社交媒体数据在药品上市后安全性监测的应用

药品上市后安全性监测体现为对药品在上市后的安全性风险的及时发现,是药物警戒的关键核心1].自发报告作为药物警戒的重要工具之一,是目前最重要的尽早发现药品不良反应(adverse drug reactions,ADR)的方法2].自发报告的来源包括医务人员和药品使用者.药品使用者自发报告,是指药品使用者在不经过医务人员的解释和说明下,主动就其自身经历的某一可疑的药品不良反应向药物警戒部门等做出的报告.药品使用者自发报告可增加药品不良反应报告的数量,与医务人员自发报告互为补充,可以提供药品不良反应的直接信息甚至影响药品不良反应"耐受性"的界定3-4],但会受到对自发报告和报告系统了解不足和不完善的报告体验的影响.社交媒体平台上由个人发布的药品及其不良反应相关内容近些年正逐渐被视为类似于药品使用者自发报告的新的数据来源,使用社交媒体数据开展药品上市后安全性监测的研究呈逐年上升趋势,因而本文就相关研究现状与面临的挑战进行综述.

Utilizing social media data in post-market safety surveillance

Post-marketing surveillance is the principal means to ensure drug use safety. The spontaneous report is the essential method of post-marketing surveillance for drug safety. Often most spontaneous reports come from medical staff and sometimes come from patients who use the drug. The posts published by individuals on social media platforms that contain drugs and related adverse reaction content have gradually been seen as a new data source similar to spontaneous reports from drug users in recent years. Those user-generated posts potentially provide researchers and regulators with new opportunities to conduct post-marketing surveillance for drug safety from patients’ perspectives mostly rather than medical professionals and can afford the possibility theoretically to discover drug-related safety issues earlier than traditional methods. Social media data as a new data source for safety signal detection and signal reinforcement have the unique advantages, such as population coverage,type of drugs, type of adverse reactions, data timeliness and quantity. Most of the social media data used in post-marketing surveillance research for drug safety are still text data in English, and even multiple languages are used by different people worldwide on several social media platforms. Unfortunately, there is still a controversy in the academic circles whether social media data can be used as reliable data sources for routine post-marketing surveillance for drug safety. A couple of obstacles of data, methods and ethics must be overcome before leveraging social media data for post-marketing surveillance. The number of Chinese social media users is large, and the social media data in the Chinese language is rapidly snowballing, which can be employed as the potential data source for post-marketing surveillance for drug safety. However, due to the Chinese language’s specific characteristics, the text’s diversity is different from the English text, and there is not enough accepted corpus in medical scenarios. Besides, the lack of domestic laws and regulations on privacy and security protection of social media data poses more challenges for applying Chinese social media data for post-market surveillance. The significance of social media data to post-marketing surveillance for drug safety is undoubtedly significant. It will be an essential development direction for future research to overcome the challenges of using social media data by developing new technologies and establishing new mechanisms.