Stoynova Veselina, Getov Ilko N, Naseva Emilia K, Lebanova Hristina V, Grigorov Evgeni E
School of Pharmacy, 2School of Public Health; Medical University Sofia, Bulgaria.
Med Glas (Zenica). 2013 Aug;10(2):365-72.
To identify the factors that influence physicians' under-reporting in Bulgaria and their attitude towards adverse event reporting system and to estimate the role of self-education by providing educational materials.
A randomized nested trial among physicians-general practitioners and specialists in Bulgaria was conducted by a validated questionnaire in order to evaluate their knowledge and attitude towards adverse event reporting system. One month after the intervention the participants were re-visited and were asked to answer the same questions again in order to estimate the change in their knowledge and attitude towards pharmacovigilance system and to obtain their evaluation for the materials provided.
The response rate was 91. Fifty seven (46.3%) physicians were not familiar with the pharmacovigilance system. The most common reason for non-reporting adverse drug reactions (ADRs) was uncertainty concerning the relationship between the suspected drug and ADRs, the ADRs were already known and the fact that the physician was not aware where they should report. Although 103 (83.7%) respondents in the entry survey and by 102 (82.9%) of those participating in the exit survey consider ADRs reporting as their obligation (p more than 0.05), only 50 (40.7%) and 31 (25.2%), respectively answered that they had ever reported ADRs; 109 (88.6%) of the surveyed physicians assessed the provided educational materials as useful for them.
The physicians in Bulgaria have poor knowledge for the pharmacovigilance system; however self-education leads to a better knowledge and positive attitude towards ADRs reporting system. National drug regulatory authority should play a more active role in improving physicians' adherence to the ADRs reporting systems and the developed educational pack can be used in nationwide campaign.
确定影响保加利亚医生漏报不良事件的因素及其对不良事件报告系统的态度，并通过提供教育材料评估自我教育的作用。
在保加利亚的全科医生和专科医生中进行了一项随机嵌套试验，采用经过验证的问卷来评估他们对不良事件报告系统的知识和态度。干预一个月后再次访问参与者，要求他们再次回答相同的问题，以评估他们对药物警戒系统的知识和态度的变化，并获取他们对所提供材料的评价。
回复率为91%。57名（46.3%）医生不熟悉药物警戒系统。未报告药品不良反应（ADR）的最常见原因是对可疑药物与ADR之间的关系不确定、ADR已为人所知以及医生不知道应向何处报告。尽管在入组调查中有103名（83.7%）受访者以及在随访调查中有102名（82.9%）受访者认为报告ADR是他们的义务（p>0.05），但分别只有50名（40.7%）和31名（25.2%）回答他们曾报告过ADR；109名（88.6%）接受调查的医生认为所提供的教育材料对他们有用。
保加利亚的医生对药物警戒系统的了解较差；然而，自我教育会使他们对ADR报告系统有更好的了解和积极的态度。国家药品监管机构应在提高医生对ADR报告系统的依从性方面发挥更积极的作用，并且所开发的教育包可用于全国性的活动。
