Interview athe pharmacologist Alessandro Mugelli
di Andrea Rossi
In the last year it is bossestato that patients suffering from obstructive hypertrophic cardiomyopathy did not find an essential drug available for their therapy. Aifa, the Italian drug agency, constantly intervenes to reduce the impact on patients of any drug shortages, but, in this specific case, the active role of Aicarm is also proving to be very important. Alessandro Mugelli, emeritus professor of pharmacology at the University of Florence, past president of the Italian Society of Pharmacology, Fellow of the European Society of Cardiology, talks about it.
Alessandro Mugelli
Professor Mugelli, an important problem for some patients suffering from cardiomyopathy is the finding of some essential drugs for their therapies. Can you explain to us how and why this happens?
A "shortage of a medicine" occurs when, at the national level, supply does not meet demand.
Therefore we speak of "deficient drug" when a medicine is not available throughout the country and for which the holder of the Marketing Authorization cannot ensure a continuous and appropriate supply with respect to the therapeutic needs of patients.
It should be immediately clarified that the phenomenon of drug shortages affects all countries and not only Italy; in Italy the phenomenon is constantly monitored by AIFA. The shortage of a drug can be determined by various factors, frequently connected to contingent production problems (lack of the active ingredient, problems related to production for health emergencies in the countries of production), unexpected increase in requests as happened for many drugs during the phase Covid pandemic. The real shortage of a medicine must be distinguished from its temporary unavailability caused by distortions of the distribution dynamics.
What do you mean by "distortions"?
Market distortions are attributable to the phenomenon of parallel trade, parallel trade, in which the wholesaler can decide to export the drug to countries where the price is higher: it is a legitimate procedure, linked to mechanisms of free circulation of goods on the market. Instead, there is another possibility, namely the fact that companies decide to suspend the marketing of a drug because it is “dated” and with a price that is too low to be profitable. This is what can happen to equivalent (or generic) drugs which sometimes have very low prices to the point of no longer being profitable. And this, mind you, is a mechanism completely independent of the effectiveness of the drug.
The drug market, however, is a market that cannot fail to have internal corrective measures, if only because it is linked to public health
Exactly, and here we enter the field of mechanisms through which AIFA, the Italian Medicines Agency, intervenes to check that there are no shortages in supplies. For example, the Agency can issue an authorization to import a deficient drug from abroad or take specific measures to prevent its export, as required by the Calabria Decree. For example, there is a "Technical table of unavailability", an informal body established and coordinated by AIFA since 2015, with the aim of addressing the distribution distortions and other market dynamics that generate a lack of drugs in the area with a targeted and shared approach. , and direct law enforcement activities. On the AIFA website there are weekly updates of the lists of deficient drugs.
What specific difficulties can a patient with cardiomyopathy encounter?
An active ingredient, disopyramide, is used for obstructive hypertrophic cardiomyopathy, both in the immediate release (ritmodan) and delayed (ritmodan retard) formulation. The German company, which obtained the transfer of the ownership of ritmodan retard from Sanofi-Aventis in October 2020, announced in July 2021 a shortage due to production problems that could only be solved starting from February 15 next year. In these months of lack of supplies, AIFA has authorized imports from countries that do not have these problems.
What can Aicarm do in these cases?
First of all, it is concerned with making specific reports to AIFA when supply shortages occur. I recently wrote personally, on behalf of Aicarm, to the Association representing the manufacturing industry of equivalent drugs (Egualia) to ask if any of their members might be interested in entering this specific market segment. Another intervention by Aicarm is to circulate knowledge on the places where certain drugs can be found, even outside our country. These problems of shortage or unavailability of drugs, however, I would like to emphasize once again, does not concern only Italy, it is much wider. The "compensation" system in our country has made great strides forward. It worked thanks to the collaboration of all the parties involved during the most critical phases of the pandemic emergency and works daily in the interest of patients to counteract any shortcomings.
To learn more: AIFA - Deficient drugs