K Tanaka1, Y Morita, E Kawabe, K Kubota. 1. Department of Medical Affairs, Health Insurance Bureau, Ministry of Health and Welfare, Japan.
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.
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.