NPO Drug Safety Research Unit Japan

Researches

1. A. J-PEM: DSRU Japan worked as the executive office for two pilot studies of Prescription-Event Monitoring in Japan (J-PEM). J-PEM has been however suspended since 2004 (See scientific publications 1-6).
2. B. Case-control study: DSRU Japan has worked as a study office of a case-control study on the association between NSAIDs and upper gastrointestinal bleeding conducted between 2002 and 2005. (See scientific publication 7).
3. C. Research on the background incidence of possible adverse drug reaction: DSRU Japan has worked as a study office of a retrospective cohort study on the background incidence of interstitial lung disease (ILD) in patients with malignant mesothelioma. ILD is known as an adverse reaction to a wide range of anti-neoplastic drugs and other agents occurring in Japan at a rate much higher than that in other countries (including other Asian countries). The research was conducted to know the background incidence of ILD in Japanese patients with malignant mesothelioma to evaluate possible occurrence of ILD associated with the new antineoplastic agents for treatment of malignant mesothelioma (See scientific publications 8,9).
4. D. Japan Statin Study (JSS): DSRU Japan has been working as a study office of the study called as Japan Statin Study (JSS) conducted as a joint research by Japanese Society for Pharmacoepidemiology (JSPE) and Japanese Society of Hospital Pharmacists (JSHP). The study is to compare the safety profiles of 6 statins available in Japan. The study was initiated in 2008 (See scientific publication 10).

Other activities

1. E. Therapeutic Risk Management: DSRU Japan has been working as an executive office of the Safety Management system for Unapproved Drugs (SMUD) by the contract with Ministry of Health, Labour and Welfare (MHLW). Though the system may be used for safety management of unapproved drugs in general in the future, it is currently used to monitor thalidomide imported by physicians. Thalidomide approved in 2008 has been used strictly for treatment of patients with malignant myeloma in Japan and thalidomide is still imported by physicians. SMUD requires physicians to register initials and date of birth, gender, diagnosis of patients for whom thalidomide will be imported. For each registered patient, the executive office sends a brochure with information needed to secure safe use of thalidomide. Doctor is also requested to report serious adverse events using the web system (see scientific publication 11).
2. F. Support for Clinical Researches: DSRU Japan has supported 3 clinical researches mainly regarding handling of safety information in the study (see reference 12).
3. G. Disproportionality measures from Japanese Spontaneous Reports for signal detection: Since 2003, DSRU Japan has provided lists of disproportionality measures (PRR, ROR, GPS and BCPNN) obtained from Japanese spontaneous reports accessible through the Internet to members of NPO DSRU Japan. In the first couple of years, the information was provided as prints. Since 2008, the information has been provided as CD or DVD (see scientific publications 13,14).
4. H. Support for database study: In 2011, the MHLW has started the provision of health care claims data (Japanese National Database, JNDB) on a trial basis. DSRU Japan supported the database study by former Department of Pharmacoepidemiology using JNDB conducted between 2011 and 2013 for various aspects such as developing codes for security, establishment of secure computer environment, etc. DSRU Japan is also involved in the database study using a commercial database in collaboration with researchers in Special Interest Group (SIG) called as Asian Pharmacoepidemiology Network (AsPEN) of International Society of Pharmacoepidmiology (ISPE).
5. I. Support for education and meetings of pharmacoepidemiology: DSRU Japan has been supporting 6-month course of pharmacoepidemiology seminar held by Union of Japanese Scientists and Engineers conducted every year since 2006. DSRU Japan worked as an executive office for the 2nd Asian Conference on Pharmacoepidemiology (ACPE2) in 2007 as well as in the 5th Asian Conference on Pharmacoepidemiology (ACPE5) in 2010. In 2010, DSRU Japan has worked as an executive office for three 1-day tutorials held by JSPE as well as for a 2-day open workshop for database research held by Department of Pharmacoepidemiology of University of Tokyo.
6. J. Consultation for pharmacoepidemiology studies: DSRU Japan has provided opportunities of consultation for those in charge of designing/conducting post-marketing studies in drug companies in Japan.