USE OF FLUOROQUI NOLONES EMEA/ CVMP/ SAGAM/ 1 8 4 6 5 1 / 2 0 0 5 – CONSULTATI ON COMMENTS of the the COMMENTS of ASSOCIATION OF VETERINARY ASSOCIATION OF VETERINARY CONSULTANTS CONSULTANTS Presented by by Dr. Klaus Hellmann (VP) Dr. Klaus Hellmann (VP) Presented 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
AVC AVC � VETERINARIANS VETERINARIANS � � CONSULTANTS CONSULTANTS � – Veterinary Veterinary Medicinal Medicinal Products Products – � Quality Quality, , Safety Safety and and Efficacy Efficacy � – Feed Feed / / Feed Feed Additives Additives – – Food Food – � 44 EXPERTS ( 44 EXPERTS ( most most from from Europe) Europe) � � ETHICAL and SCIENTIFIC CODE ETHICAL and SCIENTIFIC CODE � 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
AVC RESPONSE AVC RESPONSE � AVC agrees with the concept that antimicrobials should be AVC agrees with the concept that antimicrobials should be � used wisely, within a rational programme, and that it is used wisely, within a rational programme, and that it is preferable and important to reserve critical antimicrobials preferable and important to reserve critical antimicrobials for those conditions where their use can be justified on the for those conditions where their use can be justified on the grounds that only they are likely to have a positive clinical grounds that only they are likely to have a positive clinical or animal welfare impact or animal welfare impact � Quinolones Quinolones and fluoroquinolones are not comparable or and fluoroquinolones are not comparable or � equal in terms of their usage in the EU or their equal in terms of their usage in the EU or their breakpoints in different species, conditions and body breakpoints in different species, conditions and body compartments. Therefore, we believe it is misleading and compartments. Therefore, we believe it is misleading and potentially damaging to use quinolones quinolones alone as the alone as the potentially damaging to use benchmarks for decisions on fluoroquinolones, except benchmarks for decisions on fluoroquinolones, except possibly for campylobacter. possibly for campylobacter. � The entire topic of breakpoints is one that deserves The entire topic of breakpoints is one that deserves � separate discussion. separate discussion. 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Importance of Fluoroquinolones in Importance of Fluoroquinolones in food- -producing animals producing animals food � They m ay be the only effective class of They m ay be the only effective class of � drugs drugs – Colisepticaemia Colisepticaemia in turkeys in turkeys – – Colisepticaemia Colisepticaemia in broilers in broilers – – Colisepticaemia – Colisepticaemia in newborn calves in newborn calves – Colisepticaemia Colisepticaemia in piglets in piglets – – A. A. pleuropneumoniae pleuropneumoniae in in pigs pigs – – E. coli E. coli mastitis mastitis – � Tissue distribution and penetration unique Tissue distribution and penetration unique � � Essential for treatm ent of anim als w ith life Essential for treatm ent of anim als w ith life- - � threatening diseases threatening diseases 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Use of Fluoroquinolones of Fluoroquinolones Use � The The influence influence of of veterinary veterinary use use on on � antimicrobial resistance resistance in in humans humans is is likely likely antimicrobial to be be very very low low to � AVC believes that farm anim al use of AVC believes that farm anim al use of � fluoroquinolones is probably a m inor fluoroquinolones is probably a m inor relevant source of resistance in term s of relevant source of resistance in term s of im pact on hum ans im pact on hum ans 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Use of Fluoroquinolones of Fluoroquinolones Use � Although Although relevant relevant data data is is presented presented, , more more � data is is needed needed from from individual individual countries countries data and set set in in relation relation to MA to MA for for and Fluoroquinolones present present Fluoroquinolones � Patent situation m ay be used as Patent situation m ay be used as � guide: guide: – Markets Markets with with extensive extensive use use since since 15 15 years years – – Markets Markets with with limited limited use use – 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Amount of of use use of FQ in of FQ in non non- - Amount regulated markets markets regulated � Dependent Dependent on on availability availability of of � „ generic generic/ / cheap cheap“ “ products products: : „ – e.g e.g. . various various Eastern European MS Eastern European MS – – e.g e.g. Spain/ Portugal . Spain/ Portugal – Generics available available for for 15 15 years years � Generics � Prices per per unit unit very very low low ( ( 10 % of 10 % of � Prices � reference) ) reference High use use of of FQs FQs in in poultry poultry and and swine swine � High � Broad use use as as preventional preventional treatment treatment � Broad � High rates rates of of resistance resistance � High � 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Use of FQ in of FQ in regulated regulated markets markets Use � E.g E.g. Germany, UK, DK . Germany, UK, DK � – FQ FQ are are high high priced priced products products – – Well Well controlled controlled, , prescription prescription only only since since – launch launch – Relatively Relatively low low use use, , mainly mainly – therapeutic/ / treatment treatment therapeutic – Low Low rates rates of of resistance resistance – 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Danmap 2004 2004 Danmap MIC 90 Chicken Cattle Swine MIC Chicken Cattle Swine 90 % sensitive µg/ ml µg/ ml µg/ ml % sensitive µg/ ml µg/ ml µg/ ml E. Coli Coli 0,12 0,03 0,03 E. 0,12 0,03 0,03 88 % 100 % 96,6 % 88 % 100 % 96,6 % Salm. 0,06 0,06 0,06* Salm. 0,06 0,06 0,06* spp spp 100 % 100 % 98,1 % 100 % 100 % 98,1 % Breakpoint used: 0,03 µg/ ml, Including broilers and layers * Highest MIC measured: 0,5 µg/ ml 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Germany Germany E. Coli Coli Chicken Dairy M M Cattle Swine E. Chicken Dairy Cattle Swine µg/ ml µg/ ml µg/ ml µg/ ml µg/ ml µg/ ml µg/ ml µg/ ml MIC 90 0,016# 0,06* 0,016# 0,016# MIC 0,016# 0,06* 0,016# 0,016# 90 96 % 98 % 100 % 100 % 96 % 98 % 100 % 100 % % sensitive % sensitive MIC 90 0,5* 0,06* * 16* 0,06- - 0,5* 0,5* MIC 0,5* 0,06* * 16* 0,06 90 ~ 98 % N= 187 72,1 % 92- - 98 % 98 % ~ 98 % N= 187 72,1 % 92 % sensitive % sensitive * Wallmann, Kroker: 3rd Conf Vet Antimicrobials, Orlando, USA, 2006; * * Krabisch und Gangl, TU 2002; # De Jong et al., ICAAC 2006 (Abattoirs samples) 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Portugal / Spain Portugal / Spain E. Coli Coli Chicken Calves Swine E. Chicken Calves Swine µg/ ml µg/ ml µg/ ml µg/ ml µg/ ml µg/ ml MIC 90 32* 64* 16* MIC 32* 64* 16* 90 % sensitive 50,8 % 56,9 % 76,9 % % sensitive 50,8 % 56,9 % 76,9 % Spain# 8 0,25 Spain# 8 0,25 76,5 % 98 % 76,5 % 98 % Various Fluoroquinolones marketed including Generics * Baptista et al. (2006): 11 EAVPT, Torino, 2006; Breakpoint used: 4µg/ ml # De Jong et al., ICAAC 2006 (Abattoirs samples) 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Hungary Hungary • Fluoroquinolones since 1989, first generic licensed 1991 • ~ 25 % of antibiotics used in animal health are now Fluoroquinolones • Prices reduced from 75 to 5, same time use up by 750% , 100 being Baytril • No public data on resistance 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Consequence? ? Consequence Increase the price? Can it be that simple? 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
Off Label Use Use/Illegal /Illegal Use Use Off Label � Care needs to be taken by over-regulating the market! E.g. Illegal use of nitrofurans in food animals: contribution to human salmonellosis* (Portugal): 65 % of Samonella isolates from several sources (most human and poultry) with decreased susceptibility, most S. enteritidis * Antunes et al. (2006) Clinical Microbiology and Infection 12th Oct 2006 12th Oct 2006 EMEA Int. Parties Meeting EMEA Int. Parties Meeting
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