52005SC1746

[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 22.12.2005

SEC(2005)1746

COMMISSION STAFF WORKING DOCUMENT

Detailed analysis of Member States’ reports on the implementation of the Council recommendation (2002/77/EC) on the prudent use of antimicrobial agents in human medicine{COM(2005) 684 final}

TABLE OF CONTENTS

INTRODUCTION 4

1. NATIONAL STRATEGIES & INTERSECTORAL MECHANISMS 4

Introduction 4

Main findings 4

Intersectoral mechanisms (IMs) 4

Implementation gaps 5

2. SURVEILLANCE SYSTEMS FOR ANTIMICROBIAL RESISTANCE 6

Introduction 6

Main findings 6

Implementation gaps 7

3. SURVEILLANCE SYSTEMS FOR ANTIMICROBIAL USE 7

Introduction 7

Main findings 8

New member states and Bulgaria 8

Implementation gaps 9

4. CONTROL & PREVENTIVE MEASURES 9

Introduction 9

Main findings 9

Implementation gaps 11

5. EDUCATION & TRAINING 11

Introduction 11

Main findings 11

Implementation gaps 12

6. NATIONAL RESEARCH INITIATIVES 12

Introduction 12

Main findings 12

Implementation gaps 12

7. ACTIONS BY THE COMMISSION 13

In the area of surveillance: 13

In the area of prevention: 14

In the area of research and product development: 14

8. RESULTS FROM THE SAR-PROJECT (SELF MEDICATION WITH ANTIBIOTICS AND RESISTANCE) 15

SAR phase 1: Prevalence of self-medication with antibiotics in Europe 15

Figure 1: Actual self medication and ‘at risk’ use of self-medication (intended self-medication or storage) with systemic antibiotics 16

SAR phase 2: determinants of self-medication with systemic antibiotics 17

9. TABLES SUMMARISING MEMBER STATES RESPONSES TO THE QUESTIONNAIRE 18

Table 1: responses on National Strategies & Intersectoral Mechanisms 18

Table 2: responses on surveillance systems for antimicrobial resistance 19

Table 3: responses on surveillance systems for antimicrobial use 20

Table 4: responses on control & preventive measures 21

Table 5.1: responses on education & training (1) 22

Table 5.2: – responses on education & training (2) 23

Addendum: list of relevant web sites 24

INTRODUCTION

The Council Recommendation on the prudent use of antimicrobial agents in human medicine (2002/77/EC) (hereinafter referred to as Recommendation) asks Member States and EEA countries to put in place specific strategies on prudent use of antimicrobial agents comprising measures in relation to surveillance of antimicrobial resistance and use, control and preventive measures, education and training, and research and to report to the Commission on its implementation.

The Commission convened representatives of the different Member States in a ‘Working Group on the prudent use of antimicrobial agents in human medicine’ that developed a template for reporting. This template has taken the format of a questionnaire to facilitate reporting in a concise and comparable manner, allowing for better collation and analysis of the information. This Commission Staff Working Document provides detailed descriptions, information and tables about the answers to the questionnaire from the Member States and identifies main findings and implementation gaps.

1. NATIONAL STRATEGIES & INTERSECTORAL MECHANISMS

Introduction

In their replies to the questionnaire countries specified whether they have a national strategy to contain the problem of antimicrobial resistance and whether a national action plan has been formulated. To co-ordinate the implementation of strategies and for the purpose of information exchange and co-ordination with the Commission and other Member States, the Council recommended that each Member State should have in place rapidly and if possible by November 2002 an appropriate intersectoral mechanism.

Main findings

- Sixteen Member States have a National Strategy and ten countries are developing such a strategy to address the problem of antimicrobial resistance. Two countries (Estonia, Slovenia) did not report that they have a National strategy under preparation.

- Nine countries (Belgium, Finland, France, Malta, Netherlands, UK, Norway, Iceland, Bulgaria) have formulated a National Action plan and in 14 countries it is under preparation. Five Member States (Denmark, Estonia, Italy, Portugal, Slovenia) did not formulate a plan nor do they indicate that they are preparing one.

