In dem englischen Dokument bezieht Lidl UK sich auf die ", RUMA" (Responsible Use of Medicines in Agriculture). Bei ruma.org sind mit Google nur 2 Texte zu finden, die sich auf Homöopathie beziehen:
"POSITION PAPER ON ANTIBIOTIC RESISTANCE AND
ANTIBIOTIC USE IN LIVESTOCK"
http://www.ruma.org.uk/wp-content/uploads/2014/09/RUMA-POSITION-PAPER-ON-ANTIBIOTIC-RESISTANCE-AND-ANTIBIO.pdf[*quote*]
[Tuesday, September 09, 2014 02:22:08 PM]
25. RUMA has concerns that the use of medicines, especially antibiotics, is being vieweda product differential for some of the agricultural production systems, especially the organic and ‘aspirational’ production methods such as biodynamics. Veterinary medicines are an important tool in protecting the health needs of animals and the consuming public, and we do not feel that it is appropriate to politicise them in this way. Under certain regimes, antibiotics may only be used as a last resort after treatment with alternative medicines, such as herbal or homeopathic products, has failed. In other words, antibiotics with proven efficacy are preferentially withheld in favour of treatment with products of unproven efficacy.
This presents a huge potential to increase or extend the animals’ suffering beyond that which is necessary or acceptable in order to appeal to the ethical wants of some consumers.
There is considerable economic pressure on organic farmers not to use antibiotics as repeated doses can lead to the removal of organic status and the related financial premium.
RUMA calls on the Soil Association, and others licensing organic production, to allow antibiotics, and all other authorised medicines, to be used responsibly in the interests of animal welfare.[*/quote*]
"INFORMATION NOTE ON ANTIBIOTIC RESISTANCE AND THE
RESPONSIBLE USE OF ANTIBIOTICS IN FARM ANIMALS"
http://www.ruma.org.uk/wp-content/uploads/2014/04/RUMA-ANTIBIOTIC-RESISTANCE-INFORMATION-NOTE.pdf[*quote*]
[Tuesday, April 22, 2014 09:59:07 AM]
In organic farming, rules are set to limit the use of antibiotics to situations
where alternative treatments such as homeopathic and herbal preparations
are considered not to work. Control and preventive treatments are not
normally permitted in organic farming.[*/quote*]
Diese beiden Datumsangaben [Tuesday, September 09, 2014 02:22:08 PM] [Tuesday, April 22, 2014 09:59:07 AM] beziehen sich auf die Erstellung der PDF-Dateien. Damit sind beide britischen RUMA-Papiere älter als die deutschen Stellungnahmen von Lidl.
Wenn Lidl sich in Großbritannien auf die RUMA beruft, kann Lidl nicht behaupten, den Inhalt dieser Papiere nicht zu kennen. Damit steht Lidl UK in klarem Gegensatz zu Lidl Deutschland.
Die Position der RUMA ist eindeutig:
"POSITION PAPER ON ANTIBIOTIC RESISTANCE AND
ANTIBIOTIC USE IN LIVESTOCK"
http://www.ruma.org.uk/wp-content/uploads/2014/09/RUMA-POSITION-PAPER-ON-ANTIBIOTIC-RESISTANCE-AND-ANTIBIO.pdf[*quote*]
[Tuesday, September 09, 2014 02:22:08 PM]
Under certain regimes, antibiotics may only be used as a last resort
after treatment with alternative medicines, such as herbal or homeopathic products, has failed.In other words, antibiotics with proven efficacy are preferentially withheld in favour of treatment with products of unproven efficacy.This presents a huge potential to increase or extend the animals’ suffering beyond that which is necessary or acceptable in order to appeal to the ethical wants of some consumers.RUMA calls on the Soil Association, and others licensing organic production, to allow antibiotics, and all other authorised medicines, to be used responsibly in the interests of animal welfare.[*/quote*]
Das ist eine eindeutige Aussage. Wie kann Lidl sich in Deutschland über diese Aussage hinwegsetzen!? Die Tiermedizinen in Deutschland sind die gleichen wie überall sonst auf der Erde. Was in Großbritannien gilt, gilt in jedem anderen Land gleichermaßen. Die Regeln der Physik und der Chemie und der Biologie sind in Großbritannien die gleichen wie in jedem anderen Land.
Warum setzt sich Lidl Deutschland über diese anerkannten Grundlagen der Tiermedizin und der Ethik in der Tierzucht hinweg?
Ist jemand bei Lidl Deutschland völlig verblödet (und bringt im Abstand von mehreren Jahren den gleichen Unsinn über Homöopathie) oder belügt die deutsche Firmenzentrale Käufer und Lieferanten?
Wir reden hier nicht über Kleinigkeiten. Lidl ist ein internationales Unternehmen mit Milliardenumsätzen. Da darf es einen derart derben Verstoß gegen die Grundregeln der Tiermedizin nicht geben, erst recht nicht, wenn sich Lidl auf solche Grundregeln beruft.
Lidl muß Farbe bekennen!
Beide PDFs nun im vollen Wortlaut wiedergegeben.
http://www.ruma.org.uk/wp-content/uploads/2014/04/RUMA-ANTIBIOTIC-RESISTANCE-INFORMATION-NOTE.pdf[*quote*]
INFORMATION NOTE ON ANTIBIOTIC RESISTANCE AND THE
RESPONSIBLE USE OF ANTIBIOTICS IN FARM ANIMALS
This briefing paper aims to:
1.
2.
3.
4.
5
Explain antibiotic resistance and why it matters to human and animal health
Set out why and how antibiotics are used in UK farms
Identify the risks to public health from use of antibiotics in farming
Explain the responsible use of antibiotics in farming
Identify the changes in legislative controls (for antibiotic use in veterinary
medicines and feed additives) that RUMA believes are appropriate and
proportionate to manage the limited risk of antibiotic use in farm animals
leading to clinical treatment problems in humans.
SCOPE OF THIS BRIEFING PAPER
This briefing relates to antibiotic resistance.
Despite using the broader term antimicrobial resistance (AMR), the European
Commission, European Parliament, Member State Governments, the World Health
Organisation (WHO) and The World Organisation for Animal Health (OIE) are
primarily concerned about the efficacy of antibiotics to treat humans and whether
the use of antibiotics in animals increases the risk of untreatable resistant bacteria
in humans.
