By Jane Chin, Ph.D.
In theory, engaging social media in pharmacovigilance is attractive, if not sensible.
In practice, engaging social media in pharmacovigilance will be fraught with such high noise-to-signal ratio that both pharma companies and regulatory agencies may struggle to embrace it.
Let’s look at how pharmacovigilance has fared from the field perspective. We (used to) have over 100,000 sales reps in the field, who are exposed to adverse events signals every single day, I’d even surmise at least once a day.
All company employees in the U.S. pharmaceutical industry are legally obligated to report an adverse event within 24 hours of receipt from the field or through other communication channels.
Yet today adverse events reporting – sans Web 2.0 – has been bogged down with bureaucracy, and physicians who are willing to spend the time and effort to report AEs directly to the FDA are enormously frustrated with the red tape and hurdles they face. It soon became a lose-lose proposition for doctors whose continuing livelihood has come to depend on patients/day type of clinical practice management.
Will Web 2.0 perhaps simplify the process and reduce red tape? I believe the potential is there.
The question is – HOW? At least, from the regulatory / federal government side.
From the commercial side, the question for pharmaceutical companies becomes – WHY ON EARTH…?
There are so many layers of medical history and patient health context that must be addressed when an adverse event arises – were there confounding factors? was the patient compliant? – that stripping the context away makes the content dangerously misleading when interpreting the safety of a drug.