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Patients can now consult and report side effects in new European database

July 2012

As of July 2012, patients will be able to consult all reports of suspected adverse drug reactions (ADRs), more commonly known as side effects, for medicines authorised by the EU. Patients will also have the possibility to report their side effects directly.prescription_drugs_0.jpg

“This is a big step in the road towards better knowledge on medicines once they are on the market,” argues François Houÿez, Information & Access to Therapies Director at EURORDIS. “Adverse drug reactions are a real concern. They are the fifth most common cause of hospital death. This is why European authorities and Member states have decided to strengthen the surveillance of medicines, to diminish these risks.”

The measures to mitigate adverse drug reactions are part of the implementation of the EU legislation on pharmacovigilance, which entered into force this month.  The legislation makes it mandatory for all information on suspected ADRs to be collected and fed into a European database known as Eudravigilance.

Reports submitted to EudraVigilance include those made by health professionals and patients on suspected side effects of centrally authorised medicines, reported during both the pre- and post-authorisation phases. Users can sort these reports by age group, sex, type of suspected side effect and outcome. Information on other medicines, marketed at the national, level will also become public.

So far, 16 countries have some reporting tools in place to collect ADRs, and soon all 27 Member States should put systems in place. Some patient organisations have already been invited by national authorities to organise the reporting in their countries and ensure it is accessible to patients.

“Patients can help themselves and others by actively reporting their side effects,” says François Houÿez.

The implementation of the EU legislation foresees that all reporting forms will be accessible on the websites of national authorities and that all national reporting systems will in turn be accessible via a European web portal.


Discover the European Database of Suspected Adverse Drug Reaction Report

More information on the EMA’s website