2002 Volume 22 Issue 4 Pages 307-313
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.