Intersectoral mechanisms (IMs)

- Thirteen old Member States, two EEA countries, seven new Member States, and Bulgaria have an IM in place and five countries are about to create it. One Member State (Slovenia) did not report that it is creating an IM.

- The old Member States and the EEA countries indicated that the IM in their country was set up prior to the Recommendation (between 1995 and 2001) meaning that already established committees or structures have taken the form of IM.

- There are major differences in responsibilities/objectives of the IM in the Member States.

- There is considerable variation in the legal status of the IM between countries. In some countries there is specific legislation governing the IM, giving it executive powers, while in other countries the IM is merely an advisory body. In most countries the IM is part of the government or department of health, but does not have legislation defining its structure, function or powers.

- There is variation in the composition of the IM between countries. All countries involve representatives from various medical specialties and government/department of health officials. Most involve veterinary/agriculture representatives and representatives from the national surveillance institute. Five countries included pharmaceutical industry representation and three have patient/general public representation. Twelve countries include representation from their national medicines regulator.

- The source of funding for the IM is, where provided, always governmental.

Implementation gaps

Effective implementation requires several key features, including a clear action plan, delegation of authority and power to act, resources and sound mechanisms to assess the effectiveness of interventions, allowing feedback of results to influence future strategies.

- Not all countries have a national strategy nor formulated a national action plan . The Member States that have not yet done so should be encouraged to have a national strategy and formulate a national action plan and implement this.

- All but one Member State put in place an 'intersectoral mechanism' for implementing relevant measures and for effective co-ordination No specific recommendations have been made as to the nature of this IM and indeed the status, organisational structure, funding, and understanding of the responsibilities of the IM between the Member States reveal major differences. To ensure implementation of national strategies to contain antimicrobial resistance it is advisable to define better and possibly strengthen responsibilities, budget, and structure of the IMs .

- All Member States should ensure that the IM is truly intersectoral and could consider extending IM membership to involve representatives from veterinary medicine, and from patient/general public organisations as observers.

2. SURVEILLANCE SYSTEMS FOR ANTIMICROBIAL RESISTANCE

INTRODUCTION

The Recommendation asked Member States to establish or strengthen their surveillance systems on antimicrobial resistance in order to gather reliable and comparable data on the susceptibility of pathogens. These systems should be sustainable with clear regulation of data access and ownership, building upon existing national and international surveillance systems, using, wherever possible, internationally recognised classification systems and comparable methods.

- EU-wide surveillance: The European Antimicrobial Resistance Surveillance System (EARSS) is a network of national surveillance systems, currently comprising about 800 laboratories from 28 countries, that has facilitated the collection of European data on antimicrobial resistance in indicator bacteria ( Streptococcus pneumoniae, Staphylococcus aureus, Enterococcus faecium/faecalis, Escherichia coli ) in a common format. EARSS extends surveillance as from 2005 also to Pseuomonas aeruginosa and Klebsiella pneumoniae . Also other surveillance networks monitor susceptibility of pathogens: 'Enter-net' performs surveillance of Salmonella and verotoxin-producing E. coli (VTEC) infections, including the susceptibility to antimicrobials, whilst 'EuroTB' performs surveillance of tuberculosis including (multi) drug resistant TB. Also susceptibility of meningococci, gonococci and Treponema pallidum (syphilis) is being monitored through EU wide surveillance networks. These projects have provided a framework for Member State activities and facilitated progress.

MAIN FINDINGS

- IN 18 COUNTRIES THE IM is co-ordinating activities on antimicrobial resistance surveillance , in 13 countries the IM is actively collecting data , and in 19 countries (13 old Member States, three new Member States, two EEA and Bulgaria) the IM is proposing actions based on the findings.

- Fourteen countries (nine old Member States, two new Member States, two EEA and Bulgaria) reported to have the ownership of antimicrobial resistance data clearly defined.

- Several obstacles for surveillance were reported: primarily the lack of a sustained financial basis, unclear legal status and regulation of privacy issues.

- Sixteen countries have published a national report on antimicrobial resistance.

- In nine old Member States, two EEA and Bulgaria formal collaboration between human and veterinary medicine has been established regarding antibiotic resistance emergence. In all but one (Lithuania) new Member State such interaction is lacking.

- Data are mostly collected from routine laboratory systems. In most countries distinction can be made between hospital-acquired and community-acquired strains.

- Disease surveillance networks have helped to make susceptibility data more comparable but still face problems because of differences in methodology and interpretation .

- All but two countries (Cyprus, Estonia) report to have external quality assurance (EQA) systems routinely in place in all participating laboratories to verify validity of data.

- All but two countries (Latvia, Lithuania) contribute data to EARSS . All countries contribute to EURO-TB and 19 to Enter-Net .

IMPLEMENTATION GAPS

- Role of IM should be to oversee and steer surveillance . The IM should prioritise the action needed, and recommend it to the health authorities responsible for taking action.

- Ownership of the data is not clarified in all countries and should be defined properly.

- Data can often not be broken down to a local level (hospitals) where it is needed to steer policies.

- Measures to link surveillance of resistance in human and veterinary medicine should be established in all countries.

- EQA should be done for AMR surveillance systems in regular intervals in all countries.

3. SURVEILLANCE SYSTEMS FOR ANTIMICROBIAL USE

INTRODUCTION

In the Recommendation, the Member States are requested to establish or strengthen a surveillance system for the collection of data on prescription and use of antimicrobial agents at the appropriate levels to allow monitoring of overall use involving, among others, prescribers, pharmacists and other parties collecting such data. These systems should be “…sustainable with clear regulation of data access and ownership … and should build upon existing national and international surveillance systems, using, whenever possible, internationally recognised classification systems and comparable methods”.

EU-wide surveillance: Since the adoption of the Recommendation, the EU–funded project ESAC (European Surveillance of Antimicrobial Consumption) has been established. All Member States, EEA and Bulgaria participate in the ESAC project, which has facilitated the collection of European data on antimicrobial use in a common format.

MAIN FINDINGS

- Significant progress has been made in surveillance of antimicrobial use which has been facilitated through the activities of the ESAC project. In all countries some activities are in place, but not always with country-wide coverage .

- In most countries other bodies than IM are co-ordinating activities on antimicrobial consumption surveillance.

- In about half of the countries obstacles are encountered in obtaining surveillance data (mostly financial obstacles, but also others like, e.g., legal obstacles in Germany and The Netherlands).

- Linkage of antibiotic consumption data with clinical indications is only available in a few countries, mostly as specific research projects. Likewise, no single country can link consumption with resistance on a continuous basis.

- Only six countries (Belgium, Czech Republic, Finland, France, Portugal and UK) have developed indicators to monitor prescribing practices of antimicrobial agents.

- The majority of Member States co-ordinate actions to improve prescribing practices . The scope and target groups vary. In eight countries (Bulgaria, Cyprus, Denmark, Estonia, Germany, Italy, Latvia, and UK) no co-ordinated actions were reported at all. Although many countries provide some kind of feed-back to prescribers, this seems to consist of a more general information and no country provides continuous feed-back on the prescribing practices of prescribers.

In six Member States and 2 EEA countries (Denmark, Belgium, Finland, France, Iceland, Norway, Portugal and UK) a formal collaboration with veterinary surveillance is established , but in none of the new member states is such a link reported.

NEW MEMBER STATES AND BULGARIA

- In all but one country (Estonia) national surveillance systems for antimicrobial use are in place . In most of them a national strategy for the containment of antimicrobial resistance is under preparation.

- Only in three countries (Lithuania, Malta, Slovakia) surveillance of antimicrobial consumption is coordinated by an IM.

