The European Medicines Agency (EMA) has launched a public consultation on the advice drafted by its Antimicrobial Advice Ad Hoc Expert Group (AMEG), and endorsed by the Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Medicinal Products for Human Use (CHMP), to minimise sales of colistin for use in animals and restrict its use in animals to last resort treatment only. The deadline to provide comments is 26 June 2016.
The new advice is an update to AMEG’s 2013 opinion, which was requested by the European Commission following the recent discovery of a new mechanism of resistance in bacteria to colistin (caused by the mcr-1 gene), which has the potential for rapid spread. The gene can easily be transferred between different types of bacteria, potentially leading to rapid development of resistance. While the gene was first detected in bacteria (Enterobacteriaceae) in South China, it has subsequently been found also in the EU.
In light of the new evidence, EMA reconvened the AMEG to assess the importance of colistin for human and animal health, the impact of resistance and the availability of alternative treatments. In addition, the group was asked to propose suitable risk management measures.
Risk management measures
In its updated advice, AMEG recommends that Member States should reduce the use of colistin to a maximum level of 5 mg colistin/PCU (population correction unit) and consider setting stricter national targets, ideally lower than 5 mg/PCU of colistin, e.g. below 1 mg/PCU as a desirable level. The AMEG emphasises that reduction of colistin use should not be compensated for by increasing the use of other types of antimicrobials. Instead, the use of this antibiotic should be reduced through other measures such as improved farming conditions, biosecurity in between production cycles, and vaccination.
In addition, colistin should be reclassified and added to Category 2 of the AMEG classification system, which includes medicines reserved for treating infections in animals for which no effective alternative treatments exist. This category includes certain classes of antimicrobials listed by the World Health Organization (WHO) as critically important to human health. Because of the risk posed to public health by their veterinary use, these medicines are subject to specific restrictions.
Thursday May 26, 2016/ EMA/ European Union.