{"title":"Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States.","authors":"Ryohei Osako, Naoki Matsumaru, Katsura Tsukamoto","doi":"10.1007/s43441-024-00714-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The lack of label information for the pediatric population has been a global issue, leading to the introduction of several countermeasures by major health authorities. Despite various efforts by Japanese health authorities, some drugs are approved only for adults in Japan, while the United States (US) label includes information on pediatric usage for the same drugs. This suggests a potential for pediatric-specific drug loss in Japan, where overall drug loss has recently become a major concern.</p><p><strong>Methods: </strong>In this study, we compared the pediatric usage status between Japan and the US, focusing on the indications approved in both countries.</p><p><strong>Results: </strong>Of the 404 indications, 70 (17.3%) and 102 (25.2%) included pediatric usage in Japan and the US, respectively. The proportion of indications, including pediatric usage, was significantly higher in the US than in Japan (χ<sup>2</sup> test, p < 0.001). Multivariate analysis of indications for pediatric usage in the US demonstrated that simultaneous development with adults (odds ratio (OR), 24.9; 95% confidence interval (CI), 6.79-91.1) and Japan-first development (OR, 31.5; 95% CI, 2.59-384) were significantly affecting the inclusion of pediatric usage in Japan.</p><p><strong>Conclusions: </strong>Our results suggest that there was pediatric-specific drug loss in Japan compared to that in the US. The multivariate analysis demonstrated that US-first development and non-simultaneous development had a negative impact on the inclusion of pediatric usage in Japan; however, pediatric assessment request was not a significant factor. Further frameworks to promote pediatric drug development should be introduced in Japan to address pediatric-specific drug loss issues.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic innovation & regulatory science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s43441-024-00714-6","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICAL INFORMATICS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: The lack of label information for the pediatric population has been a global issue, leading to the introduction of several countermeasures by major health authorities. Despite various efforts by Japanese health authorities, some drugs are approved only for adults in Japan, while the United States (US) label includes information on pediatric usage for the same drugs. This suggests a potential for pediatric-specific drug loss in Japan, where overall drug loss has recently become a major concern.
Methods: In this study, we compared the pediatric usage status between Japan and the US, focusing on the indications approved in both countries.
Results: Of the 404 indications, 70 (17.3%) and 102 (25.2%) included pediatric usage in Japan and the US, respectively. The proportion of indications, including pediatric usage, was significantly higher in the US than in Japan (χ2 test, p < 0.001). Multivariate analysis of indications for pediatric usage in the US demonstrated that simultaneous development with adults (odds ratio (OR), 24.9; 95% confidence interval (CI), 6.79-91.1) and Japan-first development (OR, 31.5; 95% CI, 2.59-384) were significantly affecting the inclusion of pediatric usage in Japan.
Conclusions: Our results suggest that there was pediatric-specific drug loss in Japan compared to that in the US. The multivariate analysis demonstrated that US-first development and non-simultaneous development had a negative impact on the inclusion of pediatric usage in Japan; however, pediatric assessment request was not a significant factor. Further frameworks to promote pediatric drug development should be introduced in Japan to address pediatric-specific drug loss issues.
期刊介绍:
Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health.
The focus areas of the journal are as follows:
Biostatistics
Clinical Trials
Product Development and Innovation
Global Perspectives
Policy
Regulatory Science
Product Safety
Special Populations