医薬品・医療機器の製品固有情報を登録できる検査データベースの構築

摘要

医薬品において，特定のフィブリノゲン製剤が投与されたことによってC型肝炎に感染しているが，投与した薬剤の記録や投与履歴がないために未だ全患者が特定されていないという事例がある.また医療機器においては血管治療に用いられたステントが何らかの原因によって脱落し，死亡した事例が起こっている.2002年に薬事法が改正され，副作用，不具合，感染症などで生命に重篤な影響があると思われる場合に使用した医薬品，医療機器の情報とともに医療機関側から厚生労働省が定める，独立行政法人医薬品医療機器総合機構（Pharmaceuticals and Medical Devices Agency；PMDA）への報告が義務づけられた.%In Japan, patients were infected by viral hepatitis C generally by administering a specific fibrinogen injection. However, it has been difficult to identify patients who were infected as result of the injections due to the lack of medical records. It is still not a common practice by a number of medical facilities to maintain detailed information because manual record keeping is extremely time consuming and subject to human error. Due to these reasons, the regulator required Medical device manufacturers and pharmaceutical companies to attach a bar code called "GS1-128" effective March 28, 2008. Based on this new process, we have come up with the idea of constructing a new database whose records can be entered by bar code scanning to ensure data integrity. Upon examining the efficacy of this new data collection process from the perspective of time efficiency and of course data accuracy, "GS1-128" proved that it significantly reduces time and record keeping mistakes. Patients not only became easily identifiable by a lot number and a serial number when immediate care was required, but "GS1-128" enhanced the ability to pinpoint manufacturing errors in the event any trouble or side effects are reported. This data can be shared with and utilized by the entire medical industry and will help perfect the products and enhance record keeping. I believe this new process is extremely important.