Turin - Elderly, frail patients stabilized by therapy. The family doctor is asking the government that his prescriptions are not replaced in the pharmacy whenever there is a generic drug available. It is right to make the category aware of prescribing "unbranded" medicines, it is another thing to impose the replacement of the branded specialty. Furthermore, even if all the generics approved in Italy are essentially similar to the parent molecule, this does not mean that they are similar to each other; and in Italy, unlike in America, there are no transparency lists that take into account the different bioavailability of the generics in circulation. Generalists especially fear substitutions between drugs copied in pharmacies on patients at risk of poor adherence to therapy. The theme returns to the Fimmg document on drug policy (Corriere Medico of 27 January 2009). Already a year ago, at an Aifa conference, Saffi Ettore Giustini, drug policy expert of the Italian Society of General Medicine (Simg), replied to those who called for attention to the differences in terms of bioequivalence between generic and originator only for active ingredients low therapeutic index (antiepileptics and all those in general that require customized dosages because they give different clinical responses from one subject to another at the same dose) explaining that the generalist should have the last word both on low therapeutic index principles and in all the cases of elderly patients, frail or stabilized by "branded" drugs. A document from Simg on this position immediately came out. Today the document of the Fimmg union calls for the introduction of an American-style orange book in Italy. Some readers ask us if Fimmg considers the drug agency's transparency lists "wrong", perhaps because they include drugs that are not comparable in terms of technological characteristics or for which bioequivalence has not been proven. “None of that. Aifa carries out the checks and the legislation guarantees the patients. But it does not appear that the products with which the pharmacist can replace our prescription are compared. In America, on the other hand, the comparison takes place and the lists of equivalents are updated monthly», explains Roberto Venesia, a generalist from Turin, one of the inspirers of the Fimmg text. « When we generalists prescribe we are responsible for an experimentation; we expose the patient to predictable and other unpredictable effects; to such an extent we are made responsible that, if we get the prescription wrong, we reimburse the NHS. On the other hand, when the pharmacist replaces the specialty prescribed by us with the copy product, which for him involves less procurement efforts, he is not personally liable; but if there are risks for the patient and for the efficacy of the therapy, we are responsible. In Italy, I am not aware of the obligation for the pharmacist to consult a transparency list; Xorange book, on the other hand, is a 'must' for all US healthcare professionals». The Fimmg document supports the diffusion of the generic. «There are prejudices – admits Venesia – even in part of the category; I still hear that generics can contain concentrations of active ingredient in the range of plus or minus 20 percent. In practice, the variation between an originator and its generic is plus or minus 3 percent. Twenty per cent is the confidence interval admitted when comparing the concentrations, residence times and action curves of an equivalent drug and its originator. The generic-originator bioequivalence studies in Europe verify if these three indicators are comparable. These studies are sometimes observed to reflect the variability in copy and originator behavior on
