The U.S. Food and Drug Administration's Mini‐Sentinel program: status and direction

Abstract

The Mini-Sentinel is a pilot program 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 U.S. After two years, Mini-Sentinel includes 31 academic and private organizations. 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 hospitalizations, 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 characterization program, 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 epidemiologic methods to address certain gaps in analytic capabilities.Assessments are performed by distributing computer programs that are executed locally by each data partner. The system is in active use by FDA, with the majority of assessments performed using customizable, reusable queries (programs). Prospective and retrospective assessments that use customized 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.

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

“…As a result, continued postmarket surveillance of high-risk orthopaedic devices is critical to ensure patient safety [5]. Although the quality of FDA-mandated postapproval studies has been questioned [19], efforts to build national and international orthopaedic device registries [15] and electronic health record-based monitoring systems [8,17] are underway. Programs such as these may enable continued manufacturer innovation through least burdensome premarket regulation, while still maintaining sufficient postmarket oversight to limit patient safety risks.…”

Adherence to Guidelines for Glucose Assessment in Starting Second-Generation Antipsychotics

“…17,18 One of the current MiniSentinel activities is an assessment of diabetes risk in youth newly initiating an SGA and, as part of assessing diabetes risk, we explored the feasibility of using blood glucose data available from these youth for baseline confounding adjustment. The population for this overall MiniSentinel assessment of diabetes risk in youth initiating an SGA has been previously described.…”

“…[20][21][22] The Mini-Sentinel common data model includes linked tables of patient enrollment, demographic, diagnoses, procedures, and outpatient pharmacy claims data from a source US population exceeding 150 million individual records. 17,18,23 The data tables in the Mini-Sentinel Distributed Database currently are obtained from the source data of 18 data partners, including large US health insurance plans and integrated health care delivery systems. 23,24 Because claims data for laboratory procedures (ie, Current Procedural Terminology codes, including codes for individual glucose tests and for glucose tests that are part of comprehensive metabolic panels) only indicate that a laboratory test was completed and do not contain clinical results values, laboratory claims are of limited use when assessing safety outcomes associated with medication use.…”

Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness

“…With electronic healthcare data covering 178 million individuals, Sentinel could facilitate large rapid assessments of the safety and effectiveness of new generic products [18]. The FDA is currently using the system to assess the safety of various drugs, vaccines, and blood products.…”