Drug epidemiology in Italy: methods and ethical issues. The example of psychiatry

Purpose These notes aim at analysing current methods, ethical issues and major legislation changes related to drug epidemiology in Italy. Methods The design and conduct of two pharmacoepidemiological surveys carried out in the context of recent law dispositions on psychiatric care and confidentiality are presented. Results In 1978 law 180 stated that no more patients had to be admitted to psychiatric hospitals, and no more psychiatric hospitals had to be built. Chronic long-stay patients were allowed to remain in hospitals. In 1994, however, financial law 724 established a deadline for the final closure of Italian psychiatric hospitals. A survey of more than 1000 patients living in eight state psychiatric hospitals was carried out to describe the social and clinical characteristics of the inpatient population and to monitor their community placement. In 1996 law 675 established that private and confidential information could not be used for any purpose without the patient's informed consent. However, this law was not implemented that year. A survey of benzodiazepine use among general practice patients was conducted without written informed consent. Conclusions The Italian legislation has been changing for some years, and regulations might still be modified in the near future. To increase ethical practices in pharmacoepidemiology scientists and clinical researchers should guarantee high standards in terms of research objectives, design and analyses. Potential conflict of interest should always be declared. Copyright (C) 2001 John Wiley Sons, Ltd.