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Antibiotic resistance: Slowing down its development, saving lives

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In its battle against various types of antimicrobial resistance, the BfArM focuses especially on the necessity of state-of-the-art information for experts.

More than
0 infections caused by antibiotic-resistant bacteria occur per year in Europe.

In Germany, about 1200 medicines with systemically acting antibiotics are currently authorised for humans - but the treatment of bacterial infectious diseases can still be a challenge. Various pathogens show resistance to several antibiotics, and their number is increasing. The BfArM is involved in the battle against these resistances at both national and international levels. An overview of the European Antibiotics Day 2022.

The European European Centre for Disease Prevention and Control (ECDC) estimates that more than 670,000 infections caused by antibiotic-resistant bacteria occur in Europe every year. Around 33,000 people die from such infections each year.

"We realise that we cannot prevent the emergence of antibiotic resistance. But we can work together to slow down this development and thus save human lives," says biotechnologist Dr Nils Lilienthal. He heads the unit "Infectiology/Dermatology/Allergology" at the BfArM. This unit evaluates, among other things, the benefits and risks of antibiotics within marketing authorisation procedures, and prepares statements for advisory bodies of the BfArM as well as the European Medicines Agency (EMA).

Gynaecologist Dr Ellen Pantke also works in this team as an expert in the field of antibiotics. She is very well aware of the risks involved: "We are observing an increase in resistance in various bacterial pathogens. The development of new antibiotics or combinations of active substances in this field is very important in order to enable us to continue treating bacterial infections adequately in the future."

Supporting research and development

This is precisely where the BfArM supports the research on antibiotics in the German Center for Infection Research (DZIF). Universities, university hospitals, Leibniz institutions, Max Planck Institutes and Helmholtz Centers as well as federal research institutions cooperate there with the aim of developing new methods to detect, prevent and treat infectious diseases. Antibiotics play a vital role in this development.

Scientific, regulatory and economic know-how is necessary for the successful development of a medicinal product. Since 2015, the BfArM has therefore been supporting the DZIF in clarifying both regulatory and technical issues. Dr Lilienthal also heads the Office for Scientific and Regulatory Advice (OSRA) at the BfArM, which was introduced for this purpose: "We have already supervised more than 30 academic projects in the field of product development. These involve, for example, the development of new antibiotics against multi-resistant bacteria or the treatment of tuberculosis."

Then there is also the CARB-X Initiative, in which the BfArM is involved via the Federal Ministry of Education and Research in association with the DZIF. Its goal is to accelerate the development of innovative antibiotics and to develop other therapeutics, vaccines, rapid diagnostics and medical devices to combat drug-resistant bacterial infections. Here, too, the BfArM provides advice on scientific and regulatory issues, imparts regulatory knowledge in workshops and training courses and accompanies researchers on their path to potential funding.

Promoting awareness and strengthening competencies

International studies show that up to 50 percent of therapies with antibiotics are inadequate - for example, because the drugs are not prescribed in the proper dosages or for an unsuitable treatment duration. Of the 400,000 to 600,000 patients who become infected with pathogens in connection with inpatient medical treatment in Germany, about 10,000 to 15,000 die. At least one third of these infections could probably be prevented if specifically hygiene measures in hospitals were consistently ensured and the antibiotics were administered properly.

"Our physicians need to know whether an antibiotic in its corresponding dosage is currently effective against a certain pathogen," explains Dr Pantke. "They need reliable data on efficacy and safety as well as on the resistance situation in order to be able to administer the antibiotics effectively."

The BfArM has therefore advocated with the EMA that the authorisations of major antibiotics should be reviewed, re-evaluating in particular the information regarding licensed indication and recommended dosages. As some antibiotics have been on the market for a long time, their product information may no longer reflect the current scientific state-of-the-art. The BfArM has since been actively involved in these "re-evaluation procedures" in Europe. These procedures are a very concrete step towards the appropriate use of such medicinal products - and thus towards improving the resistance situation.

