The Mini-Sentinel is a pilot programme that is developing methods, tools, resources, policies and procedures to facilitate the use of routinely collected electronic healthcare data to perform active surveillance of the safety of marketed medical products, including drugs, biologics and medical devices.  The US Food and Drug Administration (FDA) initiated the programme in 2009 as part of its Sentinel Initiative, in response to a Congressional mandate in the FDA Amendments Act of 2007.

After 2 years, Mini-Sentinel includes 31 academic and private organisations.  It has developed policies, procedures and technical specifications for developing and operating a secure distributed data system comprised of separate data sets that conform to a common data model covering enrollment, demographics, encounters, diagnoses, procedures and ambulatory dispensing of prescription drugs.  The distributed data sets currently include administrative and claims data from 2000 to 2011 for over 300 million person-years, 2.4 billion encounters, 38 million inpatient hospitalisations and 2.9 billion dispensings.  Selected laboratory results and vital signs data recorded after 2005 are also available.  There is an active data quality assessment and characterisation programme, and eligibility for medical care and pharmacy benefits is known.  Systematic reviews of the literature have assessed the ability of administrative data to identify health outcomes of interest, and procedures have been developed and tested to obtain, abstract and adjudicate full-text medical records to validate coded diagnoses.  Mini-Sentinel has also created a taxonomy of study designs and analytical approaches for many commonly occurring situations, and it is developing new statistical and epidemiological methods to address certain gaps in analytical capabilities.

Assessments are performed by distributing computer programs that are executed locally by each data partner.  The system is in active use by the FDA, with the majority of assessments performed using customisable, reusable queries (programs).  Prospective and retrospective assessments that use customised protocols are conducted as well.  To date, several hundred unique programs have been distributed and executed.

Current activities include active surveillance of several drugs and vaccines, expansion of the population, enhancement of the common data model to include additional types of data from electronic health records and registries, development of new methodologic capabilities, and assessment of methods to identify and validate additional health outcomes of interest.