- All but two (Estonia, Slovakia) members have obstacles in obtaining data , mostly legal (Cyprus, Czech Republic, Latvia, Malta, Poland, Slovenia), but also financial (Bulgaria, Cyprus, Poland) or organisational (Poland, Slovenia).

- In some countries (Cyprus, Lithuania, Malta) data on total antibiotic consumption are not available . In several countries only data on either hospital or community use are available.

- None of the countries are able to link consumption data to indications and only two countries (Poland, Slovenia) can link consumption and resistance data (through specific research projects).

- Four countries (Bulgaria, Cyprus, Estonia, Latvia) have not introduced any coordinating actions for improvement of prescribing practices .

IMPLEMENTATION GAPS

- The coverage and possibilities of break-down of data could be improved in many countries.

- Linkage of antimicrobial consumption data with indications for antimicrobial consumption is an essential tool to monitor compliance with treatment guidelines but is only available in a minority of countries and only as a research project.

- Member States still experiencing obstacles (legal and/or financial) in obtaining data should endeavour to overcome them.

- Feed-back on the prescribing practices of prescribers is still under development in many countries.

- Formal collaboration with veterinary surveillance of antimicrobial consumption is lacking in many countries including in all new member states.

4. CONTROL & PREVENTIVE MEASURES

Introduction

Member States are requested to implement control and preventive measures to support the prudent use of antimicrobial agents and contribute to limit the spread of communicable diseases.

MAIN FINDINGS

- It is believed that antimicrobials sold without a prescription are still a relevant source of inappropriate antimicrobial use in seven countries. However, only in one Member State (Malta) the proportion of such use has been studied. No country was able to estimate the current proportion of all antimicrobials (systemic and local) sold without prescriptions. None of the seven countries have guidelines about a use of antimicrobial agents not subject to requirements for prescription only use in place. Sixteen other countries have measures in place to enforce regulations for prescription-only use of systemic antimicrobials. Such measures are provided by the Community pharmaceutical legislation on medicinal products for human use (Directive 2001/83/EC as last amended by Directive 2004/27/EC, Article 70 to 75) to be transposed in national law by 30 October 2005.

- Most countries have nationally accepted guidelines on appropriate use of antimicrobials for surgical prophylaxis, otitis media, sinusitis, tonsillopharyngitis, community acquired pneumonia, urinary tract infections and meningitis. Three countries (Iceland, Spain, Lithuania) report to have no guidelines at all, Portugal has only guidelines for treatment of tuberculosis (five countries have not reported unambiguously). The impact of these guidelines on prescribing practices is only monitored in a few countries (Belgium, Bulgaria, Denmark, Finland, Greece, Sweden) and if so, it does only include single indications (e.g., Belgium: surgical prophylaxis; Sweden: otitis media). In none of the new Member States prescribing practices are monitored.

- Twenty countries have regulations about sponsoring of, and/or gifts or inducements to prescribers by the pharmaceutical industry. Twenty-two countries allow free antimicrobial samples to the prescriber, nine allow free samples of antibiotics in phase IV trials. Information about the maximum inducements allowed, even when provided, is scanty. Fifteen countries monitor whether regulations on sponsoring are respected and fourteen have a disciplinary system in place to enforce these regulations. Only two of the ten new member states possess such regulations on sponsoring and disciplinary systems. Sixteen countries have a control system on good practice of marketing of antimicrobial agents in place. Such measures are provided by the Community pharmaceutical legislation on medicinal products for human use (Directive 2001/83/EC as last amended by Directive 2004/27/EC, Article 86, 87) to be transposed in national law by 30 October 2005.

- Twenty-two countries have a national programme for hospital hygiene and infection control in place, and in eighteen it is mandatory for each hospital to have an infection control committee. Only about half of the countries have legal requirements or recommendations about the number of infection control nurses per hospital bed, and have an accreditation procedure for hospitals and/or nursing homes. Only fourteen countries require infection control to be a part of the hospital accreditation procedure, and even less with respect to nursing homes accreditation procedure. Eighteen countries have national guidelines for the control of multi-resistant pathogens, however, this often includes only a single pathogen (mostly Methicllin-resistant Staphylococcus aureus , MRSA).

