According to the Cts, some therapeutic classes should be excluded from the transparency lists to ensure constant health monitoring
Incoming squeeze on the substitutability of some generics. In fact, Aifa would be about to exclude drugs of four therapeutic classes from the transparency lists of equivalents: oral anticoagulants, antiepileptics, blood products and medicines for palliative care (at the moment not yet on the list). The provision, predictably expected in the next few weeks, would be the result of a series of considerations that emerged within the CTS, the Agency's technical-scientific commission. Basically, the majority of the specialties placed in the four categories examined show narrow therapeutic margins, such as to suggest the irreplaceability of the prescribed product. «The intervention that Aifa has in the pipeline» explains Walter Marrocco, of Fimmg-Metis «should not be read as a disavowal of the validity of the generic drug, on the contrary. We just want to reassure the doctor by giving him the guarantee that the prescribed product, even if the choice falls on the generic one, will not be replaced in the pharmacy with another equivalent. In this sense, I would not rule out the extension of the measure to other therapeutic classes in the near future". The provision on transparency lists is only one of the initiatives that the Agency is planning in the field of generics. In fact, the organization of a conference – open to all operators – is also on the horizon, in which to explore the issues relating to the registration, production and distribution of "non-patented" products. In addition, a discussion between the drug agency and Federfarma (the pharmacy owners' union) should start in the next few days to put a ceiling on the discount that generic companies can grant to distributors. An issue, the latter, which has become very topical after the externalization spread in recent weeks by the regional secretary of Fimmg Lazio, Pier Luigi Bartoletti, according to which some producers would grant pharmacists discounts close to even the 90%. «The main problem of the generic» is the concluding comment of Michele Di Iorio, pharmacist, member of the Aifa Cts «consists precisely in its location in a market where national or international manufacturing companies are flanked by small regional companies. A solution could be to limit registrations only to the first ones».
THE PHARMACOLOGICAL REASONS FOR CTS There are already many European countries that have excluded the automatic substitution of original antiepileptic products with generics (Germany and Scotland among the first) and the Italian League against epilepsy (Lice) has already expressed itself in this sense in Italy . This decision derives from pharmacological considerations: most molecules have a narrow therapeutic margin, i.e. the plasma levels necessary for seizure control are close to those causing toxicity. Furthermore, the relationship between plasma concentrations and clinical effect shows high interindividual variability. Modest variations, for example of the order of 20%, in plasma levels compatible with those observable after substitution of a drug (from one originator to a generic or from one generic to another) may be sufficient to determine the reappearance of seizures. And the recurrence of even just a crisis in a previously well-controlled patient involves, in addition to the risk of injury, serious psychological, social and occupational consequences.
Il Giornale del Medico dated 11/02/2008 , article by by Alessandro Santoro N. 1 28 JANUARY 2
