Among the medical incident reports and adverse drug reaction/malfunction reports that have been collected to date, information on similar events that have been repeatedly reported and cases leading to notifications for revisions to package inserts are described on the “PMDA Medical Safety Information” site in an easily understandable manner and widely disseminated. Important reminders to encourage safe use of drugs and medical devices to healthcare professionals are included, which have been considered based on the opinions of healthcare professionals such as physicians, pharmacists, nurses, and clinical engineers, specialists such as those in the field of ergonomics, as well as industry organizations such as marketing approval holders of pharmaceuticals or medical devices.
The information below is English translation of the “PMDA Medical Safety Information”. In the event of inconsistency, the text in Japanese shall prevail.
Pharmaceuticals and Medical Devices Agency