Abstract
BACKGROUND/AIMS: In 2011, the US Food and Drug Administration (FDA) created the Blood Safety Continuous Active-Surveillance Network (Blood-SCAN), the first nationwide active surveillance system for monitoring the safety of FDA-regulated blood components and blood-derived products. Blood-SCAN employs the Mini-Sentinel Distributed Database (MSDD) which contains 126 million individuals within 17 Data Partners. Blood-SCAN is intended to augment the existing safety surveillance system and improve US biovigilance efforts. As a first step in creating Blood-SCAN, we assessed the feasibility of using the current MSDD to evaluate blood component and blood-derived product exposures and related health outcomes. METHODS: The assessment consisted of 4 activities: (1) an expert working group identified 20 blood components and blood-derived products and 10 health outcomes of interest (HOIs) to evaluate the data available in the MSDD, (2) a literature scan was conducted to identify electronic algorithms to capture these product exposures and HOIs, (3) HOI and exposure frequencies were tabulated using established Mini-Sentinel programs, and (4) structured discussions were conducted with all Mini-Sentinel Data Partners to assess the availability, content, and quality of data within their databases. RESULTS: Claims codes were available for all of the blood components and blood-derived products, and many of the claims codes for blood-derived products were sufficiently specific to allow analyses by product manufacturer, fulfilling an important regulatory need. Adequate counts of exposures to immunoglobulin products indicate the potential for future surveillance studies on these products. MSDD analyses suggest that blood-derived products are captured effectively in outpatient settings but not in inpatient settings, limiting the scope of therapeutic indications that can be assessed. Blood component exposures are also captured in outpatient settings within the MSDD; however, because most transfusions occur in inpatient settings, these data may not be completely representative of the patient population, reason for transfusion, and dose. Most Data Partners reported no current ability to access inpatient blood component exposures through existing claims data streams. CONCLUSIONS: The current MSDD supports safety surveillance for a variety of blood components and blood-derived products in the outpatient setting. Expanding the MSDD to include inpatient data streams will ensure that Blood-SCAN achieves its full potential.