Scott H D, Thacher-Renshaw A, Rosenbaum S E, Waters W J, Green M, Andrews L G, Faich G A
Rhode Island Department of Health, Providence 02908-5097.
JAMA. 1990 Apr 4;263(13):1785-8.
The Food and Drug Administration, Rockville, Md, contracted with the Rhode Island Department of Health, Providence, to conduct a project to increase reporting of suspected adverse drug reactions through physician education. Voluntary reporting, an important part of postmarketing surveillance that signals potential problems with marketed drugs, historically has been underused by physicians. After 2 years, there was a more than 17-fold increase in reports submitted directly from Rhode Island compared with the yearly average before initiation of the project. Increases in the total numbers of reports were paralleled by significant increases in the numbers of reports of severe reactions. Similar increases were not experienced nationally. Physicians in Rhode Island were surveyed before and 2 years after interventions began to determine changes in knowledge and attitudes about reporting of adverse drug reactions. Significant gains in knowledge and positive attitudes toward the reporting system occurred. We conclude that physicians can be stimulated to increase their reporting of suspected reactions, thereby improving the viability of the federal reporting system.
马里兰州罗克维尔市的食品药品监督管理局与普罗维登斯市的罗德岛州卫生部签约，开展一个通过医生教育来增加疑似药物不良反应报告的项目。自愿报告是上市后监测的重要组成部分，它能提示已上市药物的潜在问题，但从历史上看，医生对其利用不足。两年后，罗德岛州直接提交的报告数量比项目启动前的年平均水平增加了17倍多。报告总数的增加伴随着严重反应报告数量的显著增加。全国范围内并未出现类似的增长。在干预措施开始前及开始两年后，对罗德岛州的医生进行了调查，以确定他们在药物不良反应报告知识和态度方面的变化。在报告系统的知识和积极态度方面取得了显著进步。我们得出结论，医生可以被激励增加对疑似反应的报告，从而提高联邦报告系统的可行性。
