To stem the shortage of amoxicillin in France, the health authorities have authorized approved pharmacies to produce capsules of this antibiotic.
Persistent amoxicillin supply difficulties, the National Medicines Safety Agency (Ansm)authorized pharmacists at the end of December to issue their own preparations when certain drugs are missing, this “on an exceptional and temporary basis”.
In the recommendation of the Ansm, Amoxicillin in 125 mg and 250 mg is for example concerned, an antibiotic “mostly prescribed on an outpatient basis in children”, explains the Agency. This medicine is used in the treatment of abscesses, pneumonia or otitis.
As a reminder, the shortage of amoxicillin, especially pediatric, does not come from a lack of raw material, “we have above all a problem today of manufacturing the finished drug”, explained on BFMTV Fabien Bruno, pharmacist in Paris.
By having direct access to the raw material, French pharmacists can therefore prepare their own capsules.
About forty pharmacies authorized to prepare it
Preparing pharmacists are “specialized in the manufacture of tailor-made drugs”, explains to BFMTV.com Sébastien Gallice, president of the PREF (Pharmaciens des Préparatoires de France). He gives the example of children who “do not always have the right dosage of medicine for them”.
His work then consists in re-measurement of the treatment on a smaller scale for his young patient, we speak of “masterful preparation”.
These pharmacies “deliver to their colleagues” usually for certain needs, explains Philippe Besset, president of the Federation of Pharmaceutical Unions of France (FSPF), “it is a common method. On the other hand, the fact that they manufacture amoxicillin, it’s new, and not everyone can do it.”
Among the pharmacies which today in France make these magistral preparations, only about forty are approved to attack amoxicillin.
A substance “particular to handle”
This substance is indeed “particular to handle, you must not breathe it, work it under a specific hood and prevent it from spreading on other preparations”, because it presents risks, and could lead to antibiotic resistance, details Sébastien Gallice, who equipped his pharmacy in Marseille (Bouches-du-Rhône).
“We must respect the manufacturing and quality processes”, explains to France 3 Françoise El Kouri, pharmacist in Orvault (Loire-Atlantique). “Amoxicillin is manufactured under a fume hood so it requires suitable premises and well-protected personnel, but we know how to do it, and we also do it for many other molecules”.
The manufactured compound is an open capsule, the contents of which can be mixed with food. A leaflet must anyway be provided to patients with the product, to explain how to ingest it.
“Lots of overtime”
Sébastien Gallice says he is “proud” to be able to help contain a public health problem, even if this work represents a surplus for him and his teams because “there is a lot of overtime, it is important work which requires everyday reorganization”.
“We do 2 to 3 overtime hours, not really for the money but rather for the common good”, also explains a Parisian pharmacist to the newspaper The echoes.
Thousands of capsules are produced every day. “It is estimated that 30% of treatments can be overcome” with this artisanal production, explains Sébastien Gallice, “potentially 50%”. The products manufactured are traced, and “there are regular tests”, he assures.
Renaud Nadjahi, president of the URPS Pharmaciens d’Île-de-France, recalls that pharmacists have demonstrated their ability to make preparations in the midst of the Covid-19 pandemic, for example by manufacturing hydroalcoholic gel. “They are very reactive” abounds Philippe Besset.
“We are not going to replace industries”
“It is very interesting to have this force available on our territory which makes it possible to overcome the emergency”, adds the pharmacist.
The objective is not to produce these drugs over the long term. “We are not going to replace industries,” says Sébastien Gallice. He explains that the price of this artisanal drug is higher than those produced wholesale, and that it is produced more and more quickly at the industrial level. In his pharmacy, “it’s done by hand”, he recalls.
“As long as the industry works, there is no reason”, abounds Renaud Nadjahi.
The fear of pharmacists is that these shortages will multiply in the months to come. Paracetamol is still currently under pressure, especially in its pediatric form, but all classes of drugs are affected by stock shortages or supply tensions.
