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Drug use investigation (DUI) and prescription‐event monitoring in Japan (J‐PEM)
Author(s) -
Tanaka Katsutoshi,
Morita Yasuko,
Kawabe Eri,
Kubota Kiyoshi
Publication year - 2001
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.642
Subject(s) - medical prescription , medicine , observational study , confidentiality , legislation , christian ministry , informed consent , postmarketing surveillance , law , alternative medicine , pharmacology , political science , adverse effect , pathology
Abstract Objective To present ethical issues and relevant problems in observational studies of drug safety in Japan. Methods The Pharmaceutical Affairs Law, associated ordinances, and notifications relevant to Drug Use Investigations (DUIs), and published documents for two pilot studies of prescription‐event monitoring in Japan (J‐PEM) were examined, particularly with regard to the protection of privacy. Information relevant to the proposed legislation intended to protect personal information and proposed guidelines on ethical issues in epidemiological studies were also collected. Results and Conclusion The formal studies inaugurated as the ‘side‐effect investigations’ in the late 1960s and replaced by those of the DUI in 1980 have been conducted by drug manufacturers, in accordance with the Pharmaceutical Affairs Law. The first pilot study of J‐PEM was started in 1997 and the second one is currently operated under a Health Sciences Research grant, supported by the Ministry of Health and Welfare. Those observational studies have been conducted while maintaining the confidentiality of personal data, but without requiring either approval by institutional ethics boards or informed consent from patients. However, according to the Pharmaceutical Affairs Law, those involved in postmarketing surveillance studies must protect the privacy of study subjects and those who break this rule may be subject to penalties. Ethical issues associated with pharmacoepidemiological studies will be clearly determined in Japan before the end of 2001 when the law designed to protect personal information will be introduced and official guidelines on ethical issues in epidemiological studies will have come into effect. Copyright © 2001 John Wiley & Sons, Ltd.