Reporting problems related to medications in Spain. The yonotifico (I report) project, an option for citizens.

Sir, – The new European legislation concerning pharmacovigilance published in 2010 promotes the involvement of patients in spontaneous reporting programs of suspected adverse drug reactions (ADR) [1]. To facilitate this involvement, regulatory agencies of the European Union member states should develop websites for the electronic reporting by citizens; it should be the initiative of each country to develop paper formats and additional reporting systems, such as telephone, fax, or e-mail [2, 3]. In January 2013, the Spanish Agency of Medicines and Medical Devices (AEMPS) set up a website including an electronic form for direct reporting by citizens of suspected ADR (www. notificaram.es). In this way, the AEMPS is enforcing the new legislation and provides the Spanish population with the possibility of reporting ADRs and collaborating with the existing pharmacovigilance system [4]; the Spanish agency has not implemented additional reporting systems for citizens so far.