Europe’s worst antibiotic supply problem in decades, particularly in pediatric forms of amoxicillin – used to treat many of the most common infections – has prompted the entire continent to take extraordinary measures to secure supply chains and guarantees patients access to the antimicrobials they need.
In Spain, the Ministry of Health authorized pharmacies on 23 November to sell parenteral antibiotics for adults—500 mg amoxicillin boxes—so that the tablets could be split and thus obtained the 250 mg dose needed for children. Could The purpose is to “reserve” the oral suspension syrup presentations for “patients under 6 months of age” who cannot swallow tablets.
“These are difficult months, with significant supply problems. The pharmacist’s job is important to maintain the minimum necessary stocks and to provide families with good information on how to proceed with the treatment of minors, says Juan Pedro Riskez, vice president of the General Council of Pharmaceutical Colleges. The interruption of the arrival of antibiotics in pharmacies also forces the presentation prescribed by pediatricians to be changed to the one available at any time (syrup, sachets or tablets).
The developments in the pediatrician consultation have been equally important. “The most important presentations are missing for young children, especially those who take syrup. It is difficult to give them other types of medicine, such as tablets or sachets. This can lead to medication errors and the use of antibiotics which are not the most suitable. The problems are not only with amoxicillin, there are also others such as cefadroxil, very important for skin and osteoarticular infections. To solve this, we have had to resort to broad-spectrum antibiotics , which contribute to the increase in antimicrobial resistance, “said Cristina Calvo Rey, President of the Spanish Society of Pediatric Infectious Diseases (SEIP) and Coordinator of the Medicines Committee. Spanish Association of Pediatrics (AEP).
Virtually all European countries have seen how the supply of antibiotics has weakened, leading the EU to activate the Working Group on the Scarcity and Safety of Medicines (MSSG), formed by the Commission, the European Medicines Agency (EMA) and national agencies Is. and was created in March 2022 as part of measures to ensure availability of medicines following problems seen 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 previously been an intermittent problem, “are caused by geopolitical events or trends such as the war in Ukraine, the energy crisis and high inflation”, including a “recent increase in respiratory infections, which has increased demand” and problems at factories in the region, which have caused “delays” in orders and affected “production capacity”. . ,
“Europe is at a critical moment of adaptation. Savings policies and the search for competitive advantages by companies have moved most production to countries such as China and India. This model came under attack with the pandemic and everything that followed It is something that has worked for years, but it leaves us defenseless when any crisis strikes. And they do happen”, summarizes José García Carrasco, who has worked in this field for nearly four decades. Has directed the Spanish subsidiary for Spain and Portugal of the pharmaceutical company Norgin for the past 14 years.
According to data from the consulting firm Equivia, sales of boxes of amoxicillin with clavulanic acid rose by almost 50% in Spain last year. In January and February, just over 600,000 units were sold per month, rebounding in March and remaining relatively stable until September, when sales began a steady increase, reaching nearly 900,000 in December. The sector was unable to cover this growth from October and November when the most significant problems are occurring.
The EMA published an update of the data last Friday, noting that in recent days, “a positive trend has been observed in a number of Member States, while some others continue to experience low availability of these. [amoxicilina sola o con ácido clavulánico] and other antibiotics. According to Sector, this improvement has also reached Spain, but “the problems have not disappeared and the situation is far from normal.”
A note published by the Spanish Agency for Medicines and Health Products (AEMPS) indicates that the volatility in supply and the increase in demand coincide with incidents in the factories of the pharmaceutical companies Norman and Sandoz, “laboratories that have a greater market” for amoxicillin. Part in the production of “Oral Suspension”. “Sandoz Farmacéutica, SA informed AEMPS about problems in the labeling line and Norman SA reported delays in the supply of leaflets, which should be included with all medicines,” the agency said in another statement.
One of the temporary solutions adopted is the easing of strict rules regulating the marketing of medicines in Europe. “National agencies are making use of available regulatory possibilities, such as allowing exceptional supplies of medicines or preparations that may not be authorized in a particular Member State or granting full or partial exemptions from certain labeling and packaging requirements in order to To ensure that patients receive appropriate treatment”, reported the EMA.
Another measure is practical pharmacy-to-pharmacy surveillance across Europe to detect and correct supply incidents. European authorities have “worked with key players in the amoxicillin supply chain to develop potential mitigation measures, such as increasing manufacturing capacity” and “received updated information from community pharmacists on the state of pharmacies across the country.” The European Union”.
The European Commission, EMA and national agencies met last Thursday in Brussels to assess the situation and now refuse to declare a “major event” or public health emergency, a figure that could prompt governments to intervene in the area. Will give more rights. A decision that is not shared by patient associations, who call on the authorities to “more strongly demand that pharmaceutical companies comply with their obligations to supply health systems with the medicines they need and to be more transparent and compel to anticipate a possible event.” 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 growing supply chain problems and the need to confront the fragility of supply chains together with the sector. This was one of the reasons why the Commission in November 2020 adopted the so-called A new drug strategy for Europe. In Spain, the AEMPS has drawn up a list of essential drugs to protect the supply of those most vulnerable because the industry is losing interest in them and only one or two manufacturers remain (although this is usually not the case with antibiotics).
Ángel Luís Rodríguez de la Cuerda, secretary general of the Spanish Association of Generic Medicines (AESEG), believes that raising the price of many cheaper drugs—half the generics have a retail price of less than 2.5 euros—will help them in the sector. Make it more attractive to foreign investors, largely “because it will boost national production which is already very important, which will help to guarantee supply.”
“Guaranteing national manufacturing of strategic drugs will improve supply and protect the country in the face of future crises,” defends Pharmindustria, the employer of the brand-name drugs.
Global production of most drugs depends directly or indirectly on China or India, either because the nearly finished drug is imported and packaged in Europe or because the necessary raw materials are bought there, consultants specializing in access to drugs Belen Tarafeta explains. This expert says any solution must go through the consolidation of a European strategy, such as the one launched by the European Union. “When you take a deeper look at supply chains for which there is not much public information, you find 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 time and it is predictable that problems such as antibiotics will continue to occur during the transition”, he concluded.
