Rome, April 30, 2023 – Emerged in 2021, the amoxicillin deficiency – first choice antibiotic, with or without association with clavulanic acid, for all the most common infectious pathologies, essential for pediatric primary care activity – has begun to be closely monitored at European level since November last year. But, despite the optimism initially shown by the EMA, which in January spoke of a situation that would improve “in a few months”, the problem has become increasingly serious enough to take on the contours of an emergency. In our country it has been unobtainable for weeks: for some formats the end date of the shortage is indicated by the end of May but for other types it will be necessary to wait even beyond the summer for a return to full availability. In this scenario, the Cultural Association of Pediatricians (Acp), the Italian Society of Pediatrics (Sip) and the Italian Federation of Pediatricians (Fim), have launched an appeal to the Italian Medicines Agency (Aifa) so that “efficient initiatives are promptly activated to make up for the shortage of essential medicines, which today limits the quality of treatment of frequent infections in the whole population”.
If starting from 2021 the shortage concerned some formulations for hospital use for a few months – explain the pediatricians – the shortage at the territorial level concerns all formulations of amoxicillin. A phenomenon that appears cyclical in some realities and more stabilized in others.
The main cause the basis of the amoxicillin deficiency, according to the EMA, is the peak of respiratory infections which, last winter, led to a sharp increase in the demand for antibiotics. All accompanied by delays in deliveries and problems in production capacity that are affecting the pharmaceutical industry worldwide. For pediatricians, however, the problem is different. The presidents of Acp, Sip and Fim – Stefania Manetti, Annamaria Staiano, and Antonio D’Avino – point the finger at the pharmaceutical lawsuits that are not interested in producing an “antibiotic that is too inexpensive”.
In the past it is already happened for oral penicillin and erythromycin, but – warn the pediatricians – the abandonment of amoxicillin “can represent a serious risk to public health given the large number of population that may need it”. In fact, it is an effective and well-tolerated antibiotic, with low risks of adverse effects and which contributes to the control of antibiotic resistance, of which Italy has the sad primacy in Europe, together with Spain “Effective and low-cost treatment tools – underline the paediatricians – must be made available regardless of any market logic”.
To make more worrying the lack of amoxicillin is the increase in cases of positivity to group A Beta Haemolytic streptococcus: in the schools of Rome, the cases of scarlet fever, caused by this bacterium, have risen by 30% with peaks of 50%. This antibiotic is, in fact, the most suitable for treatment of pharyngotonsillitis from BEA, otitis and bacterial pneumonia, infections where – say the pediatricians – “every therapeutic alternative represents an inappropriate choice”. “We are adapting to an increasingly chronic and widespread shortage, even during the current epidemic of streptococcal infections which – explains Manetti – has in turn exacerbated the problem of scarce availability and prescribing inappropriateness, with the risk of finding ourselves faced with suppurative complications increasingly difficult to treat, as already reported by some pediatric hospital wards”.
To address this shortcoming A table has been opened at the Ministry of Health: the proposal that comes from the Associations of paediatricians is to involve the military pharmaceutical plant in Florence in production.