(AGI) - Rome, May 7 – From 3 June 2014 in all pharmacies, parapharmacies and corners of national large-scale distribution (GDO), citizens who buy a drug on which a recent change has been made to the safety information of the Package Leaflet (not yet reported in the document at the package) will receive from the pharmacist the updated Package Leaflet, approved by the Italian Medicines Agency. This was announced by Aifa adding that the latest version of the document, authorized by the Agency, will be delivered by the pharmacist to the citizen at the time of purchase of the medicine, in case of updates not yet reported inside the package. The pharmacist will deliver the updated Package Leaflet to the citizen at the time of purchase and will be able to provide him with the necessary information. In this way, opening and tampering with the medicine package will be avoided and, at the same time, the risks of temporary and supply shortages will be reduced, guaranteeing therapeutic continuity.
The operating modality, extremely innovative (Italy is the first country of the European Community to implement it), was agreed upon by AIFA with the representatives of the Companies and Pharmacists' Associations and was previously communicated to the Doctors and to patient and consumer associations. "This is a further step in favor of the citizen and healthcare professionals - explained Corrado Pani, general manager -. With the Drug Database always updated and the delivery, at the time of purchase, of the just modified AIFA's commitment to continuous, authoritative and certified information on medicines to guarantee the safety and efficacy of treatments.The new service will give citizens the certainty of an always updated leaflet and will avoid the waste of entire lots of perfectly intact and therefore safe and effective drugs. It will also ensure the continuity of therapy which could be at risk in the event of non-perfect alignment between the withdrawal of the lots and the supply of those with the updated Package Leaflet". With Resolution No. 371 "Criteria for the application of the provisions relating to the disposal of medicinal stocks", published in the Official Gazette last May 3, AIFA regulated the implementation methods of the regulatory provision which provides for the delivery to the citizen by pharmacists of the updated Package Leaflet and allows pharmacies and other establishments authorized to sell medicines (large-scale distribution corner and parapharmacy) to dispense until stocks last, even when the Package Leaflet has been modified. Every year there are thousands of variations of the Package Leaflets approved by AIFA (over 5,000 in 2013 alone) that must be reported in the new batches of medicines. It can be aspects of an administrative nature, which have no impact on citizens' health, but also new evidence resulting from clinical practice or recent studies. In these cases, the companies holding the Marketing Authorization (MA) were required until now to collect and replace the batches containing the outdated Package Leaflets, which had to be destroyed with the consequent waste of perfectly intact and safe medicines ( since it is not allowed to open and tamper with the medicine package) and the inevitable impact on the environment. (AGI).
