The AIFA technicians to Fanpage.it on the shortage of drugs, which has increased at a European level: “The shortages do not only concern pancreatic enzymes, as reported by Fedez. Alarmism should only be used in extreme cases: panic can only make the phenomenon worse, inducing people to try to grab as many packs of the drug they are using as possible.”
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“In recent years there has certainly been an increase in deficient products, but as regards Italy it is important to clarify that the increase particularly concerns products for which there is a wide availability of equivalent“.
Thus the technical offices of AIFAthe Italian Medicines Agency, responded to questions from Fanpage.it on the issue of shortages of medicines, the number of which is increasing throughout Europe. In our country there are approximately 300 medicines for which shortcomings are reported, which concern above all antibiotics, some anticancer, antidiabetics, some drugs that act on system nervous central.
Medicines, some even life-saving, are in short supply. How does AIFA deal with this situation?
“AIFA constantly monitors, through specific procedures, the availability and possible temporary unavailability of medicines on the national market, in particular those essential for the treatment of certain pathologies. Companies communicate possible shortages to the Agency with advance notice of four months, to allow the implementation of the most appropriate strategies to reduce the impact on patients. For the various types of “lack from the market” various systematic contrast strategies have already been structured over the years, depending on whether they are, for example of shortages or unavailability.
In the list of missing drugs published on the AIFA website, the mitigation strategies in place are indicated for each missing drug: for the majority of drugs it is possible to resort toequivalent on the market in our country, for some it is necessary to consult the doctor in order to use an alternative drug, and only for a few, which are devoid of identical ones in Italy, one must resort to galenic orimport through the ATS/ASL, with authorization from AIFA.
For the most critical cases, such as shortages of medicines for epilepsywhich are used for therapies that are difficult to modify quickly, AIFA defines specific support activities, agreed with clinicians, according to models such as those reported for example on the LICE website”.
The spotlight on the issue was turned back on after Fedez’s social complaint. But it’s not just pancreatic enzymes that are missing. Which ones are missing? Do you have any numbers?
“Certainly the deficiencies do not only concern pancreatic enzymes. We promptly publish a very detailed list to allow both patients and healthcare professionals to have a clear picture of the situation.
The list serves not only to comply with the obligations of transparencies, but to always keep the dialogue open with everyone. Above all, however, the lists, as well as all the information published on the AIFA website, offer practical and operational solutions, as explained before”.
What are the reasons for this shortage?
“The reasons why a drug may be lacking are various. Also thanks to the work of the “Unavailability Technical Roundtable”, in which Administrations and stakeholders in the drug supply chain continuously discuss, AIFA has been able to outline three macros areas which motivate the shortcomings: production shortagesdetermined by factors such as, for example, the unavailability of the active ingredient, problems related to production, regulatory measures, unexpected increase in requests for a particular medicine, or health emergencies; unavailabilitylinked to the removal of drugs from the market due to distributional distortions on products not declared as deficient; lack of hospital suppliesin which the delays or inconveniences to the structures are mostly due to the failure of the companies awarded local tenders to supply them.
The different types of problems require interventions of different nature: for example, blocking exports is a necessary measure in the case of distribution distortions, but would be ineffective in the case of production shortages, given the absence of the product from the network.
Italy is a point of reference at European level in this sector, precisely because of the scientific approach that has allowed us to develop many different tools to prevent and combat deficiencies of different origins.”
Can we talk about an emergency or is the situation under control in Italy?
“Alarmism should only be used in extreme cases: Panic can only make the phenomenon worse, causing people to try to grab as many packs of the drug they are using as possible, thus paradoxically generating a shortage. In this case we are talking about “lack of rebound”, with patients going to stock up on the products they fear they won’t find, making them truly disappear.
It should instead be underlined that, for critical cases, tools developed by AIFA and the network of central and local administrations have existed for years, in close collaboration with the supply chain and private stakeholders: for example, for cases like this Creon companies have for years created direct supply channels, such as the SOS services also promoted on the AIFA website, which serve to manage the distribution tension, managing quotas and direct supplies, to avoid hoarding on products that normally have a stable market.
Italy, through AIFA, is a point of reference for the European network, so much so that it is leading the Joint Action CHESSMEN, the main European project in this area, whose aim is precisely to support EU Member States in implementation of structures, measures and tools so as to address this problem in a coordinated way. Patients have the right to timely access the medicine, to have correct knowledge of the tools made available to guarantee this right and, last but not least, to receive balanced information.”
Broadening its gaze to Europe and the rest of the world, the WHO stated that in two and a half years the shortage of medicines has doubled. What advice can you give to citizens who find themselves without therapy?
“Like almost every modern phenomenon, even that relating to shortages is global in scope. In recent years there has certainly been an increase in deficient products, but as far as Italy is concerned it is important to clarify that the increase concerns in particular products for which there is a wide availability of equivalent.
The healthcare professionals who are present in the area represent a very important support for directing and helping patients when these problems arise: pharmacistsas well as the doctors and technicians of the Regions and ASL, are part of the national network to which we referred before, and have tools and knowledge that allow them to intervene effectively and promptly to support patients, who can turn to them with confidence”.