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UK Pharma Doesn’t Have to Monitor Social Networks for Adverse Event Reports

PMLive reports that UK pharma has no obligation to search the internet and social networks for reports of suspected adverse events, except on websites that they control.

The Medicines and Healthcare products Regulatory Agency (MHRA) confirmed the limits of firms’ pharmacovigilance (PV) responsibility as Europe’s July deadline for new legislation in the area looms. The legislation will herald the biggest change in pharmacovigilance in recent years, but there has been uncertainty within the industry as to the exact detail of the changes.

Several key pharmacovigilance changes outlined in the Q&A document:

• Centralised reporting of suspected adverse drug reactions (ADRs) to the EMA’s EudraVigilance database (expected to come into effect sometime in 2015, with transitional arrangements until then)

• Inclusion of reports from patients as valid, reportable ADRs

• ADRs will include all reports where harm has occurred to a patient or any reaction that is “noxious and unintended”. This means ADRs that result from error, misuse, abuse and where used off-label should also be reported.

Trust and engagement

However this might be a “good” change in relation to the amount of monitoring, people are mentioning and talking about adverse events for a reason. Whatever the reason might be, they most likely want to be heard.

Just because adverse events don’t have to be reported, it doesn’t mean marketing authorisation holders (MAHs) should not monitor them for the important reasons of trust and engagement.

What’s your opinion, should MAHs still monitor or not?