Masterarbeit
Antimicrobial Drug Resistance - Impact on the Pre- and Postlicensing Process of Veterinary Medicinal Products in the European Community
Dr. Robert Alz (2003)
Antimicrobial drugs have been used to prevent and treat diseases in animals and humans for more than 50 years. These agents have reduced morbidity and mortality and have directly influenced the increase in human life-span. The use of antimicrobials has also greatly facilitated the present methods of animal production. The discovery of antimicrobial agents has been one of medicine's greatest achievements.
The use of antimicrobial agents for preventive measures and therapy in farm animals has led to a potential increase in antimicrobial resistance in commensal bacteria, animal pathogens and zoonotic bacteria. It is unknown how much of antimicrobial resistance is related to human use or veterinary use. The same antimicrobial classes are used in both environments. Antimicrobial resistance is a complex phenomenon due to the difficulty to detect its origin.
The emergence of resistance has limited the number of effective antimicrobial agents available in human and veterinary medicine and has also increased the costs of their use.
Community legislation wants to guarantee a high level of safety and efficacy for the animal being treated and to protect the health of the consumer of foods of animal origin. This has led to a high degree of harmonisation.
It is critical that all stakeholders in the food producing chain are made aware of the importance of resistance management and of complying with prescribed strategies. Measures that can and should be taken to counter this threat of antimicrobial resistance include co-ordinated surveillance of all environments, rational antibiotic usage (prudent use), better compliance with infection control and greater use of vaccines.
Three key guidelines - recently adopted by the CVMP- have come into effect in the first half of 2003. Their aim is to minimise resistance development and encourage prudent use of antimicrobials in veterinary medicine. The new guidelines regarding antimicrobial resistance will change the regulatory environment for the development of new antimicrobial entities and for the maintenance of marketing authorisations. These guidelines contain a large number of new requirements for the marketing authorisation procedure, the renewal of anti-infectives and the surveillance of antimicrobial resistance.
It is already clear that the guidelines represent an unprecedented step forward in the regulation and harmonisation of antimicrobial resistance management. On the other hand some antimicrobial agents will no longer permit a satisfactory return of investment for the pharmaceutical firms with regard to additional studies or resistance monitoring.
Resistance data provide useful information about patterns of emerging resistance, which in turn can help the veterinarians to guide treatment decisions. Resistance monitoring programmes are an asset to outbreak investigations. Antimicrobial resistance patterns are useful in identifying the source and magnitude of resistance. Antimicrobial resistance data from humans and animals could help to develop public health recommendations for the use of anti-infectives in humans and food producing animals.
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