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ESAC – European Surveillance of Antimicrobial Consumption ESAC YEARBOOK 2008
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ESAC – European Surveillance of Antimicrobial Consumption · - ESAC Yearbook 2008 - 2 ESAC YEARBOOK 2008 In 2001, the European Commission (Directorate-General SANCO – Health Monitoring

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Page 1: ESAC – European Surveillance of Antimicrobial Consumption · - ESAC Yearbook 2008 - 2 ESAC YEARBOOK 2008 In 2001, the European Commission (Directorate-General SANCO – Health Monitoring

ESAC – European Surveillance of Antimicrobial Consumption ESAC YEARBOOK 2008

Page 2: ESAC – European Surveillance of Antimicrobial Consumption · - ESAC Yearbook 2008 - 2 ESAC YEARBOOK 2008 In 2001, the European Commission (Directorate-General SANCO – Health Monitoring

- ESAC Yearbook 2008 -

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ESAC YEARBOOK 2008

In 2001, the European Commission (Directorate-General SANCO – Health Monitoring Program) funded the European Surveillance of Antimicrobial Consumption (ESAC) project. A pilot project was established from 2001 to 2003 (referred to as ESAC-1). The aim of the project was to collect comparable and reliable data on antibiotic use in Europe in ambulatory and hospital care from publicly available sources, and to assess the time trends in human exposure to antibiotics. In this project a ‘network of networks’ approach was adopted. A multidisciplinary management team based at the University of Antwerp, Belgium, established a network of dedicated national representatives (NR), collaborating on a voluntary basis. In each country, the national representative was to contact potential data providers. Data collection was aggregated at the level of the active substance (not at brand level), using the taxonomy of the Anatomical Therapeutic Chemical (ATC) classification system, as recommended by the World Health Organisation (WHO). The original data collection was limited to the ATC class J01. Consumption was expressed in defined daily doses (DDD). In 2004, the European Commission (Directorate-General SANCO – Health Monitoring Program) decided to continue funding ESAC from 2004 to 2007 (referred to as ESAC-2). The main objective of the second phase of the ESAC project was to consolidate the continuous collection of comprehensive antibiotic consumption data. In addition, use data (i) on antibiotics not included in ATC class J01 (combinations for eradication of Helicobacter pylori, oral metronidazole, ornidazol, vancomycin, and colistin), (ii) at the package level, and (iii) of antimycotics for systemic use, were collected. In-depth consumption data for ambulatory care, hospital care, and nursing homes were investigated, and a pharmaco-economic evaluation was carried out. Finally, a set of twelve quality indicators for outpatient antibiotic use, which can be derived from ESAC data, were developed. In 2007, the ESAC project was funded by the European Centre for Disease Prevention and Control (ECDC). The project aims to consolidate the continuous collection of comprehensive antimicrobial consumption data, from ambulatory and hospital care, from the 27 EU Member States, 3 European Economic Area/European Free Trade Association (EEA/EFTA) countries (Iceland, Norway and Switzerland), 3 candidate countries (Croatia, Former Yugoslavian Republic of Macedonia and Turkey) and 2 other countries (Russian Federation and Israel). Additionally, the project aims to deepen the knowledge of antibiotic consumption by focusing on specific consumption groups and/or patterns in collaboration with those countries where the appropriate data are available. A new, easier to use interactive database is available at www.esac.ua.ac.be Period of data collection: 2008

Grant Agreement GRANT/2007/001 Specific Agreement ECD.1702 This document was prepared by the ESAC Management Team, the ESAC Scientific Advisory Board and the ESAC National Networks. ISBN number: 9789057282911 Deposit number: D/2010/12.293/4

Page 3: ESAC – European Surveillance of Antimicrobial Consumption · - ESAC Yearbook 2008 - 2 ESAC YEARBOOK 2008 In 2001, the European Commission (Directorate-General SANCO – Health Monitoring

- Table of Contents -

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TABLE OF CONTENTS

ACKNOWLEDGEMENTS ....................................................................................... 4 

SUMMARY .......................................................................................................... 5 

LIST OF ABBREVIATIONS AND RELATED PROJECTS ........................................... 6 

ESAC NETWORK ANNO 2010 .............................................................................. 7 

ESAC Organisation chart .................................................................................... 7 ESAC Management Team ................................................................................... 8 ESAC National Networks .................................................................................... 9 ESAC Advisory Board Members ......................................................................... 21 ESAC Audit Committee Members ...................................................................... 21 

CHAPTER 1.  INTRODUCTION .......................................................................... 23 

CHAPTER 2.  ESAC OBJECTIVES AND METHODOLOGICAL APPROACH .............. 25 

Aims and Objectives ....................................................................................... 25 Data collection protocol version 2009 ................................................................ 25 Collect Manager and Dataset Manager ............................................................... 27 

CHAPTER 3.  ANTIMICROBIAL CONSUMPTION IN EUROPE IN 2008 ................ 29 

Ambulatory care ............................................................................................. 29 Hospital care .................................................................................................. 38 Antimycotic and antifungal use in Europe ........................................................... 40 Antiviral use in Europe .................................................................................... 41 

CHAPTER 4.  IN-DEPTH ANALYSES .................................................................. 43 

Ambulatory Care ............................................................................................ 43 Hospital Care ................................................................................................. 46 Nursing Homes .............................................................................................. 49 Socio-Economics ............................................................................................ 53 

CHAPTER 5.  ESAC DISSEMINATION ACTIVITIES ............................................ 57 

Papers published in peer reviewed journals 2009-2010 ........................................ 57 Abstracts accepted for oral presentation 2010 .................................................... 57 Abstracts accepted for poster presentation 2010 ................................................. 58 Website ......................................................................................................... 59 Newsletter ..................................................................................................... 62 

CHAPTER 6.  CONCLUSIONS AND FUTURE OBJECTIVES ................................... 63 

ANNEX I: COUNTRY SHEETS ON ANTIMICROBIAL CONSUMPTION ................... 64 

Page 4: ESAC – European Surveillance of Antimicrobial Consumption · - ESAC Yearbook 2008 - 2 ESAC YEARBOOK 2008 In 2001, the European Commission (Directorate-General SANCO – Health Monitoring

- Acknowledgements -

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ACKNOWLEDGEMENTS

We thank the ESAC (Lead) National Representatives, the ESAC National Networks, the Members of the Scientific Advisory Board and Audit Committee, and the advisors and participants of the ESAC Sub-projects for their valuable contribution and continuous commitment to the ESAC project. Without their support, the ESAC project would not have been successful.

Herman Goossens ESAC Coordinator University of Antwerp Vaccine and Infectious Diseases Institute

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- Summary -

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SUMMARY

ESAC (European Surveillance of Antimicrobial Consumption) is an international network of national surveillance systems, collecting comparable and reliable antibiotic use data granted by ECDC (European Centre for Disease Prevention and Control; Grant Agreement GRANT/2007/001, Specific Agreement ECD.609).

ESAC aims to maintain a continuous, comprehensive and comparable (using ATC/DDD classification) database on antimicrobial consumption for all EU Member States, EU candidate countries and European Economic Area – European Free Trade Association (EEA–EFTA) countries, ensuring high standards of data collection, collation and validation (using national registers) in a timely fashion. ESAC aims to improve and expand the scope of the database on consumption data in consultation with ECDC. Additionally, the project aims to deepen the knowledge of antibiotic consumption by focusing on specific consumption groups and/or patterns in collaboration with those countries where the appropriate data are available.

The overall aim of the project is to consolidate the continuous collection of comprehensive antimicrobial consumption data, from ambulatory and hospital care, from the 27 EU Member States, 3 EEA/EFTA countries (Iceland, Norway and Switzerland), 3 candidate countries (Croatia, Former Yugoslavian Republic of Macedonia and Turkey) and 2 other countries (Russian Federation and Israel).

The ESAC yearbook 2008 covers the 1999-2008 consumption data for antimicrobials for systemic use (ATC group J01), antimycotics for systemic use (ATC group J02) and additional specific substances i.e. the data available in the ESAC database which were collected by the ESAC Management Team in 2009. Of the 35 participating countries, 30 were able to deliver 2008 outpatient data on antibiotic use, 19 hospital data and 3 total data, covering both sectors for 2008. Malta could deliver for the first time 2007 outpatient data.

In summary, in 2008, the outpatient consumption of antimicrobials for systemic use (ATC group J01) varied from 9.96 Defined Daily Doses (DDD) per 1,000 Inhabitants per Day (DID) in the Russian Federation to 45.20 DID in Greece (total care), with a median use of 19.70 DID and an interquartile range of 15.10 to 23.08 DID. The most used J01 subgroup were the penicillins (J01C), followed by the macrolides (J01F) or tetracyclines (J01A) depending on the country. The ranking of the countries slightly changed compared to previous years, mainly due to a change of data source. There seems to be a general increase in antimicrobial consumption since 2005. During the reported ten years, the countries presented different temporal patterns. Some countries had continuous trends (increasing or decreasing), other countries showed stable use and the remaining countries have a sawtooth pattern. More and more countries have implemented or plan to implement actions to control antimicrobial resistance in the community through rational use of antimicrobials.

In 2008, the hospital consumption of antimicrobials for systemic use (ATC group J01) varied from 0.99 DID in Israel to 3.31 in Finland. The most used subgroup in the hospital sector were the penicillins (J01C), followed by the cephalosporins and other beta-lactams (J01D) and the quinolones (J01M).

In 2008, 23 countries reported data on outpatient consumption of antimycotics and anitfungals for systemic use (ATC group J02 & D01B), 3 did not report data on D01B. The use varied from 0.47 DID in Croatia to 3.29 in Belgium. Terbinafine use represented more than 50% of total outpatient systemic antimycotic and antifungal use in 16 out of 20 countries.

ESAC also collected consumption data of other antimicrobials, such as antivirals and antituberculosis, next to antibiotics and antimycotics for systemic use. In 2008, total outpatient systemic antiviral use in 15 European countries varied from 0.06 DID in Croatia to 1.5 DID in the Netherlands. In most countries nucleosides and nucleotides excluding reverse transcriptase inhibitors (ATC J05AB) represented more than 50% of the total outpatient antiviral use.

Finally, antibiotic consumption for specific groups has been studied in those countries where the appropriate data are available, and data has been collected for sub-national regions.

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- List of Abbrevations and Related Projects -

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LIST OF ABBREVIATIONS AND RELATED PROJECTS

AB Antibiotic ABS International Antibiotic Strategies International AC Ambulatory Care ATC Anatomical Therapeutic Chemical BAPCOC Belgian Antibiotic Policy Coordination Committee BURDEN Burden of Resistance and Disease in European Nations CHAMP Changing behaviour of Health care professionals And the general public

towards a More Prudent use of antimicrobial agents CP Co-ordinating Practioner DDD Defined Daily Dose DID Defined Daily Doses per 1000 inhabitants per day DPP DDD per package DRG Disease related groups EARSS European Antimicrobial Resistance Surveillance System EC Socio-Economics ECDC European Centre for Disease Prevention and Control EEA European Economic Area EFTA European Free Trade Association ESAC European Surveillance of Antimicrobial Consumption ESCMID European Society of Clinical Microbiology and Infectious Diseases ESF European Science Foundation EuroDURG European Drug Utilisation Research Group GP General Practioner GRACE Genomics to combat Resistance against Antibiotics in Community-

acquired LRTI in Europe GRIN General Practice Respiratory Infections Network HC Hospital Care ICD International Statistical Classification of Diseases and Related Health

Problems ICPC International Classification of Primary Care IPH Institute of Public Health Brussels IPSE Improving Patient Safety in Europe LNR Lead National Representative LTCF Long Term Care Facility MOSAR Mastering Hospital Antimicrobial Resistance and its spread into the

community MS Member State MT Management Team NH Nursing Homes NN National Network NR National Representative PPS Point Prevalence Survey RoA Route of Administration SAR Self-Medication with Antibiotics and Resistance Levels in Europe TB Tuberculosis TC Total Care WHO World Health Organisation

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ESAC NETWORK ANNO 2010 ESAC Organisation chart

Management Team Coordinator (Herman Goossens)

Project manager (Vanessa Vankerckhoven) Data managers (Arno Muller & Ann Versporten)

Clinical scientist (Samuel Coenen) Public health epidemiologist (Sofie Vaerenberg)

Administrator (Sophie Nys) IT specialist (Nico Drapier)

Clinical scientist support (Rudi Stroobants) Clinical scientist ambulatory care (Niels Adriaenssens)

Clinical scientist hospital care (Peter Zarb) Hospital Care Support (Brice Amadeo)

Clinical scientist nursing homes (Ellen Broex) Clinical scientist economics (Christiaan Marais)

Advisory Board ESAC National Representatives

(Appointed for two years)

Arjana Andrasevic (Croatia) Sigrid Metz (Austria)

Raul Raz (Israel) Giorgio Zanetti (Switzerland)

Advisors to

the subprojects

Philippe Beutels (Economics) Peter Davey (Hospital Care)

Sigvard Mölstad (Ambulatory Care) Béatrice Jans (Nursing Homes)

Representatives of related EU

funded projects

BURDEN (H. Gründmann) CHAMP (T. Verheij)

EARSS (H. Gründmann) GRACE (H. Goossens)

IPSE (C. Suetens) MOSAR (C. Brun-Buisson)

ABS International (W. Kern)

ECDC Observer

Ole Heuer

ESAC Lead National Representatives

Austria (Helmut Mittermayer) Belgium (Sofie Vaerenberg) Bulgaria (Boyka Markova)

Croatia (Arjana Andrasevic) Cyprus (Antonis Kontemeniotis)

Czech Republic (Vlcek Jiri) Denmark (Niels Frimodt-Møller)

Estonia (Ott Laius) Finland (Jaana Vuopio)

Former Yugoslavian Republic of Macedonia (Milena Petrovska)

France (Philippe Cavalié) Germany (Winfried Kern)

Greece (Helen Giamarellou) Hungary (Gabor Ternak) Iceland (Haraldur Briem) Ireland (Robert Cunney)

Israel (Raul Raz) Italy (Pietro Folino) Latvia (Uga Dumpis)

Lithuania (Rolanda Valinteliene) Luxembourg (Marcel Bruch)

Malta (Michael Borg) Norway (Hege Salvesen)

Poland (Waleria Hryniewicz) Portugal (Malfada Ribeirinho)

Romania (Anda Baicus) Russian Federation (Svetlana Ratchina)

Slovak Republic (Viliam Foltan) Slovenia (Milan Cizman)

Spain (José Campos) Sweden (Ulrica Dohnhammar) Switzerland (Giorgio Zanetti)

The Netherlands (Stephanie Natsch) Turkey (Serhat Unal)

United Kingdom (Peter Davey)

ESAC National Networks ESAC Lead National Representatives Other National Representatives, including

representatives of the national surveillance institutes on antimicrobial use, members of the intersectorial coordinating mechanisms, healthcare workers, policy makers, scientists

Data providers

Audit Committee

M. Godycki-Cwirko (chair)

Cliodna Mc Nulty

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ESAC Management Team

FUNCTION NAME E-MAIL

Project Coordinator

Herman Goossens [email protected]

Project Manager

Vanessa Vankerckhoven [email protected]

Data Manager

Arno Muller [email protected]

Data Manager

Ann Versporten [email protected]

Administrator

Sophie Nys [email protected]

Clinical Scientist

Samuel Coenen [email protected]

Public Health Epidemiologist

Sofie Vaerenberga [email protected]

IT specialist

Nico Drapier [email protected]

Clinical scientist support

Rudi Stroobants [email protected]

Clinical scientist Ambulatory Care

Niels Adriaenssens [email protected]

Clinical scientist Hospital Care

Peter Zarbc [email protected]

Hospital Care support

Brice Amadeod [email protected]

Clinical scientist Nursing Homes

Ellen Broexa [email protected]

Clinical scientist Socio-Economics

Christiaan Marais [email protected]

ADDRESSES: ESAC – Vaccine & Infectious Disease Institute, Laboratory of Microbiology, University of Antwerp, Universiteitsplein 1, B-2610 Wilrijk-Antwerpen, Belgium / Phone +32-3-265 27 50 – Fax +32-3-265 27 52 aScientific Institute of Public Health cMater Dei Hospital, Malta dUniversity of Bordeaux, France

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ESAC National Networks

Austria Function Name(s) Affiliation E-mail Lead National Representative

Helmut Mittermayer

Institute for Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital Linz

[email protected]

Other representative

Sigrid Metz-Gercek (Gerhard Fluch)

Institute for Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital Linz

[email protected] [email protected]

National Representative Ambulatory Care

Helmut Mittermayer

Institute for Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital Linz

[email protected]

Sigrid Metz (Gerhard Fluch)

Institute for Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital Linz

[email protected]

National Representative Hospital Care

Helmut Mittermayer

Institute for Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital Linz

[email protected]

Sigrid Metz (Gerhard Fluch)

Institute for Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital Linz

[email protected]

National Representative Economics

Sigrid Metz (Gerhard Fluch)

Institute for Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital Linz

[email protected]

Belgium Function Name(s) Affiliation E-mail Lead National Representative

Sofie Vaerenberg

Scientific Institute of Public Health

[email protected]

Other representatives

Herman Goossens

University of Antwerp [email protected]

Béatrice Jans Scientific Institute of Public Health

[email protected]

Marc Struelens Université libre de Bruxelles

[email protected]

Samuel Coenen University of Antwerp [email protected] An De Sutter Ghent University

Hospital Department of General Practice and Primary Health Care

[email protected]

National Representative Ambulatory Care

Samuel Coenen University of Antwerp [email protected] An De Sutter Ghent University

Hospital Department of General Practice and Primary Health Care

[email protected]

National Representative

Herman Goossens

University of Antwerp [email protected]

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Hospital Care Hilde Janssens University Hospital Antwerp

[email protected]

National Representative Nursing Homes

Béatrice Jans Scientific Institute of Public Health

[email protected]

National Representative Economics

Sofie Vaerenberg

Scientific Institute of Public Health

[email protected]

Bulgaria Function Name(s) Affiliation E-mail Lead National Representative

Boyka Markova University Multipurpose Hospital for Active Treatment “Aleksandrovska”

[email protected]

National Representative Hospital Care

Boyka Markova University Multipurpose Hospital for Active Treatment “Aleksandrovska”

[email protected]

National Representative Nursing Homes

Violeta Voynova

[email protected]

National Representative Economics

Boyka Markova University Multipurpose Hospital for Active Treatment “Aleksandrovska”

[email protected]

Cyprus Function Name(s) Affiliation E-mail Lead National Representative

Antonis Kontemeniotis

Direrctor of the Departement of Clinical Pharmacy in Pharmaceutical Services of the Ministry of Health of Cyprus

[email protected]

Other representative

Christiana Hatzioannou

Departement of Clinical Pharmacy in Pharmaceutical Services of the Ministry of Health of Cyprus

[email protected]

National Representative Hospital Care

Antonis Kontemeniotis

Direrctor of the Departement of Clinical Pharmacy in Pharmaceutical Services of the Ministry of Health of Cyprus

[email protected]

Kontemeniotou Christiana

[email protected]

Croatia Function Name(s) Affiliation E-mail Lead National Representative

Arjana Tambic Andrasevic

University Hospital for Infectious Diseases Zagreb

[email protected] / [email protected]

Other representative

Igor Francetic Clinical Hospital Center Zagreb

[email protected]

National Representative Hospital Care

Arjana Andrasevic

University Hospital for Infectious Diseases Zagreb

[email protected] / [email protected]

National Representative Nursing Homes

Ana Budimir [email protected] / [email protected]

National Vlasta Croatian Public Health [email protected]

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Representative Economics

Dečković-Vukres

Institute

Czech Republic Function Name(s) Affiliation E-mail Lead National Representative

Vlcek Jiri Faculty of Pharmacy, Charles University

[email protected]

Other representatives

Zemkova Marcela

Faculty of Pharmacy, Charles University

[email protected]

Matoulkova Petra

Faculty of Pharmacy, Charles University

[email protected]

National Representative Ambulatory Care

Vlcek Jiri Faculty of Pharmacy, Charles University

[email protected]

National Representative Hospital Care

Vlcek Jiri Faculty of Pharmacy, Charles University

[email protected]

Petra Matoulkova

Faculty of Pharmacy, Charles University

[email protected]

National Representative Nursing Homes

Petra Matoulkova

Faculty of Pharmacy, Charles University

[email protected]

Denmark Function Name(s) Affiliation E-mail Lead National Representative

Niels Frimodt-Møller

Statens Serum Institut, National Center for Antimicrobials and Infection Control

[email protected]

Other representative

Jan Poulsen Danish Medicines Agency, Pharmacoeconomic Division

[email protected]

National Representative Ambulatory Care

Ulrich Stab Jensen

Statens Serum Institut, National Center for Antimicrobials and Infection Control

[email protected]

National Representative Hospital Care

Niels Frimodt-Møller

Statens Serum Institut, National Center for Antimicrobials and Infection Control

[email protected]

National Representative Nursing Homes

Christian Stab Jensen

Statens Serum Institut, National Center for Antimicrobials and Infection Control

[email protected]

Estonia Function Name(s) Affiliation E-mail Lead National Representative

Ly Rootslane (Ott Laius)

State Agency of Medicines Bureau of Drug Statistics

[email protected] ([email protected])

National Representative Hospital Care

Piret Mitt [email protected]

Finland Function Name(s) Affiliation E-mail Lead National Representative

Jaana Vuopio National Institute of Health

[email protected]

Other representative

Pirkko Paakkari National Agency for Medicines

[email protected]

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National Representative Ambulatory Care

Outi Lyytikainen

[email protected]

Jaana Martikainen

[email protected]

National Representative Hospital Care

Nina Elomaa [email protected]

National Representative Nursing Homes

Maija Rummukainen

[email protected]

Former Yugoslavian Republic of Macedonia Function Name(s) Affiliation E-mail Lead National Representative

Milena Petrovska

Microbiology and Parasitology Medical Faculty

[email protected]

