Pharmacovigilance (PV) has evolved and grown more complex over the past 5 to 10 years due to increasing data volumes, evolving regulations, influence of emerging markets and the emerging social media and innovative technological advances. Digital media is now used by biopharmaceutical companies for communication with patients to create awareness about diseases and treatments, clinical trial enrollments and patient support programs. It presents new channels and methods that can enable companies to move away from traditional PV systems and safety reporting methods towards more patient-centric models for reporting, analyzing and monitoring of safety data.
关键药物警戒considerations when using digital media
Biopharmaceutical companies operating in the social media space have a responsibility to document and follow-up on any potential adverse event (AE) reports communicated through these forums in compliance with the applicable regulatory guidance. Most of the regulatory guidance and hence PV activities involving social media and internet are primarily focused around screening of social media sites and follow-up of reported safety data. Additional specific guidance is required to confirm validity of safety data obtained via social media (within the norms of data privacy), protocols to guide further retrieval, analysis and integration of such data with other standard safety data (obtained from standard PV sources) along with effective use of social media for risk management and communication.
公司依靠多个AE报告渠道，如电子邮件通讯，公司网站和医师热线资源。现在有多个站点和应用程序在计算机和智能手机上捕获患者和消费者AE报告。公司现在积极参与识别和理解采用全面的光伏社会媒体策略的价值驱动因素，这些媒体策略包括主动创建社交媒体平台来征求/捕获AE数据，而不是监控和报告现有公司现有网站的被动和报告的内容进一步检查所使用的不同类型的社交媒体平台的成功和挑战。社交媒体数据与传统AE报告数据或从健康和报销记录中开采的数据提供了一些优势。社会报告迅速，更接近实时数据（在靠近事件时发生），并且潜在更丰富的来源，而不是通过HCP过滤的报告。社交媒体是新安全数据和潜在的紧急安全信号的有希望的源泉。然而，重要的是要记住，这一数据基本上是非结构化的，通过非监管环境中的不受控制和未得到管理的过程获得，并且既不是由数据质量标准的驱动，也不是由特定的业务区域方向驱动。与此同时，仔细验证通过社交媒体获得的安全数据，以确认报告和患者的“可识别性”，地址相关数据隐私问题，并验证报告的安全数据的准确性，代替潜在的偏差“记者人口”。
Pharmacovigilance challenges and solutions with digital media
Social media monitoring has become a standard practice in PV. Overcoming various social media hurdles for validation and consolidation of incoming data poses a great challenge, requiring the concerted efforts of PV teams. At the same time, careful evaluation and assessment of the use of social media as a PV tool needs to be constantly revisited; both in terms of meaningfulness and impact on outcomes. Understanding regulatory guidelines, current state and future considerations for use of social media in PV, possible areas of influence and expected challenges are critical, along with potential solutions and next steps. To learn more about future impact and potential areas to leverage social media in PV阅读这个白皮书。
