The phenomenal reach of the internet and social media over the last few years has led to a revolutionary shift in how people are communicating with one another today. Social media platforms and applications are fast becoming the go-to form and bullet speed mode of communication in today’s web era. Digital media is used by biopharmaceutical companies for communication with patients to create awareness about diseases and treatments, clinical trial enrollments and patient support programs that support the cause of drug safety. However, unlike other areas in healthcare, use of the internet and social media has progressed slower in Product Safety/Product Vigilance (PV).
The arrival of life science and service provider industry with multiple exciting, yet overwhelming, opportunities for appropriate and effective use of social media to drive innovative and meaningful changes in Pharmacovigilance and how we communicate with patients and healthcare practitioners around the world.
This whitepaper examines how the influence and reach of the Internet and social media can be harnessed to drive valuable outcomes for the PV industry. In this paper, we look at available regulatory guidelines, current state and future considerations for use of social media in PV, possible areas of influence, expected challenges, potential solutions, and next steps.
The flourishing alliance deals of the USFDA with leading pharmaceutical industries stress the need for social media connection to the level of online networking forum in order to boost the efforts employed in drug safety monitoring. One of the partners is PatientsLikeMe and with its 350,000 members representing over 2,500 health conditions, it has collected more than 110,000 adverse event reports on 1,000 different drugs.
This alliance, which is in the form of a research collaboration agreement, provides the USFDA with access to “real-world” data about patients’ drug and disease experiences. Broadly, this partnership is evidence of increasing interest, among both regulators and pharmaceutical manufacturers, in the value of social media as a tool to identify potential adverse drug reactions and safety issues.
Post-marketing surveillance conducted by the USFDA focuses on tracking the safety of drugs once they’ve reached the market. Such surveillance plays a critical role in ensuring drug safety as premarket clinical trials, which are designed to capture safety issues on the front end, have certain inherent limitations. For instance, as the clinical trials are conducted under controlled and standardized conditions, they are unable to adequately capture data that reflects “real world” use. That’s where post-marketing surveillance comes in. However, the USFDA’s current post-marketing surveillance system has clear shortcomings. Therefore, in order to monitor potential safety concerns surrounding approved drugs, the USFDA collects drug adverse event reports and compiles them into its FDA Adverse Event Reporting System (FAERS) database.
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 drug safety industry today.
Some of them include the limit of the Industry’s responsibility in collecting and reviewing social media data, details about 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, affirmation of 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, the acceptable practices on potential signals within the context of data privacy and the protocols for big data integration, analysis and interpretation, and reporting of follow-up results.
Therefore, it is of paramount importance to address the various challenges imposed by the use of social data for drug safety surveillance. However, the optimized data reveals the role of different pharmacovigilance organizations role in ensuring safety with the effective use of social media.