マサムネ　ケン   Masamune Ken   正宗　賢    所属   医学研究科 医学研究科 (医学部医学科をご参照ください)    職種   教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Effectiveness of drug postmarketing all-case surveillance as a safety measure in Japan.
掲載誌名	正式名：Therapeutic advances in drug safety 略　 称：Ther Adv Drug Saf ISSNコード：20420986/20420986
掲載区分	国外
巻・号・頁	12,pp.20420986211065215
著者・共著者	KONDO Hideyuki†, MASAMUNE Ken
発行年月	2021/12/16
概要	INTRODUCTION:The drug pharmacovigilance system in Japan is similar to those in the European Union (EU) and the United States. As a unique Japanese pharmacovigilance program, postmarketing all-case surveillance (PMACS) is required. PMACS plays a key role for postmarketing activities, but there are challenges that place much burden on PMACS conduct. This study investigates the impact of PMACS on postmarketing activities in Japan and proposes its potential improvement. This study also seeks the possibility to expand PMACS beyond Japan.MATERIALS AND METHODS:Reexamination reports issued from 2017 to 2019 were identified in September 2020 by searching 'reexamination report' and '201701' to '201912' on the Pharmaceuticals and Medical Devices Agency website. The corresponding Package Insert (PI) change orders and premarketing review reports were also identified. Reviewing these regulatory documents allowed for investigation of the PMACS impact on postmarketing activities.RESULTS:More than half (57%) of the drugs with PMACS had 'Limited dosing experience in Japan' as a reason for the PMACS requirement. As a safety measure, no PI change orders were imposed on 33% and 28% of drugs with and without PMACS, respectively. The means of the number of PI change orders were 2.23 and 2.14 for drugs with and without PMACS, respectively. There were no reexamination reports mentioning any concerns related to efficacy.DISCUSSION AND CONCLUSION:PMACS should not be imposed only because of limited dosing experience in Japan at the premarketing stage. Rather, PMACS should focus on (1) collection of safety data (not efficacy), (2) necessity of distribution control, and/or (3) collection of case details for drugs with a limited treated population. PMACS also has the potential to be utilized in the EU and the United States, as their regulatory frameworks are acceptable for PMACS. Naglazyme (galsulfase) is a case where the PMACS-like studies have been required in each region.PLAIN LANGUAGE SUMMARY
DOI	10.1177/20420986211065215
PMID	34987750