Details
FDA initiated this study in the Sentinel System to characterize the utilization of selected drug-device or biologic-device combination products to enhance understanding of factors that may define intended users of the products. Utilization was characterized in the Sentinel Distributed Database (SDD) for individuals 25 years of age or younger with incident use of drug-device or biologic-device combination products for the following drugs or biologics: adalimumab, somatropin, short-acting insulin pens, intermediate-acting insulin pens, long-acting insulin pens, epinephrine, inhaled corticosteroids, nasal corticosteroids, albuterol nebulizer, ophthalmic antibiotic drops, glucagon nasal spray, and leuprolide acetate between January 1, 2018 and February 29, 2020. The drug-device or biologic-device combination products with the highest number of users aged 25 years or younger in the SDD included: albuterol nebulizer (883,533 patients), ophthalmic antibiotic drops (622,693 patients), nasal corticosteroids (355,722 patients), and inhaled corticosteroids (240,114 patients). This analysis captured patient demographic and clinical characteristics, including age, potential indications, health conditions, and intensity of health service utilization, along with product utilization patterns by patient characteristics. Findings informed FDA’s consideration of future studies to better understand use of drug-device or biologic-device combinations, which can support FDA in providing appropriate guidance on these products.