Title: #Proposals for draft #EU #guidelines on the #prudent use of #antimicrobials in #human #medicine.
Subject: Antimicrobial Resistance, ECDC proposals for guidance.
Source: European Centre for Disease Control and Prevention (ECDC), full PDF file: (LINK). Summary.
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Proposals for draft EU guidelines on the prudent use of antimicrobials in human medicine
This report of the European Centre for Disease Prevention and Control (ECDC) was coordinated by Diamantis Plachouras.
Elias Iosifidis, Dominique Monnet, Annalisa Quattrocchi, Klaus Weist, Mike Catchpole.
Agnes Wechsler-Fördös (Rudolfstiftung Hospital); Herman Goossens (University of Antwerp); Vera Vlahović-Palcevski (University of Rijeka); Céline Pulcini (University of Lorraine); Maria Luisa Moro (Regional Health Agency Emilia-Romagna); Uga Dumpis (University of Latvia); Michael Borg (University of Malta); Inge Gyssens, (Radboud University); Annelie Monnier (Radboud University); Milan Čižman (University of Lubljan); Thomas Tängdén (University of Uppsala); Philippa Moore (Public Health England); Cliodna McNulty (Public Health England); Mike Sharland (University of London).
Radu Botgros (European Medicines Agency)
THIS DRAFT TECHNICAL REPORT IS SUBJECT TO A PUBLIC CONSULTATION PROCESS. THE RESULT OF THAT PROCESS MAY LEAD TO CHANGES IN THE FINAL REPORT
Stockholm, July 2016
© European Centre for Disease Prevention and Control, 2016 Reproduction is authorised, provided the source is acknowledged
- The exposure of microorganisms to antimicrobial agents creates the selective pressure that leads to the
- development of resistance. Inappropriate use of antimicrobials accelerates the emergence and dissemination of
- resistance. Combined with the meagre development of novel antimicrobials, the spread of resistance to existing
- ones is leading to loss of effective options for the treatment and prevention of infections, representing a health
- security threat for Europe. Antimicrobials are unique among therapeutic medicines because their use affects not
- only the person receiving the treatment but also the rest of the population, including other patients, through a
- complex effect on microbiota in the human host, other animal hosts and the environment.
- In the context of ongoing work against the rising threats from antimicrobial resistance and given the role of
- antimicrobial misuse and overuse in the emergence and spread of resistance, the European Commission asked
- ECDC to develop draft EU guidelines on the prudent use of antimicrobials in human medicine, including generic
- principles of good practice on the appropriate use of antimicrobial agents in human medical practice in the EU.
- These draft guidelines will be a key contribution to support the European Commission in its aim to produce a
- finalised EU guidelines document.
- An antimicrobial is an agent with activity against microorganisms (viruses, bacteria, fungi or parasites).
- Antimicrobials with activity against bacteria are called antibacterials. The term ‘antibiotic’ is often used to refer to
- Antimicrobial resistance (AMR) is the resistance of a microorganism to an antimicrobial agent that was
- originally effective for treatment of infections caused by this microorganism.
- Antimicrobial therapy can be empiric, when based on a reasonable informed clinical judgement regarding the
- most likely infecting organism or definitive when the identity and antimicrobial susceptibility of the infecting
- organism is known as the result of appropriate diagnostic or reference testing.
- Antimicrobial prophylaxis is the use of antimicrobials for the prevention of infections.
- Prudent or appropriate antimicrobial use aims to benefit the patient while at the same time minimises the
- probability of adverse effects and promotion of the emergence or spread of antimicrobial resistance.
- Antimicrobial stewardship programmes refer to coordinated programmes that implement interventions to
- ensure appropriate antimicrobial prescribing and effective antimicrobial treatment, in order to limit antimicrobial
- resistance and to prevent Clostridium difficile infections.
- Prescribers are all healthcare professionals qualified to prescribe antimicrobials. In addition to physicians and
- dental practitioners, the term may refer to prescribing nurses, pharmacists, clinical microbiologists and midwives,
- depending on local regulations.
- The purpose of this draft technical report is to provide guidance on generic elements of good practice on the
- prudent and appropriate use of antimicrobials in human medical practice. This includes good clinical practice and
- the resources, systems and processes that the various authorities and actors should consider in the development
- and implementation of strategies for EU health systems to support and promote the prudent use of antimicrobials.
- The present report relates to the prudent use of antimicrobials in human medicine, with special focus on
- antibacterials. However, the principles also apply to other classes of antimicrobials.
- The report will not cover specific medical conditions or specific antimicrobials.
Keywords: ECDC; Updates; European Region; Antibiotics; Drugs Resistance.