Pediatric off-label use of psychotropic drugs approved for adult use in Japan in the light of approval information regarding pediatric patients in the United States: a study of a pharmacy prescription database
Pediatric off-label use of psychotropic drugs approved for adult use in Japan in the light of approval information regarding pediatric patients in the United States: a study of a pharmacy prescription database
复制标题
根据美国儿科患者的批准信息，日本批准成人使用的精神药物的儿童超说明书使用：对药房处方数据库的研究
DOI：
10.1007/s12519-018-0213-z
复制
发表时间：
2018
影响因子：
8.7
通讯作者：
Urushihara Hisashi
中科院分区：
文献类型：
--
作者：
Tanemura Nanae;Asawa Maika;Kuroda Mayuko;Sasaki Tsuyoshi;Iwane Yoshiaki;Urushihara Hisashi
背景：在日本，儿科患者未经批准使用精神药物处方的情况一直在增加。本研究旨在澄清儿科患者在说明书外使用仅在日本被批准用于成人的精神药物。方法采用2016财年某药店提供的药品健康保险理赔数据库对精神药物使用情况进行回顾性研究。检查了七种精神药物。对于每种药物，我们计算了年龄< 16岁或低于美国批准的年龄限制的患者占所有患者的比例。研究期间每种药物的最大日剂量按年龄绘制。结果共纳入45715例患者（女性26799例，男性18916例），共纳入处方331920张。每种药物的儿童患者年龄< 16岁的比例为0.15 - 1.1%，而美国批准的年龄限制以下的比例为0 - 0.27%。奥氮平的报告比例最高。在美国，除了奥氮平之外，没有其他药物在批准的年龄限制下服用。结论：在日本，我们发现儿童超说明书使用精神药物的情况仅限于成人使用。结果表明，在临床实践中参考国际指南或证据的可能性，但这些因素并没有忽视超说明书使用存在的问题。需要在日本儿科人群中进行更多的临床试验，以解决标签外使用问题，并在包装说明书中获得有用和可靠的信息，以便将来儿科患者合理使用。
BackgroundOff-label use of psychotropic prescriptions for pediatric patients has been increasing in Japan. This study sought to clarify pediatric patients’ off-label use of psychotropics approved only for adults in Japan.MethodsThis retrospective study on psychotropic utilization employed a pharmaceutical health insurance claims database supplied by a pharmacy for the fiscal year 2016. Seven psychotropic drugs were examined. For each drug, we calculated the proportion of patients aged < 16 years or who were under the approved age limit set in the United States out of all patients. The maximum daily dose of each drug within the study period was plotted by age.ResultsData of 45,715 patients (female: 26,799, male: 18,916) with 331,920 prescriptions were examined in this study. For each drug, the proportion of pediatric patients aged < 16 years ranged from 0.15 to 1.1%, while the proportion of those under the approved age limit in the United States ranged from 0 to 0.27%. Olanzapine had the highest reported proportion. No drugs other than olanzapine were taken under the approved age limit in the United States.ConclusionsWe identified the pediatric off-label use of psychotropics that were limited to adult use in Japan. The results indicated the possibility of referring to international guidelines or evidence in clinical practice, but these factors do not discount the existing problems with off-label use. More clinical trials within the pediatric population in Japan are needed to address the issue of off-label use and obtain useful and reliable information in the package inserts for rational use in future pediatric patients.