The European Commission’s review of the veterinary medicines legislation expected
in the third quarter of 2014 will include proposals to help control antimicrobial
resistance.
ABOUT RUMA
What is RUMA? (Responsible Use of Medicines in Agriculture Alliance)
RUMA is an alliance of 23 organisations representing every stage of food production
from "farm to fork". See Annex A for full list of current member organisations.
What does RUMA do?
RUMA aims to promote a co-ordinated and integrated approach to best practice in
the use of medicines for farm animals.
How can RUMA be contacted?
Email rumasec@btinternet.com to contact the General Secretary.
More information is available at
www.ruma.org.ukDefinitions
Antibacterial compounds have a direct action on bacteria, reducing or inhibiting
their growth or killing them completely.
Antibiotic is the same as anti-bacterial.
Antibiotic resistance is the ability of a micro-organism to grow or survive in the
presence of an antibiotic that is usually sufficient to inhibit or kill micro-organisms of
the same species.
Antimicrobial is the general term for any compound with a direct action on micro-
organisms used for treatment or prevention of infections. Antimicrobials include a
wide range of compounds - anti-bacterials, anti-virals, anti-fungals and anti-
protozoals.
Antimicrobial resistance (AMR) is resistance to any compound with a direct action
on micro-organisms used for treatment or prevention of infections.
1.
ANTIBIOTIC RESISTANCE AND WHY IT MATTERS TO HUMAN AND
ANIMAL HEALTH
Antibiotic resistance is the ability of a micro-organism to grow or survive in
the presence of an antibiotic that is usually sufficient to inhibit or kill micro-
organisms of the same species.
Why is antibiotic resistance important to human and animal health?
The UK’s Chief Medical Officer, Dame Sally Davies, said “antibiotic resistance
is one of the greatest threats to modern health and we face a future without
cures for infection if antibiotics are not used responsibly” in her annual report
published in March 2013.
Antibiotic resistance makes treating infectious bacterial diseases in humans
and animals harder to treat with antibiotics.
Bacteria have been developing resistance to antibiotics for millions of years.
There is an emerging clinical crisis in human medicine because antibiotic
resistance is making infectious bacterial disease harder to treat with
antibiotics.
Since the development of medicines to treat bacterial infections, resistance
has developed as bacteria have been challenged and fight to survive.
How does antibiotic resistance develop?
Antibiotic resistance is complex since resistance factors can be transmitted to
the next generation of microbes, and even sometimes transfer to different
species of microbes.
Resistant microbes can spread between species including animals to humans
and vice versa.
Scientific evidence increasingly recognises that the problem of antibiotic
resistance in humans comes largely from the use of antibiotics in human
medicine.
(See Point 2.1, page 8 Department of Health UK 5 Year Antimicrobial Resistance
Strategy 2013 to 2018.
https://www.gov.uk/government/publications/uk-5-year-antimicrobial-resistance-strategy-2013-to-2018)
Is antibiotic resistance the same as antimicrobial resistance?
No - antibiotic resistance is included within the broader term of antimicrobial
resistance.
Antibiotic resistance relates only to the ability of a micro-organism to grow or
survive in the presence of an antibiotic, rather than other wider ranging
antimicrobial compounds.
What’s the cause of antibiotic resistance in humans and how can it be
controlled?
The consensus amongst experts is that the main cause of antibiotic
resistance in humans is the overuse and/or inappropriate use of antibiotics in
human medicine.
Inappropriate use of antibiotics could include prescribing antibiotics for viral
infections such as flu and cold where they have no effect on the virus, not
completing a course of antibiotic treatment, or prescribing the wrong antibiotic
for the bacteria involved.
The threat of increasing resistance to antibiotics is being tackled by various
initiatives in UK hospitals and GPs’ surgeries, specifically to improve
prescribing practices and reduce disease transmission.
Significant reductions in the rate of antibiotic resistance have been reported,
for example, in the rate of MRSA infections in hospitals which has been
achieved by strict infection control measures.
Can antibiotic resistance transfer between species?
There is evidence that antibiotic and antimicrobial resistance can transfer
between species.
Isolated incidents have occurred where antibiotic resistance in humans has
been directly linked to animal bacteria.
There is little evidence in the UK of transfer between species.
is concerned to ensure that the animal sector is not complacent in its use
of antibiotics. Responsible use of antibiotics is essential in both the human and
animal sectors.
Controls of the use of antibiotics in farm animals need to be proportionate to the risks
involved to humans, and the benefits to animal health and welfare.
Can antibiotic use in animals cause antibiotic resistance in humans?
There is a growing consensus that antibiotic resistance in humans is caused
by the use of, or inappropriate use of, antibiotics in humans.
Previous restrictions in certain EU countries on the use of antibiotics in
animals have not always led to reductions in antibiotic resistance in humans.
Antibiotic resistance in humans and animals is often measured differently so
comparisons of resistance levels are difficult.
2.
ANTIBIOTICS USE ON UK FARMS
Food producing animals, just like people, are susceptible to bacterial infection
and disease, whatever the system of farming. Antibiotics are used in farm
animals, as they are in people.
Effective treatment with antibiotics is sometimes necessary to protect animal
health and welfare and, ultimately, food safety and quality.
Why are antibiotics used in UK farming?
Antibiotics are used in farm animals to:
Treat and cure sick animals.
Curative treatments also know as therapy, for a sick animal or group of
animals, when the diagnosis of disease or infection has been made.
Control disease spreading in groups of animals where some are already sick.
Control treatments sometimes referred to as Metaphylaxis, for a group of
animals after a diagnosis of clinical disease within the group. This aims to
prevent the spread of disease to other animals in close contact, and at risk,
which may already be (sub-clinically) infected.
A useful comparison with human medicines would be where a child is
diagnosed with meningococcal meningitis necessitating urgent treatment of all
other in-contact children.
Prevent sickness or disease developing in a group of healthy animals where a
vet has diagnosed there could be a high risk of bacterial infection.
Preventive treatments sometimes referred to as Prophylaxis, for an animal or
a group of animals, before clinical signs of disease, to prevent the occurrence
of a disease or infection.
Preventive treatment with antibiotics in animals should:
only be applied to animals diagnosed at high risk of bacterial disease
only occur under prescription by a veterinarian on the basis of
epidemiological and clinical knowledge
not be applied routinely
not be used to compensate for poor hygiene or for inadequate husbandry
conditions.
Critically important antibiotics for human treatment should not be used
preventatively in animals or as the first line of treatment, unless there is
clear scientific justification to do so.
A useful comparison with human medicines would be where a patient is given
antibiotics before surgery to address the increased bacterial challenge during
and after the operation.
When are antibiotics used in farming?
Treating and curing infections in animals with antibiotics is under strict
veterinary direction to ensure effective disease control, and the protection of
animal health and consequent human health.
As with all infections prompt and targeted treatment is essential to prevent
unnecessary pain and suffering and animal welfare legislation requires that
sick animals receive appropriate treatment.
Antibiotics may only be used on a farm if they have been prescribed by a
veterinary surgeon.
Veterinary control is especially important for reducing the risk of animal
diseases that can pass to people.
Can antibiotics be used as growth promoters?
No. The use of antibiotics for growth promotion is not allowed in the EU.
Antibiotic growth promoters have been banned from use in the UK and all
other EU countries since 1 January 2006.
Can antibiotics be used in all farming systems?
Antibiotics are used in all farm production systems, including organic systems.
In organic systems the use of antibiotics is limited to curative treatments for
treating and curing actual infections, they are not permitted for the prevention
of sickness or disease.
How does antibiotic use differ between farming systems?
Animals in all systems of farming are vulnerable to infection and disease and
thus can be treated with antibiotics.
Antibiotics can be used under veterinary supervision and controls, in
intensive, extensive, and organic farming systems.
In organic farming, rules are set to limit the use of antibiotics to situations
where alternative treatments such as homeopathic and herbal preparations
are considered not to work. Control and preventive treatments are not
normally permitted in organic farming.Do intensive farming systems contribute more to the overall risk of
antibiotic resistance than extensive farming systems?
For optimal animal health and welfare, good animal husbandry and bio-
security practices are needed in all farming systems, whether these are
intensive, extensive, or organic.
There is no scientific evidence that intensive farming systems contribute more
to the overall risk of antibiotic resistance than extensive farming systems.
Should targets be set to reduce the amount of antibiotics used on farms?
No - all medicines on farm should be used as little as possible and as much
as necessary.
Farms should be managed to reduce the risk of disease challenge, using
medicines only when required and then using them appropriately.
Reducing dosages or the length of antibiotic treatments to use a lesser
quantity of antibiotics to meet arbitrary reduction targets is not responsible
use. It could encourage the development of antibiotic resistance and
compromise animal health and welfare.
Under UK and EU animal welfare legislation, farmers are legally required to
ensure that animals receive appropriate treatment if they become sick.
Removing their ability to do this by appropriate prescription of antibiotics could
have a negative effect on animal health and welfare.
provides free guidance to farmers and vets on the responsible and
effective use of medicines in agriculture.
Responsible use of antibiotics on farms means using antibiotics as little as possible
and as much as necessary.
Regardless of the farming system, the focus for improved animal husbandry should
include improved bio-security practices and continuous vet and farmer training about
disease prevention and the responsible use of antibiotics.
3.
RISKS TO PUBLIC HEALTH FROM THE USE OF ANTIBIOTICS IN
FARMING
Antibiotics are important for treating infection and disease and maintaining
health for both people and animals. Antibiotic resistance can develop in
people and in animals.
Antibiotic resistance develops when bacteria can survive in the presence of
concentrations of an antibiotic which would normally be lethal to bacteria of
that species.
It is possible for resistant bacteria to pass from animals to humans and vice
versa.
There is concern that the use of antibiotics in farming can cause antibiotic
resistance in humans, potentially leading to problems with the treatment of
human infections.
What is the current view of antibiotic resistance from UK experts?
The UK’s Chief Medical Officer Prof Dame Sally Davies when addressing the
All Parliamentary Scientific Committee on 11 June 2013 said “the use of
antibiotics in animals is not a massive problem in the UK – and we must work
to make sure it doesn’t become one”
It is important that all parties work together to ensure that antibiotics remain
effective for the treatment of infection and disease in people and animals, so
that when they need to be used they can be used effectively in both.
Scientific evidence increasingly recognises that the problem of antibiotic
resistance in humans comes largely from the use of antibiotics in human
medicine.
The medical profession is working to improve responsible prescribing and use
for people.
The farming sector needs to take responsible use of antibiotics and other
veterinary medicines seriously to reduce the risks of increased resistance.
Is antibiotic resistance in humans and animals the same?
Comparing human and animal resistance levels is difficult because different
ways for measuring resistance levels are often used and they are not
comparable.
The general consensus amongst microbiologists is that clinical resistance
leading to treatment failures in veterinary medicine is rare.
Different measures are used and harmonised techniques are needed in
Europe and worldwide, across animals and people, to allow for meaningful
comparisons of antibiotic resistance to be made.
What are the different measures used in humans and animals?
Most reports measure human resistance as the percentage of bacteria that
are clinically resistant to one or more antibiotics. This is known as the clinical
breakpoint (CBP).
Measurement of animal resistance depends on whether the pathogen causes
disease in animals or whether the pathogen causes disease only when
transferred to humans.
Resistance of animal pathogens is also commonly assessed by veterinarians
on the basis of appropriate clinical break points
Resistance of human pathogens in animals is more frequently measured by
the percentage of bacteria that are less susceptible to one or more antibiotics
at the epidemiological cut off value (ECV).
The ECV is a laboratory measurement of reduced susceptibility and is set at a
lower level than the clinical breakpoint and so treatment with antibiotics would
still be effective even though the ECV indicates some reduction in
susceptibility.
ECV measures reduced susceptibility, not actual clinical resistance.
ECV does not measure and is different from the clinical breakpoint.
Measuring resistance levels of human pathogens in animals (using ECVs)
effectively leads to resistance levels appearing to be higher than they are
when compared to resistance levels in humans, as the scientific methodology
is different1.
What are critically important antibiotics (CIA) and why should they be available
for use in animals?
The current range of antibiotics authorised for use in animals provides a key
element in the veterinary surgeon’s ability to treat the range of diseases they
encounter.
