Posted Nov 18, 2022, 1:08 PMUpdated on Nov. 18, 2022, 1:11 p.m.
Antibiotics are not automatic: the slogan of the public authorities to counter the overconsumption of antibiotics has obviously not been heard. Due to an early start to winter infectious epidemics this year, France recorded a peak in demand for Amoxicillin, one of the most widely used broad-spectrum antibiotics, especially for children. Result: in pharmacies, the shelves are empty. The Ministry of Health confirmed on Friday the observation made last week by the drug agency (ANSM) of “high tensions”.
The shortage might last until March 2023. But “there are alternatives because the tensions mainly concern oral solutions” therefore especially pediatric Amoxicillin, specifies the Ministry of Health.
Security stocks
The shortage of Amoxicillin is not limited to France, “the situation is European and beyond, it is global”, observes the ministry. This limits the possibilities of importing this antibiotic, which is only manufactured at three sites in Europe. On the other hand, since a first warning from the ANSM on November 9 on the existence of strong tensions, France has already prohibited wholesaler-distributors (intermediaries between manufacturers and pharmacies) from exporting the product outside France.
In addition, since September 2021, for this antibiotic, as for thousands of other medicinal products of major therapeutic interest (there are approximately 400), manufacturers are subject to the legal obligation of two months of safety stock ( for 400 drugs, the ANSM even increased the obligation to 4 months of safety stocks but Amoxicillin is not concerned). This stock made it possible to cushion the shock but is not sufficient to ultimately avoid supply disruptions.
Jump in demand
The two main causes of the shortage are known. It is first of all a peak in consumption, also observed for paracetamol, another drug in tension. “This year, from January to October, the demand for Amoxicillin is around 40 million boxes, while in 2020 and 2021 we were far below, rather around 30 million boxes”, notes the ministry.
The Covid pandemic, which had led to the wearing of masks and other barrier gestures (hand washing, confinement, etc.), had reduced infectious diseases and therefore the demand for various flu drugs. Today, seasonal epidemics are back.
The other cause is the difficulty for manufacturers to return to their pre-pandemic production level. Faced with the drop in demand, they had reduced production and “industrialists are programming their production plan, the system does not allow instant supply”, underlines the ministry.
Overuse of antibiotics
The fact that the majority of raw materials (active pharmaceutical ingredients) come from Asia is not perceived as the main explanation by the public authorities, who also recall the efforts made in recent years to relocate the pharmaceutical industry to France, through credits from France Relance or even the framework agreement signed with manufacturers, which makes it possible to increase the price of a reimbursable drug when it is produced in France.
Still, the current tensions over Amoxicillin are also due to overuse of antibiotics . “France is the fourth European country out of 27 in the consumption of antibiotics and specialists consider that adults and children combined, at least half of the prescriptions of antibiotics [faites en France, NDLR] are medically unjustified”, recalls the ministry. Antibiotics only fight bacteria, not viruses.
However, we always observe an increase in their prescription when the winter viral epidemics increase, in particular that of bronchiolitis, which is early and severe this year. There are certainly risks of infectious complications in babies with bronchiolitis , but this risk is low and treating it preventively with antibiotics develops immuno-resistance. The latter continues to increase and poses much more serious problems than the occasional tensions on oral solutions of Amoxicillin. The ANSM will publish this Friday followingnoon recommendations on the proper use of Amoxicillin and its uselessness for viral respiratory infections such as bronchiolitis or influenza.