By Eleanor Denny
The EMA has a Committee for Medicinal Products for Veterinary Use (CVMP) and one of their key objectives is to protect the health and welfare of animals by promoting the availability of effective antibiotics. A key threat to achieving this objective is antimicrobial resistance (AMR) and so a number of initiatives have been launched within the EU in order to help combat this threat. These initiatives include the production of scientific advice regarding the use of antimicrobials and the establishment of the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC), which was set up in 2009 to develop a harmonised approach to collecting and reporting data on antimicrobial use in animals in the EU.
On 15th October 2018 the eighth ESVAC report (the Report) was published, which sets out the data on sales of veterinary antimicrobials from 30 countries from the EU, EEA and Switzerland in 2016 and the changes in consumption of antimicrobials from 2010 to 2016 (25 countries provided data from 2011 to 2016). This is a highly detailed report, totalling 184 pages, but we have summarised the key findings below:
Key findings from 2016
- There was a large difference in the amount of antimicrobials sold on a country by country basis, ranging from 2.9 – 453.4 mg/PCU with a median of 57.0 mg/PCU.
- 70% of total sales were accounted for by tetracyclines (32%), penicillins (26%) and sulfonamindes (12%). The highest priority critically important antimicrobials (HP CIAs) for human use (as listed by WHO) made up 14.9%, consisting of 3rd- and 4th-generation cephalosporins, quinolones, polymyxins (colistin only) and macrolides.
- Prescribing patterns varied considerably between countries, notably within the EMA AMEG Category 2 products – 3rd- and 4th-generation cephalosporins (<0.01 – 0.7 mg/PCU), fluoroquinolones (<0.01 – 9.7 mg/PCU) and polymyxins (0 – 22 mg/PCU).
- Aggregated across the 30 countries, 90.1% of sales were for pharmaceutical forms for group treatments (e.g. premixes, oral powders and oral solutions) and of these treatments, only 17.8% contained two or more active ingredients (versus 82.2% containing only one).
Key findings from 2011-2016
- The key finding is that overall sales of antimicrobials decreased by 20.1% (based on mg/PCU) in the 25 countries that reported for these years.
- A fall in sales by more than 5% occurred in 16 countries (with decreases ranging from 8.7% to 57.8%); however, a rise of more than 5% was noted in 6 countries (ranging from 7.9% to 67.7%).
- Sales of HP CIAs were low and showed a decreasing trend; although an increase was observed for some of these antimicrobials in certain countries (e.g. overall sales of 3rd- and 4th-generation cephalosporins decreased by 15.4% but an increase in use was observed in 13 countries).
The Report notes that “tentative” explanations were provided by the countries for the decline in sales of antimicrobials between 2010 to 2016 that “include, among others, the implementation of responsible-use campaigns, the setting of targets, restriction of use, benchmarking, increased awareness of the threat of AMR, changes in animal demographics and changes in systems for collecting data.” However, the Report warned caution should be taken in interpreting these results as variations between countries are likely to be partly due to different compositions of animal populations and the production systems in each country. In addition, there have also been some changes to national data collection systems and/or for some countries it has been identified that there was under-reporting of sales figures.
Therefore, the findings of the Report indicate an overall reduction in the sales of antimicrobials, which should help to reduce the risk of AMR. The EMA noted that this “confirms that European Union (EU) guidance and national campaigns promoting prudent use of antibiotics in animals to fight antimicrobial resistance are having a positive effect” and as AMR is a key health concern for animals and humans it would be desirable for continued reduction in the sales of antimicrobials. However, further work still needs to be done as increases in sales were seen in some countries. Additionally, this is only one of the required actions needed to combat AMR and should be considered alongside the need to develop new antimicrobials and new/ alternative treatment options.
 The EMA’s scientific committee responsible for veterinary medicines
 The WHO defines this as “the ability of a microorganism (like bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals and antimalarials) from working against it. As a result, standard treatments become ineffective, infections persist and may spread to others.”
 The report uses a standardised indicator of mg/PCU (or sale in milligrams of active ingredient sold per population correction unit, which is a used as a proxy for the size of the food-producing animal population) to indicate use of antimicrobials
 “The World Health Organization has classified certain antimicrobial classes as “Highest Priority Critically Important Antimicrobials” for human medicine in the so called WHO list of critically important antimicrobials for human medicine (CIA list). The CIA list is intended for public health and animal health authorities, practicing physicians and veterinarians, and other interested stakeholders involved in managing antimicrobial resistance… In the latest version of the CIA list (5th revision, 2016), the “Highest Priority Critically Important Antimicrobials” are: quinolones, 3rd and higher generation cephalosporins, macrolides and ketolides, glycopeptides, and polymyxins.” Further detail can be found here.
 The Antimicrobial Advice Ad Hoc Expert Group (AMEG) was jointly established by the CHMP and CVMP and one of its tasks is to categorise antimicrobials based on their risk to public health due to AMR following use in animals. Current guidance on categorisation can be found here.
 Further details can be found on the EMA website here.