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Monitoring and Reporting on Antimicrobial Resistance in European Union by Pia Mäkelä, M.D.

DR. MÄKELÄ: Okay. So first of all I would like to thank for the invitation to this meeting. I think it is a good opportunity for us to see what’s happening in the U.S.A. and also to tell what we are doing in Europe, in the European Union, --— level regarding the reporting and monitoring of antimicrobial resistance.

(Slide)

And I start with a short presentation abut EFSA, EFSA is the European Food Safety Authority. It’s an EU agency and it’s responsible for risk assessments regarding foods and feed safety, so it’s a scientific organization and not a risk manager.

And the main task of EFSA is to provide independent scientific advice, to the core --- Members States specifically and scientific opinions and it also as the task to give scientific and technical support like this community data collection. And then of course we have to communicate our findings.

(Slide)

And in EU we have a number states, 27 Member States and also two non-Member States participate in our data collection meeting in Norway and Switzerland.

(Slide)

There is a collection on antimicrobial resistance in Eu, it has a legal basis in this community legislation so this directive on monitoring of zoonoses and zoonotic agents from the 2003, it applies to all EU Member States to monitor and report data on antimicrobial resistance in Salmonella and Campylobacter isolates from animals and food each year. And for this commensal indicator organisms, E. coli and Enterococci this reporting is voluntary.

And then in the human side this reporting of antimicrobial resistance in isolates from human cases that has to be made to ECDC, which is the European Center for Disease Prevention and Control. Kind of our sister agency in the human side.

(Slide)

And this kind of summarizes this ---, the data collection system in EU so members have to report the data on antimicrobial resistance in animal and food isolates to --- and answer the data in the human isolates has to be reported to ECDC and every year EFSA together with ECDC and assisted by our contractor we analyze this data together and we produce this annual community summary report.

(Slide)

So, our main output from these reporting and monitoring is really this annual community summary report prepared in excellent collaboration between EFSA and ECDC and it’s really, it’s kind of an integrated approach, so there they combine the data from food, animals and humans for antimicrobial resistance as well.

(Slide)

And of course the analysis of this data at the community --- level is a bit challenging. And in order to improve this comparability of the data and also the quality of the data we received from Member States, EFSA has issued a couple of harmonized specifications for monitoring and reporting of antimicrobial resistance to the Member States.

And in 2007 we published these guidelines for Salmonella isolates, from fowl, turkeys and pigs, the isolates mainly coming from these mandatory Salmonella control programs. And this report also has guidelines for Campylobacter isolates that are coming from commensal.

In 2008 we produce another guidance to commensal for antimicrobial resistance in commensal E. coli and Enterococci in food animals and there the isolates are mainly coming from slaughter houses sampling.

And we always prepare the specifications together with the Member States experts because of course the experts is in the Member States level. And now the Member States are in the process of implementing these harmonized monitoring schemes, practice, and this will of course improve the quality and compatibility of our data in the future.

(Slide)

And in this harmonized specification we typically define the target population to be covered, the origin of the isolates, the minimum number of the isolates to be tested. The antimicrobials to be tested, and of course the epidemiological cut-off values to be used in the interpretation and then things like lab methods and that kinds of things.

And the antimicrobials to be tested, they are chosen based on the public health importance.

And some parts of these schemes can be used also for testing of food isolates.

(Slide)

And these are just a couple of examples. Like these antimicrobials and epidemiological cut-off values to be used for Salmonella or Campylobacter. But I will just keep them in the interest of time. And okay.

(Slide)

And I said analysis of this data at the community level and is a bit of a challenge because in most cases the state of antimicrobial resistance is not fully compatible between the Member States. But we believe that the states in many cases, it is comparable between the different reporting years within one country, unless they have changed the monitoring system.

So, that’s why at the community level we look, the data for trends over the years, at the Member States specifically and whenever possible at the Member States --- and EU level.

And we believe that we could be able to see other developments going on at the community level and in the specific Member States level and also we could maybe able to identify certainly emerging resistance and that kind of things.

