Voluntary Reporting on Suspected Drug Reactions Collected via Drug Companies in Japan : Companies' View
10.3820/jjpe1996.2.111
- VernacularTitle:副作用「企業報告」の現状と企業報告の公開問題などに関する企業の認識 : 製薬企業96社に対するアンケート調査結果
- Author:
Kiyoshi KUBOTA
;
Daisuke KOIDE
;
Chikuma HAMADA
;
Akifumi YAFUNE
- Publication Type:Journal Article
- Keywords:
postmarketing surveillance;
adverse reaction;
adverse effect;
voluntary reporting system
- From:Japanese Journal of Pharmacoepidemiology
1997;2(2):111-130
- CountryJapan
- Language:Japanese
-
Abstract:
Background : In Japan most (>85%) voluntary reports on suspected drug reactions are collected by drug companies.
Objective : To know various aspects of case reports on suspected drug reactions collected by Japanese drug companies.
Methods : Questionnaires were designed by our department and mailed to 96 major drug companies in late March 1997. They were reminded in mid-May and mid-June when not having responded.
Results and Conclusion : Of 96 drug companies, 3 were found to be not eligible (e. g., selling only the OTC drugs) and excluded. Of the remaining 93 companies, 91 (98%) responded. Of all the case reports collected by drug companies (approximately 27, 000/year), 36%of serious or important cases are duly reported to Ministry of Health and Welfare (MHW) within 15 days or 30 days of receipt. In Japan individual case reports collected by drug companies and reported to MHW have been closed. Eleven companies are opposed to disclosing individual case reports while 6 agree unconditionally. Seventy companies agree to disclosing individual case reports with various conditions such as protecting patients' privacy, not disclosing the reporter's identity, and making individual case reports available to medical personnel only. Finally, 20 of 91 drug companies complained that MHW does not let them know individual case reports associated with their own products sent to MHW directly from medical doctors or via other companies. To promote pharmacoepidemiology, disclosing voluntary reports is pivotal and MHW is going to adopt this policy in two years for which however reporters and drug companies must be prepared in advance.
