Transcript of "VIV Animal Health Summit, Closing CEO-level Conference, Mr. Thomas Shryock, VIV Asia 2013"
Perspectives on Antibiotics in AnimalsInternational Federation for Animal Health (IFAH)Dr. Thomas R. Shryockrepresenting IFAH on behalf of the Asian Animal Health AssociationSenior Research Advisor Elanco Animal Health Greenfield Indiana USA Advisor, Health, Greenfield, Indiana,
What is IFAH?● Global body representing companies engaged in the research, development, manufacture and commercialisation of animal health products in both developed and developing countries across the five continents.● IFAH’s members include animal health companies and national/regional animal health associations. In turn, these associations represent a broad range of concerns, f from small, l ll local b i l businesses t i t to international enterprises. T ti l t i Together, th these companies supply approximately 80% of all animal health products used worldwide.● IFAH is an international non-profit organisation, registered under Belgian law and non profit organisation law, based in Brussels.● More information: www.ifahsec.orgPerspectives on Antibiotics in Animals 2
IFAH’s Mission● To foster a greater understanding of animal health, and to promote a predictable, science-based regulatory environment that facilitates the supply of innovative, quality products into a competitive market place. These products contribute to the supply of safe, healthy food, and to high standards of health and welfare for animals and people.Perspectives on Antibiotics in Animals 3
Working toward these goals, IFAH:● Acts as the voice of the industry in dialogue with international bodies such as the OIE, FAO, WHO, Codex and WTO, with governments, animal health stakeholders, food industry partners, and with consumers;● Encourages and assists the development of predictable, science-based regulatory procedures and standards;● Supports international harmonisation of testing requirements for animal health products, facilitating the f ilit ti th availability and d li il bilit d delivery of new and i f d innovative t l f use b th veterinary ti tools for by the t i profession and animal owners worldwide;● Provides information on the benefits of animal health products for animal health and welfare, food safety a d pub c health; ood sa ety and public ea t ;● Promotes the value of research-based medicines, developed to the highest standards and authorised in accordance with the regulatory criteria of quality, safety and efficacy;● Ensures the availability of all classes of veterinary medicines, to the benefit of animal health and welfare, and promote their responsible use;● Provides expertise on emerging diseases, fulfilling its role as part of the solution to controlling these diseases in animals.Perspectives on Antibiotics in Animals 4
Food Economics and Consumer Choice An overview of the challenge ahead1 Green, R. et al. January 2005. “Farming and the Fate of Wild Nature.” Science 307.5709: 550-555; and Tilman, D. et al. August 2002. “Agricultural sustainability and intensive production practices.” Nature 418.6898: 671-677.2 “World Agriculture: toward 2015/2030.” 2002. United Nations Food and Agriculture Organization, Rome. Accessed 12/8/08. <ftp://ftp.fao.org/docrep/fao/004/y3557e/y3557e.pdf>. TECHNOLOGY’S ROLE IN THE 21 ST CENTURY
The Issue… ●Veterinary vs. Medical need for antimicrobials ●Selective pressure of antibiotic use in animals ●Zoonotic bacteria may be exposed to drug during y p g g antimicrobial use for food animal infections and transfer to humans via contaminated food - Animal A i l antibiotic use i not the source of all h ibi i is h f ll human antibiotic resistance!
EPIDEMIOLOGY OF ANTIMICROBIAL RESISTANCE AQUACULTURE Sea / Swimming Lakes Drinking Water Drinking Rivers and water Streams Industrial & Household Antibacterial SOIL Chemicals Farm Effluents and Manure Spreading Sewage WILDLIFE DeadRendering Offal stock Vegetation, Vegetation Seed Crops, Fruit SWINE HUMAN SHEEP CATTLE Commercial COMMUNITY Animal Handling FOOD Abattoirs / Meat HOSPITALIZED - URBAN Feeds F d Preparation P ti VEAL ANIMALS Processing -RURAL Consumption CALVES POULTRY Plants OTHER EXTENDED FARMED CARE LIVESTOCK FACILITIESCOMPANION Direct ANIMALS Contact after Linton AH (1977), modified by Irwin RJ
Global "authority" Reports/Recommendations since 1997● WHO (Berlin, FQ, Global Principles of Use, Use Monitoring, Aquaculture, AGISAR)● OIE (Terrestrial Code, Scientific Technical Review, 2012)● Codex -various● Europe (CVMP, EFSA, National reports, etc.)● U.S. (NRC, CDC, FDA, GAO, IOM, Public Health Action Plan, etc.)● Australia (JETACAR)● Canada (Adv. Com. Report, CCAR)● Other reports from institutes, foundations, professional organizations, etc.
Summary ofActions and RecommendationsInternational and National Level● Responsible Use Guideines - Appropriate veterinary antibiotic use practices described; education disease education, prevention, stakeholder responsibilities● Antimicrobial Resistance Monitoring● Antimicrobial Sales Monitoring● Regulatory Controls - Risk assessment-based regulatory decisions on microbial food safety guide decisions on product use: p - Approval with appropriate label indications and use, prescription● Research - New products, new methods
Antimicrobial Resistance Monitoring● Objective - detect trends over time in AMR of food borne bacteria or animal pathogens● Harmonized testing methods and data reporting (ECV vs. BPT) are needed (CLSI X08-R; AGISAR, OIE Terrestrial Code 6.7)● Data must relate to the context of actual use on-farm for clinical practice changes; national, cumulative data provides only a high-level view Figure 1. Distribution of MICs and Categorization by Clinical Breakpoints Contrasted to ECVs. CLSI X08-R. 2011.Perspectives on Antibiotics in Animals 10
Antimicrobial Sales / Use Monitoring● Objective is to obtain data on antimicrobial use for: - Benchmarking (high versus "average" use) - Set d S t and monitor reduction t it d ti targets t - Investigate potential links between use and prevalence of resistance for risk assessment purposes - Compare use in animals with that in humans● Sales data does not inform about actual field use practices● Use data must come from on-farm records or surveys● Harmonized data collection methods are desirable to make comparisons country country- to-country or for specific assessments - OIE Terrestrial Code Chapter 6.8 - ESVAC approach for Europe - US FDA approach h● Data should ideally be collected by species● Data must relate to the context of actual use on-farm for clinical practice changes; national, cumulative data provides only a high-level viewPerspectives on Antibiotics in Animals 11
Implementation of Risk ManagementInterventions without Risk Assessment● Actions taken without full consideration of Consequences may lead to undesired and unintended negative effects with little / no positive benefits - Mandated volume reduction programmes - Removal of certain product label indications - Creation of overly restrictive product labels - Not connecting food safety interventions to exposure g y p - Categorization of antibiotics for importance without risk assessment basis● Observed unintended consequences - Shift to importing meat products in some EU countries as farms go out of business - Increased animal disease leading to increased therapeutic use - No net decrease in AMR key human pathogens (VRE, FQ resistant salmonella, etc) - Non-attributable linkage of human pathogen AMR to animal antimicrobial use (ESBLs, ESKAPE pathogens, MRSA) - Precautionary approach to new antimicrobial registration process may i hibi i P i h i i bi l i i inhibit innovation i - Antibiotic categorization acceptance leads to unnecessary formularies, avoidance of use by veterinarians and confounding in risk assessments - Alternatives that may not be characterized for quality, safety or effectivenessPerspectives on Antibiotics in Animals 12
Responsible Use GuidelinesDirected to Stakeholders or as Clinical Best Practices● Codex CAC/RCP 61-2005● OIE Terrestrial Code Chapter 6 9 6.9● WHO Responsible Use Principles 2000● WVA Global Basic Principles● EPRUMA Best Practice Framework● AVMA Judicious Therapeutic Use Guidelines● Many others others…● Note: Therapeutic Use includes Prevention, Control and Treatment
Definitions● Therapeutic - Group or Individual Treatment - Treatment – administration to clinically ill animals - Control C t l – administration t a group of animals, some of which are clinically ill some which d i i t ti to f i l f hi h li i ll ill, hi h are prodromal (incubating) and some of which are not exposed. - Prevention – administration to animals that are at high risk of becoming ill due to pathogen exposure● Non-therapeutic - Administration to healthy animals for the intention of increased performance, e.g. feed efficiency, rate of weight gain, etc. - Differentiation may be made by some regulatory agencies with regard to the type of antimicrobial agent administered, for example: • Non-human antimicrobial agent use (example: ionophores) • Medically important antimicrobial use (example: tetracyclines, etc.)
Ensuring Animal HealthPerspectives on Antibiotics in Animals 16
Veterinarian Oversight includes…● Establish veterinarian-client-patient-relationship● Establish herd/flock health care program to minimize disease prevalence● Obtain accurate disease diagnosis and/or utilize clinical judgment● Determine need for treatment and appropriate product● Administer product per label directions or extra-label use algorithm when necessary● Maintain adequate records of diagnostics, treatment and clinical outcome to guide subsequent use
Why Veterinarian Oversight?● Veterinarians are viewed as having the necessary experience and accountability to prescribe antibiotics – just like physicians - Therapeutic indications!● Disease presentation, diagnostics, client relationship and other considerations require veterinary expertise to integrate into a medication decision● Consistent with Responsible Use Principles
Consensus Clinical Practice Guidelines(directed to veterinarian)● Prevention strategies emphasized - Minimize Mi i i environmental contamination; vaccinate; bi i t l t i ti i t biosecurity, nutrition, it t iti housing, management at high levels● Minimize therapeutic use - Treat only at-risk or ill animals● Utilize only licensed products by label directions; exercise clinical judgment for off-label usages● Utili Utilize culture and sensitivity lt d iti it● Use narrow spectrum antibiotics when possible● Vet-client-patient p relationship encouraged ( p g (mandatory in some y countries)● Record keeping● Periodically review usage practices
Regulatory● Regulatory agencies for veterinary medicines should have specific antimicrobial guidelines and scientific expertise available● A stable, predictable risk assessment guideline, based on the OIE approach, should guide product evaluations as part of the approval process● Harmonisation o regulatory gu de es a e suppo ted a o sat o of egu ato y guidelines are supported - VICH - OIE Risk Assessment - AMR monitoring - Antimicrobial Sales / Use data monitoring● Novel antimicrobial agents may require unique regulatory reviews - For example, bacteriophages or novel peptides or immune enhancing agentsPerspectives on Antibiotics in Animals 20
Research● New antimicrobials for animal health will be needed in the future● Cost: up to $100M USD● Time: 7-10 years (concept to launch)Perspectives on Antibiotics in Animals 21
EPRUMA…parting thoughtIt is essential that all parties work together to ensure safe use and to minimise the development of resistance. A guiding principle with respect to antimicrobials should be: “As little as poss b e, as much as necessary” s tt e possible, uc ecessa yWe owe it to both present and future generations to use these agents with care and discrimination. discrimination In this way those to come will benefit as we have from these way, benefit, have, valuable medicines.Perspectives on Antibiotics in Animals 22