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Experts recommend restricting the use of fluoroquinolones to the therapeutically necessary degree

04/2002, 20.02.2002

Use in veterinary medicine only when no other antibiotics are available

The problem of the fluoroquinolone resistance of bacteria from man and animals was the main theme at an expert hearing in Berlin organised by BgVV for representatives from human and veterinary medicine, federal authorities, scientific circles and industry. The goal of the hearing was to clarify whether new risk management measures were needed as a consequence of the observed increase in the resistance of various microorganisms to fluoroquinolones. The experts agreed that a further increase in resistances could only be prevented by reducing the use of fluoroquinolones to the therapeutically necessary degree. These antibiotics should only be used in animals when there were no other alternatives. The existing documentation obligation of veterinary surgeons should be extended along those lines and corresponding guidelines should be anchored in law in the Veterinary Medicinal Products Reorganisation Law. The doctor of medicine and infectiologist, Professor Dieter Adam, advocated restricting the use of antibiotics through prices. "Cheap generics", commented Adam, "tempted people to use far too many antibiotics". He called on pharmaceutical entre-preneurs to live up to their responsibility for consumer health and to not apply, in the near future, for veterinary marketing authorisation for any substance classes of importance for human medicine (for instance oxazolidones and streptogramins).

The first fluoroquinolone was granted a marketing authorisation in Germany in 1983 for use in human medicine. Today, this substance group is mainly used to treat uri-nary tract infections, respiratory and sexually transmissible diseases. In human medicine fluoroquinolones are considered as reserve antibiotics to be administered when pathogens are resistant to other substances. In veterinary medicine fluoroquinolones have been used in Germany since the end of the 1980s in individual animals and in herds to treat respiratory diseases as well as stomach and intestinal disorders. They may only be used for therapeutic purposes and only when the pathogens are resistant to other substances. In veterinary medicine they are not authorised either for prophylactic use or for the treatment of minor diseases. Experts see the treatment of poultry flocks through drinking water as being a critical factor in the development of resistances because well animals are also treated, underdoses are likely and the substances are frequently administered for too long. Poultry experts, however, believe that their use is essential.

Today, fluoroquinolones account for around 1% of the antibiotics used in animals. In Europe and the USA approximately 50 tonnes were sold in 1997 for use in veterinary medicine. In addition, there are around 70 tonnes generics (cheap me-too products) and a further 470 tonnes of fluoroquinolones are produced in China. During the same period around 800 tonnes of fluoroquinolones were sold in Europe and the USA for use in human medicine and a further 1,350 tonnes of this substance group were produced in China.

For around ten years increased resistances to fluorochinolones have been observed. The fluorochinolone-resistant micro-organisms include, amongst others, specific Salmonella and Campylobacter strains. These pathogens are widespread in animals but rarely go hand in hand with disease. If they are transmitted to man, they can cause varyingly severe cases of gastro-intestinal infections. When fluoroquinolone-resistant strains are involved, therapeutic fluoroquinolones have no effect. Although many of the diseases caused by Salmonella or Campylobacter take a relatively mild course, the contribution of resistance to the severity of disease depends very much on a person's immune status. In individual cases it can be dramatic and prove fatal. Besides other paths, the food path is, therefore, seen as an important factor in the spread of resistances.

Poultry and poultry products are deemed to be particularly critical foods in the USA. The US Food and Drug Administration (FDA) conducted an extensive risk assessment and announced that it was considering banning the use of fluoroquinolones in poultry. There are plans for a hearing with the pharmaceutical entrepreneur. A study on the efficacy of risk management of this kind commissioned in parallel came, however, to the conclusion that a limited effect was to be expected because fluoroquinolone-resistant germs are to found not only on contaminated foods but also everywhere in the environment. The study mentions as the critical intervention point not the use of fluoroquinolones in poultry production but the spread of resistant micro-organisms as a consequence of poor hygiene in restaurants and canteens.

In European countries the scale of fluorochinolone resistance varies considerably. Whereas it is generally low in animals and man in Denmark, fluoroquinolone-resistant Campylobacter were detected in the United Kingdom in around 11 % of poultry and 20 % of humans. For Germany figures (some from the BgVV, too) were mentioned of under 40 % fluoroquinolone-resistant Campylobacter for poultry/poultry products and around 40 % for humans. The experts interpreted this as an indication of a correlation between the use of fluoroquinolones in poultry and resistance development in man. In the opinion of the experts, however, no clear correlation can at present be derived from the available data. Against this backdrop, the majority rejected a ban on the use of fluoroquinolones in poultry. They pointed out the potential risk of greater illegal use and increased use of other, less efficacious antibiotics.

Since the scale of resistance clearly correlates with the amounts used, they, therefore, recommend instead reducing the administration of fluoroquinolones to humans and animals. In animals fluoroquinolones should only be used when there are no proven alternatives. This is where experts see veterinary surgeons as having to shoulder the responsibility. They demand a general obligation for further training obligation for veterinary surgeons and medical doctors and believe that statutory guidelines for "Good veterinary practice" and effective controls are essential. The experts appeal to pharmaceutical entrepreneurs not to apply for veterinary marketing authorisations for substances which are considered as reserves in human medicine in the near future. Finally, they are calling for a vastly improved surveillance system for resistance development in Germany and central documentation on the consumption volumes of manufactured and used antibiotics.

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