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  • An agency of the European Union

    Units of measurement for animals for the collection of data per animal species: Defined Daily Dose (DDDvet) and Defined Course Dose (DCDvet)

    Data collection on consumption of veterinary antimicrobials in Europe achievements, challenges and way forward

    EC workshop with EMA, Brussels, 26 April 2017

    Marian Bos, Seconded National Expert EMA/ESVAC

  • Overview

    DDDvet and DCDvet

    Principles for assignment

    Lists with values

    Units of measurement 1

  • Defined Daily Dose animal (DDDvet) and

    Defined Course Dose animal (DCDvet)

    Standardised technical units of measurement.

    DDDvet: assumed daily dose per kg body weight.

    5 DDDvet used: e.g. 1 kg animal treated 5 days or 5 kg animal treated 1 day.

    DCDvet: assumed course dose per kg body weight.

    5 DCDvet used: e.g. 1 kg animal received 5 treatment courses or 5 kg animal

    received 1 treatment course.

    Units of measurement 2

  • DDDvet and DCDvet (cont.)

    Take into account differences in dosing (daily dose and treatment duration)

    between species, substances and/or formulations.

    Units of measurement 3

    0

    50000

    100000

    150000

    200000

    Oral Parenteral Oral Parenteral Oral Parenteral

    Doxycycline Oxytetracycline Oxytetracycline

    Pig Pig Cattle

    Animal weight (kg) that can be treated

    for 1 day with 1 kg active substance

    (e.g. doxycycline or oxytetracycline)

  • DDDvet and DCDvet (cont.)

    More refined reflects animal exposure to antimicrobials.

    Not necessarily be assumed to reflect daily doses recommended/prescribed

    assigned values nearly always compromise.

    Not applicable for commercial use (e.g. pricing and analyses of drug costs).

    Units of measurement 4

  • Principles for assigning DDDvet and DCDvet

    Developed in conjunction with ad hoc working group.

    Intended to guide EMA on assignment of DDDvet and DCDvet.

    To ensure consistency and transparency.

    Considered to represent optimum balance between accuracy

    and practicability.

    Harmonized to extent possible with human medicine (DDD).

    Adopted after public consultation and published on Agencys

    website (30 June 2015).

    Units of measurement 5

  • Principles for assigning DDDvet and DCDvet (cont.)

    Developed based on data for antimicrobial agents, but in general considered

    applicable in future for other veterinary therapeutic agents.

    For some therapeutic agents (e.g. with intermittent schedule) approach would have to be

    further explored.

    Antimicrobial growth promotors not authorised in EU/EEA countries, therefore

    principles do not address AGPs.

    DDDvet/DCDvet should not be used to analyse and report consumption of AGPs.

    Generally based on SPC information provided by 9 MSs (CZ, DE, DK, ES, FI, FR, NL,

    SE, UK).

    In cases where SPC info is insufficient, scientific publications/text books will be consulted.

    Units of measurement 6

  • Lists on the website (April 2016)

    Home>Veterinary regulatory>Overview>Antimicrobial resistance>European Surveillance of

    Antimicrobial Consumption>Units of measurement

    Units of measurement 7

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001493.jsp&mid=WC0b01ac0580a2fcf5http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001493.jsp&mid=WC0b01ac0580a2fcf5

  • DDDvet and DCDvet in use

    Units of measurement 8

  • The way forward

    Publication of DDDvet and DCDvet for injectable products containing

    gamithromycin, tildipirosin and tulathromycin.

    Methodology for establishing surrogate measure for duration of effect established.

    Discussion with WHO Collaborating Centre for Drug Statistics Methodology on

    maintenance of lists (pending on above).

    Encourage MSs to use DDDvet/DCDvet to report data on use by species.

    Units of measurement 9

  • Acknowledgements

    The members of the ESVAC ad hoc working group on technical units and the ESVAC

    DDDvet/DCDvet EAG Inge van Geijlswijk, Kari Grave, Christina Greko, Erik

    Jacobsen, Irene Litleskare, Grard Moulin and Cedric Mntener are thankfully

    acknowledged for assisting the development of this project as well as providing

    scientific advice and valuable comments during the development of the principles and

    the assignment of the DDDvet and DCDvet values.

    A special thank you to Kari Grave for all her work leading this project and as chair of

    the ESVAC DDDvet/DCDvet EAG.

    Units of measurement 10

  • Thank you for your attention

    esvac@ema.europa.eu

    European Medicines Agency

    30 Churchill Place Canary Wharf London E14 5EU United Kingdom

    Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555

    Send a question via our website www.ema.europa.eu/contact

    Further information

    Follow us on @EMA_News