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Increasing need to work out Risk Management options to Limit Antibiotic Resistance

Report about the conference on "Risk Management to Limit Antibiotic Resistance" in Berlin on November 15th and 16th 2004

A conference on "Risk Management to Limit Antibiotic Resistance" took place in the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - BVL) in Berlin on November 15 and 16, 2004. The conference was called by the Federal Ministry of Consumer Protection, Food and Agriculture (Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft - BMVEL) and organised by the BVL together with the Federal Institute of Risk Assessment (Bundesinstitut für Risikobewertung - BfR).

The conference served to work out risk management options to derive risk management measures to actively minimise development and spread of resistance to bacteria. Risk management recommendations developed during an earlier international conference "Towards a Risk Analysis of Antibiotic Resistance", organised by the BfR from November 9 – 11, 2003, as well as the scientific lectures read by national and international experts, provided the working basis for this conference.

About 250 scientists took part in the conference, including 29 from other European countries. In an exhibition of 40 posters from Germany and abroad dealing with antibiotic resistance were presented in parallel.The subject was worked on in five sections. The first day of the conference saw discussions in the four following sections: Section 1: "Presentation of management recommendations", giving a survey over recommendations published by various national and international organisations and institutions, Section 2: "Research and product development", Section 3: "Prevention and control", and Section 4: "Management options in the authorisation of antibiotics".

Seventeen speakers from Germany and other European countries held lectures on these subjects. "The current management situation in veterinary medicine in Germany" was presented in Section 5 on the second day of the conference. In the following a public discussion between speaker and guest scientists was performed. The discussion proceeded from the results of discussions of the first conference day concerning necessary and successful risk management measures and from a proposal for management measures made by the WHO and OIE at their joint conference in Geneva from December 1-5, 2003.

The discussion covered the following issues, which have also been raised by WHO and OIE, with regard to risk management:

  1. Consumption of antimicrobial agents in veterinary medicine must be recorded in detail.
  2. Risk-oriented monitoring of antibiotic resistance must be carried out on all levels of production of food producing animals. It has to include causal agents of zoonoses, commensals, and animal-pathogenic bacteria. Non-food producing animals should also be included.
  3. Specific risk management must be developed for particularly important antibiotics used in human medicine, efficacy of which might be impaired by veterinary antibiotics.
  4. Strategies to minimise transmission of resistant bacteria from animal to human beings are needed.
  5. Prudent use guidelines must be implemented.

Essential points of discussion are summarised as follows:

  • A preventive approach should be chosen when dealing with problems of resistance. This includes the authorisation of antibiotics, guidelines for prudent use of antibiotics, and monitoring of bacterial sensitivity.
  • The general selection pressure through use of antimicrobial agents shall be reduced by prudent use. The guidelines for prudent use of antimicrobial agents must be further developed and fixed by law, and should be implemented in the EU.The pool of resistance genes must be kept as small as possible.
  • Measures of control and intervention must be carried out on all levels of food production.This means to improve control measures on the basis of existing legal regulations.
  • According to human medical scientists, the most important resistance problems in human medicine (such as MRSA, ESBL with E. coli) are not related to the use of antibiotics in veterinary medicine. Yet, resistant zoonosis-causing agents inevitably pose a risk to human beings.
  • Transmission paths of resistant bacteria must be blocked as closely as possible.
  • Surveillance of data must be improved and databases must be networked.
  • Distribution of antibiotics must be watched more closely, and control activities must be strengthened.
  • Management measures must be performed in human as well as in veterinary medicine. Co-ordinated programmes are necessary.
  • Technical training must be intensified on all levels.
  • There is need for more research into the dynamism and frequency of spread of antibiotic resistance. Veterinary clinical breakpoints are important in therapy. The influence of exogenic factors to the spread of antibiotic resistance must be investigated.
  • Recording of consumption amounts of antimicrobial agents should be regulated by law.
  • Conditions of animal production must be improved to reduce the need for use of antibiotics.
  • The number of human deaths per year attributed to resistant salmonellas was calculated to be 20, on the basis of theoretical considerations by the 2003 BfR conference "Towards a Risk Analysis of Antibiotic Resistance". However, the Robert Koch-Institute (RKI) pointed out it had no direct proof of human deaths as a result of transmission of resistant salmonellas from veterinary uses in Germany.

The results of the conference are summarised in twelve points characterising a functioning risk management of antibiotic resistance in Germany. As a general statement, human medical experts in particular said that management measures conceived and followed in the field of veterinary medicine were of extra-ordinary standard (restrictions of authorisation, use guidelines, 11th amendment of the Drug Law, etc.).

Specific proposals for risk management were:

  1. Practical control of distribution of antimicrobial agents should be improved. Enforcement must be more efficient.
  2. Consumption amounts of antibiotics should be recorded in detail. This should be legally regulated by law.
  3. Monitoring of antibiotic resistance must be legally regulated on all levels of food production.
  4. There is need for research into exogenous factors of influence (epidemiological modelling) and into the dynamism and frequency of spread of antibiotic resistance.
  5. It is urgently necessary to work out valid veterinary breakpoints.
  6. Threshold resistance levels triggering official intervention should be defined.
  7. Antibiotics which are particularly important in human medicine should be restricted in use in veterinary medicine.
  8. Use of antimicrobial agents is not a remedy for management errors in the production of food of animal origin. Vaccination strategies and better sanitation management are needed.
  9. Equal quality of data provided, it should be made an objective to pool the knowledge of individual institutions about the development and spread of resistance in relevant databases.
  10. Guidelines for prudent use of antibiotics should be fixed legally.
  11. Management measures should be co-ordinated with relevant measures in the field of human medicine.
  12. Professional and further training concerning the use of antibiotics and the risk of that use should be intensified.

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