Patterns of platelet use evaluated in EHR networks of the Biologics Effectiveness and Safety Initiative, 2012-2018

Background: U.S. FDA's Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative leverages large electronic health records and administrative claims data to conduct active surveillance for CBER-regulated products. Improved hemovigilance of platelet transfusions provides exposure data for future outcome studies and can identify opportunities to improve management of the limited platelet supply.

Methods: Platelet utilization in three hospital networks (2012-2018) is summarized from data obtained using Information Standard for Blood and Transplant (ISBT) 128 platelet codes. Transfusion episodes, the number of units transfused, and component characteristics are described.

Results: Most platelet-transfused patients (range 59.6%-62.2% across study years for all sites) received platelets once per year and used a small proportion of the total platelets transfused per year (range 18.4%-22.5%). In contrast, a minority of patients were transfused 12 or more times in a given study year (range 4.4%-6.3%) and used a plurality of transfused platelets (range 32.2%-44.4%) per year. The overall ratio of platelets transfused to the number of patients receiving any platelet transfusion was stable over the study period (range 3.9-4.5 platelets/patient) and similar among participating data sources. For all data sources, most transfusion episodes (78%) involved one component per transfusion episode.

Conclusion: ISBT 128 coding in the BEST Initiative was used to capture platelet transfusion events, component modifications, and characterize aspects of platelet use patterns. These data can be leveraged to identify opportunities for improved management of the platelet supply and provide granular exposure information for future studies of transfusion-related adverse events.