1
This difference is highlighted in the European Union Summary Report on antimicrobial
resistance in zoonotic and indicator bacteria from humans, animals and food in 2011 (EFSA
Journal 2013; 11(5):3196 [359 pp]). This report found that for some bacteria “little or no
resistance is reported using the CLSI clinical breakpoint in any isolates from food or animals,
whereas the situation is often quite different when the EUCAST epidemiological cut-off value
is applied to the same isolates to determine resistance”.
This range of antibiotics also includes some considered to be ‘critically
important’ for use in treating humans.
Critically important antibiotics should remain available for veterinary use since
they provide key treatments against animal diseases since there are there
currently few or no viable alternatives. The use of newer, high priority,
critically important antibiotics in the veterinary sector is already low
demonstrating that vets only use these products where they are really needed
and where ‘older’ antibiotics will not be effective.
Critically important antibiotics should not be used preventively or as first line
treatment unless there is clear scientific justification to do so2.
Critically important antibiotics for human use should be clearly defined and
these definitions should apply across all Member States of the EU.
Limitations on the use of CIAs in animals, for example as first line treatments
or under the cascade system3, should be supported by scientific evidence and
clearly shown on product labels and Summary of Product Characteristics
(SPC).
2
An exception for continued use could be as a dry cow treatment to prevent
mastitis (in cows’ udders) at the end of a milking cycle since scientific evidence
shows there is little risk of antibiotic resistance developing in this case.
3
The cascade is a provision in the Veterinary Medicines Directive 2001/82 that
recognises the lack of authorised medicines available to treat all diseases in all
species. It allows vets, exceptionally, to use a medicine authorised for a different
disease and/or species, imported from another Member State, authorised for human
use, or to be made up to treat an animal to protect animal welfare.
4.
RESPONSIBLE USE OF ANTIBIOTICS IN FARMING
Like all medicines for people and animals, antibiotics in farming should be
used responsibly, which means:
Use as little as possible - farms should be managed so that the risk of
disease developing is minimised. Good husbandry practices such as
good hygiene, well ventilated sheds, access to clean water, good bio-
security controls and good farm health planning, including appropriate
vaccination strategies, will all help to reduce the disease challenge.
Use as much as necessary - when animals become ill they should be
treated in accordance with instructions on the label and from the farm’s
veterinary surgeon.
Antibiotics should be used only as prescribed by the farm’s veterinary
surgeon.
The full course of antibiotic treatment should be given.
Critically important antibiotics for human treatment should not be used
preventively, or as first line treatment in animals, unless there is clear
scientific justification to do so.
How can responsible use of antibiotics be promoted?
Antibiotics should only be prescribed by veterinary surgeons who should also
be allowed to dispense them.
A viable network of rural veterinary practices is essential for notifiable disease
surveillance and control, and for ensuring that farm animal health and welfare
is maintained.
Companies should be encouraged to develop new antibiotics and alternatives
to antibiotics for veterinary use.
More training, especially Continuing Professional Development (CPD), should
be available to vets to help them use antibiotics responsibly and to keep up to
date with developments on antibiotic resistance.
Across the EU, Member States should be encouraged and helped to produce
responsible use guidelines relevant to their national farming practices.
RUMA provided the model for the European Platform for the Responsible Use
of Medicines in Animals (EPRUMA) which is ideally placed to help develop
future guidelines in the EU.
How can irresponsible use of antibiotics be avoided?
Crude usage reduction targets should not be set for antibiotics as this can
increase the risk of resistance.
Reduced dosages or reduced treatment periods to meet reduction targets
may result in non-therapeutic levels of antibiotics being used, which in turn
could be more likely to encourage resistance development.
The use of more critically important antibiotics where less active ingredient is
required, and where less antibiotic is used in crude weight terms, could also
encourage irresponsible use of antibiotics.
Antibiotic resistance can transfer from animals to humans and vice versa
which could lead to treatment problems: RUMA acknowledges this and
promotes responsible use of antibiotics to reduce this risk.
Current scientific evidence suggests that the vast majority of antibiotic
resistance stems from the use or misuse of antibiotics in humans.
Antibiotics can also be used responsibly to prevent disease emerging where a
vet has diagnosed a serious threat of bacterial infection in a group of animals.
However, such preventive treatment with antibiotics:
should only be applied to animals diagnosed at high risk of bacterial
disease
should only occur under prescription by a veterinarian on the basis of
epidemiological and clinical knowledge
should not be applied routinely
should not be used to compensate for poor hygiene or for inadequate
husbandry conditions.
How can farmers and vets get advice on the responsible use of antibiotics?
RUMA’s guidelines on the responsible use of antibiotics and antimicrobials
stress the need for good farm management and disease prevention strategies
to minimise the risk of disease.
RUMA encourages the proper treatment of all animals that become ill.
exists to promote the responsible use of medicines in agriculture and
provides free guidance to farmers and vets on the responsible and effective use of
medicines in agriculture.
RUMA’s guidelines are available free at
www.ruma.org.uk.
Additional guidance on prescribing for veterinary surgeons is available at
www.bva.org.uk.
5
REVIEW OF LEGISLATIVE CONTROLS FOR ANTIBIOTIC RESISTANCE
This section identifies the changes RUMA believes are appropriate and
proportionate to manage the limited risk of antibiotic use in farm animals
which could lead to clinical treatment problems in humans.
The European Commission is considering what, if any, changes to make to
the Veterinary Medicines Directive (2001/82) and the Medicated Feed
Additives Directive (90/167) to reduce any risks to human treatment.
What should be considered when reviewing legislative controls?
Decisions on controls on the authorisation of antibiotics in animals should be
based on scientific evidence
proportionate, striking the right balance between controlling the risk of
AMR in animals which might affect the treatment of humans
measurable and reviewed
taken in the light of the impact of actions (in some countries) to restrict
the use of antibiotics in animals to reduce resistance levels in humans,
including an assessment of whether these measures worked, or
whether antibiotic resistance in humans continued to rise
effective to provide the medicines necessary to enable high levels of
animal health and welfare be maintained, ultimately to ensure safe
food.
Antibiotics can be used responsibly to control disease in order to prevent it
spreading to other animals in a group: this use should continue to be
permitted.
The same requirements should apply to all products whether generic or
originator.
was set up in 1997 with the specific aim of developing and
implementing responsible use of medicines in agriculture.
