国际药品不良反应报告的研究进展

International Research Progress on Adverse Drug Reaction Report

药品不良反应(ADR)不仅会给患者的健康带来危害,同时也会给患者和社会造成巨大的经济损失,因此必须加强ADR监测,而收集到的ADR报告是进行ADR监测的主要数据来源。本文通过查阅国际文献,综述目前国际上关于ADR报告的相关研究。结果显示,随着各国药物警戒制度的不断完善,ADR报告已达到一定数量,但研究发现ADR报告质量普遍较差。对于ADR上报主体,多数发达国家最新研究集中于公众上报的ADR报告的质量情况。同时,多个国家已开展在ADR监测中应用信息技术的研究,使ADR监测工作更为便捷,ADR报告收集更加全面。但针对捕获ADR报告质量问题、改善ADR报告质量方面的信息技术研究还较少。因此,在保证ADR报告数量稳步上升的同时,如何不断提高报告质量、提高数据可利用性是国际面临的共同问题。

Adverse drug reactions(ADRs)not only cause harm to patients' health,but also cause huge economic losses to patients and society.Therefore,ADR monitoring must be strengthened,and the collected ADR reports are the main data source for ADR monitoring.Through reviewing international literature,this article reviewed the current international research on ADR report.The results showed that with the continuous improvement of pharmacovigilance systems in various countries,the number of ADR report has reached a certain level.However,the study found that the quality of ADR reports is generally poor.For ADR reporting institution,the latest research of most developed countries focuses on the quality of ADR reports reported by the public.At the same time,many countries have carried out research on the application of information technology in ADR monitoring,making ADR monitoring more convenient and collecting reports more comprehensive.However,there are few information technology researches on capturing the quality of ADR reports and improving the quality of ADR reports.Therefore,while ensuring the steady increase in the number of ADR reports,how to continuously improve the quality of reports and data availability is a common problem for the international community.