Abstract
Early Post-marketing Phase Vigilance for prescription drugs was enforced in October 2001. Under this system, hospitals and other medical institutions are considered as facilities for investigation, while dispensing pharmacies are not subject to investigation. However, considering the progress that has been made in the separation of dispensing from medical practice, we feel that the dispensing pharmacy can play an important role in the collection of safety information on prescription drugs.
With this in mind, we began the collection of drug monitoring information in 1985 and more recently, we have been actively participating in Early Post-marketing Phase Vigilance as one of our activities in this regard. We have collected information on adverse drug reactions due to 20 prescription drugs in 12, 881 subjects. The number of subjects who reported adverse drug reactions was 213, and the number of adverse drug reactions reported was 220. Elderly patients of 60 years or more accounted for 36 % of the collected cases. Among adverse reactions involving body organs, the alimentary system (116 cases) came top with 52.7% of all cases and next came adverse reactions of the mental and nervous systems, accounting for 28.6% (63 cases) of the total.
Since medical institutions issue over 50% of all of Japan's prescriptions, we must continue to actively participate in Early Post-marketing Phase Vigilance in the future through the collection of information on adverse drug reactions.
