Mini-Sentinel is the Food & Drug Administration’s new tool to assist in monitoring the safety of drugs and medical products after FDA approval. It is a pilot program for FDA’s larger sentinel system, a multifaceted effort by the FDA to develop a national electronic system that will complement existing methods of safety surveillance, which is currently under development.(1) (2)

Until now, adverse events were collected through FDA’s MedWatch program and Adverse Event Reporting system (AERS) which is a “passive surveillance” system relying on voluntary spontaneous reports of adverse events from consumers and health care professionals. In contrast, Mini-Sentinel is an “active surveillance” system. Data is mined to respond to FDA queries regarding potential safety issues that may have been initially identified through passive surveillance systems. 

The FDA Amendments Act of 2007 authorized the FDA to establish a post-market risk identification and analysis system to link and analyze safety data from multiple sources, including federal health-related electronic data (e.g., data from the Medicare program) and private sector health-related data (e.g., pharmaceutical purchase data and health insurance claims).  Mini-Sentinel is intended to advance FDA’s ability to track drug safety concerns, identify potential safety signals early, analyze data for its clinical significance and determine whether a regulatory change or other solution is needed to further protect patients from drug and medical product risks. Through a contract with Harvard Pilgrim Health care and 17 data partners, FDA has continuous access to automated health care data systems. As of December 2011, data for 126 million patients are part of the Mini-Sentinel program. 

Through Mini-Sentinel, FDA has access to subgroups and special populations, longer term data and adverse events commonly occurring in the general population that tend not to get reported to FDA through its passive reporting systems. When evaluating potential safety issues, information gathered through Mini-Sentinel is reviewed in conjunction with other information (i.e., preclinical and clinical information, AERS reports, medical literature, post-market trials and studies and foreign post-market adverse event reports) in order to assist FDA in making decisions. Mini-Sentinel does not replace FDA’s existing tools, but is one more feature of the tool box used for post-market risk identification and analysis.

Results of queries are posted to the Mini-Sentinel website in order to inform the public of FDA’s work with Mini-Sentinel. It is important to note that the fact that a potential safety signal was investigated does NOT mean there is a safety issue with that drug or medical product. FDA continues to communicate safety conclusions through their existing channels, such as FDA’s press announcements, MedWatch Alerts and Drug Safety communications.

Mini-Sentinel offers the FDA an opportunity to enhance safety monitoring for the American public. However, there are challenges in using the Mini-Sentinel data for post-market risk identification and analysis. Of critical importance is ensuring that privacy of individual health information is maintained. The program must conform to the principles of fair information practices, maintain security and integrity of data and assure the confidentiality of proprietary information. 

The Mini-Sentinel program leverages health insurance claims data which is collected for purposes other than drug and medical product safety surveillance. This may represent a limitation of the program, since the primary purpose for claims data is payment and reimbursement. Therefore, data may be coded in such a way as to maximize reimbursement rather than identify safety issues. In addition, some products and information are not included in claims data such as over the counter medications, herbal products or products used off-label.  FDA needs to understand such limitation of the data available through Mini-Sentinel in order to effectively use the data in their assessment of a potential safety issue.(1) (2)

References

1. Robb, M. A., Racoosin, J. A., Sherman, R. E, Gross, T. P., Ball, R., Reichman, M. E., Woodcock, J. (2012, January). The US Food and Drug Administration’s Sentinel Initiative: Expanding the horizons of medical product safety. Phamacoepidemiology and Drug Safety, 21, 9-11.

2. Forrow, S., Campion, D. M., Herrinton, L. J., Nair, V. P., Robb, M.A., Wilson, M., & Platt, R. (2012, January). The organizational structure and governing principles of the Food and Drug Administration’s Mini-Sentinel pilot program. Phamacoepidemiology and Drug Safety, 21, 12-17.

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