University of Agricultural Sciences and Veterinary Medicine ClujNapoca

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University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Romania Since 1869 Anti-microbial resistance –

University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Romania Since 1869 Anti-microbial resistance – Urgent need to act in human and veterinary medicine Dr. Mihai Cernea, DVM, Ph. D Wednesday, 22 April 2015

Background of anti-microbial resistance § Anti-microbial resistance is a natural evolutionary process that can

Background of anti-microbial resistance § Anti-microbial resistance is a natural evolutionary process that can be slowed, but not stopped § Limited resources of the pharmaceutical industry and evolution of resistance outruns the progress of pharmaceutical research (8 -12 years for a new medicine) § Bacteria have shown the ability to become resistant to every anti-microbial that has been developed for human or animals (on average after 1 -9 years after introduction) § The more anti-microbial are used, the more quickly bacteria develop resistance § It is a worldwide and complex problem; can cross international boundaries and spread between continents, with potentially catastrophic consequences of inaction § Anti-microbial resistant infections add considerable costs to the healthcare system § Worldwide, anti-microbial are commonly used on feed for food animals to prevent, control and treat diseases, but in some countries, also to promote the growth

The current benefits of using anti-microbial in animal feed § Ensures the welfare of

The current benefits of using anti-microbial in animal feed § Ensures the welfare of animals § Can be used for prevention or treatment § Reduces suffering and pain without causing additional stress (versus injection therapy) § Allows treatment of a large number of animals in a short period of time § Easy to use medicines for all species § Low cost compared with injectable treatments (price per animal treatment, the number of employees involved and time saved)

Risks and deficiences of using anti-microbial in animal feed § Homogeneity of drug in

Risks and deficiences of using anti-microbial in animal feed § Homogeneity of drug in feed § Inevitable carry-over risk § Groups of animals treated with anti-microbial in feed are not (always) sufficiently homogeneous in terms of body weight § In a group, dominant animals will consume a greater amount of medicated feed § Sick animals consume a smaller amount of feed underdosing § Healthy animals consume a larger amount of feed overdosing § Using (sometimes) unjustified preventive medication in feed, instead of improving the hygiene conditions, nutrition, environmental conditions, management and biosecurity

Proposal for a Regulation of the European Parliament and of the European Council on

Proposal for a Regulation of the European Parliament and of the European Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC New proposals for repealing Council Directive 90/167/EEC, are necessary and useful 1. From the legal standpoint, and the risk of resistance to anti-microbial and / or antiparasitic medication, including the risk of zoonotic diseases – should not be made any difference, between the methods of prevention or therapy in animals destined for human consumption or pet animals – except withdrawal time 2. Also, medicated feed should be considered as veterinary products, with all the ensuing implications (manufacture, labeling, quality control, storage, transport, record keeping, etc. ) 3. Medicated feed (anti-microbial and antiparasitic) should be used in food-producing animals and pets only under veterinary supervision and with a prescription 4. Carry-out risk – the level established must be achievable by the all producers of medicated feed

Prevention versus treatment § Anti-microbial and antiparasitic treatments in feed are required and can

Prevention versus treatment § Anti-microbial and antiparasitic treatments in feed are required and can not be replaced in terms of animal welfare, therapeutic and economic efficiency § Preventive treatments using anti-microbials and antiparasitic administred in feed should be: prohibited, permitted or restricted ?

Preventive treatments in feed ? Implications if their preventive use is prohibited: § animal

Preventive treatments in feed ? Implications if their preventive use is prohibited: § animal welfare would be significantly affected § new facilities for the isolation of diseased animals § increase of the number of diseased animals treated with injectable therapeutic doses of anti-microbials § Increasing the amount and use of injectable antimicrobial products that are more expensive compared with those used in animal feed § increased morbidity, mortality and additional stress § lower economic efficiency - current systems of intensive livestock can not have economic efficiency without preventive treatments in feed

Preventive treatments in feed ? Implications if their preventive use is permitted: § animal

Preventive treatments in feed ? Implications if their preventive use is permitted: § animal welfare would not be affected for a period of time § easy to administer, without additional stress for animals, reduced number of employees involved, time saved § high economic efficiency § decrease of morbidity and mortality § risk of abusive use § animals do not necessarily require a better hygiene, nutrition, biosecurity and management

Preventive treatments in feed ? Implications if their preventive use is restricted: § animal

Preventive treatments in feed ? Implications if their preventive use is restricted: § animal welfare would not be affected § must be bound to the conditions that justify preventive treatments, could be, for example: § occurrence of bacterial and/or parasitic diseases § season-related illnesses (especially parasitic diseases) OR/AND § transport, regrouping and relocation of animals § weaning period § it is necessary to clearly specify which are the circumstances that allow the preventive use of anti-microbials and antiparasitic , otherwise there is the risk of abusive use § better hygiene, nutrition, biosecurity and management is needed

Expectation and core actions that will help fight against anti-microbials resistance § Preventing infections

Expectation and core actions that will help fight against anti-microbials resistance § Preventing infections and preventing the spread of resistance by responsible use of anti-microbials and antiparasitic medication in humans and animals § Improving the use of today’s anti-microbials and antiparasitic and promoting the development of new ones § Developing new diagnostic tests for resistant bacteria or parasites (especially)

Expectation and core actions that will help fight against anti-microbials resistance § It is

Expectation and core actions that will help fight against anti-microbials resistance § It is necessary to implement a program of monitoring and surveillance of anti-microbials and antiparasitic resistance in all EU Member States, concerning incidence, prevalence, mortality, cost of resistance and data on medicines use in human and animal healthcare § Clear and mandatory programs to improve prescribing medicines in humans and animals - in order to greatly slow down the development and spread of anti-microbials and antiparasitic resistant infections § Better cooperation, education and communication (between pharmaceutical industry, veterinarians, producers, researchers, owners) at national, European and international level

“No action today, no cure tomorrow” (World Health Organization) Mihai CERNEA, associate professor, DVM,

“No action today, no cure tomorrow” (World Health Organization) Mihai CERNEA, associate professor, DVM, Ph. D Pharmacology, Therapeutics & Management Department University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca , Faculty of Veterinary Medicine Manastur street, no. 3 -5, 400372 - Cluj-Napoca, Romania Phone: +40 264 596 384 / 186 Fax: +40 264 593 792 Mobile: +40 722 393 550 E-mail: [email protected] com; mihai. [email protected] ro