UK pharma won’t have to ‘trawl internet’ for adverse event reports
UK pharmaceutical companies will not be expected to search the internet for reports of suspected adverse events, except on websites that they control, according to new guidance from the country’s regulator.
There will also be no obligation for firms to monitor social media sites like Twitter and Facebook if the accounts and pages are not “under their 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.
In February the EMA unveiled its proposals for the changes, including the suggestion that pharma should “actively monitor” websites and social networks for potential reports of suspected adverse events.
If carried through this would have significantly increased the monitoring burden on marketing authorisation holders (MAHs), but the MHRA has now confirmed this scale of monitoring will not be needed, at least in the UK.
“MAHs have a responsibility to review sites under their control for valid cases and report them accordingly. There is no requirement to trawl internet sites not under the MAH’s control. This requirement also refers to blogs, chatrooms and social media pages,” the MHRA said in a Q&A document.
This also outlined several key pharmacovigilance changes:
• 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.
In its Q&A document regarding the pharmacovigilance changes, the MHRA also said the criteria for what constitutes a valid report of an ADR remains the same, with all reports needing “an identifiable patient, reporter, suspect drug and suspect reaction”.