Abstract
OBJECTIVES: This study investigated the differences in the incidence and severity of adverse drug events (ADEs) in pediatric patients with and without cancer. METHODS: We used data from the Japan Adverse Drug Events Study for pediatrics, a cohort study enrolling pediatric inpatients at two tertiary care teaching hospitals in Japan. ADEs were identified by on-site review of all medical charts, incident reports, and prescription queries by pharmacists. Two independent physicians reviewed all potential ADEs and classified ADEs in terms of severity and class of causative medication. We compared the incidence and characteristics of ADEs between pediatric cancer patients and non-cancer patients. RESULTS: We enrolled 1189 patients during the study period, 27 with cancer and 1162 without cancer. We identified 480 ADEs in 234 patients (20%): 191 ADEs among 21 cancer patients and 289 ADEs among 213 non-cancer patients (7.1 per patient vs. 0.25 per patient, respectively; p < 0.0001). The most common medications associated with ADEs in cancer patients were antitumor agents; in contrast, medications associated with fatal or life-threatening ADEs in cancer patients were most often sedatives (25%) and blood products (25%). Medications associated with fatal or life-threatening ADEs among non-cancer patients were most often sedatives (15%). The percentages of fatal or life-threatening ADEs in cancer patients and non-cancer patients were 2.1 and 4.5%, respectively. CONCLUSIONS: Pediatric patients with cancer have a higher risk for ADEs. Although the overall severity was similar between patients with and without cancer, the most common classes of causative medication and medications associated with a higher rate of severe ADEs differed. Application of this information may help minimize the impact of ADEs in pediatric patients.