At the technical table of Aifa, the drug agency, the point was made on the shortcomings, looking for answers that take into account all the parties involved
From the lack of drugs caused by the distributive distortions (when, for example, the distributor resells the medicines in a State of the European Union where they are paid much more than in Italy), the shortcomings due to problems such as the unavailability of the active ingredient and logistical difficulties. From co
ntinting of orders wholesalers, packaging traceability, databases for instant reporting of unobtainable molecules.
The technical table
The technical table on unavailability, established in 2015, deals with all critical issues related to the procurement of medicines, attributed both to deficiencies (a term used when the cause is of a production type) and to unavailability (which identifies dysfunctions and distortions in the distribution chain). The main trade associations of the supply chain are part of it (such as Farmindustria, Egualia, Federfarma, Assofarm, Association of pharmaceutical distributors, Federation of Italian pharmacist orders,) and the activity it has carried out in recent years has been summarized in the volume “The technical table unavailability” , published by the Poligrafico dello Stato and presented in Rome.
Collaborations
An apparently technical matter but vital for guaranteeing access to drugs on a constant and regular basis – underlined Nicola Magrini, general manager of Aifa. – The results of the table were highly appreciated at the European level. The Table proved to be an effective tool for comparison e co
collaboration among all stakeholders to seek timely solutions for the benefit of patients and to share good practices and projects – specified Domenico Di Giorgio, director of Aifa’s Product Quality and Pharmaceutical Crime Fighting Office, as well as promoter of the Table -. We are also working on building a website to answer patients’ questions “.
The initiative
The table was born on the basis of the Pilot project unavailable (also from 2015), which involved Aifa, the Ministry of Health, Nas and the Lazio Region to identify some illegal parallel export activities: illegitimate transactions
in medicinal
i, a
massive caparriage by wholesalers; fictitious repackaging operations by foreign wholesalers. Action against the ’roundup’ of our critical drugs led to the withdrawal of about twenty licenses and to the halving of exports of a series of products under investigation because they are chronically unavailable, declares Di Giorgio.
Distribution
The first operational outcome of the Technical Table was the Shared text on the distribution of medicines, signed in 2016 by all the acronyms in the sector, pto prevent the bleeding of packages in Northern Europe, especially in Germany, Great Britain and the Netherlands, where essential drugs are paid for at higher prices. The document reaffirms the rules on wholesale distribution, on the minimum allocation for distributors, on the rules for the owner of a pharmacy licensed as a distributor but who cannot sell to other medicines purchased from his pharmacy.
Controls and sanctions
I
l text, which for the first time clarified all the sources and rules to be respected, allowed the Regions to carry out checks and sanction illegal operators without fear of appeals and the resulting inconveniences explained Di Giorgio. The shared text therefore serves to ensure the correct functioning of the entire supply chain to protect public pharmaceutical assistance.
Users
I’m sorry but the drug is not there. When the patient hears this from the pharmacist, he is not forced to go hunting for the pill he needs in pharmacies all over the city or, worse, to run out of it. There is a solution to solve the temporary shortage. still little known both among pharmacists and among citizens. But a right and you have to know it recommends Di Giorgio. Hence the need to draft one guide to pharmacies, published in July by the Technical Roundtable, with a summary of the procedures to be followed to support patients in the event of a shortage (production) or unavailability (due to market dysfunctions) of a medicine.
The procedures
If the missing medicine is present in the Aifa deficient medicines list, patients should be referred to the general practitioner or specialist to request an alternative or equivalent treatment. If the drug is irreplaceable, the import procedure through the doctor which is then managed by hospital pharmacies or by the competent local health authorities in the area, reminds the Aifa manager. The form to activate the import procedure can be downloaded from a specific link
The initiatives
The pharmaceutical company can also import the deficient drug and it is dispensed from the hospital pharmacy or the ASL upon presentation of a medical prescription. For clarification or information, please contact the Product Quality and Pharmaceutical Crime Department at the e-mail address [email protected]. an underutilized procedure that needs to be encouraged presses the expert. If, on the other hand, the drug is not on the Aifa list, the pharmacist must contact at least three different wholesalers to check availability. Once the actual exhaustion of stocks has been ascertained, it is possible to request the product in an emergency directly from the company (AIC holder), which is obliged to supply it within 48 hours. In case of non-delivery, the pharmacist is invited to send a report to the above email. Another initiative of the Table is the Drughost platform, the portal of pharmaceutical unavailability, the first in Europe.
It is fed by hospital and local pharmacists to collect all the data on drugs unavailable on the Italian market (the lack of which is determined by distributional distortions) in order to map and quantify the phenomenon in a timely manner and to develop contrasting interventions. The contribution of the Table in 2020, when the Covid pandemic exploded, was to prevent the unavailability of drugs for intensive care and to manage shortages such as that of oxygen cylinders that had led to unjustified hoarding ”
November 23, 2021 (change November 23, 2021 | 12:59)
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