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Drugs: experts on the formulary revolution, involving those who treat patients

Rome, 6 Sept. (Adnkronos Salute) – Obsolete medicines are out of the National Pharmaceutical Handbook of our country. But the experts warn: the revision of the list of products reimbursed by the Health Service will be a long and difficult job, which cannot do without the involvement of the experts. No, therefore, to decisions that are independent of the opinion of those who deal directly with patients every day. This is what emerges, in summary, from the interviews conducted by Adnkronos Salute in the aftermath of the approval of the Balduzzi decree which provides for the review of the Formulary by the Italian Medicines Agency (Aifa), by 30 June 2013. The Aifa, "on the basis of the assessments of the technical-scientific advisory commission and of the price and reimbursement committee - reads the decree - carries out an extraordinary revision of the national pharmaceutical handbook, placing therapeutically outdated drugs" in range C ", those whose efficacy does not is sufficiently demonstrated, in the light of the evidence made available after placing it on the market, as well as those having a cost for the National Health Service deemed incongruous, even following the requested new determination of the price, in relation to the expected therapeutic result and possible alternatives of equal therapeutic utility, where available". For the pharmacologist Silvio Garattini, director of the Mario Negri Institute in Milan, "it is very difficult to say now which drugs will be released from the national formulary. However, this provision was really necessary, given that the last major revision took place in 1993 and it came into force in 1994, therefore 18 years ago, and it was really time to check whether all the medicines present are necessary or if there are any redundancies". According to Garattini, "we also need to make an assessment on the basis of price and address the question of similar products" with different costs. "In general - he concludes - it is an important provision and the time that is assigned by the decree to carry out this review is more than sufficient". Pier Luigi Canonico, president of the Italian Society of Pharmacology (Sif), points out that "there are still many aspects to be clarified and an in-depth assessment needs to be made on which drugs are to be reimbursed and which are not. Band C usually includes medicines on the basis of pathologies, or of the price, or of consolidated use. I only hope that the result is a pharmaceutical handbook as the one and only national point of reference". The selection work "must be done by AIFA by responding to the specific dictates of the decree, taking into consideration all aspects" and involving "all the interested parties in the decision-making process. I am confident that the Agency will open a discussion to carry on this delicate Work". For Alberico Catapano, full professor of Pharmacology at the University of Milan and president of the European Atherosclerosis Society, the revision of the handbook will be "a 'lottery': everything will depend on the criteria that AIFA will adopt to carry out this work and in in this sense it would be really important that it involved scientific societies. Up to now, the Medicines Agency has been a little too 'self-referring' in its work, however, especially in this case, a comparison is necessary. prevent largely unused drugs from being withheld from those subpopulations of patients

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco