A few days ago I commented critically on the content of the DM February 21, 2014, published in the Official Gazette n. 60 of last March 13, with which the Ministry reports the lists of medicines with a medical prescription and those that do not, while the determination of the dispensing methods is up to AIFA. The reason for the criticism was the inconsistency of the regime of dispensing to the public between medicines having the same composition but with different regimens. "Stone of the scandal" was the inclusion of two "copy" medicines among those available without a prescription and, therefore, also salable in "parapharmacies". These are Ciclozinil (gentamicin sulphate cream) and Sterozinil (gentamicin sulphate + betamethasone valerate cream) both from Aesculapius Farmaceutici. The composition is identical to that of many other prescription preparations, starting with Gentalin and Gentalin Beta cream respectively. If the medicines based on these active ingredients are dangerous and require prescription, it was not clear why the two compositions had been exempted from the obligation. For more than two months, the "parapharmacies" remained convinced that they could sell these medicines without a prescription and, probably, they will have stocked up on them. But on Saturday 24 May the Official Journal no. 119 published a DM entitled "Correction to the decree of 21 February 2014, containing..." where the two lists contained in the DM of 21 February have undergone exclusions and additions, including the elimination from Annex B (without a prescription) of the two medicines above quoted. From a practical point of view, we have to ask ourselves what will happen to the stocks eventually purchased by the "parapharmacies". The company will have to collect them, of course, but who has to bear the resulting costs? It would then be long to talk about the possible judicial consequences deriving from dispensing without a prescription if this has caused physical damage. Perhaps this aspect is underestimated when a medicine switches from one regimen to another.
The story then presents other aspects worthy of further study in the context of the methods for establishing the dispensing regime of all medicines pursuant to article 87 of legislative decree 219/06. In fact, knowledge of the dispensing conditions of all medicines is possible only by reading the information on the external packaging or by consulting the databases of the various "management" supplied by pharmacies. The Federfarma database also intervenes to help the citizen in "search for a drug" which, almost always, contains information on whether or not a prescription is required. Finally, one wonders why the very useful Aifa database available on the Agency's website, with the leaflets and summaries of the product characteristics, does not also report the dispensing regime, thus giving it an official character. Why? The classification must be arranged by Aifa with the release of the Aic and can also be modified later. The classification, or its modification, must in fact be homogeneous for identical products and therefore, if it changes for one, it must necessarily change for all the others having the same composition, whether "branded" or generic. Otherwise it would be legitimate to assume that factors are involved
