In recent years, the use of social media forums and channels that focus on various health related topics including diseases and associated treatments has seen an upward trend. However, unlike many other areas in the healthcare industry, the internet and social media are yet to play a major role in drug safety and pharmacovigilance (PV). At the same time, legislation to ensure appropriate pharmacovigilance and regulate the safe use of medicine continues to become more stringent.
The GVP and CIOMS guidelines and the recently issued US FDA guidelines provide guidance to the pharmaceutical and medical device industries to screen internet or digital media under their management or responsibility, for potential reports of suspected adverse reactions. They are directed to post this information on social media networks and also correct misinformation posted by others. The FDA guidance also requires companies to post both the benefits and the main risks associated with a product, potentially with a hyperlink taking the reader directly to a more detailed list of risks. These guidelines are an important first step towards providing guidance to companies to develop and implement their social media strategies for PV.
Appropriate engagement of consumers and healthcare providers through social media by PV teams certainly holds the promise of better outcomes and collaboration across the industry, including:
- Better educated consumers and HCPs
- Quicker and more complete reporting and communication of new safety concerns/issues to drug companies and regulators
- Increased insights for development of robust safety profiles, product benefit-risk evaluation and life cycle planning
- Enhanced risk evaluation and mitigations strategies
- Improved communication of updated safety information, back to patients, consumers and healthcare providers
- Improved relationship between companies and the community
- Improved health literacy (and hopefully health outcomes)
Appropriate use of the internet and social media can prove to be a significant catalyst in the transformation of the PV practice in the not so distant future. However, there is no magic pill or solution to the various challenges facing the PV industry today. New regulatory paradigms will be needed and many questions will need to be answered, like:
- What is the limit of the industry’s responsibility in collecting and reviewing social media data?
- What new tools and methods could be used to capture spontaneous reports from social media or mobile apps and provide emerging safety signals through a process of real time data mining?
- How can PV teams confirm the “identifiability” of the reporter and patient in safety data obtained via social media and establish safeguards against faulty adverse event reporting?
- What will be acceptable practices for following up on potential signals within the context of data privacy?
- What are the protocols for big data integration, analysis and interpretation, and reporting of follow-up results?
The time now seems right to elevate the PV organization’s role to a more strategic level through appropriate and effective use of social media to drive better PV outcomes. However, the questions raised here and many more will need to be addressed, before the biopharmaceutical industry can be comfortable with the use of social data for drug safety surveillance.