Vol. 57 (2007), No.6
Tetsuya KUSAKABE
Safety Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916 JAPAN
Abstract：Pharmaceutical products are beneficial to treat or prevent disease in humans, however, they can be double-edged swords which can cause adverse events including Adverse Drug Reactions (ADRs). Drug safety measures are planned and taken based on ADRs integrated and properly evaluated, and tyey are important to improve the public health in the country. Ministry of Health, Labour and Welfare, Japan, has constructed and implemented various systems to collect safety information on ADRs domestically or from abroad. This manuscript shows the importance of the post-marketing safety measures, etc. and overviews the principal system for collecting ADR information by the government.
Keywords： Pharmaceutical Affairs Law / drug safety / post-marketing safety measures / Adverse Drug Reaction (ADR) / information on ADR / ADR reporting / WHO International Drug Monitoring Programme / early phase post-marketing vigilance
Hisashi KINARI
Mochida Pharmaceutical Co.,Ltd.
1-7 Shinjuku-ku, Tokyo 160-8515 JAPAN
Abstract：The person in charge of the foreign safety information on post-marketing drugs establishes and systemizes the methods of collecting information on the same ingredients of post-marketing drugs, including information on the measures taken by the regulatory authorities, adverse events and infectious disease derived from biological products obtained with literatures and academic meetings, and the CIOMS acquired from foreign affiliate companies. Collected information is evaluated primarily by the person in charge of the foreign safety information and secondarily at the Information Evaluation Study Group held weekly. Information judged at the Information Evaluation Study Group to be reportable is submitted to the Ministry of Health, Labour and Welfare within the reporting limited date of the information.
Keywords： same ingredient product / regulatory measure / adverse drug event / infectious disease derived from biological products / increase of frequency on adverse drug events / CIOMS
Masayuki TEJIMA, Toshie OOSAKA, Kohya SHIRATORI, Yoshiro HATAKEYAMA, Hitoshi SASA
Shiseido Quality Assurance Center, Safety Research Laboratories
2-12-1 Fukuura, Kanazawa-ku, Yokohama 236-8643 JAPAN
Abstract：In accordance with the "Ordinance Concerning the Standards on Safety Management After Manufacture and Sale of Drugs, Quasi-drugs, Cosmetics and Medical Devices," which was issued and enforced in April 2005 by the Japanese Ministry of Health, Labor and Welfare, the manufactures and distributors of cosmetics are obliged to collect and record the safety related information through scientific meetings, literatures, research reports or other sources as part of the safety management duties after manufacture and sale of their products. In this communication, some of the ideas of collecting the relevant information required for cosmetovigilance, which are practiced in Shisieodo Safety Research Laboratories, are presented and discussed. In particular, a combined system of DIALOG information retrieval system and Focus Service (SDI Literature Management Portal Site), which was developed by G-Search Limited, is presented as an example of its applications.
Keywords： cosmetics / GVP / safety management information collection / cosmetovigilance / G-Search / Dialog / focus service / SDI literature management portal site
Koji OKUMURA
Japan Pharmaceutical Information Center
2-12-15 Shibuya, Shibuya-ku, Tokyo 150-0002 JAPAN
Abstract：We introduced an overview, the features, and the use of JAPIC-Q Service and drug safety databases (JAPICDOC, SOCIE, and iyakuSearch) offered by Japan Pharmaceutical Information Center (JAPIC). JAPIC-Q Service is a service for supporting post marketing surveillance in the pharmaceutical industry, focusing on quick reports. The service offers a significant amount and a variety of information from academic societies including regional meetings, as well as academic journals, together with indexed keywords relating to safety. Drug safety databases include an enormous accumulation of data, and you could easily and simply access the necessary safety information using various search methods.
Keywords： JAPIC-Q Service / JAPICDOC / SOCIE / iyakuSearch / drug safety information
Sanae TANAKA
G-Search Limited. Database Service Department
3-9-15 kaigan, Minato-ku, Tokyo 108-0022 JAPAN
Abstract：Bibliographic databases that are fundamental resource to collecting drug safety information have indexing system to search adverse reaction information. We illustrate the basic method to create search strategy with a central focus on MEDLINE and EMBASE. Additionally the technique to develop exhaustive and less noisy search strategy and other bibliographic databases are described. Two databases that complement to the bibliographic databases in Dialog service and selective dissemination of information tool named Dialog Alerts are also explained.
Keywords： Dialog / MEDLINE / EMBASE / descriptor / subheading / Adis Newsletters / ADVERSE REACTION DATABASE / alert
Kyoko SATO, Ayami NISHIOKA
International Medical Information Center
35 Shinanomachi, Shinjuku-ku, Tokyo 160-0016 JAPAN
Abstract：International Medical Information Center (IMIC) started GVP Contract Literature Research for Adverse Events from April 2005. GVP Contract Literature Research requires GVP SOPs, necessary Agreement with customers. In addition to actual literature filtering job, it needs staff training, process recording, preservation, self-inspection and others. We explain precise workflow and difference from ordinary literature search, literature screening and indexing for medicine and medical devices.
Keywords： GVP / medicine / medical devices / contract / literature research / filtering / record management / self-inspection / IMIC
Maiko NAKATSUKA
Thomson Scientific, Thomson Corporation
Palaceside Bldg. 5F, 1-1-1 Hitotsubashi, Chiyoda-ku, Tokyo 100-0003 JAPAN
Abstract：Custom Information ServicesSM (CIS) is a consultation-based unique literature monitoring and data customization service that uses the Thomson Scientific, Inc. immense literature and meeting information collection. CIS conducts efficient and confidential safety literature monitoring through customized literature scanning, scoping, indexing, abstracting, document delivery, and translation, which is completed in one workflow process. The latest value-added information on a pharmaceutical product is provided in a timely and user-friendly manner. This article discusses the importance of literature in drug safety and benefits from the use of CIS pharmacovigilance services. Also described in this article is safety execution management work that the Ministry of Health, Labor and Welfare allows to be outsourced.
Keywords： pharmacovigilance / safety execution management / literature monitoring / latest drug information / Good Vigilance Practice (GVP) / indexing / abstracting
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