Abstract / Summary
Immune-related adverse events (irAE) are adverse drug reactions that are characteristic of immune checkpoint inhibitors (ICI). IrAE can occur in multiple organs and have a wide range of onset times, making early detection difficult. Therefore, a new protocol using protocol-based pharmacotherapy management (PBPM) aimed at the early detection of irAE was developed and implemented by pharmacists at Mie Chuo Medical Center in Tsu, Japan. The protocol provides steps and instructions for blood and urine tests for outpatients receiving an ICI regimen when irAE-related tests have not been performed within the past 3 months. The clinical tests included in the protocol are free triiodothyronine, free thyroxine, thyroid-stimulating hormone, adrenocorticotropic hormone, serum cortisol, Krebs von den Lungen-6, hemoglobin A1c, blood glucose levels, and urinalysis. This study evaluated the usefulness of the protocol and examined its impact on physician behavior, using data for 277 regimens pre-PBPM and 284 regimens post-PBPM. The percentage of regimens in which all test items were performed increased from 8.3％ to 90.5％ (P < 0.001). Furthermore, the percentage of regimens in which all test items were ordered only by physicians increased from 8.3％ to 15.8％ (P = 0.006). This protocol may be useful for the continuous monitoring of irAE in patients receiving ICI regimens. Moreover, the protocol may contribute to changes in physicians’ behavior by raising their awareness of the importance of irAE-related blood and urine tests.