Father goes to several pharmacies in Madrid in search of amoxicillin. Problems with the supply of pediatric oral suspensions have made finding this antibiotic a difficult task. The image was repeated in several homes last week. The period of greatest demand for these drugs has advanced compared to other years, and laboratories with a larger market share in Spain have been hampered in preparing new batches. No market is immune to supply issues, the fallout from the war in Ukraine, or the relocation of companies making these solutions to Asia. But pharmacists and doctors ask for calmness: “No child will be left without treatment.”
Amoxicillin is an antibiotic derived from penicillin that 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 society. Generally, it’s prescribed “for some throat infections, some cases of otitis, some cases of sinusitis, and also slightly more serious respiratory infections like pneumonia,” he explains.
An increase in bronchiolitis in recent days has been mistakenly associated with amoxicillin. However, this medicine is not prescribed for these cases caused by respiratory syncytial virus. “When this period of respiratory infections comes, although we know that many are of viral origin, the use of antibiotics also increases because there is some diagnostic uncertainty,” explains Molero.
In any case, this doctor notes 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 media, may have resistance mechanisms because they have learned to protect themselves. In this case, it will be necessary to take cephalosporins, which will solve these cases of resistance,” he explains. However, there is another solution approved by the Spanish Agency for Medicines and Health Products (AEMPS) and which involves adjusting the dose to the weight of children and using other presentations that can be divided.
“Strictly, in some children who used 250 doses, because of their weight, 500 doses can be used, which reduces the amount,” says Molero, mainly thinking of children weighing more than 40 kilograms. “There are opportunities to adjust the dose and choose other presentations. There are 500 tablets that can be broken or a syrup solution that can be dosed,” he emphasizes.
“possible alternatives”
This is according to the Spanish Medicines Agency (Aemps), which published a note last Friday “A possible alternative that provides treatment for patients” Amid supply problems. Thus, the agency authorized pharmacies to “substitute amoxicillin 250 mg in a bottle for oral suspension with amoxicillin Normon 250 mg powder for oral suspension in an EFG package.” And, “if not”, in 500 mg tablets for other presentations “which can be divided to take half a tablet, which can be dissolved or dissolved in water”, although he admits that it is considered “the most affordable option”, although the technical data sheet does not consider the administration this method.
Juan Pedro Riskes, vice president of the General Council of Colleges of Pharmacy, agrees with the analysis. “The amoxicillin situation is responding to a seasonal problem. Demand increased because childhood breathing problems were expected,” adding to “low production for many reasons, but no care problems.”
“There is no shortage of antibiotics for a child who needs it,” Riskes asserts. “The agency is authorized to propose a possible replacement in these package presentations with the possibility of giving larger doses that can be divided. In addition, this effect does not occur in general. It is difficult to supply all requests, but there are many pharmacies where it is sold without any problems,” he notes.
In Spain, the Association of Pharmacists has the Farmahelp tool, a platform in which more than 5,000 institutions participate and which allows users to check which nearby pharmacy has the medicine, in case it is not available where the patient is going. . In addition, the organization has Cismed, a database that contains information on supply incidents. Their data is in line with that of the Aemps Drug tion Center (CIMA), which in its first half-year report for 2022 indicated that active supply problems had increased by 31%.
According to this source, there are currently 629 assets in Spain with supply problems, but in some cases it is a deficit that has been occurring for years because they no longer occur or are not a maintenance problem because they can be replaced by others. . “We’re coming off 2019 where there were huge overcapacity issues. It was improving in 2020 and 2021 and now there is an increase that does not reach the level of 2019”, warns Riskes, who is cautious but calls for work to solve these problems, which, however, “always exist”.
The agency notes that the problems with amoxicillin shortages echo the disruptions at Normon SA and Sandoz Farmacéutica SA laboratories, the main suppliers in Spain. “The reasons that caused these delays have been resolved and production has been accelerated to meet pending demand, so the supply situation for pediatric oral suspension is expected to return to normal by the end of the week of November 21,” the controller notes.
Sandoz notes that their “anti-infectives operation, located in Europe, faces an extremely difficult situation in the short term due to an unprecedented combination of challenges: strong fluctuations in demand, limited production capacity, shortage of raw materials and the energy crisis”. “To date, we have largely absorbed the impact of energy inflation, and our goal is to maximize production, not cut it, to meet growing patient demand and improve our unit production costs.” We continue to work to address these supply difficulties in some of these antibiotic presentations in close collaboration with health authorities,” they explained to this newsroom. ElDiario.es tried to contact Laboratorios Normon but did not receive a response.
Source: El Diario
