Against many odds, the FDA has successfully launched a major program (the Sentinel Initiative) to fulfill one of its mandates regarding public health. Here is a short summary of what it is, how it is used and what comes next.
History and Function
In 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative in response to legislative requirement (FDAAA) to create a national electronic system that actively monitors the safety of medical products in the US population.
In 2009, the FDA launched the Mini-Sentinel pilot, and reached the 100 million lives mark by 2011. In February 2016, the official fully operational Sentinel System was launched, and, to date, Sentinel has an impressive network of 18 data partners (mostly health care insurance and hospital networks) with 293 million members with pharmacy and medical coverage.
The Sentinel Initiative made possible for the FDA to securely access diverse healthcare data sources, including electronic health records (EHRs) and claims databases, and to rapidly investigate potential safety concerns. It created a distributed system where data partners retain physical control of data to protect privacy and security.
How it Works
The data is maintained with data partners (it maintains privacy);
The FDA request query is distributed to data partners by the Sentinel Operating Center (SOC);
Data Partners hold data in common data model format;
Data Partners retrieve the query, review it and run the query against their local data behind their firewalls;
Data Partners review results for accuracy and privacy compliance, and return results stripped of identifiers to SOC via a secure portal;
FDA receives aggregated data and results from SOC.
Sentinel Components
The Sentinel infrastructure includes the Active post-market Risk Identification and Analysis (ARIA) tool. ARIA is a subset of Sentinel’s full capabilities and allows predefined, parameterized and reusable searches to enable faster surveillance.
In addition, the Sentinel Initiative created focused surveillance efforts around vaccine safety using the Post-market Rapid Immunization Safety Monitoring (PRISM) system and supports regulatory review of blood and blood products with its Blood Safety Continuous Active Surveillance Network (BloodSCAN). Last, the FDA-Catalyst combines direct contact with health plan members and/or providers with data included in the Sentinel distributed dataset and leverages the Sentinel infrastructure to answer a wider range of questions.
The Primary Focus of Sentinel is ARIA.
ARIA is used during FDA review of new applications as part of the Post-market Requirement (PMR) process, and during the evaluation of post-market drug safety issues. Other utilizations include drug use questions, medication errors detection, generic drug bioequivalence analysis and REMS (Risk Evaluation and Mitigation Strategies) programs. ARIA can contribute to FDA’s regulatory process in a variety of ways, such as contributing evidence to support a label change, respond to a Citizens Petition or become part of an Advisory Committee deliberation.
All results from Sentinel System assessments are posted on the Sentinel Initiative website along with details about how the studies are conducted. These results are also published in peer-reviewed scientific journals to ensure that the methods and results of each FDA study are critically evaluated and can be reproduced by other researchers in the field.
Moving forward
The FDA will continue to expand Sentinel’s use in areas such as mother-infant linkage, vaccine registries, and linkage with the National Death Index. It will also allow an access portal for public entities (IMEDS), post analytic code and examples of analyses, and facilitate the development of mobile applications and standards allowing to collect real-world data from patients through a standard framework and secured storage environment. Future developments also include expanding its use of Electronic Health Records (EHR) data, utilize machine learning to improve algorithms for identifying health outcomes of interest, and implement natural language processing to use free text in EHRs. The future of Sentinel looks bright, and its potential uses will have an increasing impact on monitoring safety and FDA decisions regarding medical products. This is a remarkable achievement when considering the diversity and lack of standards of Electronic Healthcare records in the US.
One issue for the pharmaceutical industry is that there is currently no opportunity to use this major resource to initiate its own queries outside of partnering with academia. Hopefully the FDA will facilitate such access, as FDA and the pharmaceutical industry have aligned goals regarding public health and patient safety.
US FDA Sentinel homepage: https://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm
FDA Sentinel System Five Year Strategy: https://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM629243.pdf
Claudia White, MS RA/QA
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