Background: In Japan, many asthma inhalers do not have formal approval for use in the pediatric population because of the lack of domestic data. In real‐world settings, however, numerous off‐label medications are prescribed. Currently, the nature of off‐label prescriptions of asthma inhalers on pediatric patients in Japan remains unclear.Methods: Using public open‐source national medical claims data, we investigated the real‐world descriptive epidemiology of off‐label prescriptions for asthma inhalers for pediatric patients. We obtained the number of off‐label prescriptions of formulations for patients aged 0–14 years from anonymously summarized prescription data for a 7‐year period starting from April 2014. The actual prescription numbers and their chronology over time were then analyzed.Results: In 2019, 143,439 asthma inhalers were used off label in children and adolescents. Overall, 96.1% were inhaled corticosteroids (ICSs) or long‐acting beta stimulants (LABAs), and 3.9% were high‐dose ICS. Of ICSs and LABAs, 18.8% were off‐label prescriptions. The total number of off‐label ICS/LABA prescriptions and their percentage relative to the overall formulations gradually decreased but a notable disparity was observed among inhaler types.Conclusions: There was a surprisingly large number of off‐label prescriptions of asthma inhalers in the pediatric population in Japan. The proper use of ICSs/LABAs and expansion of insurance coverage should be advocated to reduce off‐label use.
1 January 2024 in The Tohoku Journal of Experimental Medicine
Background: The 2018 revision of social insurance in Japan allows additional fees to be calculated for pediatric magnetic resonance imaging (MRI) that must be performed under sedation. The number and trend of actual claims since this revision was established is unknown. The aim of this study to investigate the use of the additional fees and any regional differences in the use.Methods: To analyze the claims of additional fees for pediatric sedated MRI after the fiscal year (FY) 2018, the actual claims in inpatient and outpatient practice was analyzed using publicly‐available data from the Ministry of Health, Labour and Welfare (MHLW). We analyzed the calculation rate for all MRI scans. Annual changes in the actual number and calculation rate were analyzed. The ratio of the number of additional fees to the overall number of pediatric radiological procedures was used to examine the geographic disparity.Results: The number of calculations from FY 2018 to FY 2020 was available. In FY 2020, only 1347 additional fees were calculated, corresponding to 0.35% of the total number of MRI scans. The number of fees showed a decreasing trend. Most cases were in the 0–4 year age group; however, there were a few cases in the 10–14 year age group without such a decrease. The relative number of calculations by prefecture showed an up to 14‐fold disparity.Conclusions: The requirements for sedation for pediatric MRI are strict, but they are not fully utilized. Measures such as relaxing the requirements for the fee are needed to make MRI‐related sedation safer.
1 January 2016 in Nihon Shoni Arerugi Gakkaishi. The Japanese Journal of Pediatric Allergy and Clinical Immunology