Bäckström M, Mjörndal T
Division of Clinical Pharmacology, University Hospital of Umeå, Umeå, Sweden.
Eur J Clin Pharmacol. 2006 May;62(5):381-5. doi: 10.1007/s00228-005-0072-0. Epub 2006 Mar 30.
To assess the effect of a small economic inducement on the rate of spontaneous reporting of adverse drug reactions (ADRs) and the attitudes of general practitioners and physicians towards reporting of ADRs.
One intervention and one control county were selected for the study. Written information about the main purpose of spontaneous reporting of ADRs was personally addressed to all physicians in the two counties. The information was identical, except for the addition that during a period of 6 months two lottery tickets would be given to the receivers in the intervention area with the standard personal feedback to the reporter of the ADR. After the 6-month study period, the actual number of reported ADRs and the seriousness of the reported ADRs were assessed. To investigate the attitude towards this stimulation of reporting, a questionnaire was addressed to all physicians within the intervention area (IA).
From the IA a total number of 57 ADR reports were received containing 62 suspected ADRs, 40% of which were assessed as serious reactions. From the control area (CA), 49 reports containing 50 suspected ADRs were received, 32% of which were assessed as serious reactions. The increase of ADR reports from the IA compared to the same time period the previous year was 59% as compared to an unchanged reporting from the CA. Of those responding to the questionnaire, 80% did not believe that a small economic bonus would be a useful tool to improve the reporting rate.
A small economic inducement is associated with an increase in the reporting of suspected ADRs.
评估小额经济诱因对药品不良反应(ADR)自发报告率的影响,以及全科医生和医师对ADR报告的态度。
选择一个干预县和一个对照县进行研究。向两县所有医师亲自发送关于ADR自发报告主要目的的书面信息。除了增加一条信息,即在6个月期间将向干预地区的接收者发放两张彩票,并对ADR报告者提供标准的个人反馈外,信息内容完全相同。在为期6个月的研究期结束后,评估报告的ADR实际数量以及所报告ADR的严重程度。为调查对这种报告激励措施的态度,向干预地区(IA)的所有医师发放了一份问卷。
从IA共收到57份ADR报告,包含62例疑似ADR,其中40%被评估为严重反应。从对照地区(CA)收到49份报告,包含50例疑似ADR,其中32%被评估为严重反应。与上一年同期相比,IA的ADR报告增加了59%,而CA的报告数量没有变化。在回复问卷的人中,80%不认为小额经济奖励是提高报告率的有效工具。
小额经济诱因与疑似ADR报告的增加有关。