1.7.2017   

EN

Official Journal of the European Union

C 212/1

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4.1.

4.2.

4.3.

4.4.

4.5.

4.6.

4.7.

4.8.

4.9.

4.10.

4.11.

4.12.

4.13.

4.14.

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Regulation of access and use of antimicrobials.

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Antimicrobial prescribing and stewardship

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Education of health professionals.

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Ensure access to the antimicrobials recommended in clinical guidance, by conducting a review of national market availability, implementing measures to support sustained market availability for both innovative and generic products and tackling shortages. At the same time, limit the use of last-resort antimicrobials to safeguard their effectiveness, by establishing restrictive measures for use.

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Ensure that information on the risks of antimicrobial resistance and inappropriate use of antimicrobials is included in the SmPC and in patient information leaflets.

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Review, or establish if not in place, the legal provisions on availability of antimicrobials over the internet.

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Ensure compliance with the regulations with regards to the dispensing of antimicrobials by pharmacies without prescription.

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Explore per-unit dispensing of antimicrobials taking into consideration all relevant guidelines and regulations.

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Consider the introduction of additional labelling of antimicrobial packages to highlight the risk of increasing antimicrobial resistance through unwarranted use.

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Provide guidelines and tools for the implementation of antimicrobial stewardship programmes covering the community, long-term care facilities and hospitals.

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Ensure an appropriate number of experts in the field of antimicrobial stewardship through education of a sufficient number of specialists in infectious diseases and clinical microbiology and other professionals.

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Monitor and audit the appropriate use of antimicrobials, including the introduction of relevant quantity and quality indicators and systems for monitoring these indicators. Ensure regular feedback of the results to prescribers.

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Ensure the introduction and monitoring of electronic antimicrobial prescribing systems that are preferably able to link clinical indication, microbiological and consumption data.

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Ensure availability of adequate microbiology services and diagnostics, including rapid and point-of-care diagnostic tests.

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Consider and, if appropriate, implement incentive systems for appropriate prescribing.

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Fund, design, implement and assess the outcome of national awareness and educational campaigns on antimicrobial use by targeting health professionals and the general public (including children, teenagers, students, older people and vulnerable groups).

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Promote behavioural interventions to reduce inappropriate antimicrobial prescribing.

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Explore motivational and system change approaches to optimise antimicrobial prescribing.

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Identify best practices on antimicrobial promotional activity in collaboration with the pharmaceutical industry, to ensure it aligns with promoting appropriate antimicrobial prescribing and dispensing.

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Introduce appropriate disposal systems in the community setting, and inform the general public on the correct disposal methods for antimicrobial drugs.

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Ensure availability of national clinical guidance for prophylaxis and management of infections based on national antimicrobial resistance patterns for the community, long-term care facilities, and hospitals.

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Develop clinical pathways and provide decision support tools to encourage appropriate testing and management.

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Ensure that national clinical guidance is reviewed and revised when there is a significant change in antimicrobial resistance, or if there is new evidence on the management of infections, or at regular intervals (e.g. every 2 to 3 years); national clinical guidance should take into consideration the last valid summary of product characteristics of a medicinal product (SmPC).

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Ensure accessibility of the guidelines to all prescribers by ensuring wide distribution, training and promotion.

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Ensure availability of guidelines for therapeutic and prophylactic antimicrobial prescribing for particular categories of clinical setting including dental practice.

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Make sure that the competency of all healthcare professionals is guaranteed by continuous professional development activities on appropriate antimicrobial use.

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Ensure that antimicrobial stewardship is included in all specialty training curricula for clinical specialties.

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Include training on prudent antimicrobial use in medical, nursing, pharmacy, dentistry and midwifery schools. This training should include a strong practical component as part of an inter-professional approach.

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Introduce education on prudent antimicrobial use, antimicrobial resistance, vaccination and hygiene in primary and secondary education.

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Establish and provide the necessary funding and resources for antimicrobial stewardship programmes in each healthcare facility, linked with the infection prevention and control programme and/or the patient safety programme.

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Ensure timely access to clinical microbiology laboratory services and transmission of results.

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Promote the uptake of rapid diagnostic tools.

