ABSTRACT
Background : As the consequence of the decision at the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) progress, drug safety information reporting system in Japan is being revised. This has led to inevitable increases in the number of safety reports submitted to the industries and in turn, the Ministry of Health and Welfare (MHW). In 1997, the MHW announced they would publicize this acquired information starting in 1999. In the USA, Food and Drug Administration (FDA) has released safety related information to the public, acquired over the years since 1969, though such means in the Web page of MEDWatch using the internet.<BR>Purpose : (1) To review accessibility of individual adverse experience (AE) reports in MEDWatch through internet, (2) to give advise to other possible Japanese users on the use of it and, (3) to give recommendation to the new system being developed in Japan by the MHW and/or other regulatory agency. <BR>Method : Case study started by using personal computer.<BR>Results : (1) The information cannot be accessible only using personal computers. Computer expert assistance and big computer are needed to access the information. (2) Information from more than a million AE cases is accessible. (3) Searches for information can be organized by pharmaceutical name, event term, patient demographics, and others. (4) The detailed information such as the course of the individual case from which drug causality could be assessed is not accessible. (5) The improvement of system should be needed for easy access such as “quick search”. (6) More “user friendly” system is desired to be developed by the MHW and/or other regulatory agency in Japan which enable easy and full access of the information.
ABSTRACT
Objective : To get first-hand information on and understand MEDWatch, a newly created program of the US FDA, on safety information reporting and management.<BR>Design and Method : Through a visit to the FDA office by Japanese members of the ICH M1 (Medical Terminology) Expert Working Group (EWG) and other concerned experts, and discussion with relevant FDA staffs.<BR>Results and Conclusion : (1) The MEDWatch program was introduced in June 1993, to accelerate the spontaneous reporting of adverse events (AE) to FDA by developing a single Adverse Event Reporting Form, i.e., FDA 3500, for (1) drugs, (2) biologics (except vaccine), (3) medical devices, (4) food, and (5) veterinary medicines; (2) Five responsible sectors in FDA have been working together to develop a smooth flow of information from health care professionals and industries; (3) The remarkable result from the development of this new program is the increased reporting of serious AE; (4) Much efforts have been exerted by FDA on the education of health professionals through various health societies and through publications; (5) Some of the issues which remain unresolved include database integration of NDA and PMS information; (6) Advocacy of the AE concept and importance of reporting thereof by health care professionals and the use of simple, easy-to-fill-out form is recommended in Japan.