Pharmaceutical Issues Priority Action Team

August, 2012

Dear Member:

As you probably remember from the last meeting, this Priority Action Team is tasked with creating key messages about antimicrobial use in livestock and poultry. These key messages are meant to function as short answers to questions from media, and from producers. Key messages are also meant to pique interest and send people to the Alberta Platform for
Responsible Use of Medicine in Animals (APRUMA.ca) website.

In the next few weeks and months, this team will continue to build relationships and create information related to this topic. As instructed by the steering committee, we will also be providing AFAHW Steering Committee members with short articles that can be used in newsletters, on websites and in speaking notes.

Please note: these key messages are intended to support steering committee members. Some members already have their
own key messages; others may find it useful to amend them.

Dr. Duane Landals

Registrar, Alberta Veterinary Medical Association

Lead, AFAHWSC Pharmaceutical Issues Priority Action Team

Key Messages for Media

Our industry is aware of and very concerned about the issue of antimicrobial resistance and the ways in which our
antimicrobial use may contribute to it.

Antimicrobial resistance is a complex problem that will require close collaboration among human health and animal
health professionals around the world.

Antimicrobial use is essential to ensure the health and welfare of animals as well to maintain a safe and adequate food
supply.

Our industry is committed to lowering the risk of AMR to human health by promoting the use of:

• the right drug
• for the right reason
• at the right dose
• for the right duration.

If you need more specific information,APRUMA.ca is a great resource for more info, or please call Dr. Duane Landals, Registrar of the Alberta Veterinary Medical Association.

Key messages for producers

AMR is an issue whenever we use drugs: it is up to us to make sure we do things properly.

The issue of AMR and antimicrobial use in agriculture is not to going away; we have to do things properly in order to
ensure continued access to the drugs we need.

It is important to use:

• the right drug
• for the right reason
• at the right dose
• for the right duration.

If you need more specific information, APRUMA.ca is a great resource for more info. If you have a specific question, please contact the association as we have contacts in the professional community to help us access information and advice.

Source: Clinical Infectious Diseases; September 2012, Vol. 55 Issue: Number 5 p687-687, 1p

Background. Therapeutic antibiotic use in humans is a significant driver of antibiotic resistance. The seasonal effect of antibiotic use on antibiotic resistance has been poorly quantified because of lack of large-scale, spatially disaggregated time-series data on antibiotic use and resistance. Methods. We used time-series analysis (Box–Jenkins) on US antibiotic usage from IMS Health and on antibiotic resistance from The Surveillance Network from 1999–2007 to estimate the effect of aminopenicillin, fluoroquinolone, trimethoprim/sulfamethoxazole, and tetracycline usage on resistance of Escherichia coli to drugs within these classes. We also quantified the effect of fluoroquinolone and macrolide/lincosamide usage on resistance of methicillin-resistant Staphylococcus aureus (MRSA) to ciprofloxacin and clindamycin (which has a similar mode of action to macrolides), respectively. Results. Prevalence of resistant Escherichia coli was significantly correlated with lagged (by 1 month) antibiotic prescriptions for aminopenicillins (0.22, P = .03) and fluoroquinolones (0.24, P = .02), which are highly prescribed, but was uncorrelated to antibiotic classes with lower prescription levels. Fluoroquinolone prescriptions were also significantly correlated with a 1-month lag with the prevalence of ciprofloxacin-resistant MRSA (0.23, P = .03). Conclusions. Large-scale usage of antibiotics can generate seasonal patterns of resistance that fluctuate on a short time scale with changes in antibiotic retail sales, suggesting that use of antibiotics in the winter could have a significant effect on resistance. In addition, the strong correlation between community use of antibiotics and resistance isolated in the hospital indicates that restrictions imposed at the hospital level are unlikely to be effective unless coordinated with campaigns to reduce unnecessary antibiotic use at the community level.

June 25, 2012

The policy objective in the Netherlands of a 20% reduction in the use of antibiotics in the years 2009-11 has been achieved, according to new data relating to the veterinary use of antibiotics published by LEI Wageningen UR.

According to the announcement, in the pig and broiler sectors, the use of antibiotics has
declined considerably. On the basis of the random sample, the decrease in use within the veal calf sector in 2009-11 was a little under 20%, but a decrease had already been achieved in this area before 2009. In the dairy farming sector, the use of antibiotics has remained fairly stable and at a relatively low level.

More than 50% of all the randomly selected farms have antibiotic use below the targets set for 2011 by the Animal Drug Authority (Autoriteit Diergeneesmiddelen, SDa). Fewer than 10% of the farms have usage levels above the signaling value and/or action value.

In the period from 2009 to the end of 2011, total sales of antibiotics in Dutch livestock farming dropped by almost 32%, from 495 metric tons in 2009 to 338 mt in 2011, the
report said. In comparison with 2007, when sales were at their highest level, the decrease is 40%. This is demonstrated by the sales figures provided by FIDIN, the Dutch federation of the veterinary pharmaceutical industry.

Full text: http://tinyurl.com/6v4ea3q

By William Dotinga

Courthouse News

June 25, 2012

(CN) – EU legislators expressed concern about the rising threat of antibiotic and antimicrobial resistance in human and animal populations, calling the situation “a growing
European and global health problem.”

In a six-page document released Friday, the Council of the European Union called on member states to develop and implement national strategies or action plans for countering
antimicrobial resistance (AMR), primarily through the reduced use of antibiotics and antimicrobial agents. The plan also orders European countries to enforce laws prohibiting the illegal sale of antibiotics, limit the use of critically important antimicrobials to acute illnesses and to curtail the use of the drugs as preventative measures.

“The Council of the European Union recognizes that the development of AMR is accelerated by excessive and inappropriate use of antimicrobial agents which, together with poor hygiene or poor infection control practices, creates favorable conditions for the development, spread and persistence of resistant microorganisms in both humans and animals,” the council said, also underlining the need for making all antimicrobial agents available by prescription only.

Full text:

http://www.courthousenews.com/2012/06/25/47782.htm

—————————————————————–

Dear Canadian Medical Association Journal:

Re: Editorial, Farm-grown Superbugs: While the world acts, Canada dawdles

The Alberta Veterinary Medical Association (ABVMA) is the professional regulatory organization responsible for the practice of veterinary medicine in Alberta, under the authority of the Veterinary Profession Act. Veterinarians registered under this act are medical practitioners with the authority to prescribe medications for the treatment of animals. Like our colleagues in the human health field, we are acutely aware of the hazards posed by the use of antimicrobial drugs.

We believe every effort must be taken to maintain the utility and safety of these products both for animal and human health. The ABVMA is partnering with animal industry stakeholders in an effort to increase awareness in all sectors of the need for appropriate stewardship of this essential commodity. We have launched a program called Alberta Platform for the Responsible Use of Medications in Animals (APRUMA) and have developed a site to exchange information on this topic, www.apruma.ca.

While we applaud the effect Barbara Sibbald, Deputy Editor, has had in stimulating awareness of this timely topic, we believe the published editorial also highlights some common areas of confusion. Certain antimicrobials can be and are used in animal agriculture in both a preventative and growth promoting capacity. These are not the same purpose, although one might support the other. In reality, both of these uses are in accordance with existing drug label claims as approved by Health Canada, and therefore should not be confused with “off label use”.

When used according to label, however, these antimicrobials do not require a prescription from a veterinarian and consequently professional supervision might be lacking.

The writer is correct in stating that the practice of veterinary medicine is regulated provincially. The classification of pharmaceuticals as either prescription only or non-prescription, however, is the federal responsibility of Health Canada. A drug classified as non-prescription is available for over the counter sales for use in animals. These then fall outside of the scope of regulated veterinary practice.

While appreciating the writers’ assertion that improved agricultural practices can contribute to safer use of antimicrobials, I believe it might be more correct to say that improved standards of animal production and hygiene might lead to improved animal welfare and reduced use of antimicrobials. There is real concern that restriction of appropriate antimicrobial use might actually lead to animal welfare concerns. This apparently has been seen in other jurisdictions.

My final reservation comes from the reference to the total percentage volume of antimicrobials used in animals versus human health. These numbers are seemingly meaningless unless the biomass of patients treated is considered.  These numbers are commonly discussed and I am not certain anyone has the best solution of how to report and compare volume of antimicrobial use.

Despite these reservations, I think the editorial is successful in once again raising the signal flag that our processes need to continually be reviewed and updated where necessary.

Sincerely,

Dr. Duane Landals BSc. Ag., DVM

Registrar, Alberta Veterinary Medical Association

Vice President, World Veterinary Association

Source: Canadian Medical Association Journal online, by Paul Christopher Webster

The contrast is alarming, experts say.

In the United States, judicial decisions and regulatory announcements are becoming daily fodder for news mills as the evidence mounts against subtherapeutic farmyard use of antibiotics. The consequences of growing antimicrobial resistance on the treatment of human diseases has become so worrisome that the World Health Organization (WHO) urged a rackdown on farm use as part of a broader action plan to contain resistance  http://whqlibdoc.who.int/publications/2012/9789241503181_eng.pdf), while Dr. Margaret Chan, WHO’s director-general, warned that the world stands on the precipice of “the end of modern medicine” (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-4164).

The Canadian response?

Utter silence.

It’s doubly ironic, the experts add, given that Canadian research and surveillance played a contributory factor in several US Food and Drug Administration (FDA) measures, including a recent ban on off-label use of cephalosporins in most food-producing animals (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-4094).

“The juxtaposition is bizarre,” notes Jim Hutchinson, medical director for antibiotic stewardship at the Vancouver Island Health Authority in Victoria, British Columbia. “Canadian government-funded research is influencing sensible policy changes in many parts of the world but is completely ignored in Canada.”

A judicial ruling and the Canadian data helped propel FDA to issue nonbinding guidance earlier this year that antibiotics important to human health be used in livestock only for medical purposes and under veterinary supervision (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-4094).

US District Court Judge Theodore H. Katz of the Southern District of New York had kickstarted a 35-year-old FDA plan to outlaw the subtherapeutic use of penicillin and tetracycline antibiotics in animal feed by ruling that the agency has a statutory obligation to commence withdrawal proceedings when safety is an issue http://nysd.uscourts.gov/cases/show.php?db=special&id=162 and www.cmaj.ca/lookup/doi/10.1503/cmaj.109-4194).

Katz again waded into the battle when he ruled earlier this month that FDA’s voluntary, nonbinding guidance is not an adequate response to its statutory obligation “to ensure the safety and effectiveness of all drugs sold in interstate commerce.”

In denying the citizen petitions of the Natural Resources Defense Council, the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen and the Union of Concerned Scientists to conduct a full evaluation of the safety of farm use of antibiotics on the grounds that doing so would be “too time consuming and resource intensive,” FDA’s actions were “arbitrary and capricious and otherwise not in accordance with the law,” Katz ruled (www.louise.house.gov/images/stories/Order_on_Petitions_Claim.pdf).

“In an eleventh hour response, the Agency pointed to a guidance program that encourages industry to use these drugs ‘judiciously,’ with no hard evidence that the drug sponsors have agreed to or will agreed to the proposed measures,”
Katz added. “By refusing to make findings as to the proposed measures. By refusing to make findings as to the drugs’ safety — or provide a statutorily based reason for refusing to make such findings — the Agency avoided the
Congressionally mandated scheme for addressing drugs not shown to be safe.”

Some critics allege FDA footdragging amounts to deregulation by stealth. “We have to hold their feet to the fire,” says Gail Hansen, senior officer for the Pew Campaign on Human Health and Industrial Farming in Washington, District of Columbia,
and former state epidemiologist and state public health veterinarian for the Kansas Department of Health and Environment.

But FDA has gone considerably further than Canada in the area. Canadian efforts to contain antimicrobial resistance are stagnant (www.cmaj.ca/cgi/doi/10.1503/cmaj.109-3109), although experts say that the Public Health Agency of Canada’s (PHAC) data warrant restrictions on off-label farm use of cephalosporins (www.cmaj.ca/cgi/doi/10.1503/cmaj.091009).
FDA’s ban on off-label use of cephalosporins was based in part on that data from the Canadian Integrated Program for Antimicrobial Surveillance. It is “one piece of a larger body of scientific data that supported our finding that extralabel uses of cephalosporin drugs in food-producing animals are likely contributing to cephalosporin-resistance in certain human pathogens,” says William Flynn, deputy director for science policy at FDA’s Center for Veterinary Medicine.

While some Canadian veterinary drug regulators are urging a crackdown (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-4055) and an internal PHAC report concluded the government’s oversight of antimicrobial resistance is deficient (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-3921), many observers are convinced that the federal government is stalling.

In failing to act on data from Canadian government scientists, the federal government has created a situation in which the nation’s regulatory regime is far laxer than in the US, says Jennifer Grant, a medical microbiologist at the Vancouver
General Hospital and Health Services Center, in Vancouver, BC. “We are not taking the opportunity to act on the evidence we are finding.”

But Health Canada rejects that notion. The department has taken “a variety of measures to promote the judicious use of antimicrobial drugs in animals and to limit the development of antimicrobial resistance,” spokesman Olivia Caron writes in an email. “These measures include the addition of warning statements specifying the conditions for antimicrobial use on the drug product labels. Health Canada is currently reassessing those antimicrobial drug products that make growth
promotion claims.”

http://www.cmaj.ca/site/earlyreleases/13june12_farmyard-drug-use-a-us-battlefield-and-a-canadian-wasteland.xhtml

“Each World Veterinary Day theme is decided months in advance of the actual day itself. From the perspective of our global organisation, the WVA, to the individual veterinarian treating an animal, there can be no more crucial theme as that selected for 2012.

“Regional guidance and national guidance on responsible use of antimicrobial medicines are easily accessible. A terrific example is the BVA’s 8-point plan for responsible use of antimicrobials in veterinary practice.  However, more species-specific guidance on best practice protocols are needed. We must all implement such guidance in our day to day work in order that the veterinary profession continues to be the recognised custodians of animal health as well as concerned professionals for human health. World Veterinary Day 2012 provides a critical wake up call for all veterinarians worldwide.”

Last October in Cape Town the WVA held a summit on antimicrobial resistance.  BVA President Elect, Peter Harlech Jones, gave a presentation on the veterinary perspective on responsible use.  Looking to the future and what the global veterinary profession can do to help, Peter stressed that every vet must be made aware of the problem; every vet should be held accountable for which antimicrobial is used; every vet must accept constraints on the use of certain classes of antimicrobials; and every professional association must communicate better the need for veterinary antimicrobials.

Antimicrobials have revolutionised medical and veterinary practice since their introduction over 60 years ago.  Today they are essential for the treatment and prevention of infectious and zoonotic diseases in both animals and humans. 

Interest in antimicrobial resistance shows no sign of abating and in many countries and regions of the world this issue is being discussed – but political efforts to tackle resistance are focusing particularly on the use of antimicrobials in animals, when effort is needed across the board.

This subject is high on the BVA’s agenda and in welcoming this year’s World Veterinary Day, BVA President Carl Padgett said:

“Antimicrobial resistance is a global problem that needs urgent action. A coordinated approach under the ‘One Health’ banner is needed to tackle resistance worldwide and I am delighted that this crucially important issue has been designated as the theme for this year’s World Veterinary Day.

“Antimicrobial resistance is a very serious problem for both human and animal health. As veterinary surgeons – no matter where in the world we live and work – we have a duty to use these medicines responsibly for the good of animal health and welfare, as well as public health.

“Preserving the efficacy of antimicrobials for use in people is vital, but the fact remains that they are also needed to treat animals.  Antibiotics are a vital tool in our armoury to combat animal diseases and the
global veterinary profession must ensure they are used prudently and responsibly if we are to avoid a crisis.

“We preach a clear message of responsible use. In both the human and veterinary worlds we must use these vital medicines responsibly, or risk losing them completely.”

Antimicrobial resistance will be discussed at this year’s BVA Congress (to be held in Liverpool from
September 28 to 29) in a debate that will consider the issues from both a veterinary and public health perspective.

Notes to editors

1.     World Veterinary Day was founded by the World Veterinary Association (WVA) in 2001 to
highlight the work of the veterinary profession around the world in food
safety/public health, border controls and quarantine, clinical practice, animal
health, animal welfare, environmental protection, research and development and
wildlife conservation.

2.      World Veterinary Day logo:

3.      Photo of Bob Stevenson, WVA European Councillor (please contact the Media Office
for a high resolution version):

4.      WVA Summit (October 2011) presentation by Peter Jones

5.      BVA’s 8-point plan for responsible use of antimicrobials in veterinary practice
(downloadable)

6.     BVA Congress Liverpool, 28-29 September 2012

7.      For further information please contact the BVA press office on 020 7908 6340 or
email media@bva.co.uk

Have you visited BVA’s new online newsroom  yet? www.bva.co.uk/news

By Lisa M. Keefe, 4/17/2012

Bacteria may have a built-in resistance to antibiotics that can be traced back millions of years, according to research recently published online by the Public Library of Science.

Adding to the debate over whether antibiotics should be administered to livestock for reasons other than to treat disease, researchers from McMaster University in Ontario, Canada, and University of Akron in Ohio, collected and cultured a sample of the microbiome of Lechuguilla Cave in New Mexico, from a region of the cave that has been isolated for more than 4 million years, according to the abstract posted online.

“We report that, like surface microbes, these bacteria were highly resistant to antibiotics; some strains were resistant to 14 different commercially available antibiotics,” they wrote.

“The implications of this study are significant to our understanding of the prevalence of resistance, even in microbiomes isolated from human use of antibiotics. This supports a growing understanding that antibiotic resistance is natural, ancient, and hard wired in the microbial pangenome.”

NY Times Article US Tightens Rules on Antibiotics