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Utilise validated rapid and/or point-of-care diagnostics for defined patient groups to complement clinical assessment and optimise antimicrobial treatment when available.

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Ensure information technology support for antimicrobial stewardship activities, including electronic prescription and introduce electronic decision support systems as tools to improve antimicrobial prescribing.

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Contribute to facility-wide, national and regional surveillance systems, studies and prevalence surveys of antimicrobial resistance and antimicrobial consumption, including molecular epidemiological investigations.

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Ensure that antimicrobial stewardship activities are in place, under the coordination and with active involvement of the healthcare professionals in these settings, as dictated by the level of care, identified areas of antimicrobial overuse and misuse, and by national and local provisions.

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Establish a multi-faceted approach including elements such as clinic-based education, patient information leaflets and posters, pharmacist counselling of patients on antimicrobial treatment, prescriber feedback and clinician training in communication skills.

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Ensure sufficient time for consultation to allow for proper assessment and counselling of patients.

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An antimicrobial committee or similar formal organisational structure with senior management support.

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An antimicrobial stewardship team including ideally a clinician with training, expertise and professional involvement in the diagnosis, prevention and treatment of infections (if possible an infectious disease specialist), a hospital pharmacist and a microbiologist (if possible a clinical microbiologist). The composition of the team is dictated by the hospital size and level of care and by national and local provisions.

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Salary support and dedicated time for antimicrobial stewardship activities.

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Guidelines for the diagnosis and management of infections and for perioperative antimicrobial prophylaxis.

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Documentation in the patient records of indication, drug choice, dose, route and duration of treatment.

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A policy for pre-authorisation and or post-prescription review of selected antimicrobial prescriptions.

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Microbiology laboratory services for acute care hospitals should be provided on a 24/7 basis for critical specimens.

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The availability of facility-specific cumulative susceptibility reports for common bacterial pathogens against antibiotics that are recommended in the relevant treatment guidelines.

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An audit of perioperative antimicrobial prophylaxis indication, choice, timing and duration.

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An annual report on antimicrobial stewardship activities which includes an evaluation of effectiveness, reported to the management.

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Monitoring of quality indicators and quantity metrics of antimicrobial use with feedback to prescribers and prescriber actions agreed.

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Ensure that antimicrobial stewardship activities are in place and are given dedicated time and management support, under the coordination and with active involvement of the healthcare professionals in these settings, as dictated by national and local provisions.

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Establish a multi-faceted approach which includes elements such as education of nursing and medical staff, audits of antimicrobial use, feedback to the prescribers, and targeting identified areas of antimicrobial overuse and misuse.

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Ensure that susceptibility testing and reporting are in accordance with treatment guidelines (selective reporting) and European (i.e. EUCAST) and national standards. Ensure timely diagnosis and communication of critical results (e.g. blood cultures).

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Provide facility-specific cumulative susceptibility reports for common bacterial pathogens against antibiotics that are recommended in the guidelines.

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Be available to clinicians for counselling on diagnostics of infectious diseases, including correct sampling and interpretation of test results, difficult-to-treat pathogens and complicated infections.

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As full members of the antimicrobial stewardship team, take on responsibilities that include coordination, planning, post-prescription review and feedback.

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Be available for consultation on diagnostic evaluation and treatment of infectious diseases including difficult-to-treat pathogens and complicated infections, as well as appropriate antimicrobial use.

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As full members of the antimicrobial stewardship team, take on responsibilities that include coordination, planning, post-prescription review and feedback.

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Ensure that they are familiar with the relevant guidelines, the last valid SmPC and prescribing advice before prescribing an antimicrobial.

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Keep themselves up to date regarding antimicrobial prescribing; this can be achieved by attending training courses, being aware of guidelines, and following guidelines.

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Seek and take advice from specialists regarding antimicrobial prescribing.

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Make a diagnosis during an in-person patient consultation before prescribing antibiotics, except in exceptional circumstances.

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Ensure that appropriate microbiological samples are taken before starting antimicrobial treatment.

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Avoid antibacterial treatment when there is only evidence of viral infection or of a self-limiting bacterial infection.

