addressing amr: innovation and best practices for infection ......2014/04/14 · hospital based...

| International Clinical Trials Registry Platform 1

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

| Health Systems and Innovation 2

Infection prevention

and control (IPC)

2

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



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


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


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


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


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)


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


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


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


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


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



Development of health

technologies - the global R&D Observatory

- antibiotics

- diagnostics

15

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!


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


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?


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


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…



May 13, 2014, Geneva

Informal consultation on various

proposed "business models"

21


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


Thank you for your attention

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addressing amr: innovation and best practices for infection ......2014/04/14 · hospital based...

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