Background

History

The Sentinel Initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the safety of FDA-regulated medical products.

The Initiative is the FDA’s response to the Food and Drug Administration Amendments Act (FDAAA) requirement that the FDA work with public, academic, and private entities to develop a system to obtain information from existing electronic health care data from multiple sources to assess the safety of approved medical products.

Target Medical Products

The Mini-Sentinel pilot focuses on drugs, vaccines, other biologics (such as blood products), and medical devices. Work focused specifically on vaccines is known as the Post-Licensure Rapid Immunization Safety Measurement (PRISM) program. Work focused specifically on blood products is known as the Blood Safety Continuous Active-Surveillance Network (Blood-SCAN).

Key Features

Active Surveillance: Mini-Sentinel monitors the safety of FDA-regulated medical products through assessment of routinely collected electronic healthcare data in response to FDA concerns. It does not require patients or clinicians to initiate reports to FDA.

Assessment of the Impact of FDA Actions: Mini-Sentinel also assesses changes in the use of regulated medical products in response to FDA regulatory actions, such as the addition of boxed warnings regarding appropriate use.

Distributed Data Network: Mini-Sentinel uses a distributed data approach in which Data Partners retain control over data in their possession as a result of normal activities. Data Partners execute standardized computer programs within their own institutions and, under most circumstances, share aggregated results.

Rapid Response: Mini-Sentinel is building the capacity to respond to many of FDA’s safety questions within days or weeks.

Transparency: Transparency is a fundamental principle of the operations of the Mini-Sentinel pilot. Results of Mini-Sentinel activities are placed in the public domain.

Privacy: Mini-Sentinel activities adhere to applicable privacy-related laws and regulations governing public health practice. Whenever possible, aggregate data or individual level data without direct identifiers are used. Mini-Sentinel's privacy policy is described in detail in the statement of Principles and Policies.