lundi 18 juin 2012
The European Medicines Agency has begun publishing suspected side effect
reports for medicines authorised in the European Economic Area (EEA) on
a new public website. The reports come directly from the European Union
(EU) medicines safety database EudraVigilance, and are one of the many
types of data used by regulators to monitor the benefits and risks of a
medicine once authorised.
The launch of the new website is part of the Agency's continuing
efforts to ensure EU regulatory processes are transparent and open and
is a key step in the implementation of the EudraVigilance access policy.
The published information relates to approximately 650 medicines and
active substances authorised through the centralised procedure, which is
managed by the Agency. Information on the website is presented in the
form of a single report per medicine or active substance. Each report
pulls together the total number of individual suspected side effect
reports submitted to EudraVigilance by Member States and marketing
authorisation holders. These aggregated data can be viewed by age group,
sex, type of suspected side effect and by outcome. Within a year the
Agency aims to additionally publish suspected side effect reports for
common drug substances used in nationally authorised medicines.
A side effect (also known as an adverse drug reaction) includes side
effects arising from use of a medicine within the terms of the marketing
authorisation as well as from use outside the termsof the marketing
authorisation, including overdose, misuse, abuse and medication errors,
and those associated with occupational exposure.
All information on the website relates to suspected side effects.
Suspected side effects may not be related to or caused by the medicine,
and as a result, the published information cannot be used to determine
the likelihood of experiencing a side effect or as an indication that a
medicine is harmful. All users of the website are asked to read and
accept a disclaimer explaining how to understand the information before
they view a web report.
Medicines are an important part of modern healthcare, providing
effective treatments for many diseases and conditions. For a medicine to
be authorised for use in the EU the benefits of the medicine must
always outweigh the risks.
Today's launch also highlights the importance of side effect reporting
and pharmacovigilance in safeguarding public health within the European
Union. Side-effect reporting is a key element in ensuring the detection
of new or changing safety issues, and the Agency continues to further
strengthen its work with partners and stakeholders across Europe to
ensure a robust system for safety signal detection.
In June, the Agency will launch the website in the remaining 22 official EU languages.
The European database of suspected adverse drug reaction reports: http://www.adrreports.eu
http://www.worldpharmanews.com/ema/2097-european-medicines-agency-boosts-eu-transparency
CLUB ALGÉRIEN DES PHARMACIENS DE L'INDUSTRIE