France Function Name(s) Affiliation E-mail Lead National Representative

Philippe Cavalié Direction de l’Evaluation de la Publicité et des Produits Cosmétiques et Biocides Agence Française de sécurité sanitaire des produits de santé

[email protected]

Other Representative

Didier Guillemot

Unité des agents antibactériens, Institut Pasteur

[email protected]

National Representative Ambulatory Care

Philippe Cavalié Direction de l’Evaluation de la Publicité et des Produits Cosmétiques et Biocides Agence Française de sécurité sanitaire des produits de santé

[email protected]

National Representative Hospital Care

Xavier Bertrand [email protected] Isabelle Patry [email protected]

National Representative Nursing Homes

Gaetan Gavazzi [email protected]

National Representative Economics

Philippe Cavalié Direction de l’Evaluation de la Publicité et des Produits Cosmétiques et Biocides Agence Française de sécurité sanitaire des produits de santé

[email protected]

Germany Function Name(s) Affiliation E-mail Lead National Representative

Winfried V. Kern

Center for Infectious Diseases and Travel medicine University hospital

[email protected]

Other Representative

Helmut Schröder

Wissenschaftliches Institut der AOK (WidO)

[email protected]

National Representative Ambulatory Care

Helmut Schröder

Wissenschaftliches Institut der AOK (WidO)

[email protected]

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National Representative Hospital Care

Katja de With Center for Infectious Diseases and Travel medicine University hospital

[email protected]

National Representative Nursing Homes

Nicoletta Wischnewski

[email protected]

National Representative Economics

Katja de With Center for Infectious Diseases and Travel medicine University hospital

[email protected]

Greece Function Name(s) Affiliation E-mail Lead National Representative

Helen Giamarellou

4th Department of Internal Medicine of Athens Medical School, University General Hospital ATTIKON

[email protected]

Other Representative

Anastasia Antoniadou

4th Department of Internal Medicine of Athens Medical School, University General Hospital ATTIKON

[email protected]

National Representative Hospital Care

Anastasia Antoniadou

4th Department of Internal Medicine of Athens Medical School, University General Hospital ATTIKON

[email protected]

Hungary Function Name(s) Affiliation E-mail Lead National Representative

Gabor Ternak Univ. of Pecs, Institute of Infectiology, Disaster-medicine and Oxyology

[email protected] / [email protected]

Other representatives

Ria Benko Colleges of Clinical Pharmacy Department, University of Szeged, Clinical Pharmacy, Department

[email protected]

Maria Matuz Colleges of Clinical Pharmacy Department, University of Szeged, Clinical Pharmacy, Department

[email protected]

Edit Hajdú University of Szeged, Faculty of Medicine, Institute of Clinical Microbiology

[email protected]

National Representative Ambulatory Care

Gabor Ternak Univ. of Pecs, Institute of Infectiology, Disaster-medicine and Oxyology

[email protected] / [email protected]

National Representative Hospital Care

Gabor Ternak Univ. of Pecs, Institute of Infectiology, Disaster-medicine and Oxyology

[email protected] / [email protected]

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National Representative Nursing Homes

Karolina Borocz [email protected]

Iceland Function Name(s) Affiliation E-mail Lead National Representative

Haraldur Briem Directorate of Health [email protected]

Ireland Function Name(s) Affiliation E-mail Lead National Representative

Robert Cunney Sta National Disease Surveillance Centre

[email protected]

Other Representative

Ajay Oza Sta National Disease Surveillance Centre

[email protected]

National Representative Ambulatory Care

Robert Cunney Sta National Disease Surveillance Centre

[email protected]

National Representative Hospital Care

Robert Cunney Sta National Disease Surveillance Centre

[email protected]

National Representative Nursing Homes

Robert Cunney Sta National Disease Surveillance Centre

[email protected]

Israel Function Name(s) Affiliation E-mail Lead National Representative

Raul Raz Infectious Diseases Unit

[email protected]

National Representatives Ambulatory Care

Raul Raz Infectious Diseases Unit

[email protected]

Hana Edelstein Infectious Diseaeses Unit

[email protected]

National Representative Economics

Raul Raz Infectious Diseases Unit

[email protected]

Italy Function Name(s) Affiliation E-mail Lead National Representative

Pietro Folino Gallo

Agenzia Italiana del Farmaco Ufficio Centro Studi

[email protected]

Other representatives

Annalisa Pantosti

Dipartimento Malattie Infettive, Parassitarie e Immunomediate Istituto Superiore di Sanità

[email protected]

Maria Grazia Pompa

Ufficio V Direzione Generale Prevenzione Sanitaria Ministero della Salute

[email protected]

Maria Luisa Moro

Area di Programma Rischio Infettivo Agenzia Sanitaria Regionale

[email protected]

Giuseppe Cornaglia

Facoltà di Medicina e Chirurgia Istituto Microbiologia Università di Verona

[email protected]

National Representative Ambulatory Care

Roberto Raschetti

Centro Nazionale di Epidemiologia, Sorveglianza e Promozione della Salute Istituto Superiore di Sanità

[email protected]

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National Representative Hospital Care

Silvio Brusaferro

[email protected]

National Representative Nursing Homes

Maria Luisa Moro

Area di Programma Rischio Infettivo Agenzia Sanitaria Regionale

[email protected]

National Representative Economics

Pietro Folino Gallo

Agenzia Italiana del Farmaco Ufficio Centro Studi

[email protected]

Latvia Function Name(s) Affiliation E-mail Lead National Representative

Uga Dumpis University of Latvia [email protected]

National Representative Ambulatory Care

Uga Dumpis University of Latvia [email protected]

National Representative Hospital Care

Uga Dumpis University of Latvia [email protected] Elina Pujate University of Latvia [email protected]

National Representative Nursing Homes

Elina Pujate University of Latvia [email protected]

Lithuania Function Name(s) Affiliation E-mail Lead National Representative

Rolanda Valinteliene

Institute of Hygiene [email protected]

National Representative Hospital Care

Asta Palekauskaite

Institute of Hygiene [email protected]

National Representative Nursing Homes

Rolanda Valinteliene

Institute of Hygiene [email protected]

Luxembourg Function Name(s) Affiliation E-mail Lead National Representative

Bruch Marcel Direction de la Santé [email protected]

Other representative

Hemmer Robert

Centre Hospitalier de Luxembourg

[email protected]

National Representative Ambulatory Care

Bruch Marcel Direction de la Santé [email protected]

National Representative Hospital Care

Bruch Marcel Direction de la Santé [email protected]

National Representative Nursing Homes

Bruch Marcel Direction de la Santé [email protected]

National Representative Economics

Bruch Marcel Direction de la Santé [email protected]

Malta Function Name(s) Affiliation E-mail Lead National Representative

Michael Borg Infection Control Unit Mater Dei Hospital

[email protected]

Other representative

Peter Zarb Infection Control Unit Mater Dei Hospital

[email protected]

National Representative Hospital Care

Peter Zarb Infection Control Unit Mater Dei Hospital

[email protected]

National Peter Zarb Infection Control Unit [email protected]

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Representative Nursing Homes

Mater Dei Hospital

Norway Function Name(s) Affiliation E-mail Lead National Representative

Hege Salvesen Blix

Norwegian Institute of Public Health

[email protected] / [email protected]

National Representative Hospital Care

Jon Birger Haug

Aker University Hospital

[email protected]

National Representative Nursing Homes

Hanne-Merete Eriksen

Norwegian Institute of Public Health

[email protected]

National Representative Economics

Hege Salvesen Blix

Norwegian Institute of Public Health

[email protected]

Poland Function Name(s) Affiliation E-mail Lead National Representative

Waleria Hryniewicz

National Medicines Institute

[email protected]

Other representative

Malgosia Kravana

National Medicines Institute

[email protected]

National Representative Ambulatory Care

Anna Olczak-Pieńkowska

National Medicines Institute

[email protected]

National Representative Hospital Care

Janina Pawlowksa

[email protected]

Portugal Function Name(s) Affiliation E-mail Lead National Representative

Mafalda Ribeirinho

Instituto Nacional da Farmacia e do Medicamento (INFARMED), OMPS – Observatório do Medicamento e Produtos de Saúde

[email protected]

Other representative

Luis Caldeira Instituto Nacional da Farmacia e do Medicamento (INFARMED), OMPS – Observatório do Medicamento e Produtos de Saúde

[email protected]

National Representative Ambulatory Care

Mafalda Ribeirinho

Instituto Nacional da Farmacia e do Medicamento (INFARMED), OMPS – Observatório do Medicamento e Produtos de Saúde

[email protected]

National Representative Economics

Mafalda Ribeirinho

Instituto Nacional da Farmacia e do Medicamento (INFARMED), OMPS – Observatório do Medicamento e Produtos de Saúde

[email protected]

Romania Function Name(s) Affiliation E-mail Lead National Representative

Băicuş Anda Director, National Institute of Research Development for

[email protected]

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Microbiology and Immunology

Other representative

Mircea Ioan Popa

“Carol Davila” University of Medicine and Pharmacy, Bucharest

[email protected]

Russian Federation Function Name(s) Affiliation E-mail Lead National Representative

Svetlana Ratchina

Department of Clinical Pharmacology, Smolensk State Medical Academy

[email protected]

Other representative

Roman Kozlov Institute of Antimicrobial Chemotherapy, Smolensk State Medical Academy

[email protected]

Data management

Alexander Fokin

Department of Clinical Pharmacology, Smolensk State Medical Academy

[email protected]

Roman Pavlukov

Institute of Antimicrobial Chemotherapy, Smolensk State Medical Academy

[email protected]

National Representative Economics

Svetlana Ratchina

Department of Clinical Pharmacology, Smolensk State Medical Academy

[email protected]

Slovakia Function Name(s) Affiliation E-mail Lead National Representative

Viliam Foltan Comenius University, Faculty of Pharmacy,

[email protected]

Other representative

Tomas Tesar Comenius University, Faculty of Pharmacy,

[email protected]

National Representative Nursing Homes

Maria Stefkovicova

[email protected]

Slovenia Function Name(s) Affiliation E-mail Lead National Representative

Milan Čižman University Medical Centre, Department of Infectious Diseases

[email protected]

National Representative Ambulatory Care

Milan Čižman University Medical Centre, Department of Infectious Diseases

[email protected]

National Representative Hospital Care

Milan Čižman University Medical Centre, Department of Infectious Diseases

[email protected]

National Representative Nursing Homes

Tatjana Lejko [email protected]

National Representative Economics

Milan Čižman University Medical Centre, Department of Infectious Diseases

[email protected]

Spain Function Name(s) Affiliation E-mail Lead National Representative

José Campos Centro Nacional de Microbiología,

[email protected]

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Instituto de Salud Carlos III.

Other representatives

Francisco de Abajo

División de Farmacoepidemiología y Farmacovigilancia Agencia Española de Medicamentos y PS

[email protected]

Edurne Lázaro División de Farmacoepidemiología y Farmacovigilancia Agencia Española de Medicamentos y PS

[email protected]

Juan Luis Moreno

Dirección General de Farmacia y Productos Sanitarios.

[email protected]

Jesús Oteo Centro Nacional de Microbiología, Instituto de Salud Carlos III

[email protected]

National Representative Hospital Care

Mercedes Sora Servicio de Farmacia,Hospital de Bellvitge, Barcelona

[email protected]

Sweden Function Name(s) Affiliation E-mail Lead National Representative

Gunilla Skoog (Ulrica Dohnhammar)

Strama [email protected] [email protected]

Other representatives

Otto Cars Strama [email protected] Gunilla Stridh Strama [email protected]

National Representative Ambulatory Care

Gunilla Stridh Strama [email protected] Sigvard Mölstad

[email protected]

National Representative Hospital Care

Gunilla Skoog Strama [email protected] Mats Erntell [email protected]

National Representative Nursing Homes

Gunilla Skoog Strama [email protected]

National Representative Economics

Gunilla Skoog Strama [email protected]

Switzerland Function Name(s) Affiliation E-mail Lead National Representative

Giorgio Zanetti Service de Médicine Préventive Hospitalière, Lausanne University Hospital

[email protected]

Other representative

Christian Ruef Division of Infectious Diseases and Hospital Epidemiology University Hospital of Zürich

[email protected]

Giuliano Masiero

Institute of Microeconomics and Public Economics University of Lugano

[email protected]

Catherine Suard

Pharmacy Lausanne University Hospital

[email protected]

National Representative Ambulatory

Giorgio Zanetti Service de Médicine Préventive Hospitalière,

[email protected]

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Care Lausanne University Hospital

National Representative Hospital Care

Giorgio Zanetti Service de Médicine Préventive Hospitalière, Lausanne University Hospital

[email protected]

National Representative Economics

Giorgio Zanetti Service de Médicine Préventive Hospitalière, Lausanne University Hospital

[email protected]

The Netherlands Function Name(s) Affiliation E-mail Lead National Representative

Stephanie Natsch

Radboud University Nijmegen Medical center

[email protected]

National Representative Ambulatory Care

Theo Verheij Julius Centre for Health Sciences and Primary care

[email protected]

Paul van der Linden

Tergooizikenhuizen Dept.of Clinical

[email protected]

National Representative Hospital Care

Stephanie Natsch

Radboud University Nijmegen Medical center

[email protected]

National Representative Nursing Homes

Marie-José Veldman

RIVM-Centrum infectiebestrijdingen

Turkey Function Name(s) Affiliation E-mail Lead National Representative

Serhat Unal Haceteppe University, Department of Medicine, School of Medicine

[email protected]

Other representative

Deniz Gür Haceteppe University [email protected]

National Representative Hospital Care

Serhat Unal Haceteppe University [email protected] Yesim Cetinkaya Sardan

Haceteppe University [email protected]

UK Function Name(s) Affiliation E-mail Lead National Representative

Peter Davey University of Dundee [email protected]

Other representatives

Tracey Guise British Society for Antimicrobial Chemotherapy

[email protected]

Hayley Wickens British Society for Antimicrobial Chemotherapy, ESAC Co-ordinator

[email protected]

Jonathan Cooke

Department of Health’s Advisory Committee on AMR & HAI

[email protected]

Maggie Heginbothom

Welsh Antimicrobial Research Programme: Surveillance Unit

[email protected]

Hugh Webb Northern Ireland Antimicrobial Resistance Action Plan

[email protected]

Jacqueline Sneddon

Scottish Antimicrobial Prescribing Group

[email protected]

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National Representative Ambulatory Care

Peter Davey (UK)

University of Dundee [email protected]

Sally Wellsteed Department of Health, England

[email protected]

Tracey Guise British Society for Antimicrobial Chemotherapy

[email protected]

Hugh Webb (Northern Ireland)

Northern Ireland Antimicrobial Resistance Action Plan

[email protected]

Margaret Heginbothom (Wales)

Welsh Antimicrobial Research Programme: Surveillance Unit

[email protected]

William Malcolm (Scotland)

NHS National Services Scotland

[email protected]

Jonathan Cooke (England)

Department of Health’s Advisory Committee on AMR & HAI

[email protected]

National Representative Hospital Care

Hugh Webb (Northern Ireland)

Northern Ireland Antimicrobial Resistance Action Plan

[email protected]

Margaret Heginbothom (Wales)

Welsh Antimicrobial Research Programme: Surveillance Unit

[email protected]

William Malcolm (Scotland)

NHS National Services Scotland

[email protected]

Jacqueline Sneddon (Scotland)

Scottish Antimicrobial Prescribing Group

[email protected]

Hayley Wickens (England)

UK Clinical Pharmacy Association Infection Management Group

[email protected]

Conor Jamieson (England)

UK Clinical Pharmacy Association Infection Management Group

[email protected]

Peter Davey (Scotland)

University of Dundee [email protected]

National Representative Nursing Homes

Peter Davey (Scotland)

University of Dundee [email protected]

National Representative Economics

Peter Davey University of Dundee [email protected]

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ESAC Advisory Board Members

Name Affiliation On behalf of Country Arjana Tambic Andrasevic

University Hospital for Infectious Diseases, Zagreb

Lead National Representative

Croatia

Raul Raz Infectious Diseases Unit, Afula

Lead National Representative

Israel

Giorgio Zanetti Service de Médicine Préventive Hospitalière, Lausanne University Hospital

Lead National Representative

Switzerland

Sigrid Metz-Gercek Institute for Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital Lenz

National Representative

Austria

Philippe Beutels University of Antwerp Scientific advisor of the Economics subproject

Belgium

Peter Davey University of Dundee Scientific advisor of the Hospital Care subproject

UK

Sigvard Mölstad University of Linköping Scientific advisor of the Ambulatory Care subproject

Sweden

Béatrice Jans Institute of Public Health Scientific advisor of the Nursing Home subproject

Belgium

Hajo Gründmann RIVM BURDEN/EARSS The Netherlands

Theo Verheij University of Utrecht CHAMP The Netherlands

Herman Goossens University of Antwerp GRACE Belgium Christian Brun-Buisson

Université Paris Val de Marne

MOSAR France

Winfried V. Kern Freiburg University Hospital Abteilung Medizin, Infektiologie

ABS International Germany

Carl Suetens ECDC IPSE Sweden Ole Heuer ECDC ECDC Sweden

ESAC Audit Committee Members

Name Affiliation Country Maciek Godycki-Cwirko (chair)

Medical University of Lodz Poland

Cliodna Mc Nulty Gloucestershire Royal Hospital UK

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CHAPTER 1. INTRODUCTION ESAC (European Surveillance of Antimicrobial Consumption) is an international network of national surveillance systems, collecting comparable and reliable antibiotic use data. After a successful pilot phase of the ESAC project (2001-2004), another three-year term was approved by DG SANCO for the period 2004-2007 (Agreement number: 2003/211). This was followed by another 3 year-term from 2007-2010, granted by ECDC (Grant Agreement GRANT/2007/001, Specific Agreement ECD.609). ESAC aims to maintain a continuous, comprehensive and comparable (using ATC/DDD classification) database on antimicrobial consumption for all Member States, candidate countries and EFTA-EEA countries, ensuring high standards of data collection, collation and validation (using national registers) in a timely fashion. ESAC aims to improve and expand the scope of the database on consumption data on antiviral, antimycotic and anti-TB drugs in consultation with ECDC. Additionally, the project aims to deepen the knowledge of antibiotic consumption by focusing on specific consumption groups and/or patterns in collaboration with those countries where the appropriate data are available. A multi-disciplinary Management Team (MT) (with expertise in information technology, data management, microbiology, infectious diseases, epidemiology, ambulatory care medicine, hospital care medicine, pharmacology, and health economics) was installed at the University of Antwerp, Belgium, but also has members in Brussels, Dundee (UK) and Ljubljana (Slovenia). This MT ensures day-to-day management and monitoring of the network activities. Participating countries have established National Networks (NN) consisting of relevant experts in the field of antimicrobial consumption. These networks are coordinated by Lead National representatives (LNR). An Advisory Board was established which (i) provides scientific support to the MT and (ii) liaises with ECDC as well as EU funded projects on antimicrobial use and resistance. Next to an Advisory Board, an Audit Committee was established which monitors the progress of the project and helps resolve problems. In the current report, Chapter 2 gives an overview of the aims and objectives as well as the methodology used in ESAC. In Chapter 3, data is presented on antimicrobial consumption in Europe from 1999 until 2008 whereas Chapter 4 provides an overview of the different subprojects collecting in-depth data on Ambulatory Care, Hospital Care, Nursing Homes, and Socio-Economics. Chapter 5 summarizes the dissemination activities of ESAC in 2010. In Chapter 6 concluding remarks and future objectives are provided. Finally, data from 1999-2008 at the country level can be found in the different country sheets in Annex I.

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CHAPTER 2. ESAC OBJECTIVES AND METHODOLOGICAL APPROACH Aims and Objectives

The overall aim of the project is to consolidate the continuous collection of comprehensive antimicrobial consumption data, from ambulatory and hospital care, from the 27 Member States, 3 EEA/EFTA, 3 candidate countries (Croatia, Former Yugoslavian Republic of Macedonia and Turkey) and 2 other countries (Russian Federation and Israel). The project aims to provide the community with timely information, on antimicrobial consumption. The European database is used to develop (i) health indicators of antimicrobial use and (ii) evidence-based guidelines and educational tools to manage the risk of infections and antimicrobial resistance. The project provides regular feed-back to the relevant authorities of the participating countries. Additionally, the project aims deepen the knowledge of antibiotic consumption by focusing on specific consumption groups and/or patterns in collaboration with those countries where the appropriate data are available. For hospital care, data will be collected for individual hospitals with a linkage of the consumption to the DRG (Disease Related Groups). For ambulatory care, detailed data will be collected on the consumption in specific age and sex categories, specific prescriber groups, specific high consumers groups and for specific indications (in collaboration with existing networks of sentinel practices). For nursing homes, detailed information will be collected on the frequency, indications, characteristics and seasonal variations of antibiotic prescriptions, as well as on the institutional determinants of antibiotic use. Additionally, the effects of socio-economic determinants on antimicrobial consumption of European countries will be explored, and regional variation within a particular country will be studied, by means of econometric models.

Data collection protocol version 2009

The 2008 data on antibiotic use, for ambulatory care (AC) and hospital care (HC), according the ATC/DDD classification, 2008 version, should be delivered at the product level, expressed in number of packages. Moreover, a valid national register of available antibiotics and population data covering the dataset should also be delivered.

Alternatively, in the participating countries that are not able to deliver data on a product level due to objective constraints, data on volume of antibiotic consumption for 2008 should be collected at the ATC5 + Route of Administration (RoA) level. As the number of antibiotics with multiple DDDs for an “Oral” and “Parenteral” is increasing over the time, antibiotic consumption data for all ATC codes should be split up according to the route of administration

Scope of the 2008 data collection

Similar to 2007, the 2008 data will include sub-national data. The NUTS classification (http://ec.europa.eu/eurostat/ramon/nuts/splash_regions.html) will be used to collect the data. For optimal analysis of the data, we ask the participating countries to deliver data at the NUTS 3 level. But depending on the availability of the data, the participating countries can deliver data as well as at higher levels (NUTS 2, NUTS 1 or even at the country level). The antimicrobials to be collected are: J01, J02, J04A, J05 and additional substances (P01AB, D01BA, A07AA09).

