Stratégie et action européennes

Dominique L. Monnet, Senior Expert and Head of Disease Programme Antimicrobial resistance and Healthcare-associated infections (ARHAI) European Centre for Disease Prevention and Control

Paris, 21 November 2012

Résistance aux antibiotiques : une impasse thérapeutique ? Implications nationales et internationales

Methicillin-resistant Staphylococcus aureus (MRSA) in Europe, 1990-1991

Source: Voss A, et al. Eur J Clin Microbiol Infect Dis 1994;13.50-55

<3%

3 – 9%

10 – 29%

>30%

Did not participate

0

10

20

30

40

50

60

70

MR

SA

(%

)

Henri-Mondor Hospital, Paris

Denmark • Increased awareness about hospital hygiene • More rational use of broad-spectrum antibiotics

Meticillin-resistant Staphylococcus aureus (MRSA) in one hospital in Paris (all isolates) and in Denmark (blood isolates), 1960-1995

Source: Danish Staphylococcus Reference Laboratory (in DANMAP 1997); Leclercq R. In: MRSA. Maurice Rapin Colloquia series, 1995.

• Antimicrobial resistance is a major European and global problem

• Set up surveillance for antimicrobial resistance and consumption of antimicrobial agents

• Pharmaceutical companies should be encouraged to develop new antimicrobial agents, but these will not solve the problem in the near future

• Coordinated research on antimicrobial resistance: high priority

• Encourage the adoption of a wide range of measures to promote prudent use of antimicrobial agents

• A way should be found to review progress with these recommendations and proposals

EU Conference on the Microbial Threat, 1998

Available from: http://soapimg.icecube.snowfall.se/strama/Kopenhamnsmotet_1998.pdf

The Copenhagen Recommendations

Source: Cars O, et al. Lancet 2001; 357: 1851-3

Antibiotic consumption in primary care, 15 EU countries, 1997

Community strategy against antimicrobial resistance, 2001

15 action points

• Surveillance: 2 action points

- Antimicrobial resistance (human+vet.)

- Antimicrobial consumption (all sectors)

• Prevention: 8 action points, e.g.

- AMR information for market authorisation (human+vet.)

- Education campaigns

- Prescription-only rule

- Prevention programmes, incl. immunisation

- Monitoring of residues in foods

- Phase out antimicrobial growth promoters

• Research and product development (3 points)

• International cooperation (2 action points)

Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine (2002/77/EC)

Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections (2009/C 151/01)

Commission Decisions 1999-2012 & Council Recommendations, 2001 & 2009

xxxxxxx

Commission Decision of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No. 2119/98/EC (2000/96/EC).

Commission Implementing Decision of 8 August 2012 amending Decision 2002/253/EC laying down case definitions for reporting communicable diseases…

Regulation EC (EC) No 1831/2003 of the European Parliament and the of the Council of 22 September 2003 on additives for use in animal nutrition

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolidated 30/12/2008)

Directive on medicinal products,2001 & Regulation on additives for use in animal nutrition, 2003

Photo: Keith Weller.

What is the role of ECDC in its Founding Regulation?

… to identify, assess and communicate current and emerging health threats to human health from communicable diseases.

— ECDC Founding Regulation (851/2004), Article 3

• EU-level disease surveillance and epidemic intelligence

• Scientific opinions and studies

• Early Warning System and response

• Technical assistance and training

• Communication to scientific community

• Communication to the public

Council Conclusions, 2008, 2009 & 2012

Council Conclusions on the impact of antimicrobial resistance in the human health sector and in the veterinary sector –a “One Health” perspective (22 June 2012)

Council Conclusions on Antimicrobial Resistance (AMR) (10 June 2008)

Council Conclusions on innovative incentives for effective antibiotics (1 December 2009)

Based on preparatory work

- Staff working paper 2009 and public consultation

- Council conclusions on AMR

- EP resolutions on AMR

Holistic approach

- public health - non therapeutic use - consumer safety - environment - food safety - animal health & welfare

Objective: combat the rising threat of AMR

- to reduce and prevent the spread of AMR - to preserve the ability to treat and prevent microbial infections

European Commission action plan to combat AMR, 2011

Communication from the Commission to the European Parliament and the Council. Action plan against the rising threats from Antimicrobial Resistance (COM (2011) 748)

To mitigate the risk of developing AMR in humans from the use of antimicrobials both in humans and animals by effectively ensuring across the EU their appropriate use, and promoting microbiological diagnosis as the means to determine, to the extent possible, the need for antimicrobials

To put in place effective ways to prevent microbial infections and their spread

To develop effective antimicrobials or alternatives for treatment of human and animal infections

To join forces with international partners to contain the risks of spreading AMR form international trade and travel and via the environment

To reinforce research to develop the scientific basis and innovative means to combat AMR

To improve communication, education and training

European Commission action plan to combat AMR, 2011: overall aims

1st report from the Commission to the Council on the basis of Member States’ reports on the implementation of the Council Rec.ommendation 2009/C 151/01

2nd report from the Commission to the Council on the basis of Member States’ reports on the implementation of the Council Rec.ommendation 2002/77/EC

Special Eurobarometer 338 “Antimicrobial resistance”

(9 April 2010)

Reports on implementation of Council Recommendations & Eurobarometer, 2010-2012

Implementation of National Intectoral Coordination Mechanisms on AMR

Adapted from: European Commission, Directorate - General Health and Consumers, 2010.

