Citation

Isozaki M. Yakugaku Zasshi 2015; 135(2): 271-275.

Affiliation

Safety Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare.

Copyright

(Copyright © 2015, Pharmaceutical Society of Japan)

DOI

10.1248/yakushi.14-00232-1

PMID

25747225

Abstract

Safety information on drugs is provided through package inserts, which are the most basic tool offered by pharmaceutical companies, "Emergency Safety Information" and "Pharmaceuticals and Medical Devices Safety Information", etc. issued by the Ministry of Health, Labour and Welfare (MHLW). In addition, the Pharmaceuticals and Medical Devices Agency (PMDA) recently established an information website, and the provision of enhanced information is now being promoted not only for health care professionals but also for patients. "Drug Guide for Patients" is one of the information tools for patients. The "Drug Guide for Patients" is presented so that the patient understands the correct use of the prescribed drug and serious adverse drug reactions can be recognized at an early stage. It is expected to contribute to the prevention of such adverse reactions by early detection and rapid cure. However, the guides have a low profile and are not yet fully exploited. They are currently being prepared without the direct involvement of patients although they are prepared from a patient point of view. These issues need to be resolved by encouraging broad use, a review of the contents and the involvement of patient groups to provide truly useful information. It is hoped that with these steps the guides will aid in further increasing risk communication to patients reading them.

Language: en