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Prudent use of antimicrobial agents in human medicine
This Recommendation calls on Member States to implement specific strategies for the prudent use of antimicrobial agents in human medicine. The objective is to contain the spread of antimicrobial resistance and thus preserve the effectiveness of these agents.
Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine [COM(2001) 333 final Volume II - Not published in the Official Journal].
The proposal follows on from the Commission Communication setting out a strategy to address the disturbing problem of resistance to antimicrobial agents.
The Recommendation will be implemented in close cooperation with the network on epidemiological surveillance and control of communicable diseases established in 1999. The network supplies important information on the spread of communicable diseases for which antimicrobial agents constitute the main method of treatment.
Main areas of action
There are six main strands to the Recommendation:
The measures are, in the main, to be implemented by a national organisation in each Member State, which is responsible for drawing up a general strategy for this purpose. The Commission is to be provided with a strategy plan within one year of adoption of the Recommendation, and this plan must be put in place progressively over a period not exceeding four years. The Member States must submit a report on implementation of the measures within one year and subsequently on an annual basis.
This entails establishing or improving surveillance systems for antimicrobial resistance and the consumption of antimicrobial agents in order to gather reliable and comparable data on the susceptibility of pathogens to antimicrobial agents and on the prescription and consumption of these agents. The information is intended to allow analysis of the development of the problem and to potentially link prescription and consumption of antimicrobial agents to the development of pathogens resistant to those agents.
Prevention and control
Principles and guidelines are to be developed on good practice in disease management. Important elements are disease prevention and the control of agents.
It is essential to enforce control measures on the prudent use of antimicrobial agents. The main objective is to ensure that antibacterial agents are only available on prescription. Initially, for agents not subject to the prescription-only requirement, this means setting rules for their use. Whether it is necessary to apply this rule to all antimicrobial agents as a precautionary measure should also be examined. The Commission and the Member States will work together on establishing the monitoring indicators for prescription practices.
Disease prevention and restricting the use of antimicrobial agents are two important aspects in combating microbial resistance. This means optimising the choice of medicament, dose and duration of the treatment. Where the prevention of communicable diseases is concerned, it is a question in particular of promoting and reinforcing immunisation programmes and hygiene and infection control measures in institutions (hospitals, childcare facilities, nursing homes, etc.).
Education and information
Education of health professionals is essential for the implementation of measures to tackle this problem. This includes teaching principles and guidelines on the appropriate use of antimicrobial agents and focussing on training on hygiene and infection control standards and on immunisation programmes.
Information campaigns to increase awareness among the general public as consumers of antimicrobial agents can also play an important role.
The Member States are under an obligation to inform the Commission and the other Member States of national research initiatives in this field.
It is important to focus on research on:
- the mechanisms of emergence and spread of antimicrobial resistance;
- developing new means of preventing and treating infections;
- developing alternatives to antimicrobial agents.
Provisions concerning products
The Recommendation contains provisions in respect of the products themselves. Control systems for the marketing of antimicrobial agents are to be put in place within two years to ensure that it complies with the principles of good management of communicable diseases.
The Commission and the Member States will also initiate activities to harmonise and update product information.
Role of the Commission
The Commission will have a coordinating role, facilitating information, consultation and cooperation. It will also be responsible for establishing texts on principles and guidelines for best practice on the prudent use of antimicrobial agents. The Commission is to set up a Community information system linking prescribers, pharmacists, etc. and the general public. It is also necessary to step up the participation of the applicant countries within the framework of the Network on epidemiological surveillance and control of communicable diseases in the Community.