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Substitutability of drugs, doctors perplexed but the law is clear

The question of the possibility for the pharmacist to substitute a drug prescription periodically returns to the fore. Finally, a recent survey has shown that 91% of the doctors interviewed categorically rejects that this can happen [Editor's note: you see: http://www.federaisf.org/Start/HDefault.aspx?Newsid=8001]. The vice president of Utifar Maurice Cini addresses the issue from a legislative point of view, emphasizing how the law speaks clearly and does not lend itself to convenient interpretations with respect to which actions are granted to the pharmacist.

«A recent survey on the substitutability of medicines with generic drugs demonstrates how among the medical profession, and in particular among general practitioners, there is a veritable jungle of beliefs and attitudes in the face of a regulatory text which, instead, it should not allow for interpretations of convenience.
For many years the problem has been taken up by laws with an economic content but, with Legislative Decree 95/12 as converted into law 135/12 also known as "spending review", all doubts (or almost) had to be overcome. The text of the art. 15, paragraph 11-bis, was then replaced by Legislative Decree 179/12 and converted into law 221/12. This text was also commented on by the guidelines of 25 February 2013 published on the website of the Health Card project of the Ministry of Economy and Finance. The text of the law reads verbatim:
"The doctor who treats a patient, for the first time, for a chronic pathology, or for a new episode of non-chronic pathology, for the treatment of which more equivalent medicines are available, indicates the name of the active ingredient in the prescription of the National Health Service contained in the drug or the name of a specific medicine based on the same active ingredient accompanied by the name of the latter. The indication of the specific medicinal product is binding for the pharmacist if the non-substitutability clause referred to in article 11, paragraph 12 of the decree-law of 24 January 2012, n. 1, converted, with amendments, by law 24 March 2012, n. 27. The indication is binding for the pharmacist even when the drug indicated has a price equal to the reimbursement price, without prejudice to the customer's different request".

But what is the only doubt left? It is the one linked to the existence of a chronic pathology being treated before the entry into force of the law (August 15, 2012), for which the pharmacist is not able to know the start of the therapy, thus not being able to verify whether the prescription of the specific medicine without justification is legitimate or not. However, the problem is limited to these situations, which are destined to become extinct over time. However, it can never be argued that an antibiotic pertains to a chronic pathology because, it is clear, that the drug to which reference is made is the one that cures the chronic pathology, while the possible onset of an acute episode, albeit linked to the chronicity of the treatment, has nothing to do with the spirit of the law. To antibiotics you can then add many other active ingredients intended for acute events and that the pharmacist is able to identify

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