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 taken. 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 2006, 34 countries participated in ESAC, all 27 countries of the European Union, 2 applicant countries (Turkey, Croatia), and 5 other countries joined the project (Iceland, Israel, Norway, Russia and Switzerland). Many papers in peer-reviewed journals described the antibiotic use patterns in hospital and ambulatory care, both at the European level as well as at the country and/or regional level.
ESAC data have been used to explain the variation of antibiotic resistance and to assess the impact of intervention campaigns to reduce antibiotic prescribing.
Problem:
Antibiotic resistance is a major European and global public health problem, and international efforts are needed to counteract the emergence of resistance. There is a wealth of information on the prevalence of resistance in human pathogens, and these data show that there are substantial geographic differences in the proportion of resistance to various classes of antibiotics in Europe. Antibiotic use is increasingly recognised as the main driver for resistance and differential selection pressure of antibiotics agents may be responsible for some of these observed differences. On November 15, 2001, the EU Council Recommendation on the Prudent Use of Antimicrobial Agents in Human Medicine stated that specific strategies should pursue to collect data on antibiotic use. ESAC has been collecting data since 2001. However, explanations for the variation of antibiotic resistance need to be further explored as well as assessing the impact of intervention campaigns to reduce antibiotic prescribing.
Aim:
The overall aim of the project will be to consolidate the continuous collection of comprehensive antimicrobial consumption data, from ambulatory and hospital care, from the 27 Member States, 3 EEA/EFTA and 3 candidate countries (Croatia, Former Yugoslavian Republic of Macedonia and Turkey). The project will provide the community with timely information, on antimicrobial consumption. The European database will be 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 will give regular feed-back to the relevant authorities of the participating countries.
Additionally, the project will 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.
Expected and obtained results:
- The continuous collection of comprehensive antimicrobial consumption data, from ambulatory and hospital care, from the 27 Member States, 3 European Economic Area (EEA) / European Free Trade Association (EFTA) and 3 candidate countries (Croatia, Former Yugoslavian Republic of Macedonia and Turkey) will be consolidated.
- Regional maps of antibiotic use in Europe will be published.
- Hospital and individual patient consumption data linked with DRG (Disease Related Groups) will be available.
- Detailed ambulatory care data will be available on the consumption in specific age and sex categories, specific prescriber groups, specific consumers groups and for specific indications.
- Nursing home and individual nursing home residents information on the frequency, indications, characteristics and seasonal variations of antibiotic prescriptions will be available, as well as on the nursing home determinants of antibiotic use.
- Timely information and regular feed-back on antimicrobial use in ambulatory, hospital and nursing home care will be provided to the community.
- Individual reports to participating hospitals and nursing homes on institutional and individual antibiotic consumption will be sent automatically.
- Health indicators of antimicrobial use will be expanded (ambulatory care) and developed (hospital care).
- Tools for the assessment of interventions on antimicrobial prescribing will be available.
- 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.
Potential applications:
Data on systemic antibiotic use aggregated at the level of the active substance have been collected (WHO ATC/DDD methodology; Br J Clin Pharmacol 2004; 58: 419-28) based on standardised and validated national data from 34 participating countries throughout Europe and are publicly available through the interactive database on the ESAC website. Since 2004 data on systemic antimycotic use have been collected. During the next phase of ESAC, data on antivirals, antituberculosis drugs will also be collected. Furthermore, ESAC will collect data on ambulatory care and hospital care separately, ie quarterly for AC and yearly for HC, but also regional data will be collected.
These ESAC data allow to document variations in antimicrobial consumption and to translate them into quality indicators for public health monitoring over time and place in order to target interventions, to assess the effectiveness of prevention programmes and the relation to antibiotic resistance patterns.
As a first step in the development of valid quality indicators of outpatient antibiotic use an Exploratory Workshop on Antibiotic Prescribing Quality Indicators, granted by the European Science Foundation, was convened in Antwerp on 7-9 September 2005. It built on the interdisciplinary expertise within EURODURG (European Drug Utilisation Research Group), GRIN (General Practice Respiratory Infections Network), BAPCOC (Belgian Antibiotic Policy Coordination Committee) and ESCMID (European Society for Clinical Microbiology and Infectious Diseases). In 2009, a similar workshop will be organised on Hospital Care Quality Indicators.