RUMA is well placed to advise and assist Member States develop and amend
guidelines on the responsible use of medicines in animals.
ANNEX A
The RUMA Alliance is made up of the following 23 organisations:
Agricultural Industries Confederation
www.agindustries.org.ukAnimal Health Distributors Association
www.ahda.co.ukAnimal Medicines Training Regulatory Authority
www.amtra.org.ukBPEX and EBLEX
www.bpex.org.uk www.eblex.org.ukBritish Egg Industry Council
www.egginfo.co.ukBritish Poultry Council
www.britishpoultry.org.ukBritish Retail Consortium
www.brc.org.ukBritish Veterinary Association
www.bva.co.ukCity and Guilds Land Based Services
www.cityandguilds.comDairyCo
www.dairyco.org.ukDairy UK
www.dairyuk.orgGame Farmers’ Association
www.gfa.org.ukLEAF
www.leafuk.orgNational Beef Association
www.nationalbeefassociation.comNational Farmers' Union
www.nfuonline.comNational Office of Animal Health
www.noah.co.ukNational Pig Association
www.npa-uk.org.ukNational Sheep Association
www.nationalsheep.org.ukNFU Scotland
www.nfus.org.ukRed Tractor Assurance
www.redtractor.org.ukRoyal Association of British Dairy Farmers
www.rabdf.co.ukRSPCA
www.rspca.org.ukRoyal Pharmaceutical Society
www.rpharms.com[*/quote*]
[*quote*]
RUMA® POSITION PAPER ON ANTIBIOTIC RESISTANCE AND
ANTIBIOTIC USE IN LIVESTOCK
Introduction
1. There is much debate at present on antibiotic resistance in human medicine and
antibiotic use in human and veterinary medicine. The Prime Minister has raised the issue
and two Parliamentary Committees have considered it with various groups, including RUMA,
making submissions. Most of these submissions have been balanced but a paper by the
Alliance to Save Our Antibiotics (ASOA) (1) has once again raised various assertions about
the use of antibiotics in livestock that need to be addressed. This paper clarifies RUMA’s
position on antibiotic resistance and how antibiotics can be responsibly used in UK livestock.
It also addresses some of the inaccurate assertions in the ASOA paper.
About RUMA
2. The Responsible Use of Medicines in Agriculture Alliance (RUMA) was set up in 1997 with
the aim of promoting responsible use of all medicines in agriculture. It involves organisations
from across the food chain including veterinary bodies, farming organisations, the veterinary
medicines industry and retailers. A list of member organisations is at Annex 1. RUMA’s
work is funded entirely by members’ annual fees with an annual turnover of around £20,000.
3. One of the ways that RUMA promotes responsible use is by providing free guidelines for
farmers and vets. RUMA’s responsible use guidelines stress the need for good farm
management and disease prevention strategies to minimise the risk of disease and the need
to use medicines and then encourage the proper treatment of animals that become ill.
4. RUMA’s guidelines are applicable to all farming production systems.
5. Antibiotic resistance is an important One Health issue and RUMA supports the initiatives
on responsible use in both human and animal medicine. Antibiotics are important for
maintaining the health of both humans and animals and it is vital that all parties should work
together to ensure that antibiotics remain an effective tool in the treatment of humans and
animals so that they continue to be available and effective when needed. The key driver for
any controls on the use of antibiotics in animals is to reduce the risk of resistance in humans,
be it through the provision of safe food from healthy animals and/or preventing the potential
transfer of bacteria that have acquired resistance in animals to man. It is also important that
we ensure that veterinary antibiotics remain effective so that animal diseases can be treated
for animal health and welfare reasons.
RUMA® is a registered trademark of The Responsible Use of Medicines in Agriculture Alliance
1
Antibiotic Resistance in Humans
6. Antibiotic resistance is important. There is a clinical crisis in human medicine because
antibiotic resistance is making infections due to bacteria harder to treat with antibiotics. UK
Chief Medical Officer Professor Dame Sally Davies said “antibiotic resistance is one of the
greatest threats to modern health and we face a future without cures for infection if
antibiotics are not used responsibly”.
7. Antibiotic resistance is complex. Antibiotic resistance can and does arise through
naturally occurring mutations of the bacteria. Resistance factors can be transmitted to the
next generation of bacteria and sometimes transfer to different species of bacteria. These
resistant bacteria can spread between species including from animals to humans and vice
versa and to and from the environment.
8. We know that bacteria can transfer from animals to humans and from humans to animals
and that some of these bacteria could be resistant. But scientific evidence increasingly
recognises that the problem of antibiotic resistance in humans comes largely from the over-
use and mis-use of antibiotics in human rather than animal medicine. The Department of
Health’s 5 Year Strategy on Antimicrobial Resistance said ‘Increasing scientific evidence
suggests that the clinical issues with antimicrobial resistance that we face in human
medicine are primarily the result of antibiotic use in people, rather than antibiotics in
animals’.2 Unfortunately, despite considerable work by Public Health England, the results of
a study by the Royal College of General Practitioners3 found that though the proportion of
cases of coughs and colds where antibiotics were used decreased from 47% in 1995 to 36%
in 1999, it then increased to 51% in 2011. So there is clear and recent evidence that
antibiotics continue to be mis-used in human medicine.
9. The European Centre for Disease Control also agrees that the main cause of resistance in
humans is the use of antibiotics in people. Their Antimicrobial Resistance Fact Sheet for the
General Public 4 says “ Certain resistant bacteria that are associated with food consumption,
such as Campylobacter or Salmonella, may be transferred from animals to humans through
food. People may also acquire resistant bacteria from direct contact with animals. However,
the major cause of antibiotic resistance in humans remains the use of antibiotics in human
medicine”.
10. The House of Commons Science and Technology Select Committee’s Report “Ensuring
Access to Working Antimicrobials”5 says (paragraph 51) that “there is circumstantial
evidence that antimicrobial resistance can be transmitted from animal pathogens to human
pathogens although the evidence base is incomplete”. RUMA supports the Committee’s
call for more research into this area particularly as more recent studies have found that
resistant bacteria in humans and animals are genetically different which suggests that
animal use of antibiotics does not contribute to human resistance6,7,8. This is in direct
contrast to earlier studies referenced in the ASOA report which suggests animal use is a
major factor. We need to consider very carefully the consequences of reducing necessary
antibiotic use in animals, which can have serious animal welfare/health implications, for
possibly no benefit to reducing resistance in humans. Indeed, whilst measures in some
countries such as Denmark and The Netherlands have reduced antibiotic use in animals,
resistance by some bacteria in humans in those countries continues to increase9,10 and there
are reports of consequent animal welfare problems.
2
11. However, there can be no complacency in animal use. Antibiotics must be used
responsibly in agriculture to stop the possibility of their use leading to problems in animalhuman medicine.
Antibiotic Resistance in Animals
12. Antibiotics have been a major benefit to farm animal welfare for many years. Despite
the criticisms of the way antibiotics are used in animals there is no clinical crisis in animal
medicine as, apart from isolated cases of swine dysentery, some penicillin-resistance in
Streptococcus suis and some reported resistance to newer antimicrobials in respiratory
pathogens of animals, antibiotics continue to work for all animal treatments. Current
evidence shows that despite many years of continuous antibiotic use under veterinary
supervision their use is not leading to significant resistance problems in animals.
13. Comparing the quantity of antibiotics used in humans and animals in the UK is not
possible as we don’t actually know what volume of antibiotics is used in humans. However,
data from the Health and Social Care Information Centre shows that 376 tonnes of just one
class of antibiotic, the β-lactams, was used by GPs in England in 2012. This does not factor
in other classes of antibiotic, or any of the antibiotic use in hospitals. In contrast, the total
sales of all antibiotics for use in all animals, including companion animals, for the whole UK
in 2012 was 409 tonnes, 82 tonnes of which were β-lactams11. There is also a danger in
focusing on total usage figures as this can undermine the important responsible use
message that it is important to complete an antibiotic course. A simple ‘use less’ message
could lead some to reduce usage by not completing the full course of treatment which
increases the risk of resistance.
14. Comparison of human and animal resistance levels can be confusing and misleadingresistance is often measured differently in human and animal bacteria. In human medicine
resistance is reported when the antibiotic does not work clinically, whereas in veterinary
medicine resistance is often reported where there is laboratory detected reduced
susceptibility, even though the antimicrobial may still be effective when used to treat a sick
animal. Using the human standard of measurement would result in much lower levels of
reported antibiotic resistance in animal bacteria 12.
Responsible Use of Antibiotics on Farm
or
as
15. Farm animals, regardless of the management system, have a commercial value on farm,
a value which is directly linked to their production capability. It is therefore in the best interest
of a livestock keeper to look after his animals and to make sure that they are healthy. Much
work has been done in recent years to recognise farm animals as sentient beings and to
improve welfare standards. Indeed, farmers and vets have a legal obligation to meet high
statutory welfare standards for the animals in their care. UK farmers have a good reputation
in the EU for introducing and maintaining high welfare standards before other member
states.
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16. Animals, like humans, become ill and need to be treated with medicines. Also like
humans, medicines are used to prevent disease and, therefore, suffering in animals.
Antibiotics may only be used on farm following diagnosis and prescription by a veterinary
surgeon and they are used in the following ways:
Curative treatment (also referred to as Therapy)
Treatment of a sick animal or group of animals following the diagnosis of infection and/or
clinical disease.
Control treatment (sometimes referred to in veterinary medicine as Metaphylaxis) – whichmostly equivalent in human medicine to Prophylaxis
is
Treatment of a group of animals after the diagnosis of infection and/or clinical disease in part
of the group, with the aim of preventing the spread of infectious disease to animals in close
contact and at considerable risk and which may already be (sub-clinically) infected.
(A useful comparison with human medicines would be where a child in a classroom is
diagnosed with meningococcal meningitis necessitating urgent treatment of all other in-
contact children).
Preventive treatment (sometimes referred to as Prophylaxis)
Treatment of an animal or a group of animals, before clinical signs of infectious disease, in
order to prevent the occurrence of disease or infection.
Preventive treatment or Prophylaxis with antibiotics:
must only be applied to animals diagnosed at high risk of bacterial disease, and
must only occur under prescription by a veterinarian on the basis of epidemiological
and clinical knowledge, and
must not be applied systematically or routinely, and
must not be used to compensate for poor hygiene or for inadequate husbandry
conditions or where improvements in animal husbandry could reduce the need for
antibiotic treatment. Prophylactic treatment may be appropriate on a temporary basis,
to prevent disease in animals while the vet and farmer make improvements to bio-
security and animal husbandry on the farm, to reduce the likelihood of subsequent
batches of animals requiring treatment in this manner.
17. In order to prevent residues from a medicine that could be harmful to humans a
withdrawal period is set by the independent regulatory authorities who assess the medicine’s
features before it can be placed on the market. This is a period of time following the last
treatment during which none of the animal may be used for human consumption. After that
period tests have shown that any medicinal residue in the animal will be safe for consumers.
18. RUMA supports the call from various quarters for the collection of better data on the
usage of antibiotics in animals. We have basic information on total quantities of each
antibiotic supplied to the market but we need more detailed information on how much
antibiotic is used in each species and, ideally, why that antibiotic was used.
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19. The veterinary profession has taken a strong lead in recent years in encouraging its
members to adopt the responsible use of antibiotics. The British Veterinary Association
(BVA) and its specialist divisions have published and promoted general guidelines and
species specific guidance targeted for different sectors, some of which recommends a
formulary approach to the correct selection and use of antibiotics for the many indicationsthe wide variety of species to be treated.
Should Antibiotics be used to Prevent Illness?
20. RUMA agrees with the general premise that prevention is better than cure and believes
that antibiotics can be used responsibly in both human and animal medicine to prevent
disease and suffering. RUMA does not, however, support the routine preventive use of
antibiotics where such disease challenge can be prevented by better husbandry and farm
management. RUMA published a statement on the preventive use of antibiotics in farm
animals in April 2013 13 and this sets out how antibiotics can be used responsibly on farmprevent disease. Like in peri-operative human surgery there are times e.g. post weaning,
when animals are more susceptible to bacterial disease which will cause suffering that can
be prevented by using antibiotics.
21. The ASOA paper highlighted the benefits of the routine preventive use of antibiotics in
human surgery (page 7) and yet at the same time called for a ban on the routine preventive
(prophylactic) use of antibiotics in agriculture. The suggestion here is that preventive useagriculture leads to an increased risk of resistance which could then be transferred to
humans while the direct preventive use of antibiotics in humans does not! If there is
scientific evidence that using antibiotics in human and/or animal medicine to prevent disease
increases the risk of resistance in humans then such use of antibiotics in humans and
animals should be reduced. But why do ASOA single out the animal preventive use and
laud the human preventive use? This would appear to be an attack on conventional farming
methods and has nothing to do with saving antibiotics, the use of which the principal movers
in the ASOA, the Soil Association, spurn.
RUMA’s Position on Agricultural Production Systems
in
to
in
22. Responsible use applies to all livestock production systems used in UK farming. Farm
animals have an economical function and a commercial value: fundamentally they are there
to provide consumable livestock products. There is, therefore, a direct benefit to the
farmer/animal keeper in providing explicit care to those animals. This care is often
recognised by the emphasis on protecting and enhancing the health and welfare needs of
the animal, as expressed in the Farm Animal Welfare Committee’s (FAWC) 5 Freedoms.
Thus, farm animals are fed, housed, protected from predators and disease and generally
provided with more beneficial resources than they would experience in their ‘natural’ or ‘wild’
state. This should be the case regardless of whether the animal is organically or
conventionally managed, free ranging, outdoor or indoor housed, intensive or extensive.
5
23. The key defining success factor is the quality of the care and the level of knowledge and
understanding of the animals’ needs provided by the animal keeper, in other words the
quality of his stockmanship skills. A highly skilled stockman understands the needs of his
animals and will fulfil those needs through proper management of the environment, the
nutrition, breeding decisions, veterinary professional advice and the use of veterinary
medicines to protect the health of the animals. RUMA therefore, has no prejudice towards
any agricultural production system. All animals should be cared for in a manner that is
appropriate to their breed and their surroundings. RUMA believes that the responsible useantibiotics, and other veterinary medicines, is an important component of that care.
24. Antibiotics and other authorised medicines play an important role in preventing disease
and treating sick animals. The responsible use of medicines means using medicines as little
as possible and much as necessary. Farmers and their vets are working to minimise the
need to use a medicine by reducing the chances of disease challenge e.g. good farm
management and stockmanship, keeping animals well fed and watered, with good
ventilation. Vaccination programmes and biosecurity should be part of the farm health plan.
However, when an animal becomes ill it should be treated in accordance with veterinary
surgeon instructions with the right medicine, at the right dose for the right length of time.
25. RUMA has concerns that the use of medicines, especially antibiotics, is being vieweda product differential for some of the agricultural production systems, especially the organic and ‘aspirational’ production methods such as biodynamics. Veterinary medicines are an important tool in protecting the health needs of animals and the consuming public, and we do not feel that it is appropriate to politicise them in this way. Under certain regimes, antibiotics may only be used as a last resort after treatment with alternative medicines, such as herbal or homeopathic products, has failed. In other words, antibiotics with proven efficacy are preferentially withheld in favour of treatment with products of unproven efficacy.
This presents a huge potential to increase or extend the animals’ suffering beyond that which is necessary or acceptable in order to appeal to the ethical wants of some consumers.
There is considerable economic pressure on organic farmers not to use antibiotics as repeated doses can lead to the removal of organic status and the related financial premium.
RUMA calls on the Soil Association, and others licensing organic production, to allow antibiotics, and all other authorised medicines, to be used responsibly in the interests of animal welfare.Should Critically Important Antibiotics (CIAs) for Human medicine be used in
animals?
of
as
26. Not all medicines considered to be critically important for human medicines are licensed
for veterinary use in animals e.g. carbapenems. RUMA is unaware of any need to use such
medicines in animals and would not support any change to the current situation.
27. Fluoroquinolones and 3rd and 4th generation cephalosporins are authorised for livestock
use and form an important part of the veterinary surgeon’s armoury in treating animal
disease. Removing any antibiotic from animal use will put more pressure on the antibiotic
classes used in its place thus increasing the likelihood of resistance developing. However,
the CIAs should be used sparingly and not routinely as first choice antibiotics in animals as
set out in RUMA’s preventive use statement i.e.
6
they should be used to treat animals but not be used as 1st line treatment and then
only after susceptibility testing of the diseased animals or previous experience and
laboratory history of that farm has shown other classes of antibiotic to be ineffectivethey should almost never be used to control a disease outbreak in a group of
animals, the only exception being cases when no alternative is available or feeding
systems mean healthy animals have to be treated along with sick animals which,
ideally, should be isolated/treated separately if possible
they should not be used preventively apart from dry cow therapy which is not known
to lead to resistance issues
,
28. The dry cow period is a risk period for intramammary infections and vets and farmers
should have strategies to prevent and/or treat infections for this period. Mastitis is a
bacterial infection that can affect all mammals. It can be extremely painful in humans and
dry cow therapy can be vital to avoid suffering in dairy cows. A responsible strategy for the
dry cow period is to include a review of the epidemiological history of herd health as a whole,
and each animal individually, following diagnosis by a vet based on the animal’s Somatic
Cell Count, and her mastitis history. Treatment can include teat sealants to prevent bacteria
entering the udder and/or antibiotic tubes to suppress the infecting bacteria. There is no
evidence that antibiotic use in dry cow tubes leads to resistance. Some antibiotic tubes
include 3rd generation cephalosporin as the active ingredient and there is no evidence to
show that their use as an intramammary preparation has resulted in a change in
antimicrobial resistance patterns. Vets and farmers should regularly review all products,
including 3rd generation cephalosporins, and amend their strategy accordingly.
29. Cephalosporins, primarily the third and fourth generation ones, are not regularly used in
pig medicine in the UK, unlike in many EU countries, which have used them routinely after
surgical castration of piglets during the first week of life. In the UK it is estimated that only 1-
2% of piglets are castrated. The cephalosporins are exceptionally effective products and are
occasionally used for the treatment of acute pleuropneumonia, ‘greasy pig’ disease and
infectious arthritis, when indicated by antimicrobial sensitivity testing and when all other
medications have failed.
30. With so few authorised medicines available for vets to treat the wide range of diseases
that can affect the large number of animal species, the prescribing cascade14 is a vital
decision tree to help vets prescribe the right medicine when no authorised product is
available to treat the specific disease in the affected species. Vets follow the principles of
the cascade when prescribing the off-label use of medicines however, RUMA recognises the
difficulty of determining the correct dose when using cephalosporins off-label and
recommends that their off label use is avoided.
31. Fluoroquinolones are rarely used in poultry in the UK. Commercial poultry producers
and veterinarians acknowledge the importance of these products for human medicine.
Therefore, only in the exceptional circumstances where other therapeutic options have
failed, animal welfare is compromised and on the basis of antimicrobial sensitivity testing will
treatment with fluoroquinolones be considered. The ASOA proposed ban on fluoroquinolone
use in poultry would remove this limited use opportunity from vets jeopardising animal
welfare.
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Independence of Regulatory System
32. Human and animal medicines are regulated in the same way. Veterinary pharmaceutical
companies have to carry out tests to international standards to show their medicine is safe
(to the animal, people handling the animal or eating its produce and the environment), works
effectively and can be manufactured repeatedly to the same standards. The only difference
from human medicines is that they do not have to show safety for consumers!
33. To ensure independent scrutiny of the data provided by the human and veterinary
pharmaceutical companies the Government requires expert Civil Servants to assess them.
The Government requires the companies to pay fees to cover the cost of this work. In their
report the ASOA has implied that because the companies pay for the assessment work they
have undue influence over the regulators. RUMA is not aware of any foundation for this slur
on the integrity of the staff of the Veterinary Medicines Directorate (VMD) and by implication
their human medicine equivalent. The VMD is part of the UK Civil Service which is widely
recognised for its high integrity and professionalism and the VMD is considered a world
leader in veterinary medicines regulation. The VMD has issued an objectivity and impartiality
statement15 and all VMD staff work to the Civil Service Code16 which requires adherence to
the principles of honesty, independence and integrity.
RUMA
September 2014
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References
1. Antimicrobial Resistance – why irresponsible use of antibiotics in agriculture must stop – a
briefing from the Alliance to Save Our Antibiotics
2. Point 2.1, page 8, Department of Health UK 5 Year Antimicrobial Resistance Strategy
2013 to 2018.
https://www.gov.uk/government/publications/uk-5-year-antimicrobial-resistance-strategy-2013-to-2018
3. University College London and Public Health England study reported at
http://www.bbc.co.uk/news/health-286487854. European Centre for Disease Control Antimicrobial Resistance Fact Sheet for the General
Public
http://www.ecdc.europa.eu/en/healthtopics/antimicrobial_resistance/basic_facts/Pages/factsheet_general_public.aspx
5. House of Commons Science and Technology Select Committee’s Report “Ensuring
Access to Working Antimicrobials
http://www.publications.parliament.uk/pa/cm201415/cmselect/cmsctech/509/50902.htm6. Mather AE et al (2013) Distinguishable Epidemics of Multidrug Resistant Salmonella
Typhimurium DT104 in different hosts. Science express published on line 12 September
2013
7. Wu G, Day MJ, Mafura MT, Nunez-Garcia J, Fenner JJ, et al. (2013) Comparative
Analysis of ESBL-Positive Escherichia coli Isolates from Animals and Humans from the UK,
The Netherlands and Germany. PLoS ONE 8(9): e75392. doi:10.1371/journal.pone.0075392
8. M de Been et al. ECMID 2013 Whole genome sequence-based epidemiological analysis
of ESBL-producing Escherichia Coli'
9. DANMAP 2012 Use of antimicrobial agents and occurrence of antimicrobial resistance in
bacteria from food animals, food and humans in Denmark. ISSN 1600-2032
10. MARAN and Nethmap Report 2013 Consumption of antimicrobial agents and
antimicrobial resistance among medically important bacteria in the Netherlands and
Monitoring of Antimicrobial Resistance and Antibiotic Usage in Animals in the Netherlands in
2012
11. UK Veterinary Antibiotic Resistance and Sales Surveillance report by the Veterinary
Medicines Directorate UK-VARSS 2012
http://www.vmd.defra.gov.uk/pdf/varss.pdf12. The European Union Summary Report on antimicrobial resistance in zoonotic and
indicator bacteria from humans, animals and food in 2011 (EFSA Journal 2013; 11(5):3196
[359 pp]). This report found that for some bacteria “little or no resistance is reported using
the CLSI clinical breakpoint in any isolates from food or animals, whereas the situation is
often quite different when the EUCAST epidemiological cut-off value is applied to the same
isolates to determine resistance”.
13. RUMA statement on the preventive use of antibiotics in farm animals April 2013
http://www.ruma.org.uk/news/20130307.htm9
14. The prescribing cascade is a provision in the Veterinary Medicines Directive 2001/82 that
recognises the lack of authorised medicines available to treat all diseases in all species. It
allows vets, exceptionally, to use a medicine authorised for a different disease and/or
species, imported from another Member State, authorised for human use, or to be made up
to treat an animal to protect animal welfare.
15. VMD Statement of Objectivity and Impartiality
http://www.vmd.defra.gov.uk/pdf/VMD_Objectivity.pdf16. Civil Service Code
http://resources.civilservice.gov.uk/wp-content/uploads/2011/09/civil-service-code-2010.pdf
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ANNEX 1 List of RUMA® members September 2014
RUMA membership is open to all organisations with an interest in the areas of food
safety, animal health and animal welfare. Current RUMA members are:
Agricultural Industries Confederation (AIC)
Animal Health Distributors Association (AHDA)
Animal Medicines Training Regulatory Authority (AMTRA)
Assured Food Standards (AFS) better known as Red Tractor Assurance
British Egg Industry Council (BEIC)
BPEX and EBLEX
British Poultry Council (BPC)
British Retail Consortium (BRC)
British Veterinary Association (BVA)
City and Guilds Land Based Services
DairyCo
Dairy UK
Game Farmers’ Association (GFA)
Linking Environment And Farming (LEAF)
National Beef Association (NBA)
National Farmers' Union (NFU)
National Office of Animal Health (NOAH)
National Pig Association (NPA)
National Sheep Association (NSA)
NFU Scotland (NFUS)
Royal Association of British Dairy Farmers (RABDF)
Royal Pharmaceutical Society (RPS)
Royal Society for the Prevention of Cruelty to Animals (RSPCA)
RUMA® is a registered trademark of The Responsible Use of Medicines in Agriculture Alliance
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