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Drugs: Fimmg to family doctors, indicate 'non-replaceable' on prescription

Rome, April 18. (Adnkronos Salute) - "The Fimmg has invited family doctors to indicate the wording 'non-replaceable' on the prescription, whether it is a branded drug or a generic equivalent. Unless you are professionally certain that the drug can be replaced. In this case, the doctor will have to insert the wording 'replaceable with generic equivalent' and will assume responsibility for the effects of any product that is dispensed as a generic equivalent medicine, with a lower price". national general secretary of the Federation of family doctors, Giacomo Mililo, who spoke this morning in Rome at a meeting organized by Fimmg on generic medicines and non-substitutability. A position taken by Fimmg, which seeks to shed light on the matter, also at the light of the 'Ricettopoli' report aired during the show Le Iene last March 22. A report in which doctors appeared who prescribed 'non-replaceable' generic drugs, overshadowing the suspicion that corruption by the manufacturing companies was hidden behind the prescriptions "Equivalent does not mean identical", underlines Milillo. "A patient's response - he adds - can be different when passing from the original drug to the generic or from one generic to another. Underlining this aspect does not mean questioning the validity of generics, but highlighting the delicacy of automatic substitutability, not only between 'originator' drug and generic, but also between two different generics.Very often these medicines, despite being present in the same Transparency Lists, present in their respective leaflets some differences on the indications and precautions for use because they come from different European procedures of mutual recognition. The continuous change of the product in the course of therapy for chronic diseases produces evident inconvenience for the citizen and requires dosage adjustments by the doctor. It is above all the elderly who suffer the most, who mix up the packages and make mistakes in taking medicines " For Roberto Venesia, national coordinator of the Fimmg drug commission, "the problem of 'bioequivalence' is one of the crucial issues for the 'loyalty' of family doctors to generic drugs. Since there is no statistical method to demonstrate the sameness of two products, bioequivalence studies aim to verify the absence of a clinically relevant difference through the estimation of a minimum admissible difference. Consequently, adds the expert, "equivalent medicines are presented as 'same' as the branded originator medicines, but in reality they are only similar. Bioequivalence is guaranteed only between a generic and its originator, but not between two generics different, if they have not been previously tested. The role of the doctor is therefore essential in the choice of the drug. Despite AIFA's commitment to guaranteeing the quality and safety of equivalent drugs, the solutions proposed so far are substantially scarce and neither is the mechanism of transparency list' – concludes Venesia – eliminates the most relevant critical issues persisting in the Italian market”.


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