Until 2006, ESAC used the WHO Mid-year population as reference for the denominator except in some participating countries. Since 2007, all the participating countries have to provide the population covering the datasets e.g. the population data are to be collected at the same level as the consumption data. If you collect consumption data at the NUTS 3 level, you need to provide also the population at this level. This would mean for example the collection of consumption and population data at the level of the arrondissements.

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Each type of data (register, consumption data, population data) has to be delivered using its respective template.

ESAC Templates for data collection

ESAC provides one template for the register, one template for the population data and two templates for the consumption data.

Two templates are available to submit the consumption data:

− template 1 for data expressed in packages at the product level (default format) − template 2 for data expressed in DDDs at the ATC substance level

Each template is provided in a separate excel file.

If you choose template 1, you have to deliver a valid register, the consumption data using the template 1 and the population data. Conversely, if you choose template 2, you have to deliver the consumption data using the template 2 and the population data.

Parameters of the template for the register:

- Country - Year - Medicinal Product Package Code Value: the Medicinal Product Package Code Value

(MPPCV) has to be a unique identifier of the medicinal product package (MPP). Because it is a key value in many tables it has to be stable in time, so MPP's that are no longer available on the market or that are no longer registered still can be identified for historical purposes (like prescription history).

- Label: Medicinal Product Package Label e.g.: Lanoxin compr 60 X 0,125 mg - Size of the package: Content Quantity (e.g.: 60) - Unit measurement of the size of the package: National Content Unit (e.g.: pcs, mg,...) - Form: Galenic form (eg. Capsules, Solution, Injection) Quid abbreviations? - Route of administration: Oral, Parenteral, Rectal, Inhalation - Strength: Quantity of the ingredient in each unit. In case of multi-ingredient Medicinal

products this field has to contain the ingredient strength in which the DDD is expressed. E.g.: Amoxicillin/Clavulanic acid combinations: Strength expresses the strength of the amoxicillin. Strengths of parenteral fluids are expressed as the content of 1 ampulla or 1 perfusion package. Conversely, strengths of sirups are expressed as the content of 1 measure of sirup, this can be 5 ml, 2 ml...

- Unit measurement of strength: units of strength (mg, U, …) - WHO ATC Code - Salt: for methenamin, the associated salt (hippurate or mandelate) should be specified.

For erythromycin, if the associated salt is ethylsuccinate and the galenic form is tablet, ethylsuccinate has to be specified, in all other cases (even ethylsuccinate and any other form than tablet), the salt should be left empty.

- Ingredient name: In case of multi-ingredient Medicinal products this field has to contain the ingredient in which the DDD is expressed.

- Product name: Medicinal Product name e.g.: LANOXIN, LANITOP - National DDD when the WHO DDD does not exist or specific DDDs are used at the

national level. - Unit measurement of the National DDD (mg, g, unit dose, fixed dose, …) - DDDs Per Package - Content of the package: i.e. the total amount of the first ingredient in the medicinal

product package - Unit measurement of the package content - Basic ingredient quantity: (INBASQ: e.g. 200 mg/10 ml), used for describing

concentration of fluids. It is very important to fill this field properly. To obtain good

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results one must apply the following rules for sirups/suspensions and ampullae/perfusion fluids: In sirups and solutions INBASQ describes the basic strength unit. Concerning perfusion fluids or ampullae this value is always 1 because the strength has to be expressed per amp or per perfusion package (see Strength rules)

- Unit measurement of the Basic ingredient quantity

Parameters of the template 1 for the consumption data:

- Country - Year - Sub-area level: NUTS Level (0= country, 1=NUTS1, 2=NUTS2, 3=NUTS3) - Sub-area identifier: when the sub-area level is 0 (country level), the ISO Country code

has to used. For the other sub-area levels, the NUTS code has to be used. - Sector: AC (ambulatory) / HC (hospital) / TC (total) - Periodicity: quarterly for AC / TC, annually for HC (quarterly if available) - Medicinal Product Package Code Value: Same code as the MPPCV in the register. - Volume: number of packages per medicinal product (used in a given period, sub-area

and sector) for the four quarters and the complete year.

Parameters of the template 2 for the consumption data:

- Country - Year - Sub-area level: NUTS Level (0= country, 1=NUTS1, 2=NUTS2, 3=NUTS3) - Sub-area identifier: when the sub-area level is 0 (country level), the ISO Country code

has to be used. For the other sub-area levels, the NUTS code has to be used. - Sector: AC (ambulatory) / HC (hospital) / TC (total) - Periodicity: quarterly for AC / TC, annually for HC (quarterly if available) - WHO ATC Code - WHO ATC Name - Route of administration: O, P, R, I (Oral, Parenteral, Rectal, Inhalation) or X when the

route of administration is not available - Salt - Volume: number of DDDs (WHO ATC version 2008) for the corresponding substance

(used in a given period , sub-area, sector, route of administration and salt) for the four quarters and the complete year.

Parameters of the template for the population data:

- Country - Year - Sub-area level: NUTS Level (0= country, 1=NUTS1, 2=NUTS2, 3=NUTS3) - Sub-area identifier: when the sub-area level is 0 (country level), the ISO Country code

has to used. For the other sub-area levels, the NUTS code has to be used. - population

Collect Manager and Dataset Manager

The IT ESAC has developed two applications. A web application, Collect Manager which allows the countries to submit their data for the core database and the AC database and to trace data exchange between the countries and the ESAC Management Team. A second application, the Dataset Manager allows the translation of data in excel format to an xml format. The collection process is subdivided in three steps:

o The countries use an excel template provided by ESAC to fill the dataset.

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o The countries translates the data in an xml format using the Dataset Manager that is also used as a first validation check of the data.

o The countries send the generated xml file to the Management type using Collect Manager, the data but also general information on the data are automatically saved in a database ready for processing by the Management Team.

Figure 2.1. ESAC Collect Manager

Figure 2.2. ESAC Dataset Manager

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CHAPTER 3. ANTIMICROBIAL CONSUMPTION IN EUROPE IN 2008 In 2009, ESAC collected 2008 data on :

1. antibacterials for systemic use (ATC therapeutic subgroup J01), 2. antimycotics for systemic use (ATC therapeutic subgroup J02), 3. antifungals for systemic use (ATC chemical subgroup D01BA), 4. drugs for treatment of tuberculosis (ATC pharmacological subgroup J04A), 5. antivirals for systemic use (ATC therapeutic subgroup J05), 6. oral and rectal nitroimidazole derivates as antiprotozoals use (ATC chemical subgroup

P01AB), 7. oral vancomycin as intestinal antiinfectives use (ATC chemical substance A07AA09)

in the ambulatory and/or hospital care sector in 30 out of 35 participating countries. The 2008 data on antibiotic use, for ambulatory care (AC) and hospital care (HC) was asked to be delivered at the product level, expressed in number of packages. Therefore, a valid national register of available antibiotics was needed. Forteen out of the 30 participating countries were able to deliver valid data on antibiotic consumption by providing the number of packages consumed, using the ESAC template 1 format for data collection. Those countries were able to provide us with an exhaustif antibiotic consumption register. Eleven countries delivered data using DDD as volume of antibiotic consumption (template 2). Five countries delivered an antibiotic register which was not suitable for data processing, as such, data were processed using DDD at ATC5 level (template 2). Worth noting however, we acountered a lot of difficulties using the antibiotic register due to various mistakes made in requested packsize, strength, strength unit and DPP (DDD per package). Since 2006, Bulgaria was able to provide data for ambulatory care (AC) and hospital care (HC) sectors separately, it was the consequence of a change of their data provider. Estonia could provide data for ambulatory and hospital care sectors separately in 2008 and an update of their total care (TC) 2007 data into AC and HC data. Since 2006, Greece delivered total care data, this year corresponded also to a change of their reporting system but not of their data provider. Poland provided data retrospective data for 2007 and 2008 as well as United Kingdom that provided retrospective data from 2006 to 2008. In this report, data on ATC subgroups J01, J02, D01BA and J05 will be presented.

Ambulatory care

Of the 35 participating countries (27 EU Member States, 3 EEA/EFTA countries, 3 candidate countries, and 2 others), 30 countries were able to deliver 2008 outpatient data on antibiotic use, while Cyprus, Lithuania and Greece provided total data, covering both ambulatory care and hospital care use. Malta could deliver for the first time 2007 outpatient data. The total outpatient use varied from 9.96 DID in the Russian Federation to 45.20 DID in Greece (total care) (Table 3.1). The median use and interquartile range (25%-75%) were respectively 19.70 DID and [15.10-23.08] DID. Additionally, Figure 3.1 shows a map of Europe presenting the total outpatient antibiotic use in Europe in 2008.

The distribution of total outpatient (AC) antibiotic use between 1999 and 2008 is shown for all participating countries in Figure 3.2. The general distribution of the outpatient use among the reporting countries shows a general decrease from 1999 to 2004 followed by a gradual increase up to 2008. The years 2003 and 2005 however showed a higher consumption pattern as compared to the general observation made.

When comparing the trends of outpatient antibiotic use per country, different complex temporal patterns are seen, including short-term increases or decreases and sudden changes (see Figure 3.3).

As shown by the updated figures (Fig. 3.1-3.4), the change of data reporting for Greece had an effect of a shift from 35 DID to 43 DID in 2005 to 41 DID and 43 DID in 2006 and 2007 respectively (Table 3.1).

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Since 2004, in addition to Belgium, France, Portugal, Slovenia and Sweden, many countries have implemented or plan to implement actions to control the antimicrobial resistance through the rational use of antimicrobials. The effect of those antibiotic campaigns however seems difficult to quantify using only DID. To enable this exercise, next to this measurement unit, we aimed at valid calculations of PID (number of daily packages per 1000 inhabitants per day). Next to the ATC/DDD classification system, that simple unit of measurement could be helpful because it disregards changes in package size or changes in dosing. Using information on packages of antibiotic consumption will enable us to better understand and interpret, complementary to the ATC/DDD classification, differences found between and within countries over the years.

Table 3.1: Total outpatient antibiotic use in Europe from 1999 to 2008 expressed in DDD per 1000 inhabitants and per day

Country 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Austria 13.1 12.3 11.8 11.8 12.5 12.5 14.5 14.3 14.7 14.6 Belgium 26.2 25.3 23.7 23.8 23.8 22.7 24.3 24.2 25.4 27.7 Bulgaria4) 15.1 20.2 22.7 17.3 15.5 16.4 18.0 18.1* 19.8* 20.6 Croatia 18.4 18.5 22.6 23.4 23.0 23.4 21.2 22.5 23.4 Cyprus1) 31.9 33.9 32.8 Czech Rep. 18.6 16.7 15.8 17.3 15.9 16.8 17.4 Denmark 12.1 12.3 12.8 13.2 13.5 14.1 14.6 15.2 16.0 16.0 Estonia 11.7 11.1 10.4 11.7 12.7* 11.9 Finland 18.4 19.0 19.8 17.9 18.7 17.2 18.1 17.4 18.3 18.4 France 34.1 33.2 33.2 32.2 28.9 27.0 28.9 27.9 28.6 28.0 Germany 13.6 13.6 12.8 12.7 13.9 13.0 14.6 13.6 14.5* 14.5 Greece1) 30.7 31.7 31.8 32.8 33.6 33.0 34.7 41.1* 43.2* 45.2 Hungary 23.5 18.5 18.6 17.1 19.1 18.2 19.5 17.2 15.5 15.2 Iceland2) 21.7 20.5 20.0 20.6 20.3 21.4 23.2 20.0 20.1* 20.6 Ireland 18.0 17.6 18.7 18.7 20.1 20.2 20.5 21.2 23.0 22.5 Israel 19.6 20.1 19.6 20.5 22.2 20.2 22.0 Italy 24.5 24.0 25.5 24.3 25.6 24.8 26.2 26.7 27.6 28.5 Latvia 11.0 11.8 12.1 12.0 13.0 11.0 Lithuania1) 22.7* 24.11 25.1 Luxembourg 26.8 25.9 26.5 26.4 27.5 24.1 25.2 23.9 25.6 25.1 Malta 18.0* Norway 15.6 15.7 15.6 15.7 16.8 14.8* 15.5* 15.5 Poland 22.2 22.6 24.8 21.4 19.1 19.6 20.9* 20.7 Portugal 25.2 24.9 24.5 26.5 25.1 23.8 24.5 22.7 21.8 22.6 Russian Federation 9.8 9.3 9.1 9.6 10.2 10.0 Slovakia 25.7 27.6 29.1 26.7 27.6 22.5 25.1 22.5 24.8 23.4 Slovenia 19.8 18.0 17.4 16.3 17.0 16.7 16.3 14.7 16.0 15.0 Spain3) 20.0 19.0 18.0 18.0 18.9 18.5 19.3 18.7 19.9 19.7 Sweden 15.8 15.5 15.8 15.2 14.7 14.5 14.9 15.3 15.5 14.6 Switzerland 9.0 The Netherlands 10.0 9.8 9.9 9.8 9.8 9.7 10.5 10.8 11.0 11.2 United Kingdom 14.8 14.3 14.8 14.8 15.1 15.0 15.4 15.3* 16.5* 17.0

1) Cyprus, Greece, Lithuania: total use, including the hospital sector. 2) Iceland: total use until 2005, outpatient use from 2006. 3) Spain: reimbursement data, does not include over-the-counter sales without prescriptions. 4) Bulgaria: total use until 2005, outpatient use from 2006. Change of data provider in 2006. * updated data

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Figure 3.1: Map of Europe showing total outpatient antibiotic use in 2008 in the participating countries

Figure 3.2: Distribution (boxplot) of outpatient antibiotic use between 1999 and 2008 among the participating countries

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Figure 3.3: Trends of total outpatient antibiotic use (ATC group J01) in Europe from 1999 to 2008

Dark blue bars present 2008 data * Cyprus, Greece, Lithuania: total use, including the hospital sector. ** Spain: reimbursement data, does not include over-the-counter sales without prescription. † Bulgaria: total use until 2005, outpatient use from 2006.

0 10 20 30 40 50

GR*

CY*

IT

FR

BE

LU

LT*

SK

HR

PT

IE

IL

PL

IS

BG†

ES**

FI

MT

CZ

UK

DK

NO

HU

SI

AT

SE

DE

EE

NL

LV

RU

DDD per 1000 inhabitants and per day

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Table 3.2 and Figure 3.4 present the outpatient antibiotic use broken down into seven major antibiotic pharmacological subgroups according to the ATC classification: penicillins (J01C), cephalosporins and other beta-lactams (J01D), macrolides, lincosamides and streptogramins (J01F), tetracyclines (J01A), quinolones (J01M), sulphonamides and trimethoprim (J01E) and the other antibiotics including amphenicols (J01B), aminoglycosides (J01G), combinations (J01R) and other antibacterials (J01X).

Table 3.2: Outpatient antibiotic use in 2008 subdivided into the major antibiotic classes according to ATC classification

Country

Penicillins (J01C)

Cephalosporins and other

beta-lactams (J01D)

Tetracyclines (J01A)

Macrolides, lincosamides

and streptogramins

(J01F)

Quinolones (J01M)

Sulfonamides and

trimethoprim (J01E)

Other J01

classes

Total J01

Greece* 14.92 9.51 2.41 11.54 3.05 0.42 3.35 45.20

Cyprus* 14.86 6.57 2.74 3.45 4.29 0.41 0.46 32.78

Italy 15.17 2.78 0.54 5.27 3.44 0.50 0.75 28.45

France 14.73 2.53 3.43 4.14 2.08 0.47 0.61 27.99

Belgium 15.48 2.02 2.19 2.78 2.41 0.38 2.39 27.66

Luxembourg 11.98 3.99 2.02 3.16 2.61 0.34 1.04 25.13

Lithuania* 13.04 3.20 2.36 2.04 1.56 0.01 2.89 25.10

Slovakia 9.53 3.89 1.54 5.93 2.00 0.48 0.04 23.41

Croatia 10.99 3.99 1.77 3.32 1.44 1.20 0.65 23.37

Portugal 11.60 1.98 0.82 3.87 3.05 0.43 0.85 22.61

Ireland 11.34 1.56 3.18 4.11 1.04 0.99 0.20 22.42

Israel 11.70 4.08 1.18 1.80 1.39 0.00 1.89 22.04

Poland 10.13 2.21 2.49 3.66 1.21 0.95 0.05 20.69

Iceland 10.88 0.26 5.29 1.61 0.77 1.35 0.48 20.64

Bulgaria† 9.75 2.08 2.16 3.20 2.08 0.99 0.30 20.56

Spain** 12.23 1.65 0.60 1.92 2.42 0.30 0.58 19.70

Finland 6.11 2.32 4.03 1.55 0.88 1.43 2.04 18.36

Malta^ 8.81 2.99 0.93 3.22 1.71 0.20 0.14 18.00

Czech Republic 7.25 1.39 2.51 3.33 1.24 0.87 0.83 17.41

United Kingdom 7.95 0.71 3.72 2.47 0.52 1.13 0.42 16.93

Denmark 9.99 0.03 1.55 2.32 0.52 0.77 0.79 15.97

Norway 6,76 0,14 2,79 1,89 0,50 0,77 2,68 15,53

Hungary 6,14 1,86 1,39 3,06 1,75 0,69 0,29 15,18

Slovenia 9.37 0.44 0.52 2.47 1.11 1.12 0.00 15.03

Austria 6.17 1.70 1.33 3.65 1.31 0.29 0.20 14.64

Sweden 7.37 0.30 3.22 0.45 0.83 0.57 1.87 14.60

Germany 4.38 1.92 3.21 2.39 1.42 0.81 0.41 14.54

Estonia 4.73 0.85 2.17 2.25 0.88 0.47 0.52 11.88

The Netherlands 4.42 0.04 2.63 1.48 0.90 0.58 1.17 11.24

Latvia 5.01 0.49 2.28 0.95 0.98 0.84 0.39 10.95 Russian Federation 3.30 0.37 0.90 1.53 1.89 0.86 1.11 9.96

* Cyprus, Greece, Lithuania: total use, including the hospital sector. ** Spain: reimbursement data, does not include over-the-counter sales without prescription. † Bulgaria: total use until 2005, outpatient use from 2006. ^ Malta: data for the year 2007.

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Figure 3.4: Outpatient antibiotic (J01) use in 2008 subdivided into the major antibiotic classes according to ATC classification

* Cyprus, Greece, Lithuania: total use, including the hospital sector. ** Spain: reimbursement data, does not include over-the-counter sales without prescription. ^ Malta: 2007 displayed.

Penicillins represented the most frequently prescribed antibiotic in all countries, ranging from 30.1% (Germany) to 62.6% (Denmark) of the total outpatient antibiotic use. For cephalosporins, the proportional use ranged from 0.2% in Denmark to 21.1% in Greece, from 1.9% in Italy to 25.6% in Iceland for tetracyclines, from 3.1% in Sweden to 25.5% in Greece for macrolides, and from 3.1% in the United Kingdom to 17,0% in the Russian Federation for quinolones.

Figure 3.5 Outpatient use of tetracyclines in the participating countries in 2008

Figure 3.6: Distribution of outpatient use of tetracyclines during the study period (1999-2008)

0

5

10

15

20

25

30

35

40

45

50

GR*CY* IT FR BE LU LT* SK HR PT IE IL PL IS BGES** FI MT^CZ UK DK NO HU SI AT SE DE EE NL LV RU

DD

D p

er 1

000

inha

bita

nts

and

per d

ay

Penicillins (J01C)

Cephalosporins and other beta-lactams (J01D)

Tetracyclines (J01A)

Macrolides, lincosamides and streptogramins (J01F)

Quinolones (J01M)

Sulfonamides and trimethoprim (J01E)

Other J01 classes

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The boxplots present the seven major antibiotic J01 subgroups (Figures 3.6 to 3.18); they show the median, the interquartiles 25%-75% and the minimum/maximum DID values of all participating countries in 2008. The outpatient use of tetracyclines varied from 0.5 DID in Slovenia and Italy to 5.3 DID in Israel. In general, the Scandinavian countries had a higher outpatient use of tetracyclines (Figure 3.5). The main used substance was doxycycline followed by minocycline, tetracycline and lymecycline. Since 1999, the outpatient use of this subgroup was in general continuously decreasing among the participating countries. An increase however was observed during 2007 and 2008 (Figure 3.6). Figure 3.7: Outpatient use of penicillins in the participating countries in 2008

Figure 3.8: Distribution of outpatient use of penicillins during the study period (1999-2008)

In 2008, the outpatient use of penicillins varied from 3.3 DID in the Russian Federation to 15.5 DID in Belgium (Figure 3.7). The main used sub-classes were penicillins with extended spectrum (J01CA) and combinations of penicillins, incl. beta-lactamase inhibitors (J01CR02). The two most used substances were amoxicillin (J01CA04) and amoxicillin and enzyme inhibitor (J01CR02). Phenoxymethylpenicillin was still highly used in the Scandinavian countries, it was the first penicillin class to be used in Denmark, Norway and Sweden where it represented more than half the consumption of this class of antibiotics and around 25% for Iceland and Finland. During the study period (1999-2008), it seems that there is an general increase since 2006 with the highest median of 10.1 DID in 2007 and 9.8 DID in 2008 since 1999 (Figure 3.8). Figure 3.9: Outpatient use of cephalosporins and other beta-lactams in the participating countries in 2008

Figure 3.10: Distribution of outpatient use of cephalosporins and other beta-lactamsduring the study period (1999-2008)

The outpatient use of cephalosporins and other beta-lactam antibacterials varied from 0.03 DID in Denmark to 9.51 DID in Greece (Figure 3.9). The cephalosporins group contributed for almost the entire total use within this class. Due to the reporting of total use (including hospital care sector), Greece and Cyprus had much higher levels of use of cephalosporins.

