Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States.

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-10-23 DOI:10.1007/s43441-024-00714-6
Ryohei Osako, Naoki Matsumaru, Katsura Tsukamoto
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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.

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日本的儿科专用药物流失问题:日本与美国儿科发展状况的比较。
背景:缺乏针对儿童群体的标签信息一直是一个全球性问题,导致主要卫生机构采取了多项对策。尽管日本卫生当局做出了各种努力,但有些药物在日本仅被批准用于成人,而美国的标签上却包含了相同药物的儿科用法信息。这表明日本存在儿科专用药物流失的可能性,而在日本,药物的整体流失最近已成为一个主要问题:在这项研究中,我们比较了日本和美国的儿科用药情况,重点是两国批准的适应症:结果:在 404 个适应症中,日本和美国分别有 70 个(17.3%)和 102 个(25.2%)包含儿科用药。美国包括儿科用药在内的适应症比例明显高于日本(χ2检验,p 结论:我们的结果表明,在美国和日本,儿科用药的适应症比例明显高于日本(χ2检验,p):我们的结果表明,与美国相比,日本存在儿科特异性药物流失。多变量分析表明,美国优先开发和非同步开发对日本儿科用药的纳入有负面影响;然而,儿科评估要求并不是一个重要因素。日本应进一步引入促进儿科药物开发的框架,以解决儿科特有的药物流失问题。
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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
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
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