More and more countries have implemented or plan to implement actions to control antimicrobial resistance through rational use of antibiotic. The impact of these actions will be monitored based on DID and other indicators of antibiotic use.
The different subprojects on ambulatory care, hospital care, nursing homes and socio-economics will be able to substantially deepen our interpretation of variation in antibiotic resistance.
Coordinator:
Prof. Herman Goossens
University of Antwerp - Campus Drie Eiken
Vaccine and Infectious Diseases Institute
Medical microbiology
Universiteitsplein 1
2610 Antwerp, Belgium
herman.goossens@uza.be
Partners:
Dr. Helmut Mittermayer
Krankenhaus der Elisabethinen Linz
Linz, Austria
MD. Erik Hendrickx
Scientific Institute of Public Health
Brussels, Belgium
Dr. Boyka Markova
University Hospital 'Alexandrovska'
Sofia, Bulgaria
Dr. Arjana Andrasevic
University Hospital for Infectious Diseases
Zagreb, Croatia
Dr. Antonis Kontemeniotis
Pharmaceutical Services of the Ministry of Health of Cyprus
Nicosia, Cyprus
Dr. Jiri Vlcek
Charles University of Prague
Hradec Kralove, Czech Republic
Dr. Niels Frimodt-Mller
Statens Serum Institut
Copenhagen S, Denmark
Dr. Ly Rootslane
State Agency of Medicines Bureau of Drug Statistics
Tartu, Estonia
Dr. Pentti Huovinen
National Public Health Institute
Turku, Finland
Dr. Milena Petrovska
Microbiology and Parasitology Medical Faculty
Skopje, FYROM
Dr. Philippe Cavali
Direction de l'évaluation de la publicité, des produits cosmétiques et biocides DEPPCB
Saint-Denis, France
Dr. Winfried V Kern
University Hospital - Abteilung Medizin 2
Freiburg, Germany
Prof. Helen Giamarellou
Sismanoglio Hospital
Marousi, Attica, Greece
Dr. Gabor Ternak
County Hospital
Pcs, Hungary
Prof. Karl G. Kristinsson
Landspitali - University Hospital
Reykjavik, Iceland
Dr. Robert Cunney
Sta National Disease Surveillance Centre
Dublin 1, Ireland
Dr. Raul Raz
Ha'Emek Medical Center
Afula, Israel
Dr. Pietro Folino
Agenzia Italiana del Farmaco
Rome, Italy
Dr. Uga Dumpis
University of Latvia
Riga, Latvia
Dr. Rolanda Valinteliene
Institute of Hygiene
Vilnius, Lithuania
Dr. Marcel Bruch
Direction de la Santé (Ministère de la Santé)
Luxembourg, Luxembourg
MD. Michael Borg
Infection Control Unit, Mater Dei Hospital
Msida, Malta
Dr. Hege Salvesen Blix
Norwegian Institute of Public Health
Oslo, Norway
Dr. Waleria Hryniewicz
National Institute of Public Health
Warsaw, Poland
Dr. Inês Teixeira
Instituto Nacional da Farmacia e do Medicamento
Lisbon, Portugal
Dr. Băicuş Anda
National Institute of Research Development for Microbiology and Immunology
Bucharest, Romania
Dr. Svetlana Ratchina
Smolensk State Medical Academy
Smolensk, Russia
Dr. Viliam Foltan
Comenius University
Bratislava, Slovakia
Dr. Milan Cizman
University Medical Centre Llubljana,
Department of Infectious Diseases, Japljeva 2,
SI-1525 Ljubljana, Slovenia
Dr. José Campos
Instituto Carlos III Ministry of Health
Mazadahonda-Madrid, Spain
Dr. Gunilla Skoog
The Swedish Institute for Infectious Disease Control
Solna, Sweden
Prof. Giorgio Zanetti
Service de Médicine Préventive Hospitalière
Lausanne, Switzerland
Dr. Margreet Filius
Erasmus University Medical Centre Rotterdam
Rotterdam, Netherlands
Dr. Serhat Unal
Hacettepe University
Ankara, Turkey
Dr. Peter Davey
Ninewells Hospital
Dundee, Scotland - UK