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During the study period, the distribution of the use of this class followed more or less a wave shape (Figure 3.10). Figure 3.11: Outpatient use of sulfonamides and trimethoprim in the participating countries in 2008

Figure 3.12: Distribution of outpatient use of sulfonamides and trimethoprim during the study period (1999-2008)

In 2008, the outpatient use of sulfonamides and trimethoprim varied from less than 0.01 DID in Israel to 1.4 DID in Finland (Figure 3.11). Almost all the use was a combination of sulfomethoxazole and trimethoprim (J01EE01). The general level of use of this class decreased continuously over the study period (Figure 3.12).

Figure 3.13: Outpatient use of macrolides, lincosamides and streptogramins in the participating countries in 2008

Figure 3.14: Distribution of use of macrolides, lincosamides and streptogramins during the study period (1999-2008)

The outpatient use of macrolides, lincosamides and streptogramins varied from 0.5 DID in Sweden to 5.9 DID in Slovakia and 11.5 DID in Greece, the letter been considered as outlier (Figure 3.13). Greece showed always a very high use of this class of antibiotics over the years. The most used sub-group were the macrolides. More specifically, the most used substances were clarithromycin (J01FA09) and azithromycin (J01FA10). In France, the second most used substance in this group was pristinamycin (J01FG01), a streptogramin. In two countries (Hungary and Sweden), clindamycin (J01FF01), a lincosamide was one of the two most used substances within this class. The level of use of this class went down up to 2004, since then an increasing trend is seen. (Figure 3.14).

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Figure 3.15: Outpatient use of quinolones in the participating countries in 2008

Figure 3.16: Distribution of outpatient use of quinolones during the study period (1999-2008)

The outpatient use of quinolones varied from 0.5 DID in Norway to 4.3 DID in Cyprus (Figure 3.15). Fluoroquinolones (J01MA) represented almost the entire consumption within this class. The most used substances were ciprofloxacin (J01MA02) and norfloxacin (J01MA06). The consumption of this class slightly increased over the study period, but looks like stable since 2005 (Figure 3.16).

Figure 3.17: Outpatient use of the other J01 classes (J01B, J01G, J01R, J01X) in the participating countries in 2008

Figure 3.18: Distribution of outpatient use of the other J01 classes (J01B, J01G, J01R, J01X) during the study period (1999-2008)

The outpatient use of other J01 classes including amphenicols (J01B), aminoglycosides (J01G), combinations of antimicrobials (J01R) and others antimicrobials (J01X) varied from less than 0.01 DID in Slovenia to 3.4 DID in Greece (Figure 3.17). The most used sub-class were others antimicrobials (J01X). The Scandinavian countries showed high level of use due to high consumption of methenamin. Belgium and Lithuania showed high level of use as well, but mainly due to high consumption of nitrofurantoin (J01XE01) and nifurtoinol (J01XE02) for Belgium and metronidazole (J01XD01) and nitrofurantoin (J01XE01) for Lithuania. The level of use of this class remained stable since 2004 (Figure 3.18).

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Hospital care

Of the 35 participating countries 19 were able to deliver data on antibiotic use in hospitals in 2008, Belgium however delivered 2007 data. Table 3.3 and Figure 3.19 present the hospital use of the major antibiotic groups according to the ATC classification (penicillins (J0IC), cephalosporins (J01D), macrolides (J01F), quinolones (J01M), tetracyclines (J01A), sulphonamides (J01E), and other antibiotics [concatenation of amphenicols (J01B), aminoglycosides (J01G), combinations of antibacterials (J01R) and other antibacterials (J01X)) within the hospital antibiotic use.

The proportion of penicillins use ranged from 17,9% in Finland to 56,9% in France. Nine out of 17 countries had a proportion of use of penicillins greater than one third. The proportion of cephalosporins use was highin Bulgaria (44,5%), and low in Ireland (8,4%). Tetracycline use was the highest in Sweden (12,4%). Macrolide use ranged from 3,2% in Latvia to 15,7% in Malta; and quinolone use from 6,9% in Norway to 21,8% in Hungary. Sulfonamide use was the highest in Finland (6,5%) and low in Bulgaria (0,7%). The use of other classes was high in Finland (22,0%) and the Russian Federation (20,6%).

Nevertheless, the reliability of the estimation of national aggregates of hospital antibiotic consumption must be critically evaluated. All the reporting countries derive a reliable estimate for national hospital exposure to antibiotics from wholesale data or from detailed consumption registration in all hospitals. Moreover the validity of the hospital data is much more vulnerable for biases in ambulatory/hospital case mix. Specifically in Finland, where some remote primary health care centres and nursing homes were included into the hospital data, proportional use of “other antibiotics” was 22%, predominantly due to the use of oral methenamine and nitrofurantoin.

Table 3.3: Hospital use of antimicrobials for systemic use (ATC group J01) in 2008 in the participating countries

Country

Penicillins (J01C)

Cephalosporins and other

beta-lactams (J01D)

Tetracyclines (J01A)

Macrolides, lincosamides

and streptogramins

(J01F)

Quinolones (J01M)

Sulfonamides and

trimethoprim (J01E)

Other J01

classes

Total J01

Finland 0.59 0.99 0.23 0.19 0.37 0.22 0.73 3.31 Latvia 0.73 1.09 0.15 0.10 0.35 0.06 0.48 2.97

Italy 0.83 0.36 0.02 0.19 0.48 0.04 0.35 2.27

France 1.24 0.23 0.03 0.13 0.31 0.04 0.20 2.18

Luxembourg 0.75 0.72 0.01 0.16 0.28 0.04 0.18 2.15

Estonia 0.67 0.47 0.09 0.20 0.34 0.05 0.21 2.01

Belgium* 0.91 0.40 0.01 0.09 0.25 0.03 0.21 1.90

Russian Federation 0.38 0.62 0.07 0.13 0.30 0.02 0.34 1.87

Slovakia 0.65 0.49 0.02 0.11 0.35 0.04 0.12 1.77

Denmark 0.85 0.35 0.02 0.09 0.24 0.02 0.16 1.74

Norway 0.79 0.34 0.07 0.10 0.12 0.06 0.24 1.71

Slovenia 0.67 0.39 0.01 0.16 0.25 0.06 0.16 1.68

Ireland 0.76 0.13 0.02 0.23 0.17 0.04 0.22 1.57

Bulgaria 0.34 0.68 0.03 0.15 0.12 0.01 0.21 1.55

Sweden 0.66 0.25 0.19 0.06 0.16 0.09 0.13 1.54

Croatia 0.41 0.48 0.06 0.11 0.20 0.06 0.21 1.53

Malta 0.43 0.36 0.03 0.23 0.17 0.02 0.21 1.45

Hungary 0.32 0.25 0.06 0.14 0.25 0.04 0.09 1.15

Israel 0.41 0.26 0.04 0.06 0.12 0.00 0.10 0.99

* Belgium: 2007 data

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Figure 3.19: Hospital use of antimicrobials for systemic use (ATC group J01) in the participating countries in 2008

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

FI LV IT FR LU EE BE RU SK DK NO SI IE BG SE HR MT HU IL

Penicillins (J01C)

Cephalosporins and other beta‐lactams (J01D)

Tetracyclines (J01A)

Macrolides, lincosamides and streptogramins (J01F)

Quinolones (J01M)

Sulfonamides and trimethoprim (J01E)

Other J01 classes

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Antimycotic and antifungal use in Europe

Table 3.4 and Figure 3.20 and Figure 3.21 present the outpatient antimycotic use in 2008 for 23 European countries expressed in DID and subdivided into the main used substances. Twenty countries provided both J02 and D01B data. Greece, Slovenia and Lithuania did not report D01B use.

Among those countries who provided J02 and D01B data, total outpatient antimycotic and antifungal use varied with a factor 7.0 between the country with the highest (3.29 DID in Belgium) and lowest (0.47 DID in Croatia) use. The proportion of terbinafine use varied between 88.1% and 15.2% in Norway and Luxembourg respectively. Terbinafine use represented more than 50% of the total systemic antimycotic and antifungal use in 16 out of the 20 countries.

Table 3.4: Outpatient antimycotic and antifungal (J02 & D01B) use in 2008 subdvided into the main substances according to ATC classification

Country Griseofulvine

(D01BA01) Terbinafine (D01BA02)

Amphotericin B (J02AA01)

Ketoconazole (J02AB02)

Fluconazole (J02AC01)

Itraconazole (J02AC02)

Other J02

Total J02 & D01B

Belgium - 1.78 0.00 0.08 0.69 0.73 0.01 3.29 Cyprus* 0.23 1.15 0.02 0.25 0.21 0.44 0.01 2.31 Denmark - 1.82 0.00 0.03 0.28 0.15 0.00 2.28 France 0.11 1.78 - 0.06 0.17 0.03 0.00 2.14 Portugal 0.00 1.25 - 0.05 0.25 0.40 - 1.95 Finland 1.47 0.00 0.03 0.18 0.11 0.00 1.79 Greece* - - 0.05 0.08 0.95 0.55 0.05 1.68 The Netherlands 0.00 1.22 0.00 0.03 0.10 0.32 0.01 1.67

Luxembourg - 0.25 0.00 0.04 0.53 0.84 - 1.66 Estonia 0.00 1.11 0.00 0.13 0.12 0.12 - 1.48 Hungary - 0.73 - 0.17 0.19 0.20 0.00 1.29 Slovakia - 0.74 0.00 0.21 0.23 0.07 0.02 1.28 Israel 0.14 0.72 0.00 0.12 0.07 0.11 0.00 1.17 Norway 0.00 0.99 0.00 0.03 0.10 0.00 0.00 1.13 Italy 0.04 0.21 - 0.00 0.34 0.48 0.00 1.07 Austria - 0.75 0.00 - 0.07 0.19 0.01 1.02 Czech Republic - 0.60 0.01 0.11 0.10 0.10 0.00 0.92

Bulgaria - 0.17 - 0.42 0.23 0.04 0.00 0.86 Sweden 0.000 0.56 - 0.03 0.14 0.03 0.01 0.76 Latvia - 0.32 0.00 0.13 0.06 0.08 0.00 0.58 Croatia - 0.16 0.00 0.01 0.06 0.23 - 0.47 Slovenia - - - - 0.11 0.20 0.01 0.32 Lithuania* - - - 0.10 0.14 0.05 0.00 0.29

* Cyprus, Greece, Lithuania: total use, including the hospital sector.

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Figure 3.20: Outpatient antimycotic and antifungal (J02 & D01B) use in 2008 subdivided into the main substances according to ATC classification

* Cyprus, Greece, Lithuania: total use, including the hospital sector. ° Greece, Slovenia, Lithuania : provided no D01B data.

Figure 3.21: Distribution (boxplot) of outpatient antimycotic (J02) and antifungal (D01B) use among the participating countries between 2006 and 2008.

Antiviral use in Europe

Table 3.5 and Figure 3.22 present data on outpatient use of all antivirals for systemic use (ATC J05) aggregated at the level of the active substance, expressed in DDD (WHO ATC/DDD, version 2008) per 1000 inhabitants per day (DID).

Total outpatient systemic antiviral use in 2008 in 16 European countries varied by a factor of 25.6 between the country with the highest (1.5 DID in the Netherlands) and the country with the lowest (0.06 DID in Croatia) use. In 10 out of the 16 countries nucleosides and nucleotides excluding reverse transcriptase inhibitors (ATC J05AB) represented more than 50% of the total outpatient antiviral use. In the Netherlands, Sweden, Slovakia, Austria, Norway and the Czech Republic the majority of the outpatient systemic antiviral use is represented by substances to

0

0.5

1

1.5

2

2.5

3

3.5Griseofulvine (D01BA01)

Terbinafine (D01BA02)

Amphotericin B (J02AA01)

Ketoconazole (J02AB02)

Fluconazole (J02AC01)

Itraconazole (J02AC02)

other J02 substances

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treat chronic viral infections like HIV, hepatitis B and hepatitis C (ATC J05AE, J05AF, J05AG, J05AR, J05AX).The use of neuraminidase inhibitors (ATC J05AH) was the highest in Austria (0.03 DID) and varied from 4.2% in Finland to no use reported in Portugal.

Table 3.5: Most frequently used antiviral sfor systemic use (J05A) in outpatient settings for 15 participating European countries in 2008.

Country

Nucleosides and

nucleotides excl. reverse transcriptase

inhibitors (J05AB)

Protease inhibitors (J05AE)

Nucleoside and

nucleotide reverse

transcriptase inhibitors (J05AF)

Non-nucleoside

reverse transcrip-

tase inhibitors (J05AG)

Neura-minidase inhibitors (J05AH)

Antivirals for

treatment of HIV

infections, combina-

tions (J05AR)

Other antivirals (J05AX)

all antivirals

(J05A)

The Netherlands

0.20 0.24 0.38 0.35 0.00 0.36 0.01 1.54

Luxembourg 1.24 0.02 0.10 0.02 0.00 0.03 0.00 1.41

Sweden 0.35 0.21 0.14 0.13 0.00 0.31 0.01 1.16

Slovakia 0.14 0.01 0.04 0.00 0.00 - 0.87 1.07

Austria 0.40 0.17 0.22 0.11 0.03 0.00 0.01 0.94

Norway 0.19 0.20 0.09 0.12 0.00 0.29 0.01 0.90

Slovenia 0.19 0.06 0.06 0.03 0.00 - 0.00 0.34

Denmark 0.30 0.00 0.00 0.00 0.01 0.00 - 0.31

Italy 0.26 - 0.03 0.00 0.00 0.00 0.01 0.30 Czech Republic

0.11 0.03 0.10 0.02 0.00 0.00 0.00 0.25

Finland 0.23 0.00 0.00 0.00 0.01 - - 0.24

Estonia 0.19 0.00 0.00 0.00 0.00 0.00 0.19

Hungary 0.17 - 0.02 0.00 0.00 0.00 0.00 0.18

Portugal 0.17 - 0.01 - - - - 0.18 Croatia 0.06 0.00 0.00 0.00 0.00 - - 0.06

Figure 3.22: Antiviral consumption (J05A) in outpatient settings for 15 participating European countries in 2008.

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

NL LU SE SK AT NO SI DK IT CZ FI EE HU PT HR

Nucleosides and nucleotides excl. reverse transcriptase inhibitors (J05AB)Protease inhibitors (J05AE)

Nucleoside and nucleotide reverse transcriptase inhibitors (J05AF)Non‐nucleoside reverse transcriptase inhibitors (J05AG)

Neuraminidase inhibitors (J05AH)

Antivirals for treatment  of HIV  infections, combinations (J05AR)Other antivirals (J05AX)

DDD per 1000 inhabitants per day

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CHAPTER 4. IN-DEPTH ANALYSES

Ambulatory Care

Ambulatory Care Scientific Advisor: Sigvard Mölstad, SE; Samuel Coenen, BE

Clinical Scientist Ambulatory Care: Niels Adriaenssens, BE

Aims In ESAC-3 the Ambulatory Care Subproject aims to:

• collect national dispensing data linked to the patients’ age and gender and the prescribers’ speciality (protocol A)

• collect national or sample data of prescriptions by GPs linked to the patients’ age and gender and to the indication (protocol B)

• validate further the available set of twelve indicators developed to assess the quality of antibiotic use in ambulatory care (quality indicators protocol)

• collect recommendations from evidence-based clinical guidelines, including antibiotic guides, developed for and applicable to the participating countries (guideline protocol).

Protocol A & B In this subproject we aim to explain the observed variation in outpatient antibiotic use in Europe by collecting more in-dept data. Therefore, in ESAC-3, we continued to collect national dispensing data linked to the patients’ age and gender and the prescribers’ specialty (protocol A). Preliminary analysis of protocol A data shows that controlling for demographic differences only has a very limited impact on the observed variation between countries (Figure 4.1). Figure 4.1: Outpatient antibiotic use in 8 European countries in 2005

OBS = using for each country its original age and gender distribution CON = using for each country the average European age and gender distribution in 2005 based on the Europe United Nations Population Division, World Population Prospects, 2006 Revision

Since differences in the age and gender distribution seems to provide only a very limited explanation of the observed variation, we also aspire to collect national or sample data of prescriptions by GPs linked to the patients’ age and gender and to the indication (protocol B). But, so far we have not been successful with protocol B. Either data linking GPs’ antibiotic prescribing to diagnosis are not available, or they are not available in the desired format, i.e. diagnosis linked to ICPC-2-R or ICD10 codes. For that reason, we are very happy that we can collaborate with APRES (The appropriateness of prescribing antibiotics in primary health care in Europe with respect to antibiotic resistance), a European project lead by NIVEL in the Netherlands and recently kick-off. Among other objectives, APRES aims to establish the pattern of prescribed antibiotics in primary care

0

5

10

15

20

25

30

OBS

CON

OBS

CON

OBS

CON

OBS

CON

OBS

CON

OBS

CON

OBS

CON

OBS

CON

Luxembourg Belgium Israel Slovenia Denmark Sweden Finland TheNetherlands

DD

D /

1000

inab

itant

s / d

ay

Others*TMP and sulfonamides (J01E)Tetracyclines (J01A)Quinolones (J01M)MLS (J01F)Cephalosporins (J01D)Penicillins (J01C)

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practices and its variation between nine European countries using a protocol similar to that our protocol B. Data for protocol A & B can now be submitted online using ESAC Collect Manager. Participants are also asked to complete an online questionnaires on data characteristics of the protocol A and B data, respectively. Quality indicators protocol This aim of this subproject is to further the development of indicators to assess the quality of antibiotic use in ambulatory care develop. During two earlier ESAC AC Subproject Meetings (2008, 2009), the framework for the development of quality indicators as well our previous work on so-called drug specific quality indicators was presented. Then proposals of disease specific quality indicator were discussed, i.e. a proposal based on the outcomes of the HAPPY AUDIT (Health Alliance for Prudent Prescribing, Yield and Use of Antimicrobial Drugs in the Treatment of Respiratory Tract Infections; www.happyaudit.org; FP6 2007-2010) project, and a proposal based on the outcomes of the guideline review within the CHAMP (Changing behaviour of Health care professionals And the general public towards a More Prudent use of anti-microbial agents; FP6 2007-2010) project. The latter proposal was based on consensus between different guidelines and related to 2 important questions per ICPC2-R (International Classification of Primary Care) code:

1. Is an antibiotic prescription justified? => The appropriate antibiotic prescribing interval (min%-max%)

2. If an antibiotic prescription is justified, what (kind of) antibiotic(s) is the first choice? => The appropriate first choice antibiotic prescribing interval (min%-max%)

It was suggested to focus on the six ICPC2-R codes most often associated with antibiotic prescribing, i.e. R78 (acute bronchitis), R74 (upper respiratory tract infection), R75 (acute tonsillitis), R76 (acute/chronic sinusitis), H71 (acute otitis media/myringitis),U71 (cystitis, or other urinary tract infection), and on R81 (pneumonia). Based on the discussion of these proposals, in 2010 a proposed set of Outpatient Disease-specific Antibiotic Prescribing Quality Indicators (see Table 4.1) was developed, and a group of experts in this field, i.e. in antibiotic prescribing in primary care in Europe, with a purposeful geographical and contextual spread, was invited to help us produce consensus by scoring each of the proposed indicators according to its relevance to 1. reducing antimicrobial resistance, 2. the patient health benefit, 3. cost-effectiveness, 4. policymakers and 5. individual prescribers. This work is still in progress and builds on our previous and similar development of antibiotic prescribing quality indicators on behalf of the ESAC Project Group,1 (also available on the esac website www.ua.ac.be/esac) and aims to complement work on behalf of the HAPPY AUDIT Project Group.2 In addition, this work once more emphasizes the importance and need to include primary care physicians in the ESAC NN. 1. Coenen S, Ferech M, Haaijer-Ruskamp FM, Butler CC, Vander Stichele RH, Verheij TJM, et al. European

Surveillance of Antimicrobial Consumption (ESAC): quality indicators for outpatient antibiotic use in Europe. Qual Saf Health Care 2007;16:440-5.

2. Plejdrup-Hansen M, Bjerrum L, Gahrn-Hansen B, Jarbol DE. Quality indicators for diagnosis and treatment of respiratory tract infections in general practice: A modified Delphi study. Sc J Prim Health Care 2010;28:4-11.

Guideline collection protocol For guidelines on otitis media, sore throat, sinusitis and lower respiratory tract infections collaboration with CHAMP has been very successful. For guidelines on urinary tract infections as well as on skin and soft tissue infection from ESAC countries, we rely on the ESAC National Networks (NN) to update previous ESAC guideline review work.

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Table 4.1: List of proposed disease-specific antibiotic prescribing quality indicators N° Title Label 1a. The percentage of patients aged between 18 and 75 years with acute

bronchitis/bronchiolitis (ICPC-2-R: R78) prescribed antibacterials for systemic use (ATC: J01)

[R78_J01_%]

1b. = 1a. receiving the recommended antibacterials (ATC: J01CA or J01AA)

[R78_RECOM_%]

1c. = 1a. receiving quinolones (ATC: J01M) [R78_J01M_%]

2a. The percentage of patients older than 1 year with acute upper respiratory infection (ICPC-2-R: R74) prescribed antibacterials for systemic use (ATC: J01)

[R74_J01_%]

2b. = 2a. receiving the recommended antibacterials (ATC: J01CE) [R74_RECOM_%] 2c. = 2a. receiving quinolones (ATC: J01M) [R74_J01M_%]

3a. The percentage of female patients older than 18 years with cystitis/other urinary infection (ICPC-2-R: U71) prescribed antibacterials for systemic use (ATC: J01)

[U71_J01_%]

3b. = 3a. receiving the recommended antibacterials (ATC: J01XE or J01EA or J01XX)

[U71_RECOM_%]

3c. = 3a. receiving quinolones (ATC: J01M) [U71_J01M_%]

4a. The percentage of patients older than 1 year with acute tonsillitis (ICPC-2-R: R76) prescribed antibacterials for systemic use (ATC: J01)

[R76_J01_%]

4b. = 4a. receiving the recommended antibacterials (ATC: J01CE) [R76_RECOM_%] 4c. = 4a. receiving quinolones (ATC: J01M) [R76_J01M_%]

5a. The percentage of patients older than 18 years with acute/chronic sinusitis (ICPC-2-R: R75) prescribed antibacterials for systemic use (ATC: J01)

[R75_J01_%]

5b. = 5a. receiving the recommended antibacterials (ATC: J01CA or J01CE)

[R75_RECOM_%]

5c. = 5a. receiving quinolones (ATC: J01M) [R75_J01M_%]

6a. The percentage of patients older than 2 years with acute otitis media/myringitis (ICPC-2-R: H71) prescribed antibacterials for systemic use (ATC: J01)

[H71_J01_%]

6b. = 6a. receiving the recommended antibacterials (ATC: J01CA or J01CE)

[H71_RECOM_%]

6c. = 6a. receiving quinolones (ATC: J01M) [H71_J01M_%]

7a. The percentage of patients aged between 18 and 65 years with pneumonia (ICPC-2-R: R81) prescribed antibacterials for systemic use (ATC: J01)

[R81_J01_%]

7b. = 7a. receiving the recommended antibacterials (ATC: J01CA or J01AA)

[R81_RECOM_%]

7c. = 7a. receiving quinolones (ATC: J01M) [R81_J01M_%]

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Hospital Care

Hospital Care Scientific Advisor: Peter Davey, UK

Clinical Scientist Hospital Care: Peter Zarb, MT

Hospital Care Support: Brice Amadeo, FR

Clinical Scientist Support: Rudi Stroobants, BE

Background

Within ESAC-1, it was recognised that there was no unified hospital information on antimicrobial use across the European countries. The explanations included lack of standardised methods for producing valid data.