(Slide)

We do some --- distribution on --- maps so far, but I think most importantly in this analyses we use harmonized epidemiological cut-off vales for all Member States. And we use these cut-off values both for the MIC data and inhibition zone data, disk diffusion data, and there we actually define the cut-off values by ourselves.

But we are still in the process of developing this analysis of antimicrobial resistance data to community level, in order to find what is the most appropriate way of having look at this kind of data at that level.

(Slide)

And this is just an example of how the epidemiological cut-off values that define for the disk diffusion method. It was done by our contractor in Denmark together with the Community Reference Laboratory and it was based on our data sets from Member States about the results.

(Slide)

So, we have produced two specific community summary reports for antimicrobial resistance. The first one covers years 2004 and 2007. And now we have just published another report for 2008 data.

And together 26 Member States out of 27 reported some kind of data on antimicrobial resistance in food and animal isolates and the data was mainly coming from Salmonella and Campylobacter. And what was positive is that the number of Members States provided quantitative data or MIC data or --- data increased. Mostly the data comes from animals, such as poultry, pigs, cattle and --- meat and pig meat, pork.

(Slide)

And how do we present this data. We look, I mean we report the results always specifically for its Member States and then we summarize that at reporting Member States level and we look for, you know, trends, Member States specific trends over the years and then we have a look of some geographical distribution of the resistance in EU.

(Slide)

And what did we find, I mean these are the main findings, so actually the resistance of antimicrobials most commonly found among the Salmonella, Campylobacter and this indicator organisms isolates from animals and food and there was a huge, large variation between the Member States as you can see in this figure which is for tetracycline resistance in pigs and each line is a different Member States, and as you can see the resistance varies from, almost from zero to 100 between the Member States.

But what we saw that resistance levels were quite stable over the years in most Member States but there is some decreasing or increasing tenancies over the years. And here are some examples like tetracycline resistance in Salmonella in cattle seems to be a bit decreasing and then ciprofloxacin resistance increase in at least some Member States, typically in poultry.

(Slide)

Then of course we always specifically analyze the results of the resistance to these antimicrobials which are critically important in humans medicine like fluoroquinolones and quinolones. And quite many Member States reported higher occurrence of resistance to ciprofloxacin typically in Salmonella isolates from poultry. And of course fluoroquinolones resistance was commonly found in Campylobacter isolates.

These are the examples but it’s from 2007 at the Member States reporting -- reporting Member Staves level, so in Salmonella it’s mainly fowl. And it’s turkeys, where the resistance is found and Campylobacter it’s very common, or commonly found among the Member States.

(Slide)

Yes, then a couple of words about our EU-wide baseline surveys which are quite specific exercise we have in the community. These baseline surveys, they are very well designed. Surveys which are fully harmonized across all the EU Member States and they typically take one year time. And every Member States have an obligation to attend the survey and they co-financed by the Commission.

And these baseline surveys, they are used for specific purposes like for setting for Salmonella reduction targets, animal populations or to consider specific needs for --- access at the community level.

And in 2008 we have a baseline survey for MRSA in holdings of breeding pigs. And EFSA analyzed these results and I will show you some results of this survey.

(Slide)

So, actually MRSA was quite commonly found in these holdings of the breeding pigs. This is results for production holdings with breeding pigs. And as you can see there was quite some variation between the Member States, many Member States find any MRSA with put to 51 percent of holdings where positive in some Member States, and at the EU level they did mean -- the prevalence was 26.9 percent of the holdings there positive for MRSA.

(Slide)

And we of course analyzed this data because it was fully harmonized, it was easy, quite --- and quite interestingly we found a significant positive association between the MRSA prevalence in the countries and the number of imported breeding pigs to the country. This is just to illustrate it.

But what we can see is that it seems to be that MRSA is still spreading the pig population in EU and it seems to be related to the trade of pigs between the countries, live pigs.

