Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance

EMA invites comments on a draft reflection paper by 31 January 2018

The European Medicines Agency (EMA) has launched a public consultation on its new “ Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union ”. The deadline to submit comments is 31 January 2018. Comments should be provided using this . The completed form should be sent to vet-guidelines@ema.europa.eu.

Off-label use, which includes the use of a medicine in a species or a disease other than those specifically authorised and included in the product information, is a widespread practice in veterinary medicine. It is permitted under certain circumstances. For example, owing to the great variety of veterinary species and conditions, there are often no medicines available that have been authorised to treat rarer conditions or less common species. In this case it may be allowed to use a medicine authorised for another species or condition. However, in the case of antimicrobials there are concerns that off-label prescription could increase the risk of antimicrobial resistance.

The reflection paper, prepared by EMA's Committee for Medicinal Products for Veterinary Use (CVMP) and its Antimicrobials Working Party (AWP), aims to define off-label use and to better understand the underlying reasons for the practice in relation to the use of antimicrobials. However, data on the off-label use of antimicrobials in veterinary medicine in the EU is currently too limited to allow a full assessment of the impact of these prescriptions on the spread of antimicrobial resistance and the associated risks for human and animal health.

The paper recommends measures to improve the collection of data on the off-label use of antimicrobial medicines, encourage the development of related treatment guidelines, and stimulate the development of new medicines covering a wider range of species and conditions in animals.

This is the first reflection paper issued by EMA on this topic. It has been developed in the framework of CVMP's strategy on antimicrobials 2016-2020 and builds on a joint EMA-European Food Safety Authority (EFSA) opinion on the reduction of the need to use antimicrobials in animal husbandry (RONAFA) published in January 2017.