Change Coming to Pharmacovigilance

Just about every conversation about the use of digital and social media with pharmaceutical companies starts at the same point - NO.  Even if there is a willingness, Med-Reg intimidates and shuts down the effort in most cases, causing the pharmaceutical industry to be more focused on the things it can't do in the digital space as opposed to doing the things that can be done.  

One of the main reasons often cited for this stance is the milieu of social media with its two-way conversation, opens up several fronts of risk, including one of the bears of them all - the potential to discover adverse events through interaction with patients.  From a med-reg point of view, that is a valid concern under many circumstances.  But from the patient perspective, what does it say about a company that is not interested in hearing from patients how well their product is working?  Would you want to put such a substance inside of your body?  Would you feel like the manufacturer is putting your interests in front of everything else?  The fear of adverse events speaks poorly to patient relations, surely.  

It also doesn't sit so well with policy makers who are probably going to be looking for ways to encourage more reporting of adverse events and to require actions that would be more proactive on the part of companies in doing so.

Perhaps even better hints at change that might be in store on the pharmacovigilance front come from a recent article in Pharmaceutical Executive that overviews changes that are coming to Europe's system for reporting adverse events.  It is a very good overview and includes such elements as the formation of a Pharmacovigilance Risk Assessment Advisory Committee and the potential for patient self-reporting forms to be included as part of the packaging for products in order to improve the proactive hunt for adverse events.  

The fact that such policy goals are being called for in both the U.S. and Europe should enter as an element into the industry's response now - to anticipate change and consider how to improve pharmacovigilance before policy makers act, rather than waiting for the policy shoe to drop and using a fear of adverse event discovery as a road block to participation in digital media, where brands of all companies today are being shaped.  

  

Comments

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[Betsy Raymond Stevenson]

This is a powerful opportunity for pharma to demonstrate their trustworthiness to the public by welcoming potential AE reports via social media. Mark, you are right. Pharma's public desire to avoid AE information destroys the credibility of all their other messaging about caring for patients. Pharma challenge: Put together a PR, regulatory and legal 'dream team' to be the first to have a social media AE policy in place. Then, implement it. Show pharma naysayers how wrong they are by talking publicly about actual actions taken. Gain goodwill by being the first to demonstrate your concern for the patients who are your customers.