"If equivalent drugs really can be superimposed on the original drugs, why does AIFA hurriedly communicate that 'non-substitutability' must be applied for these medicinal specialties, otherwise serious effects on the health of the patient?". The question was asked by Fimmg Lazio, with reference to the communication with which Aifa, on 17 September last, limited the substitutability of drugs containing Levetiracetam and Topiramate, asking doctors to add the non-replaceable wording to guarantee patient safety. Not only. Fimmg Lazio, which immediately contested the Spending review rule which requires doctors to prescribe drugs by active ingredient, underlines that even the EMA (the European Medicines Agency) has suspended 9 generic specialties due to the lack of adequate studies on bioequivalence. "This sounds strange after the grandiose media campaigns that accompanied the summer period in which citizens were assured that generic drugs were the same as the original drugs", comments Fimmg Lazio, according to which "it can be deduced that bioequivalence is not really that perfect, and can create problems of drug efficacy in treating a disease, but then other drugs that have a narrow therapeutic window such as anticonvulsants, digitalis, theophylline, quinidine, antico oral coagulants, diuretics (especially in the elderly)”. The regional union of family doctors also invites citizens and institutions to intervene. “On the other hand, in the specific case, around 500,000 patients with epilepsy are involved in Italy and around 50,000 in Lazio, therefore on average around 10 patients for each family doctor in Lazio, who if they take the drugs mentioned will either pay the substantial difference in the monthly price or will be exposed to the risks of the change. The costs for families are substantial: the original drug Keppra 500 mg costs €83.72 a box, while generic Levetiracetam costs €37.67. Topamax 50 costs €55.28 while generic Topiramate or Sincronil costs €27.29”.
“But – underlines Fimmg Lazio – their doctors are also involved who, due to clinical needs, will have to suffer whether to impoverish a family or risk the ineffectiveness of the drug, inducing an ethical conflict that is not easy to resolve. Therefore, institutional political rebalancing interventions are urgently needed to protect the patient and his doctor". In the meantime, "we just have to warn all doctors to be vigilant and pay close attention by punctually verifying 'the carousel of substitutability' that was triggered by the Balduzzi decree on the obligation to prescribe the active ingredient, and to stimulate citizens' associations and all institutions, so that they intervene in real protection of health, avoiding the easy populism of 'corrupt health professionals', in the name of marketing the disease that dwells elsewhere, outside of medical offices". "For years - concludes Fimmg Lazio - we have been asking for an Orange Book for biocompatibility without any results, indeed even arousing hilarity in some, but the real scandal almost kept silent by all was not so much questioning the prescriptive power of the doctor but playing monopolies with the health of the citizen".