- Considering that there are differences in the information provided by Summary of Product Characteristics (SPC) for already authorised medicinal products for human use containing same antibacterial active substance(s). National competent regulatory authorities in consultation with European Medicines Agency (EMEA) are currently undertaking initiatives to evaluate, update and harmonise as appropriate the information provided in SPC. Furthermore the criteria on which application for marketing authorisation for new antibacterial medicinal products for human use are evaluated have been further developed and updated to take fully into account the principle of containment of antimicrobial resistance.

IMPLEMENTATION GAPS

- Countries where antimicrobials sold without a prescription are still a relevant source of inappropriate antimicrobial use should have measures in place to enforce prescription-only use . Regulations need to be in place according provisions of Directive 2001/83/EC as last amended by Directive 2004/27/EC, Articles 70 to 75.

- Guidelines for the use of other antimicrobial agents not subject to requirements for prescription-only use (e.g. topical agents) should be produced in countries where this is considered an inappropriate use.

- All countries should have nationally accepted guidelines in place which recommend appropriate antibiotic treatment, at least for the most common infections. Compliance of these guidelines on prescribing practises should be assessed.

- A significant number of countries (in particular new Member States) have either not established regulations about sponsoring of and/or gifts or inducements to prescribers by the pharmaceutical industry, or do not monitor whether regulations on sponsoring are respected. Regulations need to be in place according provisions of Directive 2001/83/EC as last amended by Directive 2004/27/EC, Articles 86, 87.

- All countries should ensure that each hospital has an infection control committee , and should consider making this part of an accreditation or any other quality control procedure for hospitals.

5. EDUCATION & TRAINING

INTRODUCTION

The Member States are requested to promote education and training of health professionals on the problem of antimicrobial resistance and to inform the general public about the importance of prudent use of antimicrobial agents. In this report no distinction is made between education and campaigns, as no further information on the quality of these was available. Prescribers, pharmacists and other health professionals are grouped together as health professionals, except were indicated.

MAIN FINDINGS

- Not in all countries health-professional-undergraduates receive education on appropriate use of antimicrobials. However, they receive continuing education on selected issues later in their career.

- In all countries education is provided by non-sponsored continuing education, and in almost all of them also through sponsoring by the pharmaceutical industry.

- Eighteen countries have carried out reports and studies on the perception and knowledge of the public and health professionals on topics related to antimicrobial resistance. This most often concerns knowledge and perception on appropriate antimicrobial use.

- All but six countries have performed a campaign in some format in the past five years to raise awareness on topics related to antimicrobial resistance. Campaigns addressed more often health professionals than the general public. A number of countries did not address the public at all and in case the public was addressed it was mostly concerning vaccination programmes.

IMPLEMENTATION GAPS

- Overall it seems that education of professionals is well addressed , although in six countries relevant education for health-professional-undergraduates is missing.

- Member States should promote campaigns addressed to the public not only restricted to vaccination campaigns.

- Exchange best practice on ‘education and training’ issues should be promoted.

6. NATIONAL RESEARCH INITIATIVES

Introduction

Member States were asked whether there is a governmental body that coordinates research on Antimicrobial Resistance and were asked to provide a list of governmentally supported on-going research projects. Answers to these questions varied considerably. Some countries responded in a very detailed manner (e.g., Belgium, Netherlands, Germany, Spain, Bulgaria), others remained very concise. Hence, conclusions drawn were very limited.

MAIN FINDINGS

- IN TEN COUNTRIES A GOVERNMENTAL BODY CO-ORDINATES RESEARCH RELATED TO ANTIMICROBIAL RESISTANCE.

- In thirteen countries several activities on different aspects of a prudent use of antibiotics and increasing resistance problems in bacteria are funded by the government.

IMPLEMENTATION GAPS

In order to be able to oversee research on Antimicrobial Resistance and establish effective partnerships it will be important to collect information on national research initiatives. This could be undertaken as a separate inventory.

7. ACTIONS BY THE COMMISSION

The Commission considers antimicrobial resistance as a key priority through its public health and research programmes. It is in close relation with Member States through representatives from the intersectoral mechanisms in the so-called ‘working group on the prudent use of antimicrobial agents in human medicine’ and has funded a number of key-activities contributing about € 2,8 million over the past 3 years from the public health programme (PHP), accounting for approximately 10% of the ‘health threat’ budget (for details of surveillance networks see:

http://europa.eu.int/comm/health/ph_threats/com/comm_diseases_networks_en.htm).

Under the Framework Programmes (FP) for Research and Technological Development, a broad range of projects related to antimicrobial resistance are currently funded at an annual average EU contribution of approximately € 20 million. The project portfolio encompasses research on basic mechanisms of emergence and transmission of resistance, development of new drugs and diagnostic tests as well as clinical and epidemiological research. A comprehensive overview of all these research projects is available at: http://www.cordis.lu/lifescihealth/major/drugs.htm

Through these Programmes the Commission has initiated the following key actions at Community level:

IN THE AREA OF SURVEILLANCE:

- EARSS: the large European Antimicrobial Resistance Surveillance System is a network of national surveillance systems that currently collects resistance data from about 800 laboratories from 28 countries. The main function of EARSS is to monitor variations in resistance of indicator pathogens of main public health relevance for targeting interventions and assessing effectiveness of national intervention programmes.

- Several surveillance systems monitor susceptibility of pathogens. The 'Enter-net' network performs surveillance of Salmonella and verotoxin-producing E. coli (VTEC) infections, including the susceptibility to antimicrobials, whilst 'EuroTB' performs surveillance of tuberculosis including (multi) drug resistant TB. Also susceptibility of meningococci, gonococci and Treponema pallidum (syphilis) is being monitored.

- ESAC: the European Surveillance of Antimicrobial Consumption in humans project. Through this network, more than 30 countries deliver comprehensive national data on cost and volume of antimicrobial consumption in ambulatory and hospital care.

- ARMed: the Antimicrobial Resistance in the Mediterranean project, supported by FP5, aims to extend the implementation of the defined methodologies of EARSS and ESAC into the Mediterranean region, involving Malta, Cyprus, Turkey, Egypt, Tunisia, Morocco and Jordan.

IN THE AREA OF PREVENTION:

- TV-movie ‘the misuse of a miracle’: To support educational campaigns to avoid overuse and misuse of antimicrobial agents, the Commission has funded a television documentary on the battle against resistant bacteria to be used as an educational tool.

- EURIS: the FP5 supported European Resistance Intervention Study evaluates different approaches to reduce the prevalence of resistant pneumococci among children in European day-care centres through education of doctors, day-care staff, parents and children, optimised dosing, improved hygiene, notification of resistant strains and isolation of carriers.

- ARPAC: the Antibiotic Resistance Prevention And Control project, aimed at identifying hospital policies and prescription patterns associated with lower resistance rates to evaluate and harmonise strategies for prevention and control.

- SAR: The PHP funded project ‘Self-medication with Antibiotics and Resistance levels in Europe’ aims to quantify the consumption of antibiotics sold over-the-counter (without prescription) and of leftover (prescribed) antibiotics hoarded at home (see further).

- PNC-Euro: Regarding prevention of infections, and in particular immunisation, the Commission funded by FP5, the ‘pneumococcal disease in Europe project’ that focuses on the epidemiology of S. pneumoniae in a variety of European countries prior to the introduction of new conjugate vaccines and aims to design cost-effective prevention strategies.

- HELICS: Containment of antimicrobial resistance is linked to infection control practices. Hospitals in Europe Link for Infection Control and Surveillance is funded (under PHP) to monitor hospital acquired infections, to develop protocols for databases on surgical and intensive care unit infections, and to set up evidence-based infection control standards and recommendations.

