Europe’s worst antibiotic supply problems in decades, especially in pediatric forms of amoxicillin — used to treat many of the most common infections — have forced the entire continent to take extraordinary measures to secure supply chains and guarantee patients access to the antimicrobials they need.
In Spain, the Ministry of Health authorized pharmacies on November 23 to sell antibiotics for adults to parents when necessary —500-milligram amoxicillin boxes— to split the pills and thus obtain the necessary 250-milligram doses for children. . The objective is to “reserve” the presentations of oral suspension syrups for “patients under 6 months” who cannot swallow the tablets.
“These are difficult months, with significant supply problems. The work of pharmacists is being important to maintain the minimum necessary stocks and provide good information to families on how to proceed with the treatment of minors”, says Juan Pedro Rísquez, vice president of the General Council of Pharmaceutical Colleges. The discontinuity in the arrival of antibiotics at pharmacies also forces the presentation prescribed by paediatricians to change to serve those available at any given time (syrup, sachets or pills).
The incidents have been equally important in pediatrician consultations. “The most important presentations for young children are missing, especially those who take syrups. It is difficult for them to give other types of medication, such as pills or sachets. This can lead to medication errors and also to using antibiotics that are not the most appropriate. The problems have not been only with amoxicillin, there are also with others such as cefadroxil, very important for skin and osteoarticular infections. To solve it, we have had to resort to broader-spectrum antibiotics, which contribute to the increase in antimicrobial resistance,” notes Cristina Calvo Rey, president of the Spanish Society of Pediatric Infectious Diseases (SEIP) and coordinator of the Medicines Committee of the Spanish Association of Pediatrics (AEP).
Virtually all European countries have seen how the supply of antibiotics has weakened, which has led the European Union to activate the Executive Group on Medicines Shortages and Safety (MSSG), formed by the Commission, the European Medicines Agency (EMA) and national agencies, and created in March 2022 as part of the measures to ensure the availability of drugs after the problems observed in the pandemic.
In a statement published on the 20th, the Group described the perfect storm that has led to the current situation: shortages, which had already been an intermittent problem, “has been exacerbated by geopolitical events or trends such as the war in Ukraine, the energy crisis and high inflation rates”, to which has been added “a recent increase in respiratory infections that has caused an increase in demand” and problems in factories in the sector that have caused “delays” in orders and affected to the “production capacity”.
“Europe is at a key moment of adaptation. Savings policies and the search for competitive advantages by companies have moved most of the production to countries like China and India. This model has entered into a crisis with the pandemic and everything that has come after it. It is something that has worked for years, but it leaves us defenseless in the face of any crisis that arises. And these happen”, sums up Jose García Carrasco, who has worked for almost four decades in the sector and directed the Spanish subsidiary for Spain and Portugal of the pharmaceutical company Norgine for the last 14 years.
According to data from the consulting firm Iqvia, the sale of boxes of amoxicillin with clavulanic acid grew by almost 50% last year in Spain. In January and February, just over 600,000 units were sold per month, there was a rebound in March and they remained relatively stable until September, when a sustained rise in sales began, which in December reached almost 900,000. The sector was unable to cover this increase from October and November is when the most important problems are occurring.
The EMA published last Friday an update of the data in which it points out that, in recent days, “a positive trend has been observed in several Member States, while some others continue to experience reduced availability of these [amoxicilina sola o con ácido clavulánico] and other antibiotics. This improvement has also reached Spain, according to the sector, but “the problems have not disappeared and the situation is far from normalizing.”
A note published by the Spanish Agency for Medicines and Health Products (AEMPS) explains that the instability in the supply and the increase in demand have coincided with incidents in the factories of the pharmaceutical companies Normon and Sandoz, “the laboratories that have a greater market share” in the production of “amoxicillin oral suspensions”. “Sandoz Farmacéutica, SA informed the AEMPS of problems in the labeling line and Normon SA notified delays in the supply of leaflets that must be included in all medicines,” the Agency stated in another statement.
The relaxation of the strict regulations that regulate the marketing of medicines in Europe has been another of the temporary solutions adopted. “National agencies are making use of available regulatory possibilities, such as allowing exceptional supply of medicines or presentations that may not be authorized in a particular Member State or granting full or partial exemptions from certain labeling and packaging requirements to ensure that patients can receive the appropriate treatment”, reported the EMA.
Another measure has been practically pharmacy-to-pharmacy monitoring throughout Europe to detect and correct supply incidents. The European authorities “have engaged with key players in the amoxicillin supply chain to agree possible mitigation measures, such as increasing manufacturing capacity” and have “received updated information from community pharmacists on the situation in pharmacies across the country.” the European Union”.
The European Commission, the EMA and the national agencies met last Thursday in Brussels to assess the situation and ruled out for now declaring a “major event” or public health emergency, a figure that would give governments greater powers to intervene in the sector. A decision that is not shared by the patient associations, which demand from the authorities “greater firmness to demand that pharmaceutical companies comply with their obligations to supply the health systems with the drugs they need and force them to be more transparent and anticipating any possible incident,” says Rosa Castro, from the European Public Health Alliance (EPHA), a Brussels-based NGO that brings together patient associations and health professionals, among others.
The coronavirus pandemic has highlighted the need to face the growing supply problems and the weakness of supply chains together with the sector. This was one of the reasons that led the Commission to adopt in November 2020 the so-called A new pharmaceutical strategy for Europe. In Spain, the AEMPS has drawn up a list of essential medicines to shield the supply of those most vulnerable drugs because the industry has been losing interest in them and there are only one or two manufacturers left (although this is not usually the case for the antibiotics).
Ángel Luís Rodríguez de la Cuerda, general secretary of the Spanish Association of Generic Medicines (AESEG), the manufacturers’ association, considers that raising the price of many cheap medicines —half of the generics have a lower retail price at 2.5 euros—would help make them more attractive to the sector, largely “because it would boost national production that is already very important, which would help to guarantee supply.”
“Guaranteeing the national manufacture of strategic medicines would improve the supply and give the country security in the face of future crises,” defends the employer of brand-name medicines, Farmaindustria.
The global production of most medicines depends directly or indirectly on China or India, either because the almost finished medicine is imported and packaged in Europe or because the necessary raw materials are purchased there, explains Belén Tarrafeta, a consultant specializing in the access to medicines. Any solution, points out this expert, must go through the consolidation of a European strategy such as the one launched by the EU. “When you take a deep look at supply chains, for which there isn’t much public information, you discover that many are actually very fragile, with only one or two producers in Asia of the active ingredient. Any incident there can become a serious global problem. The EU is taking the first steps to change this, but it will take a while and during the transition it is foreseeable that problems such as antibiotics will continue to occur ”, she concludes.
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