Medicines, one in three citizens complain of shortages and on generic medicines comes the risk of stock-outs

The latest data on the drug shortage 'fever' arrives on the day on which the table on supply was convened at the Ministry of Health, bringing together the daily lives of patients and the effects of international tensions, the epicentre of which has been the Strait of Hormuz for two months. And if the undersecretary for health Marcello Gemmato, who had wanted to set up that table back in 2023, assures that "we are not in the presence of any emergency", but that "we will act promptly should the scenario change", the perception of the people of the pharmacies - practically all the inhabitants of the country - is quite different. At least according to the latest Report on Pharmacy, presented in Rome by Cittadinanzattiva with Federfarma.

More than a third of the population, according to this report, has in fact had problems in the last year in obtaining medicines, and among all of them 'suffer' especially the chronically ill, about one in ten of whom have suffered delays 'incompatible with their therapeutic needs, putting continuity of care at risk'. It is no coincidence that the document's proposals include tackling drug shortages 'by means of collaboration between all those involved, for an integrated management model of the phenomenon to be adopted on a permanent basis' and starting with the community pharmacy as the system's 'shock absorber', capable of guaranteeing continuity of treatment in most cases.

Practically all pharmacists (95 per cent) have experienced drug shortages or unavailability in the last twelve months, demonstrating a "recurring condition in the pharmaceutical supply chain, with impacts both on the health system and on the daily practice of pharmacies", reads the Cittadinanzattiva report. But the resilience tools are there, and how, and pharmacists are equipped: "They can, for example, propose replacing the drug prescribed but lacking with an equivalent or generic one, which has the same efficacy and the same active ingredient despite being 'no logo'," explains Marco Cossolo, president of Federfarma. "They can also check availability at other distributors or pharmacies and report the shortage to the doctor, who can modify the therapy. Or they can prepare galenic medicines in their laboratories and finally monitor and manage stocks of available medicines, reporting shortages".

In recent days, it was Farmindustria that had sounded the alarm over soaring costs and the 'drug risk'. Today, in particular, it is the manufacturers of generic and equivalent medicines, faced with the continuing stalemate in the US-Iran negotiations, who are sounding a further alarm bell and calling for urgent action: "The geopolitical tensions in the Middle East are causing new criticalities in the drug supply chains, affecting both logistics and the increase in costs along the entire supply chain and increasing the risk of shortages. Surveys conducted at European level show, in fact, a system that is still functioning but vulnerable, characterised by unstable balances and a growing dependence on the containment measures adopted by individual companies,' explains Egualia president Riccardo Zagaria. 'In particular,' he points out, 'strong pressures persist on transport costs, energy and raw materials, with direct effects on active pharmaceutical ingredients (APIs), packaging materials and distribution capacity, especially for the routes most exposed to the current international scenarios. The possible continuation of the crisis could also compromise safety stocks and amplify supply difficulties, with major impacts on the availability of essential medicines. 41% of companies have stocks for only 8-10 weeks. If these supply chain disruptions were to continue beyond the capacity of current stocks, short-lived, often life-saving medicines would start to become scarce'.

In this framework - the generic drug manufacturers point out - strengthening the sustainability of the expired patent medicines sector, an essential component to ensure therapeutic continuity and access to treatment, becomes a priority. On this point, which has already been pointed out to the institutions on several occasions, the need for adequate attention to be paid both to regulatory policies, including in the context of the activities of the Italian Medicines Agency, and to the sector's reform processes is called for. 'Equivalent medicines,' Zagaria concludes, 'are in fact a pillar of the National Health Service, but they require economic and industrial conditions consistent with the need to ensure production stability and continuity of supply. At the same time, there is a need to consolidate monitoring and cooperation tools at the European level, to favour the fluidity of logistic flows, and to maintain adequate margins of regulatory flexibility, including through measures aimed at containing the impact of energy costs. Only through a coordinated approach will it be possible to mitigate the risks of further shortages and preserve the resilience of the pharmaceutical system'.