The phenomenon of drug shortages in the distribution circuit is making the world of pharmacy discuss these days and reports of such cases come from several sources, both from pharmacists and from trade associations. Maurice Cini, vice president of Utifar, helps us understand who is responsible for supervising the functioning of the distribution network.
“With a note published yesterday by Farmacista33, the Italian Medicines Agency replies to a complaint published in the same electronic journal in which the Agency is accused of not taking sufficient action to counter the phenomenon of quotas for many medicines by the same pharmaceutical companies but also by intermediate distribution. Aifa claims that all reports of "shortages" relating to medicines are listed in a special space on the Agency's website. This is very true and the motivation is also published alongside each "deficient" medicine, mostly deriving from the cessation of production and/or marketing or for generic "regulatory problems" that the Italian regulatory agency does not describe better. Aifa also explains that "lacking" means the medicine that is unavailable throughout the national territory. What unfortunately does not belong to the Agency is, however, the situation denounced by Dr. Di Iorio, president of Federfarma Naples, which does not enter into the regulatory problems existing between the Industry and the Italian Medicines Agency. What Di Iorio is concerned about is that medicines that are untraceable or available "with a dropper" - which, moreover, are not on the list of "deficient" - become available again for dispensing to the public. Thus the reverse path should be followed, ie starting from the pharmacy reporting the phenomenon to arrive, through the wholesaler, up to the depositary and the holder of the Aic, in order to clarify the reasons for the phenomenon. Knowing full well that the situation has worsened since about 200 Italian pharmacies have also become wholesalers and exporters on the basis of regional authorizations issued almost always lightly and that is without verifying the punctual presence of the requirements established by law (Legislative Decree 219/06 ) which, in articles 104 and 105, provides for conditions that a pharmacy, as a rule, is unable to guarantee. It is therefore up to Nas, the regions and the Ministry of Health to supervise the functioning of the entire intermediate distribution network by assessing whether or not the conditions for maintaining the authorizations exist. Because, let it be known that "the law exists" and, therefore, it is enough to enforce it. I conclude by believing that Aifa's reply is the result of a misunderstanding due to the two different levels of the same problem: the regulatory one correctly monitored by the Agency and the territorial one referred to by the president of Federfarma Napoli.
Prof. Maurizio Cini
