Rossi A C, Knapp D E
JAMA. 1984;252(8):1030-3.
Recently, several studies of spontaneous reporting systems (SRSs) have reported on the published literature's role in producing first reports of new adverse drug reactions. In order to provide further information on other components of SRS, the Food and Drug Administration's SRS was examined with regard to its effectiveness and efficiency in identifying new adverse drug reactions and the form, consistency, and timeliness of its communication of new adverse drug reactions to the medical community. While there was evidence that the literature was more effective in producing first reports of new adverse drug reactions for the years compared, there was reason to conclude that FDA's SRS was capable of making a contribution to the alerting process. Moreover, direct participation by practitioners in FDA's SRS was found to be the most efficiently obtained FDA source of new adverse drug reaction reports.
最近，几项关于自发报告系统（SRS）的研究报告了已发表文献在产生新的药品不良反应首次报告方面的作用。为了提供关于自发报告系统其他组成部分的更多信息，对美国食品药品监督管理局的自发报告系统在识别新的药品不良反应方面的有效性和效率，以及向医学界传达新的药品不良反应的形式、一致性和及时性进行了研究。虽然有证据表明，在所比较的年份中，文献在产生新的药品不良反应首次报告方面更有效，但有理由得出结论，美国食品药品监督管理局的自发报告系统能够对警示过程做出贡献。此外，发现从业者直接参与美国食品药品监督管理局的自发报告系统是获取新的药品不良反应报告最有效的途径。