IN THE AREA OF RESEARCH AND PRODUCT DEVELOPMENT:

- Projects address novel approaches to anti-bacterial drug development through exploitation of hitherto unexplored enzymatic pathways in the bacterial cell wall synthesis (Eur-Intafar, COBRA), identification of novel natural products from antibiotics-producing organisms (ActinoGEN), development of alternatives to antibacterial drugs (PNEUMOPEP, AMIS), mechanisms of resistance and evolution of resistant strains of Streptococcus pneumoniae (PREVIS), evolutionary aspects of resistance and its possible reversibility (EAR), molecular mechanisms of horizontal gene transfer (CORANIX, DRESP2) and control of anti-fungal resistance (EURESFUN).

- Two Networks of Excellence have been established, one on the management of Lower Respiratory Tract Infections (GRACE) and the other on anti-viral drug resistance in both chronic and acute viral infections (VIRGIL).

- To provide an infrastructure for clinical trials of vaccines the European and Developing Countries Clinical Trials Partnership (EDCTP) has been set up through a joint collaborative initiative among Member States and developing countries with the Commission as supporting partner. The main goal is to support phase II and III clinical trials of promising new clinical interventions against HIV/AIDS, malaria and tuberculosis in, with, and for, developing countries.

8. RESULTS FROM THE SAR-PROJECT (SELF MEDICATION WITH ANTIBIOTICS AND RESISTANCE)

In the SAR-project the problem of self-medication with antibiotics in Europe is assessed. Use of systemic antibiotics without prescription is not allowed in European countries, but nevertheless scattered reports indicated the existence in several countries. Because of different research methods used, no comparison between countries was possible. SAR was designed to fill in that gap and enable comparison of actual and ‘at risk’ (intended use and storage at home) self-medication with antibiotics. The project aimed 1) to quantify self-medication and 2) to identify determinants of such use.

SAR PHASE 1: PREVALENCE OF SELF-MEDICATION WITH ANTIBIOTICS IN EUROPE

The study population existed of adults (> 18 years) in nineteen countries in Europe. Self-medication was assessed with a mailed questionnaire sent to a total sample of 39754 in 2003 of whom 15548 (39%) responded. The analysis was limited to systemic antibiotics, i.e. drugs that should not be available over the counter (OTC) in any of the countries.

[pic]Figure 1: Actual self medication and ‘at risk’ use of self-medication (intended self-medication or storage) with systemic antibiotics

Self-medication exists in all countries included in the study, though the level differs strongly between N, W, S and E in Europe (figure 1). Seven countries (Netherlands, Sweden, Denmark, Austria, Belgium, Luxembourg and Czech Republic) had levels lower then 10/1000 in the population of actual self-medication, three countries very high levels of more then 150/1000, and the other nine countries had levels between 12/1000 and 62/1000. Extrapolating these figures to absolute numbers makes for a worrying picture; even in countries with low levels of selfmedication, thousands of people self-medicate with antibiotics. In the Netherlands alone for example, the country with the lowest level (1/1000), this figure is more then 12000 people every year. Much more people are at risk. From 73/1000 in Austria to as much as almost half in Lithuania (449/1000) of the respondents indicate they may use antibiotics without a prescription. Another 10/1000 (Netherlands) to 379/1000 in Italy have antibiotics at home, that they could and do use.

Direct, without a prescription, from the pharmacy and leftovers are the most important sources of actual self-medication in the last 12 months, despite the fact that this is not legal (table 1). Getting antibiotics directly from the pharmacy from abroad is of minor importance. Excluding the countries with the highest level of self-medication, Lithuania and Romania, leftovers are the most important source and friends or relatives become more important, though OTC is still responsible for almost a third of all courses. Internet was only responsible for a few courses in Lithuania. Countries where more then 50% of the courses is for self-medication directly from the pharmacy, are in the South (Spain and Malta) or the East (Romania, Lithuania, Czech Republic). In the other countries the sources are primarily leftovers (in particular Italy, where 93% of self-medication is from leftovers) or friends. However, occasionally directly from the pharmacy sales occur in these countries too, with the exception of Netherlands, Luxembourg and Italy.

