For some categories of drugs, soon, the specialty or generic prescribed by the doctor may no longer be replaceable by the pharmacist with another equivalent product
In fact, the Italian Medicines Agency is starting to exclude the substitutability in pharmacies for some classes of prescription medicines: antiepileptics, blood products and biological medicines, oral anticoagulants. This is indicated by an opinion of the Agency's Technical-Scientific Commission (CTS), which will now have to be examined at the various administrative levels. According to the CTS, for the three classes of drugs - to which are added medicines for pain therapy, not currently included in the lists of replaceable drugs - the possibility for the pharmacist to replace the drug prescribed by the doctor is inadvisable due to problems of a clinical nature. Therefore, it is appropriate - argues the CTS - not to include them in the lists of equivalent medicines with relative reference prices, developed by the Agency. The reasons that led to this decision take into account scientific data, according to which the efficacy of the therapy could be reduced if the drug used is replaced with an equivalent, explained Walter Marrocco, family doctor and member of the commission. "In some cases, even the slightest chemical differences in the products – specifies the doctor – can create difficulties in the treatment of some pathologies. In these particular situations, in which even minimal variations count, it is necessary to guarantee the patient that he can keep the drug (brand or generic) that has proved to be more effective for him". Marrocco specifies that these are not limitations on the use of generics "but rather their enhancement. Even if the patient uses an equivalent drug that works, in fact, he must have the guarantee that it will not be replaced with another branded or generic product". For Marrocco, the approved opinion "is an interesting first step: we hope that the reflections made will allow us, if we identify other therapeutic classes that involve the same risks, to adopt the same type of measure". Finally, Marrocco informs that AIFA is planning a conference, probably for spring, to explore the topic of bioequivalence and generics at 360 degrees, from authorizations to production and distribution. As a Pharmacist33
