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.
Key pharmacovigilance 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.
Companies rely on multiple AE reporting channels such as email correspondences, company websites and physician hotline resources. There are now multiple sites and applications to capture patient and consumer AE reports on computers and smartphones. Companies are now actively engaged to identify and understand the value drivers for adopting a comprehensive PV social media strategy, which encompasses proactively creating social media platforms to solicit/capture AE data, rather than monitoring and reporting what comes in passively on existing company sites, and further examine the successes and challenges of the different types of social media platforms being used. Social media data offers some advantages over traditional AE reporting data or data mined from health and reimbursement records. Social reports are rapid, closer to real-time data (occurring in close proximity to the event) and potentially richer sources than reports filtered through HCPs. Social media is a promising source for new safety data and potential emergent safety signals. Yet, it is important to keep in mind that this data is essentially unstructured and obtained via uncontrolled and ungoverned processes in a non-regulated environment and is neither driven by data quality standards nor by specific business area orientation. At the same time, it is vital to carefully verify safety data obtained via social media for confirmation of the “identifiability” of both reporter and patient, address related data privacy issues and verify accuracy of reported safety data in lieu of potential bias introduced by the “reporter population”.
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 read this whitepaper.