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大学・研究所にある論文を検索できる 「日米の添付文書で伝達される安全性情報の一致性と改訂時期の比較」の論文概要。リケラボ論文検索は、全国の大学リポジトリにある学位論文・教授論文を一括検索できる論文検索サービスです。
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日米の添付文書で伝達される安全性情報の一致性と改訂時期の比較

星野 優子 北里大学

2022.09.30

概要

Purpose: It is important to make the most up-to-date drug safety information available to the public in a timely manner so that health care professionals and patients can consider the information. The aim of this research was to investigate the consistency and simultaneity of safety related label changes (Study 1) and the consistency of safety related information on drug labeling at the time of initial approval (Study 2) for novel therapeutics concurrently approved in Japan and the US.

Methods: In Study 1, new safety label changes that were made for new drugs approved concurrently both in Japan and the US in the recent 5 years were identified and reviewed for concordance and time lag analysis. Factors associated with the time lag were also investigated. In Study 2, safety information on labeling for new drugs approved concurrently in both countries in the recent 7 years were identified and reviewed for concordance. Factors associated with the discordance were also investigated.

Results: In Study 1, despite similar medical practices, population health and regulation in the two countries, a low level of concordance (40/115, 34.8%) in the decision of labeling change was found in 31 new active substances. Only 3/40 (7.5%) of the concordant changes were made simultaneously. Labeling change orders issued by regulators and domestic postmarketing adverse event reports were associated with a significant difference in the timing of labeling change between the countries. In Study 2, a low level of concordance (20.4%) in the safety information provided by drug labeling was also found in 45 new active substances. Development strategy of the drugs and having the same MAH were significantly associated with the higher concordance rate. The mean concordance rate among 9 drugs with Black Box Warning in both countries remained low (32.9%).

Conclusions: A low level of concordance between the countries in the decision of labeling changes and the timeliness of the changes were found. The discrepancy was found from the time of approval and these were observed even in clinically important information raised by Black Box Warnings. The low concordance and time lag highlighted the need for greater transparency in the decision-making process for both industry and regulators to take appropriate countermeasures.

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