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Addressing AMR: Innovation and best practices for infection control, use of medicines and technology development
Dr Marie-Paule Kieny, ADG/HIS
Strategic and Technical Advisory Group for Addressing AMR 14-16 April, 2014, WHO headquarters, Geneva
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Infection prevention
and control (IPC)
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IPC to combat AMR in health care settings
• Strong global and national programmes are in place in
some countries and evidence-based guidance is available
• Some best practices contributing to reduce AMR
transmission are clearly identified
Simple measures highly effective at low cost (e.g. hand hygiene)
More complex mix of interventions are needed for some
microorganisms (e.g. MDR Gram negative bacteria)
• However, many countries and settings are still struggling
to establish IPC programmes and infrastructure and to
implement best practices at the point of care
• Cost-effective and innovative approaches would be
beneficial for both advanced and developing settings
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Innovation and R&D perspective for IPC
– supporting IPC implementation
• North/South and South/South country and/or hospital
partnerships can support IPC programmes development
or strenghtening in developing countries (e.g. though the
APPS programme)
• Effective advocacy messages should address IPC as
patient safety and UHC issues
• New financial mechanisms are needed to promote
sustainability
• Validated mathematical models are useful for testing cost-
benefit of IPC interventions to reduce AMR burden
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Innovation and R&D perspectives for IPC
– enabling change
• Innovative approaches are needed to achieve
behavioural change of front line staff with regards to IPC
• New approaches can foster patient participation in
improving IPC practices, from the community to health-
care settings
• Human factors should be included as well as engineering
expertise in designing better systems for preventing AMR
transmission in health care settings
• Research is needed to evaluate impact and cost-
effectiveness of IPC measures in settings with limited
resources
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Innovation and R&D perspectives for IPC
– new models & technologies
• Electronic systems/databases can help monitoring
structure and process indicators to assess
implementation of IPC measures to reduce AMR (e.g.
hand hygiene compliance)
• Research is needed for understanding interactions and
transmission mechanisms of AMR infections between the
community and health-care settings
• Rapid diagnostics will be essential to identify carriage or
infection by MDR organisms, allowing early/timely IPC
measures implementation
• New technologies are needed to reduce the transmission
of MDR organisms, such as vaccines
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Use of medicines
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Evidence of problems in use of medicines in Europe Source: First data on antibiotic use in non-EU countries of WHO European region should stimulate development of
national action plans; Lancet Infect Dis, March 20, 2014
Total antibiotic use in 12 European countries and Kosovo, 2011
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Some issues identified
• Variability in levels of use: range 15.3 - 42.3 DDD/1000/day
– Turkey highest – has stimulated interventions towards rational use
– Armenia lowest – underuse may be related to poor availability
– High levels of outpatient injectable antimicrobials in some countries
• Lack of information systems: rely on sales data; however will
include antibiotics procured without a prescription
• Self-medication common: >50% sold OTC in most countries
in spite of antibiotics being prescription drugs
• Choices vary: 1. underuse of first line treatments;
2. overuse of combination amoxicillin+β-lactamase inhibitors and respiratory
quinolones, high use of amphenicols - some countries (chloramphenicol had been
widely used for diarrhoea treatment)
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How do we achieve better use of antibiotics?
– Need political commitment, intersectoral involvement & coordination (e.g. human health, animal health, agriculture)
– Availability of reliable data on use, of policy guidance and best practices
– Action at different levels – from national policies to facility
level coordinated interventions
– Build and strengthen partnerships: a) Ministries of Health & Agriculture (human and veterinary sectors)
b) Other countries and regional networks
c) International agencies
d) Organisations & institutions involved in promoting rational use
e) Civil Society and patient organizations
f) Others
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Concrete actions: Prescribers and dispensers (1)
• Undergraduate, postgraduate education programs – appropriate use of antimicrobials, disease prevention
• Use of treatment guidelines and limited medicine
formularies
• Regulate/control promotional activities of industry
• Patients' education on antimicrobial use e.g.
