Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Continuous update of antimicrobial resistance data of purely nationally authorised antibiotics for human use in Germany - a challenge for European registrations
Antje Ebermaier (Abschlußjahr: 2011)
Language: English
The discovery of antimicrobial agents at the beginning of the 20th century had been a revolution. Antibiotics turned out to be an effective weapon against infectious diseases by reducing morbidity and mortality of patients. At that time, however, it was not predictable that bacteria being exposed to antibiotics might undergo changes that would stop them being killed or inactivated by the treatments. This mechanism is called antimicrobial resistance.
There are various causes for the rise of antimicrobial resistance, of which some are natural and others human-made, the latter due to incautious handling of antibiotics.
Infections induced by resistant bacteria often cannot be treated with common first-line antibiotics. This leads to a longer duration of therapy, increased health-care costs, the spread of resistant strains to other patients and augmented hazard of death due to the ineffectiveness of treatment.
Therefore it is of vital importance to take action against the alarming development of increasing levels of resistance.
The first step is to regularly monitor local trends in the prevalence of resistance to get an overview about the local trends and developments. In this process the establishment of a constant surveillance system that records and analyses the up-to-date resistance data is to be regarded as a substantial key factor in fighting the problem of antimicrobial resistance.
The aim of this thesis is to demonstrate the specific role of the pharmaceutical industry in supporting the prudent use of antibiotics and therewith contributing to a reduction in antimicrobial resistance. The purpose, in this context, is to provide regular updates on resistance data within the Summary of Product Characteristics (SmPC). This document intended for healthcare professional information, has to provide an up-to-date and comprehensive overview about the local prevalence of resistance to support the doctors` rational behaviour in prescribing antibiotics.
After an initial section which describes some basic principles and different roots of resistance, the relevance of this topic by means of the current situation in Germany is shown.
Germany is the case used for this analysis, since it was the first country in Europe to tackle the challenge of antimicrobial resistance from the regulatory point of view, by noticing the resistance data provided within the SmPC of nationally authorised antibiotics becoming obsolete due to missing periodical updates. This approach, which consists of a close cooperation between authorities, industry, pharmaceutical associations and science, has resulted in a collaborative antibiotic resistance survey called Z.A.R.S. (Corporate Centre for Analysis of Resistance Data of Antibiotics for Systemic Use) in 2007.
The role and effectiveness of Z.A.R.S. in Germany will be investigated and an assessment will be provided regarding the possibility to introduce a similar system at the European level. Whether the necessary preconditions exist on a European basis will feature in this analysis by examining the example of EARS-Net.
Pages: 38