Barbui C
Laboratory of Epidemiology and Social Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health, Mario Negri Institute for Pharmacological Research, Milano, Italy.
Pharmacoepidemiol Drug Saf. 2001 Dec;10(7):647-52. doi: 10.1002/pds.641.
These notes aim at analysing current methods, ethical issues and major legislation changes related to drug epidemiology in Italy.
The design and conduct of two pharmacoepidemiological surveys carried out in the context of recent law dispositions on psychiatric care and confidentiality are presented.
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.
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.
本笔记旨在分析意大利与药物流行病学相关的现行方法、伦理问题及主要立法变化。
介绍了在近期关于精神科护理和保密的法律规定背景下开展的两项药物流行病学调查的设计与实施情况。
1978年第180号法律规定不再需要更多患者入住精神病院，也不再需要新建精神病院。长期住院患者可继续留在医院。然而，1994年第724号金融法规定了意大利精神病院最终关闭的最后期限。对八所国立精神病院的1000多名住院患者进行了一项调查，以描述住院患者群体的社会和临床特征，并监测他们的社区安置情况。1996年第675号法律规定，未经患者知情同意，私人和保密信息不得用于任何目的。然而，该法律当年并未实施。在未获得书面知情同意的情况下，对全科患者中苯二氮䓬类药物的使用情况进行了一项调查。
意大利的立法多年来一直在变化，法规在不久的将来可能仍会修改。为了在药物流行病学中加强伦理实践，科学家和临床研究人员应在研究目标、设计和分析方面保证高标准。应始终声明潜在的利益冲突。
