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Ashfield Pharmacovigilance attended on 22nd-23rd April The World Drug Safety Congress Americas in Chicago, IL. As we had the privilege of listening to fellow pharmacovigilance experts speak, a single theme seemed to recur, the changing landscape of the industry related to new digital forums used by patients.

The current pharmacovigilance landscape is defined by complex IT systems that require frequent upgrades, data collection from multiple sources, data entry by the biopharmaceutical company itself, and a deficiency of standard data elements for Adverse Event (AE) collection. This has led to AEs being captured into multiple databases and created multiple distribution requirements for ICSRs.

As the world around us has been changing, so has the pharmacovigilance landscape. Within the past few years the digital universe has grown exponentially. Patients are now turning to online forums to discuss their experiences and research their medications, opening a new world for reporting AEs. Biopharmaceutical companies are now exploring how to solicit drug related events via social media.

Regulatory requirements state that companies must capture all AEs that are directly reported. However, are we missing valuable data from those not calling into 1-800 numbers or going to visit their doctors? Crowdsourced data from sites such as Medwatcher, Web-RADAR, Facebook, Twitter, online patient support communities and blogs could provide direct insight into drug safety. Yet many companies are not searching these sources. Data mining through the Web requires constant attention and follow-up with anonymous or unidentifiable reporters which is more challenging than more traditional avenues.

Biopharmaceutical companies vary in their management of social media. Some companies have set up accounts that allow for a one-way stream of communication. Others are responding to AEs that are reported directly onto their company accounts while some are searching through the Web to find AEs and try to follow-up with the reporter.

For the future pharmacovigilance landscape we can hope for a more streamlined and improved data collection process. We will likely see a change in source information, namely an increase in solicited reports from digital media. Pharmacovigilance providers are also hoping for more analytical tools for benefit / risk assessments. Outsourcing will become more prevalent and the style of pharmacovigilance management will come to be more proactive.

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