Pharmacovigilance is renewed and open to citizens The new European pharmacovigilance legislation has also been operational in Italy since 2 July. Among other things, the legislation changes the very definition of an adverse reaction, now understood as a "harmful and unwanted effect resulting from the use of a medicine" and allows patients and operators to make reports via the web. This was announced by Aifa which, in the pages of the site, underlines that by changing the definition, "which is independent of the type of use of the medicine", adverse reactions deriving from therapeutic error, abuse, misuse, off-label use, overdose and occupational exposure will also be reported. «Therefore» argues Aifa «there will be an increase in reports which will correspond to greater monitoring activity». Furthermore, to increase the effectiveness, speed and transparency of pharmacovigilance interventions, citizens in all EU countries will be able to report suspected adverse reactions directly, a practice that has already been practiced for years in Italy using a paper form, but from now on, in accordance with the new directive, reports can also be made via the web. All reports will flow into the European Eudravigilance database but with a diversified timing depending on the severity of the reaction and will be accessible to the public. In terms of transparency and communication, the new legislation provides that assessment reports, summaries of product characteristics and leaflets, summaries of risk management plans are made available to the public; the list of medicines subject to additional monitoring and information on the different ways for healthcare professionals and patients to report suspected adverse reactions of medicines to the competent authorities, including data entry webform forms. Finally, the Pharmacovigilance Risk Assessment Committee (Prac) is established within the EMA, in which all Member States are represented, which covers all aspects of risk management deriving from the use of medicinal products for human use.
Source: http://www.farmacista33.it/la-farmacovigilanza-si-rinnova-e-apre-ai-cittadini/pianeta-farmaco/news-41787.html
The new pharmacovigilance legislation
Safety
28/06/2012 
