Dermatologica. 1991;182(1):12-7.
During 1988, the Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED) coordinated a pilot study aimed at evaluating the feasibility of a system for spontaneous monitoring of adverse drug reactions in dermatological practice in Italy. Approximately 400 dermatologists were asked to collaborate, and 141 agreed to the study. Procedures similar to those well established in other surveillance programs (including the use of standard forms and standardized assessment procedure) were adopted. In a 2-month period 775 reports were collected, of which 711 were maintained after careful evaluation. The general profile of the adverse reactions reported was in accordance with the experience derived by other spontaneous surveillance programs. The main purpose of spontaneous reporting systems is the identification of new reactions, and a model analysis was proposed, in our study, with reference to skin reactions to bamifylline. The demonstration of the feasibility of a drug-monitoring program in Italy, where little tradition exists in the area, is the most important result of our study.
1988年期间，意大利皮肤病学流行病学研究小组（GISED）协调开展了一项试点研究，旨在评估意大利皮肤病学实践中药物不良反应自发监测系统的可行性。约400名皮肤科医生受邀参与合作，其中141人同意参与该研究。采用了与其他监测项目中成熟做法类似的程序（包括使用标准表格和标准化评估程序）。在为期2个月的时间里，共收集到775份报告，经过仔细评估后保留了711份。所报告不良反应的总体情况与其他自发监测项目的经验相符。自发报告系统的主要目的是识别新的反应，在我们的研究中，针对巴米茶碱的皮肤反应提出了一种模型分析方法。在该领域传统较少的意大利，证明药物监测项目的可行性是我们研究的最重要成果。