ESAC-3 used the methodology developed within the ESAC-2 Hospital Care subproject. A web application was specifically developed for data entry and automatic feedback for the two Point Prevalence Surveys (PPS 2008 & PPS 2009) which used a simplified version of the protocol of the 2006 PPS.

Aims • To consolidate and enlarge the European network for point prevalence surveys. • To have as many hospitals as possible pledged to our point prevalence survey so that the

pledge is translated into improved antibiotic prescribing. • To identify targets for quality improvement. • To develop quality indicators of antimicrobial consumption in hospitals.

Methods

Patient records were the main source of information in order to try and find out what the physicians were aiming at treating. To achieve this, auditors could request additional information from nurses, pharmacists or doctors. There was no discussion about the appropriateness of prescribing. Staff were not to feel evaluated or that the intention was to implement a change in prescribing.

All patients on non-topical antibacterials and antifungals (J01, J02, A07AA, P01AB, D01BA, and J04AB02) at 8 am on the days of survey were included in the survey. Any patient who received one or more doses of prophylaxis in the 24h prior to 8 am on the day of the survey was considered so as to be able to determine whether surgical prophylaxis was prolonged >1 day. The Diagnosis Groups were categorised by anatomical site of infection treated or prevented (prophylaxis).

The survey was carried out from May to June 2009. The original aim to enroll twice as many hospitals compared to PPS-2008. However, more than three times as many hospitals participated. There was a high participation from Englan

Data collection

PPS 2009

172 hospitals from 25 countries included over 73,060 patients in the survey. The hospitals represented a broad range of types (Table 4.2). For the final report on PPS-2009 74 randomly selected hospitals using SAS software (Proc surveyselect) was applied when the hospital number per country was above five (i.e., Austria, Belgium, England, Republic of Ireland, and Scotland) in order to minimise bias which might be caused by practices within these countries.

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Table 4.2: Types of Participating hospitals in PPS 2009

Hospital type N (Total) N (Sample)

Secondary 89 32 Tertiary 57 28 Primary 21 10 Infectious diseases 3 3 Paediatrics 2 1 TOTAL 172 74

The prevalence of prescribing was 29.0%. There was a high use of parenteral antibiotics (60.5%) and varied with the specialties (Fig. 4.2). Long duration (>1 day) of surgical prophylaxis was more than 1 day in 62% of all prescribed therapies (Fig. 4.3). This is not evidence-based practice and should be 0%.

Figure 4.2: Distribution of percentage of parenteral therapies among hospitals

Figure 4.3: Proportion of type of the length of surgical prophylaxis

020

4060

80100

All Med Surg IC

%

Parenteral Oral

1 day21%

>1 day53%

1 dose26%

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LS 2009

Originally it was intended that the same 50 hospitals that participated in PPS-2008 would collect 4 years of monthly data on antimicrobial use and optionally on antimicrobial resistance in collaboration with EARSS for the period 2005-2008. However, various hospitals could not provide the consumption data. Thus quarterly data was considered, but still a number of hospitals could not provide data either. In addition, some hospitals that did provide consumption data do not participate in EARSS. Consumption data shall be aggregated at the hospital level and split by ward categories i.e., general wards/ICU/paediatrics. In total, 23 hospitals participated in the LS survey. EARSS data was requested for the organisms listed in Table 4.3 from the hospitals (laboratories) which participated in both EARSS and ESAC. The complete antibiograms as available to EARSS for invasive isolates were also requested. Antibiograms are important for evaluation of cross resistance. Table 4.3: Organism List: Staphylococcus aureus Enterococcus faecalis Enterococcus faecium Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

Table 4.4: Antibiogram details needed for cross resistance purposes Laboratory ID Sample ID Date of sample Type of ward: ICU/ general ward Species isolated (from list provided in table 4.4) Antibiogram (for isolate)

For LS2009 consumption data mining is still in progress. Resistance data shall be delivered to ESAC by ECDC.

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Nursing Homes

Nursing Homes Scientific Advisor: Béatrice Jans, BE

Clinical Scientist Nursing Homes: Ellen Broex, BE; Katrien Latour, BE

Clinical Scientist Support: Rudi Stroobants, BE

Background

Since data on antibiotic consumption in NHs are scarce and resistant organisms can be abundantly present in these settings, a European wide network of NHs was set up in order to explore the antibiotic use. The IPSE project (Improving Patient Safety in Europe) - Workpackage 7 on long term care facilities (LTCF) showed that data on antimicrobial use in these settings were only available in 4 out of 17 European countries (DDDs in only one, and in relative frequencies of antimicrobials in the remaining 3 countries). In 2006, a pilot Point Prevalence Survey (ESAC-2 PPS) was designed and tested in a limited number of NHs (n = 12) in 2 selected countries (BE, UK). An overall antibiotic use prevalence of 7.6% (95% confidence interval 6.1%-9.3%) was observed at the NH resident level. The PPS methodology appeared to be a useful, non labour-intensive tool and feasible et European level and was integrated in the ESAC-3 NH subproject.

Aims

The aims of the ESAC Nursing Home subproject are: • To measure and describe antibiotic use and prescriptions among residents in European NHs using a standardized methodology; • To explore determinants of antibiotic use at institutional and resident level.

Methods

The NH subproject contains two components: • A national (questionnaire) survey on characteristics of and on national/regional regulating

mechanisms for AB use and infection control in NHs in the participating countries (September 2008). An overview of the results can be found in the ESAC 2007 yearbook.

• Two consecutive PPS on AB use (April and November 2009) in participating NHs throughout Europe using: • a resident questionnaire for data collection on AB use and individual determinants • an institutional questionnaire in order to explore institutional determinants with possible

impact on AB use/prescription in the participating NHs, and to collect aggregated denominator data on NH and population characteristics.

1. Antimicrobial use in European nursing homes: Results from the first point prevalence survey (April 2009)

Background Facing the threat of antimicrobial resistance in healthcare settings, optimising the use of antibiotics (AB) in the nursing home (NH) population is an important priority of quality of care. However, data on AB-use in European (EU) NHs are scarce. The European Surveillance of Antimicrobial Consumption (ESAC) NH subproject team, funded by the European Centre for Disease Prevention and Control, carried out a methodology in order to measure AB use among residents living in EU NHs. Aims The aims of the ESAC NH subproject are to: 1. Create a broad EU network on antimicrobial use in NHs, 2. Develop a standardised method in order to measure AB-use,

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3. Describe antimicrobial prescriptions in EU NHs: the frequency, indications, characteristics & seasonal variations, 4. Explore determinants of AB-use on institutional and resident level in EU NHs Methods Participation rate during PPS-1: April 2009 During the month of April 2009 a point prevalence survey on antibiotic use was organised in 304 high skilled nursing homes (33,713 NH beds, 31,691 eligible residents) in 20 European countries (including 2 UK). Figure 4.4: Countries with final data delivery for the NH-PPS 1 (April 2009) & Number of participating NHs & eligible residents by country

COUNTRY n. NHs

n. eligible residents

Belgium 116 12,085 Croatia 5 1,290 Czech Republic 6 691 Denmark 5 319 Finland 8 1,706 France 29 2,211 Germany 8 425 Ireland 18 1,662 Italy 30 2,820 Latvia 5 1,195 Lithuania 1 126 Malta 5 320 Norway 5 568 Poland 5 692 Russia 4 1,740 Slovenia 6 1,421 Sweden 9 508 The Netherlands 4 712 UK: England 5 230 UK: N. Ireland 30 970 TOTAL 304 31,691

General characteristics of participating NHs - The mean number of beds per NH in the participating countries ranged between 49 and

469. Among all participating NHs, the smallest facility counted 20 beds and the largest 650 beds.

- The median bed occupancy rate reached 97.4%. In 13 countries this rate was higher than 95%.

- Also care load indicators and risk factors in the total resident population of participating NHs were very different between facilities and between countries (Table 4.5)

Table 4.5: Percentage of residents with care load indicators & risk factors in the total resident population % residents with: Country min. Country max. NH min. NH max.

CARE LOAD INDICATORS Incontinence 10.3% 84.0% 1.8% 100.0% Disorientation 6.7% 70.4 0.0% 100.0% Impaired mobility 12.9% 76.8% 1.1% 100.0%

RISK FACTORS Urinary catheter 0.0% 35.0% 0.0% 56.7% Vascular catheter 0.0% 3.6% 0.0% 17.4% Wounds 1.7% 25.1% 0.0% 79.6%

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Prevalence of AB use among residents in European NHs Among 31,691 eligible residents from 304 NHs, 1874 residents (5.9%) used an antimicrobial on the day of the survey. The median prevalence of AB-use among participating facilities reached 5.4% (min. 0% - max. 30%). In 20 NHs (7%) a zero prevalence of AB use was observed. By country, the median prevalence of AB-use ranged from 0.6% to 15.1%. Figure 4.5: Median prevalence of AB use in NHs in European countries

Characteristics of residents with AB therapy in European NHs The median age of residents with an AB treatment was 85 years (min. 35 y. – max. 109 y.) and 28.2% were male residents. Thirty-two percent of them lived in the NH less than one year and 22.9% stayed recently (whithin the 3 previous months) in an acute care hospital. The prevalence of care load indicators and risk factors was significantly higher among residents with an antibiotic treatment compared to residents without. Antimicrobials prescribed in European NHs In total, 1951 antimicrobial regimens were used on the day of the survey: 96% of the residents with ABs used a single molecule, 4% used more than one molecule (max. 3) for a single or for multiple infections. ATC level 2: A total of 95.3% of all prescribed molecules were antimicrobials for systemic use (J01). ATC level 3: The five most frequently prescribed molecules were: β-lactam antibacterials (J01C: 27.2%), other antibacterials (J01X: 25.5%), quinolones (J01M: 13.8%), other β-lactam antibacterials (J01D: 10.3%) and sulfonamides /trimethoprim (J01E: 9.9%).

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Administration route for antimicrobial therapy Of all antibiotics in use in NHs, 89.6% were administered orally and 9.4% was for parenteral use (IM/IV). The frequency of parenteral administration varied strongly by NH, ranging between 0 and 15%. Nasal application of mupirocin represented only 0.9% of all antimicrobial treatments and was only observed in 3 countries: Belgium, Northern Ireland and the Republic of Ireland. In some countries, such as Italy, Russia, Poland and the Czech republic, the proportion of parenteral treatment was important (at least 25% of all treatments). Type of antimicrobial treatments in European NHs Half (54%) of all AB treatments were empirical. Among empirical treatments, 55% were administered for respiratory tract infections and 22% for urinary tract infections. Prophylaxis was very frequent (29% of all AB prescriptions) and concerned particularly urinary tract infections (89% of all prophylaxis). Only 16% was a documented treatment, 72% of the microbiologically documented treatments were administered for urinary tract infections and 8% for surgical wound infections. Nasal decolonisation with mupirocin counted for only 1% of all treatments.

2. Antimicrobial use in European nursing homes: second point prevalence survey (November 2009)

Participation in the second ESAC NH PPS (November 2009) In November 2009, a second ESAC NH PPS was organised together with the pilot HALT PPS: Healthcare associated infections, AB-use (= ESAC-project), antimicrobial resistance and Infection control resources in LTCFs. Eight countries participated only in the AB-PPS (ESAC), 13 countries combined the ESAC (AB) and HALT (infections) project. Compared to PPS 1, 2 additional countries registered for participation: Bulgaria and Hungary. The data collection from the ESAC PPS 2 is now complete now and analysis is ongoing. The results will be presented during the ESAC annual meeting in Stockholm end of May 2010.

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Socio-Economics

Socio-Economics Scientific Advisor: Philippe Beutels, BE

Clinical Scientist Socio-Economics: Christiaan Marais, BE

Background

It’s important for policy makers to understand which contextual determinants (socio-economic, demographic, organisational) explain the differences observed between and within European countries in local use of antibiotics.

Main Aim

To construct a database on potential contextual determinants of antimicrobial consumption in EU countries, and regress this against the ESAC and IMS databases of antibiotic use.

Data collection & methods

Literature review and data extractions on antibiotic consumption per country

Previous analyses from the literature were reviewed, noting the differences in formulation of the regression models and the results obtained. It was particularly interesting that Harbarth & Monnet (2008) found education to be a significant determinant, whereas another model formulated by Masiero et al (2007) found this not to be the case. This was explained by Masiero et al as a consequence of the observation that educated people were more likely to be aware of resistance levels in a country, and resistance was used in that model as an explanatory variable of AB consumption. Data collection started in 2008 and a mother list of determinants was shown at the Athens meeting in November 2008 where it was decided that the list is sufficient. Thereafter additional variables were added and preliminary results were shared on the 22nd of June 2009 at the AC/EC Subproject Meeting which was held in Antwerp. The database had many missing values due to data constraints.

Following the subproject meeting in June 2009, a new clinical scientist, Christiaan Marais, was appointed to work on this subproject with primary focus on finding missing values in the database and adding to the number of possible variables. Through more intensive use of global databases (including Eurostat, OECD, WHO) the database was extended to include more variables and previously missing values. Up to September 2009, the database increased from 60 to 153 variables. Data for the year 2007 has also been added for both the determininants and the consumption data. In terms of the first set of variables collected, data availability increased from 49% to 68%. At the June 2009 subproject meeting a pilot survey was conducted and approved to be expanded and sent out to the 35 ESAC LNRs. The survey captured aspects which are difficult to gather from generic international databases, and aims to determine the differences between countries in terms of:

• Procedures for patients to consult with physicians • Doctor remuneration • Treatment guidelines • Feedback on Antibiotic prescription • Doctor – Pharmacist role • Marketing restrictions

The LNR survey was sent out on the 7th of August 2009 and responses from 28 LNRs were received after which the variables were added to the list of variables.

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The final database that is being used in the datamining excersise contains 183 variables with 68% data availability. Twenty seven of these variables were obtained in the LNR survey. The variable groups, with the number of variables in each group and the data availability of each group is summarized in Table 4.6. Table 4.6: Availability of variables

Group Number of variables

Average availability

Agricultural factors 7 55%

Burden of disease 35 75%

Culture and perception of illness 26 40%

Demographic factors 21 82%

Education and knowledge about antibiotics 6 47%

Healthcare system 76 68%

Socioeconomic factors 12 55%

TOTAL 183 68%

Price of antibiotics

During the ESAC Scientific Advisory Board meeting on November 27, 2009 in Paris, FR the current database was shared and planned analysis were discussed. The shortage of antibiotics cost data was shared and it was decided to ask each LNR to help with the collection of price data in their countries. Individual emails were sent to all LNRs on December 16, 2009 requesting them to indicate to what extent they will be able to provide data on the cost of antibiotics from local sources. LNRs were asked to indicate which of the following data they may be able to provide:

• EX-FACTORY PRICE: The total payment received by the pharmaceutical company for providing one package of the medication. This excludes distribution costs and the markup charged by the pharmacy for dispensing the medication

• EX-PHARMACY PRICE: The total payment received by an average non-hospital-based pharmacy for providing one package of the medication.

• OUT OF POCKET PRICE: The total amount faced by an average patient for purchasing a package of the medication at a pharmacy. This amount should not include the amount reimbursed by the national health insurance, but may include the amount covered by private insurers .

The following price data (see Table 4.7) has been received with the help of the LNRs.

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Table 4.7: Availability of price data Country Data recieved Time period for which

data is available

Norway

Cost into pharmacy (Ex-pharmacy excluding mark-up) 1999-2009

Ex-pharmacy

Portugal Ex-pharmacy 2002-2009

Croatia Ex-factory

2006, 2008, 2009 Out of pocket

Estonia Ex-pharmacy 2006-2009

Wholesale price 2003-2009

Switzerland Ex-factory

2003-2009 Ex-pharmacy

Belgium Ex-pharmacy 1999-2009

Out-of-pocket 2001-2009

Sweden Ex-pharmacy 2006-2009

Out-of-pocket 2006-2009

Slovakia Ex-factory 1999; 2001; 2004-2010

Ex-pharmacy 2001; 2004-2010

Out-of-pocket 1999; 2001; 2004-2010

Slovenia Ex-pharmacy

2007-2010 Ex-factory

Spain Ex-factory

2009-2010 Ex-pharmacy

Bulgaria Ex-factory 2005-2009

France Wholesale price

1999-2008 Ex‐pharmacy 

The following countries have indicated that they can provide data, but the data is not yet available: Country Data available Time period for which data

is available

Ireland Ex-factory

2000 onwards Possibly Ex-pharmacy

Denmark Ex-factory

1999 onwards Ex-pharmacy

The availability of data is still being investigated for the following countries: Country Data type investigated

Israel All data types

Sweden Ex-factory

Czech Republic All data types

Ireland Out of pocket price

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Currently, we expect that no price information will be available for the following countries:

• United Kingdom • Latvia • Italy • Finland • Poland • Malta • Romania • Hungary

Price data has been made available already for France. The analysis techniques will be finalised in the coming months as more price data becomes available.

Investigation into data analysis methodology

The techniques for imputing missing values were investigated and it was decided to impute missing values with a weighted average of the known values with the weight being determined by the distance in time between the known and unkown values. Explanatory variables in the dataset for which a country has no information will not be imputed. A biclustering technique of the availability matrix will then be used to chose an optimal set of rows and variables from the database for which we have 100% data availability. The random forest technique that will be used to identify influencial variables in the dataset has been investigated by means of simulation studies. When the random forest technique is used in its default form, it produces inconsistent results due to the correlated explanatory variables. The random forest will therefore be run multiple times after which influencial variables will be identified using a backward selection approach. Boosting of a regression tree will also be used as a datamining technique with backward and forward variable selection. The random forest technique has been discussed with researchers that are currently exploring the effect of correlated variables on random forests and they have indicated that this methodology is a plausible approach.

Preliminary results

Various scenarios are being created based on the availability of the explanatory variables and preliminary results will be shared at the ESAC meeting in Stockholm end of May 2010.

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CHAPTER 5. ESAC DISSEMINATION ACTIVITIES Papers published in peer reviewed journals 2008-2010

Adriaenssens N., Coenen S., Muller A., Vankerckhoven V., Goossens H. on behalf of the ESAC Project Group. European Surveillance of Antimicrobial Consumption (ESAC): outpatient systemic antimycotic and antifungal use in Europe. Journal of Antimicrobial Chemotherapy. 8/2/2010, 10.1093/jac/dkq023.

Coenen S, Muller A, Adriaenssens N, Vanessa Vankerckhoven, Erik Hendrickx, and Herman Goossens on behalf of the ESAC Project GroupEuropean Surveillance of Antimicrobial Consumption (ESAC): outpatient parenteral antibiotic treatment in Europe. J Antimicrob Chemother 2009, 64 (1): 200-205

van de Sande-Bruinsma N., Grundmann H., Verloo D., Tiemersma E., Monen J., Goossens H., Matus F., and the European Antimicrobial Resistance Surveillance System and European Surveillance of Antimicrobial Consumption Project Groups. Antimicrobial Drug Use and Resistance in Europe. Emerg Infect Dis 2008, Vol.14(11) 1722-30.

Goossens H, Coenen S, Costers M, De Corte S, De Sutter A, Gordts B, Laurier L, and Struelens M. Achievements of the Antibiotic Policy Coordination Committee (BAPCOC). Eurosurveillance 2008; 13(46) Nov 13.

Davey P, Ferech M, Ansari F, Muller A, Goossens H; on behalf of the ESAC Project Group. Outpatient Antibiotic use in the four administrations of the UK: cross-sectional and longitudinal analysis. J Antimicrob Chemother 2008; 62(6): 1441-4447.

Coenen S, Ferech M, Haaijer-Ruskamp FM, Butler CC, Vander Stichele RH, Verheij TJM, Monnet DL, Little P, Goossens H en de ESAC-Projectgroep. European Surveillance of Antimicrobial Consumption (ESAC): Kwaliteitsindicatoren voor het antibioticagebruik in de ambulante praktijk. Huisarts Nu 2008; 37: 456-462.

Richter SS, Heilmann KP, Dohrn CL, Beekmann SE, Riahi F, Garcia-de-Lomas J, Ferech M, Goossens H, Doern GV. Increasing telithromycin resistance among Streptococcus pyogenes in Europe. J Antimicrob Chemother 2008;61:603-1.

