Monday, December 5

Doctors and pharmacists ask for calm in the face of the lack of amoxicillin: “No child will be left without treatment”


A father goes through several pharmacies in Madrid in search of amoxicillin. Supply problems for pediatric oral suspensions have made finding this antibiotic a difficult task. The image was repeated last week in several homes. The period of greatest demand for these medicines has been brought forward compared to other years and the laboratories that have a greater market share in Spain have suffered delays in preparing new batches. No market is immune to supply problems, the consequences of the war in Ukraine or the relocation of companies that produce these solutions to Asia. But pharmacists and doctors ask for peace of mind: “No child is going to be left without treatment.”

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Amoxicillin is an antibiotic derived from penicillin, which is mainly used for some respiratory infections caused by bacteria. “Not all respiratory infections are caused by bacteria and not all respiratory infections caused by bacteria require the use of antibiotics,” explains Dr. José María Molero, who is a member of the Infectious Diseases working group of the Spanish Society of Family Medicine. and Community. In general, it is prescribed “for some throat infections, some cases of otitis, sinusitis, and also for slightly more serious respiratory infections, such as pneumonia,” he clarifies.

In recent days, an increase in bronchiolitis has been erroneously linked to amoxicillin. However, for these cases, caused by the respiratory syncytial virus, this medication is not prescribed. “When this period of respiratory infections arrives, although we know that many are of viral origin, the consumption of antibiotics also increases, because there is some diagnostic uncertainty,” explains Molero.

In any case, this doctor points out that there are substitutes. “For many infections there is a group of antibiotics called macrolides. The problem is that some germs, such as those that cause pneumonia or some cases of otitis, could have a resistance mechanism, because they have learned to defend themselves. In these cases, it would be necessary to go to cephalosporins, which would solve these cases of resistance ”, he explains. However, there is another solution endorsed by the Spanish Agency for Medicines and Health Products (AEMPS) and that involves adjusting the dose to the weight of the children and using other presentations that can be divided.

“Strictly, in some children who were using the 250 dose, due to their weight, the 500 dose could be used, reducing the amount,” says Molero, thinking mainly of children weighing more than 40 kilos. “There are possibilities, adjusting the dose and choosing other presentations. There are 500 tablets that can be broken or syrup solutions that can be dosed ”, he emphasizes.

“Possible alternatives”

This is what the Spanish Medicines Agency (Aemps) says, which last Friday published a note stating “possible alternatives that guarantee the treatment of patients” in the face of supply problems. In this way, the agency has authorized pharmacies to “replace the dispensing of an oral suspension of amoxicillin 250 mg in a bottle with amoxicillin Normon 250 mg powder for oral suspension in an EFG sachet.” And, “failing that”, for other presentations in 500 mg tablets “that can be divided to administer half a tablet, which can be dissolved or disintegrated in water”, although it acknowledges that it is considered “the most accessible option” although the technical data sheet Do not contemplate this modality of administration.

The vice president of the General Council of Pharmaceutical Colleges, Juan Pedro Rísquez, agrees with the analysis. “The situation with amoxicillin responds to a seasonal problem. There has been an increase in demand because childhood respiratory problems have been anticipated”, which is added to “a lower production for many reasons, but there is no care problem”.

“A child who needs it will not lack an antibiotic,” Risquez insists. “The Agency has authorized to offer possible substitutions in those sachet presentations with the possibility of giving larger doses that can be split. In addition, this affectation is not occurring in a general way. There is difficulty in supplying all the demand, but there are many pharmacies where it is being dispensed without a problem”, he points out.

The pharmacists’ associations in Spain have the Farmahelp tool, a platform in which more than 5,000 establishments participate and that allow users to check which nearby pharmacy has a medicine, in the event that it is not available in the one where the patient goes. patient. In addition, the organization has Cismed, a database with information on supply incidents. Their data coincides with those of the Aemps Drug Information Center (CIMA), which indicated in the first semi-annual report of 2022 that active supply problems had increased by 31%.

According to this source, in Spain there are currently 629 assets with supply problems, but in some cases these are shortages that have been occurring for years because they have ceased to occur or that do not represent a care problem because they can be replaced by others. “We come from the year 2019, where there was a highly exaggerated volume of supply problems. It was improving in 2020 and 2021 and now there is an increase that does not reach the levels of 2019”, warns Rísquez, who is cautious but asks to work to solve these problems that, however, “always exist”.

The Agency points out that the problems of shortages with amoxicillin respond to the delays of the Normon SA and Sandoz Farmacéutica SA laboratories, the main suppliers in Spain. “The causes that led to these delays have been resolved and production is being accelerated to meet pending demand, so the pediatric oral suspensions supply situation is expected to return to normal by the end of the week of November 21. ”, indicates the controller.

From Sandoz they point out that their “anti-infectives operation, located in Europe, is facing an exceptionally difficult situation in the short term, due to an unprecedented combination of challenges: strong fluctuations in demand, manufacturing capacity limitations, shortages of raw materials and the energy crisis”. “To date, we have been able to largely absorb the impacts of energy inflation, and our goal is to maximize production, not reduce it, to meet growing patient demand and optimize our unit production costs. We continue working to resolve these supply difficulties in some of the presentations of these antibiotics, in close collaboration with the Health Authorities”, they explained to this newsroom. ElDiario.es has tried to contact Laboratorios Normon, but has received no response.



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