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The effectiveness of risk communication regarding drug safety information: a nationwide survey by the Japanese public health insurance claims data
Author(s) -
Hagiwara Hiromi,
Nakano Shun,
Ogawa Yoshihiro,
Tohkin Masahiro
Publication year - 2015
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12256
Subject(s) - drug , actuarial science , public health , health insurance , business , risk communication , environmental health , survey data collection , public health insurance , medicine , family medicine , pharmacology , health care , nursing , statistics , economics , economic growth , mathematics
Summary What is known and objective We evaluated the effectiveness of warning letters published by the pharmaceutical regulatory agency in Japan on communication of drug safety and risk by quantitative analysis of the national health insurance claims database ( NHICD ). We then explored what factors may have affected risk communication. Methods We measured the implementation rate of the hepatitis virus‐monitoring test among methotrexate ( MTX )‐treated patients; a warning letter had been issued regarding the use of MTX , as it apparently activates the hepatitis virus. Data from the NHICD , which include 99·3% of Japanese residents, were used. A total of 4 933 481 patients with rheumatoid arthritis ( RA ) (January–June, 2010) were the focus of this study. Results The implementation rate of the hepatitis virus‐monitoring test increased from 1·4% before to 1·8% after the warning letter announcement. Logistic regression analysis suggested that the installation of a drug information management room is one of the important factors affecting risk communication. Further analysis revealed that the hepatitis virus monitoring rates in hospitals without drug information management rooms increased from 2·3% to 4·1% due to the issue of the warning letter. What is new and conclusion The warning letter from the regulatory agency plays an important role in risk communication in hospitals without drug information management rooms.