Abstracts accepted for oral presentation 2010

B. Jans, K. Latour, E. Broex, R. Stroobants, A. Muller, V. Vankerckhoven, H. Goossens on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Homes subproject group. The European Surveillance of Antimicrobial Consumption: point prevalence survey of antimicrobial prescriptions in 270 European nursing homes. 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010. (Oral presentation by B. Jans)

K. Latour, E. Broex, N. Drapier, A. Muller, V. Vankerckhoven, R. Stroobants, H. Goossens, B. Jans on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Homes subproject group. Impact of medical care and coordination on antibiotic policy and consumption: preliminary results of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Homes subproject. 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010. (Oral presentation by K. Latour)

E. Broex, K. Latour, A. Muller, N. Drapier, V. Vankerckhoven, R. Stroobants, H. Goossens, B. Jans on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Homes subproject group. The European Surveillance of Antimicrobial Consumption (ESAC) survey of wound prevalence and antibiotic use in 270 European nursing homes in 2009. 20th

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European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010. (Oral presentation by E. Broex)

B. Amadeo, P. Zarb, G. Gavazzi, A. Muller, V. Vankerckhoven, P. Davey, H. Goossens on behalf of the ESAC Hospital Care Subproject Group. The ESAC point prevalence survey: Antimicrobial prescribing in 2 age groups of elderly patients from 49 hospitals in 28 European countries in 2008. 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010. (Oral presentation by B. Amadeo)

P. Zarb, B. Amadeo, A. Muller, V. Vankerckhoven, P. Davey, H. Goossens on behalf of the ESAC Hospital Care Sub-project Group. Systemic antifungal therapy in European hospitals. Data from the ESAC point prevalence surveys 2008 and 2009. 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010. (Oral presentation by P. Zarb)

N. Adriaenssens, S. Coenen, A. Muller, V.Vankerckhoven, H. Goossens and the ESAC Project Group. European Surveillance of Antimicrobial Consumption (ESAC): Outpatient systemic antiviral use in Europe 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010. (Oral presentation by N. Adriaenssens)

P. Zarb, B. Amadeo, A. Muller, V. Vankerckhoven, P. Davey, H. Goossens, on behalf of the ESAC Hospital Care Sub-project Group. ESAC Point Prevalence Survey of Antibiotic Use in 134 European Hospitals in 2009. 5th Decennial International Conference on Healthcare-Associated Infections, Atlanta, US, 18-22 Mar, 2010 (Oral presentation by Peter Zarb).

Abstracts accepted for poster presentation 2010

B. Jans, K. Latour, E. Broex, R. Stroobants, A. Muller, V. Vankerckhoven, H. Goossens on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Homes subproject group. The European Surveillance of Antimicrobial Consumption: point prevalence survey of antimicrobial prescriptions in 116 Belgian nursing homes. 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010.

K. Latour, E. Broex, N. Drapier, A. Muller, V. Vankerckhoven, R. Stroobants, H. Goossens, B. Jans on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Homes subproject group. Infection control resources in European nursing homes and their relation to antibiotic use: data of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Homes subproject. 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010.

G. Gavazzi, P. Gilbert, L. Fontaine, R. Stroobants, E. Hendrickx, A. Muller, V. Vankerckhoven, H. Goossens, B. Jans on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Homes subproject group. Antibiotic consumption in 30 French nursing homes: a point prevalence study from the European Surveillance of Antimicrobial Consumption nursing home subproject. 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010.

V. Vankerckhoven, A. Muller, A. Versporten, S. Coenen, N. Adriaenssens, S. Vaerenberg, P. Zarb, B. Amadeo, P. Davey, E. Broex, B. Jans, C. Marais, P. Beutels, N. Drapier, S. Nys, and H. Goossens. European Surveillance of Antimicrobial Consumption (ESAC). 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, April 10-13, 2010, EU Corner.

A. Muller, N. Drapier, B. Amadeo, P. Zarb, B. Jans, V. Vankerckhoven, P. Davey, H. Goossens, on behalf of the ESAC Hospital Care Sub-project Group. The ESAC-WebPPS application: Point Prevalence Surveys on Antimicrobial Prescribing Made Online. 5th Decennial International Conference on Healthcare-Associated Infections, Atlanta, US, 18-22 Mar, 2010.

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B. Jans, A. Muller, N. Drapier, V. Vankerckhoven, R. Stroobants, K. Latour, E. Broex, H. Goossens, on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Project Group. Are frequent catheter use and presence of wounds related to higher antimicrobial prescription frequencies in nursing home populations? Data from the first point prevalence survey on antibiotic use in European nursing homes in 2009. 5th Decennial International Conference on Healthcare-Associated Infections, Atlanta, US, 18-22 Mar, 2010.

B. Jans, A. Muller, N. Drapier, V. Vankerckhoven, R. Stroobants, K. Latour, E. Broex, H. Goossens, on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Project Group. A methodology for a Point Prevalence Survey on antimicrobial prescriptions in a network of high skilled nursing homes in Europe, European Surveillance of Antimicrobial Consumption (ESAC), 2007- 2010. 5th Decennial International Conference on Healthcare-Associated Infections, Atlanta, US, 18-22 Mar, 2010.

E. Broex, K. Latour, A. Muller, N. Drapier, V. Vankerckhoven, R. Stroobants, H. Goossens, B. Jans, on behalf of the ESAC Nursing Home subproject group. The European Surveillance of Antimicrobial Consumption (ESAC) Survey of Parenteral Antibiotic Use in 270 European Nursing Homes in 2009. 5th Decennial International Conference on Healthcare-Associated Infections, Atlanta, US, 18-22 Mar, 2010.

K. Latour, E. Broex, A. Muller, N. Drapier, V. Vankerckhoven, R. Stroobants, H. Goossens, B. Jans, on behalf of the European Surveillance of Antimicrobial Consumption (ESAC) Nursing Home subproject group. The European Surveillance of Antimicrobial Consumption (ESAC) Point Prevalence Survey of Indications for Antibiotic Treatment in 270 European Nursing Homes in 2009. 5th Decennial International Conference on Healthcare-Associated Infections, Atlanta, US, 18-22 Mar, 2010.

B. Jans, K. Latour, E. Broex, A. Muller, V. Vankerckhoven, R. Stroobants, H. Goossens voor de European Surveillance of Antimicrobial Consumption (ESAC) Nursing Home projectgroep. Het antibioticumvoorschrift in Belgische woon- en zorgcentra in 2009: Resultaten van de eerste ESAC nursing home studie. 33rd Geriatrics and Gerontology Winter Meeting, Ostend, Belgium, Feb 26-27, 2010.

K. Latour, E. Broex, A. Muller, V. Vankerckhoven, R. Stroobants, H. Goossens, B. Jans namens de European Surveillance of Antimicrobial Consumption (ESAC) Nursing Home subprojectgroep. Antibiotica voor urineweginfecties in Belgische woon- en zorgcentra: data van het European Surveillance of Antimicrobial Consumption (ESAC) subproject. 33rd Geriatrics and Gerontology Winter Meeting, Ostend, Belgium, Feb 26-27, 2010.

Website

A new ESAC website has been developed and is accessible through the following link: http://www.esac.ua.ac.be. The ESAC website contains 3 parts:

An area for general information about the ESAC project. An area for the dissemination of results and knowledge. A password-protected area for the internal management of ESAC.

The electronic library (e-library): ESAC publications as well as related publications and projects can be found here. Interestingly, all National Networks can add relevant article and projects on the E-library. Please note that the library is however not a subject of scientific review.

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The public pages: Public pages for lay people and the press were created on the ESAC website. For each of the countries participating in ESAC the following items can be consulted in the country’s native languages:

ESAC What is ESAC? Why ESAC? Who to contact in your country?

Antibiotics Drugs? Bugs

Consumption antibiotics In Europe In your country Defined Daily Dose

Resistance antibiotics What is resistance What are the consequences

Useful links Figure 5.1: Screenshot of the ESAC homepage

Interactive database A new, easier to use interactive database containing ESAC data on antibiotics for the participating European countries has been released on our website. You can explore the database in 3 ways:

1. By comparing countries for one year 2. By comparing yearly trends for one country 3. By visualing maps of Europe

The interactive database was updated with 2008 data.

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Figure 5.2: Screenshot of the ESAC interactive database

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Newsletter

The first ESAC Newsletter was available as of February 2008 and the most recent newsletter dates from April 2010. In each of the newsletters 4 of the National Networks present themselves and news on the core data and/or the subprojects is presented. Upcoming events are announced and previous events such as congresses are discussed. In the April 2010 newsletter, results from the different subprojects were published. The newsletter is made available 3 times per year. A PDF version of the ESAC Newsletters can be downloaded from the ESAC website (www.esac.ua.ac.be).

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CHAPTER 6. CONCLUSIONS AND FUTURE OBJECTIVES ESAC was launced in 2001 and funded for a period of 6 years by DG Sanco of the European Commission. Since September 2007, ESAC is funded by ECDC. ESAC successfully collected 2006, 2007 and 2008 consumption data on antimicrobials for systemic use (ATC group J01), antimycotics for systemic use (ATC group J02) and additional specific substances in 26 out of the 35 participating countries. These data have been instrumental for instance to evaluate the impact of awareness campaigns in many EU Member States, such as Belgium and France, and will be crucial to monitor the impact of the EU Antibiotic Awareness Day in November, 2010. Additionally, the ESAC project will deepen the knowledge of antibiotic consumption by focusing on specific consumption groups and/or patterns (Nursing Homes, Hospital Care, and Ambulatory Care) in collaboration with those countries where the appropriate data are available. To date, 8 countries participated in the ESAC Ambulatory Care (AC) subproject. The AC subproject has 4 components. 1) Protocol A: linking age, gender and prescriber. A first analysis showed that controlling for demographic differences had a very limited impact on the observed variation between countries. 2) Protocol B: linking age, gender and indication. A collaboration has been set-up with the EU-project APRES to obtain this type of data. Information from protocols A&B will substantially broaden our interpretation of the striking variation in antibiotic use between European countries in primary care. 3) Protocol assessing the quality of 12 indicators. This component will be performed in collaboration with the EU-project HAPPY AUDIT in order to complement their work. 4) Guidelines on otitis media, sore throat, sinusitis and lower respiratory tract infections were set-up in collaboration with the EU-project CHAMP. For guidelines on urinary tract infections skin and soft tissue infections, expertise will be requested from the ESAC NNs. Twenty-eight European countries participated in the ESAC Hospital Care (HC). The HC subproject also has 4 components. 1) Point Prevalence Survey (PPS) in 2008 which was conducted in 50 hospitals from 28 European countries, 2) PPS in 2009 in 172 hospitals from 25 countries. The PPS 2008 and 2009 were conducted using the ESAC Web-PPS tool which was developed for data entry and automated data analysis. The PPS 2008 report has been published and decribes the relationship between prescribed antimicrobials, dose, site of infection, and indication at patient level. The PPS 2009 will be published shortly. Also, each of the participating hospitals can consult their results by accessing their online report on the web-PPS website. 3) 4-year Longitudinal Survey (LS) was conducted in 23 hospitals from PPS 2008 and PPS 2009 hospitals. The analysis of the results is onging and first results will be presented during the ESAC annual meeting end of May 2010. 4) Basic hospital statistics. The aim is to define a standard dataset that should be considered in comparing antibiotic use. The ESAC Hospital Questionnaire is designed to collect information on hospital characteristics. Twenty European countries participated in the ESAC Nursing Home (NH) subproject. The NH-subproject has 2 components. The first component (September 2008) was a descriptive study of the characteristics (structural, functional) of high skilled NHs and the regulating mechanisms concerning antibiotic use and infection control in these facilities in European countries. The results were presented in the ESAC 2007 yearbook. The second component concerned the organisation of 2 consecutive Point Prevalence Surveys (PPS) on antibiotic use in at least 5 high skilled NHs per country, one in April 2009 and the second in October 2009. Analysis of the results of the first PPS has been finalised and a report will be published soon. Analysis of the second PPS is ongoing and results will be presented during the ESAC annual meeting end of May 2010. Furthermore, the Ambulatory Care (AC) subproject will closely interact with a subproject on Socio-Economic Determinants (EC). The EC subproject has one component: to construct a database on potential contextual determinants of antimicrobial consumption. Through the use of global databases (including Eurostat, OECD, WHO) and an LNR survey this database was constructed. Also, a survey was performed on the price of antibiotics using local sources. Results of the datamining analyses of the variables and analysis of price of antibiotics will be presented during the ESAC annual meeting end of May 2010. The progress of all subprojects will be discussed during the ESAC annual meeting in Stockholm on May 27-28, 2010.

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ANNEX I: COUNTRY SHEETS ON ANTIMICROBIAL CONSUMPTION The country sheets presented in this section provide specific information on antimicrobial use for each of the reporting countries. The country sheets are divided into four sections.

1) The first section presents information on the source and type of data reported by the participating countries as well as the population data used to report the antimicrobial consumption.

a. Antimicrobial use data: Type of health care sector for which data are reported: ambulatory care / hospital care or total care. Type of consumption data: sales data or reimbursement data from health insurance systems. The coverage (in percentage) of the data: representativeness of the data reported in ESAC. Source of the consumption data: public or private.

b. Population data: For comparison reasons, consumption data is reported in numbers of DDDs per 1000 inhabitants and per day (DID). ESAC uses the WHO population except when this population is not relevant, i.e. when using insurance data.

2) The second section presents the consumption of antimicrobials for systemic use (ATC class J01) split into 7 major classes based on the ATC classification. Several Tables and Figures are shown:

a. A table presenting the data expressed in DDD per 1000 inhabitants per day (DID) for each of the health care sectors for which data are reported.

b. For ambulatory care, two figures are shown: • A pie plot presenting the distribution of the relative consumption of

the 7 classes • A bar plot presenting the trends of consumption of the 7 classes

from 1998 to 2007 c. For hospital care, one figure is shown:

• A pie plot presenting the distribution of the relative consumption of the 7 classes

3) The third section presents the consumption of the major antimycotics for systemic use (ATC class J02). Data are presented in two ways:

a. A table presenting the data expressed in DDD per 1000 inhabitants per day (DID) for each of the health care sectors for which data are reported.

b. A figure presenting the distribution of the relative consumption of each of the major antimycotics for systemic use for each of the health care sectors for which data are reported.

4) The fourth section presents a comment on the antimicrobial consumption in order to facilitate interpretation. The National Networks provided general comments about the antimicrobial use in their respective countries whereas the Management Team added, when required, technical comments about the presentation of the data. The comments made by the National Networks and those made by the Management Team are preceeded respectively by National Networks and Management Team.

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Reported data split by health care sectors for each of the participating countries for the year 2008 Country Ambulatory care

(N=27) Hospital care

(N=18) Total care

(N=3) Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland Former Yugoslavian Republic of Macedonia

France Germany Greece Hungary Iceland Ireland Israel Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Russian Federation Slovakia Slovenia Spain Sweden Switzerland Turkey United Kingdom * Former Yugoslavian Republic of Macedonia was not yet part of the ESAC group in 2006.

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Austria 2008Health care Data type Coverage Data source

Ambulatory care Reimbursement 100% Health Insurance Company

Population Data source

8,336,549 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 6.17

Other beta-lactam antibacterials (J01D) 1.70

Tetracyclines (J01A) 1.33

Macrolides, lincosamides and streptogramins (J01F) 3.65

Quinolone antibacterials (J01M) 1.31

Sulfonamides and trimethoprim (J01E) 0.29

Other J01 substances 0.20

Total J01 classes 14.65

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care

Terbinafine (D01BA02) 0.75

Amphotericin B (J02AA01) <0.01

Ketoconazole (J02AB02) 0.00

Fluconazole (J02AC01) 0.07

Itraconazole (J02AC02) 0.19

Voriconazole (J02AC03) <0.01

Other J02 substances <0.01

Total J02 substances 1.02

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In Austria, the overall antibiotic consumption remained static in the last years, after an increasebetween 2004 and 2005. Penicillins remained at about the same level they reached in 2005, after a constant increase,up to this year. Cephalosporins were undulant over the years without significant differences. Macrolides, lincosamidesand streptogramins are still increasing and are now almost at the same high level which they were having in 1999. Theincrease of quinolones seems to have been stopped. This could be an effect of several awareness campaigns in themedical community emphasizing on the resistance situation and on existing alternatives to quinolones in outpatient andambulatory care. The decrease of sulfonamides and trimethoprim still continues. They have lost their importance whichthey had in earlier years.

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Belgium 2008Health care Data type Coverage Data source

Ambulatory care Reimbursement 98% Health Insurance Company

Population Data source

10,666,866 Eurostat

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 15.48

Other beta-lactam antibacterials (J01D) 2.02

Tetracyclines (J01A) 2.19

Macrolides, lincosamides and streptogramins (J01F) 2.78

Quinolone antibacterials (J01M) 2.41

Sulfonamides and trimethoprim (J01E) 0.38

Other J01 substances 2.39

Total J01 classes 27.66

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care

Terbinafine (D01BA02) 1.78

Amphotericin B (J02AA01) <0.01

Ketoconazole (J02AB02) 0.08

Fluconazole (J02AC01) 0.69

Itraconazole (J02AC02) 0.73

Voriconazole (J02AC03) <0.01

Other J02 substances <0.01

Total J02 substances 3.29

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In Belgium, systemic antimicrobials for human use are prescription-only medicines and sold bypharmacies. Data on Belgian drug use are reimbursement data and are provided by the National Institute for Sicknessand Invalidity Insurance (RIZIV/INAMI). From 1 January 2008 onwards reimbursement rules changed. As a result thepopulation covered increased from about 90% in 2007 to about 98% in 2008. According to the RIZIV/INAMI totalreimbursed drug expenditures increased about 5.4% between 2007 and 2008. This suggests that also for outpatientantibiotic (J01) use, several percentages of the increase in use between 2007 and 2008 can be explained by thechanges in the reimbursement system. However, it is likely that other factors contributed to the increased J01 use in2008 as well. The biggest increases are seen for penicillins (J01C) and tetracyclines (J01A). Smaller increases are seenfor the macrolides, lincosamides and streptogramins (J01F), quinolones (J01M) and other antibacterials (J01X). Belgianantibiotic guides for ambulatory care were released in 2006 and 2008 to encourage rational antibiotic use. Increased useof some molecules like amoxicillin and azithromycin might be partly explained by a shift in antibiotic use towards therecommended substances. In 2008 Belgium launched a new public campaign focusing on antibiotic use in children at theEuropean Antibiotic Awareness Day, the eighth campaign since the start in the 2000-2001 winter season. Overallantimycotic and antifungal use (J02, D01B) increased about 9%. Most used substances are terbinafine (54%),itraconazole (22%)and fluconazole(21%). Also for antimycotic and antifungal drugs, the new reimbursement systemexplains part of the increased use.

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Bulgaria 2008Health care Data type Coverage Data source

Hospital care Sales 100% Marketing Research Company

Ambulatory care Sales 100% Marketing Research Company

Population Data source

7,623,395 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 9.75 0.34

Other beta-lactam antibacterials (J01D) 2.08 0.68

Tetracyclines (J01A) 2.16 0.03

Macrolides, lincosamides and streptogramins (J01F) 3.20 0.15

Quinolone antibacterials (J01M) 2.08 0.12

Sulfonamides and trimethoprim (J01E) 0.99 0.01

Other J01 substances 0.30 0.21

Total J01 classes 20.56 1.55

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.17 <0.01

Amphotericin B (J02AA01) 0.00 0.00

Ketoconazole (J02AB02) 0.42 0.03

Fluconazole (J02AC01) 0.23 0.03

Itraconazole (J02AC02) 0.04 <0.01

Voriconazole (J02AC03) <0.01 <0.01

Other J02 substances 0.00 <0.01

Total J02 substances 0.86 0.07

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: Surveillance of antibiotic consumption in Bulgaria started in 2001 after the country joined the ESACproject. In the period 1999 – 2006 data on Bulgarian drug use was obtained from the State Drug Agency (BDA) andrepresented the total care (TC) consumption of antibiotics. Data for 2005 – 2009 was derived from a Marketing ResearchCompany (IMS) and represented ambulatory care (AC) and hospital care (HC) consumption respectively. The mostprescribed drugs in the AC are penicillins, macrolides and tetracyclines while in hospitals these are cephalosporins,penicillins and macrolides. In 2008, we recorded a slight increase in antibiotic consumption in both AC (7%) and HC(13%) sector by comparison with the previous year. The increased consumption was most pronounced for amoxicillin(J01CA04), amoxicillin and enzyme inhibitor (J01CR02), ceftriaxone (J01DD04), cefixime (J01DD08) and clarithromycin(J01FA09). We also recorded steady decrease in the consumption of tetracycline class of drugs, mainly doxycycline(J01AA02). Antibiotic consumption in hospitals amounts to 7% of the total consumption of antibiotics.

Management Team: The reported J01 data in the ambulatory care sector are total care (included hospital data) figuresuntil 2005 and then ambulatory care only.

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Croatia 2008Health care Data type Coverage Data source

Hospital care Sales 100% Marketing Research Company

Ambulatory care Sales 100% Marketing Research Company

Population Data source

4,434,508 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 10.99 0.41

Other beta-lactam antibacterials (J01D) 3.99 0.48

Tetracyclines (J01A) 1.77 0.06

Macrolides, lincosamides and streptogramins (J01F) 3.32 0.11

Quinolone antibacterials (J01M) 1.44 0.20

Sulfonamides and trimethoprim (J01E) 1.20 0.06

Other J01 substances 0.65 0.21

Total J01 classes 23.37 1.53

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.16 <0.01

Amphotericin B (J02AA01) <0.01 <0.01

Ketoconazole (J02AB02) <0.01 <0.01

Fluconazole (J02AC01) 0.06 0.03

Itraconazole (J02AC02) 0.23 <0.01

Voriconazole (J02AC03) 0.00 <0.01

Other J02 substances 0.00 <0.01

Total J02 substances 0.47 0.05

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In ambulatory care a trend of a decrease in broad and narrow spectrum penicillin consumption and anincrease in consumption of penicillin and beta-lactamase inhibitor combinations is observed for the past two years.Amoxicillin plus clavulanic acid is the most frequently prescribed antibiotic in ambulatory care. Compared with the lastyear, a decrease in 1st generation cephalosporin and an increase in 2nd generation consumption was recorded. Adecrease in norfloxacin consumption over the past three years is followed by slight but steady increase in ciprofloxacinconsumption. Further reduction in co-trimoxazole and an increase in nitrofurantoin consumption is in accordance with thenational guidelines for the treatment of uncomplicated cystitis. Decrease in narrow spectrum penicillins and penicillinsresistant to beta-lactamases was recorded in hospital consumption which is a reflection of the shortage of these productsat the Croatian market. At the same time glycopeptide and linezolid consumption increased. Broad spectrum antibioticswith gram-negative coverage including carbapenems and colistin also increased in Croatian hospitals although the DIDfigures are quite small for hospital consumption and not sensitive enough to record shifts in hospital consumption,especially for antibiotics with restricted use.