0

1

2

3

4

5

6

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

No.

countr

ies

imple

menting t

heir

inte

rsect

ora

l co

ord

ination m

ech

anis

m

As of 2008, 18 EU Member States and Norway had implemented an Intersectoral Coordination Mechanism

Antibiotics obtained without a prescription EU Member States, 2002 & 2009

Source: European Commission, Eurobarometer. In: Lancet Infect Dis 2012 Mar;12(3):182-3.

Eurobarometer Opinion Poll, November-December 2009

Antibiotics kill viruses. True or false?

% respondents with correct answer

(i.e., ”false”): 36% (range: 14 – 73%)

Source: Special Eurobarometer 338 / 72.5 ”Antimicrobial resistance”, Nov.-Dec. 2009.

61 – 73%

41 – 60%

31 – 40%

21 – 30%

14 – 20%

Consumption of antibiotics for systemic use (ATC group J01) in the community*; EU/EEA, 2010

Source: ESAC-Net, 2012

*in Defined Daily Doses per 1000 inhabitants and per day

Greece and Iceland:

includes both community and hospital sector

Spain: reimbursement data that do not include

over-the-counter sales without a prescription

The symbols and indicate a continuous increase or decrease for the period 2008-2010, respectively. These trends were reported only for countries that consistently reported during 2008-2010.

France

4.8 packages per 1,000 inhabitants and per day

1.8 package per inhabitant and per year

Staphylococcus aureus: percentage of invasive isolates resistant to meticillin (MRSA); EU/EEA, 2008−2011

Source: EARS-Net, 2012

2008 2011

The symbols and indicate a significant increasing or decreasing trend for the period 2008-2011, respectively. These trends were calculated on laboratories that consistently reported during 2008-2011.

Escherichia coli: percentage of invasive isolates resistant to third-generation cephalosporins; EU/EEA, 2008−2011

Source: EARS-Net, 2012

2008 2011

The symbols and indicate a significant increasing or decreasing trend for the period 2008-2011, respectively. These trends were calculated on laboratories that consistently reported during 2008-2011.

Klebsiella pneumoniae: percentage of invasive isolates with combined resistance*; EU/EEA, 2008−2011

Source: EARS-Net, 2012

2008 2011 *Combined resistance: resistance to third-generation cephalosporins, fluoroquinolones and aminoglycosides

The symbols and indicate a significant increasing or decreasing trend for the period 2008-2011, respectively. These trends were calculated on laboratories that consistently reported during 2008-2011.

Consumption of antibiotics for systemic use (ATC group J01) in the hospital sector; EU/EEA, 2010

Source: ESAC-Net, 2012

* Finland: data include consumption in remote primary health care centres and nursing homes.

** Portugal: data only correspond to public hospitals

Defined D

aily

Dose

s per

1000 inhabitants

and p

er

day

Carbapenem consumption* (for the large

majority in hospitals); EU/EEA, 2007−2010

Source: ESAC-Net, 2012

2007

2010 *in Defined Daily Doses per 1000 inhabitants and per day

The symbols and indicate a significant increase or decrease between 2007 and 2010, respectively. These trends are indicated only for countries that reported relevant data for both 2007 and 2010.

Klebsiella pneumoniae: percentage of invasive isolates resistant to carbapenems; EU/EEA, 2008−2011

Source: EARS-Net, 2012

2008 2011

The symbols and indicate a significant increasing or decreasing trend for the period 2008-2011, respectively. These trends were calculated on laboratories that consistently reported during 2008-2011.

ECDC risk assessments: NDM-1 and carbapenemase-producing Enterobacteriaceae

Source: ECDC, 2010 & 2011.

Indicators

Epidemic intelligence

Coordination

Ongoing surveillance

Ad-hoc studies / projects

Point prevalence survey

Risk assessment : syst.

reviews and guidance

Communication

Training

EARS-Net ESAC-Net HAI-Net

Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Programme

Carbapenemase

survey (2013)

Contribution to WHO

Hand Hygiene Day European Antibiotic Awareness Day

Interactive database

& Reports

Point prevalence survey of HAI

and antimicrobial use in acute care hospitals

Infection control

indicators

Antibiotic stewardship

indicators

HALT-2

Infection

control prog.

Infection control

training needs

Coordination Group Coordination Group CG + Business Meet.

Joint Annual Meeting of ARHAI Networks

Short course on prevention and control of MDROs

Perioperative proph.

& Antibiotic

stewardship prog.

EPIS AMR-HAI EPIS AMR-HAI

Interactive database

& Annual report

Interactive database

& Annual report

Carbapenemase-

producing

Enterobacteriaceae

Inter-agency report (2013)

Main actions to prevent and control antibiotic resistance

Infection control (hand hygiene, screening, isolation)

New antibiotics (with a novel mechanism of action, research, development)

Prudent use of antibiotics (only when needed, correct dose, correct dose intervals, correct duration)

Human medicine 1. Appropriate use 4. Prevention infections 6. New antibiotics 9. Surveillance

European Commission action plan to combat AMR, 2011: 12 key actions

Veterinary medicine 2 & 3. Appropriate use 5. Prevention infections

7. Need for new antibiotics 10. Surveillance

Human + Veterinary 8. International cooperation 11. Research & Innovation

12. Communication, education

http://antibiotic.ecdc.europa.eu