잠시만 기다려 주세요. 로딩중입니다.

미국, 유럽, 일본의 레지스트리 구축 등 데이터기반 의료제품의 안전관리 동향

Current status and examples of patient registries in the US, Europe, and Japan and proposal of planning patient registry in Korea

약학회지 2020년 64권 5호 p.358 ~ 368
이정은, 심다영, 윤동원, 노윤하, 신주영,
소속 상세정보
이정은 ( Lee Jeong-Eun ) - Sungkyunkwan University School of Pharmacy
심다영 ( Shim Da-Young ) - Sungkyunkwan University School of Pharmacy
윤동원 ( Yoon Dong-Won ) - Sungkyunkwan University School of Pharmacy
노윤하 ( Noh Yun-Ha ) - Sungkyunkwan University School of Pharmacy
신주영 ( Shin Ju-Young ) - Sungkyunkwan University School of Pharmacy

Abstract


Over the past years regulatory agencies of Europe, the United States, and Japan have announced policies tofacilitate the establishment and utility of registries at the national level in order to enhance post-marketing surveillance.
With the recent increase in medical products safety issues, the Ministry of Food and Drug Safety (MFDS) is planning tobuild a patient registry system to monitor the safety of problematic products. The objective of this study is to examinethe initiatives and the activities of health authorities in the US, Europe, and Japan and identify the essential features ofwell-operated registries. We collected information from official documents and postings on the health authority’shomepages about activities and efforts of the initiatives. We also surveyed and analyzed the official reports, the guide foreach stakeholder of registries, and the information sheets for patients or doctors as case studies of well-designed registries.
Therefore, this study suggests future directions on how to plan a long-term follow-up system and on how to designnational level registries in Korea.

키워드

Registry; patient registration; patient safety; long-term follow up

원문 및 링크아웃 정보

등재저널 정보