Other safety alerts
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| European Union: Countries should reduce use of colistin in animals to decrease the risk of antimicrobial resistance - Goal is to cut colistin sales by 65% |
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The European Medicines Agency (EMA) has recommended that colistin-containing medicines should only be used as a second line treatment in animals and that their sales should be minimised across all European Union (EU) Member States to reduce the risk of antimicrobial resistance. The advice updates EMA guidance from 2013 and takes into account comments made by stakeholders during a public consultation that ended on 26 June 2016.
The European Commission asked for this update in response to the discovery of a new mechanism of resistance in bacteria to colistin (caused by the mcr-1 gene). The gene can be transferred between different types of bacteria, potentially causing a rapid development of resistance. The gene was first identified in bacteria (Enterobacteriaceae) in South China, and since then has also been found in the EU and other regions.
In light of the new evidence, the Antimicrobial Advice Ad Hoc Expert Group (AMEG) had been asked to re-evaluate the impact of the use of colistin on human and animal health, the consequences of resistance and what alternative treatments are available. Moreover, the group was asked to consider adequate risk management measures. The advice was endorsed by both the Committee for Medicinal Products for Veterinary Use (CVMP) and the Committee for Medicinal Products for Human Use (CHMP).
Colistin or colistimethate sodium has been used for over 50 years in both humans and animals. In human medicines it is a last resort medicine to treat bacterial infections resistant to other antibiotics. In veterinary medicine, colistin has been used to treat infections caused by Enterobacteriaceae in farm animals. Partly due to the development of resistance to other classes of antibiotics, colistin consumption has increased in recent years. Today it is one of the five most commonly used antibiotics in animals within the EU.
Over the course of the next three to four years, all Member States should reduce the use of colistin in animals at least to a target level of 5 mg colistin/population correction unit (PCU). PCU means the estimated weight of livestock and slaughtered animals. If successfully applied, this could result in an overall reduction of approximately 65% in the current sales of colistin for veterinary use at an EU level. This decrease should build on the decrease of colistin sales for veterinary use already seen between 2011 and 2013. Member States are also encouraged to set stricter national targets, ideally below 1 mg colistin/PCU as a desirable level.
In its advice, AMEG underlined that the reduction of colistin sales should not be compensated by increase in the use of other types of antimicrobials, but should be achieved through other measures such as improved farming conditions, biosecurity between production cycles, and vaccination of livestock.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002579.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are three registered pharmaceutical products containing colistin or colistimethate sodium, namely Multibio Suspension Inj (Vet) (HK-42135), Colomycin for Inj 1 Million IU (HK-58514) and Colistin Powder for Solution for Injection 150mg (HK-63662). All products are prescription only medicines. Multibio is a multiple ingredients preparation containing colistin sulfate indicated for treatment of infections for various animals including pig and cattle. There is no registered pharmaceutical product containing colistin or colistimethate sodium in oral dosage form.
EMA’s 2013 advice on colistin use in animals was posted on Drug Office website on 31 July 2013, and letters to inform local healthcare professionals were issued on the same day. In response to EMA’s recommendations, the Registration Committee of the Pharmacy and Poisons Board decided in May 2014 that indications for preventive (or prophylactic) use of colistin should not be approved in new applications for registration of pharmaceutical products. Subsequently, news on evaluation of colistin to assess whether the 2013 advice would be impacted by new evidence was posted on the Drug Office website on 12 January 2016, 25 April 2016 and 27 May 2016. So far, the Department of Health (DH) has not received any adverse drug reaction report related to colistin or colistimethate sodium. In view of the AMEG’s re-evaluation of the impact of colistin use on human and animal health, DH will remain vigilant of the conclusion and safety updated on colistin by other overseas drug regulatory authorities.
Ends/ Thursday, July 28, 2016
Issued at HKT 15:00
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