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首页> 外文期刊>Regulatory Toxicology and Pharmacology: RTP >Estimation of total prescription weights of active pharmaceutical ingredients in human medicines based on a public database for environmental risk assessment in Japan
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Estimation of total prescription weights of active pharmaceutical ingredients in human medicines based on a public database for environmental risk assessment in Japan

机译:基于公共数据库对日本环境风险评估的公共数据库估计人类药物中活性药物成分的总处方重量

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摘要

The distribution of active pharmaceutical ingredients (APIs) in prescription medicines for human consumption in Japan was estimated using the public database of the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). From the latest NDB, 2058 APIs were identified, and the prescription weight exceeded 1 tonne/year for 711 APIs. Of these, 298 APIs were selected for further analysis after removing 413 APIs that were not covered by current environmental risk assessment (ERA) directives or were combination products. Among the 298 APIs, 43 were relatively newly branded APIs that have been available on the Japanese market since 2001 or later and have no generic drugs, and only 5 of the branded APIs are used by more than 1% of the population. When prescription data from the 47 prefectures in Japan were analyzed, prescription weights for 257 of the 298 APIs were the highest in Tokyo, probably because of its large population. Though it has both advantages and limitations, this novel method based on a non-profit public database can provide a transparent, unbiased and cost-effective solution for the estimation of the environmental exposure of generic and branded human medicines distributed with prescriptions in Japan.
机译:使用国家健康保险索赔数据库和日本特定健康检查(NDB)的国家数据库估计日本人类消费中的活性药物成分(API)的分布。从最新的NDB,鉴定了2058个API,711 API的处方重量超过1吨/年。其中,在去除目前环境风险评估(时代)指令或组合产品的情况下,选择了298个API进行进一步分析。在298个API中,自2001年或以后的日本市场上有43个是相对新的品牌的API,没有通用药物,只有5个人的人口使用5个品牌API。当分析日本47个县的处方数据时,298 API中257个中的处方重量是东京的最高价,可能是因为它的人口大。虽然它具有优势和局限性,但基于非营利性公共数据库的这种新方法可以提供透明,无偏见和成本效益的解决方案,用于估计与日本处方的处方分布的通用和品牌人类药物的环境暴露。

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