Figueiras A, Tato F, Fontaiñas J, Takkouche B, Gestal-Otero J J
Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Spain.
J Eval Clin Pract. 2001 Nov;7(4):347-54. doi: 10.1046/j.1365-2753.2001.00295.x.
At the time a new drug is placed on the market, information on its therapeutic effect and toxicity is limited. Because of its simplicity and widespread use, the voluntary reporting by clinical physicians is the main method for detecting rare or unexpected adverse drug events (ADEs). However, the usefulness of this method may be compromised if the reporting rate is low. We present the results of a questionnaire-based case-control study carried out among 692 physicians from Galicia (north-west region of Spain), in which we assessed their attitudes and opinions towards ADEs. In general, the Galician physicians think it is difficult to link a given ADE with a drug (P < 0.05) and have very heterogeneous opinions on the fact that very severe ADEs are known before the drug is commercialized. They globally disagree with the proposal that ADE reporting should be renumerated and the fact that ADE reporting can be risky for the physician. Some of the beliefs concerning ADEs are incorrect. It is crucial to improve the training of the physicians through active educational strategies based on personal contact.
一种新药上市时,其治疗效果和毒性方面的信息有限。由于临床医生自愿报告方法简单且应用广泛,所以它是发现罕见或意外药物不良反应(ADEs)的主要方式。然而,如果报告率较低,这种方法的有效性可能会受到影响。我们展示了一项基于问卷调查的病例对照研究结果,该研究对来自西班牙西北部加利西亚地区的692名医生进行,评估了他们对药物不良反应的态度和看法。总体而言,加利西亚的医生认为很难将特定的药物不良反应与某种药物联系起来(P < 0.05),并且对于在药物商业化之前就已知非常严重的药物不良反应这一事实,他们的看法非常不一致。他们总体上不同意对药物不良反应报告进行报酬支付的提议,也不同意药物不良反应报告对医生可能有风险这一观点。一些关于药物不良反应的观念是不正确的。通过基于个人接触的积极教育策略来改善医生的培训至关重要。