Table 1: Sources of courses of self-medication with systemic antibiotics

percentage courses, all countries | percentage of courses, excl LI and RO |

OTC own country | 38 | 30 |

OTC abroad | 2 | 4 |

Leftovers | 32 | 47 |

Friend or relative | 8 | 15 |

Internet | 0.5 | - |

Other source | 4 | 7 |

Total | 104.5* | 103* |

* 38 courses had more then one source

Most of the self-medication is taken for health problems that do not need to be treated by antibiotics at all, such as throat symptoms, and teeth and gums symptoms, fever, cough and influenza.

These results indicate that self-medication with antibiotics is indeed a problem all over Europe. The most important sources are OTC and leftovers, implying that action is needed as well at the level of pharmacies, as at the level of the general population educating them about the risks of self-medication, and about the undesirability of using leftovers or friends.

SAR PHASE 2: DETERMINANTS OF SELF-MEDICATION WITH SYSTEMIC ANTIBIOTICS

In the second part of the study, determinants of self-medication with antibiotics were further studied in a survey based on face-to face interviews in 12 of the countries involved in SAR1 (Sweden, Netherlands, Belgium, Austria, UK, Spain, Malta, Italy, Ireland, Czech Republic, Hungary, Lithuania). Per country 50 users of actual or at risk for self-medication were selected, as well as 50 non-users. Determinants included in the study were predisposing, enabling and culturally determined values. Data were collected in the second half of 2003. The study included 1158 respondents (response rate 91%).

Of the predisposing factors, knowledge about antibiotics is clearly relevant. Contrary to what one may expect, awareness of the dangers of antibiotics is associated with a higher use of self-medication. This is in line with results from an American survey looking into consumer attitudes to antibiotics. The fear of getting more seriously ill seems the most important determinant of self-medication. In general, knowledge about antibiotics and their appropriate use vary strongly between the countries, but there is not a clear pattern indicating a different level of knowledge and levels of self-medication within a country. This is understandable in view of the results of the different components of knowledge predicting opposite directions in levels of self-medication. In general, only few people, even among the self-medication users, indicate to use self-medication with antibiotics as their usual coping strategy for a number of common illnesses. Such coping strategies were mainly seen in Lithuania, Malta and to a smaller extent Italy.

There were few differences seen between the choices to use the antibiotics available at home, or from the pharmacy without a prescription in problems these, with the exception of Italy. The use of antibiotics for diarrhea occurred only in Lithuania. In general people think antibiotics are rather easily available from a variety of sources, but the type of source varies per country. Countries with high self-medication with antibiotics think primarily of getting them without a prescription from the pharmacy or from leftovers. In other countries people tend to think it is easy to get them with the help of a friend who is a doctor or pharmacist. Overall, our results indicate that predisposing and enabling factors are relevant for deepening our understanding of the phenomenon of self- medication with antibiotics.

9. TABLES SUMMARISING MEMBER STATES RESPONSES TO THE QUESTIONNAIRE

Tables 1 to 5.2 list responses from the Member States in relation to national strategies & intersectoral mechanisms, surveillance of antimicrobial resistance and of use, control and preventive measures, education & training, respectively.

TABLE 1: RESPONSES ON NATIONAL STRATEGIES & INTERSECTORAL MECHANISMS

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TABLE 2: RESPONSES ON SURVEILLANCE SYSTEMS FOR ANTIMICROBIAL RESISTANCE

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TABLE 3: RESPONSES ON SURVEILLANCE SYSTEMS FOR ANTIMICROBIAL USE

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TABLE 4: RESPONSES ON CONTROL & PREVENTIVE MEASURES

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TABLE 5.1: RESPONSES ON EDUCATION & TRAINING (1)

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TABLE 5.2: – RESPONSES ON EDUCATION & TRAINING (2)

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Addendum: list of relevant WEB SITES

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