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Cyprus 2008Health care Data type Coverage Data source

Total care Sales 100% Medicines Agency

Population Data source

796,900 National Institute for Statistics

Antimicrobials for systemic use (J01)

J01 classes Total care

Beta-lactam antibacterials, penicillins (J01C) 14.86

Other beta-lactam antibacterials (J01D) 6.57

Tetracyclines (J01A) 2.74

Macrolides, lincosamides and streptogramins (J01F) 3.45

Quinolone antibacterials (J01M) 4.29

Sulfonamides and trimethoprim (J01E) 0.41

Other J01 substances 0.46

Total J01 classes 32.78

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Total care

Terbinafine (D01BA02) 1.15

Amphotericin B (J02AA01) 0.02

Ketoconazole (J02AB02) 0.25

Fluconazole (J02AC01) 0.21

Itraconazole (J02AC02) 0.44

Voriconazole (J02AC03) <0.01

Other J02 substances 0.23

Total J02 substances 2.31

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: Cyprus has joined the ESAC project since 2006 providing antibiotic consumption data whichrepresents the total consumption (ambulatory and hospital care). Data are collected by Pharmaceutical Services,Ministry of Health and include the consumption in both private and public sectors, and cover 100% of the total antibioticuse. The data for the private sector cover sales in private pharmacies whereas data for public sector cover distributionfrom central pharmaceutical stores to governmental pharmacies. Approximately 75% of the total antibiotic use takesplace in the private sector where the ambulatory care predominates. This can be attributed to the greater access toantibiotics in terms of number of products in the private sector compared to the public sector where a limited number ofantibiotics is available. The most often prescribed antibiotic group are beta-lactam antibacterials (J01C, J01D) whichrepresent 60% of the total antibiotic use. Our data reveal relatively high antibiotic consumption in comparison with othercountries. However, a slight decrease is noted when comparing 2008 to 2007 data, reversing the positive trend reportedin 2007. The observed decrease in consumption is mainly due to the decrease in consumption of beta-lactamantibacterials (J01C, J01D). In contrast a worrying increase is observed in quinolone group consumption in both publicand private sector implicating oral route of administration.

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Czech Republic 2008Health care Data type Coverage Data source

Ambulatory care Reimbursement 100% Health Insurance Company

Population Data source

10,429,692 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 7.25

Other beta-lactam antibacterials (J01D) 1.39

Tetracyclines (J01A) 2.51

Macrolides, lincosamides and streptogramins (J01F) 3.33

Quinolone antibacterials (J01M) 1.24

Sulfonamides and trimethoprim (J01E) 0.87

Other J01 substances 0.83

Total J01 classes 17.41

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care

Terbinafine (D01BA02) 0.60

Amphotericin B (J02AA01) <0.01

Ketoconazole (J02AB02) 0.11

Fluconazole (J02AC01) 0.10

Itraconazole (J02AC02) 0.10

Voriconazole (J02AC03) <0.01

Other J02 substances <0.01

Total J02 substances 0.92

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: Czech data consumption represent ambulatory prescribing patterns in Czech Republic. All drugs arefully or partially reimbursed and therefore we can see that this is the mirror of ambulatory systematic anti-infective drugconsumption. It is discussed wrong use of drugs - amplified amoxicillin's - mainly co-amoxiclav as a first choice drug andhigh consumption, low use of basic penicillin's and amoxicillin, no availability of guidelines for preventive use ofantibiotics and rational combination of antibiotics. The consumption of macrolides and fluoroquinolones and role ofazitromycine and norfloxacine in this groups are discussed as well due to their high consumption. Consumption ofantiviral and antifungal agents are quit low in relation to antibiotics but we will see the changes in prescribing behavior inlong time perspective. The Czech Republic is focusing on antibiotic policy long time. The experts regularly (monthly)meet in subcommittee of antibiotic policy of Medical Czech associations Jana Evangelisty Purkyne. There were basedaccording the Czech law National antibiotic program in 2010 as well. Members of both bodies are microbiologists,physicians (including general practitioners) veterinary physicians, pharmacists, epidemiologists and hygienists and weexpect that the improvement of anti-infective drug consumption will be not non rationally increased. Drug consumption(also ESAC data) and prescribing regulations are main subjects of any particular discussion.

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Denmark 2008Health care Data type Coverage Data source

Hospital care Sales 100% Medicines Agency

Ambulatory care Sales 100% Medicines Agency

Population Data source

5,475,791 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 9.99 0.85

Other beta-lactam antibacterials (J01D) 0.03 0.35

Tetracyclines (J01A) 1.55 0.02

Macrolides, lincosamides and streptogramins (J01F) 2.32 0.09

Quinolone antibacterials (J01M) 0.52 0.24

Sulfonamides and trimethoprim (J01E) 0.77 0.02

Other J01 substances 0.79 0.16

Total J01 classes 15.97 1.74

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 1.82 <0.01

Amphotericin B (J02AA01) <0.01 0.01

Ketoconazole (J02AB02) 0.03 <0.01

Fluconazole (J02AC01) 0.28 0.13

Itraconazole (J02AC02) 0.15 0.01

Voriconazole (J02AC03) <0.01 0.01

Other J02 substances <0.01 <0.01

Total J02 substances 2.28 0.18

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In Denmark, all antimicrobials for human use are prescription-only medicines and are sold bypharmacies in defined pack-ages. Data on Danish drug use is obtained from the Danish Medicines Agency (DMA). Inambulatory care, the overall sales of antibacterial agents have increased slowly over the last ten years and are stillcharacterised by the use of narrow-spectrum antibacterials. In 2008, the overall consumption decreased, however, dueto a decrease in Beta-lactamase sensitive penicillins.The percentage of DDDs prescribed in the ambulatory care hasremained stable at 90%. The use of antibacterials in hospitals has increased. Overall consumption (J01) in hospitalsincreased by 7% from 2007 when expressed in DDD/100 occupied bed-days (data not shown). Due to the generalhospital strike fewer occupied bed-days was registered in 2008 than would have been expected without the strike.Therefore, the number of DDDs per 100 occupied bed-days in 2008 is higher than if 2008 had been a year without thegeneral hospital strike.

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Estonia 2008Health care Data type Coverage Data source

Hospital care Sales 100% Medicines Agency

Ambulatory care Sales 100% Medicines Agency

Population Data source

1,340,675 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 4.73 0.67

Other beta-lactam antibacterials (J01D) 0.85 0.47

Tetracyclines (J01A) 2.17 0.09

Macrolides, lincosamides and streptogramins (J01F) 2.25 0.20

Quinolone antibacterials (J01M) 0.88 0.34

Sulfonamides and trimethoprim (J01E) 0.47 0.05

Other J01 substances 0.52 0.21

Total J01 classes 11.88 2.01

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 1.11 0.01

Amphotericin B (J02AA01) <0.01 <0.01

Ketoconazole (J02AB02) 0.13 0.02

Fluconazole (J02AC01) 0.12 0.03

Itraconazole (J02AC02) 0.12 <0.01

Voriconazole (J02AC03) 0.00 <0.01

Other J02 substances <0.01 <0.01

Total J02 substances 1.48 0.07

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: The total consumption of systemic antibacterials has been very stable in Estonia over the past tenyears indicating rather a decreasing trend. Penicillins is the most extensively used group of antibiotics in Estonia andprimarily the penicillins with extended spectrum are used which constituted to one fourth of the total antibioticsconsumption in 2008 (3.4 DID) and adding to that the consumption of penicillins with extended spectrum in combinationwith beta-lactamase inhibitors the total consumption of penicillins with extended spectrum is more than one third of thetotal consumption of antibiotics. On the other hand the consumption of beta-lactamase sensitive penicillins is marginal(0.4 DID in 2008). Other more often used antibiotics groups in Estonia were macrolides and lincosamides (2.5 DID in2008) and tetracyclines (2.3 DID). The consumption of these groups follows different patterns, though, as theconsumption of macrolides and lincosamides is rising and the consumption of tetracyclines is decreasing. Besides thetetracyclines the consumption of aminoglycosides, trimetoprim in combination with sulfonamides and the group J01X hasalso decreased yearly. In addition to penicillins and macrolides the use of other beta-lactam antibiotics and quinoloneshas also increased. Thus the consumption of antibiotics is moving toward the increased use of newer classes ofantibiotics.

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Finland 2008Health care Data type Coverage Data source

Hospital care Sales 100% Medicines Agency

Ambulatory care Sales 100% Medicines Agency

Population Data source

5,326,109 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 6.07 0.59

Other beta-lactam antibacterials (J01D) 2.30 0.99

Tetracyclines (J01A) 4.03 0.23

Macrolides, lincosamides and streptogramins (J01F) 1.55 0.19

Quinolone antibacterials (J01M) 0.88 0.37

Sulfonamides and trimethoprim (J01E) 1.43 0.22

Other J01 substances 2.04 0.73

Total J01 classes 18.30 3.31

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 1.47 0.02

Amphotericin B (J02AA01) <0.01 <0.01

Ketoconazole (J02AB02) 0.03 <0.01

Fluconazole (J02AC01) 0.18 0.08

Itraconazole (J02AC02) 0.11 <0.01

Voriconazole (J02AC03) <0.01 <0.01

Other J02 substances <0.01 <0.01

Total J02 substances 1.79 0.13

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

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France 2008Health care Data type Coverage Data source

Hospital care Sales 100% Medicines Agency

Ambulatory care Sales 100% Medicines Agency

Population Data source

64,028,000 National Institute for Statistics

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 14.73 1.24

Other beta-lactam antibacterials (J01D) 2.53 0.23

Tetracyclines (J01A) 3.43 0.03

Macrolides, lincosamides and streptogramins (J01F) 4.14 0.13

Quinolone antibacterials (J01M) 2.08 0.31

Sulfonamides and trimethoprim (J01E) 0.47 0.04

Other J01 substances 0.61 0.20

Total J01 classes 27.99 2.18

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 1.78 0.01

Amphotericin B (J02AA01) 0.00 0.01

Ketoconazole (J02AB02) 0.06 <0.01

Fluconazole (J02AC01) 0.17 0.05

Itraconazole (J02AC02) 0.03 <0.01

Voriconazole (J02AC03) 0.00 0.02

Other J02 substances 0.11 0.01

Total J02 substances 2.14 0.11

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: The 2008 data confirm the downward trend observed during the previous years. In ambulatory sector,the antibiotic consumption (J01) decreased by 2.2% in comparison with 2007. Nationwide campaigns succeeded inreducing antibiotic use. The French antibiotic consumption remains however one of the highest in Europe and the resultsmust be strengthened by new actions and drives. In ambulatory care, the breakdown of the consumption confirms thepredominance of penicillin (especially amoxicillin and amoxicillin combined with an enzyme inhibitor) and bears out thedecrease of cephalosporins. No significant development was observed in the other classes. In hospital care, theconsumption levelled off in 2008 and, except for a decrease in the consumption of quinolones, no substantial change inthe main classes was recorded.

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Germany 2008Health care Data type Coverage Data source

Ambulatory care Reimbursement 90% Health Insurance Company

Population Data source

70,243,851 Insurance company

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 4.38

Other beta-lactam antibacterials (J01D) 1.92

Tetracyclines (J01A) 3.21

Macrolides, lincosamides and streptogramins (J01F) 2.39

Quinolone antibacterials (J01M) 1.42

Sulfonamides and trimethoprim (J01E) 0.81

Other J01 substances 0.41

Total J01 classes 14.54

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Comments

National Network: The antibiotic use density in Germany has remained in the same order of magnitude over the lastdecade. The relative proportions of different antibiotic drug classes have slightly changed. Oral cephalosporins,aminopenicillin/ß-lactamase inhibitor combinations (such as amoxicillin/clavulanic acid) and fluoroquinolones wereprescribed more frequently while cotrimoxazole and tetracyclines were prescribed less frequently. Number one antibiotichas remained amoxicillin.

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Greece 2008Health care Data type Coverage Data source

Total care Sales 100% Medicines Agency

Population Data source

11,237,068 WHO

Antimicrobials for systemic use (J01)

J01 classes Total care

Beta-lactam antibacterials, penicillins (J01C) 14.92

Other beta-lactam antibacterials (J01D) 9.51

Tetracyclines (J01A) 2.41

Macrolides, lincosamides and streptogramins (J01F) 11.55

Quinolone antibacterials (J01M) 3.05

Sulfonamides and trimethoprim (J01E) 0.42

Other J01 substances 3.35

Total J01 classes 45.21

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Total care

Terbinafine (D01BA02) 0.00

Amphotericin B (J02AA01) 0.05

Ketoconazole (J02AB02) 0.08

Fluconazole (J02AC01) 0.95

Itraconazole (J02AC02) 0.55

Voriconazole (J02AC03) <0.01

Other J02 substances 0.04

Total J02 substances 1.68

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: Ambulatory (outpatient) care data include consumption of private hospitals and nursing homes (andover the counter consumption). In 2006 the reporting system changed and sales data from pharma companies areelectronically provided to the National Organization for Medicines database (the increase noticed in 2006 could reflectthis). Since 2007, also parallel exports are available and data presented do not include them. Unfortunately antibioticconsumption continues to rise.

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Hungary 2008Health care Data type Coverage Data source

Hospital care Sales 100% Marketing Research Company

Ambulatory care Sales 100% Marketing Research Company

Population Data source

10,045,401 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 6.14 0.32

Other beta-lactam antibacterials (J01D) 1.86 0.25

Tetracyclines (J01A) 1.39 0.06

Macrolides, lincosamides and streptogramins (J01F) 3.06 0.14

Quinolone antibacterials (J01M) 1.75 0.25

Sulfonamides and trimethoprim (J01E) 0.69 0.04

Other J01 substances 0.29 0.09

Total J01 classes 15.18 1.15

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.73 <0.01

Amphotericin B (J02AA01) 0.00 <0.01

Ketoconazole (J02AB02) 0.17 <0.01

Fluconazole (J02AC01) 0.19 0.02

Itraconazole (J02AC02) 0.20 <0.01

Voriconazole (J02AC03) <0.01 <0.01

Other J02 substances 0.00 <0.01

Total J02 substances 1.29 0.04

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

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Iceland 2008Health care Data type Coverage Data source

Ambulatory care Sales 100% Ministry of Health

Population Data source

319,355 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 10.88

Other beta-lactam antibacterials (J01D) 0.26

Tetracyclines (J01A) 5.29

Macrolides, lincosamides and streptogramins (J01F) 1.61

Quinolone antibacterials (J01M) 0.77

Sulfonamides and trimethoprim (J01E) 1.35

Other J01 substances 0.48

Total J01 classes 20.64

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Comments

National Network: The relatively high consumption of antimicrobial agents in Iceland can largely be attributed to theconsumption of tetracycline. Tetracycline (in Iceland doxycycline) is used in great quantities in the age group 15-19years, more than in any other neighboring countries. Tetracycline is used in this age group mainly for treating acne.Resistance to tetracycline is increasing in Iceland. Therefore, it is of importance to reduce the consumption oftetracycline. Azithromycin is consumed in relatively high quantities in the age group 0-4 years in Iceland. The mostcommon cause for the use of antibacterial agents in this age group is otitis media. Since the half life of azithromycin isextensive in the body it is likely to increase the spread of antibacterial resistance, especially of pneumococci, the mostcommon cause of otitis media. Azithromycin is not a suitable drug for the treatment of otitis media.

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Ireland 2008Health care Data type Coverage Data source

Hospital care Sales 100% National hospital network

Ambulatory care Sales 100% Marketing Research Company

Population Data source

4,239,848 National census data

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 11.34 0.76

Other beta-lactam antibacterials (J01D) 1.56 0.13

Tetracyclines (J01A) 3.18 0.02

Macrolides, lincosamides and streptogramins (J01F) 4.11 0.23

Quinolone antibacterials (J01M) 1.04 0.17

Sulfonamides and trimethoprim (J01E) 0.99 0.04

Other J01 substances 0.20 0.22

Total J01 classes 22.42 1.57

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Hospital care

Terbinafine (D01BA02) <0.01

Amphotericin B (J02AA01) 0.04

Ketoconazole (J02AB02) <0.01

Fluconazole (J02AC01) 0.03

Itraconazole (J02AC02) <0.01

Voriconazole (J02AC03) <0.01

Other J02 substances <0.01

Total J02 substances 0.09

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

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Israel 2008Health care Data type Coverage Data source

Hospital care Reimbursement 50% Health Insurance Company

Ambulatory care Reimbursement 50% Health Insurance Company

Population Data source

3,862,403 Insurance company

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 11.70 0.41

Other beta-lactam antibacterials (J01D) 4.08 0.26

Tetracyclines (J01A) 1.18 0.04

Macrolides, lincosamides and streptogramins (J01F) 1.80 0.06

Quinolone antibacterials (J01M) 1.39 0.12

Sulfonamides and trimethoprim (J01E) <0.01 <0.01

Other J01 substances 1.89 0.10

Total J01 classes 22.04 0.99

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.72 <0.01

Amphotericin B (J02AA01) <0.01 <0.01

Ketoconazole (J02AB02) 0.12 <0.01

Fluconazole (J02AC01) 0.07 <0.01

Itraconazole (J02AC02) 0.11 <0.01

Voriconazole (J02AC03) <0.01 <0.01

Other J02 substances 0.14 <0.01

Total J02 substances 1.17 0.02

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

97

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Italy 2008Health care Data type Coverage Data source

Hospital care Reimbursement 100% Medicines Agency

Ambulatory care Reimbursement 100% Medicines Agency

Population Data source

59,619,290 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 15.17 0.83

Other beta-lactam antibacterials (J01D) 2.78 0.36

Tetracyclines (J01A) 0.54 0.02

Macrolides, lincosamides and streptogramins (J01F) 5.27 0.19

Quinolone antibacterials (J01M) 3.44 0.48

Sulfonamides and trimethoprim (J01E) 0.50 0.04

Other J01 substances 0.75 0.35

Total J01 classes 28.45 2.27

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.22 <0.01

Amphotericin B (J02AA01) 0.00 0.01

Ketoconazole (J02AB02) <0.01 <0.01

Fluconazole (J02AC01) 0.34 0.08

Itraconazole (J02AC02) 0.48 0.02

Voriconazole (J02AC03) 0.00 <0.01

Other J02 substances 0.04 <0.01

Total J02 substances 1.08 0.12

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

99

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Latvia 2008Health care Data type Coverage Data source

Hospital care Sales 100% Medicines Agency

Ambulatory care Sales 100% Medicines Agency

Population Data source

2,265,483 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 5.01 0.73

Other beta-lactam antibacterials (J01D) 0.49 1.09

Tetracyclines (J01A) 2.28 0.15

Macrolides, lincosamides and streptogramins (J01F) 0.95 0.10

Quinolone antibacterials (J01M) 0.98 0.35

Sulfonamides and trimethoprim (J01E) 0.84 0.06

Other J01 substances 0.39 0.48

Total J01 classes 10.96 2.97

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.32 <0.01

Amphotericin B (J02AA01) <0.01 <0.01

Ketoconazole (J02AB02) 0.13 <0.01

Fluconazole (J02AC01) 0.06 0.02

Itraconazole (J02AC02) 0.08 <0.01

Voriconazole (J02AC03) 0.00 0.00

Other J02 substances <0.01 <0.01

Total J02 substances 0.58 0.03

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: There was a decreasing trend for ambulatory use of antibiotics in Latvia in 2008 with no significantchange in proportion of several antibiotic groups used. We do not have an explanation for this observation. TheAntibiotic Day compaign started only in November, 2008. Approximately at that same time, the country was affected bya deep economical crisis. We believe, the impact of these events will be seen mainly in 2009 data.

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Lithuania 2008Health care Data type Coverage Data source

Total care Sales 100% Medicines Agency

Population Data source

3,371,127 WHO

Antimicrobials for systemic use (J01)

J01 classes Total care

Beta-lactam antibacterials, penicillins (J01C) 13.04

Other beta-lactam antibacterials (J01D) 3.20

Tetracyclines (J01A) 2.36

Macrolides, lincosamides and streptogramins (J01F) 2.04

Quinolone antibacterials (J01M) 1.56

Sulfonamides and trimethoprim (J01E) <0.01

Other J01 substances 2.89

Total J01 classes 25.10

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Total care

Terbinafine (D01BA02) 0.00

Amphotericin B (J02AA01) 0.00

Ketoconazole (J02AB02) 0.10

Fluconazole (J02AC01) 0.14

Itraconazole (J02AC02) 0.05

Voriconazole (J02AC03) <0.01

Other J02 substances 0.00

Total J02 substances 0.29

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In Lithuania, data on antimicrobial sales are collected from wholesalers by State Medicines ControlAgency of Lithuania and further processed by Institute of Hygiene. Only total sales data are available since 2006. Overthis period a slight increase is observed mainly due to sharp increase in sales of cephalosporins (J01D) : from 0.87 DIDin 2006 to 3.20 DID in 2008, increase of quinolones (J01M) from 0.83 DID in 2006 to 1.56 DID in 2008. At the sameperiod the decrease of penicillins consumption is recorded from 15.07 DID to 13.04 DID.

