[An examination in comparison Web site with other root on the revised information of drug package insert].
To obtain revised information on drug package inserts, we evaluated the quality and comprehensibility of such information provided by the Web site of the Pharmaceuticals and Medical Devices Agency (PMDA site), medical representatives (MRS), Drug Safety Updates (DSUS), and informational publications of the wholesale distributor Company F (wholesaler F). In the comparison of the total amount of revised information obtained from April 2003 to March 2004, the PMDA site was 90% or greater of comprehensible. In comparison with the distribution information on the notice of the Ministry of Health, Labor and Welfare, an informational delay or lack occasionally occurred and variations among pharmaceutical companies were observed. Moreover, on the PMDA site, the number of revisions was 1972. Among them, clinically important information, such as warnings, contraindications, adverse effects, and drug interactions, totaled 37%. From these results, it is suggested that there are variations in the information from each pharmaceutical company on the PMDA site although the site is excellent in terms of comprehensibility.
Okuyama
Kiyoshi
K
Hachioji Medical Center, Tokyo Medical University, Hachioji, Japan. ok531@tokyo-med.ac.jp
Terasawa
Michiko
M
Takahashi
Toshiyuki
T
Yamada
Yasuhiko
Y
D016907:Adverse Drug Reaction Reporting Systems; D004345:Drug Industry; D004346:Drug Information Services; D004347:Drug Interactions; D004348:Drug Labeling; D006077:Government Agencies; D020407:Internet; D007564:Japan; D011366:Professional Review Organizations; D011785:Quality Assurance, Health Care