Northern Pharmacovigilance Center, Center for Health Tecnology and Services Research (CINTESIS), Faculty of Medicine, University of Porto, Portugal.
Faculty of Medicine and CINTESIS, University of Porto, Porto, Portugal.
J Nurs Manag. 2016 Apr;24(3):409-16. doi: 10.1111/jonm.12337. Epub 2015 Oct 20.
To identify the attitudes and knowledge associated with adverse drug reactions (ADR) under-reporting by nurses.
The voluntary reporting system is fundamental for expediting the detection of ADR during post-marketing surveillance.
We performed a case-control study. A self-administered questionnaire was sent by mail to 1325 nurses. The knowledge and attitudes related to ADR under-reporting were primarily based on Inman's seven deadly sins.
The overall response rate was 34.2%. Nurses working in primary care were 12-fold more likely to report an ADR. A change of attitude increased the probability of ADR reporting for:'The belief that the one case an individual nurse might see could not contribute to medical knowledge'; 'I do not know how the information reported is used by the system'; 'I would be more likely to report if the method was easier'; 'I think the most correct way to report is to inform the doctor' and 'I do not have time to think about the involvement of the drug in ADRs'.
Our study shows that the beliefs of nurses, such as 'one single report would not make any difference' and 'the pharmacovigilance system is very complex', act as a barrier to ADR reporting.
It is important to clarify the ADR reporting procedure and increase the nurses reporting rate.
确定护士报告不良反应(ADR)的态度和知识。
自愿报告系统对于加快上市后监测期间 ADR 的检测至关重要。
我们进行了一项病例对照研究。通过邮件向 1325 名护士发送了一份自我管理问卷。与 ADR 漏报相关的知识和态度主要基于 Inman 的七宗罪。
总体回复率为 34.2%。在初级保健机构工作的护士报告 ADR 的可能性是其他护士的 12 倍。态度的改变增加了报告 ADR 的可能性,例如:“个体护士可能看到的一个案例不可能对医学知识有贡献”;“我不知道系统如何使用报告的信息”;“如果方法更容易,我更有可能报告”;“我认为报告的最正确方法是通知医生”;“我没有时间考虑药物在 ADR 中的作用”。
我们的研究表明,护士的信念,如“单个报告不会有任何影响”和“药物警戒系统非常复杂”,是报告 ADR 的障碍。
明确 ADR 报告程序并提高护士的报告率非常重要。