encourage adherence to prescribed regimens
• Audit on antibiotics use and feedback of prescribing
performance
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Concrete actions : Policy-makers in hospitals (2)
• Establishment of effective Drugs and Therapeutics Committees
• Development of Treatment Guidelines and formularies for
hospital setting
• Implementation of “Antibiotic stewardship” programs
Hospital based programs promoting appropriate use involving multidisciplinary
teams of infectious diseases physicians, pharmacists, clinical microbiologists, and
infection control practitioners
• Monitor usage, with feedback to prescribers
• Access to appropriate laboratory facilities for testing, timely
reporting of results and surveillance reports
• Regulate/control pharmaceutical company activities in hospitals
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Concrete Actions: Governments and health
systems (3)
• Actions to contain AMR should be a national priority
Create inter-sectoral task force to develop national strategy
Use indicators to monitor and evaluate impact of the strategy
Alignment of strategy with other countries, within regional structures
• Policies and guidelines
Develop and use EML
Develop and use best practices for procurement, supply and adherence to treatments
• Education
Access to independent information; approved prescribing
literature
• Surveillance of resistance, antimicrobial usage & consumption;
sharing of information among countries & with regional and global mechanisms
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Quality of antimicrobial agents:
challenges and actions to address them
• Substandard and counterfeit antimicrobials
In 2014, reports of Coartem without active ingredient
Treatment failures lead to excessive mortality and morbidity
Promotes development of drug-resistant strains e.g. MAL, TB, HIV
• Public health responses and interventions
Strengthen medicines regulatory authorities (MRAs)
Enforce regulations relating to registration, production, and distribution; enhance
national laboratory capacity for quality control and monitoring; enhance capacity
for inspection of manufacturing facilities
Eliminate irrational antibiotic combinations and irrational pack sizes; regulate the
pharmacy and drug sellers to only sell antibiotics with prescription; regulate
veterinary market (no antibiotics as growth promoters, separate types of
antibiotics to be used in human and veterinary medicine)
Organize campaigns aimed at the public at large to reduce use of antibiotics
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Development of health
technologies - the global R&D Observatory
- antibiotics
- diagnostics
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Discovery of new classes of antibacterial
drugs (1930s to 2000s)
WHO, 2012. The evolving threat of antimicrobial resistance. Options for action.
Need for development of therapies
that do not drive resistance!
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AMR-related R&D: What would a health R&D Observatory enable users to do?
The information and data on the Observatory would enable users to:
Analyze data on financing and policy for global health R&D;
Produce analysis to inform National R&D portfolios management;
Guide R&D priority setting at national, regional and global levels;
Benchmark activities e.g. between countries
Monitor and Evaluate trends against national, regional and global strategies.
Facilitate coordination
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Build and draw on what is there
Many sources
Regional (e.g. PRAIS)
Patents
ICTRP
RICYT OECD
EURO Stat UNESCO
G-FINDER Product pipiline HRWeb
WorldRePort
Publications
Global Health
Observatory
Global Innovation Platform
Global Health R&D Observatory
National
National
National
Industry? Industry?
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Current Situation
IMI Bioventures,
IFPMA manufacturers
Company A
Market
EU, US or other investors
$300M/project
Irrational use of antibiotics
Market fall off in few years w resistance
IP IP Licensed to Agrobusiness Subsidiary Y
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Proposed Initiative: Innovation for AMR
Innovation Development Production (under contract)
Managed Market
Prizes
Initiative Consortium IP
IFPMA, Generic manufacturers
WHO IP
Academics
Biotechs
Biotechs
Pharma Pharma
Approx $2-5B
Antibiotic X, Y, Z…
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May 13, 2014, Geneva
Informal consultation on various
proposed "business models"
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Improving diagnosis: rapid methods for antimicrobial
susceptibility testing (AST) at the point-of-care in LMICs
Expert consultation in Geneva, 8-9 April 2014
Goals: • Review the status of AST in LMICs as well as current AST methods
used
• Review new methods and their potential for use in LMICs • Start developing a road map to stimulate the development of and
access to suitable tools for AST in LMICs (with a focus on PoC tools)
Participants: academia, industry, NGOs and WHO.
Results: Consensus on the need for a broad roadmap to facilitate the development, access and use of suitable diagnostic tools to combat AMR at all level of the health care systems in LMICs
Focus for working groups:
• Mapping of existing diagnostic tools for AMR • Assess the needs and develop TPPs, with very clear definitions of point
of care • Coordinate market analysis for diagnostics responding to the TPPs
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Thank you for your attention
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