Implementation of European breakpoints and the future of EUCAST
Abstract number: S12
EUCAST will soon have harmonised European breakpoints for existing antimicrobials. Also, as part of the EMEA process for approval of new drugs, EUCAST has determined breakpoints for several antimicrobials. The work of the committee now enters a wider implementation phase.
Existing classes of drugs: At the end of 2008 there will be a complete set of EUCAST clinical breakpoints and epidemiological cut-off values. By early 2009 the clinical breakpoints will be implemented in the AST systems of BSAC (UK), CA-SFM (France), CRG (Netherlands), DIN (Germany), NWGA (Norway) and SRGA (Sweden).
New antimicrobials: EUCAST determines breakpoints as part of the EMEA approval process for new antimicrobials. EUCAST breakpoints are the only breakpoints included in the Summary of Product Characteristics (SPC). Daptomycin and tigecycline are already approved and another 46 drugs will be handled during 20079.
Antimicrobial susceptibility testing devices: Work is ongoing to implement EUCAST clinical breakpoints in Phoenix (BD) and VITEK 2 (BioMerieux) and it is expected that EUCAST breakpoints will be available for both in early 2009. The fact that EUCAST breakpoints and national breakpoints will be the same will simplify the development of test panels as well as benefiting users.
EUCAST disk diffusion method: Preliminary results from a questionnaire to determine the expectations of clinical microbiologists in Europe indicate that EUCAST should take the lead in developing a disk diffusion test based on Mueller-Hinton agar.
The future of EUCAST: EUCAST has been financed by ESCMID and the national breakpoint committees of France, Germany, Norway, Sweden, The Netherlands and the UK for many years. Over the last 4 years the EU and ECDC have contributed financially. It is hoped that this will be continued by ECDC.
There is a need to sustain a European Committee on Antimicrobial Susceptibility Testing beyond the breakpoint harmonisation process. New antimicrobials will need breakpoints. Companies with approved antimicrobials will seek approval for extensions of clinical or microbiological indications or modified dosages. New resistance mechanisms occasionally necessitate the review of existing breakpoints. The establishment of a European disk diffusion test is a major undertaking and there will be a need continually to develop it to accommodate new antimicrobials and new resistance mechanisms. All these efforts are best served by a common European committee, EUCAST.
|Session name:||18th European Congress of Clinical Microbiology and Infectious Diseases|
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