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Draft Reflection Paper European Medicines Agency Veterinary Medicines and Inspections London, 18 February 2008 EMEA/CVMP/SAGAM/81730/2006-CONSULTATION COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) REFLECTION PAPER ON THE USE OF 3rd AND 4th GENERATION CEPHALOSPORINS IN FOOD-PRODUCING ANIMALS IN THE EUROPEAN UNION: DEVELOPMENT OF RESISTANCE AND IMPACT ON HUMAN AND ANIMAL HEALTH DRAFT AGREED BY SAGAM 18 October 2007 ADOPTION BY CVMP FOR RELEASE FOR CONSULTATION 13 February 2008 END OF CONSULTATION (DEADLINE FOR COMMENTS) 31 July 2008 Comments should be provided using this template to [email protected] or by Fax +44 20 7418 8447 The CVMP Scientific Advisory Group on Antimicrobials (SAGAM) has provided the scientific information included in the document. The list of Risk Management (recommendations for action) measures has been prepared by CVMP. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: [email protected] www.emea.europa.eu © European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged. TABLE OF CONTENTS TABLE OF CONTENTS ........................................................................................................................ 2 MANDATE............................................................................................................................................. 3 INTRODUCTION................................................................................................................................... 3 OBJECTIVE............................................................................................................................................ 3 BACKGROUND..................................................................................................................................... 4 Mechanism of action, classification and spectrum of activity........................................................ 4 Use of cephalosporins in human medicine ..................................................................................... 4 CEPHALOSPORINS FOR FOOD-PRODUCING ANIMALS.............................................................. 5 Cephalosporins authorised for animals in the EU .......................................................................... 5 Use of cephalosporins for animals in the EU ................................................................................. 7 RESISTANCE MECHANISMS AND GENETICS ............................................................................... 9 Resistance to cephalosporins in staphylococci ............................................................................... 9 Resistance to cephalosporins in Enterobacteriaceae...................................................................... 9 RESISTANCE IN BACTERIA FROM FOOD PROCUCING ANIMALS ......................................... 12 Methicillin resistant Staphylococcus aureus (MRSA).................................................................. 12 Resistance in Enterobacteriaceae................................................................................................. 12 Emergence of ESBLs.................................................................................................................... 14 Emergence of transferable AmpC-type beta-lactamases .............................................................. 16 INFLUENCE OF USE OF ANTIMICROBIALS ON THE EMERGENCE AND SPREAD OF RESISTANCE....................................................................................................................................... 17 Influence of cephalosporin use on occurrence of MRSA ............................................................. 17 Influence of cephalosporin use on the evolution of genes encoding beta-lactamases.................. 17 Influence of cephalosporin use on selection and amplification of genes encoding beta-lactamases ...................................................................................................................................................... 17 Co-selection of resistance in Enterobacteriaceae by non-cephalosporin antimicrobials............. 19 EXPOSURE OF HUMANS TO RESISTANT BACTERIA AND RESISTANCE GENES FROM ANIMAL SOURCES............................................................................................................................ 19 Exposure to resistant bacteria from animals................................................................................. 19 Exposure to resistance genes from bacteria associated with animals........................................... 20 IMPACT OF INFECTIONS WITH CEPHALOSPORIN-RESISTANT BACTERIA ON HUMAN AND ANIMAL HEALTH .................................................................................................................... 21 Human health................................................................................................................................ 21 Animal health ............................................................................................................................... 21 SUMMARY ASSESSMENT AND CONCLUDING REMARKS....................................................... 23 REFERENCES...................................................................................................................................... 25 RECOMMENDATIONS FOR ACTION ............................................................................................. 35 EMEA/CVMP/SAGAM/81730/2006- CONSULTATION 2/37 1 MANDATE 2 The Scientific Advisory Group on Antimicrobials (SAGAM) was mandated to give advice to the 3 CVMP on the need to exercise certain control on those classes of compounds of greater importance to 4 human medicine e.g. fluoroquinolones and 3rd and 4th generation cephalosporins. 5 6 This document discusses cephalosporins with a focus on substances of the 3rd and 4th generation and 7 food production animals, excluding aquaculture. 8 9 INTRODUCTION 10 Cephalosporins of the 3rd and 4th generation represent subclasses of antimicrobials which are very 11 important in the treatment of severe and invasive infections in humans and are therefore of special 12 interest from a public health perspective. The first nosocomial outbreaks of bacteria resisting these 13 cephalosporins by production of beta-lactamases were described in the 80s (Gniadkowski, 2001). 14 Since then, the occurrence of infections with bacteria resistant to 3rd and 4th generation cephalosporins 15 e.g. Klebsiella pneumoniae, Escherichia coli, Salmonella spp and Pseudomonas aeruginosa has 16 increased worldwide. Increased resistance implies either delayed adequate treatment or initial use of 17 second and third line alternatives. Some of the latter carry a higher risk of adverse reactions (e.g. 18 aminoglycosides) or are clearly more toxic (e.g. colistin). Due to delayed adequate therapy, the burden 19 of infections with bacteria resistant to 3rd and 4th generation cephalosporins can be substantial with 20 severe outcomes, including both higher overall and higher infection-related mortality, increased length 21 of hospital stay, and higher costs (Schwaber & Carmeli, 2007). 22 23 In Europe, infections with bacteria resistant to 3rd and 4th generation cephalosporins were previously 24 mainly caused by Klebsiella pneumoniae, and were mostly diagnosed in specialist units (Livermore et 25 al., 2007). In the last decade, this pattern has changed and resistance is rapidly emerging not only in 26 hospitals, but also in community-acquired infections. Pathogens carrying genes encoding these 27 resistance traits now include also e.g. E. coli and Salmonella (Anonymous, 2006; Canton & Coque, 28 2006; Livermore et al., 2007). Linkage to other resistance genes and co-selection by unrelated 29 antimicrobials are important in the epidemiology of these resistance genes (Canton & Coque, 2006). 30 31 This change in behaviour, with typically nosocomial organisms spreading to and from the community, 32 indicates an exchange of organisms or genes with other, perhaps non-human bacterial reservoirs. 33 Resistance has emerged in some countries in both Salmonella and E. coli from food producing animals 34 (Livermore et al., 2007). This suggests that animals may act as possible important reservoirs for 35 transferable beta-lactamases. Third and 4th generation cephalosporins are used for food producing 36 animals and could potentially influence the prevalence of resistance. In addition, co-selection by other 37 antimicrobials used for mass medication may contribute to the occurrence and dissemination of 38 resistance determinants in animals. 39 40 OBJECTIVE 41 The objective of this document is to critically review recent information on the use of cephalosporins 42 of the 3rd and 4th generation in food-producing animals in the EU, its effect on development of 43 resistance to this category of antimicrobial agents in bacterial species that are of importance for human 44 and animal health, and the potential impact on human and animal health. 45 EMEA/CVMP/SAGAM/81730/2006- CONSULTATION 3/37 46 BACKGROUND 47 Mechanism of action, classification and spectrum of activity 48 The mechanism of antibacterial activity of the cephalosporins and cephamycins is essentially the same 49 as for benzylpenicillin and other beta-lactam antimicrobials; they interfere with the formation of the 50 cell wall by binding to enzymes that are active in the synthesis of peptidoglycans (transpeptidases, also 51 called penicillin binding
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