The Ministry of Health and Welfare (presently the Ministry of Health, Labour and Welfare) officially announced the Ministerial Ordinance No. 151 on 27 December 2000 and introduced the Early Post-marketing Phase Vigilance (EPPV) system for new drugs which became effective as of 1 October 2001. It is important also from a point of view of promoting rational use of the drug to feedback early post-marketing phase adverse reaction information to health care professionals. Antecedently to enforcement of the system, a surveillance was conducted according to the EPPV on two products (FOSAMAC and SINGULAIR) marketed by Banyu Pharmaceutical Co., Ltd. as from September 2001 and adverse reaction information collected. For the purpose of feeding back this information to health care professionals, an “EPPV” information offering system consisting of “Adverse Reaction Tabulation Classified by Organ,” “Summary of Adverse Reaction Cases,” and “Detailed Case Information” (serious cases for which reporting physicians have given consent to publication) as contents was built within the UMIN (University hospital Medical Information Network). The technique and steps of procedure for public offering of information renewable monthly were examined.

 Coding should facilitate identifying pharmaceutical products and exchanging and sharing pharmaceutical information. The prevalence of multiple coding systems and local modifications of those systems in healthcare institutions in Japan, however, hinder progress towards easy transfer of pharmaceutical information between different computer systems. The existing coding systems have been developed with their own objectives which makes it difficult to identify relationships among pharmaceutical information at various settings. Further, the coding system to be used for electronic patient records should be permanent, but no exiting systems meet the requirement. A committee on coding systems for pharmaceutical products was organized under the umbrella of Medical Information System Development Center (MEDIS-DC) as one of the projects commissioned by the Ministry of Health, Labour and Welfare, to solve the problems presently encountered. The committee investigated four major coding systems which were in frequent use in healthcare institutions. The four systems are: the Japan’s Pharmaceutical Tariff coding system, the YJ coding system, the coding system for receipt processing, and the JAN coding system for distribution and commerce. A table which shows the correspondence among the four coding systems has been developed to facilitate easy conversion of one coding system to another and to facilitate easy transfer of information, and the permanent reference numbers called HOT codes are defined to maintain the table.

 The Japanese Society of Hospital Pharmacists established in 2000 a science subcommittee to conduct “studies on the rational use of drugs using pharmacoepidemiological methods.” This committee is conducting studies on “pharmacoepidemiological analysis of hospital drug usage data” and “activities to promote pharmacoepidemiological methods.”

 In the study of “the pharmacoepidemiological analysis of hospital drug usage data,” methods to conduct pharmacoepidemiological researches using the records obtained from hospital information systems of patients seen by hospital pharmacy departments and pharmacies affiliated with hospitals, namely, records not specifically intended for epidemiological studies, are evaluated. A survey was conducted on the use of antibiotics for methicillin-resistant Staphylococcus aureus (MRSA) based on drug usage data contained in hospital information systems from 3 institutions. Problems in researches on the proper use of drugs based on drug usage data from hospital information systems were discussed. Objective and efficient data collection from multiple institutions becomes possible by specifying the drug names and relevant items, and by defining the necessary basic information among the whole data present in the hospital information system; the data collected in this manner can be used for pharmacoepidemiological researches.

 These days, the system in which package insert information of medicine can be seen from the terminals of a hospital information system (HIS) has become more prevalent. Because package insert information in HIS has been revised frequently after the passing of the PL law, the task for revising it needs a lot of labor, often resulting in delays. We developed a system which supports the updating of package insert information by acquiring current electronic files semi-automatically via the Internet from the “Pharmaceuticals Information Providing System” website. The acquired electronic files were stored in the web server in our hospital. Users can search for drug information using this browser, and also directly access the page of the medicine which is designated in the prescription order entry system. It took only 61±43 seconds (mean±SD) for revising. Thus it became possible to revise package insert information in HIS every day. This system saves labor for revising the information in HIS, and so it can provide current information to the users without delay.

 In this paper, the design of information system to support health and life of senior citizen is described. In health life support, authors focused on finding the problem of senior citizen in their healthy lives and setting up communication channel among senior citizen, co-medical and clinician. Also health life support can be regarded as transferring/sharing data among them and supporting collaboration. Furthermore supporting health and life is also regarded as expanding medical. First the functions of the system have discussed by analyzing task of health care and life. Next use case and use case description are described as its software can be implemented by Unified Modeling Language. Finally software development and evaluation are described.

 We audited the medical information system based on the operation manual made according to the government’s guideline. [Audit enforcing date] The audit of the access logs went on July 4 and 13, 2001 and the audits of the others went in August. [Audited items] The user education, the user manual, security/privacy protection, and the measure against a system obstacle as described in the operation manual were audited. [Consideration] No serious problem in the system was found by this audit. There were some small troubles in usage or the system, but no serious confusion in usage. However, it was unlikely that this audit was fully effectively attained. There is no rule in detail about audit items in our manual. Moreover, methods to solve problems found by audit are not described in the operation manual at all. It is necessary to make regulations of the audit methods and the contents for medical information system in detail.

 We know the data of hospital information system is very important for various researches. However, the hospital information systems in Japan usually did not have the function to accumulate and analyze long-term patient data for clinical research or hospital administration, since most of these systems were developed only for the daily operation of the hospital. We believed it very important to create a database system of clinical as well as administrative patients’ data, which can be used to perform comprehensive search and analysis. The system, which we call the “long-term clinical database” in the National Center for Child Health and Development, was successfully developed and its applications were presented. Recently, the concept of EBM (Evidence-Based Medicine) is generally being emphasized. We think this concept will be achieved through this “long-term clinical database.” In the future, if the database systems in Japanese hospitals are standardized, we can get unified clinical data from multiple.