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Avoid treatment for colonisation without evidence of infection after relevant clinical examination and diagnostic testing unless there is a clear indication in the guidelines.

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Use antimicrobial prophylaxis only when indicated in relevant guidelines.

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Avoid antimicrobial combinations unless there is a clear indication outlined in the guidelines

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If antimicrobial treatment is not considered necessary, give the patient advice about the expected natural history of the illness, the limited or absent benefit of antimicrobial treatment, and the potential unwanted side effects of antimicrobials such as diarrhoea and rash, recommendations for symptom management, as well as advice about actions in case of worsening clinical condition (safety netting).

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Select an antimicrobial in accordance with relevant guidelines, at an appropriate dose, for the shortest effective duration and with appropriate route of administration (preferably oral if possible).

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Consider relevant host factors: age, comorbidities (e.g. immunodeficiency), renal and hepatic function, pregnancy, breastfeeding, allergies, presence of prosthetic material, potential drug interactions, body mass index and risk factors for antimicrobial resistance (e.g. history of recent antimicrobial use, history of recent travel).

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Promote allergy testing for patients with a history of allergic reaction to beta-lactams, as a measure to promote use of first-line antimicrobials in non-allergic patients.

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Select an antimicrobial with a spectrum of activity as narrow as possible. Ensure timely administration of antimicrobial treatment for patients with severe infections. Examples: sepsis, severe community-acquired pneumonia.

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If possible, inform the patient and/or responsible caregiver about the reason for antimicrobial treatment and potential side effects and ensure that the patient understands the dosage and duration of treatment; this improves adherence and increases treatment success.

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Address the patient’s expectations, questions and preferences as an essential component of patient-centred care and an effective intervention to promote the prudent use of antimicrobials.

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Reassess antimicrobial treatment and consider modification (e.g. de-escalation, discontinuation or switch to oral treatment) after 48–72 hours in hospitals and, in specific circumstances, in other settings in accordance with guidelines.

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Refrain from prescribing antibacterials for viral or self-limiting bacterial infections.

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Consider delayed antimicrobial prescribing with appropriate safety netting for adults or children in specific circumstances and in accordance with guidelines. Example: delayed antimicrobial prescribing for acute otitis media or acute rhinosinusitis.

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Evaluate symptoms and use scoring systems or symptom checking lists to guide the need for diagnostic testing, antimicrobial treatment and urgent referral.

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Document in the patient chart: indication, drug choice, dose, route and duration of treatment. Follow guidance for perioperative antimicrobial prophylaxis. Enhance timely and adequate source control for surgical infections and discourage using only antimicrobials instead of surgical treatment when there is a clear indication for surgical treatment.

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Evaluate the need for parenteral antimicrobials and switch to oral antimicrobials when possible, all in accordance with available clinical criteria.

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Therapeutic drug monitoring is recommended for adjustment of the dosing regimen in accordance with guidelines and in specific circumstances.

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Only dispense antimicrobials with prescription, unless specific provisions allow for regulated dispensation in specific circumstances.

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Ensure that the patient and/or the carer understands the dosage and duration of treatment as this can improve adherence and increase treatment success.

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Promote appropriate disposal of leftover antimicrobials.

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Notify adverse events related to antimicrobials in accordance with regulations.

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Participate in local, regional or national public health campaigns promoting the prudent use of antimicrobials.

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Provide advice to patients and health professionals with regard to contraindications, drug interactions and food–drug interactions.

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Be actively involved in antimicrobial management as part of the multidisciplinary care team.

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Ensure timely administration of antimicrobials according to prescription.

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Provide advice and educate the patient on the proper use of antimicrobials.

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Utilise protocols and tools that enable you to independently detect patients with severe infections and then trigger diagnostic and treatment algorithms.

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Remind the clinician to reassess the antimicrobial treatment after 48 to 72 hours.

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Ensure coordination and collaboration between antimicrobial stewardship programmes and infection prevention and control programmes by highlighting the essential aspects of appropriate antimicrobial use in the prevention and control of healthcare-associated infections.

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Inform themselves and, where needed, seek information from healthcare providers about appropriate antimicrobial use, antimicrobial resistance and adverse reactions to antimicrobials.

