Beninger Paul, Ibara Michael A
Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.
Clinical Data Interchange Standards Consortium, Princeton, New Jersey.
Clin Ther. 2016 Dec;38(12):2514-2525. doi: 10.1016/j.clinthera.2016.11.006. Epub 2016 Nov 29.
The discipline of pharmacovigilance is rooted in the aftermath of the thalidomide tragedy of 1961. It has evolved as a result of collaborative efforts by many individuals and organizations, including physicians, patients, Health Authorities, universities, industry, the World Health Organization, the Council for International Organizations of Medical Sciences, and the International Conference on Harmonisation. Biomedical informatics is rooted in technologically based methodologies and has evolved at the speed of computer technology. The purpose of this review is to bring a novel lens to pharmacovigilance, looking at the evolution and development of the field of pharmacovigilance from the perspective of biomedical informatics, with the explicit goal of providing a foundation for discussion of the future direction of pharmacovigilance as a discipline.
For this review, we searched [publication trend for the log value of the numbers of publications identified in PubMed] using the key words [informatics (INF), pharmacovigilance (PV), phar-macovigilance þ informatics (PV þ INF)], for [study types] articles published between [1994-2015]. We manually searched the reference lists of identified articles for additional information.
Biomedical informatics has made significant contributions to the infrastructural development of pharmacovigilance. However, there has not otherwise been a systematic assessment of the role of biomedical informatics in enhancing the field of pharmacovigilance, and there has been little cross-discipline scholarship. Rapidly developing innovations in biomedical informatics pose a challenge to pharmacovigilance in finding ways to include new sources of safety information, including social media, massively linked databases, and mobile and wearable wellness applications and sensors. With biomedical informatics as a lens, it is evident that certain aspects of pharmacovigilance are evolving more slowly. However, the high levels of mutual interest in both fields and intense global and economic external pressures offer opportunities for a future of closer collaboration.
药物警戒学科起源于1961年沙利度胺悲剧之后。它是许多个人和组织共同努力的结果，这些个人和组织包括医生、患者、卫生当局、大学、制药行业、世界卫生组织、国际医学科学组织理事会以及国际协调会议。生物医学信息学基于技术方法发展而来，并随着计算机技术的发展而演变。本综述的目的是为药物警戒提供一个全新视角，从生物医学信息学的角度审视药物警戒领域的演变与发展，明确目标是为讨论药物警戒学科的未来发展方向奠定基础。
在本综述中，我们使用关键词[信息学（INF）、药物警戒（PV）、药物警戒+信息学（PV+INF）]搜索了[1994年至2015年期间发表的研究类型文章在PubMed中识别出的出版物数量对数的出版趋势]。我们手动搜索了已识别文章的参考文献列表以获取更多信息。
生物医学信息学为药物警戒的基础设施发展做出了重大贡献。然而，尚未对生物医学信息学在加强药物警戒领域中的作用进行系统评估，且跨学科研究较少。生物医学信息学中快速发展的创新给药物警戒带来了挑战，即如何找到纳入新安全信息来源的方法，包括社交媒体、大规模链接数据库以及移动和可穿戴健康应用与传感器。以生物医学信息学为视角，很明显药物警戒的某些方面发展较为缓慢。然而，两个领域的高度共同兴趣以及强大的全球和经济外部压力为未来更紧密的合作提供了机会。
