Screening digital media for potential AEs

Changes to European pharmacovigilance rules could recommend pharma companies regularly screen digital media for potential reports of suspected adverse events (AEs).

The rule changes, which at the time of writing (April 2012) are just proposals, would cover internet sites or digital media under companies' “management or responsibility”.

“In this aspect, digital media is considered to be company sponsored if it is owned, paid for or controlled by the marketing authorisation holder,” the EMA says.

As to what should be considered to be 'digital media', the EMA suggests websites, web pages, blogs, vlogs, social networks, internet forums, chat rooms and health portals. But, the regulator notes, that list is not exhaustive.

It is also recommended that the marketing authorisation holder actively monitors special internet sites or digital media, such as those of patients' support or special diseases groups.

This should be done in order to check if they describe significant safety issues which may necessitate reporting and the frequency of this monitoring would depend on the risks associated with the medicinal product.

Meanwhile, unsolicited cases of suspected adverse reactions from the internet or digital media, should be handled as “spontaneous reports”, with the same expedited reporting time frames.

An important point to note is that the guidelines, in addition to currently being in draft form, only present a series of recommendations, rather than requirements. So how closely companies choose to stick to them may vary.

• The Guideline on Good Pharmacovigilance Practices (GVP), Module VI – Management and reporting of adverse reactions to medicinal products was published in February 2012. Once finalised it's expected to come into effect in July 2012.

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