Vallano A, Cereza G, Pedròs C, Agustí A, Danés I, Aguilera C, Arnau J M
Fundació Institut Català de Farmacologia, WHO Collaborating Centre for Research and Training in Pharmacoepidemiology, Barcelona, Spain.
Br J Clin Pharmacol. 2005 Dec;60(6):653-8. doi: 10.1111/j.1365-2125.2005.02504.x.
To describe the opinions of hospital physicians concerning problems regarding the spontaneous reporting of adverse drug reactions (ADRs) and ways to solve them.
A qualitative study was carried out. Fifteen focus groups were conducted among physicians working in a tertiary teaching hospital. A total of 208 physicians from different medical specialities participated. The focus group discussions were recorded by three different observers and the transcripts of each session were analysed for issues and themes emerging from the text.
Four types of obstacles to spontaneous reporting were considered particularly important: (i) problems with the ADR(S) diagnosis; (ii) problems with the usual workload and lack of time; (iii) problems related to the organization and activities of the pharmacovigilance system; (iv) and problems related to potential conflicts. The potential solutions suggested for improving spontaneous reporting were to define the kind of ADR(S) which should be reported, to facilitate an easy contact and quick access to the hospital pharmacovigilance system, to facilitate information and support for reporting and feedback of pharmacovigilance activities.
The perception of the different obstacles by the hospital physicians is an important factor in determining the causes of the underreporting of ADRs and addressing these obstacles could lead to an improvement in spontaneous reporting. A closer relationship between the doctors and the pharmacovigilance centre is suggested as a means of solving these problems. More information is needed to improve the spontaneous reporting of ADR(S) in specialized healthcare.
描述医院医生对药品不良反应（ADR）自发报告相关问题及解决方法的看法。
开展一项定性研究。在一家三级教学医院工作的医生中进行了15次焦点小组讨论。共有来自不同医学专业的208名医生参与。焦点小组讨论由三名不同的观察者进行记录，并对每次会议的文字记录进行分析，以找出文本中出现的问题和主题。
自发报告的四类障碍被认为尤为重要：（i）ADR诊断问题；（ii）日常工作量和时间不足问题；（iii）与药物警戒系统的组织和活动相关的问题；（iv）与潜在冲突相关的问题。为改善自发报告提出的潜在解决方案包括明确应报告的ADR类型，便利与医院药物警戒系统的轻松联系和快速访问，便利药物警戒活动报告和反馈的信息及支持。
医院医生对不同障碍的认知是确定ADR报告不足原因的重要因素，解决这些障碍可能会改善自发报告情况。建议医生与药物警戒中心建立更紧密的关系作为解决这些问题的一种方式。需要更多信息来改善专科医疗中ADR的自发报告。
