Standardised units of measurement for veterinary antimicrobials

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The European Medicines Agency (EMA) has established standardised units of measurement for reporting antimicrobial consumption in specific animal species, called the ‘defined daily dose’ and ‘defined course dose’ for animals. This initiative aims to support the harmonisation and standardisation of reporting data on veterinary antimicrobial consumption collected at European level.

Surveillance of antimicrobial consumption by animal species using standardised units of measurement is expected to improve the accuracy of estimating animal exposure to veterinary antimicrobials.

More accurate units of measurement should enable a better analysis of trends over time and a comparison between species at European level.

Ultimately, this is expected to enhance understanding of the development and occurrence of antimicrobial resistance and the impact of measures to counteract antimicrobial resistance.

Defined doses for pigs, cattle and broilers

The European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) activity has prioritised establishing ‘defined daily dose for animals’ (DDDvet) and ‘defined course dose for animals’ (DCDvet) values for antimicrobials used in three major food-producing animal species: pigs, cattle and broilers (poultry).

The values are based on an assumed average daily dose (DDDvet) or treatment course dose (DCDvet) of active substance. They take account of differences in dosing, pharmaceutical form and route of administration used in the different species.

The lists of DDDvet and DCDvet values are available in PDF or Excel format. Please note that the PDF document contains more detail on a number of exceptions to the principles for assigning 'DDDvet' and 'DCDvet' values:

ESVAC relied on detailed dosing data from nine European Union (EU) Member States when assigning the values. To report a missing ingredient or substance, please write to esvac@ema.europa.eu.

The lists are intended for use by EMA to support the ESVAC activity in analysing and reporting antimicrobial consumption using harmonised units, which facilitate comparison of different animal populations. EMA also encourages the use of the standardised units to report consumption data at national level to enable comparison between countries.

How defined doses are assigned

In 2015 the Agency published the principles for assigning the 'DDDvet' and 'DCDvet' values for veterinary antimicrobial medicines, following a public consultation:

Any party intending to use the 'DDDvet' and 'DCDvet' values for reporting consumption data should refer to this document.

ESVAC developed the approach with the help of an expert advisory group, based on collated dosage data from the summaries of product characteristics for veterinary antimicrobials provided by nine Member States. 

The 'DDDvet' and 'DCDvet' values are based on the following units for different pharmaceutical forms or administration routes:

Administration routes/formsUnits
oral and injectable productsmilligram per kilogram of animal
lactating cow intramammary productsunits per teat
dry cow intramammary productsunits per udder
intrauterine productsunits per animal
 

Background

The ESVAC activity collects sales data on veterinary antimicrobial agents at package level from the EU and European Economic Area (EEA) Member States.

To enable a more detailed analysis of trends in antimicrobial consumption, ESVAC is preparing a system for the collection of harmonised and standardised data on consumption by animal species.

ESVAC developed the 'DDDvet' and 'DCDvet' values based on the standardised unit of measurement used to report antimicrobial consumption in human medicines.

EMA's approach to establishing the collection of consumption data by species is based on a reflection paper published in October 2013, following a public consultation:

The 'DDDvet' and 'DCDvet' values are technical units of measurement resulting from a review of available information. They are intended solely for the purpose of antimicrobial consumption studies. They do not necessarily correspond to recommended or prescribed doses and are not suitable for commercial uses such as pricing or cost analysis.

The terms ‘DDDvet’ and ‘DCDvet’ are used by the ESVAC project and should not be confused with units of measurement developed by any other studies of antimicrobial consumption.

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Contact point:

esvac@ema.europa.eu