(Slide)

And now I only have my conclusions. So we believe that our annual Community Summary Report on antimicrobial resistance provides quite an interesting overview of the situation and the developments in the EU. And it is needed both by our risk managers, meaning Commission and Member States, and our risk assessors which are actually are us in EFSA. And this report is really an integrated approach, we cover the human data, animal data and food data.

And then on special occasions, we use these EU-wide baselines survey for specific purposes and that really keeps a very unique snapshot of what is the situation in the specific here. And they are used for special purposes.

And all of the reports and guidelines they are available on EFSA website, here you can see that, the address and it’s easiest to find under our unit website, zoonoses unit.

So, that was my last slide. So, thank you for your attention.

(Applause)

DR. FEDORKA-CRAY: Thank you very much, PIA.

DR. MÄKELÄ: Thank you.

DR. FEDORKA-CRAY: If anyone has a quick question for Pia while we change our speakers and slides here. We can entertain one question.

DR. NG: Lai Ng from the National Biological Laboratory, the Public Health Agency of Canada. I have a question. We have discussion from CLIS on breakpoint and you have using in Europe harmonize to use epidemiological breakpoint, so is it is not particularly for you maybe for WHO, in the integration of worldwide comparison of data, when they construct the databases that attempt of correlating the epidemiological breakpoint with the clinical breakpoints.

DR. MÄKELÄ: Okay. So maybe explain -- better explain.

DR. BARZILAY: Gabe wasn’t getting up to answer it, he wants to ask you a -- so please answer that question.

DR. MÄKELÄ: So I didn’t quite capture the place -- we believe that the use of this epidemiological cut-off values in this kind of epidemiological surveillance of antimicrobial resistance in animals and food isolates, you have to use them, and our cut-off values came mainly from this --- activities, because there is harmonization activities going on in Europe both for the human side and animal side.

But then of course how to relate this epidemiological cut-off values to the clinical breakpoints in human medicine, that is a challenge and that is something that we still have to have a look. I don’t have a good answer for that.

DR. FEDORKA-CRAY: I think we have --

DR. McDERMOTT: Pat McDermott, FDA, I just want to take a quick stab at that because there is a lot of concern about that question in this room. And I think the AGISAR’s position is let’s make sure the data is reported in such a way that you can apply any cut-off value. But then the issue is we have to make sure we know what we mean when we say the word resistant.

DR. MÄKELÄ: Of course the cut-off value is might say so, that’s why it is important to report this quantitative data with --- then you can always change that.

DR. FEDORKA-CRAY: Dave.

DR. WHITE: Thanks. Dave White, FDA, and if I could just take 30 seconds to go back to Ruth’s question before about the public health action plan and AGISAR. The caffeine did kick in so I apologize I didn’t have a quicker answer, but it definitely is in there, integration of global surveillance is in there. And in particularly we definitely do have, I know of at least a minimum one metric to work with AGISAR more.

Then also just to give kudos to CDC, for championing this new revised action plan. They’ve done quite a bit of work. And I know Doctor Patel is here as well who has done quite a bit of herding cats with all of the different organizations that have a big part. So, big kudos to CDC for getting this out. Thank you.

DR. FEDORKA-CRAY: And I’ll give Tim the opportunity since Dave jumped in there.

DR. CUMMINGS: Tim Cummings from Mississippi State University. Was fluoroquinolones approved for use in food and animal production of animals in Europe?

DR. MÄKELÄ: It is, yes.

DR. CUMMINGS: It is?

DR. MÄKELÄ: --- made but certainly related to ciprofloxacin. Yes.

DR. CUMMINGS: Okay. You just answered my question.

DR. MÄKELÄ: Yes.

DR. CUMMINGS: Thank you.

DR. FEDORKA-CRAY: Thank you very much.

DR. MÄKELÄ: Okay. Thanks a lot.

DR. FEDORKA-CRAY: There will be an opportunity later on this afternoon to ask additional questions for all of the speakers today, to bring up any topic that you want to discuss.

Our next speaker is Doctor Katie Glynn who will be representing the OIE activities for the containment of antimicrobial resistance. And Katie is actually located here at the CDC.