Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine (Text with EEA relevance)
Date: 2001-11-15
Institutions: Council of the European Union
Subjects: antibiotic, biology, infectious disease, medicine, pharmaceutical product, public health

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Official Journal of the European Communities

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II

(Acts whose publication is not obligatory)

COUNCIL

COUNCIL RECOMMENDATION

of 15 November 2001

on the prudent use of antimicrobial agents in human medicine

(Text with EEA relevance)

(2002/77/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 152(4) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

Antimicrobial agents are substances produced either
synthetically or naturally by bacteria, fungi or plants,
used to kill or inhibit the growth of micro-organisms
including bacteria, viruses and fungi, and of parasites, in
particular protozoa.

The use of antimicrobial agents has greatly contributed
to improvements in health. Such ‘antimicrobial agents’
have been introduced for decades to treat and prevent
infectious diseases and infections. However, their use has
been accompanied by an increasing prevalence of micro-
organisms that have acquired resistance to one or more
of these, so-called ‘antimicrobial resistance’. Antimicro-
to public health, may
bial resistance poses a threat
prolong the suffering of patients,
increase healthcare
costs and has economic implications for society. There-
fore concerted action is necessary at Community level to
contain this problem by encouraging the prudent use of
antimicrobial agents in human medicine and better
hygiene and infection control.

(3)

The Council of the European Union on 8 June 1999
adopted a Resolution on antibiotic resistance entitled A
strategy against the microbial threat (1). The Resolution

(4)

(5)

(6)

that

antimicrobial

increases
highlights
morbidity and mortality due to communicable diseases
and leads not only to a diminution of quality of life but
also to additional health and medical care costs, and that
action needs to be taken at Community level.

resistance

The own-initiative opinion of the Economic and Social
Committee on the Resistance to antibiotics as a threat to
public health (2) identified possible initiatives and action
that should be taken at Member State and Community
level to address the problem of antimicrobial resistance.

There is an association between the growing use of
antimicrobial agents and an increase in the prevalence of
micro-organisms resistant to those agents, but this rela-
tionship is clearly not a simple one. There are many
possible factors influencing this relationship, including
those related to the organism, to the host and to the
mode of use of each drug. However,
it is clear that
antimicrobial resistance may not necessarily be over-
come by the lengthy process of continuously developing
new antimicrobial compounds.

To develop strategies for prevention of infections and
containment of resistant pathogens, accurate surveillance
systems generating valid, reliable and comparable data
spread of
on incidence, prevalence and modes of
resistant micro-organisms as well as on prescription and
use of
established
throughout the Community. They should form an essen-
tial component for an overall surveillance strategy to
address the problem of antimicrobial resistance and in
particular, to assess the potential link between the use of
antimicrobial agents and the development of resistance
among these pathogens.

agents must be

antimicrobial

(1) OJ C 195, 13.7.1999, p. 1.

(2) OJ C 407, 28.12.1998, p. 7.

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(7)

(8)

(9)

(10)

(11)

(12)

An important step to avoid, or even reverse, further
increases in resistant micro-organisms would be to
reduce unnecessary and inappropriate use of antimicro-
bial agents. General principles and methods for the
prudent use of these agents in humans must be identi-
fied, defined and implemented.

The European Antimicrobial Resistance Surveillance
System (EARSS) and the European Surveillance of Anti-
biotic Consumption (ESAC) are Community funded
monitoring programmes which aim at collecting stan-
dardised, harmonised and comparable data on antibiotic
resistance and use.

Improved strategies for hygiene,
infection control and
infection prevention in hospitals and the community
will help to limit the spread of resistant micro-organisms
and will be an important step to reduce the quantities of
antimicrobial agents used.

To bring about the necessary changes in prescribers' and
patients' behaviour, health professionals and the general
public need to be informed on the problem of antimi-
crobial resistance and associated factors by improved
product information, by awareness-raising by adequate
information and training during professional education
and in-post training, as well as by information measures
to the general public and specifically to the patients.

