(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 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 continuity of therapy.
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. “It is a further step in favor of the citizen and of the health professionals – explained Corrado Pani, general manager -. With the Drug Database always updated and the delivery, at the time of purchase, of the newly modified Illustrative Leaflets, AIFA's commitment is confirmed for continuous, authoritative and certified information on medicines to guarantee the safety and effectiveness of the care. The new service will give citizens the certainty of an always updated leaflet and will avoid the waste of entire batches of perfectly intact and therefore safe and effective medicines. It will also ensure the continuity of therapy which could be at risk in the event of imperfect alignment between the withdrawal of the lots and the supply of those with the updated Illustrative 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).
Leaflet always updated in the pharmacy
07/05/2014 – AIFA press release
The application determination for the depletion of drug stocks was presented today at AIFA.
Activate an IT application today to access the Drug Database on a mobile device.
From 3 June 2014 in all national pharmacies, parapharmacies and corners of large-scale distribution (GDO), the citizen who buys a drug on which a recent change has been made to the safety information of the Package Leaflet (not yet reported in the document within the package) will receive from the pharmacist the updated Package Leaflet, approved by AIFA.
The initiative was presented today during a press conference by the President Sergio Pecorelli, the Director General Luca Pani and the manager of the Evaluation and Authorization Office Anna Rosa Marra in the presence of the Undersecretary of the Ministry of Health Vito De Filippo , Senator Andrea Mandelli, the General Director of Medical Devices of the Ministry of Health Marcella Marletta, Doctors, Industry, Pharmacists and representatives of the entire drug supply chain, consumer and patient associations.
The conference was also an opportunity to present the new, more functional version of the Drug Database, the official database of Package Leaflets and Summaries of Product Characteristics of all medicines authorized in Italy, available today, thanks to a dedicated application, also on mobile devices.
“The project that we are presenting today – said Pecorelli – is the result of a long work carried out by AIFA in cooperation with all the players in the drug supply chain, which will make it possible to provide citizens with reliable and always up-to-date information on drugs in real time, guaranteeing at the same time an ethical saving, as it will make the system more rational and efficient and will avoid unacceptable waste of medicines. It will also be an opportunity to strengthen the pharmacist's service role and his relationship with the citizen”.
“This is a further step in favor of the citizen and healthcare professionals; an extremely innovative operating method, which Italy was the first to adopt in Europe - said Pani -With the always updated Drug Database, the IT application that allows access via mobile devices, delivery, at the time of purchase of the newly modified Package Leaflets confirms AIFA's commitment to continuous, authoritative and certified information on medicines to guarantee the safety and efficacy of treatments. The new service will also ensure therapeutic continuity which could be at risk in the event of imperfect alignment between the withdrawal of the lots and the supply of those with the updated Package Leaflet".
Anna Rosa Marra illustrated the Determination with which AIFA regulated the methods of implementation of the regulatory provision which provides for the delivery to the citizen by pharmacists of the updated Illustrative Leaflet and allows pharmacies and other establishments authorized to sell drugs (corner Large-scale distribution and parapharmacies) to dispense until stocks last, even when changes have been made to the Package Leaflet.
“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 – said Marra – These may be aspects of an administrative nature, which have no impact on health of citizens, but also of new evidence arising from clinical practice or recent studies. In these cases, the companies holding the Marketing Authorization (AIC) were required up to now to collect and replace batches containing out-of-date Package Leaflets, which had to be destroyed, with the consequent waste of perfectly intact and safe medicines (since it is not permitted to open and tamper with the medicine packaging) and inevitable impact on the 'environment".
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. This will prevent opening and tampering with the medicine package and, at the same time, reduce the risks of temporary and supply shortages, ensuring continuity of therapy.
Attached:
