Post on 06-Mar-2018
World Organisation for Animal Health · Protecting animals, Preserving our future | 1
Dr Jean-Pierre OrandHead of French Agency for Veterinary Medicinal Products
OIE Collaborating Center for Veterinary Medicinal products
Combatting Antimicrobial resistance through a One Health approach:
Actions and OIE Strategy
Paris 24 May 2016
84th General Session
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AMR – shared responsibility
Antimicrobial resistance (AMR) is not a new phenomenon, but concerns are growing
Antimicrobial agents are essential to ensure human health, animal health and welfare, and food security
The human, animal and plant sectors have a shared responsibility to prevent or minimise the development of antimicrobial resistance by both human and non-human pathogens.
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One Health Approach
A holistic and coordinated management across the animal, food and human sectors in different ecosystems and geographic locations
Improved intersectoral collaboration where regulations of medicines are managed by different entities
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FAO-OIE-WHO Tripartite Agreement/Vision
The Global Action Plan published by WHO in 2015 is a next step in the collaboration between WHO, FAO and OIE:- Tripartite approach, collective actions to fight
against AMR- Ensure that antimicrobials continue to be effective
and useful- Promote prudent and responsible use- Ensure global access to medicines of good quality
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International Standards and Guidelines
Good Governance to ensure good quality and prudent use of antimicrobial agents
Surveillance and collection of data on the use of antimicrobial agents in animals
Capacity building and PVS tools
Communication
The OIE fully contributes to this strategy:
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Point 1
International Standards and Guidelines
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OIE Standards and GuidelinesWHO and FAO participate in the ad hoc Group on AMR
Terrestrial and Aquatic Code “Chapters” cover Harmonisation of national antimicrobial resistance
surveillance programmes Monitoring of the quantities and usage patterns Responsible and prudent use Risk assessment (linked to the use of antimicrobial
agents in animals) Veterinary legislation
Updated and adopted between 2012 and 2015
http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/
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OIE Standard and Guidelines
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals defines General Guidelines :
3.1. Laboratory methodologies forbacterial antimicrobial susceptibility Testing
revision will be needed in light of veterinary pathogen resistance surveillance
http://www.oie.int/en/international-standard-setting/terrestrial-manual/access-online/
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OIE List of Antimicrobial Agents of Veterinary Importance
Updated in 2014 to take into account concerns for human health
For a number of antimicrobial agents there are no or few alternatives for the treatment of diseases in target species. Among the Veterinary Critically Important Antimicrobial Agents, some are also of critical importance for human health (third and fourth generation Cephalosporins, and Fluoroquinolones):
• Not to be used as preventive treatment in feed or water or in absence of clinical signs
• Not to be used as first line, unless justified and bacteriolgicaltest
• Extra label/off label limited and reserved for instances no alternatives are available.
http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/OIE_list_antimicrobials.pdf
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Point 2
Good Governance to ensure good quality and prudent use of
antimicrobial agents
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Good GovernanceBenefitsAntimicrobial agents as other veterinary medicinalproducts (VMPs) are veterinary tools, contributing to theimprovement of animal and public health worldwide, and toeconomic development
Risks Animal safety User safety Food safety Environmental safety Antimicrobial resistance
Good Governance for good quality, safety, efficacy
Manufacturer
Wholesaler
Retailerveterinarianspharmacist
others
Consumer
Antimicrobial chain
Farm
Importer
IllegalImport
CounterfeitingFalsification
Animal HealthZoonosis, decrease of
production
EnvironmentPollution
efficacy toxicity
residue
Manufacturer
Wholesaler
Retailerveterinarianspharmacist
others
Authorisation: antimicrobials, premisesand activities
Farm
Importer
LicenseFor activity
Transparency :- Official list of
the premises- website
Good practices :- Conditions of manufacturing- Traceability- Conditions of Storage- Conditions of deliverance
GMPGDP
Registrationof Antimicrobials
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VICH =International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VMPs)
Canada
Observers
Full Members
OIE : Associate Member, IFAH : Secretariat
Outreach Forum
14
Registration of VMPs harmonisation
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Role and benefits of VICH
• To harmonise technical requirements for data necessary for registration
• Use of internationally harmonised guidelines to: Increase availability of new Veterinary Medicinal
Products, facilitate and accelerate their authorisation, Ensure safe, efficient products of good quality, Reduce animal testing and costs of development Contribute to public/animal health, environment
Manufacturer
Wholesaler
RetailerveterinariansPharmacist
others
Control of Antimicrobials
Farm
Importer
Control of :- Antimicrobials are authorised- Traceability- Conditions of Storage- Conditions of deliverance
InspectionSampling
IllegalImport
CounterfeitingFalsification
Quality Control
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Veterinarians play a crucial role with their responsibility in prescribing and delivering antimicrobial agents
Education of Veterinarians and paraprofessionnals
OIE ad hoc Group on Veterinary Education develop OIE Guidelines setting out minimum competencies required:• Best practices for antimicrobial agents
• Mechanism leading to AMR
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Point 3
Surveillance and collection of data on the use of
antimicrobial agents in animal
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Recommendations of the OIE Global Conferenceon the responsible and prudent use of antimicrobial
agents for animals
To the OIE Member Countries3. To develop and set up an official harmonised
national system for collecting data on the monitoring of antimicrobial resistance in relevant animal pathogens and quantities of antimicrobial agents used in food producing animals at the national level based on the OIE standards.
To the OIE7. To collect harmonised quantitative data on the
use of antimicrobial agents in animals with the view to establish a global database.
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Supported by tripartite (FAO/OIE/WHO)
Developed and followed by ad hoc Group (WHO and FAO participate)
Tested in OIE National Focal Point Trainings
Part of Global Action Plan on AMR
Endorsed by OIE Delegates (Resolution No. 26 adopted in 2015)
OIE global database on the use of antimicrobial agents in animals
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Status: OIE global database on the use of antimicrobial agents in animals
Phase One: questionnaire sent to Member Countries: October/November 2015
Training of OIE Regional and Sub‐regional technical contact points: October 2015
4th cycle National Focal Point training (Uganda,Japan, Senegal)
Ad hoc Group meeting: January and June 2016 Feedback to the OIE World Assembly: May 2016
global sustainable long-term investment
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Baseline information [All]all OIE Member Countries (MCs) can provide at least part of the requested details
Three Reporting Options:
REPORTING OPTIONS
1 Overall amount sold for/used in animals by antimicrobial class; with the possibility to separate by type of use (therapeutic use / growth promoter)
2 Overall amount sold for/used in animals by antimicrobial class; with the possibility to separate by type of use and species group
3 Overall amount sold for/used in animals by antimicrobial class; with the possibility to separate by type of use, species group and route of administration
OIE Database on the use of antimicrobial agents
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81,5
65,5
81,3
67,9
41,7
AFRICA AMERICA ASIA EUROPE MIDDLE EAST
Proportion of OIE Member Countries submitting questionnaires by OIE Region
44/5419/29
26/3236/53
5/12130 (72%)Member Countries responded
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Completeness of Templates (global)
Baseline Information + Option
28%
23%
49%
No reply
Baseline Information onlyn=180
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Reporting Options
n=89
32%
64%
3%33%
68%
BASELINEINFORMATION
OPTION 1
OPTION 2
OPTION 3
Quantitative
QualitativeData
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Proportion of OIE Member Countries that authorise antimicrobial agents as growth promoters
YES = 34 NO = 96n=130
26%74%
YES NO
Decrease in % of countries that authorise growth promotors(49% in 2012)
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42
9
33
61
11
7
17 17
IMPORTS MANUFACTUERS MARKETINGAUTHORISATIONS
HOLDERS
WHOLESALERS FEEDMANUFACTURES
USE VETERINARIANS PHARMACIE0
10
20
30
40
50
60
70
Global Data Source
n=89
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84%
15%
1%
Oral Injection Other
Global Route of Administration
n=29
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1,9% 0,9% 0,0% 0,3% 0,3% 0,1%
4,0%
0,0% 0,3% 1,1%
15,8%
0,1% 0,1% 0,1%
7,4%
0,5%
4,8%
0,1% 0,0%
7,3%
47,8%
0,6%
7,0%
0,0%
10,0%
20,0%
30,0%
40,0%
50,0%
60,0%
First evaluation of the respective use of the antimicrobial classes
n=89
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How the OIE global database will benefit Member Countries
The database will not only provide a solid foundation for the work of the three organisations in their fight against bacterial resistance, but the information gathered will also make it easier for Member Countries to:
• analyse and control the source of the veterinary products, • obtain more reliable information on imports, • trace their movements, and • better evaluate the quality of the products in circulation• to measure trends in the use of antimicrobial agents in
animals over time
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Point 4
Capacity building and PVS tools
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OIE support to Good Veterinary Governance
• Collaborating Centres
• Twinning
• PVS Evaluation
• Network of National Focal Points
• Standards and Guidelines
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Capacity Building, Specific Activities,
Projects and Programs
PVSGap Analysis
PVS Evaluation
PVS EvaluationFollow-Up Missions
Veterinary Legislation
Public / PrivatePartnerships
VeterinaryEducation
Laboratories
Diagnosis Prescription
Treatment
including Veterinary Services’ Strategic Priorities
The OIE collaborates with governments, donors and interested parties
PVS Pathway: A tool for evaluation of veterinary governance
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Twinning Twinning Programme involves creating and supporting a
link that facilitates the exchange of knowledge, ideas and experience between two Veterinary entities
Method for improving institutional capacity in Member Countries
Ultimate aim is to create more centres of excellence for veterinary education/Labs in geographical areas that are currently under-represented
Twinning is part of the wider OIE initiative to improve the capacity of Veterinary Services; it therefore has synergy with the OIE PVS Pathway
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National Focal Points for Veterinary Products
The OIE has launched a global programme of capacity building for OIE Delegates and OIE National Focal Points.
One of the objectives is to provide good governance concepts to the main actors of National Veterinary Services.
Among the elements of governance, the OIE grants great importance to the good management of veterinary products, from both animal and public health points of view.
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Resolution No. 25 (2009) Recommendations to OIE Member Countries
4. Nominate a national focal point for OIE on matters related to veterinary products according to the suggested Terms of Reference and encourage his/her participation in training sessions and appropriate international gatherings and meetings.
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Establish a network of veterinary product experts within his/her country or communicate with existing network;
Establish and maintain a dialogue with the Competent Authority for veterinary products in his country, and to facilitate cooperation and communication among several authorities where responsibility is shared;
Terms of Reference: Specific tasks
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OIE Relevant Collaborating Centres:
• ANSES (ANMV), Fougères, France
• NVAL, Tokyo, Japan
• FDA (CVM), Rockville, USA
• USDA, Ames, USA
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Point 5
Communication
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Communication on AMR
• AMR is a whole of society problem
• To promote behavioural changes needs awareness of all actors including consumers
• OIE actions for communication: – World Antibiotic Awareness: Free access material to facilitate
communication– Materials: Codes, Scientific and Technical Review, compilation of
OIE standards, guidelines and Resolution– International conferences– website
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Information is available at the OIE website
41
Antibiotic Awareness Week
Access the WHO page dedicated to World Awareness Week 2015
http://www.oie.int/es/para-los-periodistas/amr-es/related-links-es/
http://www.oie.int/en/for-the-media/amr/waaw2015/
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Communication and capacity building
The OIE Strategy regarding antimicrobial agents
Now available from www.oie.int/boutique
Product title: Antimicrobial resistance in animal and public health Scientific and Technical Review 31 (1)
Author(s): J. Acar & G. Moulin; Ed.: 2012
Summary :The focus of this Review is to address the various factors that must be taken into account when trying to understand the antimicrobial resistance problem, with a particular focus on the use of antimicrobials in animals.
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Information is available at the OIE website
ANTIMICROBIAL RESISTANCE (AMR):
• http://www.oie.int/en/our-scientific-expertise/veterinary-products/antimicrobials/
• http://www.oie.int/en/for-the-media/amr/multimedia-ressources/
OIE Standards, Guidelines and Resolution on antimicrobial resistance and the use of antimicrobial agents
Author(s) : O IE; Ed. 2015
This special publication has been prepared to support the Global Action Plan on Antimicrobial Resistance (GAP-AMR) that WHO is developing in collaboration w ith FAO and OIE
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Conclusion
AMR is a major public health concern
Awareness raising at all levels, AMR is a priority and the OIE developped several actions
to help control the risks: • Setting standards and guidelines• Implementation of capacity building programmes for better
governance with the aim of improved veterinary stewardship on veterinary products
• Surveillance and data collection on antimicrobial use in animals
• Awareness and communication
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Conclusion
OIE seeks for support to enable Member Countries
to implement standards and recommendations
to build capacity and strengthen veterinary services
to establish national action plans
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Conclusion
In line with the OIE Sixth Strategic Plan (2016 - 2020) and contributing to the Global Action Plan on AMR adopted in May 2015 , all OIE actions should be
compiled and presented as the
OIE Strategy on antimicrobial resistance