiently the potential of real-world health care data. 4…”

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confidence: 99%

Real‐World Data, Advanced Analytics, and the Evolution of Postmarket Drug Safety Surveillance

Pan

2019

Clin Pharma and Therapeutics

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The FDA Sentinel Initiative — An Evolving National Resource

Cited by 154 publications

References 2 publications

An evaluation of statistical approaches to postmarketing surveillance

An evaluation of statistical approaches to postmarketing surveillance

A new analytic tool developed to assess safe use recommendations

Real‐World Data, Advanced Analytics, and the Evolution of Postmarket Drug Safety Surveillance

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