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Luxembourg 2008Health care Data type Coverage Data source

Hospital care Reimbursement 100% Community pharmacists

Ambulatory care Reimbursement >95% Health Insurance Company

Population Data source

488,650 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 11.98 0.75

Other beta-lactam antibacterials (J01D) 3.99 0.72

Tetracyclines (J01A) 2.02 0.01

Macrolides, lincosamides and streptogramins (J01F) 3.16 0.16

Quinolone antibacterials (J01M) 2.61 0.28

Sulfonamides and trimethoprim (J01E) 0.34 0.04

Other J01 substances 1.04 0.18

Total J01 classes 25.13 2.15

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.25 0.00

Amphotericin B (J02AA01) <0.01 0.00

Ketoconazole (J02AB02) 0.04 <0.01

Fluconazole (J02AC01) 0.53 0.09

Itraconazole (J02AC02) 0.84 <0.01

Voriconazole (J02AC03) 0.00 <0.01

Other J02 substances 0.00 0.02

Total J02 substances 1.66 0.12

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In Luxembourg antibacterial agents for systemic human use (J01) in ambulatory care are prescription-only and reimbursed medicines. Data based on drug prescription are provided by the Luxemburgish GeneralInspectorate of Social Security (IGSS) and refer to the insured resident population covered by the public healthinsurance regime which constitutes about 95% of the total population.When expressed in DDDs per thousand inhabitants per day (DID), the use of the entire group (J01) was high, butdecreased slightly by 1.9% in comparison with 2007. The most used antibiotics were penicillins (J01CA/J01CR) withextended spectrum (mainly amoxicillin) and combinations of penicillins with beta-lactamase inhibitors (amoxicillin withclavulanic acid) each representing 16.7% and 29.8% of the total ambulatory care use respectively. Other frequently usedantibiotics were cephalosporins, macrolides and fluoroquinolones, each representing 15.9%, 12.6% and 10.4% of thetotal use respectively. In the past decade, the use of penicillins (J01) increased continuously whereas a decrease of theuse of tetracyclines was observed.Antibacterial agents for systemic human use (J01) in hospital care have been monitored since 1997. In 2008 antibioticuse decreased slightly and accounts for 7.9% of the total use.Reimbursement data at individual level made possible to determine the proportion of treated patients in the residentpopulation. In 2008, 43.2% of the general population and 43.6% of the children and adolescents (0-19 years) havereceived at least one antibiotic treatment.

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Malta 2008Health care Data type Coverage Data source

Hospital care Sales >90% Ministry of Health

Population Data source

412,001 WHO

Antimicrobials for systemic use (J01)

J01 classes Hospital care

Beta-lactam antibacterials, penicillins (J01C) 0.42

Other beta-lactam antibacterials (J01D) 0.36

Tetracyclines (J01A) 0.03

Macrolides, lincosamides and streptogramins (J01F) 0.23

Quinolone antibacterials (J01M) 0.17

Sulfonamides and trimethoprim (J01E) 0.02

Other J01 substances 0.21

Total J01 classes 1.44

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Hospital care

Terbinafine (D01BA02) 0.00

Amphotericin B (J02AA01) 0.01

Ketoconazole (J02AB02) <0.01

Fluconazole (J02AC01) 0.02

Itraconazole (J02AC02) 0.00

Voriconazole (J02AC03) <0.01

Other J02 substances <0.01

Total J02 substances 0.04

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: The HC consumption of J01C has been on the decrease for the past decade. It accounted for >60% oftotal consumption in 1999 down to about 33% in 2008. The other antibiotic classes did not show any major shifts in use.AC data (distribution) was available for the first time for 2008. The penicillins (J01C) accounted for almost half the totalconsumption in AC followed by macrolides, cephalosporins and fluoroquinolones respectively. These 4 classesaccounted for 75% of all AC use.

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Netherlands 2008Health care Data type Coverage Data source

Ambulatory care Sales 90% Community pharmacists

Population Data source

15,029,000 Insurance system

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 4.42

Other beta-lactam antibacterials (J01D) 0.04

Tetracyclines (J01A) 2.63

Macrolides, lincosamides and streptogramins (J01F) 1.48

Quinolone antibacterials (J01M) 0.90

Sulfonamides and trimethoprim (J01E) 0.58

Other J01 substances 1.17

Total J01 classes 11.24

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care

Terbinafine (D01BA02) 1.22

Amphotericin B (J02AA01) <0.01

Ketoconazole (J02AB02) 0.03

Fluconazole (J02AC01) 0.10

Itraconazole (J02AC02) 0.32

Voriconazole (J02AC03) <0.01

Other J02 substances <0.01

Total J02 substances 1.67

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: Data on use of antibiotics in primary health care in the Netherlands are yearly published in theSWAB/RIVM NethMap report. Over the past 10 years the overall use of antibiotics for systemic use in primary healthcare remained almost constant. From 1998-2004 use was 10 DDD/1000 inhabitants per day. Over the past four yearsuse increased gradually to 11 DDD/1000 inhabitants per day. Tetracyclines (mainly doxycycline) represented 24% oftotal use in primary health care. Other frequently used antibiotics were penicillins with extended spectrum (mainlyamoxicillin), combinations of penicillins with beta-lactamase inhibitors (essentially amoxicillin with clavulanic acid) andmacrolides, each representing 17%, 15% and 14% of the total use respectively. In the past 10 years the use of penicillinswith beta-lactamase inhibitors, macrolides and nitrofurantoin increased whereas the use of tetracyclines and penicillinswith extended spectrum decreased. Moreover, subtle shifts in the patterns of use within the various classes of antibioticsare observed. The overall consumption of the fluoroquinolones remained almost constant whereas the increased use ofciprofloxacin seems to be offset by a decrease in ofloxacin and norfloxacin. Also, within the class of the macrolides wesee a shift from erythromycin to the newer macrolides such as clarithromycin and azithromycin. The remarkable increasein the use of nitrofurantoin may be explained by the national guidelines of the Dutch College of General practitioners(NHG) that have been changed over the years with regard to the pharmacotherapy of urinary tract infections. In 2005,these guidelines were revised and because of lower resistance levels nitrofurantoin was classified as the drug of firstchoice (5 days treatment). Trimethoprim is nowadays ranked as a urinary tract infection antibiotic of second choice.

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Norway 2008Health care Data type Coverage Data source

Hospital care Sales 100% National hospital network

Ambulatory care sales 100% National Institute

Population Data source

4,768,211 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 6.76 0.79

Other beta-lactam antibacterials (J01D) 0.14 0.34

Tetracyclines (J01A) 2.79 0.07

Macrolides, lincosamides and streptogramins (J01F) 1.89 0.10

Quinolone antibacterials (J01M) 0.50 0.12

Sulfonamides and trimethoprim (J01E) 0.77 0.06

Other J01 substances 2.68 0.24

Total J01 classes 15.53 1.71

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.99 0.00

Amphotericin B (J02AA01) <0.01 <0.01

Ketoconazole (J02AB02) 0.03 <0.01

Fluconazole (J02AC01) 0.10 0.04

Itraconazole (J02AC02) <0.01 <0.01

Voriconazole (J02AC03) <0.01 <0.01

Other J02 substances <0.01 <0.01

Total J02 substances 1.13 0.05

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In Norway, antimicrobials are prescription-only medicines and the majority of antibacterial use inambulatory care is not reimbursed. Data on use of antibiotics in Norway – both for humans and animals – are providedfrom the Norwegian Institute of Public Health and cover the entire population in Norway. Data on annual antimicrobialuse are published in three different publications; Drug consumption in Norway, The Norwegian Prescription databaseand NORM/NORM-vet. The overall sales of antibacterials for systemic use in Norway have been relatively stable formany years and is characterised by the use of narrow-spectred antibacterials. Phenoxymethylpenicillin is theantibacterial most frequently used in Norway, representing 25% of all use in ambulatory care measured in DDDs. InNorway, the sales of methenamine (J01XX05) is high, representing 15% of all use measured in DDDs. Methenamine isan urinary tract antiseptic hardly used in other countries. In the ESAC report, data have been retrieved from differentdatabases over the years, which results in some differences in the figures shown. In 2007 and 2008 the data forambulatory care have been retrieved from the Norwegian prescription database (NorPD) which contains data on allprescriptions to individuals with a personal identification number in Norway. The use of antibacterials in hospitals hasincreased. This could be explained by increased clinical activity, use of higher doses and patients being treated moreintensively. For hospital care, a new method for data harvesting is used since 2007; including an automatically collectionfrom all hospital pharmacies to a common database.

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Poland 2008Health care Data type Coverage Data source

Ambulatory care Reimbursement 100% National Health Fund

Population Data source

38,115,641 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 10.13

Other beta-lactam antibacterials (J01D) 2.21

Tetracyclines (J01A) 2.49

Macrolides, lincosamides and streptogramins (J01F) 3.66

Quinolone antibacterials (J01M) 1.21

Sulfonamides and trimethoprim (J01E) 0.95

Other J01 substances 0.05

Total J01 classes 20.69

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Comments

National Network: The data on antibiotic usage in Poland is based on reimbursement data from the National HealthFund. The system of completing those data is being under modernization. For that reason, results found might be biasedover the years. In Poland, antibiotics are available only with doctor's prescription. All antibiotics are in some percentagereimbursed, as such, the data should cover most of the primary care sales (it doesn't cover hospital care).

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Portugal 2008Health care Data type Coverage Data source

Ambulatory care Sales 100% Ministry of Health

Population Data source

8,222,310 National Health Service (NHS)

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 11.60

Other beta-lactam antibacterials (J01D) 1.98

Tetracyclines (J01A) 0.82

Macrolides, lincosamides and streptogramins (J01F) 3.87

Quinolone antibacterials (J01M) 3.05

Sulfonamides and trimethoprim (J01E) 0.43

Other J01 substances 0.85

Total J01 classes 22.61

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care

Terbinafine (D01BA02) 1.25

Amphotericin B (J02AA01) 0.00

Ketoconazole (J02AB02) 0.05

Fluconazole (J02AC01) 0.25

Itraconazole (J02AC02) 0.40

Voriconazole (J02AC03) 0.00

Other J02 substances <0.01

Total J02 substances 1.95

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In ambulatory care, the utilization of antimicrobials reached 22.61 DID in 2008. This is an increase by3.7% when compared to 2007. Several campaigns such as, among others, Antibiotic Resistance Awareness as a part ofthe National Program on Antimicrobial Resistance Prevention and more recently the Antibiotic European Day have beenlaunched in order to promote appropriate antibiotic use. In general, Portugal’s tendency is to decrease antimicrobialsutilization. An exception although is been observed for the years 2002, 2005 and 2008, but these figures only count for avariation between 3% to 8%. The most prescribed antibiotics were penicillins (J01C) representing 51% of total antibioticuse, followed by macrolides, lincosamides and streptogramins (J01F) with 17% and quinolones (J01M) with 14% of totaluse.

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Russian Federation 2008Health care Data type Coverage Data source

Hospital care Sales 100% Marketing Research Company

Ambulatory care Sales 100% Marketing Research Company

Population Data source

141,780,032 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 3.30 0.36

Other beta-lactam antibacterials (J01D) 0.37 0.62

Tetracyclines (J01A) 0.90 0.08

Macrolides, lincosamides and streptogramins (J01F) 1.53 0.13

Quinolone antibacterials (J01M) 1.89 0.30

Sulfonamides and trimethoprim (J01E) 0.86 0.02

Other J01 substances 1.11 0.39

Total J01 classes 9.96 1.90

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Slovakia 2008Health care Data type Coverage Data source

Hospital care Sales 100% Medicines Agency

Ambulatory care Sales 100% Medicines Agency

Population Data source

5,406,972 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 9.53 0.65

Other beta-lactam antibacterials (J01D) 3.89 0.49

Tetracyclines (J01A) 1.54 0.02

Macrolides, lincosamides and streptogramins (J01F) 5.93 0.11

Quinolone antibacterials (J01M) 2.00 0.35

Sulfonamides and trimethoprim (J01E) 0.48 0.04

Other J01 substances 0.04 0.12

Total J01 classes 23.40 1.77

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.74 <0.01

Amphotericin B (J02AA01) <0.01 <0.01

Ketoconazole (J02AB02) 0.21 0.04

Fluconazole (J02AC01) 0.23 0.02

Itraconazole (J02AC02) 0.07 0.01

Voriconazole (J02AC03) <0.01 0.01

Other J02 substances 0.02 <0.01

Total J02 substances 1.28 0.10

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In recent years the antibiotic costs are increasing at annual rate of around 11%. Hospital care reportedhigher increases than ambulatory care at a rate of 17% (measured in the consumption by unit). As a consequence of theS-MedDial project, the health insurance company Všeobecná Zdravotná Poisova managed to reduce the yearly totalexpenditure on antibiotics by more than 3.3 million Euros. The elimination of resistance shows promising results, forexample in Zvolen region the streptococci resistance to antibiotics have reduced from more than 54% to 22% and inBratislava region by 10%, which is considered a big success, as the antibiotic resistance is in general increasing. Themost important prerequisite for changing physician’s prescribing habits is his own awareness of prescribing comparedwith the general recommendations and also to his colleagues. An important part of the S-MedDial project is to provide afeedback on prescribing habits to a specific physician.Since 2008 each doctor receives a certificate, in addition to thefeedback. The certificate states the following goals to be achieved in the prescribing: 1) the proportion of patients withantibiotics (to be reduced), 2) the ratio of patients with antibiotics to all registered patients (to be reduced), 3) theproportion of antibiotics for treating acute respiratory infections in DDD (to be reduced), 4) the share antibiotics costs (inEuro) for treating acute respiratory infections (to be reduced), 5) the cost per patient with acute respiratory infections (tobe reduced), 6) the proportion of amino-penicillins for acute tonsillitis in DDD (to be reduced), 7) the share of antibioticsfor treatment of sinusititis acuta in DDD (to be reduced), 8) the ratio of total prescribed antibiotics to macrolides in DDD(to be increased), 9) the share of broad spectrum penicillins to macrolides in DDD (to be increased).

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Slovenia 2008Health care Data type Coverage Data source

Hospital care Sales 100% National hospital network

Ambulatory care Sales 100% National Institute

Population Data source

2,039,399 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 9.37 0.67

Other beta-lactam antibacterials (J01D) 0.44 0.39

Tetracyclines (J01A) 0.52 0.01

Macrolides, lincosamides and streptogramins (J01F) 2.47 0.16

Quinolone antibacterials (J01M) 1.11 0.25

Sulfonamides and trimethoprim (J01E) 1.12 0.06

Other J01 substances <0.01 0.16

Total J01 classes 15.03 1.68

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.00 <0.01

Amphotericin B (J02AA01) 0.00 0.01

Ketoconazole (J02AB02) 0.00 <0.01

Fluconazole (J02AC01) 0.11 0.06

Itraconazole (J02AC02) 0.20 <0.01

Voriconazole (J02AC03) <0.01 <0.01

Other J02 substances <0.01 <0.01

Total J02 substances 0.32 0.08

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: In Slovenia the consumption of antibiotics in AC and HC is moderate, with the trend of decreasing usein AC and stable use in HC. The consumption in HC was recently published. Cizman M et al. Nationwide use ofantibiotics in Slovenian hospitals in the period 2004-2008.-From national to department level. Zdrav Vestn 2009;78:717-25 (abstract in english is available at http://vestnik.szd.si/ang/ang-index.htm)

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Spain 2008Health care Data type Coverage Data source

Ambulatory care Reimbursement 100% Health Insurance Company

Population Data source

46,157,822 National Institute of Statistics

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 12.23

Other beta-lactam antibacterials (J01D) 1.65

Tetracyclines (J01A) 0.60

Macrolides, lincosamides and streptogramins (J01F) 1.92

Quinolone antibacterials (J01M) 2.42

Sulfonamides and trimethoprim (J01E) 0.30

Other J01 substances 0.58

Total J01 classes 19.70

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Comments

National Network: Since 1997 there has been a downward trend in the overall use of antibiotics in Spain until 2003 whena slight increase was detected. The pattern of use continues to be essentially the same, with broad-spectrum penicillinsaccounting for 62% of the overall use in 2008. The ratio amoxicillin/amoxicillin-clavulanic acid was maintained greaterthan 1 up to 2001 when an inversion occurred, reaching 0.58 in 2008. The increase in use of amoxicillin-clavulanic acidexpressed in DDD per 1000 inhabitants per day was mostly due to the progressive increase of share of high-strengthpresentations, while the number of packages sold did not substantially change. The use of cephalosporins andmacrolides has steadily decreased until 2008 where the historical minimum was reached (1.7 and 1.9 DID respectively).The use of quinolones, as a group appeared to be rather stable, though there was an increase in the use ofLevofloxacine compensated by a decrease in the use of Moxifloxacine, Norfloxacine and Ofloxacine . In the 2006 and2007 the Ministry of Health launched two widely publicised campaigns on the rational use of antibiotics (TV, radio,newspapers) focused on several issues including over-the-counter consumption. According to data available in ESAC,there is not a highlighted change in the use. Nevertheless, to assess the overall impact of the campaigns we needstudies to analyse whether the illegal but relevant over-the-counter consumption has significantly decreased or not.

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Sweden 2008Health care Data type Coverage Data source

Hospital care Sales 100% Community pharmacists

Ambulatory care Sales 100% Community pharmacists

Population Data source

9,182,923 WHO

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care Hospital care

Beta-lactam antibacterials, penicillins (J01C) 7.37 0.66

Other beta-lactam antibacterials (J01D) 0.30 0.25

Tetracyclines (J01A) 3.22 0.19

Macrolides, lincosamides and streptogramins (J01F) 0.45 0.06

Quinolone antibacterials (J01M) 0.83 0.16

Sulfonamides and trimethoprim (J01E) 0.57 0.09

Other J01 substances 1.87 0.13

Total J01 classes 14.60 1.54

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Antimycotics and antifungals for systemic use (J02, D01BA)

J02 substances Ambulatory care Hospital care

Terbinafine (D01BA02) 0.56 <0.01

Amphotericin B (J02AA01) 0.00 <0.01

Ketoconazole (J02AB02) 0.03 <0.01

Fluconazole (J02AC01) 0.14 0.04

Itraconazole (J02AC02) 0.03 <0.01

Voriconazole (J02AC03) <0.01 <0.01

Other J02 substances <0.01 <0.01

Total J02 substances 0.76 0.06

Use of antimycotics and antifungals for systemic use expressed in DDD/1000 inh./day in 2008

Comments

National Network: Antibiotic consumption in Sweden is surveyed and analyzed by Strama – the Swedish StrategicProgramme Against Antimicrobial Resistance. Data is retrieved from a national agency responsible for infrastructureservices to pharmacies. All purchases of medicines, both prescriptions to patients and sales to hospital wards etc. arerecorded. Therefore, data represent total sales of antibiotics. An annual report covering antibiotic utilization andresistance in human medicine, SWEDRES, is published by Strama and the Swedish Institute for Infectious DiseaseControl. Antibiotic use in veterinary medicine is covered in the SVARM report, produced by the National VeterinaryInstitute. Ambulatory care data include primary healthcare and open specialist surgeries, and hospital care datarepresent sales to hospitals and certain nursing homes. Narrow spectrum penicillins are the most commonly usedantibiotics in Sweden, both in ambulatory and hospital care. Tetracyclines and cephalosporins are also large groups. Inrecent years there have been national and local campaigns and educational activities to improve compliance toguidelines regarding the treatment of lower urinary tract infections in women. As a result, the use of fluoroquinolones andtrimethoprim is decreasing, and pivmecillinam and nitrofurantoin are used instead. After the publication of a proposedaction plan against ESBL resistance in enteric bacteria in November 2007, the use of cephalosporins in hospital caredecreased while an increased use of narrow spectrum penicillins was observed. Dentists’ prescribing of antibioticsaccounts for about eight percent of J01 in ambulatory care. The substances prescribed are penicillin V, amoxicillin andclindamycin. In Sweden, about 10 percent of the total use of the ATC-group J01 (measured in DDDs) is the urinary tractantiseptic methenamine.

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United Kingdom 2008Health care Data type Coverage Data source

Ambulatory care Reimbursement 100% Ministry of Health

Population Data source

61,383,100 National Institute for Statistics

Antimicrobials for systemic use (J01)

J01 classes Ambulatory care

Beta-lactam antibacterials, penicillins (J01C) 7.95

Other beta-lactam antibacterials (J01D) 0.71

Tetracyclines (J01A) 3.72

Macrolides, lincosamides and streptogramins (J01F) 2.47

Quinolone antibacterials (J01M) 0.52

Sulfonamides and trimethoprim (J01E) 1.13

Other J01 substances 0.42

Total J01 classes 16.92

Use of antimicrobials for systemic use expressed in DDD/1000 inh./day in 2008

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Comments

National Network: The United Kingdom is divided into four constituent countries: England, Northern Ireland, Scotland andWales. Each of these countries has its own Health Administration. In 2008 the total population of the UK was61,383,100. The population for each administration was England 51,446,200, Northern Ireland 1,775,000, Scotland5,168,500 and Wales 2,993,400.(Source UK Office of National Statistics: http://www.statistics.gov.uk/statbase/Product.asp?vlnk=15106)The data for ambulatory care antibiotic use were collected by the Department of Health in each of the four constituentcountries of the UK. The data come from reimbursement to Community Pharmacies for the cost of dispensing medicinesto patients in the National Health Service. In 2008 total expenditure (public and private) on healthcare in the UK was£125.4 billion of which £103.6 billion (83%) was public expenditure on the National Health Service.(Source UK Office of National Statistics: http://www.statistics.gov.uk/cci/nugget.asp?id=669)The prescriptions dispensed by Community Pharmacies are mainly written by General Practitioners in Primary Care. TheUK Ambulatory Care data do not include antibiotics dispensed by hospitals for ambulatory care (for example fromAccident and Emergency or Outpatient departments). However the data do include most prescriptions dispensed topatients in Nursing Homes because these are usually issued by General Practitioners and dispensed from CommunityPharmacies.Data about antibiotic prescribing in each of the four administrations of the UK from 1997-2005 have been published:Davey P, Ferech M, Ansari F, Muller A, Goossens H, on behalf of the ESAC Project Group. Outpatient antibiotic use inthe four administrations of the UK: cross-sectional and longitudinal analysis. J Antimicrob Chemother 62(6), 1441 - 1447(2008).http://jac.oxfordjournals.org/cgi/content/full/dkn386v1ed

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