Support of research will be essential for tackling the
problem of the modes of spread of antimicrobial resis-
tance. Research could include inter alia the evaluation
and cost effectiveness of intervention strategies to opti-
mise
and the
community.

antibiotic prescribing

in hospitals

There is also a relationship between the occurrence of
antimicrobial resistance in certain human pathogens and
their occurrence in animals and the environment. Coor-
dination between human, veterinary and environment
sectors should be ensured and the magnitude of the
relationship between the occurrence of antimicrobial
resistant pathogens in humans, animals and the environ-
ment should be further clarified and therefore this
Recommendation does not preclude further initiatives in
other areas.

(13) Measures taken by the Member States in this area, and
the way they have taken into account this Recommenda-
tion, should be the object of reports at national and
Community level.

(14)

In accordance with the principle of subsidiarity set out
in Article 5 of the Treaty, any new measure taken in an
area which does not fall within the exclusive compet-
ence of the Community, such as protection of the public

against the increase of infectious agents resistant to anti-
microbial agents, may be taken up by the Community
only if, by reason of the scale or effects of the proposed
action, the objectives proposed can be better achieved by
the Community than by Member States. Antimicrobial
resistance, as is the case with communicable diseases,
cannot be confined to a geographical region or Member
State. Therefore, coordinated action at Community level
is required,

HEREBY RECOMMENDS MEMBER STATES:

I. to ensure that specific strategies exist and are implemented
targeted towards the prudent use of antimicrobial agents in
the aim of containing the increase of pathogens resistant to
these agents. These strategies should be based on the best
available scientific evidence and should comprise measures
in relation to surveillance, education, information, preven-
tion and control, and research.

These specific strategies should pursue the following objec-
tives:

1. establish or strengthen surveillance systems on antimi-
crobial resistance and the use of antimicrobial agents in
order to:

(a) gather reliable, comparable data on the susceptibility
of pathogens to antimicrobial agents and the infec-
tions caused by them. These data should allow time
trend analysis and early warnings and monitoring of
the spread of resistance at national, regional, and
community level;

(b) collect 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 surveillance systems should be sustainable with
clear regulation of data access and ownership. They
should comply with the data protection regulations and
guarantee the confidentiality and security of data. These
systems should build upon existing national and inter-
national surveillance systems, using, wherever possible,
internationally recognised classification systems and
comparable methods;

2.

implement control and preventive measures to support
the prudent use of antimicrobial agents and contribute
to limiting the spread of communicable diseases by:

(a) restricting systemic antibacterial agents to prescrip-

tion-only use;

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(b) setting guidelines for the use of other antimicrobial
agents not subject to requirements for prescription-
only use;

4.

inform the general public of the importance of prudent
use of antimicrobial agents by:

(c) developing evidence-based principles and guidelines
on good practice for the management of commu-
nicable diseases,
to maintain the effectiveness of
antimicrobial agents. These practices should include:

— assessing the value of clinical and microbiolo-
infections,

gical
including the use of rapid diagnostic tests,

diagnosis

criteria

for

of

— optimising choice of drug, dosage and duration
for the treatment and prevention of infections,

— promoting optimal prescription practices for
antibacterial agents subject to prescription-only
use,

— assessment of the need for changes in the guide-
lines for other antimicrobial agents not subject
to prescription-only use;

(d) establishing and implementing control systems on
good practice of marketing of antimicrobial agents
to ensure compliance with the evidence-based prin-
ciples and guidelines on the prudent use of antimi-
crobial agents for the management of communic-
able diseases;

(e)

implementing hygiene and infection control stan-
dards in institutions (hospitals, child care facilities,
nursing homes etc.) and in the community, and
assessing their impact in the prevention of commu-
nicable diseases and the need for antimicrobial
agents;

(f) encouraging national immunisation programmes to
progressively eliminate vaccine preventable diseases;

3. promote education and training of health professionals

on the problem of antimicrobial resistance by:

(a)

including teaching principles and guidelines on the
appropriate use of antimicrobial agents into under-
graduate and postgraduate training and in regular
continuous
infectious
diseases clinicians, dentists, pharmacists and nurses
and others in the medical professions;

for physicians,

training

(b) enhancing training on hygiene and infection control
standards,
thereby limiting the spread of micro-
organisms and thus eventually reducing the need for
antimicrobial agents;