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Use antimicrobials only when prescribed.

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Refrain from using antimicrobials which have not been prescribed such as leftover antimicrobials, antimicrobials prescribed for another person, or antimicrobials obtained without a prescription.

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Return leftover antimicrobials to pharmacies and local collection, in accordance with local disposal regulations.

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Cooperate closely with the regulatory authorities in all relevant domains to ensure that the proposed measures to promote the prudent use of antimicrobials are evidence-based and feasible.

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Promote prudent use of antimicrobials among their members through activities that include guideline development and training.

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Supporting information and awareness raising activities to promote prudent use of antimicrobials

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Avoid conflicts of interest and commercial consideration.

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Promote and conduct relevant research.

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Promote research that assesses and compares behavioural change interventions for antimicrobial prescribing, taking into account cultural differences, in order to improve our understanding how rational antimicrobial prescribing practices can be achieved.

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Promote research on interventional studies for antimicrobial prescribing.

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Promote research on the potential of specific antimicrobials and antimicrobial classes to create a selective pressure toward antimicrobial resistance in microbiota.

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Promote clinical research studies on existing antimicrobials, including pharmacokinetic/pharmacodynamics studies, ensuring that studies sufficiently consider sex/gender and age factors across the lifespan.

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Promote research on diagnostic tools, including rapid and point-of-care diagnostics to support evidence-based guidelines for the role of diagnostics in appropriate antimicrobial prescribing.

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Promote research studies in antimicrobial therapeutic drug monitoring in special populations (e.g. critically ill patients, burned patients, paediatric patients, patients receiving continuous renal replacement therapy).

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Promote research on educational and awareness interventions which target the public and patients.

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Support activities to enable research to be translated into practice, systematic reviews and meta-analyses, and the use of research results to inform clinical guideline development and decision-making.

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Ensure that marketing and promotional activities to healthcare professionals are in accordance with the EU legislation e.g. the advertising of a medicinal product to healthcare professionals must comply with the particulars listed in the summary of product characteristics and should encourage the rational use of the medicinal product.

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Ensure that financial incentives within companies are aligned with the stewardship principles laid out above.

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Ensure the monitoring of resistance and off-label use after launching new compounds in accordance with post-marketing obligations.

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Engage with national and international policymakers and regulators to support the development of policies that promote appropriate antimicrobial prescribing, including the design of novel reimbursement systems, adaptation of pack size and other processes that contribute to the goals of access and conservation.

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Address the different needs for diagnostics including point-of-care testing and surveillance.

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Collaborate with scientific societies and public health in the development of evidence-based guidelines on the use of tests for the diagnosis of infection, including novel diagnostics and point-of-care tests.

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Support studies on the effect of novel diagnostics on the prudent use of antimicrobials, and on the cost-effectiveness of diagnostics.

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Facilitate the coordination of response to cross-border threats relating to antimicrobial-resistant organisms.

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Design, implement and monitor antimicrobial stewardship interventions and campaigns to support appropriate antimicrobial use and reduce inappropriate antimicrobial use.

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Establish mechanisms for sharing best practice interventions on appropriate antimicrobial use and their impact on relevant qualitative and quantitative outcomes.

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Enable cooperation on the surveillance of antimicrobial consumption and antimicrobial resistance using a harmonised methodology with the aim of providing timely information regarding cross-border threats from resistant organisms, as well as providing valid and internationally comparable information on resistance and consumption.

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Harmonisation of clinical breakpoints and methods for antimicrobial susceptibility testing.

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Support the development of good evidence-based clinical practice guidelines that address the most common infections and are adaptable to local resistance patterns and available licensed antibacterials.

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Facilitate access to essential antimicrobials and diagnostic tests by supporting market availability and tackling shortages.

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Encourage, at the national level, the development of standards and adoption of selective reporting of microbiology results to optimise antimicrobial prescribing.

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Support the development of evidence-based guidelines on the use of rapid and point-of-care diagnostics.

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Promote and financial support of research and development of new antimicrobials and new point-of-care tests.

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Facilitate cross-sectoral collaboration in the animal health, food production and healthcare sectors regarding the surveillance of, and policies for, antimicrobial use.