Voluntary Reporting on Suspected Drug Reactions Collected via Drug Companies in Japan : Companies' View / 薬剤疫学
Japanese Journal of Pharmacoepidemiology
; : 111-130, 1997.
Artigo
em Japonês
| WPRIM (Pacífico Ocidental)
| ID: wpr-376033
Biblioteca responsável:
WPRO
ABSTRACT
Background:
In Japan most (>85%) voluntary reports on suspected drug reactions are collected by drug companies.<BR>Objective:
To know various aspects of case reports on suspected drug reactions collected by Japanese drug companies.<BR>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.<BR>Results andConclusion:
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.
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Contexto em Saúde:
Agenda de Saúde Sustentável para as Américas
Problema de saúde:
Objetivo 3: Recursos humanos em saúde
Base de dados:
WPRIM (Pacífico Ocidental)
Idioma:
Japonês
Revista:
Japanese Journal of Pharmacoepidemiology
Ano de publicação:
1997
Tipo de documento:
Artigo