(c)

training on immunisation programmes and their
role in preventing infections,
thereby reducing
outbreaks of diseases and thus the demand for anti-
microbial agents;

(a) raising awareness of the problem of antimicrobial
resistance and encouraging realistic public expecta-
tions for prescribing of antimicrobial agents;

involving the
(b) launching information initiatives
patients on the importance of
interventions to
reduce the unnecessary use of antimicrobial agents,
and on the principles and guidelines on good prac-
tice to motivate patients' adherence;

(c) highlighting the value of basic hygiene and the
impact of vaccination programmes on reducing the
need for antimicrobial agents;

II. to have in place rapidly and if possible within one year of
the adoption of this Recommendation an appropriate inter-
sectoral mechanism for the coordinated implementation of
the above strategies as well as for the purposes of informa-
tion exchange and coordination with the Commission and
the other Member States;

III. to cooperate with the Commission and the other Member

States on:

1. the development of indicators to monitor prescribing
practices of antimicrobial agents using the evidence-
based principles and guidelines on good practice for the
management of communicable diseases;

2. the evaluation of these indicators once developed with
regard to potential improvements of prescribing prac-
tices and feedback to prescribers;

3. the further development of European surveillance and
exchange of information at Community level through
the Network on epidemiological
and
control of communicable diseases;

surveillance

4. the

information and communication on national
research initiatives relating to the containment of anti-
microbial resistance, with emphasis on:

(a) the mechanisms of emergence and spread of antimi-
crobial resistance among humans and from animals
to man;

(b) the relationship between antimicrobial resistance,
resistance mechanisms, clonality, and use of antimi-
crobial agents;

(c)

the results of intervention strategies in hospitals and
the community to improve the prudent use of anti-
microbial agents;

(d) the accuracy of diagnostic tools and the develop-
ment of rapid and reliable diagnostic and suscepti-
bility testing;

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(e)

(f)

the development of new modalities for prevention
and treatment of infections;

the development of alternatives to antimicrobial
agents to contain the spread of infections; and

(g) the development of new surveillance methods to

contain antimicrobial resistance

with a view to enhancing their coordination;

5.

initiating activities aimed at evaluating and, as necessary,
updating the product information (SPC) for antibacterial
medicinal products particularly related to indications,
dose and dose regimen and prevalence of resistance;

IV. to report to the Commission on the implementation of this
Recommendation within two years of the adoption of this
Recommendation and subsequently on request by the
Commission with a view to contributing to the follow-up
of this Recommendation at Community level and acting as
appropriate in the context of the programmes of action in
the field of public health,

HEREBY INVITES THE COMMISSION:

to facilitate mutual information, consultation, cooperation,
and action through the procedures and mechanisms avail-
able in the Community Network for the epidemiological
surveillance
diseases
(Decision No 2119/98/EC)
in the field covered by this
Recommendation;

communicable

control of

and

1.

2.

teristics (SPC), which lays the basis for all promotional
activities of an antimicrobial agent, having regard, where
relevant, to the activities of the European Agency for the
Evaluation of Medicinal Products (EMEA);

to propose, where appropriate, common methodology,
case definitions and nature and type of data to be collected
for the surveillance on the susceptibility of pathogens
resistant
these
agents;

to antimicrobial agents and the use of

to develop a strategy for access to surveillance information
and volume of antimicrobial use;

to keep matters covered by this Recommendation under
review, with a view to its revision and updating, and
submit regular reports to the Council on the basis of
Member States' reports accompanied, as appropriate, by
proposals in order to promote the prudent use of antimi-
crobial agents in human medicine;

to strengthen participation of applicant countries within
the framework of the Network on epidemiological surveil-
lance and control of communicable diseases
in the
Community, to ensure that the problems of antimicrobial
resistance are properly taken into account by these States;

to cooperate with the World Health Organisation (WHO)
and other relevant international organisations within the
fields covered by this Recommendation.

3.

4.

5.

6.

7.

Done at Brussels, 15 November 2001.

to establish texts on principles and guidelines of best prac-
tice on the prudent use of antimicrobial agents in human
medicine having regard to national policies and to the
Community requirements for market authorisation and on
the quality and content of the Summary of Product Charac-

For the Council

The President

M. AELVOET