Joint statement by the European Medicines Agency on antibiotic supply interruptions in the EU

The National Medicines Agency informs that the European Commission and the heads of the European Medicines Agency (HMA), working together in the Medicines Supply Interruption and Safety Coordination Executive Group (MSSG), are monitoring and reacting to the current antibiotic supply interruptions in the EU.

Drug supply disruptions are a major public health issue, and the situation in the EU has recently been exacerbated by geopolitical events and trends such as the war in Ukraine, the energy crisis and high inflation.

The recent increase in respiratory infections has increased the demand for antibiotics such as amoxicillin (alone or in combination with clavulanic acid), especially in pediatric formulations. In addition, production delays and problems with production capacity have caused supply disruptions affecting most EU member states. Supply disruptions also affect countries outside the EU, and the European Medicines Agency (EZA) exchanges information with other international regulators. A number of measures are in place at Member State level to ensure that patients can receive appropriate treatment.

The MSSG and its working group (SPOC Working Group[1]) have been closely monitoring this situation since November 2022 and are contacting key companies involved in the amoxicillin supply chain to agree on corrective actions such as increasing production capacity. EZA is also working with stakeholders, including pharmacists working in pharmacies, to get up-to-date information on the situation in pharmacies across the EU.

The national responsible authorities, in cooperation with the MSSG, use the existing adaptability in the regulatory framework, for example by allowing the out-of-order supply of medicinal products or dosage forms not registered in the given Member State or by applying a partial or full exemption from labeling or packaging requirements to ensure that patients can receive appropriate treatment. In addition, the MSSG supports short-term measures at the national level, such as the dispensing of dosage units and the preparation of medicines in pharmacies.

The European Commission, the HMA and the EZA are working together to investigate whether additional measures can be taken to mitigate the impact of the disruption in the supply of these medicines.

EZA will continue to work with stakeholders and partners at the global level, and the SPOC working group will continue to work with companies to provide regulatory support to increase supply.

The MSSG, together with the European Commission and EU Member States, will continue to closely monitor the current situation. Based on the available information from companies and interested parties and the measures taken, the situation is expected to improve in the coming months. Patients and healthcare professionals are reminded that alternatives are available in the event of a drug supply interruption.

It is important that antibiotics are used with caution to maintain their effectiveness and avoid antibacterial resistance. Antibiotics, including amoxicillin, should only be prescribed to treat bacterial infections. They are not suitable for treating viral infections such as colds and flu because they are not effective against them.

The MSSG notes that transparency is important when it comes to drug supply disruptions and emphasizes the need for all parties involved to communicate with each other in order to objectively and responsibly avoid inappropriate public health concerns.

Specialists of the Latvian State Agency of Medicines also participate in EZA scientific committees and working groups, including MSSG, SPOC, and HMA.

More information on MSSG and SPOC

• With the new mandate (Regulation on the enhanced role of the EZA (Regulation (EU) 2022/123)), the EZA has been given a new task to monitor interruptions in the supply of critical medicines that may lead to a crisis situation. The Medicines Supply Disruption and Safety Coordination Executive Group (MSSG) was established to take coordinated action in the event of a medicine supply disruption caused by large-scale events or public health emergencies. The MSSG consists of representatives of EU member states, one representative of the European Commission, one representative of the EZA, as well as an observer from the EZA Patient and Consumer Working Group (PCWP) and Healthcare Professional Working Group (HCPWP). More information is available here.

• The SPOC working group monitors and reports on events that may affect the supply of medicines in the EU. It provides advice to the EZA MSSG on any matters relating to the monitoring and management of supply disruptions and other matters affecting the availability of human and veterinary medicinal products. More information is available here.

• See here for more information on EZA’s responsibilities for monitoring and mitigating shortages of medicines and medical devices under Regulation (EU) 2022/123.

The State Medicines Agency has prepared infographics on the consumption and availability of antibiotics, ibuprofen and paracetamol suspensions in Latvia, and also provides recommendations on what to do to the population

The State Medicines Agency has prepared infographics on the consumption and availability of antibiotics, ibuprofen and paracetamol suspensions in Latvia, and also provides recommendations on what to do to the population if these drugs are needed.

We inform you that in many cases therapeutic alternatives are available for these drugs – analogue drugs, drugs from the same or another drug group.

Due to seasonal effects and increased demand, there are sometimes temporary unavailability of medicines with a specific name. However, the State Medicines Agency calls you to remember that for symptomatic treatment against pain, increased temperature and inflammation, analog drugs (ie drugs with a different name or a different active substance) can often be used. For example, you can choose paracetamol instead of ibuprofen. Also, if there is no medicine available in a specific form, there is a possibility to find a solution using another form of medicine (for example, suppositories can be used instead of a suspension for children).

It is also possible to prepare antibiotics and ibuprofen suspensions for children on site at the pharmacy. We recommend asking the pharmacy about such an option.

Drug consumption data show that antibiotics, ibuprofen and paracetamol suspensions are supplied to Latvia. Wholesalers supply these drugs to pharmacies. At the same time, taking into account seasonal effects, there are times when demand exceeds supply.

Zaļā Josta - Reklāma
Zaļā Josta - Reklāma