On the BfArM’s initiative, the Central Office for the Evaluation of Resistance Data on Systemic Antibiotics (Z.A.R.S.) was also founded in Germany. This Office evaluates the resistance data from Germany of approximately 60 systemically acting antibiotics at regular intervals and compiles corresponding resistance tables for the information of experts. After evaluation by the BfArM, these data are prepared in such a manner that they can be made available there in tables that are easy to read. Thus, physicians can obtain information on the current resistance situation in Germany, which should facilitate and promote the administration of a calculated antibiotic therapy. Changes in the national resistance situation and possible consequences are discussed with the BfArM at annual intervals.

The BfArM also supports the German Antimicrobial Resistance Strategy "DART 2020". It was developed by the Federal Ministry of Health together with the Federal Ministries of Food and Agriculture as well as the Federal Ministry of Education and Research. DART 2020 concentrates the measures necessary to reduce antibiotic resistance by focusing on cross-sectoral cooperation (One Health Approach).

3 Questions for…
Dr. Ellen Pantke, expert on antibiotics with the BfArM

Dr. Pantke, do you have an uneasy feeling when you have to take an antibiotic?

Antibiotics are very important medicines that are urgently needed for the treatment of bacterial infections. If the diagnosis is made correctly, their use is absolutely justified. The current therapy guidelines and consideration of the resistance situation in Germany are the basis for an appropriate administration. Recently, physicians have been becoming more and more aware of this responsible, or rational, use of antibiotics. In this respect, I don't have a bad feeling at all when I have to take an antibiotic.

Which measures do you consider to be the most important in the battle against antibiotic resistance?

Most bacterial infectious diseases are treated with antibiotics that have been approved for a long time. Maintaining their efficacy is of central importance. At the same time, the development of new antibiotics and combinations of active ingredients is a high priority. And, of course, the agents must be used properly and according to the current scientific state-of-the art. We promote this by providing up-to-date resistance information in the expert information.

More and more resistant bacteria are opposed by fewer and fewer effective antibiotics. Can this battle still be won at all?

It is true that lately there has been an increase particularly in multiresistant Gram-negative bacteria. For these pathogens, there are now only very few effective antibiotics available to treat infections. Here, the development of new antibiotics is urgently needed to ensure adequate therapy of such infections in the future. At the same time, however, we also see favourable resistance developments, which can be attributed to the various measures taken in the fight against antibiotic resistance. For example, we have been observing a decrease in the rate of methicillin-resistant Staphylococcus aureus (MRSA) of late. These are bacteria that can cause infections in hospitals, for example after operations. In recent years, several new antibiotics have been approved that show efficacy against MRSA. This confirms that the activities in the field of antibiotic resistance are effective and that we can be successful with the appropriate strategies.

Dr. Ellen Pantke

Dr. Ellen Pantke

Study of human medicine. From 1999 to 2006, specialist training at the University Gynaecological Clinics in Cologne and Aachen. Specialist and functional senior physician at the Clinic for Gynaecology and Obstetrics at the University Hospital RWTH Aachen from 2006 to 2008. Since 2008, she has been working as a clinical assessor at the BfArM and has been responsible for the authorisation of antibiotics since 2012. Collaboration in European and national committees such as the Infectious Diseases Working Party (IDWP) of the EMA and the ART Commission at the RKI.

Dr. Nils Lilienthal

Dr. Nils Lilienthal

Bachelor of Science & Master of Science Biotechnology/Molecular Biotechnology focusing on Immunology at RWTH Aachen University; Dr. rer. nat. at the University Hospital/University of Cologne; graduate of the graduate programme "Pharmacology and Therapy Research" of Bayer Health Care AG, Wuppertal & University Hospital Cologne; has been working as an assessor at the BfArM since 2011; Head of the unit “Infectiology/Dermatology/Allergology” at the BfArM and project manager of the infrastructure "Office for Scientific and Regulatory Affairs" of the German Center for Infection Research (DZIF) since 2020.